[Title 9 CFR ]
[Code of Federal Regulations (annual edition) - January 1, 2006 Edition]
[From the U.S. Government Printing Office]



[[Page i]]



          9


          Part 200 to End

                         Revised as of January 1, 2006


          Animals and Animal Products
          
          


________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of January 1, 2006
          With Ancillaries
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration
                    A Special Edition of the Federal Register

[[Page ii]]

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 9:
          Chapter II--Grain Inspection, Packers and Stockyards 
          Administration (Packers and Stockyards Programs), 
          Department of Agriculture                                  3
          Chapter III--Food Safety and Inspection Service, 
          Department of Agriculture                                 79
  Finding Aids:
      Material Approved for Incorporation by Reference........     731
      Table of CFR Titles and Chapters........................     733
      Alphabetical List of Agencies Appearing in the CFR......     751
      List of CFR Sections Affected...........................     761

[[Page iv]]





                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 9 CFR 201.1 refers 
                       to title 9, part 201, 
                       section 1.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

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noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
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HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
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    To determine whether a Code volume has been amended since its 
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EFFECTIVE AND EXPIRATION DATES

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OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
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OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
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INCORPORATION BY REFERENCE

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This material, like any other properly issued regulation, has the force 
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    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
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the revision dates of the 50 CFR titles.

[[Page vii]]


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                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

January 1, 2006.

[[Page ix]]



                               THIS TITLE

    Title 9--Animals and Animal Products is composed of two volumes. The 
first volume contains chapter I--Animal and Plant Health Inspection 
Service, Department of Agriculture (parts 1-199). The second volume 
contains chapter II--Grain Inspection, Packers and Stockyards 
Administration (Packers and Stockyards Programs), Department of 
Agriculture and chapter III--Food Safety and Inspection Service, 
Department of Agriculture (part 200-end). The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of January 1, 2006.

    For this volume, Carol A. Conroy was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Frances D. McDonald, assisted by Alomha S. Morris.

[[Page 1]]



                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS




                  (This book contains part 200 to end)

  --------------------------------------------------------------------

  Editorial Note: Other regulations issued by the Department of 
Agriculture appear in title 7, title 36, chapter II, and title 41, 
chapter 4.
                                                                    Part

chapter ii--Grain Inspection, Packers and Stockyards 
  Administration (Packers and Stockyards Programs), 
  Department of Agriculture.................................         201

chapter iii--Food Safety and Inspection Service, Department 
  of Agriculture............................................         301

[[Page 3]]



  CHAPTER II--GRAIN INSPECTION, PACKERS AND STOCKYARDS ADMINISTRATION 
       (PACKERS AND STOCKYARDS PROGRAMS),DEPARTMENT OF AGRICULTURE




  --------------------------------------------------------------------
Part                                                                Page
200             [Reserved]
201             Regulations under the Packers and Stockyards 
                    Act.....................................           5
202             Rules of practice governing proceedings 
                    under the Packers and Stockyards Act....          30
203             Statements of general policy under the 
                    Packers and Stockyards Act..............          48
204             Organization and functions..................          59
205             Clear title--protection for purchasers of 
                    farm products...........................          64
206             Swine contract library......................          72

[[Page 5]]

                           PART 200 [RESERVED]



PART 201_REGULATIONS UNDER THE PACKERS AND STOCKYARDS ACT--Table of 
Contents




                               Definitions

Sec.
201.1 Meaning of words.
201.2 Terms defined.

                             Administration

201.3 Authority.

                     Applicability of Industry Rules

201.4 Bylaws, rules and regulations, and requirements of exchanges, 
          associations, or other organizations; applicability, 
          establishment.

                              Registration

201.10 Requirements and procedures.
201.11 Suspended registrants; officers, agents, and employees.

                     Schedules of Rates and Charges

201.17 Requirements for filing tariffs.

                       General Bonding Provisions

201.27 Underwriter; equivalent in lieu of bonds; standard forms.
201.28 Duplicates of bonds or equivalents to be filed with Regional 
          Supervisors.

                 Market Agency, Dealer and Packer Bonds

201.29 Market agencies, packers and dealers required to file and 
          maintain bonds.
201.30 Amount of market agency, dealer and packer bonds.
201.31 Conditions in market agency, dealer and packer bonds.
201.32 Trustee in market agency, dealer and packer bonds.
201.33 Persons damaged may maintain suit; filing and notification of 
          claims; time limitations; legal expenses.
201.34 Termination of market agency, dealer and packer bonds.

                            Proceeds of Sale

201.39 Payment to be made to consignor or shipper by market agencies; 
          exceptions.
201.42 Custodial accounts for trust funds.

                          Accounts and Records

201.43 Payment and accounting for livestock and live poultry.
201.44 Market agencies to render prompt accounting for purchases on 
          order.
201.45 Market agencies to make records available for inspection by 
          owners, consignors, and purchasers.
201.49 Requirements regarding scale tickets evidencing weighing of 
          livestock, live poultry, and feed.

                             Trade Practices

201.53 Persons subject to the Act not to circulate misleading reports 
          about market conditions or prices.
201.55 Purchases, sales, acquisitions, payments and settlements to be 
          made on actual weights.
201.56 Market agencies selling on commission; purchases from 
          consignment.
201.61 Market agencies selling or purchasing livestock on commission; 
          relationships with dealers.
201.67 Packers not to own or finance selling agencies.
201.69 Furnishing information to competitor buyers.
201.70 Restriction or limitation of competition between packers and 
          dealers prohibited.

                                Services

201.71 Scales; accurate weights, repairs, adjustments or replacements 
          after inspection.
201.72 Scales; testing of.
201.73 Scale operators to be qualified.
201.73-1 Instructions for weighing livestock.
201.76 Reweighing.
201.81 Suspended registrants.
201.82 Care and promptness in weighing and handling livestock and live 
          poultry.

                          Inspection of Brands

201.86 Brand inspection: Application for authorization, registration and 
          filing of schedules, reciprocal arrangements, and maintenance 
          of identity of consignments.

                                 General

201.94 Information as to business; furnishing of by packers, live 
          poultry dealers, stockyard owners, market agencies, and 
          dealers.
201.95 Inspection of business records and facilities.
201.96 Unauthorized disclosure of business information prohibited.
201.97 Annual reports.
201.98 Packers and dealers not to charge, demand, or collect commission, 
          yardage, or other service charges.
201.99 Purchase of livestock by packers on a carcass grade, carcass 
          weight, or carcass grade and weight basis.

                Poultry--Packers and Live Poultry Dealers

201.100 Records to be furnished poultry growers and sellers.
201.108-1 Instructions for weighing live poultry.

[[Page 6]]

201.200 Sale of livestock to a packer on credit.

    Authority: 7 U.S.C. 222 and 228; 7 CFR 2.22 and 2.81.

                               Definitions



Sec. 201.1  Meaning of words.

    Words used in this part in the singular form shall be deemed to 
import the plural, and vice versa, as the case may demand.

[19 FR 4524, July 22, 1954]



Sec. 201.2  Terms defined.

    The definitions of terms contained in the Act shall apply to such 
terms when used in the Regulations under the Packers and Stockyards Act, 
9 CFR part 201; Rules of Practice Governing Proceedings under the 
Packers and Stockyards Act, 9 CFR part 202; Statements of General Policy 
under the Packers and Stockyards Act, 9 CFR part 203; and Organization 
and Functions, 9 CFR part 204. In addition the following terms used in 
these parts shall be construed to mean:
    (a) Act means the Packers and Stockyards Act, 1921, as amended and 
supplemented (7 U.S.C. 181 et seq.).
    (b) Department means the United States Department of Agriculture.
    (c) Secretary means the Secretary of Agriculture of the United 
States, or any officer or employee of the Department authorized to act 
for the Secretary.
    (d) Administration or agency means the Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards Programs).
    (e) Administrator or agency head means the Administrator of the 
Administration or any person authorized to act for the Administrator.
    (f) Regional Supervisor means the regional supervisor of the Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) for a given area or any person authorized to act 
for the regional supervisor.
    (g) Person means individuals, partnerships, corporations, and 
associations.
    (h) Registrant means any person registered pursuant to the 
provisions of the Act and the regulations in this part.
    (i) Stockyard means a livestock market which has received notice 
under section 302(b) of the Act that it has been determined by the 
Secretary to come within the definition of ``stockyard'' under section 
302(a) of the Act.
    (j) Schedule means a tariff of rates and charges filed by stockyard 
owners and market agencies.
    (k) Custom Feedlot means any facility which is used in its entirety 
or in part for the purpose of feeding livestock for the accounts of 
others, but does not include feeding incidental to the sale or 
transportation of livestock.

[46 FR 50510, Oct. 14, 1981]

                             Administration



Sec. 201.3  Authority.

    The Administrator shall perform such duties as the Secretary may 
require in enforcing the provisions of the act and the regulations in 
this part.

[19 FR 4524, July 22, 1954]

                     Applicability of Industry Rules



Sec. 201.4  Bylaws, rules and regulations, and requirements of 
exchanges, associations, or other organizations; applicability, establishment.

    (a) The regulations in this part shall not prevent the legitimate 
application or enforcement of any valid bylaw, rule or regulation, or 
requirement of any exchange, association, or other organization, or any 
other valid law, rule or regulation, or requirement to which any packer, 
stockyard owner, market agency, or dealer shall be subject which is not 
inconsistent or in conflict with the act and the regulations in this 
part.
    (b) Market agencies selling livestock on commission shall not, in 
carrying out the statutory duty imposed upon them by section 307 of 
title III of the act, permit dealers, packers, or others representing 
interests which conflict with those of consignors, to participate, 
directly or indirectly, in determination of the need for, or in the 
establishment of, regulations governing,

[[Page 7]]

or practices relating to, the responsibilities, duties, or obligations 
of such market agencies to their consignors.

(7 U.S.C. 181 et seq.)

[19 FR 4524, July 22, 1954, as amended at 44 FR 45361, Aug. 2, 1979]

                              Registration



Sec. 201.10  Requirements and procedures.

    (a) Every person operating or desiring to operate as a market agency 
or dealer as defined in section 301 of the Act shall apply for 
registration under the Act. To apply for registration, such persons 
shall file a properly executed application for registration, on forms 
furnished by the Agency, and the bond as required in Sec. Sec. 201.27 
through 201.34.
    (b) Each application for registration shall be filed with the 
regional supervisor for the region in which the applicant proposes to 
operate. If the Administrator has reason to believe that the applicant 
is unfit to engage in the activity for which application has been made, 
a proceeding shall be promptly instituted in which the applicant will be 
afforded opportunity for full hearing in accordance with the rules of 
practice governing such proceedings, for the purpose of showing cause 
why the application for registration should not be denied. In the event 
it is determined that the application should be denied, the applicant 
shall not be precluded, as soon as conditions warrant, from again 
applying for registration.
    (c) Any person regularly employed on salary, or other comparable 
method of compensation, by a packer to buy livestock for such packer 
shall be subject to the registration requirements of the Act and the 
regulations. Such person shall be registered as a dealer to purchase 
livestock for slaughter.
    (d) Every person clearing or desiring to clear the buying operations 
of other registrants shall apply for registration as a market agency 
providing clearing services by filing a properly executed application, 
on forms furnished by the Agency, and the bond as required in Sec. Sec. 
201.27 through 201.34.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 203, 204, 207, 217a, 222 and 228)

[49 FR 33003, Aug. 20, 1984, as amended at 54 FR 37094, Sept. 7, 1989; 
56 FR 2127, Jan. 22, 1991; 68 FR 75388, Dec. 31, 2003]



Sec. 201.11  Suspended registrants; officers, agents, and employees.

    Any person whose registration has been suspended, or any person who 
was responsible for or participated in the violation on which the order 
of suspension was based, may not register in his own name or in any 
other manner within the period during which the order of suspension is 
in effect, and no partnership or corporation in which any such person 
has a substantial financial interest or exercises management 
responsibility or control may be registered during such period.

(7 U.S.C. 203, 204, 207, 217a and 228)

[49 FR 33003, Aug. 20, 1984]

                     Schedules of Rates and Charges



Sec. 201.17  Requirements for filing tariffs.

    (a) Schedules of rate changes for stockyard services. Each stockyard 
owner and market agency operating at a posted stockyard shall file with 
the regional supervisor for the region in which they operate a signed 
copy of all schedules of rates and charges, supplements and amendments 
thereto. The schedules, supplements and amendments must be conspicuously 
posted for public inspection at the stockyard, and filed with the 
regional supervisor, at least 10 days before their effective dates, 
except as provided in paragraphs (b) and (c) of this section. Each 
schedule, supplement and amendment shall set forth its effective date, a 
description of the stockyard services rendered, the stockyard at which 
it applies, the name and address of the stockyard owner or market 
agency, the kind of livestock covered by it, and any rules or 
regulations which affect any rate or charge contained therein. Each 
schedule of rates and charges filed shall be designated by successive 
numbers. Each supplement and amendment to such schedule shall be 
numbered and

[[Page 8]]

shall designate the number of the schedule which it supplements or 
amends.
    (b) Feed charges. When the schedule in effect provides for feed 
charges to be based on an average cost plus a specified margin, the 10-
day filing and notice provision contained in section 306(c) of the Act 
is waived. A schedule of the current feed charges based on average feed 
cost and showing the effective date shall be conspicuously posted at the 
stockyard at all times. Changes in feed charges may become effective 2 
days after the change is posted at the stockyard.
    (c) Professional veterinary services. The 10-day filing and notice 
provision contained in section 306(a) of the Act is waived for a 
schedule of charges for professional veterinary services. A schedule of 
charges for professional veterinary services rendered by a veterinarian 
at a posted stockyard shall be conspicuously posted at the stockyard at 
all times. The schedule of charges and any supplement or amendment 
thereto may become effective 2 days after the schedule, supplement, or 
amendment is posted at the stockyard.
    (d) Joint schedules. If the same schedule is to be observed by more 
than one market agency operating at any one stockyard, one schedule will 
suffice for such market agencies. The names and business addresses of 
those market agencies adhering to such schedule must appear on the 
schedule.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 203, 204, 207, 217a, 222 and 228)

[49 FR 33003, Aug. 20, 1984, as amended at 68 FR 75388, Dec. 31, 2003]

                       General Bonding Provisions



Sec. 201.27  Underwriter; equivalent in lieu of bonds; standard forms.

    (a) The surety on bonds maintained under the regulations in this 
part shall be a surety company which is currently approved by the United 
States Treasury Department for bonds executed to the United States; and 
which has not failed or refused to satisfy its legal obligations under 
bonds issued under said regulations.
    (b) Any packer, market agency, or dealer required to maintain a 
surety bond under these regulations may elect to maintain, in whole or 
partial substitution for such surety bond, a bond equivalent as provided 
below. The total amount of any such surety bond, equivalent, or 
combination thereof, must be the total amount of the surety bond 
otherwise required under these regulations. Any such bond equivalent 
must be in the form of:
    (1) A trust fund agreement governing funds actually deposited or 
invested in fully negotiable obligations of the United States or 
Federally-insured deposits or accounts in the name of and readily 
convertible to currency by a trustee as provided in Sec. 201.32, or
    (2) A trust agreement governing funds which may be drawn by a 
trustee as provided in Sec. 201.32, under one or more irrevocable, 
transferrable, standby letters of credit, issued by a Federally-insured 
bank or institution and physically received and retained by such 
trustee.
    (c) The provisions of Sec. Sec. 201.27 through 201.34 shall be 
applicable to the trust fund agreements, trust agreements and letters of 
credit authorized in paragraph (b) of this section.
    (d) Bonds, trust fund agreements, letters of credit and trust 
agreements shall be filed on forms approved by the Administrator.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[56 FR 2128, Jan. 22, 1991, as amended at 61 FR 36279, July 10, 1996; 62 
FR 11759, Mar. 13, 1997; 68 FR 75388, Dec. 31, 2003]



Sec. 201.28  Duplicates of bonds or equivalents to be filed with Regional 
Supervisors.

    Fully executed duplicates of bonds, trust fund agreements, and trust 
agreements maintained under the regulations in this part, and fully 
executed duplicates of all endorsements, amendments, riders, indemnity 
agreements, and other attachments thereto, and photographically 
reproduced copies of any letter of credit or amendment thereto, shall be 
filed with the Regional Supervisor for the region in which the 
registrant, packer, or person applying for registration resides, or in 
the case of a corporation, where the corporation has its home office: 
Provided, that if such registrant, packer,

[[Page 9]]

or person does not engage in business in such area, the foregoing 
documents shall be filed with the Regional Supervisor for the region in 
which the place of business of the registrant or packer or person is 
located.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[56 FR 2128, Jan. 22, 1991, as amended at 68 FR 75388, Dec. 31, 2003]

                 Market Agency, Dealer and Packer Bonds



Sec. 201.29  Market agencies, packers and dealers required to file and 
maintain bonds.

    (a) Every market agency, packer, and dealer, except as provided in 
paragraph (d) of this section, and except packer buyers registered as 
dealers to purchase livestock for slaughter only, shall execute and 
maintain a reasonable bond on forms approved by the Administrator 
containing the appropriate condition clauses, as set forth in Sec. 
201.31 of the regulations, applicable to the activity or activities in 
which the person or persons propose to engage, to secure the performance 
of obligations incurred by such market agency, packer, or dealer. No 
market agency, packer, or dealer required to maintain a bond shall 
conduct his operations unless there is on file and in effect a bond 
complying with the regulations in this part.
    (b) Every market agency buying on a commission basis and every 
dealer buying for his own account or for the accounts of others shall 
file and maintain a bond. If a registrant operates as both a market 
agency buying on a commission basis and as a dealer, only one bond to 
cover both buying operations need be filed. Any person operating as a 
market agency selling on a commission basis and as a market agency 
buying on a commission basis or as a dealer shall file and maintain 
separate bonds to cover his selling and buying operations.
    (c) Each market agency and dealer whose buying operations are 
cleared by another market agency shall be named as clearee in the bond 
filed and maintained by the market agency registered to provide clearing 
services. Each market agency selling livestock on a commission basis 
shall file and maintain its own bond.
    (d) Every packer purchasing livestock, directly or through an 
affiliate or employee or a wholly-owned subsidiary, except those packers 
whose annual purchases do not exceed $500,000, shall file and maintain a 
reasonable bond. In the event a packer maintains a wholly-owned 
subsidiary or affiliate to conduct its livestock buying, the wholly-
owned subsidiary or affiliate shall be registered as a packer buyer for 
its parent packer firm, and the required bond shall be maintained by the 
parent packer firm.

(7 U.S.C. 204, 228(a))

[48 FR 8806, Mar. 2, 1983]



Sec. 201.30  Amount of market agency, dealer and packer bonds.

    (a) Market agency selling livestock on commission. To compute the 
required amount of bond coverage, divide the dollar value of livestock 
sold during the preceding business year, or the substantial part of that 
business year, in which the market agency did business, by the actual 
number of days on which livestock was sold. The divisor (the number of 
days on which livestock was sold) shall not exceed 130. The amount of 
bond coverage must be the next multiple of $5,000 above the amount so 
determined. When the computation exceeds $50,000, the amount of bond 
coverage need not exceed $50,000 plus 10 percent of the excess over 
$50,000, raised to the next $5,000 multiple. In no case shall the amount 
of bond coverage for a market agency selling on commission be less than 
$10,000 or such higher amount as required to comply with any State law.
    (b) Market agency buying on commission or dealer. The amount of bond 
coverage must be based on the average amount of livestock purchased by 
the dealer or market agency during a period equivalent to 2 business 
days. To compute the required amount of bond coverage, divide the total 
dollar value of livestock purchased during the preceding business year, 
or substantial part of that business year, in which the dealer or market 
agency or both did business, by one-half the number of days on which 
business was conducted.

[[Page 10]]

The number of days in any business year, for purposes of this 
regulation, shall not exceed 260. Therefore, the divisor (one-half the 
number of days on which business was conducted) shall not exceed 130. 
The amount of the bond coverage must be the next multiple of $5,000 
above the amount so determined. When the computation exceeds $75,000, 
the amount of bond coverage need not exceed $75,000 plus 10 percent of 
the excess over $75,000, raised to the next $5,000 multiple. In no case 
shall the amount of bond coverage be less than $10,000 or such higher 
amount as required to comply with any State law.
    (c) Market agency acting as clearing agency. The amount of bond 
coverage must be based on the average amount of livestock purchased by 
all persons for whom the market agency served as a clearor during a 
period equivalent to 2 business days. To compute the required amount of 
bond coverage, divide the total dollar value of livestock purchased by 
all persons for whom the market agency served as a clearor during the 
preceding business year, or substantial part of that business year, in 
which the market agency acting as clearing agency did business, by one-
half the number of days on which business was conducted. The number of 
days in any business year, for purposes of this regulation, shall not 
exceed 260. Therefore, the divisor (one-half the number of days on which 
business was conducted) shall not exceed 130. The amount of bond 
coverage must be the next multiple of $5,000 above the amount so 
determined. When the computation exceeds $75,000, the amount of bond 
coverage need not exceed $75,000 plus 10 percent of the excess over 
$75,000, raised to the next $5,000 multiple. In no case shall the amount 
of bond coverage be less than $10,000 or such higher amount as required 
to comply with any State law.
    (d) Packer. The amount of bond coverage must be based on the average 
amount of livestock purchased by the packer during a period equivalent 
to 2 business days. To compute the required amount of bond coverage, 
divide the total dollar value of livestock purchased during the 
preceding business year, or substantial part of that business year, in 
which the packer did business, by one-half the number of days on which 
business was conducted. The number of days in any business year, for 
purposes of this regulation, shall not exceed 260. Therefore, the 
divisor (one-half the number of days on which business was conducted) 
shall not exceed 130. The amount of the bond coverage must be the next 
multiple of $5,000 above the amount so determined. In no case shall the 
amount of bond coverage for a packer be less than $10,000.
    (e) If a person applying for registration as a market agency or 
dealer has been engaged in the business of handling livestock before the 
date of the application, the value of the livestock handled, if 
representative of future operations, must be used in computing the 
required amount of bond coverage. If the applicant for registration is a 
successor in business to a registrant formerly subject to these 
regulations, the amount of bond coverage of the applicant must be at 
least that amount required of the prior registrant, unless otherwise 
determined by the Administrator. If a packer becomes subject to these 
regulations, the value of livestock purchased, if representative of 
future operations, must be used in computing the required amount of bond 
coverage. If a packer is a successor in business to a packer formerly 
subject to these regulations, the amount of bond coverage of the 
successor must be at least that amount required of the prior packer, 
unless otherwise determined by the Administrator.
    (f) Whenever the Administrator has reason to believe that a bond is 
inadequate to secure the performance of the obligations of the market 
agency, dealer or packer covered thereby, the Administrator shall notify 
such person to adjust the bond to meet the requirements the 
Administrator determines to be reasonable.

(7 U.S.C. 204, 228(a))

[48 FR 8806, Mar. 2, 1983]



Sec. 201.31  Conditions in market agency, dealer and packer bonds.

    Each market agency, dealer and packer bond shall contain conditions 
applicable to the activity or activities

[[Page 11]]

in which the person or persons named as principal or clearees in the 
bond propose to engage, which conditions shall be as follows or in terms 
to provide equivalent protection:
    (a) Condition Clause No. 1: When the principal sells livestock for 
the accounts of others. If the said principal shall pay when due to the 
person or persons entitled thereto the gross amount, less lawful 
charges, for which all livestock is sold for the accounts of others by 
said principal.
    (b) Condition Clause No. 2: When the principal buys livestock for 
his own account or for the accounts of others. If the said principal 
shall pay when due to the person or persons entitled thereto the 
purchase price of all livestock purchased by said principal for his own 
account or for the accounts of others, and if the said principal shall 
safely keep and properly disburse all funds, if any, which come into his 
hands for the purpose of paying for livestock purchased for the accounts 
of others.
    (c) Condition Clause No. 3: When the principal clears other 
registrants buying livestock and thus is responsible for the obligations 
of such other registrants. If the said principal, acting as a clearing 
agency responsible for the financial obligations of other registrants 
engaged in buying livestock, viz: (Insert here the names of such other 
registrants as they appear in the application for registration), or if 
such other registrants, shall (1) pay when due to the person or persons 
entitled thereto the purchase price of all livestock purchased by such 
other registrants for their own account or for the accounts of others; 
and (2) safely keep and properly disburse all funds coming into the 
hands of such principal or such other registrants for the purpose of 
paying for livestock purchased for the accounts of others.
    (d) Condition Clause No. 4: When the principal buys livestock for 
his own account as a packer. If the said principal shall pay when due to 
the person or persons entitled thereto the purchase price of all 
livestock purchased by said principal for his own account.

[47 FR 32695, July 29, 1982]



Sec. 201.32  Trustee in market agency, dealer and packer bonds.

    Bonds may be in favor of a trustee who shall be a financially 
responsible, disinterested person satisfactory to the Administrator. 
State officials, secretaries or other officers of livestock exchanges or 
of similar trade associations, attorneys at law, banks and trust 
companies, or their officers, are deemed suitable trustees. If a trustee 
is not designated in the bond and action is taken to recover damages for 
breach of any condition thereof, the Administrator shall designate a 
person to act as trustee. In those States in which a State official is 
required by statute to act or has agreed to act as trustee, such 
official shall be designated by the Administrator as trustee when a 
designation by the Administrator becomes necessary.

[41 FR 53774, Dec. 9, 1976]



Sec. 201.33  Persons damaged may maintain suit; filing and notification 
of claims; time limitations; legal expenses.

    Each bond and each bond equivalent filed pursuant to the regulations 
in this part shall contain provisions that:
    (a) Any person damaged by failure of the principal to comply with 
any condition clause of the bond or bond equivalent may maintain suit to 
recover on the bond or bond equivalent even though such person is not a 
party named in the bond or bond equivalent;
    (b) Any claim for recovery on the bond or bond equivalent must be 
filed in writing with either the surety, if any, or the trustee, if any, 
or the Administrator, and whichever of these parties receives such a 
claim shall notify the other such party or parties at the earliest 
practical date;
    (c) The Administrator is authorized to designate a trustee pursuant 
to Sec. 201.32;
    (d) The surety on the bond, or the trustee on the bond equivalent, 
as the case may be, shall not be liable to pay any claim if it is not 
filed in writing within 60 days from the date of the transaction on 
which the claim is based or if suit thereon is commenced less than 120 
days or more than 547 days from the date of the transaction on which the 
claim is based;

[[Page 12]]

    (e) The proceeds of the bond or bond equivalent, as the case may be, 
shall not be used to pay fees, salaries, or expenses for legal 
representation of the surety or the principal.

[56 FR 2128, Jan. 22, 1991]



Sec. 201.34  Termination of market agency, dealer and packer bonds.

    (a) Each bond shall contain a provision requiring that, prior to 
terminating such bond, at least 30 days notice in writing shall be given 
to the Administrator, Grain Inspection, Packers and Stockyards 
Administration (Packers and Stockyards Programs), U.S. Department of 
Agriculture, Washington, DC 20250, by the party terminating the bond. 
Such provision may state that in the event the surety named therein 
writes a replacement bond for the same principal, the 30-day notice 
requirement may be waived and the bond will be terminated as of the 
effective date of the replacement bond.
    (b) Each bond filed by a market agency who clears other registrants 
who are named in the bond shall contain a provision requiring that, 
prior to terminating the bond coverage of any clearee named therein, at 
least 30 days notice in writing shall be given to the Administrator, 
Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs), U.S. Department of Agriculture, Washington, DC 
20250, by the surety. Such written notice shall be in the form of a 
rider or endorsement to be attached to the bond of the clearing agency.
    (c) Each trust fund agreement and trust agreement shall contain a 
provision requiring that, prior to terminating such agreement, at least 
30 days notice in writing shall be given to the Administrator, Grain 
Inspection, Packers and Stockyards Administration, U.S. Department of 
Agriculture, Washington, DC 20250, by the party terminating the 
agreement. Such provision shall state that in the event the principal 
named therein files an acceptable bond or bond equivalent to replace the 
agreement, the 30-day notice requirement may be waived and the agreement 
will be terminated as of the effective date of the replacement bond or 
bond equivalent.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[47 FR 32695, July 29, 1982, as amended at 54 FR 26349, June 23, 1989; 
61 FR 36279, July 10, 1996; 68 FR 75388, Dec. 31, 2003]

                            Proceeds of Sale



Sec. 201.39  Payment to be made to consignor or shipper by market 
agencies; exceptions.

    (a) No market agency shall, except as provided in paragraph (b) of 
this section, pay the net proceeds or any part thereof, arising from the 
sale of livestock consigned to it for sale, to any person other than the 
consignor or shipper of such livestock except upon an order from the 
Secretary or a court of competent jurisdiction, unless (1) such market 
agency has reason to believe that such person is the owner of the 
livestock, (2) such person holds a valid, unsatisfied mortgage or lien 
upon the particular livestock, or (3) such person holds a written order 
authorizing such payment executed by the owner at the time of or 
immediately following the consignment of such livestock: Provided, That 
this paragraph shall not apply to deductions made from sales proceeds 
for the purpose of financing promotion and research activities, 
including educational activities, relating to livestock, meat, and other 
products covered by the Act, carried out by producer-sponsored 
organizations.
    (b) The net proceeds arising from the sale of livestock, the 
ownership of which has been questioned by a market agency duly 
authorized to inspect brands, marks, and other identifying 
characteristics of livestock may be paid in accordance with the 
directions of such brand inspection agency if the laws of the State from 
which such livestock originated or was shipped to market make provision 
for payment of the proceeds in the manner directed by the brand 
inspection agency and if the market agency to which the livestock was 
consigned, and the consignor or consignors concerned, are unable to 
establish the ownership of the livestock

[[Page 13]]

within a reasonable period of time, not to exceed 60 days after sale.

(7 U.S.C. 181 et seq.)

[19 FR 4528, July 22, 1954, as amended at 28 FR 7218, July 13, 1963; 44 
FR 45361, Aug. 2, 1979]



Sec. 201.42  Custodial accounts for trust funds.

    (a) Payments for livestock are trust funds. Each payment that a 
livestock buyer makes to a market agency selling on commission is a 
trust fund. Funds deposited in custodial accounts are also trust funds.
    (b) Custodial accounts for shippers' proceeds. Every market agency 
engaged in selling livestock on a commission or agency basis shall 
establish and maintain a separate bank account designated as ``Custodial 
Account for Shippers' Proceeds,'' or some similar identifying 
designation, to disclose that the depositor is acting as a fiduciary and 
that the funds in the account are trust funds.
    (c) Deposits in custodial accounts. The market agency shall deposit 
in its custodial account before the close of the next business day (the 
next day on which banks are customarily open for business whether or not 
the market agency does business on that day) after livestock is sold (1) 
the proceeds from the sale of livestock that have been collected, and 
(2) an amount equal to the proceeds receivable from the sale of 
livestock that are due from (i) the market agency, (ii) any owner, 
officer, or employee of the market agency, and (iii) any buyer to whom 
the market agency has extended credit. The market agency shall 
thereafter deposit in the custodial account all proceeds collected until 
the account has been reimbursed in full, and shall, before the close of 
the seventh day following the sale of livestock, deposit an amount equal 
to all the remaining proceeds receivable whether or not the proceeds 
have been collected by the market agency.
    (d) Withdrawals from custodial accounts. The custodial account for 
shippers' proceeds shall be drawn on only for payment of (1) the net 
proceeds to the consignor or shipper, or to any person that the market 
agency knows is entitled to payment, (2) to pay lawful charges against 
the consignment of livestock which the market agency shall, in its 
capacity as agent, be required to pay, and (3) to obtain any sums due 
the market agency as compensation for its services.
    (e) Accounts and records. Each market agency shall keep such 
accounts and records as will disclose at all times the handling of funds 
in such custodial accounts for shippers' proceeds. Accounts and records 
must at all times disclose the name of the consignors and the amount due 
and payable to each from funds in the custodial account for shippers' 
proceeds.
    (f) Insured banks. Such custodial accounts for shippers' proceeds 
must be established and maintained in banks whose deposits are insured 
by the Federal Deposit Insurance Corporation.
    (g) Certificates of deposit and/or savings accounts. Funds in a 
custodial account for shippers' proceeds may be maintained in an 
interest-bearing savings account and/or invested in one or more 
certificates of deposit, to the extent that such deposit or investment 
does not impair the ability of the market agency to meet its obligations 
to its consignors. The savings account must be properly designated as a 
party of the custodial account of the market agency in its fiduciary 
capacity as trustee of the custodial funds and maintained in the same 
bank as the custodial account. The certificates of deposit, as property 
of the custodial account, must be issued by the bank in which the 
custodial account is kept and must be made payable to the market agency 
in its fiduciary capacity as trustee of the custodial funds.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[47 FR 32696, July 29, 1982, as amended at 54 FR 26349, June 23, 1989; 
68 FR 75388, Dec. 31, 2003]

                          Accounts and Records



Sec. 201.43  Payment and accounting for livestock and live poultry.

    (a) Market agencies to make prompt accounting and transmittal of net 
proceeds. Each market agency shall, before the close of the next 
business day following the sale of any livestock consigned to it for 
sale, transmit or deliver to the

[[Page 14]]

consignor or shipper of the livestock, or the duly authorized agent, in 
the absence of any knowledge that any other person, or persons, has any 
interest in the livestock, the net proceeds received from the sale and a 
true written account of such sale, showing the number, weight, and price 
of each kind of animal sold, the date of sale, the commission, yardage, 
and other lawful charges, and such other facts as may be necessary to 
complete the account and show fully the true nature of the transaction.
    (b) Prompt payment for livestock and live poultry--terms and 
conditions. (1) No packer, market agency, or dealer shall purchase 
livestock for which payment is made by a draft which is not a check, 
unless the seller expressly agrees in writing before the transaction 
that payment may be made by such a draft. (In cases of packers whose 
average annual purchases exceed $500,000, and market agencies and 
dealers acting as agents for such packers, see also Sec. 201.200).
    (2)(i) No packer, market agency, or dealer purchasing livestock for 
cash and not on credit, whether for slaughter or not for slaughter, 
shall mail a check in payment for the livestock unless the check is 
placed in an envelope with proper first class postage prepaid and 
properly addressed to the seller or such person as he may direct, in a 
post office, letter box, or other receptacle regularly used for the 
deposit of mail for delivery, from which such envelope is scheduled to 
be collected (A) before the close of the next business day following the 
purchase of livestock and transfer of possession thereof, or (B) in the 
case of a purchase on a ``carcass'' or ``grade and yield'' basis, before 
the close of the first business day following determination of the 
purchase price.
    (ii) No packer, market agency, or dealer purchasing livestock for 
slaughter, shall mail a check in payment for the livestock unless (A) 
the check is made available for actual delivery and the seller or his 
duly authorized representative is not present to receive payment, at the 
point of transfer of possession of such livestock, on or before the 
close of the next business day following the purchase of the livestock 
and transfer of possession thereof, or, in the case of a purchase on a 
``carcass'' or ``grade and yield'' basis, on or before the close of the 
first business day following determination of the purchase price; or 
unless (B) the seller expressly agrees in writing before the transaction 
that payment may be made by such mailing of a check.
    (3) Any agreement referred to in paragraph (b) (1) or (2) of this 
section shall be disclosed in the records of any market agency or dealer 
selling such livestock, and in the records of the packer, market agency, 
or dealer purchasing such livestock, and retained by such person for 
such time as is required by any law, or by written notice served on such 
person by the Administrator, but not less than two calendar years from 
the date of expiration thereof.
    (4) No packer, live poultry dealer, market agency, or livestock 
dealer shall as a condition to its purchase of livestock or poultry, 
impose, demand, compel or dictate the terms or manner of payment, or 
attempt to obtain a payment agreement from a seller through any threat 
of retaliation or other form of intimidation.
    (c) Purchaser to promptly reimburse agents. Each packer, market 
agency, or dealer who utilizes or employs an agent to purchase livestock 
for him, shall, in transactions where such agent uses his own funds to 
pay for livestock purchased on order, transmit or deliver to such agent 
the full amount of the purchase price before the close of the next 
business day following receipt of notification of the payment of such 
purchase price, unless otherwise expressly agreed between the parties 
before the purchase of the livestock. Any such agreement shall be 
disclosed in the records of the principal and in the records of any 
market agency or dealer acting as such agent.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46)

[49 FR 6083, Feb. 17, 1984, as amended at 49 FR 8235, Mar. 6, 1984; 54 
FR 16355, Apr. 24, 1989; 68 FR 75388, Dec. 31, 2003]



Sec. 201.44  Market agencies to render prompt accounting for purchases 
on order.

    Each market agency shall, promptly following the purchase of 
livestock on

[[Page 15]]

a commission or agency basis, transmit or deliver to the person for 
whose account such purchase was made, or the duly authorized agent, a 
true written account of the purchase showing the number, weight, and 
price of each kind of animal purchased, the names of the persons from 
whom purchased, the date of purchase, the commission and other lawful 
charges, and such other facts as may be necessary to complete the 
account and show fully the true nature of the transaction.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 181 et seq.)

[44 FR 45360, Aug. 2, 1979, as amended at 54 FR 26349, June 23, 1989; 68 
FR 75388, Dec. 31, 2003]



Sec. 201.45  Market agencies to make records available for inspection by 
owners, consignors, and purchasers.

    Each market agency engaged in the business of selling or buying 
livestock on a commission or agency basis shall, on request from an 
owner, consignor, or purchaser, make available copies of bills covering 
charges paid by such market agency for and on behalf of the owner, 
consignor, or purchaser which were deducted from the gross proceeds of 
the sale of livestock or added to the purchase price thereof when 
accounting for the sale or purchase.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 181 et seq.; Pub. L. 96-511, 94 Stat. 2812 (44 U.S.C. 3501 et 
seq.))

[19 FR 4528, July 22, 1954, as amended at 44 FR 45361, Aug. 2, 1979; 47 
FR 746, Jan. 7, 1982; 54 FR 26349, June 23, 1989; 68 FR 75388, Dec. 31, 
2003]



Sec. 201.49  Requirements regarding scale tickets evidencing weighing 
of livestock, live poultry, and feed.

    (a) Livestock. When livestock is weighed for the purpose of purchase 
or sale, a scale ticket shall be issued which shall be serially numbered 
and used in numerical sequence. Sufficient copies shall be executed to 
provide a copy to all parties to the transaction. In instances where the 
weight values are automatically recorded directly on the account of 
purchase, account of sale or other basic record, this record may serve 
in lieu of a scale ticket. When livestock is purchased on a carcass 
weight or carcass grade and weight basis, the hot carcass weights shall 
be recorded using a scale equipped with a printing device, and such 
printed weights shall be retained as part of the person or firm's 
business records to substantiate settlement on each transaction. Scale 
tickets issued under this section shall show:
    (1) The names and location of the agency performing the weighing 
service,
    (2) The date of the weighing;
    (3) The name of the buyer and seller or consignor, or a designation 
by which they may be readily identified;
    (4) The number of head;
    (5) Kind of livestock;
    (6) Actual weight of each draft of livestock; and
    (7) The name, initials, or number of the person who weighed the 
livestock, or if required by State law, the signature of the weigher.
    (b) Poultry. When live poultry is weighed for the purpose of 
purchase, sale, acquisition, or settlement by a live poultry dealer, a 
scale ticket shall be issued which shall show:
    (1) The name of the agency performing the weighing service;
    (2) The name of the live poultry dealer;
    (3) The name and address of the grower, purchaser, or seller;
    (4) The name or initials or number of the person who weighed the 
poultry, or if required by State law, the signature of the weigher;
    (5) The location of the scale;
    (6) The gross weight, tare weight, and net weight;
    (7) The date and time gross weight and tare weight are determined;
    (8) The number of poultry weighed;
    (9) The weather conditions;
    (10) Whether the driver was on or off the truck at the time of 
weighing; and
    (11) The license number of the truck or the truck number; provided, 
that when live poultry is weighed on a scale other than a vehicle scale, 
the scale ticket need not show the information specified in paragraphs 
(b)(9)-(11) of this section. Scale tickets issued under

[[Page 16]]

this paragraph shall be at least in duplicate form and shall be serially 
numbered and used in numerical sequence. One copy shall be furnished to 
the grower, purchaser, or seller, and one copy shall be furnished to or 
retained by the live poultry dealer.
    (c) Feed. (1) Whenever feed is weighed by or on behalf of a 
stockyard owner, market agency, dealer, packer, or live poultry dealer 
where the weight of feed is a factor in determining payment or 
settlement to a livestock grower or poultry grower, a scale ticket shall 
be issued which shall show:
    (i) The name of the agency performing the weighing service or the 
name and location of the firm responsible for supplying the feed;
    (ii) The name and address of the livestock grower or poultry grower;
    (iii) The name or initials or number of the person who weighed the 
feed, or if required by State law, the signature of the weigher;
    (iv) The location of the scale;
    (v) The gross weight, tare weight, and net weight of each lot 
assigned to an individual grower, if applicable;
    (vi) The date and time gross weight and tare weight, if gross and 
tare weights are applicable, are determined;
    (vii) The identification of each lot assigned to an individual 
grower by vehicle or trailer compartment number and seal numbers, if 
applicable;
    (viii) Whether the driver was on or off the truck at the time of 
weighing, if applicable; and
    (ix) The license number or other identification numbers on the truck 
and trailer, if weighed together, or trailer if only the trailer is 
weighed, if applicable.
    (2) Scale tickets issued under this paragraph shall be at least in 
duplicate form and shall be serially numbered and used in numerical 
sequence. One copy shall be retained by the person subject to the P&S 
Act, and a second copy shall be furnished to the livestock grower or 
poultry grower.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[61 FR 36281, July 10, 1996, as amended at 65 FR 17762, Apr. 5, 2000]

                             Trade Practices



Sec. 201.53  Persons subject to the Act not to circulate misleading 
reports about market conditions or prices.

    No packer, live poultry dealer, stockyard owner, market agency, or 
dealer shall knowingly make, issue, or circulate any false or misleading 
reports, records, or representation concerning the market conditions or 
the prices or sale of any livestock, meat, or live poultry.

[54 FR 16355, Apr. 24, 1989]



Sec. 201.55  Purchases, sales, acquisitions, payments and settlements 
to be made on actual weights.

    (a) Except as provided in paragraph (b) of this section, whenever 
livestock or live poultry is bought, sold, acquired, paid, or settled on 
a weight basis, or whenever the weight of feed is a factor in 
determining payment or settlement to a livestock grower or poultry 
grower by a stockyard owner, market agency, dealer, packer, or live 
poultry dealer when livestock or poultry is produced under a growing 
arrangement, payment or settlement shall be on the basis of the actual 
weight of the livestock, live poultry, and/or feed shown on the scale 
ticket. If the actual weight used is not obtained on the date and at the 
place of transfer of possession, this information shall be disclosed 
with the date and location of the weighing on the accountings, bills, or 
statements issued. Any adjustment to the actual weight shall be fully 
and accurately explained on the accountings, bills, or statements 
issued, and records shall be maintained to support such adjustment.
    (b) Whenever the weight of feed is a factor in determining payment 
or settlement to such livestock grower or poultry grower when the 
livestock or poultry is produced under a livestock or poultry growing 
arrangement, any feed that is picked up from or returned by a livestock 
grower or poultry grower must be weighed or its weight must be 
reasonably determined. When feed is picked up or returned and not 
weighed, the stockyard owner, market agency, dealer, packer, or live 
poultry dealer must document that the method used reasonably determines 
weight and is

[[Page 17]]

mutually acceptable to it and the livestock grower or poultry grower. 
The stockyard owner, market agency, dealer, packer, or live poultry 
dealer must document and account for the picked up or returned feed 
weight.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[65 FR 17762, Apr. 5, 2000]



Sec. 201.56  Market agencies selling on commission; purchases from 
consignment.

    (a) Livestock to be sold openly at highest available bid. Every 
market agency engaged in the business of selling livestock on a 
commission or agency basis shall sell the livestock consigned to it 
openly, at the highest available bid, and in such a manner as to best 
promote the interest of each consignor.
    (b) Purchases from consignment. No market agency engaged in the 
business of selling livestock on a commission basis shall purchase 
livestock from consignments, and no such market agency shall permit its 
owners, officers, agents, employees or any firm in which such market 
agency or its owners, officers, agents, or employees have an ownership 
or financial interest to purchase livestock consigned to such market 
agency, without first offering the livestock for sale in an open and 
competitive manner to other available buyers, and then only at a price 
higher than the highest available bid on such livestock.
    (c) Key employees not to purchase livestock out of consignments. No 
market agency engaged in selling livestock on commission shall permit 
its auctioneers, weighmasters, or salesmen to purchase livestock out of 
consignment for any purpose for their own account, either directly or 
indirectly.
    (d) Purchase from consignments; disclosure required. When a market 
agency purchases consigned livestock or sells consigned livestock to any 
owner, officer, agent, employee, or any business in which such market 
agency, owner, officer, agent, or employee has an ownership or financial 
interest, the market agency shall disclose on the account of sale the 
name of the buyer and the nature of the relationship existing between 
the market agency and the buyer.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46)

[49 FR 6084, Feb. 17, 1984, as amended at 49 FR 13003, Apr. 2, 1984; 58 
FR 52886, Oct. 13, 1993; 68 FR 75388, Dec. 31, 2003]



Sec. 201.61  Market agencies selling or purchasing livestock on 
commission; relationships with dealers.

    (a) Market agencies selling on commission. No market agency selling 
consigned livestock shall enter into any agreement, relationship or 
association with dealers or other buyers which has a tendency to lessen 
the loyalty of the market agency to its consignors or impair the quality 
of the market agency's selling services. No market agency selling 
livestock on commission shall provide clearing services for any 
independent dealer who purchases livestock from consignment to such 
market agency without disclosing, on the account of sale to the 
consignor, the name of the buyer and the nature of the financial 
relationship between the buyer and the market agency.
    (b) Market agencies buying on commission. No market agency 
purchasing livestock on commission shall enter into any agreement, 
relationship, or association with dealers or others which will impair 
the quality of the buying services furnished to its principals. No 
market agency purchasing livestock on commission shall, in filling 
orders, purchase livestock from a dealer whose operations it clears or 
finances without disclosing the relationship between the market agency 
and dealer to its principals on the accountings furnished to the 
principals.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46)

[49 FR 6085, Feb. 17, 1984, as amended at 60 FR 42779, Aug. 17, 1995; 68 
FR 75388, Dec. 31, 2003]



Sec. 201.67  Packers not to own or finance selling agencies.

    No packer subject to the Act shall have an ownership interest in, 
finance, or participate in the management or operation of a market 
agency selling

[[Page 18]]

livestock on a commission basis, nor shall such a market agency permit a 
packer to have an ownership interest in, finance, or participate in the 
management or operation of such market agency.

(7 U.S.C. 228, 228b, 222, 15 U.S.C. 46)

[49 FR 32844, Aug. 17, 1984]



Sec. 201.69  Furnishing information to competitor buyers.

    No packer, dealer, or market agency, in connection with transactions 
subject to the provisions of the act, shall, in person, or through 
employed buyers, for the purpose of restricting or limiting competition, 
manipulating livestock prices, or controlling the movement of livestock, 
prior to, or during the conduct of, his buying operations: (a) Furnish 
competitor packers, dealers, market agencies, or their buyers or 
representatives, similarly engaged in buying livestock, with information 
concerning his proposed buying operations, such as the species, classes, 
volume of livestock to be purchased, or prices to be paid; or (b) 
furnish any other buying information to competitor buyers.

[19 FR 4531, July 22, 1954, as amended at 24 FR 3183, Apr. 24, 1959]



Sec. 201.70  Restriction or limitation of competition between packers and 
dealers prohibited.

    Each packer and dealer engaged in purchasing livestock, in person or 
through employed buyers, shall conduct his buying operations in 
competition with, and independently of, other packers and dealers 
similarly engaged.

[24 FR 3183, Apr. 24, 1959]

                                Services



Sec. 201.71  Scales; accurate weights, repairs, adjustments or replacements 
after inspection.

    (a) All scales used by stockyard owners, market agencies, dealers, 
packers, and live poultry dealers to weigh livestock, livestock 
carcasses, live poultry, or feed for the purposes of purchase, sale, 
acquisition, payment, or settlement shall be installed, maintained, and 
operated to ensure accurate weights. Such scales shall meet applicable 
requirements contained in the General Code, Scale Code, and Weights Code 
of the 1996 edition of National Institute of Standards and Technology 
(NIST) Handbook 44, ``Specifications, Tolerances, and Other Technical 
Requirements for Weighing and Measuring Devices,'' which is hereby 
incorporated by reference. This incorporation by reference was approved 
by the Director of the Federal Register on January 11, 1989, in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. These materials are 
incorporated as they exist on the date of approval and a notice of any 
change in these materials will be published in the Federal Register. 
This handbook is for sale by the Superintendent of Documents, U.S. 
Government Printing Office, Washington, DC 20402. It is also available 
for inspection at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html.
    (b) All scales used by stockyard owners, market agencies, dealers, 
packers, and live poultry dealers to weigh livestock, livestock 
carcasses, live poultry, or feed for the purpose of purchase, sale, 
acquisition, payment, or settlement of livestock or live poultry, and 
all scales used for the purchase, sale, acquisition, payment, or 
settlement of livestock on a carcass weight basis shall be equipped with 
a printing device which shall record weight values on a scale ticket or 
other document.
    (c) All vehicle scales used to weigh livestock, live poultry, or 
feed for purposes of purchase, sale, acquisition, payment, or settlement 
of livestock or live poultry shall be of sufficient length and capacity 
to weigh the entire vehicle as a unit: Provided, That a trailer may be 
uncoupled from the tractor and weighed as a single unit.
    (d) No scale shall be operated or used by any stockyard owner, 
market agency, dealer, packer, or live poultry dealer to weigh 
livestock, livestock carcasses, live poultry, or feed for purposes of 
purchase, sale, acquisition, payment, or settlement of livestock,

[[Page 19]]

livestock carcasses or live poultry unless it has been found upon test 
and inspection, as specified in Sec. 201.72, to be in a condition to 
give accurate weight. If a scale is inspected or tested and found to be 
in a condition to give incorrect or inaccurate weights or if any 
repairs, adjustments or replacements are made to a scale, it shall not 
be used until it has been inspected and tested and determined to meet 
all accuracy requirements specified in the regulations in this section.

[65 FR 17763, Apr. 5, 2000, as amended at 69 FR 18803, Apr. 9, 2004]



Sec. 201.72  Scales; testing of.

    (a) Each stockyard owner, market agency, dealer, packer, or live 
poultry dealer who weighs livestock, live poultry, or feed for purposes 
of purchase, sale, acquisition, payment, or settlement of livestock or 
live poultry, or who weighs livestock carcasses for the purpose of 
purchase on a carcass weight basis, or who furnishes scales for such 
purposes, shall cause such scales to be tested by competent persons in 
accordance with the regulations in this part at least twice during each 
calendar year at intervals of approximately 6 months. More frequent 
testing will be required in cases where the scale does not maintain 
accuracy between tests.
    (b) Each stockyard owner, market agency, dealer, packer, or live 
poultry dealer who weighs livestock, livestock carcasses, live poultry, 
or feed for purposes of purchase, sale, acquisition, payment, or 
settlement of livestock, livestock carcasses or live poultry shall 
furnish reports of such tests and inspections on forms prescribed by the 
Administrator. The stockyard owner, market agency, dealer, packer or 
live poultry dealer shall retain one copy of the test and inspection 
report and shall file one copy with the P&S regional office for the 
region in which the scale is located.
    (c) When scales used for weighing livestock, livestock carcasses, 
live poultry, or feed are tested and inspected by an agency of a State 
or municipality or other governmental subdivision, the forms ordinarily 
used by such agency for reporting test and inspection of scales shall be 
accepted in lieu of the forms prescribed for this purpose by the 
Administrator if such forms contain substantially the same information.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[65 FR 17763, Apr. 5, 2000]



Sec. 201.73  Scale operators to be qualified.

    Stockyard owners, market agencies, dealers, packers, and live 
poultry dealers shall employ qualified persons to operate scales for 
weighing livestock, livestock carcasses, live poultry, or feed for the 
purposes of purchase, sale, acquisition, payment, or settlement of 
livestock, livestock carcasses, or live poultry, and they shall require 
such employees to operate the scales in accordance with the regulations 
in this part.

[65 FR 17763, Apr. 5, 2000]



Sec. 201.73-1  Instructions for weighing livestock.

    Stockyard operators, market agencies, dealers, and packers who 
operate scales on which livestock is weighed in purchase or sales 
transactions are responsible for the accurate weighing of such 
livestock. They shall supply copies of the instructions in this section 
to all persons who perform weighing operations for them and direct such 
person to familiarize themselves with the instructions and to comply 
with them at all times. This section shall also apply to any additional 
weighers who are employed at any time. Weighers must acknowledge their 
receipt of these instructions and agree to comply with them, by signing 
in duplicate, P&SA Form 215 provided by the Packers and Stockyards 
Programs. One copy of the form is to be filed with a regional office of 
the Packers and Stockyards Programs and the other retained by the agency 
employing the weighers.
    (a) Balancing the empty scale. (1) The empty scale shall be balanced 
each day before weighing begins, and maintained in correct balance which 
weighing operations continue. The zero balance shall be verified at 
intervals of not more than 15 drafts or 15 minutes,

[[Page 20]]

whichever is completed first. In addition, the zero balance of the scale 
shall be verified whenever a weigher resumes weighing duties after an 
absence from the scale and also whenever a load exceeding half the scale 
capacity or 10,000 pounds (whichever is less) has been weighed and is 
followed by a load of less than 1,000 pounds, verification to occur 
before the weighing of the load of less than 1,000 pounds.
    (2) The time at which the empty scale is balanced or its zero 
balance verified shall be recorded on scale tickets or other permanent 
records. Balance tickets must be filed with other scale tickets issued 
on that date.
    (3) Before balancing the empty scale, the weigher shall assure 
himself that the scale gates are closed and that no persons or animals 
are on the scale platform or in contact with the stock rack, gates, or 
platform. If the scale is balanced with persons on the scale platform, 
the zero balance shall be verified whenever there is a change in such 
persons. When the scale is properly balanced and ready for weighing, the 
weigher shall so indicate by an appropriate signal.
    (4) Weighbeam scales shall be balanced by first seating each poise 
securely in its zero notch and then moving the balance ball to such 
position that a correct zero balance is obtained. A scale equipped with 
a balance indicator is correctly balanced when the pointer comes to rest 
at zero. A scale not equipped with a balance indicator is correctly 
balanced if the weighbeam, when released at the top or bottom of the 
trig loop, swings freely in the trig loop in such manner that it will 
come to rest at the center of the trig loop.
    (5) Dial scales shall be balanced by releasing all drop weights and 
operating the balance ball or other balancing device to obtain a correct 
zero balance. The indicator must visually indicate zero on the dial and 
the ticket printer must record a correct zero balance.
    (6) Electronic digital scales should be properly warmed up before 
use. In most cases, it is advisable to leave the electric power on 
continuously. The zero load balance shall be verified by recording the 
zero balance on a scale ticket. The main indicating element and the 
remote visual weight display shall indicate zero when the balance is 
verified. The proper procedure for balancing this type of scale will 
vary according to the manufacturer. Refer to the operator's manual for 
specific instructions.
    (b) Weighing the load. (1) Before weighing a draft of livestock, the 
weigher shall assure himself that the entire draft is on the scale 
platform with the gates closed and that no persons or animals off the 
scale are in contact with the platform, gates, or stock rack.
    (i) On a weighbeam scale with a balance indicator, the weight of a 
draft shall be determined by seating the poises at such positions that 
the pointer will come to rest within the central target area or within 
\1/4\ (0.25) inch of the zero mark.
    (ii) On a weighbeam scale without a balance indicator, the weight 
shall be determined by seating the poises at such positions that the 
weighbeam, when released from the top or bottom of the trig loop, will 
swing freely and come to rest at the approximate center of the trig 
loop.
    (iii) On a dial scale, the weight is indicated automatically when 
the indicator moves around the dial face and comes to rest.
    (iv) On an electronic digital scale, the weight of a draft is 
indicated automatically when the weight value indicated stabilized.
    (2) The correct weight of a livestock draft is the value in pounds 
indicated when a correct load balance is obtained. The weigher should 
always concentrate his attention upon the beam tip, balance indicator or 
dial indicator while weighing and not concern himself with reading the 
visible weight indications until correct load balance is obtained. On 
electronic digital scales, the weigher should concentrate on the pulsing 
or flickering of weight values to assure that the unit indicates a 
stable weight before activating the print button.
    (c) Recording the weight. (1) The weight of each draft shall be 
recorded immediately after the load balance is obtained and before any 
poises are moved or the load is removed from the scale platform. The 
weigher shall make

[[Page 21]]

certain that the printed weight record agrees with the weight value 
visually indicated when correct load balance is obtained. He shall also 
assure himself that the printed weight value is distinct and legible.
    (2) The weight printing device on a scale shall be operated only to 
produce a printed or impressed record of the weight value while the 
livestock load is on the scale and correctly balanced. If the weight 
value is not printed clearly and correctly, the ticket shall be marked 
void and a new one printed before the livestock is removed from the 
scale.
    (d) Scale tickets. (1) Scale tickets used to record the weight 
values of livestock in purchase or sales transactions shall be used, at 
any given scale, in the order of their consecutive serial numbers unless 
otherwise marked to show the order of their use. All tickets shall show 
the date of the weighing and the name or initials of the weigher 
performing the weighing service.
    (2) No scale tickets shall be destroyed or otherwise disposed of 
because they are soiled, damaged, incorrectly executed, or voided. They 
shall be preserved and filed to comprise a complete serial number 
sequence.
    (3) No scale ticket shall be used to record the weight of a 
livestock draft for ``catch-weight,'' inventory, transportation charge 
or other nonsale purposes unless the ticket is clearly marked to show 
why the weight was determined.
    (4) When weight values are recorded by means of automatic recording 
equipment directly on the accounts of sale or other basic records, such 
record may serve in lieu of a scale ticket.
    (e) Weigher's responsibilities. (1) The primary responsibility of a 
weigher is to determine and accurately record the weight of livestock 
drafts without prejudice or favor to any person or agency and without 
regard for livestock ownership, price, condition, fill, shrink, or other 
considerations. A weigher shall not permit the representations or 
attitudes of any persons or agencies to influence his judgment or action 
in performing his duties.
    (2) Unused scale tickets, or those which are partially executed but 
without a printed weight value, shall not be left exposed or accessible 
to unauthorized personnel. All such tickets shall be kept under lock 
when the weigher is not at his duty station.
    (3) Accurate weighing and correct weight recording require that a 
weigher shall not permit his operations to be hurried to the extent that 
inaccurate weights or incorrect weight rec ords may result. Each draft 
of livestock must be weighed accurately to the nearest minimum weight 
value that can be indicated or recorded. Manual operations connected 
with balancing, weighing, and recording shall be performed with the care 
necessary to prevent damage to the accurately machined and adjusted 
parts of weighbeams, poises, and printing devices.
    (4) Livestock owners, buyers, or others having legitimate interest 
in a livestock draft must be permitted to observe the balancing, 
weighing, and recording procedures, and a weigher shall not deny them 
that right or withhold from them any information pertaining to the 
weight of that draft. He shall check the zero balance of the scale or 
reweigh a draft of livestock when requested by such parties.
    (f) Sensitivity control. (1) A scale must be sensitive in response 
to platform loading if it is to yield accurate weights. It, therefore, 
is the duty of a weigher to assure himself that interferences, weighbeam 
friction, or other factors do not impair sensitivity. He should satisfy 
himself, at least twice each day, that the scale is sufficiently 
sensitive, and if the following requirements are not met, he should 
report the facts to his superior or employer immediately.
    (2) A weighbeam scale with a balance indicator is sufficiently 
sensitive if, when the scale is balanced with the pointer at the center 
of the target, movement of the fractional poise one graduation will 
change the indicator rest point \1/4\ inch (0.25) or the width of the 
central target area, whichever is greater.
    (3) A weighbeam scale without a balance indicator is sufficiently 
sensitive if, when the scale is balanced with the weighbeam at the 
center of the trig loop, movement of the fractional poise two 
graduations will cause the

[[Page 22]]

weighbeam to come to rest at the bottom of the trig loop.
    (4) Adjustable damping devices are incorporated in balance 
indicators and in dial scales to absorb the effects of load impact and 
assist in bringing the indicator to rest. The weigher should be familiar 
with the location and adjustment of these damping devices and should 
keep them adjusted so that the pointer will oscillate freely through at 
least one complete cycle of movement before coming to rest at its 
original position.
    (5) Friction at weighbeam bearings may reduce the sensitivity of the 
scale, cause sluggish weighbeam action and affect weighing accuracy. A 
weigher should inspect the weighbeam assembly daily to make certain that 
there is clearance between the weighbeam and the pivot bearings.
    (6) Interferences or binding of the scale platform, stock rack, 
gates or other ``live'' parts of the scale are common causes of weighing 
inaccuracy. A weigher should satisfy himself, at the beginning of each 
weighing period, that all such ``live'' parts have sufficient clearance 
to prevent interferences.
    (g) General precautions. (1) The poises of weighbeam scales are 
carefully adjusted and sealed to a definite weight at the factory and 
any change in that weight seriously affects weighing accuracy. A 
weigher, therefore, should be certain that poise parts do not become 
broken, loose or lost and that no material is added to a poise. 
Balancing or weighing shall not be performed while a scale ticket is in 
the slot of a weighbeam poise.
    (2) Stops are provided on scale weighbeams to prevent movement of 
poises back of the zero graduation when balancing or weighing. When the 
stops become worn or broken and allow a poise to be set behind the zero 
position, this condition should be reported and corrected without delay.
    (3) Foreign objects or loose material in the form of nuts, bolts, 
washers or other material on any part of the weighbeam assembly, 
including the counter-balance hanger or counter-balance weights, are 
potential sources of weighing error. Loose balancing material must be 
enclosed in the shot cup of the counter-balance hanger, and counter-
balance weights must not be of the slotted type which can readily be 
removed.
    (4) Whenever for any reason a weigher has reason to believe that a 
scale is not functioning properly or not yielding correct weight values, 
he shall discontinue weighing, report the facts to the parties 
responsible for scale maintenance, and request inspection, test, or 
repair of the scale.
    (5) When a scale has been adjusted, modified, or repaired in any 
manner which may affect the accuracy of weighing or weight recording, 
the weigher shall not use the scale until it has been tested and 
inspected and found to be accurate.
    (6) Count-off men, gate men, or others assigned to open or close 
scale gates or to drive livestock on or off the scale, shall perform 
those functions as directed by the weigher's signals or spoken 
instructions. They shall prevent persons or animals off the scale from 
being in contact with any part of the scale platform, stock rack, or 
gates while the scale is being balanced or used for weighing. They shall 
not open gates or remove livestock from the scale until directed by the 
weigher.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 222 and 228 and 15 U.S.C. 46)

[39 FR 40277, Nov. 15, 1974, as amended at 49 FR 39516, Oct. 9, 1984; 61 
FR 36282, July 10, 1996; 68 FR 75388, Dec. 31, 2003]



Sec. 201.76  Reweighing.

    Stockyard owners, market agencies, dealers, packers and live poultry 
dealers shall reweigh livestock, livestock carcasses or live poultry on 
request of any authorized representative of the Secretary.

[54 FR 16356, Apr. 24, 1989]



Sec. 201.81  Suspended registrants.

    No stockyard owner, packer, market agency, or dealer shall employ 
any person who has been suspended as a registrant to perform activities 
in connection with livestock transactions subject to the jurisdiction of 
the Secretary under the Act during the period of such suspension: 
Provided, That the provisions of this section shall not be construed to 
prohibit the employment of

[[Page 23]]

any person who has been suspended as a registrant until such time as the 
person demonstrates solvency or obtains the bond required under the Act 
and regulations. No such person shall be employed, however, until after 
the expiration of any specified period of suspension contained in the 
order of suspension.

(7 U.S.C. 222 and 228 and 15 U.S.C. 46)

[49 FR 37374, Sept. 24, 1984]



Sec. 201.82  Care and promptness in weighing and handling livestock and 
live poultry.

    (a) Each stockyard owner, market agency, dealer, packer and live 
poultry dealer shall exercise reasonable care and promptness with 
respect to loading, transporting, holding, yarding, feeding, watering, 
weighing or otherwise handling livestock or live poultry to prevent 
waste of feed, shrinkage, injury, death or other avoidable loss.
    (b) Whenever live poultry is obtained under a poultry growing 
arrangement, the poultry shall be transported promptly after loading and 
the gross weight for grower payment purposes shall be determined 
immediately upon arrival at the processing plant, holding yard, or other 
scale normally used for such purpose.

[54 FR 16356, Apr. 24, 1989; 54 FR 18713, May 2, 1989]

                          Inspection of Brands



Sec. 201.86  Brand inspection: Application for authorization, registration 
and filing of schedules, reciprocal arrangements, and maintenance of identity of 
          consignments.

    (a) Application for authorization. Any department or agency or duly-
organized livestock association of any State in which branding or 
marking of livestock as a means of establishing ownership prevails by 
custom or statute, which desires to obtain an authorization to charge 
and collect a fee for the inspection of brands, marks, and other 
identifying characteristics of livestock, as provided in section 317 of 
the Act, shall file with the Administrator an application in writing for 
such authorization. In case two or more applications for authorization 
to collect a fee for the inspection of brands, marks, and other 
identifying characteristics of livestock are received from the same 
State, a hearing will be held to determine which applicant is best 
qualified.
    (b) Registration and filing of schedules. Upon the issuance of an 
authorization to an agency or an association, said agency or association 
shall register as a market agency in accordance with the provisions of 
Sec. 201.10, except that no bond need be filed or maintained, and shall 
file a schedule of its rates and charges for performing the service in 
the manner and form prescribed by Sec. 201.17.
    (c) Reciprocal arrangements. Any authorized agency or association 
may make arrangements with an association or associations in the same or 
in another State, where branding or marking livestock prevails by custom 
or statute, to perform inspection service at stockyards on such terms 
and conditions as may be approved by the Administrator: Provided, That 
such arrangements will tend to further the purpose of the Act and will 
not result in duplication of charges or services.
    (d) Maintenance of identity of consignments. All persons having 
custody at the stockyard of livestock subject to inspection shall 
preserve the identity of the consignment until inspection has been 
completed by the authorized inspection agency. Agencies authorized to 
conduct such inspection shall perform the work as soon after receipt of 
the livestock as practicable and as rapidly as is reasonably possible in 
order to prevent delay in marketing, shrinkage in weight, or other 
avoidable losses.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 203, 204, 207, 217a, 222 and 228)

[49 FR 33005, Aug. 20, 1984, as amended at 68 FR 75388, Dec. 31, 2003]

                                 General



Sec. 201.94  Information as to business; furnishing of by packers, live 
poultry dealers, stockyard owners, market agencies, and dealers.

    Each packer, live poultry dealer, stockyard owner, market agency, 
and dealer, upon proper request, shall give to the Secretary or his duly 
authorized

[[Page 24]]

representatives in writing or otherwise, and under oath or affirmation 
if requested by such representatives, any information concerning the 
business of the packer, live poultry dealer, stockyard owner, market 
agency, or dealer which may be required in order to carry out the 
provisions of the Act and regulations in this part within such 
reasonable time as may be specified in the request for such information.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[54 FR 16356, Apr. 24, 1989, as amended at 54 FR 26349, June 23, 1989; 
68 FR 75388, Dec. 31, 2003]



Sec. 201.95  Inspection of business records and facilities.

    Each stockyard owner, market agency, dealer, packer, and live 
poultry dealer, upon proper request, shall permit authorized 
representatives of the Secretary to enter its place of business during 
normal business hours and to examine records pertaining to its business 
subject to the Act, to make copies thereof and to inspect the facilities 
of such persons subject to the Act. Reasonable accommodations shall be 
made available to authorized representatives of the Secretary by the 
stockyard owner, market agency, dealer, packer, or live poultry dealer 
for such examination of records and inspection of facilities.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[54 FR 16356, Apr. 24, 1989, as amended at 54 FR 26349, June 23, 1989; 
68 FR 75388, Dec. 31, 2003]



Sec. 201.96  Unauthorized disclosure of business information prohibited.

    No agent or employee of the United States shall, without the consent 
of the stockyard owner, market agency, dealer, packer or live poultry 
dealer concerned, divulge or make known in any manner, any facts or 
information regarding the business of such person acquired through any 
examination or inspection of the business or records of the stockyard 
owner, market agency, dealer, packer or live poultry dealer, or through 
any information given by the stockyard owner, market agency, dealer, 
packer, or live poultry dealer pursuant to the Act and regulations, 
except to such other agents or employees of the United States as may be 
required to have such knowledge in the regular course of their official 
duties or except insofar as they may be directed by the Administrator or 
by a court of competent jurisdiction, or except as they may be otherwise 
required by law.

[54 FR 16356, Apr. 24, 1989]



Sec. 201.97  Annual reports.

    Every packer, live poultry dealer, stockyard owner, market agency, 
and dealer (except a packer buyer registered to purchase livestock for 
slaughter only) shall file annually with the Administration a report on 
prescribed forms not later than April 15 following the calendar year end 
or, if the records are kept on a fiscal year basis, not later than 90 
days after the close of his fiscal year. The Administrator on good cause 
shown, or on his own motion, may grant a reasonable extension of the 
filing date or may waive the filing of such reports in particular cases.

(Approved by the Office of Management and Budget under Control Number 
0580-0015)

[54 FR 16356, Apr. 24, 1989, as amended at 68 FR 75388, Dec. 31, 2003]



Sec. 201.98  Packers and dealers not to charge, demand, or collect 
commission, yardage, or other service charges.

    No packer or dealer shall, in connection with the purchase of 
livestock in commerce, charge, demand, or collect from the seller of the 
livestock any compensation in the form of commission, yardage, or other 
service charge unless the charge is for services mandated by law or 
statute and is not inconsistent with the provisions of the Act.

[61 FR 36282, July 10, 1996]



Sec. 201.99  Purchase of livestock by packers on a carcass grade, 
carcass weight, or carcass grade and weight basis.

    (a) Each packer purchasing livestock on a carcass grade, carcass 
weight, or carcass grade and weight basis shall, prior to such purchase, 
make known to the seller, or to his duly authorized

[[Page 25]]

agent, the details of the purchase contract. Such details shall include, 
when applicable, expected date and place of slaughter, carcass price, 
condemnation terms, description of the carcass trim, grading to be used, 
accounting, and any special conditions.
    (b) Each packer purchasing livestock on a carcass grade, carcass 
weight, or carcass grade and weight basis, shall maintain the identity 
of each seller's livestock and the carcasses therefrom and shall, after 
determination of the amount of the purchase price, transmit or deliver 
to the seller, or his duly authorized agent, a true written account of 
such purchase showing the number, weight, and price of the carcasses of 
each grade (identifying the grade) and of the ungraded carcasses, an 
explanation of any condemnations, and any other information affecting 
final accounting. Packers purchasing livestock on such a basis shall 
maintain sufficient records to substantiate the settlement of each 
transaction.
    (c) When livestock are purchased by a packer on a carcass weight or 
carcass grade and weight basis, purchase and settlement therefor shall 
be on the basis of carcass price. This paragraph does not apply to 
purchases of livestock by a packer on a guaranteed yield basis.
    (d) Settlement and final payment for livestock purchased by a packer 
on a carcass weight or carcass grade and weight basis shall be on actual 
hot weights. The hooks, rollers, gambrels or other similar equipment 
used at a packing establishment in connection with the weighing of 
carcasses of the same species of livestock shall be uniform in weight. 
The tare shall include only the weight of such equipment.
    (e) Settlement and final payment for livestock purchased by a packer 
on a USDA carcass grade shall be on an official (final--not preliminary) 
grade. If settlement and final payment are based upon any grades other 
than official USDA grades, such other grades shall be set forth in 
detailed written specifications which shall be made available to the 
seller or his duly authorized agent. For purposes of settlement and 
final payment for livestock purchased on a grade or grade and weight 
basis, carcasses shall be final graded before the close of the second 
business day following the day the livestock are slaughtered.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(Pub. L. 96-511, 94 Stat. 2812 (44 U.S.C. 3501 et seq.); 7 U.S.C. 222 
and 228 and 15 U.S.C. 46)

[33 FR 2762, Feb. 9, 1968, as amended at 33 FR 5401, Apr. 5, 1968; 49 FR 
37375, Sept. 24, 1984; 54 FR 37094, Sept. 7, 1989; 68 FR 75388, Dec. 31, 
2003]

                Poultry--Packers and Live Poultry Dealers



Sec. 201.100  Records to be furnished poultry growers and sellers.

    (a) Contracts; contents. Each live poultry dealer who enters into a 
growout (feeding) contract with a poultry grower shall furnish the 
grower a true written copy of the contract, which shall clearly specify:
    (1) The duration of the contract and conditions for the termination 
of the contract by each of the parties; and
    (2) All terms relating to the payment to be made to the poultry 
grower, including among others, where applicable, the following:
    (i) The party liable for condemnations, including those resulting 
from plant errors;
    (ii) The method for figuring feed conversion ratios;
    (iii) The formula or method used to convert condemnations to live 
weight;
    (iv) The per unit charges for feed and other inputs furnished by 
each party; and
    (v) The factors to be used when grouping or ranking poultry growers.
    (b) Settlement sheets; contents; supporting documents. Each live 
poultry dealer, who acquires poultry pursuant to a contract with a 
poultry grower, shall prepare a true and accurate settlement sheet 
(final accounting) and furnish a copy thereof to the poultry grower at 
the time of settlement. The settlement sheet shall contain all 
information necessary to compute the payment due the poultry grower. For 
all such arrangements in which the weight of birds affects payment, the 
settlement sheet shall show, among other things, the number of live 
birds

[[Page 26]]

marketed, the total weight and the average weight of the birds, and the 
payment per pound.
    (c) Condemnation and grading certificates. Each live poultry dealer, 
who acquires poultry pursuant to a contract with a poultry grower which 
provides that official U.S. Department of Agriculture condemnations or 
grades, or both, are a consideration affecting payment to the grower, 
shall obtain an official U.S. Department of Agriculture condemnation or 
grading certificate, or both, for the poultry and furnish a copy thereof 
to the poultry grower prior to or at the time of settlement.
    (d) Grouping or ranking sheets. Where the contract between the live 
poultry dealer and the poultry grower provides for payment to the 
poultry grower based upon a grouping or ranking of poultry growers 
delivering poultry during a specified period, the live poultry dealer 
shall furnish the poultry grower, at the time of settlement, a copy of a 
grouping or ranking sheet which shows the grower's precise position in 
the grouping or ranking sheet for that period. The grouping or ranking 
sheet need not show the names of other growers, but shall show the 
actual figures upon which the grouping or ranking is based for each 
grower grouped or ranked during the specified period.
    (e) Live poultry purchases. Each live poultry dealer who purchases 
live poultry shall prepare and deliver a purchase invoice to the seller 
at time of settlement. The purchase invoice shall contain all 
information necessary to compute payment due the seller. When U.S. 
Department of Agriculture condemnations or U.S. Department of 
Agriculture grades, or both, of poultry purchased affect final payment, 
copies of official U.S. Department of Agriculture condemnation 
certificates or grading certificates, or both, shall be furnished to the 
seller at or prior to the time of settlement.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[54 FR 16356, Apr. 24, 1989; 54 FR 18713, May 2, 1989, as amended at 68 
FR 75388, Dec. 31, 2003]



Sec. 201.108-1  Instructions for weighing live poultry.

    Live poultry dealers who operate scales on which live poultry is 
weighed for purposes of purchase, sale, acquisition, or settlement are 
responsible for the accurate weighing of such poultry. They shall supply 
copies of the instructions in this section to all persons who perform 
weighing operations for them and direct such persons to familiarize 
themselves with the instructions and to comply with them at all times. 
This section shall also apply to any additional weighers who are 
employed at any time. Weighers must acknowledge their receipt of these 
instructions and agree to comply with them by signing in duplicate, a 
form provided by the Packers and Stockyards Programs, Grain Inspection, 
Packers and Stockyards Administration. One copy of this form is to be 
filed with a regional office of the Packers and Stockyards Programs, 
Grain Inspection, Packers and Stockyards Administration and the other 
copy retained by the Agency employing the weighers. The following 
instructions shall be applicable to the weighing of live poultry on all 
scales, except that paragraph (c)(1) of this section is only applicable 
to the weighing of live poultry on vehicle scales.
    (a) Balancing the empty scale. (1) The scale shall be maintained in 
zero balance at all times. The empty scale shall be balanced each day 
before weighing begins and thereafter its zero balance shall be verified 
before any poultry is weighed. In addition, the zero balance of the 
scale shall be verified whenever a weigher resumes weighing duties after 
an absence from the scale.
    (2) Before balancing the empty scale, the weigher shall notify 
parties outside the scale house of his/her intention and shall be 
assured that no persons or vehicles are in contact with the platform. 
When the empty scale is balanced and ready for weighing, the weigher 
shall so indicate by appropriate signal.
    (3) Weighbeam scales shall be balanced by first seating each poise 
securely in its zero notch and then moving the balance ball to such 
position that a correct zero balance is obtained. A scale equipped with 
a balance indicator is correctly balanced when the indicator comes to 
rest in the center of the target area. A scale not equipped with a 
balance indicator is correctly

[[Page 27]]

balanced if the weighbeam, when released at the top or bottom of the 
trig loop, swings freely in the trig loop in such manner that it will 
come to rest at the center of the trig loop.
    (4) Dial scales shall be balanced by releasing all drop weights and 
operating the balance ball or other balancing device to obtain a correct 
zero balance. The indicator must visibly indicate zero on the dial 
reading face and the ticket printer must record a correct zero balance. 
``Balance tickets'' shall be filed with other scale tickets issued on 
that date.
    (5) Electronic digital scales should be properly warmed up before 
use. In most cases it is advisable to leave the electric power on 
continuously. The zero balance shall be verified by recording the zero 
balance on a scale ticket. The main indicating element and the remote 
visual weight display shall indicate zero when the balance is verified. 
The proper procedure for balancing this type of scale will vary 
according to the manufacturer. Refer to the operator's manual for 
specific instructions.
    (6) A balance ball or other balancing device shall be operated only 
when balancing the empty scale and shall not be operated at any time or 
for any other purpose.
    (7) The time at which the empty scale is balanced or its zero 
balance verified shall be marked on scale tickets or other permanent 
records.
    (b) Sensitivity control. (1) A scale must be sensitive in response 
to platform loading if it is to yield accurate weights. It, therefore, 
is the duty of a weigher to assure himself that interferences, weighbeam 
friction, or other factors do not impair sensitivity. He shall satisfy 
himself, at least twice each day, that the scale is sufficiently 
sensitive, and, if the following requirements are not met, he must 
report the facts to his superior or employer immediately.
    (2) A weighbeam scale with a balance indicator is sufficiently 
sensitive if, when the scale is balanced with the indicator at the 
center of the target, movement of the fractional poise one graduation 
will change the indicator rest point (\1/4\) inch (0.25) or the width of 
the central target area, whichever is greater.
    (3) A weighbeam scale without a balance indicator is sufficiently 
sensitive if, when the scale is balanced with the weighbeam at the 
center of the trig loop, movement of the fractional poise two 
graduations will cause the weighbeam to come to rest at the bottom of 
the trig loop.
    (4) Adjustable damping devices are incorporated in balance 
indicators and in dial scales to absorb the effects of load impact and 
to bring the indicator to rest. The weigher must be familiar with the 
location and adjustment of these damping devices and keep them so 
adjusted that when the indicator is displaced from a position of rest, 
it will oscillate freely through at least one complete cycle of movement 
before coming to rest at its original position.
    (5) Friction at weighbeam bearings may reduce the sensitiveness of 
the scale, cause sluggish weighbeam action and affect weighing accuracy. 
A weigher must inspect the weighbeam assembly daily to make certain that 
there is clearance between the weighbeam and the pivot bearings.
    (6) Interferences or binding of the scale platform, or other 
``live'' parts of the scale, are common causes of weighing inaccuracy. A 
weigher shall satisfy himself, at the beginning of each weighing period, 
that all such ``live'' parts have sufficient clearance to prevent 
interference.
    (c) Weighing the load. (1) Vehicle scales used to weigh live poultry 
shall be of sufficient length and capacity to weigh an entire vehicle as 
a unit; provided, that a trailer may be uncoupled from a tractor and 
weighed as a single unit. Before weighing a vehicle, either coupled or 
uncoupled, the weigher shall be assured that the entire vehicle is on 
the scale platform and that no persons are on the scale platform.
    (i) On a weighbeam scale with a balance indicator the weight of a 
vehicle shall be determined by moving the poises to such positions that 
the indicator will come to rest within the central target area.
    (ii) On a weighbeam scale without a balance indicator the weight 
shall be determined by moving the poises to such positions that the 
weighbeam, when released from the top or bottom of the trig loop, will 
swing freely in the

[[Page 28]]

trig loop and come to rest at the approximate center of the trig loop.
    (iii) On a dial scale the weight of a vehicle is indicated 
automatically when the indicator revolves around the dial face and comes 
to rest.
    (iv) On an electronic digital scale the weight of a vehicle is 
indicated automatically when the weight value indicated is stable.
    (2) The correct weight is the value in pounds indicated by a 
weighbeam, dial or digital scale when a stable load balance is obtained. 
In any case, the weigher should concentrate on the beam tip, balance 
indicator, dial or digital indicator while weighing and not be concerned 
with reading the visible weight indications until a stable load balance 
is obtained. On electronic digital scales, the weigher should 
concentrate on the pulsing or flickering of weight values to assure that 
the unit indicates a stable weight before activating the print button.
    (d) Recording the weight. (1) The gross or tare weight shall be 
recorded immediately after the load balance is obtained and before any 
poises are moved or load removed from the scale platform. The weigher 
shall make certain that the printed weight record agrees with the weight 
value visibly indicated on the weighbeam, dial or digital indicator when 
correct load balance is obtained. The weigher shall also assure that the 
printed weight value is sufficiently distinct and legible.
    (2) The weight printing device on a scale shall be operated only to 
produce a printed or impressed record of the weight while the load is on 
the scale and correctly balanced. If the weight is not printed clearly 
and correctly, the ticket shall be marked void and a new one printed 
before the load is removed from the scale.
    (e) Weigher's responsibilities. (1) The primary responsibility of a 
weigher is to determine and record the true weight of live poultry 
without prejudice or favor to any person or agency and without regard 
for poultry ownership, price, condition, shrink, or other 
considerations. A weigher shall not permit the representations or 
attitudes of any persons or agencies to influence their judgment or 
action in performing his/her duties.
    (2) Scale tickets issued shall be serially numbered and used in 
numerical sequence. Sufficient copies shall be executed to provide a 
copy to all parties to the transaction. Unused scale tickets or those 
which are partially executed shall not be left exposed or accessible to 
other parties. All such tickets shall be kept under lock when the 
weigher is not at his duty station.
    (3) Accurate weighing and weight recording require that a weigher 
shall not permit operations to be hurried to the extent that inaccurate 
weights or incorrect weight records may result. The gross, tare and net 
weights must be determined accurately to the nearest minimum graduation. 
Manual operations connected with balancing, weighing, and recording 
shall be performed with the care necessary to prevent damage to the 
accurately machined and adjusted parts of weighbeams, poises, and 
printing devices. Rough handling of these parts shall be avoided.
    (4) Poultry growers, live poultry dealers, sellers, or others having 
legitimate interest in a load of poultry are entitled to observe the 
balancing, weighing, and recording procedures. A weigher shall not deny 
such persons that right or withhold from them any information pertaining 
to the weight. The weigher shall check the zero balance of the scale or 
reweigh a load of poultry when requested by such parties or duly 
authorized representatives of the administrator.
    (f) General precautions. (1) The poises of weighbeam scales are 
carefully adjusted and sealed to a definite weight at the factory and 
any change in that weight seriously affects weighing accuracy. A 
weigher, therefore, shall observe if poise parts are broken, loose or 
lost or if material is added to a poise and shall report any such 
condition to his/her superior or employer. Balancing or weighing shall 
not be performed while a scale ticket is in the slot of a weighbeam 
poise.
    (2) Stops are provided on scale weighbeams to prevent movement of 
poises back of the zero graduation when balancing or weighing. When the 
stops become worn or broken and allow a poise to be set behind the zero 
position, this condition must be reported

[[Page 29]]

by the weigher to their superior or employer and corrected without 
delay.
    (3) Motion detection circuits are a part of electronic scales. They 
are designed to prevent the printing of weight values if the load has 
not stabilized within prescribed limits. The weighmaster's duty is to 
print the actual weight of the load within these limits. This requires 
printing the actual weight of the load, not one of the other weights 
that may be within the motion detection limits.
    (4) Foreign objects or loose material in the form of nuts, bolts, 
washers, or other material on any part of the weighbeam assembly, 
including the counter-balance hanger or counter-balance weights, are 
potential sources of weighing error. Loose balancing material must be 
enclosed in the shot cup of the counter-balance hanger and counter-
balance weights must not be of the slotted type which can readily be 
removed.
    (5) Whenever, for any reason, a weigher has reason to believe that a 
scale is not functioning properly or not yielding correct weight values, 
the weigher shall discontinue weighing, report the facts to the parties 
responsible for scale maintenance and request inspection, test or repair 
of the scale.
    (6) When a scale has been adjusted, modified, or repaired in any 
manner which can affect the accuracy of weighing or weight recording, 
the weigher shall not use the scale until it has been tested and 
inspected and found to be accurate.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[37 FR 4955, Mar. 8, 1972, as amended at 61 FR 36282, July 10, 1996; 68 
FR 75388, Dec. 31, 2003]



Sec. 201.200  Sale of livestock to a packer on credit.

    (a) No packer whose average annual purchases of livestock exceed 
$500,000 shall purchase livestock on credit, and no dealer or market 
agency acting as an agent for such a packer shall purchase livestock on 
credit, unless: (1) Before purchasing such livestock the packer obtains 
from the seller a written acknowledgment as follows:

    On this date I am entering into a written agreement for the sale of 
livestock on credit to ----------------, a packer, and I understand that 
in doing so I will have no rights under the trust provisions of section 
206 of the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 196, 
Pub. L. 94-410), with respect to any such credit sale. The written 
agreement for such selling on credit

Covers a single sale.
Provides that it will remain in effect until (date).
Provides that it will remain in effect until canceled in writing by 
either party.
(Omit the provisions not applicable.)
Date____________________________________________________________________
Signature_______________________________________________________________

    (2) Such packer retains such acknowledgment, together with all other 
documents, if any, setting forth the terms of such credit sales on which 
the purchaser and seller have agreed, and such dealer or market agency 
retains a copy thereof, in his records for such time as is required by 
any law, or by written notice served on such person by the 
Administrator, but not less than two calendar years from the date of 
expiration of the written agreement referred to in such acknowledgment; 
and
    (3) Such seller receives a copy of such acknowledgment.
    (b) Purchasing livestock for which payment is to be made by a draft 
which is not a check, shall constitute purchasing such livestock on 
credit within the meaning of paragraph (a) of this section. (See also 
Sec. 201.43(b)(1).)
    (c) The provisions of this section shall not be construed to permit 
any transaction prohibited by Sec. 201.61(a) relating to financing by 
market agencies selling on a commission basis.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(Sec. 401, 42 Stat. 168 (7 U.S.C. 221); sec. 409, as added by sec. 7, 90 
Stat. 1250 (7 U.S.C 228b); 7 CFR 2.17, 2.54; 42 FR 35625; Pub. L. 96-
511, 94 Stat. 2812 (44 U.S.C. 3501 et seq.); 7 U.S.C. 222 and 228 and 15 
U.S.C. 46)

[42 FR 49929, Sept. 8, 1977, as amended at 49 FR 39516, Oct. 9, 1984; 54 
FR 37094, Sept. 7, 1989; 68 FR 75388, Dec. 31, 2003]

[[Page 30]]



PART 202_RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE PACKERS AND 
STOCKYARDS ACT--Table of Contents




            Rules of Practice Applicable to Rate Proceedings

Sec.
202.1 Applicability of other rules.
202.2 Definitions.
202.3 Institution of proceedings.
202.4 Answer and reply.
202.5 Hearing.
202.6 Taking no position on the merits.
202.7 Modification or vacation of final order.

         Rules of Practice Applicable to Reparation Proceedings

202.101 Rule 1: Meaning of words.
202.102 Rule 2: Definitions.
202.103 Rule 3: Beginning a reparation proceeding.
202.104 Rule 4: Agency action.
202.105 Rule 5: Filing; time for filing; service.
202.106 Rule 6: Answer.
202.107 Rule 7: Reply.
202.108 Rule 8: Docketing of proceeding.
202.109 Rule 9: Depositions.
202.110 Rule 10: Prehearing conference.
202.111 Rule 11: Hearing, oral or written.
202.112 Rule 12: Oral hearing.
202.113 Rule 13: Written hearing.
202.114 Rule 14: Post-hearing procedure.
202.115 Rule 15: Submission for final consideration.
202.116 Rule 16: Issuance of order.
202.117 Rule 17: Petition to reopen a hearing; to rehear or reargue a 
          proceeding; to reconsider an order; or to set aside a default 
          order.
202.118 Rule 18: Presiding officer.
202.119 Rule 19: Fees of witnesses.
202.120 Rule 20: Official notice.
202.121 Rule 21: Intervention.
202.122 Rule 22: Ex parte communications.
202.123 Rule 23: Action by Secretary.

    Authority: 7 U.S.C. 228(a); 7 CFR 2.17(e), 2.56.

    Source: 43 FR 30510, July 14, 1978, unless otherwise noted.

            Rules of Practice Applicable to Rate Proceedings

    Source: Sections 202.1 through 202.7 appear at 53 FR 51236, Dec. 21, 
1988, unless otherwise noted.



Sec. 202.1  Applicability of other rules.

    The Rules of Practice Governing Formal Adjudicatory Proceedings 
Instituted by the Secretary Under Various Statutes, 7 CFR part 1, 
subpart H, are applicable to all rate proceedings under Sections 304, 
305, 306, 307 and 310 of the Packers and Stockyards Act, 1921, as 
amended, 7 U.S.C. 205, 206, 207, 208 and 211, except insofar as those 
Rules are in conflict with any provision herein.



Sec. 202.2  Definitions.

    As used in these rules:
    (a) Rate proceeding means a proceeding involving the determination 
and prescription of any rate or charge made or proposed to be made for 
any stockyard service furnished at a stockyard by a stockyard owner or 
market agency, or a proceeding involving any rule, regulation or 
practice affecting any such rate or charge; and
    (b) Administrator means the Administrator of the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
(GIPSA), or any officer or employee of GIPSA to whom authority has 
heretofore been delegated, or to whom authority may hereafter be 
delegated, to act for the Administrator.



Sec. 202.3  Institution of proceedings.

    (a) Informal complaint. Any interested person desiring to complain 
of the lawfulness of any rate or charge made or proposed to be made for 
any stockyard service furnished at a stockyard by a stockyard owner or 
market agency, or rule, regulation or practice affecting any such rate 
or charge, may file an informal complaint with the Administrator.
    (b) Investigation. If there appears to be any reasonable ground for 
doing so, the Administrator will investigate the matter complained of. 
If the Administrator reasonably believes that there are not sufficient 
facts to form the basis for further proceeding, the matter may be 
dropped. If it is dropped, the person filing the informal complaint will 
be informed.
    (c) Status of person filing. A person filing an informal complaint 
will be a party to a rate proceeding if the Administrator files such 
person's informal complaint as a formal complaint, or if the Judge 
permits such person to intervene upon written application.

[[Page 31]]

    (d) Formal complaint. A rate proceeding may be instituted only upon 
filing of a formal complaint by the Administrator. A formal complaint 
may be filed on the initiative of the Administrator, or on the basis of 
an informal complaint, or by filing the informal complaint as a formal 
complaint. A formal complaint filed by the Administrator, or a summary 
thereof, will be published in the Federal Register, together with notice 
of the time by which, and the place where, any interested person may 
file a written request to be heard.



Sec. 202.4  Answer and reply.

    Respondent is not required to file an answer. If an answer is filed, 
complainant is not required to file a reply.



Sec. 202.5  Hearing.

    The hearing will be oral unless all parties waive oral hearing. It 
will be written if not oral. Notice of the date, time and place of oral 
hearing, or of the date and place for filing of written submissions in a 
written hearing, will be served on the Administrator and the respondent, 
and on such other persons as have requested in writing to be heard.



Sec. 202.6  Taking no position on the merits.

    The proceeding may be instituted by filing of the informal complaint 
as a formal complaint, and the Administrator may take no position on the 
merits of the case.



Sec. 202.7  Modification or vacation of final order.

    (a) Informal petition. Any interested person may file an informal 
petition to modify or vacate a final order at any time. Any such 
petition must be filed with the Administrator, be based on matters 
arising after the issuance of the final order, and set forth such 
matters, and the reasons or conditions relied on, with such 
particularity as is practicable. Any such informal petition will be 
handled as otherwise provided for an informal complaint.
    (b) Formal motion. A final order may be modified or vacated at any 
time only upon filing of a formal motion by the Administrator. Such a 
motion may be filed on the initiative of the Administrator, on the basis 
of an informal petition, or by filing of an informal petition as a 
formal motion.
    (c) Publication. If the modification or vacation sought would 
involve an increase of a rate or charge lawfully prescribed by the 
Secretary, or involve a rate or charge in addition to what is specified 
in the final order, or involve a regulation or practice so affecting 
such a rate or charge, the formal motion, or a summary thereof, will be 
published in the Federal Register, together with notice of the place, 
and the time by which, any interested person may file a written request 
to be heard.
    (d) Proceedings. Proceedings upon such a formal motion will be as 
otherwise provided for a formal complaint.

         Rules of Practice Applicable to Reparation Proceedings



Sec. 202.101  Rule 1: Meaning of words.

    In these rules, words in the singular form shall be deemed to import 
the plural, and vice versa, as the case may demand.



Sec. 202.102  Rule 2: Definitions.

    Terms defined in the Act shall mean the same in these rules as in 
the Act. In addition, and except as may be provided otherwise in these 
rules:
    Act means the Packers and Stockyards Act, 1921, and legislation 
supplementary thereto and amendatory thereof, 7 U.S.C. 181 et seq.;
    Agency means those divisions and offices of the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
of the Department which are charged with administration of the Act;
    Agency Head means the Administrator, Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards Programs) of the 
Department, or any officer or employee of the Agency to whom authority 
is lawfully delegated to act for the Administrator;
    Complainant means the party who files a complaint and claims 
reparation, or on whose behalf a complaint is filed and reparation is 
claimed, in a reparation proceeding;

[[Page 32]]

    Department means the United States Department of Agriculture;
    Docketing of a reparation proceeding means transmittal of papers to 
the Hearing Clerk and assignment of a docket number as provided in Rule 
8, Sec. 202.108, of these rules;
    Hearing means that part of a reparation proceeding which involves 
the submission of evidence for the record and means either an oral or a 
written hearing;
    Hearing Clerk means the Hearing Clerk of the Department (see 7 CFR 
2.25(a)(3));
    Judicial Officer means the official of the Department delegated 
authority by the Secretary, pursuant to the Act of April 4, 1940 (7 
U.S.C. 450c-450g) and Reorganization Plan No. 2 of 1953, to perform the 
function involved (see 7 CFR 2.35);
    Mail means to deposit an item in the United States mail with postage 
affixed and addressed as necessary to cause it to be delivered to the 
address shown by ordinary mail, or by certified or registered mail if 
specified.
    Presiding Officer means any attorney who is employed in the Office 
of the General Counsel of the Department and is assigned so to act in a 
reparation proceeding;
    Re-mail means to mail by ordinary mail to an address an item that 
has been returned after being sent to the same address by certified or 
registered mail.
    Reparation proceeding or Proceeding means a proceeding under the Act 
before the Secretary, in which an order for the payment of money is 
claimed and in which the Secretary is not a party of record;
    Report means the report to the Judicial Officer of the presiding 
officer's recommended findings of fact and conclusions with respect to 
all material issues of fact, law or discretion, as well as the reasons 
or basis therefor, and order, in a reparation proceeding.
    Respondent means the party against whom a complaint is filed and 
reparation is claimed, in a reparation proceeding;
    Secretary means the Secretary of Agriculture of the United States, 
or any officer or employee of the Department to whom authority is 
lawfully delegated to act for the Secretary;

[43 FR 30510, July 14, 1978, as amended at 46 FR 60414, Dec. 10, 1981; 
55 FR 41183, Oct. 10, 1990; 60 FR 8465, Feb. 14, 1995]



Sec. 202.103  Rule 3: Beginning a reparation proceeding.

    (a) Filing. A reparation proceeding is begun by filing a complaint. 
Any interested person (including any agency of a state or territory 
having jurisdiction over persons subject to the Act in such state or 
territory) desiring to complain of anything done or omitted to be done 
by any stockyard owner, market agency, or dealer in violation of 
sections 304, 305, 306, or 307, or of an order of the Secretary made 
under title III, of the Act, may file a complaint to begin a reparation 
proceeding.
    (b) Form. The complaint must be in writing, state the facts of the 
matter complained of, identify each person complained against 
(respondent), and identify each person who complains against such 
respondent and claims reparation from such respondent. It may be on a 
printed form supplied by the Agency, or may be a formal document, or may 
be a letter, mailgram, or telegram. It may be typewritten or 
handwritten. If it is not on a printed form supplied by the Agency, the 
Agency Head may, prior to docketing of the proceeding, recommend to the 
complainant that an amended complaint be filed on such a printed form.
    (c) Contents and attachments. So far as practicable, the complaint 
should include the following items as applicable:
    (1) Date and place where the alleged violation occurred;
    (2) Quantity and quality of the livestock involved;
    (3) Whether a sale is involved and, if so, the date, sale price, and 
amount actually paid and received;
    (4) Whether a consignment is involved and, if so the date, reported 
proceeds, gross, net;
    (5) Amount of reparation claimed, and method of computation;
    (6) Name and address of each partner or member, if a partnership or 
joint venture is involved;

[[Page 33]]

    (7) Name and address of each person involved, including any agent 
representing the complainant or the respondent in the transaction 
involved;
    (8) Other material facts, including terms of contract; and
    (9) True copies of all available papers relating to the transaction 
complained about, including shipping documents, letters, telegrams, 
invoices, manifests, accounts of sales, and special contracts or 
agreements, and checks and drafts. If it appears that any such item has 
been omitted from the complaint, the Agency Head may, prior to docketing 
of the proceeding, recommend to the complainant that such item be 
supplied by written amendment to the complaint.
    (d) Where to file. The complaint should be transmitted or delivered 
to any area office of the Agency, or to the headquarters of the Agency 
in Washington, DC, or delivered to any full time employee of the Agency.
    (e) Time for filing. The complaint must be received by the 
Department within 90 days after accrual of the cause of action alleged 
in it. If a complaint is transmitted or delivered to an office of the 
Department, it shall be deemed to be received by the Department when it 
reaches such office. If a complaint is delivered to a full time employee 
of the Agency, it shall be deemed to be received by the Department when 
it is received by such employee.
    (f) Amendment. The complaint may be amended at any time prior to the 
close of an oral hearing or the filing of the last evidence in a written 
hearing, except that:
    (1) An amendment cannot add a respondent if it is filed more than 90 
days after accrual of the cause of action against such respondent;
    (2) An amendment cannot state a new and different cause of action if 
it is filed more than 90 days after accrual of such new and different 
cause of action; and
    (3) After the first amendment, or after the filing of an answer by 
the respondent, an amendment may not be filed without the written 
consent of the respondent, or leave of the presiding officer, or, prior 
to docketing of the proceeding, leave of the Agency Head. Any such 
amendment must be filed in writing and signed by the complainant or the 
attorney or representative of the complainant. If any such amendment is 
filed before the initial service of the complaint on the respondent, it 
shall be served on the respondent only if the complaint is served as 
provided in Rule 4(b), Sec. 202.104(b). If any such amendment is filed 
after such service, it shall be served on the respondent in any case.
    (g) Withdrawal. At any time, a complainant may withdraw a complaint 
filed by or on behalf of the same complainant, thus terminating the 
reparation proceeding on such complaint unless a counterclaim or another 
complaint is pending therein. If a complainant fails to cooperate with 
the Secretary in the disposition of the matter complained of, such 
complainant may be presumed to desire to withdraw the complaint filed by 
or on behalf of such complainant, after service on the parties of 
written notice of the facts of such failure and reasonable opportunity 
for such complainant to state whether such presumption is correct.

[43 FR 30510, July 14, 1978, as amended at 60 FR 8465, Feb. 14, 1995]



Sec. 202.104  Rule 4: Agency action.

    (a) Informal disposition. If there appears to be any reasonable 
ground for doing so, the Agency Head shall investigate the matter 
complained of. If the Agency Head reasonably believes that there are not 
sufficient facts to form the basis for further proceeding, the matter 
may be dropped, without prejudice to subsequent court action on the same 
cause of action; if it is dropped, the person filing the complaint shall 
be informed. If the statements in the complaint, and information 
obtained in the investigation, seem to warrant such action, the Agency 
Head may make an effort to obtain the consent of the parties to an 
amicable or informal adjustment of the matter by communication with the 
parties or their attorneys or representatives. Such communication may be 
written or oral or both.
    (b) Service of complaint. If the matter is not disposed of as 
provided in paragraph (a), the complaint, together with any amendment 
which has been filed,

[[Page 34]]

shall be served on the respondent with a notice that an answer is 
required.
    (c) Service of report of investigation. A report prepared by the 
Agency, of its investigation of the matter complained of, and 
supplements to such a report, may be served on the parties and made a 
part of the record of the proceeding. Whether such a report or 
supplement shall be prepared, and whether it shall be served on the 
parties and made a part of the record, and its contents, shall be in the 
discretion of the Agency Head. The Judicial Officer shall consider 
information in such a report or supplement as part of the evidence in 
the proceeding, to the extent that such information is relevant and 
material to the proceeding. Any party may submit evidence in rebuttal of 
such information as is provided generally in these rules for the 
submission of evidence. Oral testimony, to the extent credible, shall be 
given greater weight as evidence than such information.



Sec. 202.105  Rule 5: Filing; time for filing; service.

    (a) Filing; number of copies. Prior to docketing of a proceeding 
under these rules, all documents and papers other than the initial 
complaint, filed in the proceeding, shall be filed with the Agency. 
After such docketing of a proceeding, all such documents and papers 
shall be filed with the hearing clerk, Provided, That all such documents 
and papers, except a petition for disqualification of a presiding 
officer, shall be filed with the presiding officer if the parties have 
been served with written notice to do so. Each such document or paper 
shall be filed in quadruplicate with an extra copy for each party in 
excess of two, except as otherwise provided in these rules. Any document 
or paper not filed in the required number of copies, except an initial 
complaint, may be returned to the party filing it.
    (b) Effective date of filing. Any document or paper other than an 
initial complaint, filed in a proceeding under these rules, shall be 
deemed to be filed at the time when it reaches the headquarters of the 
Department in Washington DC, or, if authorized to be filed with an 
officer or employee of the Department at any place outside the District 
of Columbia, it shall be deemed to be filed at the time when it reaches 
the office of such officer or employee.
    (c) Additional time for filing. The time for the filing of any 
document or paper other than an initial complaint, in a proceeding under 
these rules, may upon request be extended as reasonable, by the agency 
head prior to docketing of the proceeding, or by the presiding officer, 
or by the judicial officer; notice of any extension of time shall be 
served on all parties. After docketing of the proceeding, in all 
instances in which time permits, notice of a request for extension of 
time shall be given to parties other than the one filing such request, 
with opportunity to submit views concerning the request.
    (d) Computation of time. Saturdays, Sundays, and Federal holidays 
shall be included in computing the time allowed for the filing of any 
document or paper: Provided, That, when such time expires on a Saturday, 
Sunday, or Federal holiday, such time shall be extended to include the 
next following business day.
    (e) Who shall make service. Copies of all documents or papers 
required or authorized by the rules in this part to be filed with the 
Agency shall be served on the parties by the Agency, and copies of all 
documents or papers required or authorized by the rules in this part to 
be filed with the Hearing Clerk shall be served on the parties by the 
Hearing Clerk, unless any such document or paper is served by some other 
employee of the Department, or by a U.S. marshal or deputy marshal, or 
as otherwise provided herein, or as otherwise directed by the presiding 
officer or Judicial Officer.
    (f) Service on party. (1) Any complaint or other document initially 
served on a person to make that person a party respondent in a 
proceeding, a final order, or other document specifically ordered by the 
presiding officer or Judicial Officer to be served by certified or 
registered mail, shall be deemed to be received by any party to a 
proceeding on the date of delivery by certified or registered mail to 
the last known principal place of business of such party, last known 
principal place of business of the attorney or representative of record 
of such party, or last known residence of such party if an individual,

[[Page 35]]

provided that, if any such document or paper is sent by certified on 
registered mail but is returned marked by the postal service as 
unclaimed or refused, it shall be deemed to be received by such party on 
the date of remailing by ordinary mail to the same address.
    (2) Any document or paper, other than one specified in paragraph 
(f)(1) of this section or written questions for a deposition as provided 
in Sec. 202.109(c)(3), shall be deemed to be received by any party to a 
proceeding on the date of mailing by ordinary mail to the last known 
principal place of business of such party, last known principal place of 
business of the attorney or representative or record of such party, or 
last known residence of such party if an individual.
    (3) Any document or paper served other than by mail on any party to 
a proceeding shall be deemed to be received by such party on the date 
of:
    (i) Delivery to any responsible individual at, or leaving in a 
conspicuous place at, the last known principal place of business of such 
party, last known principal place of business of the attorney or 
representative of record of such party, or last known residence of such 
party if an individual, or
    (ii) Delivery to such party if an individual, to an officer or 
director of such party if a corporation, or to a member of such party if 
a partnership, at any location.
    (g) Service on another. Any subpoena or other document or paper 
served on any person other than a party to a proceeding shall be deemed 
to be received by such person on the date of:
    (1) Delivery by certified mail or registered mail to the last known 
principal place of business of such person, last known principal place 
of business of the attorney or representative of record of such person, 
or last known residence of such person if an individual;
    (2) Delivery other than by mail to any responsible individual at, or 
leaving in a conspicuous place at, any such location; or
    (3) Delivery to such party if an individual, to an officer or 
director of such party if a partnership, at any location.
    (h) Proof of service. Any of the following, in the possession of the 
Department, showing such service, shall be deemed to be accurate:
    (1) A certified or registered mail receipt returned by the postal 
service with a signature;
    (2) An official record of the postal service;
    (3) An entry on a docket record or a copy placed in a docket file by 
the Hearing Clerk of the Department or by an employee of the Hearing 
Clerk in the ordinary course of business;
    (4) A certificate of service, which need not be separate from and 
may be incorporated in the document or paper of which it certifies 
service, showing the method, place and date of service in writing and 
signed by an individual with personal knowledge thereof, Provided that 
such certificate must be verified by oath or declaration under penalty 
of perjury if the individual certifying service is not a party to the 
proceeding in which such document or paper is served, an attorney or 
representative of record for such a party, or an official or employee of 
the United States or of a State of political subdivision thereof.

[43 FR 30510, July 14, 1978, as amended at 55 FR 41183, Oct. 10, 1990; 
60 FR 8465, Feb. 14, 1995]



Sec. 202.106  Rule 6: Answer.

    (a) Filing and service. Within 20 days after service on a 
respondent, of a complaint or amendment of a complaint, such person 
shall file an answer in writing, signed by such person or by the 
attorney or representative of such person. If a respondent desires an 
oral hearing, a request for it should be included with the answer of 
such person. If any answer or amended answer is filed, it shall be 
served on the complainant.
    (b) Required contents. If a respondent desires to make a defense, 
the answer of such person shall contain a precise statement of the facts 
which constitute the grounds of defense, and shall specifically admit, 
deny, or explain each of the allegations of the complaint, except that, 
if the respondent is without knowledge, such answer shall state that. If 
a respondent does not desire to make a defense, the answer of such 
person shall contain an admission of all the allegations of the 
complaint, or an

[[Page 36]]

admission of liability to the complainant in the full amount claimed by 
the complainant as reparation, or both. An answer may be stricken for 
failure to comply with these requirements; notice of an order so 
striking an answer shall be served on the parties; within 20 days after 
service on a respondent of such a notice, such person shall file an 
answer which complies with these requirements.
    (c) Setoff, counterclaim or cross-claim. The answer may assert a 
setoff, counterclaim, or cross-claim, or any combination thereof. No 
counterclaim or cross-claim shall be considered unless it is based on a 
violation for which the act authorizes reparation to be ordered to be 
paid, and filed within 90 days after accrual of the cause of action 
alleged therein: Provided, That a counterclaim not filed within such 
time limit may be considered if based on a transaction complained of in 
the complaint. Any cross-claim asserted against a co-respondent, based 
on a violation for which the act authorizes reparation to be ordered to 
be paid, and filed within 90 days after accrual of the cause of action 
alleged therein, shall be served on such person as a complaint; within 
20 days after such service, such person shall file an answer thereto in 
compliance with the above requirements for an answer to a complaint.
    (d) Failure to file. If a respondent fails to file an answer as 
required above, such persons shall be deemed to have admitted all the 
allegations of the complaint or cross-claim against such person, and to 
have consented to the issuance of a final order in the proceeding, based 
on all evidence in the record. For this purpose, the evidence in the 
record may include information contained in a report of investigation 
made a part of the record pursuant to rule 4(c), Sec. 202.104(c), and 
evidence received in a hearing, oral or written, held subsequent to the 
expiration of the time for filing such answer, but shall not be limited 
to such information and evidence. Such a respondent shall not be 
entitled to service provided in these rules, of any notice or document 
except the final order in the proceeding.



Sec. 202.107  Rule 7: Reply.

    (a) Filing and service. If the answer asserts a counterclaim or a 
setoff, the complainant may file a reply in writing within 20 days after 
service of the answer on such person. If any reply or amended reply is 
filed, it shall be served on the respondent.
    (b) Contents. The reply shall be confined strictly to the matters 
alleged in the counterclaim or setoff asserted in the answer. It shall 
contain a precise statement of the facts which constitute the grounds of 
defense to the counterclaim or setoff and shall specifically admit, 
deny, or explain each of the allegations of the answer constituting such 
counterclaim or setoff, except that, if the complainant is without 
knowledge, the reply shall state that.
    (c) Failure to file. If no reply is filed, the allegations of the 
answer shall be regarded as denied.

[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990]



Sec. 202.108  Rule 8: Docketing of proceeding.

    Promptly following receipt of the answer, or the reply (if the 
answer asserts a counterclaim or a setoff), or following the expiration 
of the period of time prescribed above for the filing of the answer or 
of the reply, the agency head shall transmit all of the papers which 
have been filed in the proceeding (including the investigation report if 
any has been served on the parties) to the hearing clerk, who shall 
assign a docket number to the proceeding. Thereafter the proceeding 
shall be referred to by such number. The hearing clerk shall promptly 
transmit all such papers to the Office of the General Counsel for 
assignment of a presiding officer.



Sec. 202.109  Rule 9: Depositions.

    (a) Application. Any party may file an application for an order for 
the taking of testimony by deposition, at any time after docketing of a 
proceeding and before the close of an oral hearing or the filing of such 
party's evidence in a written hearing therein. The application shall set 
forth: (1) The name and address of the proposed deponent; (2)

[[Page 37]]

the name and address of the person (referred to in this section as the 
``officer'') before whom the proposed examination is to be made; (3) the 
reasons why such deposition should be taken, which must show that it may 
be able to be used as set forth in paragraph (i) of this section; (4) 
whether the proposed examination is to be on interrogatories or oral; 
and (5) if oral, a suggested time and place where the proposed 
deposition is to be made and a suggested manner in which the proposed 
deposition is to be conducted (telephone, audio-visual 
telecommunication, or by personal attendance of the individuals who are 
expected to participate in the deposition). The application for an order 
for the taking of testimony by deposition shall be made in writing, 
unless it is made orally on the record at an oral hearing.
    (b) Response; service. If any such application is made orally on the 
record at an oral hearing, each party other than the applicant, present 
at such hearing, may respond to it orally. If any such application is in 
writing it shall be served on each party other than the applicant, and 
each such other party shall have not less than 20 days, from the date of 
service on such party of the application, to file a written response to 
it.
    (c) Written questions (interrogatories). (1) If the examination will 
be oral, parties who will not be present or represented at it may file 
written questions with the officer prior to the time of the examination.
    (2) The presiding officer may direct, or the parties may agree, that 
the deposition, if taken, shall be taken by means of written questions. 
If the presiding officer finds, upon the protest of a party to the 
proceeding, that such party has a principal place of business or 
residence more than 100 miles from the place of the examination and that 
it would constitute an undue hardship on such party to be present or 
represented at an oral examination at such place, the deposition, if 
taken, shall be taken by means of written questions. In any such case, 
the presiding officer shall state on the record at the oral hearing 
that, or shall serve the parties with notice that, the deposition, if 
taken, shall be taken by means of written questions.
    (3) If the examination is conducted by means of written questions, 
copies of the applicant's questions must be received by the other party 
to the proceeding and the officer at least 10 days prior to the date set 
for the examination unless otherwise agreed, and any cross questions of 
a party other than the applicant must be received by the applicant and 
the officer at any time prior to the time of the examination.
    (d) Order. (1) The presiding officer, if satisfied that good cause 
for taking the deposition is present, may order the taking of the 
deposition.
    (2) The order shall be served on the parties and shall include:
    (i) The name and address of the officer before whom the deposition 
is to be made;
    (ii) The name of the deponent;
    (iii) Whether the deposition will be oral or on written questions;
    (iv) If the deposition is oral, the manner in which the deposition 
is to be conducted (telephone, audio-visual telecommunication, or 
personal attendance of those who are to participate in the deposition); 
and
    (v) The time, which shall not be less than 20 days after the 
issuance of the order, and place.
    (3) The officer, time, place, and manner of the deposition as stated 
in the presiding officer's order need not be the same as the officer, 
time, place, and manner suggested in the application.
    (4) The deposition shall be conducted in the manner (telephone, 
audio-visual telecommunication, or personal attendance of those who are 
to participate in the deposition) agreed to by the parties.
    (5) If the parties cannot agree on the manner in which the 
deposition is to be conducted:
    (i) The deposition shall be conducted by telephone unless the 
presiding officer determines that conducting the deposition by audio-
visual telecommunication:
    (A) Is necessary to prevent prejudice to a party;
    (B) Is necessary because of a disability of any individual expected 
to participate in the deposition; or

[[Page 38]]

    (C) Would cost less than conducting the deposition by telephone.
    (ii) If the deposition is not conducted by telephone, the deposition 
shall be conducted by audio-visual telecommunication unless the 
presiding officer determines that conducting the deposition by personal 
attendance of any individual who is expected to participate in the 
deposition:
    (A) Is necessary to prevent prejudice to a party;
    (B) Is necessary because of a disability of any individual expected 
to participate in the deposition; or
    (C) Would cost less than conducting the deposition by telephone or 
audio-visual telecommunication.
    (e) Qualifications of officer. No deposition shall be made except 
before an officer authorized by the law of the United States or by the 
law of the place of the examination to administer oaths, or before an 
officer authorized by the Secretary to administer oaths, or before the 
presiding officer. No deposition shall be made before an officer who is 
a relative (within the third degree by blood or marriage), employee, 
attorney, or representative of any party (or an employee of an attorney 
or representative of any party), or who is financially interested in the 
result of the proceeding.
    (f) Procedure on examination. The deponent shall be examined under 
oath or affirmation, and the testimony of the deponent shall be recorded 
by the officer, or by some person under the direction and in the 
presence of the officer. If the examination is on interrogatories, they 
shall be propounded by the officer. If the examination is oral, the 
deponent shall be examined first by the party at whose instance the 
deposition is taken, or the representative of such party, and shall be 
subject to cross-examination by any other party or the representative 
thereof who is present at the examination; the officer shall propound 
any interrogatories filed with the officer by parties not present or 
represented at the examination.
    (g) Certification and filing by officer. The officer shall certify 
on the transcript or recording that the deponent was duly sworn by the 
officer and that the transcript or recording is a true record of the 
deponent's testimony, with such exceptions as the certificate shall 
specify. The officer shall then securely seal the transcript or 
recording, together with three copies of the transcript or recording, 
with an extra copy for each party in excess of two, in an envelope, and 
mail the same by registered or certified mail to the presiding officer.
    (h) Service; correction. After the transcript or recording is 
received by the presiding officer, it shall promptly be served on all 
parties. Any party, within 20 days after such service, may file a 
written motion proposing corrections to the transcript or recording. Any 
such motion shall be served on each party other than the one filing it, 
who shall have 10 days to file a written response to it. Any such 
response shall be served on each party other than the one filing it. 
Such documents, if filed, shall be a part of the record of the 
proceeding if any portion of the transcript or recording is made a part 
of the record. All portions of the transcript or recording which are not 
referred to in any such motion shall be presumed to be accurate except 
for obvious typographical errors.
    (i) Use. If a written hearing is held, a transcript or recording, of 
a deposition ordered and taken in accord with this section, may be made 
a part of the record as evidence by any party, by written motion filed 
with such party's evidence. If an oral hearing is held, except as 
otherwise provided in these rules, such a transcript or recording may be 
made a part of the record as evidence, on written motion filed by any 
party, or oral motion of any party made at the oral hearing, if no party 
objects after reasonable notice and opportunity to do so, or if the 
presiding officer finds that the evidence is otherwise admissible and:
    (1) That the witness is dead;
    (2) That the witness is unable to attend or testify for any good 
reason including age, sickness, infirmity, or imprisonment;
    (3) That the party offering the transcript or recording has tried 
without success to procure the attendance of the witness by subpoena; or

[[Page 39]]

    (4) That such exceptional circumstances exist as to make it 
desirable, in the interests of justice and with due regard to the 
importance of presenting the testimony orally before the presiding 
officer, to allow the transcript or recording to be used.

If any portion of a transcript or recording of a deposition is made a 
part of the record as evidence on motion of any party, any other party 
may make a part of the record as evidence the remainder, or any other 
portion, of the transcript or recording.
    (j) Expenses. Fees and reimbursements payable to an officer taking a 
deposition, or other person recording the testimony in the deposition, 
shall be paid by the party at whose instance the deposition is taken.
    (k) Subpoenas. No subpoena can issue, to compel attendance, 
testimony, or production of documentary evidence, at an examination 
under this rule 9.
    (l) Agreement of parties. In any case, any transcript or recording 
of any deposition, or any part of such a transcript or recording, may be 
made a part of the record as evidence by agreement of the parties other 
than a party failing to file an answer as required in these rules.

[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990; 
60 FR 8465, Feb. 14, 1995]



Sec. 202.110  Rule 10: Prehearing conference.

    (a) The presiding officer, at any time prior to the commencement of 
the hearing, may request the parties or their counsel to appear at a 
conference before the presiding officer to consider:
    (1) The simplification of issues;
    (2) The necessity of amendments to pleadings;
    (3) The possibility of obtaining stipulations of fact and of the 
authenticity, accuracy, and admissibility of documents, which will avoid 
unnecessary proof;
    (4) The limitation of the number of expert or other witnesses;
    (5) The negotiation, compromise, or settlement of issues;
    (6) The exchange of copies of proposed exhibits;
    (7) The identification of documents or matters of which official 
notice may be requested;
    (8) A schedule to be followed by the parties for completion of the 
actions decided at the conference; or
    (9) Such other matters as may expedite and aid in the disposition of 
the proceeding.

No transcript or recording of such a conference shall be made, but the 
presiding officer shall prepare and file for the record a written 
summary if any action is taken at the conference, which shall 
incorporate any written stipulations or agreements made by the parties 
at the conference or as a result of the conference.
    (b) Manner of the prehearing conference. (1) The prehearing 
conference shall be conducted by telephone or correspondence unless the 
presiding officer determines that conducting the prehearing conference 
by audio-visual telecommunication:
    (i) Is necessary to prevent prejudice to a party;
    (ii) Is necessary because of a disability of any individual expected 
to participate in the prehearing conference; or
    (iii) Would cost less than conducting the prehearing conference by 
telephone or correspondence. If the presiding officer determines that a 
prehearing conference conducted by audio-visual telecommunication would 
measurably increase the United States Department of Agriculture's cost 
of conducting the prehearing conference, the prehearing conference shall 
be conducted by personal attendance of any individual who is expected to 
participate in the prehearing conference, by telephone, or by 
correspondence.
    (2) If the prehearing conference is not conducted by telephone or 
correspondence, the prehearing conference shall be conducted by audio-
visual telecommunication unless the presiding officer determines that 
conducting the prehearing conference by personal attendance of any 
individual who is expected to participate in the prehearing conference:
    (i) Is necessary to prevent prejudice to a party;
    (ii) Is necessary because of a disability of any individual expected 
to

[[Page 40]]

participate in the prehearing conference; or
    (iii) Would cost less than conducting the prehearing conference by 
audio-visual telecommunication.

[43 FR 30510, July 14, 1978, as amended at 60 FR 8466, Feb. 14, 1995]



Sec. 202.111  Rule 11: Hearing, oral or written.

    (a) When held. A hearing, oral or written, shall be held unless:
    (1) Each respondent admits or is deemed to admit sufficient 
allegations of the complaint to support the full amount claimed by the 
complainant as reparation;
    (2) Each respondent admits liability to the complainant in the full 
amount claimed by the complainant as reparation;
    (3) Before a hearing has been completed the parties agree in writing 
that the proceeding may be decided on the basis of the record as it 
stands at the time such agreement is filed; or
    (4) Before a hearing has been completed the parties settle their 
dispute or the complainant withdraws the complaint.
    (b) Whether oral or written. The hearing provided for in paragraph 
(a) of this section shall be oral if:
    (1) $10,000 or more is in controversy and any respondent files a 
written request for an oral hearing with such respondent's answer; or
    (2) $10,000 or more is in controversy and any complainant files a 
written request for an oral hearing on or before the 20th day after 
service on such complainant of notice that no respondent has filed a 
timely request for an oral hearing; or
    (3) Less than $10,000 is in controversy and the presiding officer 
determines, upon written request by any party thereto, that an oral 
hearing is necessary to establish the facts and circumstances giving 
rise to the controversy. The hearing shall be written if not oral.
    (c) Withdrawal of request. If $10,000 or more is in controversy and 
a party has timely filed a request for oral hearing, such party may 
withdraw such request at any time prior to completion of an oral 
hearing. If such a withdrawal leaves no pending request for oral hearing 
in the proceeding, and if the presiding officer has not decided that the 
hearing should be oral, each other party shall be served with notice of 
this and shall be given 20 days to request an oral hearing. If any party 
files a request for oral hearing in such time, the hearing shall be oral 
in accordance with paragraph (b) of this section.
    (d) Presiding Officer's recommendation. The presiding officer may 
recommend voluntary withdrawal of a request for oral hearing, timely 
filed. Declining to make such withdrawal shall not affect the rights or 
interests of any party.
    (e) Representation. Any party may appear in an oral hearing, or file 
evidence in a written hearing, in person or by counsel or other 
representative. For unethical or contumacious conduct in or in 
connection with a proceeding, the presiding officer may preclude a 
person from further acting as attorney or representative for any party 
to the proceeding; any such order of the presiding officer shall be 
served on the parties; an appeal to the Judicial Officer may be taken 
from any such order immediately.

[51 FR 42083, Nov. 21, 1986, as amended at 55 FR 41184, Oct. 10, 1990]



Sec. 202.112  Rule 12: Oral hearing.

    (a) Time, place, and manner. (1) If and when the proceeding has 
reached the stage where an oral hearing is to be held, the presiding 
officer shall set a time, place, and manner for oral hearing. The time 
shall be set based upon careful consideration to the convenience of the 
parties. The place shall be set in accordance with paragraph (a)(2) of 
this section and careful consideration to the convenience of the 
parties. The manner in which the hearing is to be conducted shall be 
determined in accordance with paragraphs (a)(3) and (a)(4) of this 
section.
    (2) The place shall be set in accordance with paragraphs (e) and (f) 
of section 407 of the Act, if applicable. In essence, under paragraphs 
(e) and (f) of section 407 of the Act, if the complainant and the 
respondent, or all of the parties, if there are more than two, have 
their principal places of business or residence within a single unit of

[[Page 41]]

local government, a single geographical area within a State, or a single 
State, the oral hearing is to be held as near as possible to such places 
of business or residence, depending on the availability of an 
appropriate location for conducting the hearing. If the parties have 
such places of business or residence distant from each other, then 
paragraphs (e) and (f) of section 407 of the Act are not applicable.
    (3) The oral hearing shall be conducted by audio-visual 
telecommunication unless the presiding officer determines that 
conducting the oral hearing by personal attendance of any individual who 
is expected to participate in the hearing:
    (i) Is necessary to prevent prejudice to a party;
    (ii) Is necessary because of a disability of any individual expected 
to participate in the hearing; or
    (iii) Would cost less than conducting the hearing by audio-visual 
telecommunication. If the presiding officer determines that a hearing 
conducted by audio-visual telecommunication would measurably increase 
the United States Department of Agriculture's cost of conducting the 
hearing, the hearing shall be conducted by personal attendance of any 
individual who is expected to participate in the hearing or by 
telephone.
    (4) The presiding officer may, in his or her sole discretion or in 
response to a motion by a party to the proceeding, conduct the hearing 
by telephone if the presiding officer finds that a hearing conducted by 
telephone:
    (i) Would provide a full and fair evidentiary hearing;
    (ii) Would not prejudice any party; and
    (iii) Would cost less than conducting the hearing by audio-visual 
telecommunication or personal attendance of any individual who is 
expected to participate in the hearing.
    (b) Notice. (1) A notice stating the time, place, and manner of oral 
hearing shall be served on each party prior to the time of the oral 
hearing. The notice shall state whether the oral hearing will be 
conducted by telephone, audio-visual telecommunication, or personal 
attendance of any individual expected to participate in the hearing. If 
any change is made in the time, place, or manner of the oral hearing, a 
notice of the change shall be served on each party prior to the time of 
the oral hearing as changed, unless the change is made during the course 
of an oral hearing and shown in the transcript or on the recording. Any 
party may waive such notice, in writing, or orally on the record at an 
oral hearing and shown in the transcript or on the recording.
    (2) If the presiding officer orders an oral hearing, any party may 
move that the hearing be conducted by telephone or personal attendance 
of any individual expected to attend the hearing rather than by audio-
visual telecommunication. Any motion that the hearing be conducted by 
telephone or personal attendance of any individual expected to attend 
the hearing must be accompanied by a memorandum in support of the motion 
stating the basis for the motion and the circumstances that require the 
hearing to be conducted other than by audio-visual telecommunication.
    (3) Within 10 days after the presiding officer issues a notice 
stating the manner in which the hearing is to be conducted, any party 
may move that the presiding officer reconsider the manner in which the 
hearing is to be conducted. Any motion for reconsideration must be 
accompanied by a memorandum in support of the motion stating the basis 
for the motion and the circumstances that require the hearing to be 
conducted other than in accordance with the presiding officer's notice.
    (c) Failure to appear. If any party to the proceeding, after being 
duly notified, fails to appear at the oral hearing in person or by 
counsel or other representative, such party shall be deemed to have 
waived the right to add any further evidence to the record in the 
proceeding, or to object to the admission of any evidence; if the 
parties who are present are all adverse to such party, they shall have 
an election to present evidence, in whole or in part, in the form of 
oral testimony before the presiding officer, affidavits, or depositions.
    (d) Order of proceeding. Complainant shall proceed first, if present 
at the commencement of the oral hearing.

[[Page 42]]

    (e) Written statements of direct testimony. (1) Except as provided 
in paragraph (e)(2) of this section, each party must exchange with all 
other parties a written narrative verified statement of the oral direct 
testimony that the party will provide at any hearing to be conducted by 
telephone; the direct testimony of each employee or agent of the party 
that the party will call to provide oral direct testimony at any hearing 
to be conducted by telephone; and the direct testimony of each expert 
witness that the party will call to provide oral direct testimony at any 
hearing to be conducted by telephone. The written direct testimony of 
witnesses shall be exchanged by the parties at least 10 days prior to 
the hearing. The oral direct testimony provided by a witness at a 
hearing conducted by telephone will be limited to the presentation of 
the written direct testimony, unless the presiding officer finds that 
oral direct testimony which is supplemental to the written direct 
testimony would further the public interest and would not constitute 
surprise.
    (2) The parties shall not be required to exchange testimony in 
accordance with this paragraph if the hearing is scheduled to begin less 
than 20 days after the presiding officer's notice stating the time of 
the hearing.
    (f) Evidence--(1) In general. The testimony of witnesses at an oral 
hearing shall be on oath or affirmation and subject to cross-
examination. Any witness other than a party may be examined separately 
and apart from all other witnesses, in the discretion of the presiding 
officer. The presiding officer shall exclude evidence which is 
immaterial, irrelevant, or unduly repetitious, or which is not of the 
sort on which responsible persons are accustomed to rely, insofar as 
practicable.
    (2) Objections. If a party objects to the admission of any evidence 
or to the limitation of the scope of any examination or cross-
examination or to any other ruling of the presiding officer, such party 
shall state briefly the grounds of such objection, and the presiding 
officer shall rule on it. The transcript or recording shall include 
argument or debates on objections, except as ordered by the presiding 
officer, and shall include the ruling of the presiding officer. 
Objections not made before the presiding officer may not subsequently be 
relied on in the proceeding.
    (3) Offer of proof. Whenever evidence is excluded by the presiding 
officer, the party offering such evidence may make an offer of proof. 
The offer of proof shall consist of a brief statement, which shall be 
included in the transcript or recording, describing the evidence 
excluded. If the evidence consists of a brief oral statement, it shall 
be included in full in the transcript or recording. If the evidence 
consists of an exhibit, it shall be marked for identification and 
inserted in the record. In either such event, if the judicial officer 
decides that the presiding officer's ruling in excluding the evidence 
was erroneous and prejudicial, such evidence shall be considered a part 
of the record. If the taking of such evidence will consume a 
considerable length of time at the hearing, the presiding officer shall 
not allow the insertion of such evidence in full and, if the judicial 
officer decides that the presiding officer's ruling in excluding the 
evidence was erroneous and prejudicial, the hearing shall be reopened to 
permit the taking of such evidence.
    (4) Depositions and affidavits. Except as is otherwise provided in 
these rules, admission of the deposition of any witness shall be subject 
to the provisions of rule 9, Sec. 202.109, and affidavits, and 
statements under penalty of perjury as provided in 28 U.S.C. 1746, Pub. 
L. 94-550, may be admitted only if the evidence is otherwise admissible 
and no party objects.
    (5) Department records. A true copy of any written entry in any 
record of the Department, made by an officer or employee of the 
Department in the course of the official duty of such officer or 
employee, and relevant to the issues involved in the hearing, shall be 
admissible as prima facie evidence of the facts stated in the record of 
the Department, without the production of such officer or employee.
    (6) Exhibits. (i) For each exhibit offered by a party, copies in 
addition to the original shall be filed with the presiding officer for 
the use of all other parties to the proceeding, except where the 
presiding officer finds that the furnishing of copies is impracticable. 
The

[[Page 43]]

presiding officer shall tell the parties the number of copies required 
to be filed, make the proper distribution of the copies, and have this 
noted on the record.
    (ii) If the testimony of a witness refers to any document, the 
presiding officer shall determine whether it shall be produced at the 
hearing and made a part of the record as an exhibit, or whether it shall 
be incorporated in the record by reference.
    (iii) If relevant and material matter is embraced in a document 
containing irrelevant or immaterial matter, such irrelevant or 
immaterial matter shall be designated by the party offering the document 
in evidence, and shall be segregated and excluded, insofar as 
practicable.
    (g) Subpoenas--(1) Issuance. The attendance and testimony of 
witnesses and the production of documentary evidence, from any place in 
the United States, on behalf of any party to the proceeding, may be 
required by subpoena at any designated place for oral hearing. Subpoenas 
may be issued by the presiding officer, on a written application filed 
by a party, showing the grounds and necessity thereof, and, with respect 
to subpoenas for the production of documentary evidence, showing their 
competency, relevancy, and materiality and the necessity for their 
production. Subpoenas may be issued on the motion of the presiding 
officer.
    (2) Service; proof of service. A subpoena may be served by any 
natural person over the age of 18 years. The party at whose instance a 
subpoena is issued shall be responsible for serving it, however, at the 
request of such party the Secretary will attempt to serve it.
    (h) Oral argument. The presiding officer shall permit oral argument 
by the parties or their counsel who are present at an oral hearing, but 
may limit such argument to any extent that the presiding officer finds 
necessary for the expeditious or proper disposition of the case.
    (i) Transcript or recording. (1) Hearings to be conducted by 
telephone shall be recorded verbatim by electronic recording device. 
Hearings conducted by audio-visual telecommunication or the personal 
attendance of any individual who is expected to participate in the 
hearing shall be transcribed, unless the presiding officer finds that 
recording the hearing verbatim would expedite the proceeding and the 
presiding officer orders the hearing to be recorded verbatim. The 
presiding officer shall certify that to the best of his or her knowledge 
and belief any recording made pursuant to this paragraph with exhibits 
that were accepted into evidence is the record of the hearing.
    (2) If a hearing is recorded verbatim, a party requests the 
transcript of a hearing or part of a hearing, and the presiding officer 
determines that the disposition of the proceeding would be expedited by 
a transcript of the hearing or part of a hearing, the presiding officer 
shall order the verbatim transcription of the recording as requested by 
the party.
    (3) Parties to the proceeding who desire copies of the transcript or 
recording of the oral hearing may make arrangements with the reporter, 
who will furnish and deliver such copies direct to such parties, upon 
receipt from such parties of payment for the transcript or recording, at 
the rate provided by the contract between the reporter and the 
Department for such reporting service.
    (j) Filing, and presiding officer's certificate, of the transcript 
or recording. As soon as practicable after the close of the oral 
hearing, the reporter shall transmit to the presiding officer the 
original transcript or recording of the testimony, and as many copies of 
the transcript or recording as may be required by paragraph (j) of this 
section for the area offices of the Agency and as may be required for 
the Washington office of the Agency. At the same time the reporter shall 
also transmit a copy of the transcript or recording to each party who 
shall have arranged and paid for it, as provided in paragraph (h) of 
this section. Upon receipt of the transcript or recording, the presiding 
officer shall attach to the original transcript or recording a 
certificate stating that, to the best of the presiding officer's 
knowledge and belief, the transcript or recording is a true, correct, 
and complete transcript or recording of the testimony given at the 
hearing and that the exhibits mentioned in it are

[[Page 44]]

all the exhibits received in evidence at the hearing, with such 
exceptions as the certificate shall specify. Such certificate shall be 
served on each party and a copy thereof shall be attached to each copy 
of the transcript or recording received by the presiding officer. In 
accordance with such certificate the presiding officer shall note, on 
the original transcript or recording, each correction detailed in such 
certificate by adding or crossing out (but without obscuring the texts 
as originally transcribed or recorded) at the appropriate places any 
words necessary to make the text conform to the correct meaning, as 
certified by the presiding officer. The presiding officer shall send the 
copies of the transcript or recording to the hearing clerk who shall 
send them to the Agency.
    (k) Keeping of copies of the transcript or recording. During the 
period in which the proceeding has an active status in the Department, a 
copy of the transcript or recording shall be kept at the area office of 
the Agency most convenient to the respondent; however, if there are two 
or more respondents and they are located in different regions, such copy 
of the transcript or recording shall be kept at the area office of the 
Agency nearest to the place where the hearing was held. In addition, a 
copy of the transcript or recording shall be kept at the area office of 
the Agency most convenient to the complainant. Any such copy shall be 
available for examination during official hours of business at the area 
office, but shall remain the property of the Department and shall not be 
removed from such office.

[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990; 
60 FR 8466, Feb. 14, 1995]



Sec. 202.113  Rule 13: Written hearing.

    (a) Evidence. As used in this section, the term ``evidence'' shall 
mean depositions, affidavits, or statements under penalty of perjury as 
provided in 28 U.S.C. 1746, Pub. L. 94-550, of persons having knowledge 
of the facts, or documents properly identified by such deposition, 
affidavit, or statement, or otherwise authenticated in such a manner 
that they would be admissible in evidence at an oral hearing, except as 
provided hereinafter. Testimony on deposition, to the extent credible, 
shall be given greater weight as evidence, than such affidavits or 
statements. In a case in which a party, entitled to oral hearing as 
provided in rule 11, Sec. 202.111, withdraws such party's request for 
oral hearing on condition that only depositions be used if a written 
hearing is held, only depositions, and documents properly identified 
therein, shall be made a part of the record as evidence by the parties 
if a written hearing is held.
    (b) Verification. Any facts must be verified, by oath or affirmation 
before a person legally authorized to administer oaths or before a 
person designated by the Secretary for the purpose (except in the case 
of a statement under penalty of perjury as provided in 28 U.S.C. 1746, 
Pub. L. 94-550), by a person who states, in the deposition, affidavit, 
or statement, that such person has actual knowledge of the facts. Except 
under unusual circumstances, which shall be set forth in the deposition, 
affidavit, or statement, any such person shall be one who would appear 
as a witness if an oral hearing were held.
    (c) Complainant's evidence. The complainant shall be served with 
notice of an opportunity to file evidence. Within 20 days after such 
service, the complainant may file evidence. What the complainant files 
in response to that notice shall be served promptly on the respondent.
    (d) Respondent's evidence. After expiration of the time for the 
filing of complainant's evidence, the respondent shall be served with 
notice of an opportunity to file evidence. Within 20 days after such 
service, the respondent may file evidence. What the respondent files in 
response to that notice shall be served promptly on the complainant.
    (e) Complainant's rebuttal. If the respondent files anything 
pursuant to paragraph (d) of this section, the complainant shall be 
served with notice of an opportunity to file evidence in rebuttal of 
what the respondent has filed. Within 20 days after such service, the 
complainant may file such evidence, which shall be confined strictly to 
rebuttal of what the respondent has filed. What the complainant files in 
response

[[Page 45]]

to that notice shall be served promptly on the respondent.
    (f) Failure to file. Failure to file any evidence authorized under 
this section, within the time prescribed, shall constitute a waiver of 
the right to file such evidence.
    (g) Extension of time for depositions. If any party timely files an 
application for an order for the taking of testimony by deposition 
pursuant to rule 9, Sec. 202.109, time for the filing of such party's 
evidence shall be extended as reasonable, to permit consideration of the 
application, and taking of depositions if ordered.
    (h) Investigation report. No provision of this rule 13 shall change 
the status of an investigation report served on the parties and made a 
part of the record pursuant to rule 4, Sec. 202.104.

[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990]



Sec. 202.114  Rule 14: Post-hearing procedure.

    (a) Oral hearing. Any party present or represented at an oral 
hearing, desiring to file any written argument or brief, proposed 
findings of fact, conclusions, and order, or statement of objections to 
rulings made by the presiding officer, must so inform the presiding 
officer at the oral hearing; upon being so informed, the presiding 
officer shall set a reasonable time for the filing of such documents, 
and state it on the record at the oral hearing.
    (b) Written hearing. After filing of the last evidence in a written 
hearing, notice shall be served on each party that such party may file, 
within 20 days after such service on such party, written argument of 
brief, proposed findings or fact, conclusions, and order.
    (c) Service; delay in preparation of report. If any such document is 
filed by any party, it shall be served on all other parties. The report 
shall not be prepared before expiration of such time for filing.

[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990]



Sec. 202.115  Rule 15: Submission for final consideration.

    (a) Report. The presiding officer, with the assistance and 
collaboration of such employees of the Department as may be assigned for 
the purpose, shall prepare a report. The report shall be prepared on the 
basis of the evidence in the record, including the investigation report 
if one is prepared by the agency head and served on the parties, and any 
allegations admitted or deemed to be admitted, and any stipulations. The 
report shall be prepared in the form of a final order for signature by 
the judicial officer, and shall be filed with the hearing clerk. The 
report shall not be served on the parties unless and until it is signed 
by the judicial officer.
    (b) Record. At the same time as the report is filed with the hearing 
clerk, the record shall also be filed with the hearing clerk. The record 
shall include: Pleadings; motions and requests filed and rulings 
thereon; the investigation report if one is prepared by the agency head 
and served on the parties; the transcript or recording of an oral 
hearing, and exhibits received, if an oral hearing was held; evidence 
filed by the parties if a written hearing was held; documents filed in 
connection with pre-hearing conferences; any proposed findings of fact, 
conclusions and orders, statements of objections, and briefs; any 
stipulations; and proof of service.
    (c) Submission to judicial officer. Unless the hearing clerk 
reasonably believes that the record is not complete and in proper order, 
the record and the report shall be submitted to the judicial officer for 
decision.
    (d) Oral argument. There shall be no right to oral argument other 
than that provided in rule 12(h), Sec. 202.112(h).

[43 FR 30510, July 14, 1978, as amended at 60 FR 8467, Feb. 14, 1995]



Sec. 202.116  Rule 16: Issuance of order.

    (a) As soon as practicable after the receipt of the record and 
report from the hearing clerk, the judicial officer, on the basis of and 
after due consideration of the record, shall issue an order in the 
proceeding, which shall be served on the parties.
    (b) If the judicial officer deems it advisable to do so, the order 
may be made a tentative order. In such event, a presiding officer shall 
be assigned and the tentative order shall be served on each party, and 
each party shall have 20 days in which to file written exceptions

[[Page 46]]

to it, and arguments or briefs in support of such exceptions. If no 
party timely files exceptions, the tentative order shall automatically 
become the final order in the proceeding, and notice of such fact shall 
be served on the parties. If any party timely files such exceptions, 
they shall be handled in the same manner as a petition filed under rule 
17, Sec. 202.117.



Sec. 202.117  Rule 17: Petition to reopen a hearing; to rehear or 
reargue a proceeding; to reconsider an order; or to set aside a default order.

    (a) Filing of petition--(1) To reopen a hearing. Any party may file 
a petition to reopen a hearing to take further evidence, at any time 
prior to the issuance of the final order, or prior to a tentative order 
becoming final. Such a petition must state the nature and purpose of the 
evidence to be offered, show that it is not merely cumulative, and state 
a good reason why it was not offered at the hearing if oral, or filed in 
the hearing if written.
    (2) To rehear or reargue a proceeding or reconsider an order. Any 
party may file a petition to rehear or reargue a proceeding or 
reconsider an order of the judicial officer, at any time within 20 days 
after service on such party of such order. Such a petition must specify 
the matters claimed to have been erroneously decided, and the basis for 
the petitioner's claim that such matters were erroneously decided.
    (3) To set aside a default order. Any respondent against whom an 
order is issued by the judicial officer, upon failure to file an answer 
as required, may file a petition to set aside such order, at any time 
within 20 days after service on such respondent of such order. Such a 
petition must state a good reason why an answer was not filed as 
required.
    (b) Brief or memorandum of law. If such a petitioner wishes to file 
a brief or memorandum of law in support of such a petition, it must be 
filed with such petition.
    (c) Procedure. A presiding officer shall be assigned upon the filing 
of any such petition, or upon notice to the hearing clerk (which may be 
written or oral, or by telephone) that any party intends to file any 
such petition. The party filing any such petition shall be referred to 
as the complainant or respondent, depending on the original designation 
of such party in the proceeding; such party shall have the burden of 
establishing that such petition should be granted. If a petition to 
reopen is timely filed, the order shall not be issued pending decision 
whether to grant or deny the petition. If a petition to rehear or 
reargue or reconsider, or to set aside a default order, is timely filed, 
operation of the order shall be stayed automatically pending decision 
whether to grant or deny it; if such a petition is not timely filed, 
operation of the order shall not be stayed unless the Judicial Officer 
shall determine otherwise.
    (d) Service; answer. No such petition shall be granted unless it, 
with the brief or memorandum of law in support of it, if any, is first 
served on each party to the proceeding other than the one filing it. 
Each such other party, within 20 days after such service on such party, 
may file an answer to such petition. If any such party wishes to file a 
brief or memorandum of law in support of such an answer, it must be 
filed with such answer. Any such answer, with the brief or memorandum of 
law in support of it, if any, shall be served on each party to the 
proceeding other than the one filing it. Any such petition may be denied 
without such service.
    (e) Submission for decision; service of order. The presiding officer 
shall prepare a recommendation with respect to the petition, and submit 
it to the judicial officer for decision. Such a recommendation shall be 
prepared in the form of a final order for signature by the judicial 
officer. It shall not be served on the parties unless and until it is 
signed by the judicial officer. The order of the judicial officer shall 
be served on the parties.
    (f) Practice upon decision. If the judicial officer decides to 
reopen a hearing, or to rehear or permit reargument of a proceeding, or 
to set aside a default order, a presiding officer shall be assigned and 
the rules of practice shall be followed thereafter as applicable.

[[Page 47]]



Sec. 202.118  Rule 18: Presiding officer.

    (a) Powers. Subject to review as provided elsewhere in these rules, 
the presiding officer assigned to any proceeding shall have power to:
    (1) Set the time, place, and manner of a prehearing conference and 
an oral hearing, adjourn the oral hearing from time to time, and change 
the time, place, and manner of oral hearing;
    (2) Administer oaths and affirmations;
    (3) Issue subpoenas requiring the attendance and testimony of 
witnesses and the production of documentary evidence at an oral hearing;
    (4) Summon and examine witnesses and receive evidence at an oral 
hearing;
    (5) Take or order the taking of depositions;
    (6) Admit or exclude evidence;
    (7) Hear oral argument on facts or law;
    (8) Require each party to provide all other parties and the 
presiding officer with a copy of any exhibit that the party intends to 
introduce into evidence prior to any oral hearing to be conducted by 
telephone or audio-visual telecommunication;
    (9) Require each party to provide all other parties with a copy of 
any document that the party intends to use to examine a deponent prior 
to any deposition to be conducted by telephone or audio-visual 
telecommunication;
    (10) Require that any hearing to be conducted by telephone or audio-
visual telecommunication be conducted at locations at which the parties 
and the presiding officer are able to transmit and receive documents 
during the hearing;
    (11) Require that any deposition to be conducted by telephone or 
audio-visual telecommunication be conducted at locations at which the 
parties are able to transmit and receive documents during the 
deposition; and
    (12) Do all acts and take all measures necessary for the maintenance 
of order and the efficient conduct of the proceeding, including the 
exclusion of contumacious counsel or other persons.
    (b) Motions and requests. The presiding officer is authorized to 
rule on all motions and requests filed in the proceeding prior to 
submission of the presiding officer's report to the judicial officer, 
Provided, That a presiding officer is not authorized to dismiss a 
complaint. Submission or certification of any question to the judicial 
officer, prior to submission of the report, shall be in the discretion 
of the presiding officer.
    (c) Reassignment. For any good reason, including absence, illness, 
resignation, death, or inability to act, of the attorney assigned to act 
as a presiding officer in any proceeding under these rules, the powers 
and duties of such attorney in the proceeding may be assigned to any 
other attorney who is employed in the Office of the General Counsel of 
the Department, without abatement of the proceeding.
    (d) Disqualification. No person shall be assigned to act as a 
presiding officer in any proceeding who (1) has any material pecuniary 
interest in any matter or business involved in the proceeding; (2) is 
related within the third degree by blood or marriage to any party to the 
proceeding; or (3) has any conflict of interest which might impair such 
person's objectivity in the proceeding. A person assigned to act as a 
presiding officer shall ask to be replaced, in any proceeding in which 
such person believes that reason exists for disqualification of such 
person.
    (e) Procedure on petition for disqualification. Any party may file a 
petition for disqualification of the presiding officer, which shall set 
forth with particularity the grounds of alleged disqualification. Any 
such petition shall be filed with the hearing clerk, who shall 
immediately transmit it to the judicial officer and inform the presiding 
officer. The record of the proceeding also shall immediately be 
transmitted to the judicial officer. After such investigation or hearing 
as the judicial officer deems necessary, the judicial officer shall 
either deny the petition or direct that another presiding officer be 
assigned to the proceeding. The petition, and notice of the order of the 
judicial officer, shall be made a part of the record and served on the 
parties; if any record is made on such a petition, it shall be a part of 
the record of the proceeding.

[43 FR 30510, July 14, 1978, as amended at 60 FR 8467, Feb. 14, 1995]

[[Page 48]]



Sec. 202.119  Rule 19: Fees of witnesses.

    Witnesses subpoenaed before the presiding officer, and witnesses 
whose depositions are taken, shall be entitled to the same fees and 
mileage as are paid for like services in the courts of the United 
States. Fees and mileage shall be paid by the party at whose instance 
the witness appears or the deposition is taken.



Sec. 202.120  Rule 20: Official notice.

    Official notice shall be taken of such matters as are judicially 
noticed by the courts of the United States and of any other matter of 
technical or scientific fact of established character: Provided, That 
the parties shall be given notice of matters so noticed, and shall be 
given adequate opportunity to show that such facts are erroneously 
noticed.



Sec. 202.121  Rule 21: Intervention.

    At any time after docketing of a proceeding and before commencement 
of a hearing, oral or written, therein, the presiding officer may, upon 
petition, and for good cause shown, permit any person to intervene 
therein. The petition shall state with preciseness and particularity: 
(a) The petitioner's relationship to the matters involved in the 
proceeding; (b) the nature of the material the petitioner intends to 
present in evidence; (c) the nature of the argument the petitioner 
intends to make; and (d) the reasons why the petitioner should be 
allowed to intervene. Any such petition, and notice of the order 
thereon, shall be served on the parties and made a part of the record in 
the proceeding.



Sec. 202.122  Rule 22: Ex parte communications.

    (a) At no stage of the proceeding between its docketing and the 
issuance of the final decision shall the presiding officer or judicial 
officer discuss ex parte the merits of the proceeding with any party, or 
attorney or representative of a party: Provided, That procedural matters 
shall not be included within this limitation; and Provided further, That 
the presiding officer or judicial officer may discuss the merits of the 
case with such a person if all parties to the proceeding or their 
attorneys or representatives have been served with notice and an 
opportunity to participate. A memorandum of any such discussion shall be 
included in the record.
    (b) No party, or attorney or representative of a party, or other 
person not an employee of the Department, shall make or knowingly cause 
to be made to the presiding officer or judicial officer an ex parte 
communication relevant to the merits of the proceeding.
    (c) If the presiding officer or judicial officer receives an ex 
parte communication in violation of this section, the one who receives 
the communication shall place in the public record of the proceeding:
    (1) Such communication if written, or a memorandum stating the 
substance of such communication if oral; and
    (2) A copy of any written response or a memorandum stating the 
substance of any oral response thereto.
    (d) Copies of all such items placed or included in the record, as 
provided in this section, shall be served on all parties.
    (e) For purposes of this section ``ex parte communication'' means an 
oral or written communication not on the public record with respect to 
which reasonable prior notice to all parties is not given, but it shall 
not include a request for a status report on any matter or the 
proceeding.



Sec. 202.123  Rule 23: Action by Secretary.

    The Secretary may act in the place and stead of a presiding officer 
or the judicial officer in any proceeding hereunder, or any matter in 
connection therewith.



PART 203_STATEMENTS OF GENERAL POLICY UNDER THE PACKERS AND STOCKYARDS 
ACT--Table of Contents




Sec.
203.1 [Reserved]
203.2 Statement of general policy with respect to the giving by meat 
          packers of meat and other gifts to Government employees.
203.3 [Reserved]
203.4 Statement with respect to the disposition of records by packers, 
          live poultry

[[Page 49]]

          dealers, stockyard owners, market agencies and dealers.
203.5 Statement with respect to market agencies paying the expenses of 
          livestock buyers.
203.6 [Reserved]
203.7 Statement with respect to meat packer sales and purchase 
          contracts.
203.8-203.9 [Reserved]
203.10 Statement with respect to insolvency; definition of current 
          assets and current liabilities.
203.11 [Reserved]
203.12 Statement with respect to providing services and facilities at 
          stockyards on a reasonable and nondiscriminatory basis.
203.13 [Reserved]
203.14 Statement with respect to advertising allowances and other 
          merchandising payments and services.
203.15 Trust benefits under sections 206 and 207 of the Act.
203.16 Mailing of checks in payment for livestock purchased for 
          slaughter, for cash and not on credit.
203.17 Statement of general policy with respect to rates and charges at 
          posted stockyards.
203.18 Statement with respect to packers engaging in the business of 
          custom feeding livestock.
203.19 Statement with respect to packers engaging in the business of 
          livestock dealers or buying agencies.

    Authority: 7 CFR 2.22 and 2.81.



Sec. 203.1  [Reserved]



Sec. 203.2  Statement of general policy with respect to the giving by 
meat packers of meat and other gifts to Government employees.

    (a) In recent months, the Department has received information, 
confirmed by investigation, that a number of packers subject to the 
Packers and Stockyards Act have made gifts of meat to Government 
employees responsible for conducting service activities of the 
Department. Such gifts have the implications of fraud, even if not made 
specifically for the purpose of influencing these employees in the 
performance of their duties.
    (b) It is a violation of the Meat Inspection Act for any person, 
firm, or corporation to give to any employee of the Department 
performing duties under such act anything of value with intent to 
influence such employee in the discharge of his duties, or for such 
employee to receive from any person, firm, or corporation engaged in 
interstate or foreign commerce any gift given with any intent or purpose 
whatsoever (21 U.S.C. 90). Under the Federal meat grading regulations, 
the giving or attempting to give by a packer of anything of value to any 
employee of the Department authorized to perform any function under such 
regulations is a basis for the withdrawal of Federal meat grading 
service (7 CFR 53.13). The receiving by an employee of the Department of 
any gift from any person for whom grading, inspection, or other service 
work is performed is specifically prohibited by Departmental 
regulations.
    (c) Upon the basis of paragraphs (a) and (b) of this section, it is 
the view of the Department that it is an unfair and deceptive practice 
in violation of section 202(a) of the Packers and Stockyards Act (7 
U.S.C. 192(a)) for any person subject to the provisions of Title II of 
said Act to give or offer to give meat, money, or anything of value to 
any Government employee who performs inspection, grading, reporting, or 
regulatory duties directly relating to the purchase or sale of livestock 
or the preparation or distribution of meats, meat food products, 
livestock products in unmanufactured form, poultry or poultry products.

(Sec. 407, 42 Stat. 169; 7 U.S.C. 228; 9 CFR 201.3)

[26 FR 710, Jan. 25, 1961; 29 FR 4081, Mar. 28, 1964]



Sec. 203.3  [Reserved]



Sec. 203.4  Statement with respect to the disposition of records by 
packers, live poultry dealers, stockyard owners, market agencies and dealers.

    (a) Records to be kept. Section 401 of the Packers and Stockyards 
Act (7 U.S.C. 221) provides, in part, that every packer, live poultry 
dealer, stockyard owner, market agency, and dealer shall keep such 
accounts, records, and memoranda as fully and correctly disclose all 
transactions involved in his business, including the true ownership of 
such business by stockholding or otherwise. In order to properly 
administer the P&S Act, it is necessary that records be retained for 
such periods of time as may be required to permit the

[[Page 50]]

Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) a reasonable opportunity to examine such records. 
Section 401 of the Act does not, however, provide for the destruction or 
disposal of records. Therefore, the Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards Programs) has 
formulated this policy statement to provide guidance as to the periods 
of time after which records may be disposed of or destroyed.
    (b) Records may be disposed of after two years except as otherwise 
provided. Except as provided in paragraph (c) of this section, each 
packer, live poultry dealer, stockyard owner, market agency, and dealer 
may destroy or dispose of accounts, records, and memoranda which 
contain, explain, or modify transactions in its business subject to the 
Act after such accounts, records, and memoranda have been retained for a 
period of two full years; Provided, That the following records made or 
kept by a packer may be disposed of after one year: cutting tests; 
departmental transfers; buyers' estimates; drive sheets; scale tickets 
received from others; inventory and products in storage; receiving 
records; trial balances; departmental overhead or expense 
recapitulations; bank statements, reconciliations and deposit slips; 
production or sale tonnage reports (including recapitulations and 
summaries of routes, branches, plants, etc.); buying or selling pricing 
instructions and price lists; correspondence; telegrams; teletype 
communications and memoranda relating to matters other than contracts, 
agreements, purchase or sales invoices, or claims or credit memoranda; 
and Provided further, That microfilm copies of records may be 
substituted for and retained in lieu of the actual records.
    (c) Retention for longer periods may be required. The periods 
specified in paragraph (b) of this section shall be extended if the 
packer, live poultry dealer, stockyard owner, market agency, or dealer 
is notified in writing by the Administrator that specified records 
should be retained for a longer period pending the completion of any 
investigation or proceedings under the Act.
    (d) Unauthorized disposal of records. If it is found that any person 
subject to the Act has disposed of accounts, records, and memoranda 
which are necessary to fully and correctly disclose all transactions in 
its business prior to the periods specified in this statement, 
consideration will be given to the issuance of a complaint charging a 
violation of section 401 of the Act and seeking an appropriate order. 
The administrative proceeding initiated will be conducted in accordance 
with the Rules of Practice Governing Formal Adjudicatory Proceedings 
Instituted by the Secretary (7 CFR 1.130 et seq.).

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46)

[49 FR 6085, Feb. 17, 1984, as amended at 54 FR 16357, Apr. 24, 1989; 68 
FR 75388, Dec. 31, 2003]



Sec. 203.5  Statement with respect to market agencies paying the expenses 
of livestock buyers.

    It has become a practice in certain areas of the country for market 
agencies, engaged in the business of selling consigned livestock on a 
commission basis, to pay certain of the business or personal expenses 
incurred by buyers attending livestock sales conducted by such market 
agencies, such as, expenses for meals, lodging, travel, entertainment 
and long distance telephone calls. Investigation by the Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs), discloses that this practice tends to become a 
method of competition between similarly engaged market agencies and 
results in undue and unreasonable cost burdens on such market agencies 
and the livestock producers who sell their livestock through such market 
agencies.
    It is the view of the Grain Inspection, Packers and Stockyards 
Administration (Packers and Stockyards Programs) that it constitutes 
violations of the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 
181 et seq.), for any market agency engaged in the business of selling 
consigned livestock on a commission basis, to pay, directly or 
indirectly, any personal or business expenses of livestock buyers 
attending

[[Page 51]]

sales conducted by such market agency. In the future, if any market 
agency engages in such practice, consideration will be given by the 
Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) to the issuance of a complaint charging the market 
agency with violation of the Act. In the formal administrative 
proceeding initiated by any such complaint, the Judicial Officer of the 
Department will determine, after full hearing, whether the market agency 
has violated the Act and should be ordered to cease and desist from 
continuing such violation, and whether the registration of such market 
agency should be suspended for a reasonable period of time.

(Secs. 407, 4, 42 Stat. 169, 72 Stat. 1750; 7 U.S.C. 228. Interprets or 
applies secs. 304, 307, 312, 42 Stat. 164, 165, 167; 7 U.S.C. 205, 208, 
213)

[29 FR 311, Jan. 14, 1964; 29 FR 3304, Mar. 12, 1964, as amended at 32 
FR 7700, May 26, 1967]



Sec. 203.6  [Reserved]



Sec. 203.7  Statement with respect to meat packer sales and purchase 
contracts.

    (a) The Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) receives numerous complaints 
concerning the failure or refusal of buyers to pay the full purchase 
price for, or to accept delivery of, their purchases of meat and meat 
food products and sellers failing to meet contractual specifications. 
Most such complaints arise out of disputes concerning condition, grade, 
weight, or shipping instructions.
    (b) It is believed that both seller and buyer should take the 
following points into consideration when selling and buying meat and 
meat food products:
    (1) Terms of shipment and time of arrival. Terms and conditions of 
shipment and delivery should be specified in the contract and both 
parties should understand fully all terms and conditions of the 
contract. Any deviation from normal practices, such as a guaranty by the 
shipper as to the date of arrival at destination, or a deviation from 
the normal meaning of terms, should also be fully understood and made a 
part of the contract.
    (2) Quality and condition. (i) A seller has the responsibility of 
making certain that the meat and meat food products shipped are in 
accordance with the terms of the contract specifications.
    (ii) When a buyer believes that the shipment does not meet the terms 
of the contract, he should immediately contact the seller or the 
seller's agent and advise him of the nature of the complaint. This 
affords the seller an opportunity to renegotiate the contract, to 
personally inspect the meat or meat food products, or to have an 
impartial party inspect or examine the meat or meat food products. 
Inspection and examination service of this type is available nationally 
through the USDA meat grading service and locally through various 
impartial persons or agencies.
    (iii) All terms of a transaction should be made clear in the 
contract, whether written or verbal. If there is any chance of 
misunderstanding, a written confirmation should be exchanged between the 
parties. In any case where a contract dispute cannot be settled between 
the parties and either party intends to file a complaint, such complaint 
should be brought to the attention of the nearest Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
area office as soon as possible. However, a concerted effort on the part 
of both buyer and seller to negotiate clear and complete contracts will 
greatly reduce misunderstandings which can result in the filing of 
complaints with the Administration.
    (c) If the Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) has reason to believe that any packer 
unjustifiably (1) has refused to pay the contractual price for meat or 
meat food products purchased, (2) has refused to accept a shipment of 
meat or meat food products, or (3) has failed to ship meat or meat food 
products in accordance with the terms of the contract specifications, 
consideration will be given to the issuance of a complaint charging the 
packer with violation of section 202 of the Act. In the formal 
administrative proceeding initiated by any such complaint, the Judicial 
Officer of the Department will determine,

[[Page 52]]

upon the basis of the record in the proceeding, whether the packer has 
violated the Act and should be ordered to cease and desist from 
continuing such violation.

(Secs. 407(a), 4, 42 Stat. 169, 72 Stat. 1750; 7 U.S.C. 228(a). 
Interprets or applies sec. 202, 42 Stat. 161 et seq., as amended; 7 
U.S.C. 192)

[30 FR 14966, Dec. 3, 1965, as amended at 32 FR 7701, May 26, 1967]



Sec. Sec. 203.8-203.9  [Reserved]



Sec. 203.10  Statement with respect to insolvency; definition of current 
assets and current liabilities.

    (a) Under the Packers and Stockyards Act, 1921, as amended and 
supplemented (7 U.S.C. 181 et seq.), the principal test of insolvency is 
to determine whether a person's current liabilities exceed his current 
assets. This current ratio test of insolvency under the Act has been 
reviewed and affirmed by a United States Court of Appeals. Bowman v. 
United States Department of Agriculture, 363 F. 2d 81 (5th Cir. 1966).
    (b) For the purposes of the administration of the Packers and 
Stockyards Act, 1921, the following terms shall be construed, 
respectively, to mean:
    (1) Current assets means cash and other assets or resources commonly 
identified as those which are reasonably expected to be realized in cash 
or sold or consumed during the normal operating cycle of the business, 
which is considered to be one year.
    (2) Current liabilities means obligations whose liquidation is 
reasonably expected to require the use of existing resources principally 
classifiable as current assets or the creation of other current 
liabilities during the one year operating cycle of the business.
    (c) The term current assets generally includes: (1) Cash in bank or 
on hand; (2) sums due a market agency from a custodial account for 
shippers' proceeds; (3) accounts receivable, if collectable; (4) notes 
receivable and portions of long-term notes receivable within one year 
from date of balance sheet, if collectable; (5) inventories of livestock 
acquired for purposes of resale or for purposes of market support; (6) 
feed inventories and other inventories which are intended to be sold or 
consumed in the normal operating cycle of the business; (7) accounts due 
from employees, if collectable; (8) accounts due from officers of a 
corporation, if collectable; (9) accounts due from affiliates and 
subsidiaries of corporations if the financial position of such 
subsidiaries and affiliates justifies such classification; (10) 
marketable securities representing cash available for current operations 
and not otherwise pledged as security; (11) accrued interest receivable; 
and (12) prepaid expenses.
    (d) The term current assets generally excludes: (1) Cash and claims 
to cash which are restricted as to withdrawal, such as custodial funds 
for shippers' proceeds and current proceeds receivable from the sale of 
livestock sold on a commission basis; (2) investments in securities 
(whether marketable or not) or advances which have been made for the 
purposes of control, affiliation, or other continuing business 
advantage; (3) receivables which are not expected to be collected within 
12 months; (4) cash surrender value of life insurance policies; (5) land 
and other natural resources; and (6) depreciable assets.
    (e) The term current liabilities generally includes: (1) Bank 
overdrafts (per books); (2) amounts due a custodial account for 
shippers' proceeds; (3) accounts payable within one year from date of 
balance sheet; (4) notes payable or portions thereof due and payable 
within one year from date of balance sheet; (5) accruals such as taxes, 
wages, social security, unemployment compensation, etc., due and payable 
as of the date of the balance sheet; and (6) all other liabilities whose 
regular and ordinary liquidation is expected to occur within one year.

(Sec. 407(a), 42 Stat. 169, 72 Stat. 1750; 7 U.S.C. 228(a). Interprets 
or applies secs. 202, 307, 312, 502, 505; 42 Stat. 161 et seq., as 
amended; 7 U.S.C. 192, 208, 213, 218a, 218d)

[32 FR 6901, May 5, 1967]



Sec. 203.11  [Reserved]



Sec. 203.12  Statement with respect to providing services and facilities 
at stockyards on a reasonable and nondiscriminatory basis.

    (a) Section 304 of the Packers and Stockyards Act (7 U.S.C. 205) 
provides that: ``All stockyard services furnished

[[Page 53]]

pursuant to reasonable request made to a stockyard owner or market 
agency at such stockyard shall be reasonable and nondiscriminatory and 
stockyard services which are furnished shall not be refused on any basis 
that is un reasonable or unjustly discrimina tory * * *.''
    (b) Section 305 of the Act (7 U.S.C. 206) states that: ``All rates 
or charges made for any stockyard services furnished at a stockyard by a 
stockyard owner or market agency shall be just, reasonable, and 
nondiscrimina tory * * *.''
    (c) Section 307 (7 U.S.C. 208) provides that: ``It shall be the duty 
of every stockyard owner and market agency to establish, observe, and 
enforce just, reasonable, and non discriminatory regulations and 
practices in respect to the furnishing of stockyard services * * *.''
    (d) Section 312(a) (7 U.S.C. 213(a)) provides that: ``It shall be 
unlawful for any stockyard owner, market agency, or dealer to engage in 
or use any unfair, unjustly discriminatory, or deceptive practice or 
device in connection with determining whether persons should be 
authorized to operate at the stockyards, or with the receiving, 
marketing, buying, or selling on a commission basis or otherwise, 
feeding, watering, holding, delivery, shipment, weighing or handling, in 
commerce, of livestock.''
    (e) Section 301(b) (7 U.S.C. 201(b)) defines ``stockyard services'' 
as any ``services or facilities furnished at a stockyard in connection 
with the receiving, buying, or selling on a commission basis or 
otherwise, marketing, feeding, watering, holding, delivery, shipment, 
weighing, or handling, in commerce, of livestock.''
    (f) It is the view of the Grain Inspection, Packers and Stockyards 
Administration (Packers and Stockyards Programs) that it is a violation 
of sections 304, 307, and 312(a) of the Act for a stockyard owner or 
market agency to discriminate, in the furnishing of stockyard services 
or facilities or in establishing rules or regulations at the stockyard, 
because of race, religion, color, or national origin of those persons 
using the stockyard services or facilities. Such services and facilities 
include, but are not limited to, the restaurant, restrooms, drinking 
fountains, lounge accommodations, those furnished for the selling, 
weighing, or other handling of the livestock, and facilities for 
observing such services.
    (g) If the Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) has reason to believe that any 
stockyard owner or market agency has so discriminated in the furnishing 
of stockyard services or facilities, consideration will be given to the 
issuance of a complaint charging the stockyard or market agency with 
violations of the Act.

(Sec. 407(a), 42 Stat. 159, 72 Stat. 1750; 7 U.S.C. 228(a). Interprets 
or applies secs. 304, 307, 312, 42 Stat. 161 et seq., as amended, 7 
U.S.C. 205, 208, 213)

[33 FR 17621, Nov. 26, 1968]



Sec. 203.13  [Reserved]



Sec. 203.14  Statement with respect to advertising allowances and other 
merchandising payments and services.

                             The Guidelines

    1. Who is a customer? (a) A customer is a person who buys for resale 
directly from the packer, or through the packer's agent or broker; and 
in addition, a customer is any buyer of the packer's product for resale 
who purchases from or through a wholesaler or other intermediate 
reseller.

    (Note: In determining whether a packer has fulfilled its obligations 
toward its customers, the Grain Inspection, Packers and Stockyards 
Administration (Packers and Stockyards Programs) will recognize that 
there may be some exceptions to this general definition of ``customer.'' 
For example, the purchaser of distress merchandise would not be 
considered a ``customer'' simply on the basis of such purchase. 
Similarly, a retailer who purchases solely from other retailers or one 
who makes only sporadic purchases, or one who does not regularly sell 
the packer's product or who is a type of retail outlet not usually 
selling such products will not be considered a ``customer'' of the 
packer unless the packer has been put on notice that such retailer is 
selling its product.)

    (b) Competing customers are all businesses that compete in the 
resale of the packer's products of like grade and quality at the same 
functional level of distribution, regardless of whether they purchase 
direct from the packer or through some intermediary.


[[Page 54]]


    Example: A packer sells directly to some independent retailers, 
sells to the headquarters of chains and of retailer-owned cooperatives, 
and also sells to wholesalers. The direct-buying independent retailers, 
the headquarters of chains and of retailer-owned cooperatives, and the 
wholesalers' independent retailer customers are customers of the packer. 
Individual retail outlets which are part of the chains or members of the 
retailer-owned cooperatives are not customers of the packer.

    2. Definition of services. Services are any kind of advertising or 
promotion of a packer's product, including but not limited to, 
cooperative advertising, handbills, window and floor displays, 
demonstrators and demonstrations, customer coupons, and point of 
purchase activity.
    3. Need for a plan. If a packer makes payments or furnishes 
services, it should do so under a plan that meets several requirements. 
If there are many competing customers to be considered, or if the plan 
is at all complex, the packer would be well advised to put its plan in 
writing. The requirements are:
    (a) Proportionally equal terms--The payments or services under the 
plan should be made available to all competing customers on 
proportionally equal terms. This means that payments or services should 
be made proportionately on some basis that is fair to all customers who 
compete in the resale of the packer's products. No single way to achieve 
the proper proportion is prescribed, and any method that treats 
competing customers on proportionally equal terms may be used. 
Generally, this can best be done by basing the payments made or the 
services furnished on the dollar volume or on the quantity of goods 
purchased during a specified period. Other methods which are fair to all 
competing customers are also acceptable.

    Example 1: A packer may properly offer to pay a specified part (say 
50 percent) of the cost of local advertising up to an amount equal to a 
set percentage (such as 5 percent) of the dollar volume of such 
purchases during a specified time.
    Example 2: A packer may properly place in reserve for each customer 
a specified amount of money for each unit purchased and use it to 
reimburse those customers for the cost of advertising and promoting the 
packer's product during a specified time.
    Example 3: A packer's plan should not provide an allowance on a 
basis that has rates graduated with the amount of goods purchased, as 
for instance, 1 percent of the first $1,000 purchases per month, 2 
percent on second $1,000 per month, and 3 percent on all over that.

    (b) Packer's duty to inform--The packer should take reasonable 
action, in good faith, to inform all its competing customers of the 
availability of its promotional program. Such notification should 
include all the relevant details of the offer in time to enable 
customers to make an informed judgment whether to participate. Where 
such one-step notification is impracticable, the packer may, in lieu 
thereof, maintain a continuing program of first notifying all competing 
customers of the types of promotions offered by the packer and a 
specific source for the customer to contact in order to receive full and 
timely notice of all relevant details of the packer's promotions. Such 
notice should also inform all competing customers that the packer offers 
advertising allowances and/or other promotional assistance that are 
usable in a practical business sense by all retailers regardless of 
size. When a customer indicates its desire to be put on the notification 
list, the packer should keep that customer advised of all promotions 
available in its area as long as the customer so desires. The packer may 
make the required notification by any means it chooses; but in order to 
show later that it gave notice to a certain customer, it is in a better 
position to do so if it was given in writing or a record was prepared at 
the time of notification showing date, person notified, and contents of 
notification.
    If more direct methods of notification are impracticable, a packer 
may employ one or more of the following methods, the sufficiency of 
which will depend upon the complexity of its own distribution system. 
Different packers may find that different notification methods are most 
effective for them:
    (1) The packer may enter into contracts with its wholesaler, 
distributors or other third parties which conform to the requirements of 
item 5, infra.
    (2) The packer may place appropriate announcements on product 
containers or inside thereof with conspicuous notice of such enclosure 
on the outside.
    (3) The packer may publish notice of the availability and essential 
features of a promotional plan in a publication of general distribution 
in the trade.

    Example 1: A packer has a wholesaler-oriented plan directed to 
wholesalers distributing its products to retailing customers. It should 
notify all the competing wholesalers distributing its products of the 
availability of this plan, but the packer is not required to notify 
retailing customers.
    Example 2: A packer who sells on a direct basis to some retailers in 
an area, and to other retailers in the area through wholesalers, has a 
plan for the promotion of its products at the retail level. If the 
packer directly notifies not only all competing direct purchasing 
retailers but also all competing retailers purchasing through the 
wholesalers as to the availability, terms and conditions

[[Page 55]]

of the plan, the packer is not required to notify its wholesalers.
    Example 3: A packer regularly engages in promotional programs and 
the competing customers include large direct purchasing retailers and 
smaller customers who purchase through wholesalers. The packer may 
encourage, but not coerce, the retailer purchasing through a wholesaler 
to designate a wholesaler as its agent for receiving notice of, 
collecting, and using promotional allowances for the customer. If a 
wholesaler or other intermediary by written agreement with a retailer is 
actually authorized to collect promotional payments from suppliers, the 
packer may assume that notice of and payment under a promotional plan to 
such wholesaler or intermediary constitutes notice and payment to the 
retailer.
    (A packer should not rely on a written agreement authorizing an 
intermediary to receive notice of and/or payment under a promotional 
plan for a retailer if the packer knows, or should know, that the 
retailer was coerced into signing the agreement. In addition, a packer 
should assume that an intermediary is not authorized to receive notice 
of and/or payment under a promotional plan for a retailer unless there 
is a written authorization signed by such retailer.)

    (c) Availability to all competing customers--The plan should be such 
that all types of competing customers may participate. It should not be 
tailored to favor or discriminate against a particular customer or class 
of customers but should, in its terms, be usable in a practical business 
sense by all competing customers. This may require offering all such 
customers more than one way to participate in the plan or offering 
alternative terms and conditions to customers for whom the basic plan is 
not usable and suitable. The packer should not, either expressly or by 
the way the plan operates, eliminate some competing customers, although 
it may offer alternative plans designed for different customer classes. 
If it offers alternative plans, all of the plans offered should provide 
the same proportionate equality and the packer should inform competing 
customers of the various alternative plans.
    When a packer, in good faith, offers a basic plan, including 
alternatives, which is reasonably fair and nondiscriminatory and 
refrains from taking any steps which would prevent any customer, or 
class of customers, from participating in its program, it shall be 
deemed to have satisfied its obligation to make its plan functionally 
available to all customers, and the failure of any customer or customers 
to participate in the program shall not be deemed to place the packer in 
violation of the provisions of the Packers and Stockyards Act.

    Example 1: A packer offers a plan of short term store displays of 
varying sizes, including some which are suitable for each of its 
competing customers and at the same time are small enough so that each 
customer may make use of the promotion in a practical business sense. 
The plan also calls for uniform, reasonable certification of performance 
by the retailer. Because they are reluctant to process a reasonable 
amount of paperwork, some small retailers do not participate. This fact 
is not deemed to place a packer in violation of Item 3(c) and it is 
under no obligation to provide additional alternatives.
    Example 2: A packer offers a plan for cooperative advertising on 
radio, television, or in newspapers of general circulation.\1\ Because 
the purchases of some of its customers are too small, this offer is not 
``functionally available'' to them. The packer should offer them 
alternative(s) on proportionally equal terms that are usable by them and 
suitable for their business.
---------------------------------------------------------------------------

    \1\ In order to avoid the tailoring of promotional programs that 
discriminate against particular customers or class of customers, the 
packer in offering to pay allowances for newspaper advertising should 
offer to pay the same percentage of the cost of newspaper advertising 
for all competing customers in a newspaper of the customer's choice, or 
at least in those newspapers that meet the requirements for second class 
mail privileges.
---------------------------------------------------------------------------

    (d) Need to understand terms--In informing customers of the details 
of a plan, the packer should provide them sufficient information to give 
a clear understanding of the exact terms of the offer, including all 
alternatives, and the conditions upon which payment will be made or 
services furnished.
    (e) Checking customer's use of payments--The packer should take 
reasonable precautions to see that services it is paying for are 
furnished and also that it is not overpaying for them. Moreover, the 
customer should expend the allowance solely for the purpose for which it 
was given. If the packer knows or should know that what it pays or 
furnishes is not being properly used by some customers, the improper 
payments or services should be discontinued.\2\
---------------------------------------------------------------------------

    \2\ The granting of allowances or payments that have little or no 
relationship to cost or approximate cost of the service provided by the 
retailer may be considered a violation of section 202 of the Act.
---------------------------------------------------------------------------

    A packer who, in good faith, takes reasonable and prudent measures 
to verify the performance of its competing customers will be deemed to 
have satisfied its obligations under the Act. Also, a packer who, in 
good faith, concludes a promotional agreement with wholesalers or other 
intermediaries and who otherwise conforms to the standards of Item 5 
shall be deemed to have satisfied this obligation. If a packer has taken 
such steps,

[[Page 56]]

the fact that a particular customer has retained an allowance in excess 
of the cost, or approximate cost if the actual cost is not known, of 
services performed by the customer shall not alone be deemed to place a 
packer in violation of the Act.
    (When customers may have different but closely related costs in 
furnishing services that are difficult to determine such as the cost for 
distributing coupons from a bulletin board or using a window banner, the 
packer may furnish to each customer the same payment if it has a 
reasonable relationship to the cost of providing the service or is not 
grossly in excess thereof.)
    4. Competing customers. The packer is required to provide in its 
plan only for those customers who compete with each other in the resale 
of the packer's products of like grade and quality. Therefore a packer 
should make available to all competing wholesalers any plan providing 
promotional payments or services to wholesalers, and similarly should 
make available to all competing retailers any plan providing promotional 
payments or services to retailers. With these requirements met, a packer 
can limit the area of its promotion. However, this section is not 
intended to deal with the question of a packer's liability for use of an 
area promotion where the effect may be to injure the packer's 
competition.
    5. Wholesaler or third party performance of packer's obligations. A 
packer may, in good faith, enter into written agreements with 
intermediaries, such as wholesalers, distributors or other third 
parties, including promoters of tripartite promotional plans, which 
provide that such intermediaries will perform all or part of the 
packer's obligations under this part. However, the interposition of 
intermediaries between the packer and its customers does not relieve the 
packer of its ultimate responsibility of compliance with the provisions 
of the Packers and Stockyards Act. The packer, in order to demonstrate 
its good faith effort to discharge its obligations under this part, 
should include in any such agreement provisions that the intermediary 
will:
    (1) Give notice to the packer's customers in conformity with the 
standards set forth in items 3(b) and (d), supra;
    (2) Check customer performance in conformity with the standards set 
forth in item 3(e), supra;
    (3) Implement the plan in a manner which will insure its functional 
availability to the packer's customers in conformity with the standards 
set forth in item 3(c), supra (This must be done whether the plan is one 
devised by the packer itself or by the intermediary for use by the 
packer's customers.); and
    (4) Provide certification in writing and at reasonable intervals 
that the packer's customers have been and are being treated in 
conformity with the agreement.
    A packer who negotiates such agreements with its wholesalers, 
distributors or third party promoters will be considered by the 
Administration to have justified its ``good faith'' obligations under 
this section only if it accompanies such agreements with the following 
supplementary measures: At regular intervals the packer takes 
affirmative steps to verify that its customers are receiving the 
proportionally equal treatment to which they are entitled by making spot 
checks designed to reach a representative cross section of its 
customers. Whenever such spot checks indicate that the agreements are 
not being implemented in such a way that its customers are receiving 
such proportionally equal treatment, the packer takes immediate steps to 
expand or to supplement such agreements in a manner reasonably designed 
to eliminate the repetition or continuation of any such discriminations 
in the future.
    Intermediaries, subject to the Packers and Stockyards Act, 
administering promotional assistance programs on behalf of a packer may 
be in violation of the provisions of the Packers and Stockyards Act, if 
they have agreed to perform the packer's obligations under the Act with 
respect to a program which they have represented to be usable and 
suitable for all the packer's competing customers if it should later 
develop that the program was not offered to all or, if offered, was not 
usable or suitable, or was otherwise administered in a discriminatory 
manner.
    6. Customer's liability. A customer, subject to the Packers and 
Stockyards Act, who knows, or should know, that it is receiving payments 
or services which are not available on proportionally equal terms to its 
competitors engaged in the resale of the same packer's products may be 
in violation of the provisions of the Act. Also, customers (subject to 
the Packers and Stockyards Act) that make unauthorized deductions from 
purchase invoices for alleged advertising or other promotional 
allowances may be proceeded against under the provisions of the Act.

    Example: A customer subject to the Act should not induce or receive 
an allowance in excess of that offered in the packer's advertising plan 
by billing the packer at ``vendor rates'' or for any other amount in 
excess of that authorized in the packer's promotion program.

    7. Meeting competition. A packer charged with discrimination under 
the provisions of the Packers and Stockyards Act may defend its actions 
by showing that the payments were made or the services were furnished in 
good faith to meet equally high payments made by a competing packer to 
the particular customer, or to meet equivalent services furnished by a 
competing packer to the particular customer. This defense, however,

[[Page 57]]

is subject to important limitations. For instance, it is insufficient to 
defend solely on the basis that competition in a particular market is 
very keen, requiring that special allowances be given to some customers 
if a packer is ``to be competitive.''
    8. Cost justification. It is no defense to a charge of unlawful 
discrimination in the payment of an allowance or the furnishing of a 
service for a packer to show that such payment or service could be 
justified through savings in the cost of manufacture, sale, or delivery.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[58 FR 52886, Oct. 13, 1993; 58 FR 58902, Nov. 4, 1993, as amended at 68 
FR 75388, Dec. 31, 2003]



Sec. 203.15  Trust benefits under sections 206 and 207 of the Act.

    (a) Within the times specified under sections 206(b) and 207(d) of 
the Act, any livestock seller, live poultry seller or grower, to 
preserve his interest in the statutory trust, must give written notice 
to the appropriate packer or live poultry dealer and file such notice 
with the Secretary. One of the ways to satisfy the notification 
requirement under these provisions is to make certain that notice is 
given to the packer or live poultry dealer within the prescribed time by 
letter, mailgram, or telegram stating:
    (1) Notification to preserve trust benefits:
    (2) Identification of packer or live poultry dealer;
    (3) Identification of seller or poultry grower;
    (4) Date of the transaction;
    (5) Date of seller's or poultry grower's receipt of notice that 
payment instrument has been dishonored (if applicable); and
    (6) Amount of money due; and to make certain that a copy of such 
letter, mailgram, or telegram is filed with a GIPSA Regional Office or 
with GIPSA, USDA, Washington, DC 20250, within the prescribed time.
    (b) While the above information is desirable, any written notice 
which informs the packer or live poultry dealer and the Secretary that 
the packer or live poultry dealer has failed to pay is sufficient to 
meet the above-mentioned statutory requirement if it is given within the 
prescribed time.

(Approved by the Office of Management and Budget under control number 
0580-0015)

[54 FR 16357, Apr. 24, 1989, as amended at 68 FR 75388, Dec. 31, 2003]



Sec. 203.16  Mailing of checks in payment for livestock purchased for 
slaughter, for cash and not on credit.

    (a) The Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) recognizes that one who sells 
livestock to a packer, market agency, or dealer, who is purchasing for 
slaughter, may not intend to be present at the point of transfer of 
possession of the livestock, to receive payment, at the time a check in 
payment for such livestock may be delivered by the purchaser, and may 
not wish to authorize a representative to receive such a check; or for 
other reasons such a seller may prefer that such a purchaser make 
payment by mailing a check within the time limit as prescribed in 
section 409(a) of the Act. In cases when the seller does not intend to 
be present, he may use the following form of notification to the 
purchaser:

    I do not intend to be present at the point of transfer of possession 
of livestock sold by me to (name of packer, market agency, or dealer) 
for the purpose of receiving a check in payment for such livestock.
    I hereby direct (name of packer, market agency, or dealer) to make 
payment for livestock purchased from me, by mailing a check for the full 
amount of the purchase price before the close of the next business day 
following the purchase of livestock and transfer of possession thereof 
or, in the case of a purchase on a ``carcass'' or ``grade and yield'' 
basis, not later than the close of the first business day following 
determination of the purchase price.
    This does not constitute an extension of credit to (name of packer, 
market agency or dealer). This is subject to cancellation by me at any 
time, and if not cancelled by (date), it shall terminate on that date.


If the seller, for reasons other than not being present to receive 
payment, prefers to have the packer, market agency, or dealer make 
payment by mailing a check within the time limit as provided in section 
409(a), he may use the above form but should not include the

[[Page 58]]

statement in the first sentence that he does not intend to be present.
    (b) The Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) believes that such an agreement would 
not constitute an extension of credit within the meaning of section 206 
of the Act because it would not give the purchaser any more time to 
issue a check than is provided in section 409(a).

(Approved by the Office of Management and Budget under control number 
0580-0015)

(Sec. 401, 42 Stat. 168 (7 U.S.C 221); sec. 407, 42 Stat. 169 (7 U.S.C. 
228); sec. 409, as added by sec. 7, 90 Stat. 1250 (7 U.S.C. 228b); 7 CFR 
2.17, 2.54; 42 FR 35625; Pub. L. 96-511, 94 Stat. 2812 (44 U.S.C. 3501 
et seq.); 7 U.S.C. 222 and 228 and 15 U.S.C. 46)

[42 FR 49929, Sept. 28, 1977, as amended at 49 FR 39516, Oct. 9, 1984; 
68 FR 75388, Dec. 31, 2003]



Sec. 203.17  Statement of general policy with respect to rates and 
charges at posted stockyards.

    (a) Requests have been received from stockyard operators, market 
agencies, and livestock producers urging a reduction of rate regulation 
at posted stockyards. Their requests are based on the belief that 
competition among markets will set a level of rates and charges fair to 
both the market operator and to the livestock producer. Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) will accept for filing tariffs containing any level 
of charges after 10 days' notice to the public and to the Secretary as 
required by the Act.
    (b) Grain Inspection, Packers and Stockyards Administration (Packers 
and Stockyards Programs) will not investigate the level of rates and 
charges established by stockyard owners and market agencies for 
reasonableness except upon receipt of a valid complaint or under 
compelling circumstances warranting such an investigation. Stockyard 
owners and market agencies will have substantial flexibility in setting 
their own rates and charges.
    (c) Complaints filed about the reasonableness of rates and charges 
will be investigated to determine the validity of such complaints and 
appropriate action taken if warranted.
    (d) Grain Inspection, Packers and Stockyards Administration (Packers 
and Stockyards Programs) will continue to insure that the schedules of 
rates and charges filed with the Department are applied uniformly and in 
a nondiscriminatory manner.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 203, 204, 207, 217a, 222 and 228)

[49 FR 33004, Aug. 20, 1984, as amended at 68 FR 75388, Dec. 31, 2003]



Sec. 203.18  Statement with respect to packers engaging in the business 
of custom feeding livestock.

    (a) In its administration of the Packers and Stockyards Act, the 
Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) has sought to promote and maintain open and fair 
competition in the livestock and packing industries, and to prevent 
unfair or anticompetitive practices when they are found to exist. It is 
the opinion of the Administration that the ownership or operation of 
custom feedlots by packers presents problems which may, under some 
circumstances, result in violations of the Packers and Stockyards Act.
    (b) Packers contemplating entering into such arrangements with 
custom feedlots are encouraged to consult with the Administration prior 
to the commencement of such activities. Custom feedlots are not only 
places of production, but are also important marketing centers, and in 
connection with the operation of a custom feedlot, it is customary for 
the feedlot operator to assume responsibility for marketing fed 
livestock for the accounts of feedlot customers. When a custom feedlot 
is owned or operated by a packer, and when such packer purchases fed 
livestock from the feedlot, this method of operation potentially gives 
rise to a conflict of interest. In such situations, the packer's 
interest in the fed livestock as a buyer is in conflict with its 
obligations to feedlot customers to market their livestock to the 
customer's best advantage. Under these circumstances, the packer should 
take appropriate measures to eliminate any

[[Page 59]]

conflict of interest. At a minimum, such measures should insure:
    (1) That feedlot customers are fully advised of the common ties 
between the feedlot and the packer, and of their rights and options with 
respect to the marketing of their livestock;
    (2) That all feedlot customers are treated equally by the packer/
custom feedlot in connection with the marketing of fed livestock; and
    (3) That marketing decisions rest solely with the feedlot customer 
unless otherwise expressly agreed.
    (c) Packer ownership or operation of custom feedlots may also give 
rise to competitive problems in some situations. Packers contemplating 
or engaging in the business of operating a custom feedlot should 
carefully review their operations to assure that no restriction of 
competition exists or is likely to occur.
    (d) The Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) does not consider the existence of 
packer/custom feedlot relationships, by itself, to constitute a 
violation of the Act. In the event it appears that a packer/custom 
feedlot arrangement gives rise to a violation of the Act, an 
investigation will be made on a case-by-case basis, and, where 
warranted, appropriate action will be taken.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 203, 204, 207, 217a, 222 and 228)

[49 FR 33004, Aug. 20, 1984, as amended at 68 FR 75388, Dec. 31, 2003]



Sec. 203.19  Statement with respect to packers engaging in the business 
of livestock dealers or buying agencies.

    (a) In its administration of the Packers and Stockyards Act, the 
Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) has sought to prevent conflicts of interest and to 
maintain open and fair competition in the livestock and meat packing 
industries. The ownership or operation of livestock dealers or buying 
agencies by packers, under some circumstances, may result in violations 
of the Packers and Stockyards Act.
    (b) Traditionally, livestock dealers and buying agencies purchase 
livestock for resale or to fill orders for farmers, ranchers, producers, 
other livestock firms and packers. When a livestock dealer or buying 
agency is owned or operated by a packer, and when such packer is also 
buying livestock for its own operational requirements, there is a 
potential conflict of interest. Furthermore, the purchase and sale of 
livestock by meat packers may result in control of markets and prices 
which could adversely affect both livestock producers, competing 
packers, and consumers.
    (c) Arrangements between packers and dealers or buying agencies 
which do not normally create a conflict of interest or result in a 
restraint of competition include:
    (1) Operations utilizing different species or classes of livestock; 
(2) operations where the business activities are widely separated 
geographically; and (3) operations where tie-in purchases or sales are 
not involved. Packers contemplating engaging in the business of a 
livestock dealer or a buying agency are encouraged to consult with the 
Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) prior to the commencement of such activities.
    (d) In the event a packer/dealer or a packer/buying agency 
arrangement appears to give rise to a violation of the Act, an 
investigation will be made on a case-by-case basis and, where warranted, 
appropriate action will be taken.

(Approved by the Office of Management and Budget under control number 
0580-0015)

(7 U.S.C. 228, 228b, 222, 15 U.S.C. 46)

[49 FR 32845, Aug. 17, 1984; 54 FR 26349, June 23, 1989, as amended at 
68 FR 75388, Dec. 31, 2003]



PART 204_ORGANIZATION AND FUNCTIONS--Table of Contents




                           Public Information

Sec.
204.1 Introduction.
204.2 Organization.
204.3 Delegation of authority.
204.4 Public inspection and copying.
204.5 Indexes.
204.6 Requests for records.

[[Page 60]]

204.7 Appeals.

    Authority: 5 U.S.C. 552.

    Source: 49 FR 46528, Nov. 27, 1984, unless otherwise noted.

                           Public Information



Sec. 204.1  Introduction.

    The Grain Inspection, Packers and Stockyards Administration (Packers 
and Stockyards Programs) hereby describes its central and field 
organization; indicates the established places at which, and methods 
whereby, the public may secure information; directs attention to the 
general course and method by which its functions are channeled; and sets 
forth the procedures governing the availability of opinions, orders, and 
other records in the files of said Administration.



Sec. 204.2  Organization.

    (a) The Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) consists of a headquarters office 
located in the South Building of the U.S. Department of Agriculture in 
Washington, DC, and 12 regional offices. The Washington headquarters 
office is organized to include the Office of the Administrator and two 
Divisions, the Packer and Poultry Division and the Livestock Marketing 
Division.
    (b) Office of the Administrator. This office has overall 
responsibility for administering the provisions of the Packers and 
Stockyards Act, 1921, as amended and supplemented (7 U.S.C. 181 et 
seq.), for enforcement of the Truth-in-Lending Act (15 U.S.C. 1601-1665) 
with respect to any activities subject to the Packers and Stockyards Act 
and for executing assigned civil defense and defense mobilization 
activities. These responsibilities include formulation of current and 
long-range programs relating to assigned functions; execution of the 
policies and programs administered by the Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards Programs); review and 
evaluation of program operations for uniform, effective, and efficient 
administration of the Packers and Stockyards Act; and maintenance of 
relations and communications with producer and industry groups.
    (1) Administrator. The Secretary of Agriculture has delegated 
responsibility for administration of the Packers and Stockyards Act to 
the Administrator who is responsible for the general direction and 
supervision of programs and activities assigned to the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
except such activities as are reserved to the Judicial Officer (32 FR 
7468). The Administrator reports to the Assistant Secretary for 
Marketing and Inspection Services.
    (2) Deputy Administrator. The Deputy Administrator assists the 
Administrator in the overall responsibility for the general direction 
and supervision of programs and activities assigned to the Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs).
    (3) Assistant to the Administrator. The Assistant to the 
Administrator participates with the Administrator and Deputy 
Administrator in the development and analysis of policies and programs, 
and directs the management support services and related activities of 
the Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs).
    (4) Director, Industry Analysis Staff. The Director of the Industry 
Analysis Staff participates with the Administrator and Deputy 
Administrator in the development and analysis of policies and programs 
and directs economic studies of structure and performance of the 
livestock, meat, and poultry marketing, processing, and wholesaling 
industries. The results of these studies are used to provide economic 
advice to the Administrator in developing overall policy on antitrust 
matters and effects of practices or impediments in the marketing system. 
The Director works closely with the Directors of the Packer and Poultry 
and the Livestock Marketing Divisions in connection with investigations 
to provide economic advice and expert testimony in trials and 
administrative hearings. The Director also coordinates activities and 
works closely with the Federal Trade Commission and Justice Department 
in studying the effects of

[[Page 61]]

mergers and antitrust matters in the livestock, meat packing and poultry 
industries.
    (c) Packer and Poultry Division. This Division carries out the 
enforcement of the provisions of the Packers and Stockyards Act relating 
to packers and live poultry dealers and handlers. The responsibilities 
and functions include: Determination of applicability of the provisions 
of the Act to individual packer and poultry operations; surveillance of 
these operations; investigation of complaints; initiation of formal 
proceedings, when warranted, to correct illegal practices; and 
maintenance of working relationships with the meat packer and poultry 
industries. These responsibilities and functions are accomplished with 
programs and activities directed through the Livestock Procurement 
Branch, Meat Merchandising Branch, and Poultry Branch. The Division 
Director participates with the Administrator and Deputy Administrator in 
the development and evaluation of policies and programs to fulfill the 
Agency's responsibilities and functions. The Director implements and 
directs the policies and programs pertaining to the Packer and Poultry 
Division through the three branches.
    (d) Livestock Marketing Division. This Division enforces those 
provisions of the Packers and Stockyards Act relating to stockyard 
owners, market agencies, and dealers. The responsibilities and functions 
include: determination of the applicability of the jurisdiction, 
bonding, financial and trade practice provisions of the Act to 
individual operations; supervision of the installation, maintenance, and 
testing of scales; surveillance and investigations of stockyards, market 
agencies, and dealers; initiation of formal proceedings, when warranted, 
to correct illegal practices; and maintenance of working relationships 
with producer and industry groups. These responsibilities and functions 
are accomplished with programs and activities directed through the 
Financial Protection Branch, Marketing Practices Branch, and Scales and 
Weighing Branch. The Division Director participates with the 
Administrator and Deputy Administrator in the development and evaluation 
of policies and programs to fulfill the Agency's responsibilities and 
functions. The Director implements and directs the policies and programs 
pertaining to the Livestock Marketing Division through the three 
branches.
    (e) Field Services. (1) The field services of the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
is divided into 12 regional offices. These offices are responsible for 
supervision of operations of stockyard companies, market agencies, 
dealers, packers and live poultry dealers and handlers to assure 
compliance with the Act. They formulate recommendations relating to the 
enforcement of the Act; receive and investigate complaints, including 
reparation complaints; audit books, records, and reports of persons 
subject to the Act; conduct investigations to determine the existence of 
and develop evidence of unfair, deceptive, and discriminatory trade 
practices; prepare investigative reports and recommend corrective 
action; assist in the prosecution of cases; review applications for 
registration and rate changes for accuracy and compliance; and maintain 
relationships with producers, the trade, States and other groups 
interested in the welfare of the livestock, meat packing, and poultry 
industries concerning enforcement of the Act.
    (2) The addresses and the States covered by these offices, which are 
under regional supervisors, are as follows:

Atlanta--Room 338, 1720 Peachtree Street, NW., Atlanta, Georgia 30309 
(Alabama, Florida, Georgia, South Carolina)
Bedford--Turnpike Road, Box 101E, Bedford, Virginia 25423 (District of 
Columbia, Delaware, Maryland, North Carolina, Virginia, West Virginia)
Denver--208 Livestock Exchange Building, Denver, Colorado 80216 
(Colorado, Montana, New Mexico, Utah, Wyoming)
Fort Worth--Room 8A36, Federal Building, 819 Taylor Street, Fort Worth, 
Texas 76102 (Oklahoma, Texas)
Indianapolis--Room 434 Federal Building and U.S. Courthouse, 46 E. Ohio 
Street, Indianapolis, Indiana 46204 (Illinois, Indiana, Kentucky, 
Michigan, Ohio)
Kansas City--828 Livestock Exchange Building, Kansas City, Missouri 
64102 (Kansas, Missouri)
Lawndale--15000 Aviation Boulevard, Room 2W6, P.O. Box 6102, Lawndale, 
California 90261 (Arizona, California, Hawaii, Nevada)
Memphis--Room 459, Federal Building, 167 Main Street, Memphis, Tennessee 
38103

[[Page 62]]

(Arkansas, Louisiana, Mississippi, Tennessee)
North Brunswick--825 Georges Road, Room 303, North Brunswick, New Jersey 
08902 (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New 
York, Pennsylvania, Rhode Island, Vermont)
Omaha--909 Livestock Exchange Building, Omaha, Nebraska 68107 (Iowa, 
Nebraska)
Portland--9370 S.W. Greenburg Road, Suite E, Portland, Oregon 97223 
(Alaska, Idaho, Oregon, Washington)
South St. Paul--208 Post Office Building, Box 8, South St. Paul, 
Minnesota 55075 (Minnesota, North Dakota, South Dakota, Wisconsin)



Sec. 204.3  Delegation of authority.

    (a) Deputy Administrator. Under the direction of the Administrator, 
the Deputy Administrator is hereby delegated authority to perform all 
the duties and exercise all the functions and powers which are now or 
which may hereafter be, vested in the Administrator (including the power 
of redelegation).
    (b) Division Directors. The Directors of the Industry Analysis 
Staff, the Livestock Marketing Division, and the Packer and Poultry 
Division, under administrative and technical direction of the 
Administrator and the Deputy Administrator, are hereby individually 
delegated authority, in connection with the respective functions 
assigned to each of said organizational units in Sec. 204.2 to perform 
all the duties and to exercise all the functions and powers which are 
now, or which may hereafter be, vested in the Administrator (including 
the power of redelegation) except such authority as is reserved to the 
Administrator and Deputy Administrator under paragraph (g) of this 
section.
    (c) Regional Supervisors. (1) The Regional Supervisors of the Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) are hereby individually delegated authority under 
the provisions of section 402 of the Packers and Stockyards Act, 1921, 
as amended (7 U.S.C. 222), to issue special orders pursuant to the 
provisions of section 6(b) of the Federal Trade Commission Act (15 
U.S.C. 46(b)), and, with respect thereto, to issue notices of default 
provided for in section 10 of the Federal Trade Commission Act (15 
U.S.C. 50); to notify persons deemed to be subject to the bonding 
requirements in 7 U.S.C. 204 of their obligations to file bonds or trust 
fund agreements in conformity with regulations issued under this chapter 
including authority to determine that a bond is inadequate under Sec. 
201.30(f) of this chapter and to give notice to the person of the amount 
of bond required; to notify persons deemed to be subject to the 
reporting requirements in Sec. 201.97 of this chapter of their 
obligations to file annual reports; and to grant reasonable requests for 
extensions of 30 days or less for the filing of such annual reports.
    (2) The Regional Supervisors are hereby individually delegated 
authority, when there is reason to believe that there is a question as 
to the true ownership of livestock sold by any person, to disclose 
information relating to such questionable ownership to any interested 
person.
    (d) Investigative employees. All employees of the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
assigned to or responsible for investigations in the enforcement of the 
Packers and Stockyards Act, 1921, as amended (7 U.S.C. 181 et seq.), or 
the enforcement of the Truth-in-Lending Act (15 U.S.C. 1601-1665), with 
respect to any activities subject to the Packers and Stockyards Act, are 
hereby individually delegated authority under the Act of January 31, 
1925, 43 Stat. 803, 7 U.S.C. 2217, to administer to or take from any 
person an oath, affirmation, or affidavit whenever such oath, 
affirmation, or affidavit is for use in any prosecution or proceeding 
under or in the enforcement of the aforementioned Acts. This authority 
may not be redelegated and will automatically expire upon the 
termination of the employment of such employees with the Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs).
    (e) Concurrent authority. No delegation prescribed herein shall 
preclude the Administrator or Deputy Administrator from exercising any 
of the powers or functions or from performing any of the duties 
conferred upon them, and any such delegation is subject at all times to 
withdrawal or amendment

[[Page 63]]

by the Administrator or Deputy Administrator or the Division Director 
responsible for the function involved.
    (f) Prior delegations. All prior delegations and redelegations of 
authority relating to any function or activity covered by these 
delegations of authority shall remain in effect except as they are 
inconsistent herewith or are hereafter amended or revoked. Nothing 
herein shall affect the validity of any action heretofore taken under 
prior delegations or redelegations of authority or assignment of 
functions.
    (g) Reservations of authority. It is hereby reserved to the 
Administrator and Deputy Administrator authority with respect to 
proposed rulemaking and final action for the issuance of regulations 
(Sec. 201.1 of this chapter et seq.), rules of practice governing 
proceedings (Sec. 202.1 of this chapter et seq.), and statements of 
general policy (Sec. 203.1 of this chapter et seq.), and the issuance 
of moving papers as prescribed in the rules of practice governing formal 
adjudicatory administrative proceedings instituted by the Secretary (7 
CFR part 1, subpart H, Sec. 1.133); and the authority to make final 
determinations in accordance with the provisions of 7 CFR part 1, 
subpart A, as to the availability of official records and information 
made or obtained in connection with the administration of the Packers 
and Stockyards Act which are considered exempt from disclosure under 
Sec. 204.7 of this part. Further, authority to issue subpoenas (7 
U.S.C. 222 and 15 U.S.C. 49) is reserved to the Administrator and Deputy 
Administrator.



Sec. 204.4  Public inspection and copying.

    (a) Facilities for public inspection and copying of the indexes and 
materials required to be made available under 7 CFR 1.2(a) will be 
provided by the Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) during normal hours of operation. 
Requests for this information should be made to the Freedom of 
Information Act Officer, Grain Inspection, Packers and Stockyards 
Administration (Packers and Stockyards Programs, United States 
Department of Agriculture, Washington, DC 20250.
    (b) Copies of such materials may be obtained in person or by mail. 
Applicable fees for copies will be charged in accordance with the 
regulations prescribed by the Director of Information, Office of 
Governmental and Public Affairs, USDA.



Sec. 204.5  Indexes.

    Pursuant to the regulations in 7 CFR 1.4(b), the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
will maintain and make available for public inspection and copying 
current indexes of all material required to be made available in 7 CFR 
1.2(a). Notice is hereby given that publication of these indexes is 
unnecessary and impractical, since the material is voluminous and does 
not change often enough to justify the expense of publication.



Sec. 204.6  Requests for records.

    (a) Requests for records under 5 U.S.C. 552(a)(3) shall be made in 
accordance with 7 CFR 1.3(a). Authority to make determinations regarding 
initial requests in accordance with 7 CFR 1.4(c) is delegated to the 
Freedom of Information Act Officer of the Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards Programs). Requests 
should be submitted to the FOIA Officer at the following address: 
Freedom of Information Act Officer (FOIA Request), Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs), 
United States Department of Agriculture, Washington, DC 20250.
    (b) The request shall identify each record with reasonable 
specificity as prescribed in 7 CFR 1.3.
    (c) The FOIA Officer is authorized to receive requests and to 
exercise the authority to (1) make determination to grant requests or 
deny initial requests; (2) extend the administrative deadline; (3) make 
discretionary release of exempt records; and (4) make determinations 
regarding charges pursuant to the fee schedule.



Sec. 204.7  Appeals.

    Any person whose request under Sec. 204.6 of this part is denied 
shall have

[[Page 64]]

the right to appeal such denial in accordance with 7 CFR 1.3(e). Appeals 
shall be addressed to the Administrator, Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards Programs), U.S. 
Department of Agriculture, Washington, DC 20250.



PART 205_CLEAR TITLE_PROTECTION FOR PURCHASERS OF FARM PRODUCTS--Table 
of Contents




                               Definitions

Sec.
205.1 Definitions.

                               Regulations

205.101 Certification--request and processing.
205.102 Name of person subjecting a farm product to a security interest, 
          on EFS and master list--format.
205.103 EFS--minimum information.
205.104 Registration of buyer, commission merchant, or selling agent--
          minimum information.
205.105 Master list and portion thereof distributed to registrants--
          format.
205.106 Farm products.
205.107 Crop year.

                          Interpretive Opinions

205.201 System operator.
205.202 ``Effective financing statement'' or EFS.
205.203 Place of filing EFS.
205.204 Filing ``notice'' of EFS.
205.205 Fees.
205.206 Farm products.
205.207 ``Amount'' and ``reasonable description of the property.''
205.208 Distribution of portions of master list--registration--
          information to non-registrants on request.
205.209 Amendment or continuation of EFS.
205.210 Effect of EFS outside State in which filed.
205.211 Applicability of court decisions under the UCC.
205.212 ``Buyer in ordinary course of business'' and ``security 
          interest.''
205.213 Obligations subject--``person indebted''--``debtor.''
205.214 Litigation as to whether a system is operating in compliance 
          with the Section.

    Authority: 7 U.S.C. 1631 and 7 CFR 2.22, 2.81.

    Source: 51 FR 29451, Aug. 18, 1986, unless otherwise noted.

                               Definitions



Sec. 205.1  Definitions.

    Terms defined in section 1324 of the Food Security Act of 1985, Pub. 
L. 99-198, 99 Stat. 1535, 7 U.S.C. 1631, shall mean the same in this 
part as therein. In addition, except as otherwise specified, as used in 
this part:
    (a) The Secretary means the Secretary of Agriculture of the United 
States;
    (b) The Section means section 1324 of the above-cited Act, and 
``subsection'' means a subsection of that Section;
    (c) System means central filing system as defined in subsection 
(c)(2);
    (d) EFS means effective financing statement as defined in subsection 
(c)(4);
    (e) System operator means Secretary of State or other person 
designated by a State to operate a system;
    (f) Registrant means any buyer of farm products, commission 
merchant, or selling agent, as referred-to in the Section, registered 
with a system under subsection (c)(2)(D);
    (g) Master list means the accumulation of data in paper, electronic, 
or other form, described in subsection (c)(2)(C);
    (h) Portion means portion of the master list distributed to 
registrants under subsection (c)(2)(E);
    (i) UCC or Uniform Commercial Code means the Uniform Commercial Code 
prepared under the joint sponsorship of the American Law Institute and 
the National Conference of Commissioners on Uniform State Laws, and in 
effect in most States of the United States at the time of enactment of 
Pub. L. 99-198.

                               Regulations



Sec. 205.101  Certification--request and processing.

    (a) To obtain certification of a system, a written request for 
certification must be filed together with such documents as show that 
the system complies with the Section. If such material is voluminous, a 
summary, table of contents, and index must accompany it as necessary to 
facilitate review.
    (b) The request must:
    (1) Include an introductory explanation of how the system will 
operate;

[[Page 65]]

    (2) Identify the information which will be required to be supplied 
on an EFS;
    (3) Identify where an EFS, amendment thereto, or continuation 
thereof, will be filed and, if elsewhere than with the system operator, 
explain how and in what form the system operator will receive 
information needed to compile and update the master list;
    (4) Explain the method for recording the date and hour of filing of 
an EFS, amendment thereto, or continuation thereof;
    (5) Explain how the master list will be compiled, including the 
method and form of storage and arrangement of information, explain the 
method and form of retrieval of information from the master list, the 
method and form of distribution of portions of the master list to 
registrants as required by subsection (c)(2)(E), and the method and form 
of furnishing of information orally with written confirmation as 
required by subsection (c)(2)(F) (details of computer hardware and 
software need not be furnished but the results it will produce must be 
explained);
    (6) Explain how the list of registrants will be compiled, including 
identification of where and how they will register, what information 
they must supply in connection with registration, and the method and 
form of storage and retrieval of such information (details of computer 
hardware and software need not be furnished but the results it will 
produce must be explained);
    (7) Show how frequently portions of the master list will be 
distributed regularly to registrants;
    (8) Show the farm products according to which the master list will 
be organized;
    (9) Show how the system will interpret the term ``crop year'' and 
how it will classify as to crop year an EFS not showing crop year;
    (10) Show what fee will be charged and explain how the costs of the 
system will be covered if not by such fee and the general revenue of the 
State; and
    (11) Include copies of:
    (i) All State legislation or other legal authority under which the 
system is created and operated, and the system operator is designated;
    (ii) All regulations, rules and requirements issued under such 
legislation or other legal authority and governing operation of the 
system, designation of the system operator, and use of the system by 
members of the public; and
    (iii) All printed and electronic forms required to be used in 
connection with the system.
    (c) Any such request and attachments must be filed in triplicate 
(one copy for public inspection, a second copy for use in GIPSA, and a 
third copy for use in the Office of the General Counsel, USDA). All 
three copies must be received in the headquarters of the Grain 
Inspection, Packers and Stockyards Administration Packers and Stockyards 
Programs), USDA, Washington, DC 20250.
    (d) A refusal to certify such a system, if any, will be explained in 
writing. Reconsideration of such a refusal must be requested in writing 
with specification of errors believed to have been made.
    (e) To make changes to an existing certified central filing system, 
including changes necessitated or made possible by amendments to the 
Act, a written request to amend the existing certified central filing 
system must be filed together with such documents as are necessary to 
show that the system complies with the Act. The request must contain 
relevant new information consistent with the requirements specified 
elsewhere in this section.

[51 FR 29451, Aug. 18, 1986, as amended at 61 FR 54728, Oct. 22, 1996]



Sec. 205.102  Name of person subjecting a farm product to a security 
interest, on EFS and master list--format.

    On an EFS, and on a master list, the name of the person subjecting a 
farm product to a security interest must appear as follows:
    (a) In the case of a natural person, the surname (last name or 
family name) must appear first;
    (b) In the case of a corporation or other entity not a natural 
person, the name must appear beginning with the first word or character 
not an article or punctuation mark.

[[Page 66]]



Sec. 205.103  EFS--minimum information.

    (a) The minimum information necessary on an EFS is as follows:
    (1) Crop year unless every crop of the farm product in question, for 
the duration of the EFS, is to be subject to the particular security 
interest;
    (2) Farm product name (see Sec. Sec. 205.106, 205.206);
    (3) Each county or parish in the same State where the farm product 
is produced or to be produced;
    (4) Name and address of each person subjecting the farm product to 
the security interest, whether or not a debtor (see Sec. 205.102);
    (5) Social security number or, if other than a natural person, IRS 
taxpayer identification number, of each such person;
    (6) Further details of the farm product subject to the security 
interest if needed to distinguish it from other such product owned by 
the same person or persons but not subject to the particular security 
interest (see Sec. 205.207); and
    (7) Secured party name and address.
    (b) A requirement of additional information on an EFS is 
discretionary with the State.
    (c) Whether to permit one EFS to reflect multiple products, or 
products in multiple counties, is discretionary with the State.



Sec. 205.104  Registration of buyer, commission merchant, or selling 
agent--minimum information.

    (a) The minimum information necessary on a registration of a buyer, 
commission merchant, or selling agent is as follows:
    (1) Buyer, commission merchant, or selling agent name and address;
    (2) Farm product or products (see Sec. Sec. 205.106, 205.206) in 
which registrant is interested; and
    (3) If registrant is interested only in such product or products 
produced in a certain county or parish, or certain counties or parishes, 
in the same State, the name of each such county or parish.
    (b) A registrant, if not registered for any specified county or 
parish, or counties or parishes, must be deemed to have registered for 
all counties and parishes shown on the master list.
    (c) A requirement of additional information on a registration form 
is discretionary with the State.



Sec. 205.105  Master list and portion thereof distributed to 
registrants--format.

    (a) The master list must contain all the information on all the 
EFS's filed in the system, so arranged that it is possible to deliver to 
any registrant all such information relating to any product, produced in 
any county or parish (or all counties or parishes), for any crop year, 
covered by the system. The system must be able to deliver all such 
information to any registrant, either in alphabetical order by the word 
appearing first in the name of each person subjecting a product to a 
security interest (see Sec. 205.102), in numerical order by social 
security number (or, if other than a natural person, IRS taxpayer 
identification number) of each such person, or in both alphabetical and 
numerical orders, as requested by the registrant.
    (b) Section (c)(2)(E) requires the portion to be distributed in 
``written or printed form.'' This means recording on paper by any 
technology in a form that can be read by humans without special 
equipment. The system may, however, honor requests from registrants to 
substitute recordings on any medium by any technology including, but not 
limited to, electronic recording on tapes or discs in machine-readable 
form, and on photographic recording on microfiche. It also includes, if 
requested by registrants, electronic transmissions whereby registrants 
can print their own paper copies.
    (c) After distribution of a portion of a master list, there can be 
supplementary distribution of a portion showing only changes from the 
previous one. However, if this is done, cumulative supplements must be 
distributed often enough that readers can find all the information given 
to them for any one crop year in no more than three distributions.

[51 FR 29451, Aug. 18, 1986, as amended at 61 FR 54728, Oct. 22, 1996]

[[Page 67]]



Sec. 205.106  Farm products.

    The farm products, according to which the master list must be 
organized as required by subsection (c)(2), and which must be identified 
on an EFS as required by subsection (c)(4)(D)(iv), must be specific 
commodities, species of livestock, and specific products of crops or 
livestock. The Section does not permit miscellaneous categories.



Sec. 205.107  Crop year.

    (a) The crop year, according to which subsection (c)(2)(C)(ii)(IV) 
requires the master list to be arranged ``within each such product,'' 
must be:
    (1) For a crop grown in soil, the calendar year in which it is 
harvested or to be harvested;
    (2) For animals, the calendar year in which they are born or 
acquired;
    (3) For poultry or eggs, the calendar year in which they are sold or 
to be sold.
    (b) An EFS or notice thereof which does not show crop year (the 
Section does not require it to do so) must be regarded as applicable to 
the crop or product in question for every year for which subsection 
(c)(4)(F) makes the EFS effective.

                          Interpretive opinions



Sec. 205.201  System operator.

    The system operator can be the Secretary of State of a State, or any 
designee of the State pursuant to its laws. Note that the provision in 
subsection (c)(2) for a system refers to operation by the Secretary of 
State of a State, but the definition in (c)(11) of ``Secretary of 
State'' includes ``designee of the State.''



Sec. 205.202  ``Effective financing statement'' or EFS.

    (a) An EFS under subsection (c)(4) need not be the same as a 
financing statement or security agreement under the Uniform Commercial 
Code (or equivalent document under future successor State law), but can 
be an entirely separate document meeting the definition in (c)(4). Note 
that (c)(4) contains a comprehensive definition of the term which does 
not include any requirement that the EFS be the instrument by which a 
security interest is created or perfected. Note also the House Committee 
Report on Pub. L. 99-198, No. 99-271, Part 1, September 13, 1985, at 
page 110: ``[T]he bill would not preempt basic state-law rules on the 
creation, perfection, or priority of security interests.''
    (b) An EFS may be filed electronically provided a State allows 
electronic filing of financing statements without the signature of the 
debtor under applicable State law under provisions of the Uniform 
Commercial Code or may be a paper document. An electronically filed EFS 
need not be a paper document and need not be signed. If an original or 
reproduced paper document of an EFS is filed with the State, it must be 
signed by both the secured party and the debtor, and be filed by the 
secured party.
    (c) Countermeasures against mishandling after filing, such as a 
requirement that a copy be date stamped and returned to the secured 
party, are discretionary with the State. If a State chooses to adopt 
such countermeasures, it is responsible for establishing procedures for 
recording the date and time when an EFS is received, and for meeting all 
legal requirements associated with filing and distributing information 
about security interests as required by Sec. 205.101.

[51 FR 29451, Aug. 18, 1986, as amended at 61 FR 54728, Oct. 22, 1996]



Sec. 205.203  Place of filing EFS.

    The place of filing an EFS is wherever State law requires, which 
need not be with the system operator so long as the system operator 
receives the information needed for the master list, including the 
information required in subsection (c)(4)(D). Note that the requirements 
in subsection (c)(4) for an EFS include the requirement that it be 
``filed with the Secretary of State,'' but the definition in (c)(11) of 
``Secretary of State'' includes ''designee of the State,'' and the 
requirements in (c)(2) for a system refer in (A) to filing with the 
system operator of ``effective financing statements or notice of such 
financing statements.'' (emphasis added)

[[Page 68]]



Sec. 205.204  Filing ``notice'' of EFS.

    (a) If an EFS is filed somewhere other than with the system 
operator, and if notice of it is filed with the system operator, such 
notice could be electronic filing, telephoned information, or any other 
form of notice which gives the system operator the information needed 
for the master list. Such notice need not be signed. Note that the 
Section does not contain any requirement for such notice except the one 
in subsection (c)(4)(B) that an EFS must be filed somewhere pursuant to 
State law as discussed above.
    (b) Countermeasures against falsifications, errors or omissions in 
such notices or in the handling of them by the system operator, such as 
requirements that the notices be on paper and signed, with copies date-
stamped and returned to the persons filing them, however advisable they 
might be from other standpoints, are discretionary with the State and 
not required by the Section.



Sec. 205.205  Fees.

    The Section provides at subsection (c)(4)(H) for a fee for filing an 
EFS. The fee can be set in any manner provided by the law of the State 
in which such EFS is filed. The basis for this is that (c)(4)(H) 
provides for the fee to be set by the ``Secretary of State'' but (c)(11) 
defines the latter term to include ``designee of the State.'' The fee 
structure is discretionary with the State.



Sec. 205.206  Farm products.

    (a) The master list must be organized by farm product as required by 
subsection (c)(2), and the farm product must be identified on an EFS as 
required by subsection (c)(4)(D)(iv). The following is a list of such 
farm products.

Rice, rye, wheat, other food grains (system must specify by name)
Barley, corn, hay, oats, sorghum grain, other feed crops (system must 
specify by name)
Cotton
Tobacco
Flaxseed, peanuts, soybeans, sunflower seeds, other oil crops (system 
must specify by name)
Dry beans, dry peas, potatoes, sweet potatoes, taro, other vegetables 
(system must specify by name)
Artichokes, asparagus, beans lima, beans snap, beets, Brussels sprouts, 
broccoli, cabbage, carrots, cauliflower, celery, corn sweet, cucumbers, 
eggplant, escarole, garlic, lettuce, onions, peas green, peppers, 
spinach, tomatoes, other truck crops (system must specify by name)
Melons (system must specify by name)
Grapefruit, lemons, limes, oranges, tangelos, tangerines, other citrus 
fruits (system must specify by name)
Apples, apricots, avocados, bananas, cherries, coffee, dates, figs, 
grapes (& raisins), nectarines, olives, papayas, peaches, pears, 
persimmons, pineapples, plums (& prunes), pomegranates, other noncitrus 
fruits (system must specify by name)
Berries (system must specify by name)
Tree nuts (system must specify by name)
Bees wax, honey, maple syrup, sugar beets, sugar cane, other sugar crops 
(system must specify by name)
Grass seeds, legume seeds, other seed crops (system must specify by 
name)
Hops, mint, popcorn, other miscellaneous crops (system must specify by 
name)
Greenhouse & nursery products produced on farms (system must specify by 
name)
Mushrooms, trees, other forest products (system must specify by name)
Chickens, ducks, eggs, geese, turkeys, other poultry or poultry products 
(system must specify by name)
Cattle & calves, goats, horses, hogs, mules, sheep & lambs, other 
livestock (system must specify by name)
Milk, other dairy products produced on farms (system must specify by 
name)
Wool, mohair, other miscellaneous livestock products produced on farms 
(system must specify by name)
Fish, shellfish
Other farm products (system must specify by name).

    (b) Note the definition of the term ``farm product'' at subsection 
(c)(5), and the Conference Report on Pub. L. 99-198, No. 99-447, 
December 17, 1985, at page 486.
    (c) A State may establish a system for specified products and not 
for all. A State establishing a system for specified products and not 
for all will be deemed to be ``a State that has established a central 
filing system'' as to the specified products, and will be deemed not to 
be such a State as to other products.



Sec. 205.207  ``Amount'' and ``reasonable description of the property.''

    (a) The ``amount'' of farm products and ``reasonable description of 
the property including county or parish,''

[[Page 69]]

on an EFS and on the master list under subsections (c)(4)(D)(iv) and 
(2)(C)(iii), need not be shown on every EFS and master list entry.
    (b) Any EFS and master list entry will identify a product. If they 
do not show an amount, this constitutes a representation that all of 
such product owned by the person in question is subject to the security 
interest in question.
    (c) Any EFS and master list entry will identify each county or 
parish in the same State where the product is or is to be produced. If 
they do not show any further identification of the location of the 
product, this constitutes a representation that all such product 
produced in each such county or parish, owned by such person, is subject 
to the security interest.
    (d) The need to supply additional information arises only where some 
of that product owned by that person is subject to the security interest 
and some is not.
    (e) The additional information about amount and property must be 
sufficient to enable a reader of the information to identify what 
product owned by that person is subject, as distinguished from what of 
the same product owned by the same person is not subject. The precision 
needed, in the description of the amount and location, would vary from 
case to case.
    (f) The basis for this is the purpose of the entire exercise, to 
make information available as necessary to enable an identification of 
what product is subject to a security interest as distinguished from 
what is not.



Sec. 205.208  Distribution of portions of master list--registration--
information to non-registrants on request.

    (a) The provisions in the Section regarding registration of ``buyers 
of farm products, commission merchants, and selling agents,'' 
``regular'' distribution of ``portions'' of the master list, furnishing 
of ``oral confirmation * * * on request,'' and the effect of all this, 
that is, subsections (c)(2) (D), (E) and (F), (e) (2) and (3), and 
(g)(2) (C) and (D), must be read together.
    (b) The Section does not require such persons to register. Not 
registering with a particular system operator has the effect, under 
subsections (e)(2) and (g)(2)(C), of making such persons, whether they 
are inside or outside the State covered by that system, subject to 
security interests shown on that system's master list whether or not 
such persons know about them, so that such persons for their own 
protection will need to query the system operator about any seller 
``engaged in farming operations,'' of a farm product produced in the 
State covered by that system, with whom they deal.
    (c) The effect of registration by such persons with a particular 
system is to get them on the list for regular distribution of portions 
of that system's master list, the portions to be determined by the 
registration. They are subject only to security interests shown on the 
portions which they receive, and are not subject to such interests as 
are shown on the master list but not shown on portions which they 
receive. Also, if a particular security interest is shown on the master 
list, but has been placed on it since the last regular distribution of 
portions of that list to registrants, registrants would not be subject 
to that security interest. These conclusions are based on the provisions 
in subsections (e)(3)(A) and (g)(2)(D)(i) that such persons are subject 
to a security interest only if they receive ``written notice * * * that 
specifies both the seller and the farm product.''
    (d) A question arises as to the length of time for which a 
registration is effective, and whether a registrant, wishing to change 
registration as to county or product, can amend an existing registration 
or must file a new one. This is discretionary with the State since the 
Section is silent about it.
    (e) A question arises whether persons can register to receive only 
portions of the list for products in which they do not deal, and thus 
not be subject to security interests in products in which they deal 
because they are registrants but do not receive written notice of them. 
For example, can cattle dealers register to receive portions of the 
master list only for oranges, and thus take cattle free and clear of 
security interests shown on the master list, but as to which they do not 
receive written notice because they have not registered

[[Page 70]]

to receive the portion for cattle? Registrants will be deemed to be 
registered only as to those portions of the master list for which they 
register, and will be deemed to have failed to register as to those 
portions for which they do not register.
    (f) The Section requires ``regular'' distribution, to registrants, 
of portions of the master list as amended from time to time by the 
filing of EFS's and amendments to EFS's. The requirement that the 
distribution be ``regular'' necessarily refers to an interval specified 
in advance. The interval may vary according to product and region. The 
frequency of such distribution must be a consideration in review for 
certification since distribution must be timely to serve its purpose. 
While subsection (c)(2)(E) (providing that distribution be made 
``regularly as prescribed by the State'') gives each State discretion to 
choose the interval between distributions, whatever interval a State 
chooses will inevitably make possible some transactions in which 
security interests are filed in the system but registrants are not 
subject to them.
    (g) Legislative history of the Section shows that buyers, commission 
merchants, and selling agents are not intended to be liable for errors 
or other inaccuracies generated by the system. See Nov. 22, 1985 Cong. 
Rec., Senate, pg. S16300, and Dec. 18, 1985 Cong. Rec., House, pg. 
H12523.
    (h) In furnishing to non-registrants ``oral confirmation within 24 
hours of any [EFS] on request followed by written confirmation,'' by a 
system operator pursuant to subsection (c)(2)(F), any failure in use of 
a telephone caused by a ``busy signal'' could not be the basis of 
liability of the system operator. The basis for this is that subsection 
(c)(2)(F) does not mention telephones. Also, while it mentions 
furnishing information orally, it does not contain any provision as to 
how queries are to be received, that is, orally, in writing, or 
otherwise.
    (i) Of course it is to be expected that telephones would be used in 
most cases, but use of them is not required by the legislation and is 
discretionary with the State.
    (j) In the matter of receiving queries and giving oral replies to 
them, subsection (c)(2)(F) will be complied with if a system operator 
maintains an office and staff where a query can be received on business 
days and during business hours such as are regular in the State, and 
where an oral reply will be available on the regular business day 
following the day on which the query is received, at or before the time 
of day when it was received.
    (k) Written confirmation is required, by subsection (c)(2)(F), to be 
given to any non-registered buyer, commission merchant, or selling 
agent.
    (l) Such a written confirmation pursuant to subsection (c)(2)(F) 
does not alter the liability of the non-registrant querying the system 
and receiving information about a security interest recorded in it. The 
basis of this, as above, is that non-registrants are subject to security 
interests recorded in a system whether or not they know about them, and 
must query the system for their own protection.
    (m) The Section does not specify when or how the written 
confirmation must be furnished, but provides only that it must follow 
the oral information. Thus the time and method of furnishing written 
confirmation is discretionary with the State.



Sec. 205.209  Amendment or continuation of EFS.

    (a) The ``material change,'' required by subsection (c)(4)(E) to be 
reflected in an amendment to an EFS and master list entry, is whatever 
change would render the master list entry no longer informative as to 
what is subject to the security interest in question. That will vary 
from case to case. The basis for this is the purpose for which the 
information is supplied, that is, to make information available, to a 
buyer, commission merchant, or selling agent who proposes to enter into 
a transaction in a product, whether it is subject to a security 
interest. The requirement to amend arises when the information already 
made available no longer serves the purpose and other information is 
needed in order to do so.

[[Page 71]]

    (b) Where an owner of a product makes a change, such as planting a 
different crop or purchasing different animals from what was 
represented, without informing the secured party, so that the master 
list entry is rendered not informative, but the EFS and master list are 
not amended through no fault of the secured party, the Section is silent 
as to the consequences. However, see the legislative history cited in 
Sec. 205.208(f).
    (c) The amendment must be filed in the same manner as the original 
filing. Note the requirement of section (c)(4)(E). The amendment may be 
filed electronically provided a State allows electronic filing of 
financing statements without the signature of the debtor under 
applicable State law under provisions of the Uniform Commercial Code. An 
electronically filed amendment need not be signed. However, if an 
original or reproduced paper document is filed, the amendment must be 
signed by the secured party and the debtor, and be filed by the secured 
party.
    (d) An effective financing statement remains effective for a period 
of 5 years from the date of filing and may be continued in increments of 
5-year periods beyond the initial 5-year filing period by refiling an 
effective financing statement or by filing a continuation statement 
within 6 months before expiration of the effective financing statement. 
A continuation statement may be filed electronically or as a paper 
document, and need not contain the signature of the debtor.

[51 FR 29451, Aug. 18, 1986, as amended at 61 FR 54728, Oct. 22, 1996; 
63 FR 66721, Dec. 3, 1998]



Sec. 205.210  Effect of EFS outside State in which filed.

    (a) A question arises whether, if an EFS is filed in one State, a 
notice of it can be filed in another State and shown on the master list 
for the second State. There is nothing in the Section to prevent this, 
but it would serve no purpose.
    (b) The Section provides only for filing an EFS, covering a given 
product, in the system for the State in which it is produced. Upon such 
filing in such system, subsections (e)(2) and (g)(2)(C) make buyers, 
commission merchants and selling agents not registered with that system 
subject to the security interest in that product whether or not they 
know about it, even if they are outside that State. Subsections (e)(3) 
and (g)(2)(D) make persons registered with that system subject if they 
receive written notice of it even if they are outside that State. All of 
these provisions apply only where an EFS is filed in the system for the 
State in which the product is produced. They do not apply to a filing in 
another system.
    (c) What constitutes ``receipt'' of notice is determined by the law 
of the State in which the intended recipient of notice resides. This is 
based on subsection (f) which follows provisions for notice to buyers, 
and (g)(3) which follows provisions for notice to commission merchants 
and selling agents. Each of those provisions uses the word ``buyer'' but 
it means ``intended recipient of notice.''



Sec. 205.211  Applicability of court decisions under the UCC.

    (a) Court decisions under the Uniform Commercial Code (UCC), about 
the scope of the ``farm products'' exception in Section 9-307(1) 
thereof, and interpreting the terms therein, particularly ``person 
engaged in farming operations'' which is not defined in the Section, are 
applicable to an extent in interpreting the Section. The basis of this 
is the legislative intent of the Section to pre-empt State laws 
reflecting that ``farm products'' exception, as shown in the House 
Committee Report on Pub. L. 99-198, No. 99-271, Part 1, September 13, 
1985, at pages 108 et seq.
    (b) That UCC Section 9-307(1) reads as follows:

    (1) A buyer in ordinary course of business (subsection (9) of 
Section 1-201) other than a person buying farm products from a person 
engaged in farming operations takes free of a security interest created 
by his seller even though the security interest is perfected and even 
though the buyer knows of its existence. (emphasis added)



Sec. 205.212  ``Buyer in ordinary course of business'' and ``security 
interest.''

    The terms ``buyer in ordinary course of business'' and ``security 
interest'' are defined in subsections (c) (1) and (7). There are 
differences between those

[[Page 72]]

definitions and the UCC definitions of the same terms. In interpreting 
those differences, the following would be pertinent:
    (a) The legislative intent discussed above in Sec. 205.211, to pre-
empt State laws reflecting the ``farm products'' exception; and
    (b) The legislative intent shown in subsections (a) and (b) that 
certain persons take free and clear of certain interests of a ``secured 
lender'' ``when the seller fails to repay the lender,'' unless such 
persons have information about such interests made available to them as 
provided in the Section.



Sec. 205.213  Obligations subject--``person indebted''--``debtor.''

    (a) A debt need not exist at the time of filing of an EFS. The basis 
for this is that subsection (c)(4) does not require the EFS, and 
subsection (c)(2)(C) does not require the master list, to show any 
amount of debt.
    (b) The Section does not provide for the transaction in which one 
person subjects a product to a security interest for another's debt. 
However the terms ``person indebted'' and ``debtor'' in the Section 
refer to the person who owns a product and subjects it to a security 
interest, whether or not that person owes a debt to the secured party. 
The basis for this is the purpose for which the information is supplied. 
Any buyer of a farm product, commission merchant, or selling agent 
querying a master list or system operator about a prospective seller of 
a farm product is interested in whether that seller has subjected that 
product to a security interest, not in whether the debt is owed by that 
seller or by another.
    (c) Security interests existing prior to establishment of a system 
can be filed in such a system and reflected in the master list if 
documents are in existence or are created which meet the requirements of 
subsection (c)(4) besides filing, if such documents are filed wherever 
State law requires, and if the system operator receives the information 
about them needed for the master list.
    (d) A system can be in compliance with the Section, although it 
reflects security interests not supported by EFS's as defined in the 
legislation, and although it reflects security interests on items other 
than farm products. However, subsections (e) (2) and (3), and (g)(2) (C) 
and (D), will apply only as to entries reflecting farm products and 
supported by EFS's as defined in the Section, and it must be possible to 
distinguish the entries to which these provisions apply from the other 
entries.



Sec. 205.214  Litigation as to whether a system is operating in compliance 
with the Section.

    (a) The requirements for a system in subsection (c) are written as 
the definition of the term ``central filing system,'' so that failure of 
a system to meet any such requirement, either at the time of its 
establishment or later, will mean that it is not a ``central filing 
system'' as defined.
    (b) The issue whether a system, after certification, is operating in 
compliance, thus whether it is a ``central filing system'' as defined, 
could be litigated and ruled on in a case involving only private 
parties, such as a lender and a buyer of a farm product. The only 
immediate effect of a finding in such a case, that a system is not a 
``central filing system'' as defined, would be that the rights of the 
secured party in the case would be as if the State had no system. 
However, others would be in doubt as to whether they could safely rely 
on the same system.



PART 206_SWINE CONTRACT LIBRARY--Table of Contents




Sec.
206.1 Definitions.
206.2 Swine contract library.
206.3 Monthly report.

    Authority: Sec. 941, Pub. L. 106-78, 113 Stat. 1135; 7 CFR 2.22 and 
2.81.

    Source: 68 FR 47826, Aug. 11, 2003, unless otherwise noted.



Sec. 206.1  Definitions.

    The definitions in this section apply to the regulations in this 
part. The definitions in this section do not apply to other regulations 
issued under the Packers and Stockyards Act (P&S Act) or to the P&S Act 
as a whole.
    Accrual account. (Synonymous with ``ledger,'' as defined in this 
section.) An

[[Page 73]]

account held by a packer on behalf of a producer that accrues a running 
positive or negative balance as a result of a pricing determination 
included in a contract that establishes a minimum and/or maximum level 
of base price paid. Credits and/or debits for amounts beyond these 
minimum and/or maximum levels are entered into the account. Further, the 
contract specifies how the balance in the account affects producer and 
packer rights and obligations under the contract.
    Base price. The price paid for swine before the application of any 
premiums or discounts, expressed in dollars per unit.
    Contract. Any agreement, whether written or verbal, between a packer 
and a producer for the purchase of swine for slaughter, except a 
negotiated purchase (as defined in this section).
    Contract type. The classification of contracts or risk management 
agreements for the purchase of swine committed to a packer, by the 
determination of the base price and the presence or absence of an 
accrual account or ledger (as defined in this section). The contract 
type categories are:
    (1) Swine or pork market formula purchases with a ledger,
    (2) Swine or pork market formula purchases without a ledger,
    (3) Other market formula purchases with a ledger,
    (4) Other market formula purchases without a ledger,
    (5) Other purchase arrangements with a ledger, and
    (6) Other purchase arrangements without a ledger.
    Formula price. A price determined by a mathematical formula under 
which the price established for a specified market serves as the basis 
for the formula.
    Ledger. (Synonymous with ``accrual account,'' as defined in this 
section.) An account held by a packer on behalf of a producer that 
accrues a running positive or negative balance as a result of a pricing 
determination included in a contract that establishes a minimum and/or 
maximum level of base price paid. Credits and/or debits for amounts 
beyond these minimum and/or maximum levels are entered into the account. 
Further, the contract specifies how the balance in the account affects 
producer and packer rights and obligations under the contract.
    Negotiated purchase. A purchase, commonly known as a ``cash'' or 
``spot market'' purchase, of swine by a packer from a producer under 
which:
    (1) The buyer-seller interaction that results in the transaction and 
the agreement on actual base price occur on the same day; and
    (2) The swine are scheduled for delivery to the packer not later 
than 14 days after the date on which the swine are committed to the 
packer.
    Noncarcass merit premium or discount. An increase or decrease in the 
price for the purchase of swine made available by an individual packer 
or packing plant, based on any factor other than the characteristics of 
the carcass, if the actual amount of the premium or discount is known 
before the purchase and delivery of the swine.
    Other market formula purchase. A purchase of swine by a packer in 
which the pricing determination is a formula price based on any market 
other than the markets for swine, pork, or a pork product. The pricing 
determination includes, but is not limited to:
    (1) A price formula based on one or more futures or options 
contracts;
    (2) A price formula based on one or more feedstuff markets, such as 
the market for corn or soybeans; or
    (3) A base price determination using more than one market as its 
base where at least one of those markets would be defined as an ``other 
market formula purchase.''
    Other purchase arrangement. A purchase of swine by a packer that is 
not a negotiated purchase, swine or pork market formula purchase, or 
other market formula purchase, and does not involve packer-owned swine.
    Packer. Any person engaged in the business of buying swine in 
commerce for purposes of slaughter, of manufacturing or preparing meats 
or meat food products from swine for sale or shipment in commerce, or of 
marketing meats or meat food products from swine in an unmanufactured 
form acting as a wholesale broker, dealer, or

[[Page 74]]

distributor in commerce. The regulations in this part only apply to a 
packer purchasing at least 100,000 swine per year and slaughtering swine 
at a federally inspected swine processing plant that meets either of the 
following conditions:
    (1) A swine processing plant that slaughtered an average of at least 
100,000 swine per year during the immediately preceding 5 calendar 
years, with the average based on those periods in which the plant 
slaughtered swine; or
    (2) Any swine processing plant that did not slaughter swine during 
the immediately preceding 5 calendar years that has the capacity to 
slaughter at least 100,000 swine per year, based on plant capacity 
information.
    Producer. Any person engaged, either directly or through an 
intermediary, in the business of selling swine to a packer for slaughter 
(including the sale of swine from a packer to another packer).
    Swine. A porcine animal raised to be a feeder pig, raised for 
seedstock, or raised for slaughter.
    Swine or pork market formula purchase. A purchase of swine by a 
packer in which the pricing determination is a formula price based on a 
market for swine, pork, or a pork product, other than a futures contract 
or option contract for swine, pork, or a pork product.



Sec. 206.2  Swine contract library.

    (a) Do I need to provide swine contract information? Each packer, as 
defined in Sec. 206.1, must provide information for each swine 
processing plant that it operates or at which it has swine slaughtered 
that has the slaughtering capacity specified in the definition of packer 
in Sec. 206.1.
    (b) What existing or available contracts do I need to provide and 
when are they due? Each packer must send, to the Grain Inspection, 
Packers and Stockyards Administration (GIPSA), an example of each 
contract it currently has with a producer or producers or that is 
currently available at each plant that it operates or at which it has 
swine slaughtered that meets the definition of packer in Sec. 206.1. 
This initial submission of example contracts is due to GIPSA on the 
first business day of the month following the determination that the 
plant has the slaughtering capacity specified in the definition of 
packer in Sec. 206.1.
    (c) What available contracts do I need to provide and when are they 
due? After the initial submission, each packer must send GIPSA an 
example of each new contract it makes available to a producer or 
producers within one business day of the contract being made available 
at each plant that it operates or at which it has swine slaughtered that 
meets the definition of packer in Sec. 206.1.
    (d) What criteria do I use to select example contracts? For purposes 
of distinguishing among contracts to determine which contracts may be 
represented by a single example, contracts will be considered to be the 
same if they are identical with respect to all of the following four 
example-contract criteria:
    (1) Base price or determination of base price;
    (2) Application of a ledger or accrual account (including the terms 
and conditions of the ledger or accrual account provision);
    (3) Carcass merit premium and discount schedules (including the 
determination of the lean percent or other merits of the carcass that 
are used to determine the amount of the premiums and discounts and how 
those premiums and discounts are applied); and
    (4) Use and amount of noncarcass merit premiums and discounts.
    (e) Where and how do I send my contracts? Each packer may submit the 
example contracts and notifications required by this section by either 
of the following two methods:
    (1) Electronic report. Example contracts and notifications required 
by this section may be submitted by electronic means. Electronic 
submission may be by any form of electronic transmission that has been 
determined to be acceptable to the Administrator. To obtain current 
options for acceptable methods to submit example contracts 
electronically, contact GIPSA through the Internet on the GIPSA Web site 
(http://www.usda.gov/gipsa/) or at USDA GIPSA, Suite 317, 210 Walnut 
Street, Des Moines, IA 50309.

[[Page 75]]

    (2) Printed report. Each packer that chooses to submit printed 
example contracts and notifications must deliver the printed contracts 
and notifications to USDA GIPSA, Suite 317, 210 Walnut Street, Des 
Moines, IA 50309.
    (f) What information from the swine contract library will be made 
available to the public? GIPSA will summarize the information it has 
received on contract terms, including, but not limited to, base price 
determination and the schedules of premiums or discounts. GIPSA will 
make the information available by region and contract type as defined in 
Sec. 206.1, for public release one month after the initial submission 
of contracts. Geographic regions will be defined in such a manner to 
provide as much information as possible while maintaining 
confidentiality in accordance with section 251 of the Agricultural 
Marketing Act (7 U.S.C. 1636).
    (g) How can I review information from the swine contract library? 
The information will be available on the Internet on the GIPSA Web site 
(http://www.usda.gov/gipsa/) and at USDA GIPSA, Suite 317, 210 Walnut 
Street, Des Moines, IA 50309. The information will be updated as GIPSA 
receives information from packers.
    (h) What do I need to do when a previously submitted example 
contract is no longer a valid example due to contract changes, 
expiration, or withdrawal? Each packer must submit a new example 
contract when contract changes result in changes to any of the four 
example-contract criteria specified in paragraph (d) of this section and 
notify GIPSA if the new example contract replaces the previously 
submitted example contract. Each packer must notify GIPSA when an 
example contract no longer represents any existing or available contract 
(expired or withdrawn). Each packer must submit these example contracts 
and notifications within one business day of the change, expiration, or 
withdrawal.

(Approved by the Office of Management and Budget under control number 
0580-0021)



Sec. 206.3  Monthly report.

    (a) Do I need to provide monthly reports? Each packer, as defined in 
Sec. 206.1, must provide information for each swine processing plant 
that it operates or at which it has swine slaughtered that has the 
slaughtering capacity specified in the definition of packer.
    (b) When is the monthly report due? Each packer must send a separate 
monthly report for each plant that has the slaughtering capacity 
specified in the definition of packer in Sec. 206.1. Each packer must 
deliver the report to the GIPSA Regional Office in Des Moines, IA, by 
the close of business on the 15th of each month, beginning at least 45 
days after the initial submission of example contracts. The GIPSA 
Regional Office closes at 4:30 p.m. Central Time. If the 15th day of a 
month falls on a Saturday, Sunday, or federal holiday, the monthly 
report is due no later than the close of the next business day following 
the 15th.
    (c) What information do I need to provide in the monthly report? The 
monthly report that each packer files must be reported on Form P&SP-341, 
which will be available on the Internet on the GIPSA Web site (http://
www.usda.gov/gipsa/) and at USDA GIPSA, Suite 317, 210 Walnut Street, 
Des Moines, IA 50309. In the monthly report, each packer must provide 
the following information:
    (1) Number of swine to be delivered under existing contracts. 
Existing contracts are contracts the packer currently is using for the 
purchase of swine for slaughter at each plant. Each packer must provide 
monthly estimates of the number of swine committed to be delivered under 
all of its existing contracts (even if those contracts are not currently 
available for renewal or to additional producers) in each contract type 
as defined in Sec. 206.1.
    (2) Available contracts. Available contracts are the contracts the 
packer is currently making available to producers, or is making 
available for renewal to currently contracted producers, for the 
purchase of swine for slaughter at each plant. On the monthly report, a 
packer will indicate each contract type, as defined in Sec. 206.1, that 
the packer is currently making available.
    (3) Estimates of committed swine. Each packer must provide an 
estimate of the total number of swine committed under existing contracts 
for delivery to each plant for slaughter within each of

[[Page 76]]

the following 12 calendar months beginning with the 1st of the month 
immediately following the due date of the report. The estimate of total 
swine committed will be reported by contract type as defined in Sec. 
206.1.
    (4) Expansion clauses. Any conditions or circumstances specified by 
clauses in any existing contracts that could result in an increase in 
the estimates specified in paragraph (c)(3) of this section. Each packer 
will identify the expansion clauses in the monthly report by listing a 
code for the following conditions:
    (i) Clauses that allow for a range of the number of swine to be 
delivered;
    (ii) Clauses that require a greater number of swine to be delivered 
as the contract continues;
    (iii) Other clauses that provide for expansion in the numbers of 
swine to be delivered.
    (5) Maximum estimates of swine. The packer's estimate of the maximum 
total number of swine that potentially could be delivered to each plant 
within each of the following 12 calendar months, if any or all of the 
types of expansion clauses identified in accordance with the requirement 
in paragraph (c)(4) of this section are executed. The estimate of 
maximum potential deliveries must be reported for all existing contracts 
by contract type as defined in Sec. 206.1.
    (d) What if a contract does not specify the number of swine 
committed? To meet the requirements of paragraphs (c)(3) and (c)(5) of 
this section, the packer must estimate expected and potential deliveries 
based on the best information available to the packer. Such information 
might include, for example, the producer's current and projected swine 
inventories and planned production.
    (e) When do I change previously reported estimates? Regardless of 
any estimates for a given future month that may have been previously 
reported, current estimates of deliveries reported as required by 
paragraphs (c)(3) and (c)(5) of this section must be based on the most 
accurate information available at the time each report is prepared.
    (f) Where and how do I send my monthly report? Each packer may 
submit monthly reports required by this section by either of the 
following two methods:
    (1) Electronic report. Information reported under this section may 
be reported by electronic means, to the maximum extent practicable. 
Electronic submission may be by any form of electronic transmission that 
has been determined to be acceptable to the Administrator. To obtain 
current options for acceptable methods to submit information 
electronically, contact GIPSA through the Internet on the GIPSA Web site 
(http://www.usda.gov/gipsa/) or at USDA GIPSA, Suite 317, 210 Walnut 
Street, Des Moines, IA 50309.
    (2) Printed report. Each packer may deliver its printed monthly 
report to USDA GIPSA, Suite 317, 210 Walnut Street, Des Moines, IA 
50309.
    (g) What information from monthly reports will be made available to 
the public and when and how will the information be made available to 
the public?--(1) Availability. GIPSA will provide a monthly report of 
estimated deliveries by contract types as reported by packers in 
accordance with this section, for public release on the 1st business day 
of each month. The monthly reports will be available on the Internet on 
the GIPSA Web site (http://www.usda.gov/gipsa/) and at USDA GIPSA, Suite 
317, 210 Walnut Street, Des Moines, IA 50309, during normal business 
hours of 7 a.m. to 4:30 p.m. Central Time, Monday through Friday.
    (2) Regions. Information in the report will be aggregated and 
reported by geographic regions. Geographic regions will be defined in 
such a manner to provide as much information as possible while 
maintaining confidentiality in accordance with section 251 of the 
Agricultural Marketing Act (7 U.S.C. 1636) and may be modified from time 
to time.
    (3) Reported information. The monthly report will provide the 
following information:
    (i) The existing contract types for each geographic region.
    (ii) The contract types currently being made available to additional 
producers or available for renewal to currently contracted producers in 
each geographic region.

[[Page 77]]

    (iii) The sum of packers' reported estimates of the total number of 
swine committed by contract for delivery during the next 6 and 12 months 
beginning with the month the report is published. The report will 
indicate the number of swine committed by geographic reporting region 
and by contract type.
    (iv) The types of conditions or circumstances as reported by packers 
that could result in expansion in the numbers of swine to be delivered 
under the terms of expansion clauses in the contracts at any time during 
the following 12 calendar months.
    (v) The sum of packers' reported estimates of the maximum total 
number of swine that potentially could be delivered during each of the 
next 6 and 12 months if all expansion clauses in current contracts are 
executed. The report will indicate the sum of estimated maximum 
potential deliveries by geographic reporting region and by contract 
type.

(Approved by the Office of Management and Budget under control number 
0580-0021)

[[Page 79]]



     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter III appear at 69 FR 
18803, Apr. 9 2004.

 SUBCHAPTER A--AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND 
 POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION
Part                                                                Page
300             Agency mission and organization.............          81
301             Terminology; Adulteration and misbranding 
                    standards...............................          84
302             Application of inspection and other 
                    requirements............................          89
303             Exemptions..................................          90
304             Application for inspection; grant of 
                    inspection..............................          98
305             Official numbers; inauguration of 
                    inspection; withdrawal of inspection; 
                    reports of violation....................          99
306             Assignment and authorities of program 
                    employees...............................         100
307             Facilities for inspection...................         101
308

[Reserved]

309             Ante-mortem inspection......................         106
310             Post-mortem inspection......................         114
311             Disposal of diseased or otherwise 
                    adulterated carcasses and parts.........         131
312             Official marks, devices and certificates....         140
313             Humane slaughter of livestock...............         145
314             Handling and disposal of condemned or other 
                    inedible products at official 
                    establishments..........................         151
315             Rendering or other disposal of carcasses and 
                    parts passed for cooking................         154
316             Marking products and their containers.......         155
317             Labeling, marking devices, and containers...         160
318             Entry into official establishments; 
                    reinspection and preparation of products         237
319             Definitions and standards of identity or 
                    composition.............................         304
320             Records, registration, and reports..........         324
321             Cooperation with States and territories.....         326
322             Exports.....................................         327

[[Page 80]]

325             Transportation..............................         329
327             Imported products...........................         340
329             Detention; seizure and condemnation; 
                    criminal offenses.......................         358
331             Special provisions for designated States and 
                    Territories; and for designation of 
                    establishments which endanger public 
                    health and for such designated 
                    establishments..........................         360
335             Rules of practice governing proceedings 
                    under the Federal Meat Inspection Act...         365
350             Special services relating to meat and other 
                    products................................         366
351             Certification of technical animal fats for 
                    export..................................         369
352             Exotic animals; voluntary inspection........         375
354             Voluntary inspection of rabbits and edible 
                    products thereof........................         383
355             Certified products for dogs, cats, and other 
                    carnivora; inspection, certification, 
                    and identification as to class, quality, 
                    quantity, and condition.................         407
362             Voluntary poultry inspection regulations....         419
381             Poultry products inspection regulations.....         423
                       SUBCHAPTERS B-C [RESERVED]
    SUBCHAPTER D--FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE 
                               PROVISIONS
390             Freedom of information and public 
                    information.............................         624
391             Fees and charges for inspection services and 
                    laboratory accreditation................         626
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION 
               ACT AND THE POULTRY PRODUCTS INSPECTION ACT
416             Sanitation..................................         628
417             Hazard Analysis and Critical Control Point 
                    (HACCP) Systems.........................         632
424             Preparation and Processing Operations.......         636
430             Requirements for specific classes of product         662
441             Consumer Protection Standards: Raw Products.         665
500             Rules of Practice...........................         667
                  SUBCHAPTER I--EGG PRODUCTS INSPECTION
590             Inspection of eggs and egg products (Egg 
                    Products Inspection Act)................         670
592             Voluntary inspection of egg products........         716

[[Page 81]]



  SUBCHAPTER A_AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND 
 POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION





PART 300_AGENCY MISSION AND ORGANIZATION--Table of Contents




Sec.
300.1 Purpose.
300.2 FSIS responsibilities.
300.3 FSIS organization.
300.4 Organizational terminology; personnel.
300.6 Access to establishments and other places of business.

    Authority: 21 U.S.C. 451-470, 601-695, 1031-1056; 7 U.S.C. 138-138i, 
450, 1621-1627, 1901-1906; 7 CFR 2.7, 2.18, 2.53.

    Source: 63 FR 72354, Dec. 31, 1998, unless otherwise noted.



Sec. 300.1  Purpose.

    This part describes the duties and organization of the Food Safety 
and Inspection Service (FSIS), an agency of the United States Department 
of Agriculture (USDA). It also includes rules on the access of 
government employees to regulated places of business.

[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]



Sec. 300.2  FSIS responsibilities.

    (a) Delegations of authority. The Secretary of Agriculture and Under 
Secretary for Food Safety have delegated to the Administrator of the 
Food Safety and Inspection Service the responsibility for exercising the 
functions of the Secretary of Agriculture under various statutes (see 7 
CFR 2.7, 2.18, and 2.53).
    (b) Implementing regulations. This chapter of title 9 of the Code of 
Federal Regulations (9 CFR chapter III) includes, in addition to 
administrative rules, rules and regulations that implement provisions of 
the following statutes:
    (1) The Federal Meat Inspection Act, as amended (FMIA) (21 U.S.C. 
601 et seq.), except provisions pertaining to the inspection and 
certification of the condition of animals for export, and related 
legislation;
    (2) The Poultry Products Inspection Act, as amended (PPIA) (21 
U.S.C. 451 et seq.);
    (3) The Egg Products Inspection Act, as amended (EPIA) (21 U.S.C. 
1031 et seq.), except for the shell egg surveillance program, voluntary 
laboratory analyses of egg products, and the voluntary grading program;
    (4) The Humane Slaughter Act (7 U.S.C. 1901-1906);
    (5) The Talmadge-Aiken Act (7 U.S.C. 450), with respect to 
cooperation with States in the administration of the Federal Meat 
Inspection Act and the Poultry Products Inspection Act;
    (6) The Agricultural Marketing Act of 1946, as amended (7 U.S.C. 
1621-1627), relating to voluntary inspection of poultry and edible 
products thereof; voluntary inspection and certification of technical 
animal fat; certified products for dogs, cats, and other carnivora; 
voluntary inspection of rabbits and edible products thereof; and 
voluntary inspection and certification of edible meat and other 
products; and
    (7) The National Laboratory Accreditation Program (7 U.S.C. 138-
138i) with respect to laboratories accredited only for pesticide residue 
analysis in meat and poultry products.

[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]



Sec. 300.3  FSIS organization.

    (a) General. The organization of FSIS reflects the agency's primary 
regulatory responsibilities: implementation of the FMIA, the PPIA, and 
the EPIA. FSIS implements the inspection provisions of the FMIA, the 
PPIA, and the EPIA through its field structure.
    (b) Headquarters. FSIS has eight principal components or offices, 
each of which is under the direction of a Deputy Administrator. The 
Deputy Administrators, along with their staffs, and the Administrator, 
along with the Office of the Administrator and three

[[Page 82]]

staff offices that report to the Administrator, are located at U.S. 
Department of Agriculture headquarters in Washington, DC.
    (1) Program Offices. FSIS's headquarters offices are the Office of 
Public Health and Science, which provides scientific analysis, advice, 
data, and recommendations on matters involving public health and 
science; the Office of Management, which provides centralized 
administrative and support services; the Office of Policy and Program 
Development, which develops and articulates the Agency's policies 
regarding food safety and other consumer protections; the Office of 
Field Operations, which manages regulatory oversight and inspection (see 
paragraph (c) of this section); the Office of Food Security and 
Emergency Preparedness, which works to prevent or, if necessary, 
coordinate a response to an intentional attack on the food supply; the 
Office of Program Evaluation, Enforcement, and Review, which acts to 
ensure that Agency programs are functioning in an efficient and 
effective manner; the Office of Public Affairs, Education, and Outreach, 
which is responsible for facilitating communications between FSIS and 
Congress, the Agency's constituents, and the media; and the Office of 
International Affairs, which is responsible for recommending and 
developing international policy activities.
    (2) [Reserved]
    (c) Field. FSIS's field structure consists of eighteen district 
offices and a technical center.
    (1) District offices. Each district office, under the direction of a 
District Manager, manages a farm-to-table food safety program of 
regulatory oversight and inspection in a district consisting of a State 
or several States and territories.
    The locations of the district offices and the districts' geographic 
boundaries are as follows:

------------------------------------------------------------------------
 
------------------------------------------------------------------------
Alameda, CA.......................  California.
Boulder, CO.......................  Arizona, Colorado, Nevada, New
Salem, OR (satellite office)......   Mexico, Utah, Alaska, American
                                     Samoa, Guam, Hawaii, Idaho,
                                     Northern Mariana Islands, Oregon,
                                     and Washington.
Minneapolis, MN...................  Minnesota, Montana, North Dakota,
                                     South Dakota, and Wyoming.
Des Moines, IA....................  Iowa and Nebraska.
Lawrence, KS......................  Kansas and Missouri.
Springdale, AR....................  Arkansas, Louisiana, and Oklahoma.
Dallas, TX........................  Texas.
Madison, WI.......................  Michigan and Wisconsin.
Chicago, IL.......................  Illinois, Ohio, and Indiana.
Pickering, OH, (satellite office).
Philadelphia, PA..................  Pennsylvania and New Jersey.
Albany, NY........................  Connecticut, Maine, Massachusetts,
                                     New Hampshire, New York, Rhode
                                     Island, and Vermont.
Beltsville, MD....................  Delaware, District of Columbia,
                                     Maryland, Virginia, and West
                                     Virginia.
Raleigh, NC.......................  North Carolina, South Carolina, and
                                     Kentucky.
Atlanta, GA.......................  Florida, Georgia, Puerto Rico, and
                                     the Virgin Islands.
Jackson, MS.......................  Alabama, Mississippi, and Tennessee.
------------------------------------------------------------------------

    (2) Technical Service Center. The Technical Service Center, which is 
located in Omaha, Nebraska, provides technical guidance, review, and 
training on the interpretation and application of regulatory 
requirements.

[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]



Sec. 300.4  Organizational terminology; personnel.

    (a) Unless otherwise specifically provided or required in the 
context of a particular part of the regulations:

[[Page 83]]

    Administrator means the Administrator of the Food Safety and 
Inspection Service or any other officer or employee of the Department to 
whom authority has been or may in the future be delegated to act in his 
or her stead.
    Circuit Supervisor means the official of the Inspection Service who 
is assigned responsibility for supervising the conduct of inspection at 
a specific group of official establishments.
    Inspection program, inspection service, or program means the 
organizational unit within the Department with responsibility for 
carrying out the FMIA, the PPIA, and the EPIA.
    Inspection program employee, inspection service employee, or program 
employee means an inspector or other government employee who is 
authorized to conduct any inspection or perform any other duty in 
connection with the inspection program, inspection service, or program.
    Inspection service supervisor or Inspection program supervisor means 
an inspection program or service employee or program employee who is 
delegated authority to exercise supervision over one or more phases of 
the inspection program.
    Inspector means an inspector of the inspection program, inspection 
service, and program. (``Inspector'' includes an employee or official of 
the Federal government or the government of a State or territory or the 
District of Columbia who is authorized by the Administrator to inspect 
meat and meat products or poultry and poultry products under the 
authority of the FMIA or the PPIA, respectively, under an agreement 
entered into between the Administrator and the appropriate State or 
other agency.)
    Inspector in charge or IIC means an inspection program employee, 
inspection service employee, or program employee who has primary 
responsibility for inspection program functions at a particular official 
establishment.
    Secretary means the Secretary of Agriculture of the United States or 
his or her delegate.
    (b) FSIS has replaced the regional office and import field office 
structure referenced in some parts of subchapter A of this chapter. 
Authority previously delegated to Regional Directors now is delegated to 
district managers; authority previously delegated to area supervisors 
and import supervisors now is delegated to inspection program 
supervisors in the successor district offices.

[69 FR 253, Jan. 5, 2004]



Sec. 300.6  Access to establishments and other places of business.

    (a) General. Upon presentation of credentials--
    (1) Persons subject to provisions of the FMIA or the PPIA must 
afford representatives of the Secretary access to establishments that 
slaughter or otherwise prepare livestock products or process poultry 
products and to other places of business subject to regulation 
thereunder; and
    (2) Persons subject to provisions of the EPIA must afford 
representatives of the Secretary access as specified in part 590 of this 
chapter.
    (b) Meat and poultry establishments and related industries. (1) At 
all times, by day or night, whether the establishment is being operated 
or not, inspection program employees must have access to the premises 
and to every part of an establishment that slaughters livestock or 
otherwise prepares meat products or slaughters poultry or otherwise 
processes poultry products that are subject to inspection for the 
purpose of conducting an inspection or performing any other inspection 
program duty. The numbered official badge of an inspection program 
employee is sufficient identification to entitle him or her to 
admittance to all parts of such an establishment and its premises.
    (2) At all ordinary business hours, upon presentation of credentials 
by a representative of the Secretary, any person (including any firm or 
corporation or other business unit) subject to recordkeeping 
requirements under section 202 of the FMIA or section 11(b) of the PPIA 
must permit such representative to enter his or her place of business to 
examine the facilities and inventory and to examine and copy the records 
specified in Sec. 320.1 and Sec. 381.175, respectively, of this 
chapter and, upon payment of the fair market value

[[Page 84]]

therefor, take reasonable samples of the inventory.

[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 254, Jan. 5, 2004]



PART 301_TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS--Table 
of Contents




Sec.
301.1 General.
301.2 Definitions.

    Authority: 21 U.S.C. 601-695; 7 U.S.C. 138-138i, 450, 1901-1906; 7 
CFR 2.7, 2.18, 2.53.



Sec. 301.1  General.

    For purposes of this chapter and unless otherwise specifically 
provided by regulation or required in the context of particular 
regulations:
    (a) Terms have the meanings set forth in this part;
    (b) The singular form also imports the plural, and the masculine 
form also imports the feminine and vice versa.

[69 FR 254, Jan. 5, 2004]



Sec. 301.2  Definitions.

    As used in this subchapter, unless otherwise required by the 
context, the following terms shall be construed, respectively, to mean:
    The Act. The Federal Meat Inspection Act, as amended, (34 Stat. 
1260, as amended, 81 Stat. 584, 84 Stat. 438, 92 Stat. 1069, 21 U.S.C., 
sec. 601 et seq.).
    Adulterated. This term applies to any carcass, part thereof, meat or 
meat food product under one or more of the following circumstances:
    (1) If it bears or contains any such poisonous or deleterious 
substance which may render it injurious to health; but in case the 
substance is not an added substance, such article shall not be 
considered adulterated under this clause if the quantity of such 
substance in or on such article does not ordinarily render it injurious 
to health;
    (2)(i) If it bears or contains (by reason of administration of any 
substance to the live animal or otherwise) any added poisonous or added 
deleterious substance (other than one which is:
    (A) A pesticide chemical in or on a raw agricultural commodity;
    (B) A food additive; or
    (C) A color additive which may, in the judgment of the 
Administrator, make such article unfit for human food;
    (ii) If it is, in whole or in part, a raw agricultural commodity and 
such commodity bears or contains a pesticide chemical which is unsafe 
within the meaning of section 408 of the Federal Food, Drug, and 
Cosmetic Act;
    (iii) If it bears or contains any food additive which is unsafe 
within the meaning of section 409 of the Federal Food, Drug, and 
Cosmetic Act;
    (iv) If it bears or contains any color additive which is unsafe 
within the meaning of section 706 of the Federal Food, Drug, and 
Cosmetic Act: Provided, That an article which is not deemed adulterated 
under paragraphs (aa)(2) (ii), (iii), or (iv) of this section shall 
nevertheless be deemed adulterated if use of the pesticide chemical food 
additive, or color additive in or on such article is prohibited by the 
regulations in this subchapter in official establishments;
    (3) If it consists in whole or in part of any filthy, putrid, or 
decomposed substance or is for any other reason unsound, unhealthful, 
unwholesome, or otherwise unfit for human food;
    (4) If it has been prepared, packed, or held under unsanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health;
    (5) If it is, in whole or in part, the product of an animal which 
has died otherwise than by slaughter;
    (6) If its container is composed, in whole or in part, of any 
poisonous or deleterious substance which may render the contents 
injurious to health;
    (7) If it has been intentionally subjected to radiation, unless the 
use of the radiation was in conformity with a regulation or exemption in 
effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic 
Act;
    (8) If any valuable constituent has been in whole or in part omitted 
or abstracted therefrom; or if any substance has been substituted, 
wholly or in part therefor; or if damage or inferiority has been 
concealed in any manner; or if any substance has been added thereto or 
mixed or packed therewith so as to

[[Page 85]]

increase its bulk or weight, or reduce its quality or strength, or make 
it appear better or of greater value than it is; or,
    (9) If it is margarine containing animal fat and any of the raw 
material used therein consisted in whole or in part of any filthy, 
putrid, or decomposed substance, or is otherwise adulterated.
    Anesthesia. Loss of sensation or feeling.
    Animal food. Any article intended for use as food for dogs, cats, or 
other animals derived wholly, or in part, from the carcass or parts or 
products of the carcass of any livestock, except that the term animal 
food as used herein does not include:
    (1) Processed dry animal food or
    (2) Livestock or poultry feeds manufactured from processed livestock 
byproducts (such as meatmeal tankage, meat and bonemeal, bloodmeal, and 
feed grade animal fat).
    Animal food manufacturer. Any person engaged in the business of 
manufacturing or processing animal food.
    Artificial coloring. A coloring containing any dye or pigment, which 
dye or pigment was manufactured by a process of synthesis or other 
similar artifice, or a coloring which was manufactured by extracting a 
natural dye or natural pigment from a plant or other material in which 
such dye or pigment was naturally produced.
    Artificial flavoring. A flavoring containing any sapid or aromatic 
constituent, which constituent was manufactured by a process of 
synthesis or other similar artifice.
    Biological residue. Any substance, including metabolites, remaining 
in livestock at time of slaughter or in any of its tissues after 
slaughter as the result of treatment or exposure of the livestock to a 
pesticide, organic or inorganic compound, hormone, hormone-like 
substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or 
other therapeutic or prophylactic agent.
    Capable of use as human food. This term applies to any carcass, or 
part or product of a carcass, of any livestock, unless it is denatured 
or otherwise identified as required by the applicable provisions of 
Sec. Sec. 314.3, 314.10, 325.11, and 325.13 of this subchapter to deter 
its use as a human food, or it is naturally inedible by humans; e.g., 
hoofs or horns in their natural state.
    Captive bolt. A stunning instrument which when activated drives a 
bolt out of a barrel for a limited distance.
    Carbon dioxide. A gaseous form of the chemical formula 
CO2.
    Carbon dioxide concentration. Ratio of carbon dioxide gas and 
atmospheric air.
    Carcass. All parts, including viscera, of any slaughtered livestock.
    Chemical preservative. Any chemical that, when added to a meat or 
meat food product, tends to prevent or retard deterioration thereof, but 
does not include common salt, sugars, vinegars, spices, or oils 
extracted from spices or substances added to meat and meat food products 
by exposure to wood smoke.
    Other definitions, if any, that are applicable only for purposes of 
a specific part of the regulations in this subchapter, are set forth in 
such part.
    Commerce. Commerce between any State, any Territory, or the District 
of Columbia, and any place outside thereof; or within any Territory not 
organized with a legislative body, or the District of Columbia.
    Consciousness. Responsiveness of the brain to the impressions made 
by the senses.
    Cutting up. Any division of any carcass or part thereof, except that 
the trimming of carcasses or parts thereof to remove surface 
contaminants is not considered as cutting up.
    Dead livestock. The body (cadaver) of livestock which has died 
otherwise than by slaughter.
    Dying, diseased, or disabled livestock. Livestock which has or 
displays symptoms of having any of the following:
    (1) Central nervous system disorder;
    (2) Abnormal temperature (high or low);
    (3) Difficult breathing;
    (4) Abnormal swellings;
    (5) Lack of muscular coordination;
    (6) Inability to walk normally or stand;
    (7) Any of the conditions for which livestock is required to be 
condemned

[[Page 86]]

on ante-mortem inspection in accordance with the regulations in part 309 
of this subchapter.
    Edible. Intended for use as human food.
    Experimental animal. Any animal used in any research investigation 
involving the feeding or other administration of, or subjection to, an 
experimental biological product, drug, or chemical or any 
nonexperimental biological product, drug, or chemical used in a manner 
for which it was not intended.
    Exposure time. The period of time an animal is exposed to an 
anesthesia-producing carbon dioxide concentration.
    Federal Food, Drug, and Cosmetic Act. The Act so entitled, approved 
June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or 
supplementary thereto.
    Firm. Any partnership, association, or other unincorporated business 
organization.
    Further processing. Smoking, cooking, canning, curing, refining, or 
rendering in an official establishment of product previously prepared in 
official establishments.
    Immediate container. The receptacle or other covering in which any 
product is directly contained or wholly or partially enclosed.
    Inedible. Adulterated, uninspected, or not intended for use as human 
food.
    Inhumane slaughter or handling in connection with slaughter. 
Slaughter or handling in connection with slaughter not in accordance 
with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901 through 
1906, as amended by the Humane Methods of Slaughter Act of 1978, 92 
Stat. 1069) and part 313 of this subchapter.
    ``Inspected and passed'' or ``U.S. Inspected and Passed'' or ``U.S. 
Inspected and Passed by Department of Agriculture'' (or any authorized 
abbreviation thereof). This term means that the product so identified 
has been inspected and passed under the regulations in this subchapter, 
and at the time it was inspected, passed, and identified, it was found 
to be not adulterated.
    Label. A display of written, printed, or graphic matter upon the 
immediate container (not including package liners) of any article.
    Labeling. All labels and other written, printed, or graphic matter:
    (1) Upon any article or any of its containers or wrappers, or
    (2) Accompanying such article.
    Livestock. Cattle, sheep, swine, goat, horse, mule, or other equine.
    Meat. (1) The part of the muscle of any cattle, sheep, swine, or 
goats which is skeletal or which is found in the tongue, diaphragm, 
heart, or esophagus, with or without the accompanying and overlying fat, 
and the portions of bone (in bone-in product such as T-bone or 
porterhouse steak), skin, sinew, nerve, and blood vessels which normally 
accompany the muscle tissue and that are not separated from it in the 
process of dressing. As applied to products of equines, this term has a 
comparable meaning.
    (i) Meat does not include the muscle found in the lips, snout, or 
ears.
    (ii) Meat may not include significant portions of bone, including 
hard bone and related components, such as bone marrow, or any amount of 
brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG).
    (2) [Reserved]
    Meat broker. Any person engaged in the business of buying or selling 
carcasses, parts of carcasses, meat or meat food products of livestock 
on commission, or otherwise negotiating purchases or sales of such 
articles other than for his/her own account or as an employee of another 
person.
    Meat byproduct. Any part capable of use as human food, other than 
meat, which has been derived from one or more cattle, sheep, swine, or 
goats. This term, as applied to products of equines, shall have a 
meaning comparable to that provided in this paragraph with respect to 
cattle, sheep, swine, and goats.
    Meat food product. Any article capable of use as human food which is 
made wholly or in part from any meat or other portion of the carcass of 
any cattle, sheep, swine, or goats, except those exempted from 
definition as a meat food product by the Administrator in specific cases 
or by the regulations in part 317 of this subchapter, upon a 
determination that they contain meat or other portions of such carcasses 
only in

[[Page 87]]

a relatively small proportion or historically have not been considered 
by consumers as products of the meat food industry, and provided that 
they comply with any requirements that are imposed in such cases or 
regulations as conditions of such exemptions to assure that the meat or 
other portions of such carcasses contained in such articles are not 
adulterated and that such articles are not represented as meat food 
products. This term, as applied to food products of equines, shall have 
a meaning comparable to that provided in this paragraph with respect to 
cattle, sheep, swine, and goats.
    Misbranded. This term applies to any carcass, part thereof, meat or 
meat food product under one or more of the following circumstances:
    (1) If its labeling is false or misleading in any particular;
    (2) If it is offered for sale under the name of another food;
    (3) If it is an imitation of another food, unless its label bears, 
in type of uniform size and prominence, the word ``imitation'' and 
immediately thereafter, the name of the food imitated;
    (4) If its container is so made, formed, or filled as to be 
misleading;
    (5) If in a package or other container unless it bears a label 
showing:
    (i) The name and place of business of the manufacturer, packer, or 
distributor; and
    (ii) An accurate statement of the quantity of the contents in terms 
of weight, measure, or numerical count; except as otherwise provided in 
part 317 of this subchapter with respect to the quantity of contents;
    (6) If any word, statement, or other information required by or 
under authority of the Act to appear on the label or other labeling is 
not prominently placed thereon with such conspicuousness (as compared 
with other words, statements, designs, or devices, in the labeling) and 
in such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use;
    (7) If it purports to be or is represented as a food for which a 
definition and standard of identity or composition has been prescribed 
by the regulations in part 319 of this subchapter unless:
    (i) It conforms to such definition and standard, and
    (ii) Its label bears the name of the food specified in the 
definition and standard and, insofar as may be required by such 
regulations, the common names of optional ingredients (other than 
spices, flavoring, and coloring) present in such food;
    (8) If it purports to be or is represented as a food for which a 
standard or standards of fill of container have been prescribed by the 
regulations in part 319 of this subchapter, and it falls below the 
standard of fill of container applicable thereto, unless its label 
bears, in such manner and form as such regulations specify, a statement 
that it falls below such standard;
    (9) If it is not subject to the provisions of paragraph (vv)(7)(ii) 
of this section unless its label bears:
    (i) The common or usual name of the food, if any there be, and
    (ii) In case it is fabricated from two or more ingredients, the 
common or usual name of each such ingredient, except as otherwise 
provided in part 317 of this subchapter;
    (10) If it purports to be or is represented for special dietary 
uses, unless its label bears such information concerning its vitamin, 
mineral, and other dietary properties as is required by the regulations 
in part 317 of this subchapter.
    (11) If it bears or contains any artificial flavoring, artificial 
coloring, or chemical preservative, unless it bears a label stating that 
fact; except as otherwise provided by the regulations in part 317 of 
this subchapter; or
    (12) If it fails to bear, directly thereon or on its containers, 
when required by the regulations in part 316 or 317 of this subchapter, 
the inspection legend and, unrestricted by any of the foregoing, such 
other information as the Administrator may require in such regulations 
to assure that it will not have false or misleading labeling and that 
the public will be informed of the manner of handling required to 
maintain the article in a wholesome condition.
    Nonfood compound. Any substance proposed for use in official 
establishments, the intended use of which will

[[Page 88]]

not result, directly or indirectly, in the substance becoming a 
component or otherwise affecting the characteristics of meat food and 
meat products, excluding labeling and packaging materials as covered in 
part 317 of the subchapter.
    Official certificate. Any certificate prescribed by the regulations 
in this subchapter for issuance by an inspector or other person 
performing official functions under the Act.
    Official device. Any device prescribed by the regulations in part 
312 of this subchapter for use in applying any official mark.
    Official establishment. Any slaughtering, cutting, boning, meat 
canning, curing, smoking, salting, packing, rendering, or similar 
establishment at which inspection is maintained under the regulations in 
this subchapter.
    Official import inspection establishment. This term means any 
establishment, other than an official establishment as defined in 
paragraph (zz) of this section, where inspections are authorized to be 
conducted as prescribed in Sec. 327.6 of this subchapter.
    Official inspection legend. Any symbol prescribed by the regulations 
in this subchapter showing that an article was inspected and passed in 
accordance with the Act.
    Official mark. The official inspection legend or any other symbol 
prescribed by the regulations in this subchapter to identify the status 
of any article or animal under the Act.
    Packaging material. Any cloth, paper, plastic, metal, or other 
material used to form a container, wrapper, label, or cover for meat 
products.
    Person. Any individual, firm, or corporation.
    Pesticide chemical, food additive, color additive, raw agricultural 
commodity. These terms shall have the same meanings for purposes of the 
Act and the regulations in this subchapter as under the Federal Food, 
Drug, and Cosmetic Act.
    Prepared. Slaughtered, canned, salted, rendered, boned, cut up, or 
otherwise manufactured or processed.
    Process authority. A person or organization with expert knowledge in 
meat production process control and relevant regulations. This 
definition does not apply to subpart G of part 318.
    Process schedule. A written description of processing procedures, 
consisting of any number of specific, sequential operations directly 
under the control of the establishment employed in the manufacture of a 
specific product, including the control, monitoring, verification, 
validation, and corrective action activities associated with production. 
This definition does not apply to subpart G of part 318.
    Product. Any carcass, meat, meat byproduct, or meat food product, 
capable of use as human food.
    Renderer. Any person engaged in the business of rendering carcasses 
or parts or products of the carcasses of any livestock except rendering 
conducted under inspection or exemption under Title I of the Act.
    Shipping container. The outside container (box, bag, barrel, crate, 
or other receptacle or covering) containing or wholly or partly 
enclosing any product packed in one or more immediate containers.
    State. Any State of the United States or the Commonwealth of Puerto 
Rico.
    Supervision. The controls, as prescribed in instructions to Program 
employees, to be exercised by them over particular operations to insure 
that such operations are conducted in compliance with the Act and the 
regulations in this subchapter.
    Surgical anesthesia. A state of unconsciousness measured in 
conformity with accepted surgical practices.
    Territory. Guam, the Virgin Islands of the United States, American 
Samoa, and any other territory or possession of the United States, 
excluding the Canal Zone.
    U.S. Condemned. This term means that the livestock so identified has 
been inspected and found to be in a dying condition, or to be affected 
with any other condition or disease that would require condemnation of 
its carcass.
    U.S. Inspected and Condemned (or any authorized abbreviation 
thereof). This term means that the carcass, viscera, other part of 
carcass, or other product so identified has been inspected, found to be 
adulterated, and condemned

[[Page 89]]

under the regulations in this subchapter.
    U.S. Passed for Cooking. This term means that the meat or meat 
byproduct so identified has been inspected and passed on condition that 
it be cooked or rendered as prescribed by the regulations in part 315 of 
this chapter.
    U.S. Passed for Refrigeration. This term means that the meat or meat 
byproduct so identified has been inspected and passed on condition that 
it be refrigerated or otherwise handled as prescribed by the regulations 
in part 311 of this subchapter.
    U.S. Retained. This term means that the carcass, viscera, other part 
of carcass, or other product, or article so identified is held for 
further examination by an inspector to determine its disposal.
    U.S. Suspect. This term means that the livestock so identified is 
suspected of being affected with a disease or condition which may 
require its condemnation, in whole or in part, when slaughtered, and is 
subject to further examination by an inspector to determine its 
disposal.
    United States. The States, the District of Columbia, and the 
Territories of the United States.

[35 FR 15554, Oct. 3, 1970]

    Editorial Note: For Federal Register citations affecting Sec. 
301.2, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



PART 302_APPLICATION OF INSPECTION AND OTHER REQUIREMENTS--Table of 
Contents




Sec.
302.1 Establishments requiring inspection.
302.2 Application of requirements in designated States or Territories; 
          and to designated plants endangering public health.
302.3 Livestock and products entering official establishments.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



Sec. 302.1  Establishments requiring inspection.

    (a) Inspection under the regulations in this subchapter is required 
at:
    (1) Every establishment, except as provided in Sec. 303.1 (a) and 
(b), or (c) of this subchapter, in which any livestock are slaughtered 
for transportation or sale as articles of commerce, or in which any 
products of, or derived from, carcasses of livestock are, wholly or in 
part, prepared for transportation or sale as articles of commerce, which 
are intended for use as human food;
    (2) Every establishment, except as provided in Sec. 303.1 (a) and 
(b), or (d) of this subchapter, within any State or organized Territory 
which is designated pursuant to paragraph 301(c) of the Act, at which 
any livestock are slaughtered or any products of any livestock are 
prepared, for use as human food solely for distribution within such 
jurisdiction; and
    (3) Every establishment, except as provided in Sec. 303.1 (a) and 
(b) of this subchapter, that is designated by the Administrator pursuant 
to paragraph 301(c) of the Act as one producing adulterated products 
which would clearly endanger the public health.

[35 FR 15556, Oct. 3, 1970, as amended at 36 FR 12002, June 24, 1971]



Sec. 302.2  Application of requirements in designated States or 
Territories; and to designated plants endangering public health.

    Special provisions with respect to establishments and their 
operations and transactions by any persons in designated States and 
Territories and with respect to establishments designated as producing 
adulterated products which clearly endanger public health, and the 
operators thereof, in any State or Territory appear in part 331 of this 
subchapter, and apply to such establishments, operations and 
transactions in lieu of the regulations elsewhere in this subchapter 
except insofar as such regulations are made applicable by the provisions 
in part 331 of this subchapter.

[35 FR 15556, Oct. 3, 1970, as amended at 51 FR 29909, Aug. 21, 1986]



Sec. 302.3  Livestock and products entering official establishments.

    All livestock and all products entering any official establishment 
and all products prepared, in whole or in part, therein, shall be 
inspected, handled,

[[Page 90]]

stored, prepared, packaged, marked, and labeled as required by the 
regulations in this subchapter.

[35 FR 15556, Oct. 3, 1970]



PART 303_EXEMPTIONS--Table of Contents




Sec.
303.1 Exemptions.
303.2 Experimentation: Intensity of inspection coverage.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



Sec. 303.1  Exemptions.

    (a) The requirements of the Act and the regulations in this 
subchapter for inspection of the preparation of products do not apply 
to:
    (1) The slaughtering by any individual of livestock of his own 
raising, and the preparation by him and transportation in commerce of 
the carcasses, parts thereof, meat and meat food products of such 
livestock exclusively for use by him and members of his household and 
his nonpaying guests and employees;
    (2) The custom slaughter by any person of cattle, sheep, swine, or 
goats delivered by the owner thereof for such slaughter, and the 
preparation by such slaughterer and transportation in commerce of the 
carcasses, parts thereof, meat and meat food products of such livestock, 
exclusively for use, in the household of such owner, by him and members 
of his household and his nonpaying guests and employees; nor to the 
custom preparation by any person of carcasses, parts thereof, meat or 
meat food products derived from the slaughter by any individual of 
cattle, sheep, swine, or goats of his own raising or from game animals, 
delivered by the owner thereof for such custom preparation, and 
transportation in commerce of such custom prepared articles, exclusively 
for use in the household of such owner, by him and members of his 
household and his nonpaying guests and employees: Provided, That the 
following requirements are met by such custom operator;
    (i) Establishments that conduct custom operations must be maintained 
and operated in accordance with the provisions of Sec. Sec. 416.1 
through 416.6, except for: Sec. 416.2(g)(2) through (6) of this 
chapter, regarding water reuse and any provisions of part 416 of this 
chapter relating to inspection or supervision of specified activities or 
other action by a Program employee. If custom operations are conducted 
in an official establishment, however, all of the provisions of Part 416 
of this chapter of shall apply to those operations.
    (ii) If the custom operator prepares or handles any products for 
sale, they are kept separate and apart from the custom prepared products 
at all times while the latter are in his custody;
    (iii) The custom prepared products are plainly marked ``Not for 
Sale'' as provided in Sec. 316.16 of this subchapter, immediately after 
being prepared and are kept so identified until delivered to the owner; 
and
    (iv) If exempted custom slaughtering or other preparation of 
products is conducted in an official establishment, all facilities and 
equipment in the official establishment used for such custom operations 
shall be thoroughly cleaned and sanitized before they are used for 
preparing any products for sale.
    (b)(1) The exempted custom prepared products shall be prepared and 
handled in accordance with the provisions of Sec. Sec. 318.5, 318.6, 
318.7, 318.10, and 318.300 through 318.311 of this subchapter and shall 
not be adulterated as defined in paragraph 1(m) of the Act: Provided, 
That the provisions of Sec. Sec. 318.5, 318.6, 318.10, and 318.300 
through 318.311 relating to inspection or supervision of specified 
activities or other action by a Program inspector, and the provisions of 
Sec. 318.6(b)(9) and (10), shall not apply to the preparation and 
handling of such exempted products.
    (2) The exempted custom prepared products shall comply with the 
requirements of Sec. Sec. 316.16 and 317.16 of this subchapter.
    (3) The custom operators claiming exemption under paragraph (a)(2) 
of this section shall keep records, in addition to records otherwise 
required by part 320 of this subchapter, showing the numbers and kinds 
of livestock slaughtered on a custom basis, the quantities and types of 
products prepared on a custom basis, and the names and addresses of the 
owners of the livestock and products.

[[Page 91]]

    (4) Articles capable of use as human food, resulting from the 
exempted custom slaughter or other preparation of products shall be 
promptly denatured or otherwise identified in accordance with Sec. 
325.13 of this subchapter and not removed from the establishment where 
the custom operations are conducted until so identified, unless they are 
delivered to the owner of the articles for use in accordance with 
paragraph (a)(2) of this section.
    (c) It has been determined that it is impracticable to provide 
inspection of the preparation of products at establishments in any 
unorganized Territory at which livestock are slaughtered or their 
products are prepared for distribution solely within such jurisdiction 
and that exempting such establishments from requirements of the Act for 
such inspections under the conditions stated in this section will 
otherwise facilitate enforcement of the Act. Therefore, such inspection 
requirements of the Act and of the regulations in this subchapter shall 
not apply at such establishments if they are operated in accordance with 
the regulations in part 416, Sec. Sec. 416.1 through 416.5 of this 
chapter. However, the Administrator may refuse, withdraw, or modify any 
exemption under this paragraph when he determines in any specific case 
in accordance with the applicable rules of practice that such action is 
necessary to effectuate the purposes of this Act.
    (d)(1) The requirements of the Act and the regulations in this 
subchapter for inspection of the preparation of products do not apply to 
operations of types traditionally and usually conducted at retail stores 
and restaurants, when conducted at any retail store or restaurant or 
similar retail-type establishment for sale in normal retail quantities 
or service of such articles to consumers at such establishments.
    (2) For purposes of paragraph (d)(1) of this section:
    (i) Operations of types traditionally and usually conducted at 
retail stores and restaurants are the following:
    (a) Cutting up, slicing, and trimming carcasses, halves, quarters, 
or wholesale cuts into retail cuts such as steaks, chops, and roasts, 
and freezing such cuts;
    (b) Grinding and freezing products made from meat;
    (c) Curing, cooking, smoking, rendering or refining of livestock 
fat, or other preparation of products, except slaughtering or the retort 
processing of canned products;
    (d) Breaking bulk shipments of products;
    (e) Wrapping or rewrapping products.
    (ii) Any quantity or product purchased by a consumer from a 
particular retail supplier shall be deemed to be a normal retail 
quantity if the quantity so purchased does not in the aggregate exceed 
one-half carcass. The following amounts of product will be accepted as 
representing one-half carcass of the species identified:

------------------------------------------------------------------------
                                                               One-half
                                                                carcass
                                                                pounds
------------------------------------------------------------------------
Cattle......................................................         300
Calves......................................................        37.5
Sheep.......................................................        27.5
Swine.......................................................         100
Goats.......................................................          25
------------------------------------------------------------------------

    (iii) A retail store is any place of business where:
    (a) The sales of product are made to consumers only;
    (b) At least 75 percent, in terms of dollar value, of total sales of 
product represents sales to household consumers and the total dollar 
value of sales of product to consumers other than household consumers 
does not exceed the dollar limitation per calendar year set by the 
Administrator. This dollar limitation is a figure which will 
automatically be adjusted during the first quarter of each calendar 
year, upward or downward, whenever the Consumer Price Index, published 
by the Bureau of Labor Statistics, Department of Labor, indicates a 
change in the price of this same volume of product which exceeds $500. 
Notice of the adjusted dollar limitation will be published in the 
Federal Register. \1\
---------------------------------------------------------------------------

    \1\ The dollar limitation currently in effect may be obtained by 
contacting Director, Slaughter Inspection Standards and Procedures 
Division, Technical Services, Food and Safety Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250 (202) 447-3219.

---------------------------------------------------------------------------

[[Page 92]]

    (c) Only federally or State inspected and passed product is handled 
or used in the preparation of any product, except that product resulting 
from the custom slaughter or custom preparation of product may be 
handled or used in accordance with paragraph (a)(2) and (b) of this 
section but not for sale;
    (d) No sale of product is made in excess of a normal retail quantity 
as defined in paragraph (d)(2)(ii) of this section;
    (e) The preparation of products for sale to household consumers is 
limited to traditional and usual operations as defined in paragraph 
(d)(2)(i) of this section; and
    (f) The preparation of products for sale to other than household 
consumers is limited to traditional and usual operations as defined in 
paragraph (d)(2)(i) (a), (b), (d), and (e) of this section. (A retail 
store at which custom slaughtering or preparation of products is 
conducted is not thereby disqualified from exemption as a retail store 
under this paragraph (d).)
    (iv) Restaurants. (a) A restaurant is any establishment where:
    (1) Product is prepared only for sale or service in meals or as 
entrees directly to individual consumers at such establishments;
    (2) Only federally or State inspected and passed product or such 
product prepared at a retail store exempted under paragraph (d)(2)(iii) 
of this section is handled or used in the preparation of any product;
    (3) No sale of product is made in excess of a normal retail quantity 
as defined in paragraph (d)(2)(ii) of this section; and
    (4) The preparation of product is limited to traditional and usual 
operations as defined in paragraph (d)(2)(i) of this section.
    (b) The definition of a restaurant includes a caterer which delivers 
or serves product in meals, or as entrees, only to individual consumers 
and otherwise meets the requirements of this paragraph.
    (c) For purposes of this paragraph, operations conducted at a 
restaurant central kitchen facility shall be considered as being 
conducted at a restaurant if the restaurant central kitchen prepares 
meat or meat food products that are ready to eat when they leave such 
facility (i.e., no further cooking or other preparation is needed, 
except that they may be reheated prior to serving if chilled during 
transportation), transported directly to a receiving restaurant by its 
own employees, without intervening transfer or storage, maintained in a 
safe, unadulterated condition during transportation, and served in meals 
or as entrees only to customers at restaurants, or through vending 
machines, owned or operated by the same person that owns or operates 
such facility, and which otherwise meets the requirements of this 
paragraph: Provided, That the requirements of Sec. Sec. 320.1 through 
320.4 of this subchapter apply to such facility. Provided further, That 
the exempted facility may be subject to inspection requirements under 
the Act for as long as the Administrator deems necessary, if the 
Administrator determines that the sanitary conditions or practices of 
the facility or the processing procedures or methods at the facility are 
such that any of its meat or meat food products are rendered 
adulterated. When the Administrator has made such determination and 
subjected a restaurant central kitchen facility to such inspection 
requirements, the operator of such facility shall be afforded an 
opportunity to dispute the Administrator's determination in a hearing 
pursuant to rules of practice which will be adopted for this proceeding.
    (v) Similar retail-type establishment: Any establishment which is a 
combination retail store and restaurant; any delicatessen which meets 
the requirements for a retail store or restaurant as prescribed in 
paragraphs (d)(2) (iii) or (iv) of this section; or other establishment 
as determined by the Administrator in specific cases.
    (vi) Consumer: Any household consumer, hotel, restaurant, or similar 
institution as determined by the Administrator in specific cases.
    (3) Whenever any complaint is received by the Administrator from any 
person alleging that any retail store claiming exemption under this 
paragraph (d), in any designated State or organized Territory that is 
identified under section 205 of the Act (as one

[[Page 93]]

that does not have or is not exercising adequate authority with respect 
to recordkeeping requirements) has been operated in violation of the 
conditions prescribed in this section for exemption, and the 
Administrator, upon investigation of the complaint, has reason to 
believe that any such violation has occurred, he shall so notify the 
operator of the retail store and afford him reasonable opportunity to 
present his views informally with respect to the matter. Thereafter, if 
the Administrator still has reason to believe that such a violation has 
occurred, and that a requirement that the operator keep records 
concerning the operations of the retail store would effectuate the 
purposes of the Act, the Administrator shall order the operator to 
maintain complete, accurate, and legible records of total monthly 
purchases and of total monthly sales of meat, meat byproducts, and meat 
food products, in terms of dollar values of the products involved. Such 
records shall separately show total sales to household consumers and 
total sales to other consumers and shall be maintained for the period 
prescribed in Sec. 320.3 of this subchapter. If the operator maintains 
copies of bills of lading, receiving and shipping invoices, warehouse 
receipts, or similar documents which give the information required 
herein, additional records are not required by this subparagraph.
    (e)(1) The requirements of the Act and the regulations in this 
subchapter for inspection of the preparation of products do not apply to 
meat pizzas containing meat food product ingredients which were 
prepared, inspected, and passed in a cured or cooked form as ready-to-
eat (i.e., no further cooking or other preparation is needed) in 
compliance with the requirements of the Act and these regulations; and 
the meat pizzas are to be served in public or private nonprofit 
institutions, provided that the meat pizzas are ready-to-eat (i.e., no 
further cooking or other preparation is needed, except that they may be 
reheated prior to serving if chilled during transportation), transported 
directly to the receiving institution by employees of the preparing 
firm, receiving institution, or a food service management company 
contracted to conduct food service at the public or private nonprofit 
institution, without intervening transfer or storage.
    (2) The definitions at Chapter 1, 1-102, except 1-102(z) and the 
provisions of Chapters 2 through 8, except sections 2-102(a) and (b), 2-
302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506, 2-
508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c), 5-
203, and 6-105, part IV, of the Food and Drug Administration's Food 
Service Sanitation Manual (1976 Recommendations), DHEW Publication No. 
(FDA) 78-2081, which is incorporated by reference, shall apply to the 
facilities and operations of businesses claiming this exemption. (These 
materials are incorporated as they exist on the date of approval. This 
incorporation by reference was approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be purchased from the Superintendent of Documents, U.S. Government 
Printing Office, Washington, DC 20402. It is also available for 
inspection at the FSIS Hearing Clerk, room 3171, South Building, Food 
Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (3) Facilities and operations of businesses claiming this exemption 
shall also conform to the following requirements:
    (i) Manual cleaning and sanitizing. (A) For manual washing, rinsing 
and sanitizing of utensils and equipment, a sink with not fewer than 
three compartments shall be provided and used. Sink compartments shall 
be large enough to permit the accommodation of the equipment and 
utensils, and each compartment of the sink shall be supplied with hot 
and cold potable running water. Fixed equipment and utensils and 
equipment too large to be cleaned in sink compartments shall be washed 
manually or cleaned through pressure spray methods.

[[Page 94]]

    (B) Drain boards or easily movable dish tables of adequate size 
shall be provided for proper handling of soiled utensils prior to 
washing and for cleaned utensils following sanitizing and shall be 
located so as not to interfere with the proper use of the dishwashing 
facilities.
    (C) Equipment and utensils shall be preflushed or prescraped and, 
when necessary, presoaked to remove gross food particles and soil.
    (D) Except for fixed equipment and utensils too large to be cleaned 
in sink compartments, manual washing, rinsing and sanitizing shall be 
conducted in the following sequence:
    (1) Sinks shall be cleaned prior to use.
    (2) Equipment and utensils shall be thoroughly washed in the first 
compartment with a hot detergent solution that is kept clean.
    (3) Equipment and utensils shall be rinsed free of detergent and 
abrasives with clean water in the second compartment.
    (4) Equipment and utensils shall be sanitized in the third 
compartment according to one of the methods prescribed in paragraph 
(e)(3)(i)(E) (1) through (4) of this section.
    (E) The food-contact surfaces of all equipment and utensils shall be 
sanitized by:
    (1) Immersion for at least \1/2\ minute in clean, hot water at a 
temperature of at least 170 [deg]F; or
    (2) Immersion for at least 1 minute in a clean solution containing 
at least 50 parts per million of available chlorine as a hypochlorite 
and at a temperature of at least 75 [deg]F; or
    (3) Immersion for at least 1 minute in a clean solution containing 
at least 12.5 parts per million of available iodine and having a pH not 
higher than 5.0 and at a temperature of at least 75 [deg]F; or
    (4) Immersion in a clean solution containing any other chemical 
sanitizing agent allowed under 21 CFR 178.1010 that will provide the 
equivalent bactericidal effect of a solution containing at least 50 
parts per million of available chlorine as a hypochlorite at a 
temperature of at least 75 [deg]F for 1 minute; or
    (5) Treatment with steam free from materials or additives other than 
those specified in 21 CFR 173.310 in the case of equipment too large to 
sanitize by immersion, but in which steam can be confined; or
    (6) Rinsing, spraying, or swabbing with a chemical sanitizing 
solution of at least twice the strength required for that particular 
sanitizing solution under paragraph (e)(3)(i)(E)(4) of this section in 
the case of equipment too large to sanitize by immersion.
    (F) When hot water is used for sanitizing, the following facilities 
shall be provided and used:
    (1) An integral heating device or fixture installed in, on, or under 
the sanitizing compartment of the sink capable of maintaining the water 
at a temperature of at least 170 [deg]F; and
    (2) A numerically scaled indicating thermometer, accurate to 3 [deg]F, convenient to the sink for frequent checks of 
water temperature; and
    (3) Dish baskets of such size and design to permit complete 
immersion of the tableware, kitchenware, and equipment in the hot water.
    (G) When chemicals are used for sanitization, they shall not have 
concentrations higher than the maximum permitted under 21 CFR 178.1010 
and a test kit or other device that accurately measures the parts per 
million concentration of the solution shall be provided and used.
    (ii) Mechanical cleaning and sanitizing. (A) Cleaning and sanitizing 
may be done by spray-type or immersion dishwashing machines or by any 
other type of machine or device if it is demonstrated that it thoroughly 
cleans and sanitizes equipment and utensils. These machines and devices 
shall be properly installed and maintained in good repair.
    Machines and devices shall be operated in accordance with 
manufacturers' instructions, and utensils and equipment placed in the 
machine shall be exposed to all dishwashing cycles. Automatic detergent 
dispensers, wetting agent dispensers, and liquid sanitizer injectors, if 
any, shall be properly installed and maintained.
    (B) The pressure of final rinse water supplied to spray-type 
dishwashing machines shall not be less than 15 nor

[[Page 95]]

more than 25 pounds per square inch measured in the water line 
immediately adjacent to the final rinse control valve. A \1/4\-inch IPS 
valve shall be provided immediately up stream from the final rinse 
control valve to permit checking the flow pressure of the final rinse 
water.
    (C) Machine or water line mounted numerically scaled indicating 
thermometers, accurate to 3 [deg]F, shall be 
provided to indicate the temperature of the water in each tank of the 
machine and the temperature of the final rinse water as it enters the 
manifold.
    (D) Rinse water tanks shall be protected by baffles, curtains, or 
other effective means to minimize the entry of wash water into the rinse 
water. Conveyors in dishwashing machines shall be accurately timed to 
assure proper exposure times in wash and rinse cycles in accordance with 
manufacturers' specifications attached to the machines.
    (E) Drain boards shall be provided and be of adequate size for the 
proper handling of soiled utensils prior to washing and of cleaned 
utensils following sanitization and shall be so located and constructed 
as not to interfere with the proper use of the dishwashing facilities. 
This does not preclude the use of easily movable dish tables for the 
storage of soiled utensils or the use of easily movable dishtables for 
the storage of clean utensils following sanitization.
    (F) Equipment and utensils shall be flushed or scraped and, when 
necessary, soaked to remove gross food particles and soil prior to being 
washed in a dishwashing machine unless a prewashcycle is a part of the 
dishwashing machine operation. Equipment and utensils shall be placed in 
racks, trays, or baskets, or on conveyors, in a way that food-contact 
surfaces are exposed to the unobstructed application of detergent wash 
and clean rinse waters and that permits free draining.
    (G) Machines (single-tank, stationary-rack, door-type machines and 
spray-type glass washers) using chemicals for sanitization may be used: 
Provided, That,
    (1) The temperature of the wash water shall not be less than 120 
[deg]F.
    (2) The wash water shall be kept clean.
    (3) Chemicals added for sanitization purposes shall be automatically 
dispensed.
    (4) Utensils and equipment shall be exposed to the final chemical 
sanitizing rinse in accordance with manufacturers' specifications for 
time and concentration.
    (5) The chemical sanitizing rinse water temperature shall be not 
less than 75 [deg]F nor less than the temperature specified by the 
machine's manufacturer.
    (6) Chemical sanitizers used shall meet the requirements of 21 CFR 
178.1010.
    (7) A test kit or other device that accurately measures the parts 
per million concentration of the solution shall be available and used.
    (H) Machines using hot water for sanitizing may be used provided 
that wash water and pumped rinse water shall be kept clean and water 
shall be maintained at not less than the following temperatures:

    (1) Single-tank, stationary-rack, dual-temperature machine:

Wash temperature..............................................150 [deg]F
Final rinse temperature.......................................180 [deg]F

    (2) Single-tank, stationary-rack, single-temperature machine:

Wash temperature..............................................165 [deg]F
Final rinse temperature.......................................165 [deg]F

    (3) Single-tank, conveyor machine:

Wash temperature..............................................160 [deg]F
Final rinse temperature.......................................180 [deg]F

    (4) Multitank, conveyor machine:

Wash temperature..............................................150 [deg]F
Pumped rinse temperature......................................160 [deg]F
Final rinse temperature.......................................180 [deg]F

    (5) Single-tank, pot, pan, and utensil washer (either stationary or 
moving-rack):
Wash temperature..............................................140 [deg]F
Final rinse temperature.......................................180 [deg]F

    (I) All dishwashing machines shall be thoroughly cleaned at least 
once a day or more often when necessary to maintain them in a 
satisfactory operating condition.
    (iii) Steam. Steam used in contact with food or food-contact 
surfaces shall be free from any materials or additives

[[Page 96]]

other than those specified in 21 CFR 173.310.
    (4) For purposes of this paragraph, the term ``private nonprofit 
institution'' means ``a corporation, and any community chest, fund, or 
foundation, organized and operated exclusively for religious, 
charitable, scientific, testing for public safety, literary, or 
educational purposes, or to foster national or international amateur 
sports competition (but only if no part of its activities involve the 
provision of athletic facilities or equipment), or for the prevention of 
cruelty to children or animals, no part of the net earnings of which 
inures to the benefit of any private shareholder or individual, no 
substantial part of the activities of which is carrying on propaganda, 
or otherwise attempting, to influence legislation, and which does not 
participate in, or intervene in (including the publishing or 
distribution of statements), any political campaign on behalf of (or in 
opposition to) any candidate for public office.''
    (5) The Administrator may withdraw or modify the exemption set forth 
in Sec. 303.1(e)(1) for a particular establishment when he or she 
determines that such action is necessary to ensure food safety and 
public health. Before such action is taken, the owner or operator of the 
particular establishment shall be notified, in writing, of the reasons 
for the proposed action and shall be given an opportunity to respond, in 
writing, to the Administrator within 20 days after notification of the 
proposed action. The written notification shall be served on the owner 
or operator of the establishment in the manner prescribed in section 
1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)). 
In those instances where there is conflict of any material fact, the 
owner or operator of the establishment, upon request, shall be afforded 
an opportunity for a hearing with respect to the disputed fact, in 
accordance with rules of practice which shall be adopted for the 
proceeding. However, such withdrawal or modification shall become 
effective pending final determination in the proceeding when the 
Administrator determines that an imminent threat to food safety or 
public health exists, and that such action is, therefore, necessary to 
protect the public health, interest or safety. Such withdrawal or 
modification shall be effective upon oral or written notification, 
whichever is earlier, to the owner or operator of the particular 
establishment as promptly as circumstances permit. In the event of oral 
notification, written confirmation shall be given to the owner or 
operator of the establishment as promptly as circumstances permit. This 
withdrawal or modification shall continue in effect ending the 
completion of the proceeding and any judicial review thereof, unless 
otherwise ordered by the Administrator.
    (f) The adulteration and misbranding provisions of the Act and the 
regulations in this subchapter, other than the requirement of the 
official inspection legend, apply to articles which are exempted from 
inspection or not required to be inspected under this section. This 
includes the requirement that any pork and any product containing pork 
be prepared only in compliance with any applicable requirement for the 
destruction of trichina as provided in Sec. 318.10 of this subchapter.
    (g) The Administrator may extend the requirements of titles I and IV 
of the Act to any establishment in any State or organized Territory at 
which products are prepared for distribution solely within such 
jurisdiction, if he determines in accordance with the provisions of 
paragraph 301(c)(1) of the Act that it is producing adulterated products 
which would clearly endanger the public health.
    (h) The Administrator may in specific classes of cases waive for 
limited periods any provisions of the regulations in this subchapter in 
order to permit appropriate and necessary action in the event of a 
public health emergency or to permit experimentation so that new 
procedures, equipment, and/or processing techniques may be tested to 
facilitate definite improvements: Provided, That such waivers of the 
provisions of such regulations are not in

[[Page 97]]

conflict with the purposes or provisions of the Act.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[35 FR 15558, Oct. 3, 1970, as amended at 36 FR 12002, 12004, June 24, 
1971; 45 FR 27922, Apr. 25, 1980; 46 FR 46288, Sept. 18, 1981; 47 FR 
746, Jan. 7, 1982; 51 FR 29909, Aug. 21, 1986; 52 FR 10032, Mar. 30, 
1987; 52 FR 48091, Dec. 18, 1987; 53 FR 24679, June 30, 1988; 57 FR 
34182, Aug. 3, 1992; 64 FR 56415, Oct. 20, 1999]



Sec. 303.2  Experimentation: Intensity of inspection coverage.

    (a) Pursuant to the Processed Products Inspection Improvement Act of 
1986, Title IV of the Futures Trading Act of 1986 (Pub. L. 99-641), in 
establishments preparing products at which inspection under the Act and 
regulations is required, the frequency with which and the manner in 
which meat food products made from livestock previously slaughtered in 
official establishments are examined and inspected by Program employees 
is to be based on considerations relevant to effective regulation of 
meat food products and protection of the health and welfare of 
consumers. In order to test procedures for use in making such 
determinations and, in particular, for determining whether and, is so, 
to what extent the intensity of inspection coverage exceeds that which 
should be considered necessary pursuant to section 6 of the Act, as 
amended by section 403(a) of the Futures Trading Act of 1986, the 
Administrator is initiating experimentation of a new system of 
inspection for reviewing the performance of establishments and for 
designing the supervision and other conditions and methods of inspection 
coverage. For the period of such experimentation, the Administrator 
shall identify establishments for review, and the frequency and the 
manner of inspection by Program employees shall be determined on the 
basis of the results of those reviews and be otherwise in accordance 
with this section.
    (b) The determinations referred to in paragraph (a) of this section 
shall be made by the program and shall reflect evaluations of the 
performance and the characteristics and such establishments.
    (1) In assessing the performance of an establishment, the following 
factors are appropriate for consideration:
    (i) The history of compliance with applicable regulatory 
requirements by the person conducting operations at such establishment 
or by anyone responsibly connected with the business conducting 
operations at such establishment, as ``responsibly connected'' is 
defined in section 401(g) of the Act,
    (ii) The competence of the person conducting operations at such 
establishment, as indicated by:
    (A) Knowledge of appropriate manufacturing practices and applicable 
regulatory requirements,
    (B) Demonstrated ability to apply such knowledge in a timely and 
consistent manner, and
    (C) Commitment to correcting deficiencies noted by Program employees 
and otherwise assuring compliance with applicable regulatory 
requirements, and
    (iii) The procedures used in such establishment to control the 
production process, environment, and resulting product in order to 
assure and monitor compliance with the requirements of the Act and the 
rules and regulations promulgated thereunder.
    (2) In assessing the characteristics of an establishment, the 
following factors are appropriate for consideration:
    (i) The complexity of the processing operation(s) conducted at such 
establishment,
    (ii) The frequency with which each such operation is conducted at 
such establishment,
    (iii) The volume of product resulting from each such operation at 
such establishment,
    (iv) Whether and to what extent slaughter operations also are 
conducted at such establishment,
    (v) What, if any, food products not regulated under this Act or the 
Poultry Products Inspection Act also are prepared at such establishment, 
and
    (vi) The size of such establishment.
    (c)(1) For the period of experimentation described in paragraph (a) 
of this section, the frequency of inspection by Program employees of 
operations other than slaughter may be reduced in an establishment in 
which the procedures referred to therein are

[[Page 98]]

being tested if and only if the evaluation of the performance of such 
establishment described in paragraph (b)(1) indicates that there are:
    (i) No instances, documented in records compiled no earlier than 10 
years before, of substantial and recent noncompliance with applicable 
regulatory requirements (taking into account both the nature and 
frequency of any such noncompliance), and
    (ii) The competence and control procedures needed to assure and 
monitor compliance with applicable regulatory requirements.
    (2)(i) The frequency of Federal inspection and other conditions and 
methods of inspection coverage in any establishment in which the 
frequency of Federal inspection is reduced shall be based on:
    (A) The evaluation of the characteristics of such establishment 
described in paragraph (b)(2) of this section,\1\
---------------------------------------------------------------------------

    \1\ These evaluations will be based upon guidelines developed by 
FSIS and the complexity categorization in FSIS Directive 1030.2 
(Documentation of Processing and Combination Assignments, 4/22/85). The 
guidelines and Directive will be available for public inspection and 
copying in the Policy Office, Room 3168, South Agriculture Building, 
14th Street and Independence Avenue, SW., Washington, DC.
---------------------------------------------------------------------------

    (B) The significance of potential public health consequences of 
noncompliance, and
    (C) The availability of Program employees.
    (ii) To the extent that such frequency of inspection or other 
conditions and methods of inspection coverage are identified as 
conflicting with provisions of the regulations in this subchapter, the 
Administrator will waive such provisions for the period of 
experimentation, in accordance with Sec. 303.1(g) of this subchapter.

[52 FR 10032, Mar. 30, 1987 and 52 FR 48091, Dec. 18, 1987]



PART 304_APPLICATION FOR INSPECTION; GRANT OF INSPECTION--Table of Contents




Sec.
304.1 Application for inspection.
304.2 Information to be furnished; grant or refusal of inspection.
304.3 Conditions for receiving inspection.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.



Sec. 304.1  Application for inspection.

    (a) Before the inspection is granted, each person conducting 
operations at an establishment subject to the Act, whether tenant, 
subsidiary, or landlord, shall make application therefor to the 
Administrator as provided for in this part.
    (b) Every application under this section shall be made on an 
official form furnished by the Program, available from any Regional 
Director identified in Sec. 301.2(kkk) of this subchapter, and shall be 
completed to include all information requested. Trade names of the 
applicant for labeling purposes, shall be inserted in the appropriate 
blank in the application. Each applicant for inspection will be held 
responsible for compliance with the Act and the regulations in this 
subchapter if inspection is granted. Preparation of product and other 
operations at the establishment for which inspection is granted may be 
conducted only by the applicant named in the application.
    (c) In cases of change of ownership or location, a new application 
shall be made.

[40 FR 2575, Jan. 14, 1975, as amended at 53 FR 49848, Dec. 12, 1988]



Sec. 304.2  Information to be furnished; grant or refusal of inspection.

    (a) FSIS shall give notice in writing to each applicant granted 
inspection and shall specify in the notice the establishment, including 
the limits of the establishment's premises, to which the grant pertains.
    (b) The Administrator is authorized to grant inspection upon his 
determination that the applicant and the establishment are eligible 
therefor and to refuse to grant inspection at any establishment if he 
determines that it does not meet the requirements of this part or the 
regulations in parts 305, 307, and part 416, Sec. Sec. 416.1 through 
416.6 of this chapter or that the applicant has not received approval of 
labeling and containers to be used at the establishment as required by 
the regulations in parts 316 and 317. Any application for

[[Page 99]]

inspection may be refused in accordance with the rules of practice in 
part 500 of this chapter.
    (c)(1) Any applicant for inspection at an establishment where the 
operations thereof may result in any discharge into the navigable waters 
in the United States is required by subsection 21(b) of the Federal 
Water Pollution Control Act, as amended (84 Stat. 91), to provide the 
Administrator with a certification as prescribed in said subsection that 
there is reasonable assurance that such activity will be conducted in a 
manner which will not violate the applicable water quality standards. No 
grant of inspection can be issued after April 3, 1970 (the date of 
enactment of the Water Quality Improvement Act), unless such 
certification has been obtained, or is waived because of failure or 
refusal of the State, interstate agency or the Secretary of the Interior 
to act on a request for certification within a reasonable period (which 
shall not exceed 1 year after receipt of such request).
    (2) However, certification is not initially required in connection 
with an application for inspection granted after April 3, 1970, for 
facilities existing or under construction on April 3, 1970, although 
certification for such facilities is required to be obtained within the 
3-year period immediately following April 3, 1970. Failure to obtain 
such certification and meet the other requirements of subsection 21(b) 
prior to April 3, 1973, will result in the termination of inspection at 
such facilities on that date.

Further, any application for inspection pending on April 3, 1970, and 
granted within 1 year thereafter shall not require certification for 1 
year following the grant of inspection but such grant of inspection 
shall terminate at the end of 1 year after its issuance unless prior 
thereto such certification has been obtained and the other requirements 
of subsection 21(b) are met.

[35 FR 15558, Oct. 3, 1970, as amended at 41 FR 4889, Feb. 3, 1976; 44 
FR 68813, Nov. 30, 1979; 62 FR 45024, Aug. 25, 1997; 64 FR 56415, Oct. 
20, 1999; 64 FR 66545, Nov. 29, 1999; 65 FR 2284, Jan. 14, 2000]



Sec. 304.3  Conditions for receiving inspection.

    (a) Before being granted Federal inspection, an establishment shall 
have developed written sanitation Standard Operating Procedures, as 
required by part 416 of this chapter.
    (b) Before being granted Federal inspection, an establishment shall 
have conducted a hazard analysis and developed and validated a HACCP 
plan, as required by Sec. Sec. 417.2 and 417.4 of this chapter. A 
conditional grant of inspection shall be issued for a period not to 
exceed 90 days, during which period the establishment must validate its 
HACCP plan.
    (c) Before producing new product for distribution in commerce, an 
establishment shall have conducted a hazard analysis and developed a 
HACCP plan applicable to that product in accordance with Sec. 417.2 of 
this chapter. During a period not to exceed 90 days after the date the 
new product is produced for distribution in commerce, the establishment 
shall validate its HACCP plan, in accordance with Sec. 417.4 of this 
chapter.

[61 FR 38864, July 25, 1996]



PART 305_OFFICIAL NUMBERS; INAUGURATION OF INSPECTION; WITHDRAWAL OF 
INSPECTION; REPORTS OF VIOLATION--Table of Contents




Sec.
305.1 Official numbers; subsidiaries and tenants.
305.2 Separation of official establishments.
305.3 Sanitation and adequate facilities.
305.4 Inauguration of inspection.
305.6 Reports of violations.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 15559, Oct. 3, 1970, unless otherwise noted.



Sec. 305.1  Official numbers; subsidiaries and tenants.

    (a) An official number shall be assigned to each establishment 
granted inspection. Such number shall be used to identify all inspected 
and passed products prepared in the establishment. More than one number 
shall not be assigned to an establishment.

[[Page 100]]

    (b) Two or more official establishments under the same ownership or 
control may be granted the same official number, provided a serial 
letter is added in each case to identify each establishment and the 
products thereof.
    (c) When inspection has been granted to any applicant at an 
establishment, it shall not be granted to any other person at the same 
establishment. However, persons operating as separate entities in the 
same building or structure may operate separate establishments therein 
only under their own grant of inspection. All such persons operating 
separate establishments in the same building or structure shall be 
responsible for compliance with the Act and regulations in their own 
establishments, which shall include common areas, e.g., hallways, 
stairways, and elevators.

[35 FR 15559, Oct. 3, 1970, as amended at 40 FR 2576, Jan. 14, 1975]



Sec. 305.2  Separation of official establishments.

    (a) Each official establishment shall be separate and distinct from 
any unofficial establishment except a poultry products processing 
establishment operated under Federal inspection under the Poultry 
Products Inspection Act or under State inspection.
    (b) The slaughter or other preparation of products of horses, mules, 
or other equines required to be conducted under inspection pursuant to 
the regulations in this subchapter shall be done in establishments 
separate from any establishment in which cattle, sheep, swine, or goats 
are slaughtered or their products are prepared.
    (c) Inspection shall not be inaugurated in any building, any part of 
which is used as living quarters, unless the part for which inspection 
is requested is separated from such quarters by floors, walls, and 
ceilings of solid concrete, brick, wood, or similar material, and the 
floors, walls, and ceilings are without openings that directly or 
indirectly communicate with any part of the building used as living 
quarters.



Sec. 305.3  Sanitation and adequate facilities.

    Inspection shall not be inaugurated if an establishment is not in a 
sanitary condition nor unless the establishment agrees to maintain a 
sanitary condition and provides adequate facilities for conducting such 
inspection.



Sec. 305.4  Inauguration of inspection.

    When inspection is granted, the circuit supervisor shall, at or 
prior to the inauguration of inspection, inform the operator of the 
establishment of the requirements of the regulations in this subchapter. 
If the establishment, at the time inspection is inaugurated, contains 
any product which has not theretofore been inspected, passed, and marked 
in compliance with the regulations in this subchapter, the identity of 
the same shall be maintained, and it shall not be distributed in 
commerce, or otherwise subject to the requirements of such regulations, 
or dealt with as inspected and passed under the regulations. The 
establishment shall adopt and enforce all necessary measures and shall 
comply with all such directions as the circuit supervisor may prescribe, 
for carrying out the purposes of this section.



Sec. 305.6  Reports of violations.

    Program employees shall report, in a manner prescribed by the 
Administrator, all violations of the Act or regulations in this 
subchapter of which they have information.



PART 306_ASSIGNMENT AND AUTHORITIES OF PROGRAM EMPLOYEES--Table of 
Contents




Sec.
306.1 Designation of circuit supervisor and assistants.
306.2 Program employees to have access to establishments.
306.3 Badge as identification of inspectors.
306.4 Assignment of Program employees where members of family employed; 
          soliciting employment; procuring product from official 
          establishments.
306.5 Appeals.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.7, 2.18, 2.53.

    Source: 35 FR 15559, Oct. 3, 1970, unless otherwise noted.

[[Page 101]]



Sec. 306.1  Designation of circuit supervisor and assistants.

    [See Sec. Sec. 300.3 and 300.4 of this chapter regarding FSIS' 
organization and inspection program supervisors.]

[69 FR 254, Jan. 5, 2004]



Sec. 306.2  Program employees to have access to establishments.

    [See Sec. 300.6 of this chapter regarding access to establishments 
and other places of business.]

[69 FR 254, Jan. 5, 2004]



Sec. 306.3  Badge as identification of inspectors.

    Each inspector will be furnished with a numbered official badge, 
which he shall not allow to leave his possession, and which he shall 
wear in such manner and at such times as the Administrator may 
prescribe.

[35 FR 15559, Oct. 3, 1970, as amended at 69 FR 254, Jan. 5, 2004]



Sec. 306.4  Assignment of Program employees where members of family 
employed; soliciting employment; procuring product from official establishments.

    (a) Except as specifically authorized by the Administrator, no 
Program employee shall be detailed for duty at an establishment where 
any member of his family is employed by the operator of the 
establishment, or any tenant or subsidiary of such operator nor shall 
any circuit supervisor or other employee acting in a supervisory 
capacity be continued on duty at a circuit where any member of his 
family is so employed at any establishment under his jurisdiction. 
Program employees are forbidden to solicit, for any person, employment 
at any official establishment, or by any officer, manager, or employee 
thereof.
    (b) Program employees shall not procure product from any official 
establishment or any other establishment if its operations or products 
are inspected or regulated under the Poultry Products Inspection Act or 
the Agricultural Marketing Act of 1946, as amended, or any other law 
administered by the Department unless the store or outlet from which the 
purchase is made is open to the general public and the price paid by 
such employee is the same as the price paid by the general public. 
Program employees must pay, and obtain receipts for money paid to such 
establishments for all such product and keep such receipts subject to 
inspection by supervisory employees or other authorized Department 
employees.



Sec. 306.5  Appeals.

    Any appeal from a decision of any Program employee shall be made to 
his/her immediate supervisor having jurisdiction over the subject matter 
of the appeal, except as otherwise provided in the applicable rules of 
practice.

[48 FR 11418, Mar. 18, 1983, as amended at 60 FR 67454, Dec. 29, 1995]



PART 307_FACILITIES FOR INSPECTION--Table of Contents




Sec.
307.1 Facilities for Program employees.
307.2 Other facilities and conditions to be provided by the 
          establishment.
307.3 Inspectors to furnish and maintain implements in a sanitary 
          condition.
307.4 Schedule of operations.
307.5 Overtime and holiday inspection service.
307.6 Basis of billing for overtime and holiday services.
307.7 Safety requirements for electrical stimulating (EST) equipment.

    Authority: 7 U.S.C. 394, 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 15560, Oct. 3, 1970, unless otherwise noted.



Sec. 307.1  Facilities for Program employees.

    Office space, including necessary furnishings, light, heat, and 
janitor service, shall be provided by official establishments, rent 
free, for the exclusive use for official purposes of the inspector and 
other Program employees assigned thereto. The space set aside for this 
purpose shall meet with approval of the circuit supervisor and shall be 
conveniently located, properly ventilated and provided with lockers 
suitable for the protection and storage of Program supplies and with 
facilities suitable for Program employees to

[[Page 102]]

change clothing if such clothes changing facilities are deemed necessary 
by the circuit supervisor. At the discretion of the Administrator, small 
plants requiring the services of less than one full time inspector need 
not furnish facilities for Program employees as prescribed in this 
section, where adequate facilities exist in a nearby convenient 
location. Laundry service for inspectors' outer work clothing shall be 
provided by each establishment.



Sec. 307.2  Other facilities and conditions to be provided by the 
establishment.

    When required by the circuit supervisor, the following facilities 
and conditions, and such others as may be found to be essential to 
efficient conduct of inspection and maintenance of sanitary conditions, 
shall be provided by each official establishment:
    (a) Satisfactory pens, equipment, and assistants for conducting 
ante-mortem inspection and for separating, marking and holding apart 
from passed livestock those marked ``U.S. suspect'' and those marked 
``U.S. condemned'' (pens, alleys, and runways shall be paved, drained, 
and supplied with adequate hose connections for cleanup purposes);
    (b) Sufficient light to be adequate for proper conduct of 
inspection;
    (c) Racks, receptacles, or other suitable devices for retaining such 
parts as the head, tongue, tail, thymus gland, and viscera, and all 
parts and blood to be used in the preparation of meat food products or 
medical products, until after the post-mortem examination is completed, 
in order that they may be identified in case of condemnation of the 
carcass; equipment, trucks, and receptacles for the handling of viscera 
of slaughtered animals so as to prevent contact with the floor; and 
trucks, racks, marked receptacles, tables, and other necessary equipment 
for the separate and sanitary handling of carcasses or parts passed for 
cooking;
    (d) Tables, benches, and other equipment on which inspection is to 
be performed, of such design, material, and construction as to enable 
Program employees to conduct their inspection in a ready, efficient and 
clean manner;
    (e) Watertight metal trucks or receptacles for holding and handling 
diseased carcasses and parts, so constructed as to be readily cleaned; 
such trucks or receptacles to be marked in a conspicuous manner with the 
phrase ``U.S. condemned'' in letters not less than 2 inches high, and, 
when required by the circuit supervisor, to be equipped with facilities 
for locking or sealing;
    (f) Adequate arrangements, including liquid soap and cleansers, for 
cleansing and disinfecting hands, for sterilizing all implements used in 
dressing diseased carcasses, floors, and such other articles and places 
as may be contaminated by diseased carcasses or otherwise;
    (g) In establishments in which slaughtering is done, rooms, 
compartments, or specially prepared open places, to be known as ``final 
inspection places,'' at which the final inspection of retained carcasses 
may be conducted (competent assistants for handling retained carcasses 
and parts shall be provided by the establishment; final inspection 
places shall be adequate in size and their rail arrangement and other 
equipment shall be sufficient to prevent carcasses and parts passed for 
food or cooking, from being contaminated by contact with condemned 
carcasses or parts; they shall be equipped with hot water, lavatory, 
sterilizer, tables, and other equipment required for ready, efficient, 
and sanitary conduct of the inspection; the floors shall be of such 
construction as to facilitate the maintenance of sanitary conditions and 
shall have proper drainage connections, and when the final inspection 
place is part of a larger floor, it shall be separated from the rest of 
the floor by a curb, railing, or otherwise);
    (h) Retention rooms, cages, or other compartments, and receptacles 
in which carcasses and product may be held for further inspection (these 
shall be in such number and in such locations as the needs of the 
inspection in the establishment may require; they shall be equipped for 
secure locking or sealing and shall be held under locks or official 
seals furnished by the Department; the keys of such locks shall not 
leave the custody of Program employees. Every such room, compartment, or 
receptacle shall be marked conspicuously with the phrase ``U.S. 
retained''

[[Page 103]]

in letters not less than 2 inches high; rooms or compartments for these 
purposes shall be secure and susceptible of being kept clean, including 
a sanitary disposal of the floor liquids; establishment employees shall 
not enter any retention rooms or compartments or open any retention 
receptacles unless authorized by Program employees);
    (i) Adequate facilities, including denaturing materials, for the 
proper disposal of condemned articles in accordance with the regulations 
in this subchapter (tanks or other rendering equipment which, under the 
regulations in this subchapter, must be sealed, shall be properly 
equipped for sealing as specified by the regulations in part 314 of this 
subchapter or by the circuit supervisor in specific cases);
    (j) Docks and receiving rooms, to be designated by the operator of 
the official establishment, with the circuit supervisor, for the receipt 
and inspection of all products as provided in Sec. 318.3 of this 
subchapter.
    (k) Suitable lockers in which brands bearing the official inspection 
legend and other official devices (excluding labels) and official 
certificates shall be kept when not in use (all such lockers shall be 
equipped for sealing or locking with locks or seals to be supplied by 
the Department; the keys of such locks shall not leave the custody of 
Program employees);
    (l) Sanitary facilities and accommodations as prescribed by Sec. 
416.2(c), (d), (e), (f), and (h) of this chapter.
    (m) In addition to any facilities required to accomplish sanitary 
dressing procedures, the following inspection station facilities for 
cattle and swine slaughter lines described in Sec. 310.1(b) of this 
subchapter are required:
    (1) An inspection station consisting of 5 feet of unobstructed line 
space for each head or carcass inspector and, for viscera table kills, 8 
feet for each viscera inspector on the inspector's side of the table.
    (2) A minimum of 50 foot candles of shadow-free lighting at the 
inspection surfaces of the head, viscera, and carcass.
    (3) A handwash lavatory (other than one which is hand operated), 
furnished with soap, towels, and hot and cold water, and located 
adjacent to the inspector's work area. In addition, for each head and 
viscera inspector on cattle slaughter lines, and each head inspector on 
swine slaughter lines, a sterilizer located adjacent to the inspector's 
work area.
    (4) For mechanized operations, a line control switch located 
adjacent to each inspection station.
    (5) Facilities to position tally sheets or other recording devices, 
such as digital counters, and facilities to contain condemned brands.
    (6) For swine slaughter lines requiring three or more inspectors, 
and for those one- and two-inspector configurations where the 
establishment installs a mirror: At the carcass inspection station one 
glass or plastic, distortion-free mirror, at least 5 feet x 5 feet, 
mounted far enough away from the vertical axis of the moving line to 
allow the carcass to be turned, but not over 3 feet away, and so mounted 
that any inspector standing at the carcass inspection station can 
readily view the back of the carcass.

[35 FR 15560, Oct. 3, 1970, as amended at 47 FR 33676, Aug. 4, 1982; 50 
FR 19902, May 13, 1985; 64 FR 56415, Oct. 20, 1999]



Sec. 307.3  Inspectors to furnish and maintain implements in a sanitary 
condition.

    Inspectors shall furnish their own work clothing and implements, 
such as flashlights and triers, for conducting inspection and shall 
maintain their implements in sanitary condition as prescribed by Sec. 
416.3(a) of this chapter.

[64 FR 56415, Oct. 20, 1999]



Sec. 307.4  Schedule of operations.

    (a) No operations requiring inspection shall be conducted except 
under the supervision of a Program employee. All slaughtering of animals 
and preparation of products shall be done with reasonable speed, 
considering the official establishment's facilities.
    (b) A shift is a regularly scheduled operating period, exclusive of 
mealtime. One lunch period is the only official authorized interruption 
in the inspector's tour of duty once it begins. Lunch periods may be 30 
minutes, 45 minutes, or in any case may not exceed one hour in duration. 
Once established,

[[Page 104]]

the lunch period must remain relatively constant as to time and 
duration. Lunch periods for inspectors shall not, except as provided 
herein, occur prior to 4 hours after the beginning of scheduled 
operations nor later than 5 hours after operations begin. In plants 
where a company rest break of not less than 30 minutes is regularly 
observed, approximately midpoint between start of work and the lunch 
period, and the inspector is allowed this time to meet his personal 
needs, the lunch period may be scheduled as long as 5\1/2\ hours after 
the beginning of scheduled operations.
    (c) Official establishments, importers, and exporters shall be 
provided inspection service, without charge, up to 8 consecutive hours 
per shift during the basic workweek subject to the provisions of Sec. 
307.5: Provided, That any additional shifts meet requirements as 
determined by the Administrator or his designee. The basic workweek 
shall consist of 5 consecutive 8-hour days within the administrative 
workweek Sunday through Saturday, excluding the lunch period; except 
that, when possible, the Department shall schedule the basic workweek so 
as to consist of 5 consecutive 8-hour days Monday through Friday, 
excluding lunch period. The Department may depart from the basic 
workweek in those cases where maintaining such a schedule would 
seriously handicap the Department in carrying out its function. These 
provisions are applicable to all official establishments except in 
certain cases as provided in Sec. 318.4(h) of this subchapter.
    (d)(1) Each official establishment shall submit a work schedule to 
the area supervisor for approval. In consideration of whether the 
approval of an establishment work schedule shall be given, the area 
supervisor shall take into account the efficient and effective use of 
inspection personnel. The work schedule must specify daily clock hours 
of operation and lunch periods for all departments of the establishment 
requiring inspection.
    (2) Establishments shall maintain consistent work schedules. Any 
request by an establishment for a change in its work schedule involving 
an addition or elimination of shifts shall be submitted to the area 
supervisor at least 2 weeks in advance of the proposed change. Frequent 
requests for change shall not be approved: Provided, however, minor 
deviations from a daily operating schedule may be approved by the 
inspector in charge, if such request is received on the day preceding 
the day of change.
    (3) Request for inspection service outside an approved work schedule 
shall be made as early in the day as possible for overtime work to be 
performed within that same workday; or made prior to the end of the 
day's operation when such a request will result in overtime service at 
the start of the following day: Provided, That an inspector may be 
recalled to his assignment after completion of his daily tour of duty 
under the provisions of Sec. 307.6(b).

[40 FR 45799, Oct. 3, 1975, as amended at 40 FR 50719, Oct. 31, 1975; 41 
FR 15401, Apr. 13, 1976; 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept. 
11, 1986]



Sec. 307.5  Overtime and holiday inspection service.

    (a) The management of an official establishment, an importer, or an 
exporter shall reimburse the Program, at the rate specified in Sec. 
391.3, for the cost of the inspection service furnished on any holiday 
as specified in paragraph (b) of this section; or for more than 8 hours 
on any day, or more than 40 hours in any administrative workweek Sunday 
through Saturday.
    (b) Holidays for Federal employees shall be New Year's Day, January 
1; Birthday of Martin Luther King, Jr., the third Monday in January; 
Washington's Birthday, the third Monday in February; Memorial Day, the 
last Monday in May; Independence Day, July 4; Labor Day, the first 
Monday in September; Columbus Day, the second Monday in October; 
Veterans' Day, November 11; Thanksgiving Day, the fourth Thursday in 
November; Christmas Day, December 25. When any of the above-listed 
holidays falls outside the basic workweek, the nearest workday within 
that week shall become a holiday.

[40 FR 45800, Oct. 3, 1975, as amended at 43 FR 51754, Nov. 7, 1978; 50 
FR 724, Jan. 7, 1985; 50 FR 51513, Dec. 18, 1985; 52 FR 4, Jan. 2, 1987; 
53 FR 13397, Apr. 22, 1988; 54 FR 6389, Feb. 10, 1989]

[[Page 105]]



Sec. 307.6  Basis of billing for overtime and holiday services.

    (a) Each recipient of overtime or holiday inspection service, or 
both, shall be billed as provided for in Sec. 307.5(a) and at the rates 
specified in Sec. 391.3, in increments of quarter hours. For billing 
purposes, 8 or more minutes shall be considered a full quarter hour. 
Billing will be for each quarter hour of service rendered by each 
Program employee.
    (b) Official establishments, importers, or exporters requesting and 
receiving the services of a Program employee after he has completed his 
day's assignment and left the premises, or called back to duty during 
any overtime or holiday period, shall be billed for a minimum of 2 hours 
overtime or holiday inspection service at the established rate.
    (c) Bills are payable upon receipt and become delinquent 30 days 
from the date of the bill. Overtime or holiday inspection will not be 
performed for anyone having a delinquent account.

[40 FR 45800, Oct. 3, 1975, as amended at 54 FR 6389, Feb. 10, 1989]



Sec. 307.7  Safety requirements for electrical stimulating (EST) 
equipment.

    (a) General. Electrical stimulating (EST) equipment is equipment 
that provides electric shock treatment to carcasses for the purpose of 
accelerating rigor mortis of facilitating blood removal. These 
provisions do not apply to electrical equipment used to stun and/or 
slaughter animals or to facilitate hide removal. Electrical stimulating 
equipment consists of two separate pieces--the control system and the 
applicator. The EST control system contains the circuitry to generate 
pulsed DC or AC voltage for stimulation and is separate from the 
equipment used to apply the voltage to the carcass. The voltage is 
applied by inserting a probe that penetrates the carcass or is inserted 
in the rectum, placing a clamp in the nose, a carcass rub-bar, a 
conveyor with energized surfaces traveling with the carcass, or any 
other acceptable method.
    (b) Safety requirements--(1) Circuits, grounding. Either a bonded 
grounding conductor shall lead from each section of the carcass rail 
within the stimulating enclosure to the service ground, or the secondary 
voltage (stimulating circuit) shall be insulated from the service 
ground. If the stimulating section of the carcass rail and carcass drive 
mechanisms are insulated from the service ground then the stimulating 
rail or the return path shall be electrically bonded to the transformer 
secondary to isolate the stimulation voltage.
    (2) Enclosure. Electrical stimulation shall occur in an area that 
will prevent persons from contacting an energized surface. If the area 
is surrounded by physical barriers, the enclosure shall be either 
electrically grounded or it shall be made of materials that do not 
conduct electricity. The interior of the stimulating area shall be 
visible from the start switch so the operator can be assured that there 
is no person, equipment or material present that should not be there 
prior to starting the stimulating sequence. If light or sound beam 
sensors form the enclosure, the stimulating equipment shall be 
automatically shut off when the sensor signals are broken.
    (3) Mandatory Warning Devices and Signals. The following warning 
devices or signals shall be installed at each opening to the stimulating 
area through which a person would normally enter:
    (i) A red light that flashes distinctly during the operating cycle 
of the stimulating equipment.
    (ii) An ANSI Z53.1-Color Code sign reading (a) ``Danger Electrical 
Hazard'' for stimulating voltage below 50 or (b) ``Danger High Voltage'' 
for stimulating voltage above 50.
    (iii) An emergency stop button.
    (4) Optional Warning Device--Horn or Bell. If a warning horn or bell 
is installed, the signal shall be audible above background noises in the 
vicinity, and it shall sound for at least 1 second before each manual 
stimulation or before the carcass chain is started in an automatic 
system.
    (c) Operation--
    (1) Training. Only persons who have received safety instruction by 
the equipment manufacturer or designee may operate electrical 
stimulating equipment.
    (2) Cleaning and Maintenance. To prevent an electrical shock to 
personnel,

[[Page 106]]

the electricity supplied to the stimulating surfaces shall be locked-off 
when cleaning, mechanical inspection, maintenance or testing are 
performed.
    (3) Water. To prevent an electrical shock, personnel shall not spray 
streams of water on energized carcasses or on energized stimulating 
surfaces.
    (d) Special provisions for manually operated equipment.
    (1) Stimulating probes or clamps shall be stored in a sanitary 
container which is insulated with a material approved by the 
Administrator.\1\
---------------------------------------------------------------------------

    \1\ A list of approved insulation materials is available upon 
request from the Facilities, Equipment and Sanitation Division, 
Technical Services, Food Safety and Inspection Service, U.S. Department 
of Agriculture, Washington, DC 20250.
---------------------------------------------------------------------------

    (2) The electric wires attached to a clamp or probe shall not allow 
for contact between the probe or clamp and an electrical ground and 
shall not extend outside the enclosure.

[53 FR 46432, Nov. 17, 1988, as amended at 64 FR 56415, Oct. 20, 1999]

                           PART 308 [RESERVED]



PART 309_ANTE-MORTEM INSPECTION--Table of Contents




Sec.
309.1 Ante-mortem inspection in pens of official establishments.
309.2 Livestock suspected of being diseased or affected with certain 
          conditions; identifying suspects; disposition on post-mortem 
          inspection or otherwise.
309.3 Dead, dying, disabled, or diseased and similar livestock.
309.4 Livestock showing symptoms of certain metabolic, toxic, nervous, 
          or circulatory disturbances, nutritional imbalances, or 
          infectious or parasitic diseases.
309.5 Swine; disposal because of hog cholera.
309.6 Epithelioma of the eye.
309.7 Livestock affected with anthrax; cleaning and disinfection of 
          infected livestock pens and driveways.
309.8 Cattle affected with anasarca and generalized edema.
309.9 Swine erysipelas.
309.10 Onset of parturition.
309.11 Vaccine livestock.
309.12 Emergency slaughter; inspection prior to.
309.13 Disposition of condemned livestock.
309.14 Brucellosis-reactor goats.
309.15 Vesicular diseases.
309.16 Livestock suspected of having biological residues.
309.17 Livestock used for research.
309.18 Official marks and devices for purposes of ante-mortem 
          inspection.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 15563, Oct. 3, 1970, unless otherwise noted.



Sec. 309.1  Ante-mortem inspection in pens of official establishments.

    (a) All livestock offered for slaughter in an official establishment 
shall be examined and inspected on the day of and before slaughter 
unless, because of unusual circumstances, prior arrangements acceptable 
to the Administrator have been made in specific cases by the circuit 
supervisor for such examination and inspection to be made on a different 
day before slaughter.
    (b) Such ante-mortem inspection shall be made in pens on the 
premises of the establishment at which the livestock are offered for 
slaughter before the livestock shall be allowed to enter into any 
department of the establishment where they are to be slaughtered or 
dressed or in which edible products are handled. When the holding pens 
of an official establishment are located in a public stockyard and are 
reserved for the exclusive use of the establishment, such pens shall be 
regarded as part of the premises of that establishment and the operator 
of the establishment shall be responsible for compliance with all 
requirements of the regulations in this subchapter with respect to such 
pens.



Sec. 309.2  Livestock suspected of being diseased or affected with 
certain conditions; identifying suspects; disposition on post-mortem 
inspection or otherwise.

    (a) Any livestock which, on ante-mortem inspection, do not clearly 
show, but are suspected of being affected with any disease or condition 
that, under part 311 of this subchapter, may cause condemnation of the 
carcass on post-mortem inspection, and any livestock which show, on 
ante-mortem inspection, any disease or condition that, under part 311 of 
this subchapter would cause condemnation of only part of the carcass on 
post-mortem inspection, shall be so handled as to retain

[[Page 107]]

its identity as a suspect until it is given final post-mortem 
inspection, when the carcass shall be marked and disposed of as provided 
in parts 310 and 311 of this subchapter, or until it is disposed of as 
otherwise provided in this part.
    (b) All seriously crippled animals and non-ambulatory disabled 
livestock shall be identified as U.S. Suspects and disposed of as 
provided in Sec. 311.1 of this subchapter unless they are required to 
be classed as condemned under Sec. 309.3. Non-ambulatory disabled 
livestock are livestock that cannot rise from a recumbent position or 
that cannot walk, including, but not limited to, those with broken 
appendages, severed tendons or ligaments, nerve paralysis, fractured 
vertebral column, or metabolic conditions.
    (c) Livestock which have reacted to a test for leptospirosis, or 
anaplasmosis, but which show no symptoms of the disease, shall be 
identified as U.S. Suspects and disposed of as provided in Sec. 311.10 
of this subchapter.
    (d) Livestock which are known to have reacted to the tuberculin test 
shall be identified as U.S. Suspects and disposed of as provided in 
Sec. 311.2 of this subchapter, except that livestock bearing an 
official ``USDA Reactor'' or similar State reactor tag shall not be 
tagged as U.S. Suspects.
    (e) Any cattle found on ante-mortem inspection to be affected with 
epithelioma of the eye or of the orbital region to a lesser extent than 
as described in Sec. 309.6 shall be identified as a U.S. Suspect and 
disposed of as provided in Sec. 311.12 of this subchapter.
    (f) Cattle found on ante-mortem inspection to be affected with 
anasarca to a lesser extent than as described in Sec. 309.8 shall be 
identified as U.S. Suspects and disposed of as provided in Sec. 311.8 
of this subchapter or paragraph (g) of this section.
    (g) Any livestock suspected of being affected with anasarca may be 
set apart and held for treatment under Program or other responsible 
official supervision approved by the area supervisor. If at the 
expiration of the treatment period the livestock upon examination is 
found to be free from disease, it may be released for any purpose. 
Otherwise, it shall be identified as U.S. Suspect and disposed of as 
provided in Sec. 311.8 of this subchapter or condemned and disposed of 
as provided in Sec. 309.8, whichever is appropriate.
    (h) All hogs suspected on ante-mortem inspection of being affected 
with swine erysipelas shall be identified as U.S. Suspects and disposed 
of as provided in Sec. 311.5 of this subchapter or paragraph (i) of 
this section.
    (i) A hog suspected of being affected with swine erysipelas may be 
set apart and held for treatment under Program or other responsible 
official supervision approved by the area supervisor. If at the 
expiration of the treatment period the animal upon examination is found 
to be free from disease, it may be released for any purpose. Otherwise, 
it shall be identified as U.S. Suspect and disposed of as provided in 
Sec. 311.5 of this subchapter, or condemned and disposed of as provided 
in Sec. 309.13, whichever is appropriate.
    (j) Any livestock which is affected with vesicular exanthema or 
vesicular stomatitis, but which has recovered to the extent that the 
lesions are in process of healing, the temperature is within normal 
range, and the livestock shows a return to normal appetite and activity, 
shall be identified as U.S. Suspect and disposed of as provided in Sec. 
311.32 of this subchapter, except that if desired, such livestock may be 
set apart and held under supervision of a Program employee or other 
official designated by the area supervisor for treatment. If the 
livestock is set aside for treatment, the U.S. Suspect identification 
device will be removed by a Program employee, following such treatment, 
if the livestock is found to be free from any such disease. Such 
livestock found to be free from any such disease may be released for 
slaughter or for purposes other than slaughter, provided that in the 
latter instance, the operator of the official establishment or the owner 
of the animal shall first obtain permission from the local, State, or 
Federal livestock sanitary official having jurisdiction over the 
movement of such livestock.
    (k) Livestock which are offered for ante-mortem inspection under 
this

[[Page 108]]

part, and which are regarded by the inspector as immature, shall be 
identified as U.S. Suspects and, if slaughtered, the disposition of 
their carcasses shall be determined by the post-mortem findings in 
connection with the ante-mortem conditions. If not slaughtered as 
suspects, such livestock shall be held under supervision of a Program 
employee or other official designated by the area supervisor, and after 
sufficient development may be released for slaughter or may be released 
for any other purpose, provided they have not been exposed to any 
infectious or contagious disease. If such exposure occurs, permission 
should be obtained from the nearest Veterinary Services unit of the 
Animal and Plant Health Inspection Service prior to release of such 
livestock.
    (l) Livestock previously condemned for listeriosis, if released for 
slaughter under Sec. 309.13(b) shall be identified as a U.S. Suspect in 
accordance with Sec. 309.13(c).
    (m) Each animal required by this part to be treated as a U.S. 
Suspect shall be identified as such by or under the supervision of a 
Program employee with an official device in accordance with Sec. 
309.18. No such device shall be removed except by a Program employee.
    (n) Each animal identified as a U.S. Suspect on ante-mortem 
inspection shall be set apart and shall be slaughtered separately from 
other livestock at that establishment unless disposed of as otherwise 
provided in this part.
    (o) Each animal identified as a U.S. Suspect on ante-mortem 
inspection, when presented for slaughter shall be accompanied with a 
form MP 402-2 on which the inspector at the establishment shall record 
the U.S. Suspect identification number and any other identifying tag 
numbers present and a brief description of the animal and of the disease 
or condition for which the animal was classed as a suspect, including 
its temperature when the temperature of such animal might have a bearing 
on the disposition of the carcass on post-mortem inspection.
    (p) When any animal identified as a U.S. Suspect is released for any 
purpose or reason, as provided in this part, the official identification 
device shall be removed only by a Program employee and he shall report 
his action to the area supervisor. When a suspect is to be released 
under the provisions of this part for a purpose other than slaughter, 
the operator of the official establishment or the owner of the animal 
shall first obtain permission for the removal of such animal from the 
local, State or Federal livestock sanitary official having jurisdiction.

[35 FR 15563, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973; 39 
FR 36000, Oct. 17, 1974; 69 FR 1873, Jan. 12, 2004]



Sec. 309.3  Dead, dying, disabled, or diseased and similar livestock.

    (a) Livestock found to be dead or in a dying condition on the 
premises of an official establishment shall be identified as U.S. 
Condemned and disposed of in accordance with Sec. 309.13.
    (b) Livestock plainly showing on ante-mortem inspection any disease 
or condition that, under part 311 of this subchapter, would cause 
condemnation of their carcasses on post-mortem inspection shall be 
identified as U.S. Condemned and disposed of in accordance with Sec. 
309.13.
    (c) Any swine having a temperature of 106 [deg]F. or higher and any 
cattle, sheep, goats, horses, mules, or other equines having a 
temperature of 105 [deg]F. or higher shall be identified as U.S. 
Condemned. In case of doubt as to the cause of the high temperature, or 
when for other reasons a Program employee deems such action warranted, 
any such livestock may be held for a reasonable time under the 
supervision of a Program employee for further observation and taking of 
temperature before final disposition of such livestock is determined. 
Any livestock so held shall be reinspected on the day it is slaughtered. 
If, upon such reinspection, or when not held for further observation and 
taking of temperature, then on the original inspection, the animal has a 
temperature of 106 [deg]F. or higher in the case of swine, or 105 
[deg]F. or higher in the case of other livestock, it shall be condemned 
and disposed of in accordance with Sec. 309.13.
    (d) Any livestock found in a comatose or semicomatose condition or 
affected with any condition not otherwise covered in this part, which 
would preclude release of the animal for

[[Page 109]]

slaughter for human food, shall be identified ``U.S. Condemned'' and 
disposed of in accordance with Sec. 309.13, except that such animal may 
be set apart and held for further observation or treatment under 
supervision of a Program employee or other official designated by the 
area supervisor and for final disposition in accordance with this part.
    (e) Non-ambulatory disabled cattle shall be condemned and disposed 
of in accordance with Sec. 309.13.

[35 FR 15563, Oct. 3, 1970, as amended at 69 FR 1873, Jan. 12, 2004]



Sec. 309.4  Livestock showing symptoms of certain metabolic, toxic, 
nervous, or circulatory disturbances, nutritional imbalances, or 
infectious or parasitic diseases.

    (a) All livestock showing, on ante-mortem inspection, symptoms of 
anaplasmosis, ketosis, leptospirosis, listeriosis, parturient paresis, 
pseudorabies, rabies, scrapie, tetanus, grass tetany, transport tetany, 
strangles, purpura hemorrhagica, azoturia, infectious equine 
encephalomyelitis, toxic encephalomyelitis (forage poisoning), dourine, 
acute influenza, generalized osteoporosis, glanders (farcy), acute 
inflammatory lameness or extensive fistula shall be identified as U.S. 
Condemned and disposed of in accordance with Sec. 309.13.
    (b) If any equine is suspected on ante-mortem inspection of being 
infected with glanders or dourine, the nearest Veterinary Services unit 
of the Animal and Plant Health Inspection Service shall be so informed 
by a Program employee. Tests shall be performed by said unit to 
determine whether the animal is, in fact, infected with such disease. If 
it is found on such tests to be infected, the animal shall be disposed 
of in accordance with paragraph (a) of this section. Otherwise, the 
animal shall be identified as a U.S. Suspect and disposed of as provided 
in Sec. 311.10 of this subchapter.

[35 FR 15563, Oct. 3, 1970 as amended at 38 FR 29214, Oct. 23, 1973]



Sec. 309.5  Swine; disposal because of hog cholera.

    (a) All swine found by an inspector to be affected with hog cholera 
shall be identified as U.S. Condemned and disposed of in accordance with 
Sec. 309.13. Immediate notification shall be given by the inspector to 
the official in the Veterinary Services unit of the Animal and Plant 
Health Inspection Service who has responsibility for the control of 
swine diseases in the State where the swine are located.
    (b) All swine, even though not themselves identified as U.S. 
Suspects, which are of lots in which one or more animals have been 
condemned or identified as U.S. Suspect for hog cholera, shall, as far 
as possible, be slaughtered separately and apart from all other 
livestock passed on ante-mortem inspection.

[40 FR 27225, June 27, 1975]



Sec. 309.6  Epithelioma of the eye.

    Any animal found on ante-mortem inspection to be affected with 
epithelioma of the eye and the orbital region in which the eye has been 
destroyed or obscured by neoplastic tissue and which shows extensive 
infection, suppuration, and necrosis, usually accompanied with foul 
odor, or any animal affected with epithelioma of the eye or of the 
orbital region which, regardless of extent, is accompanied with cachexia 
shall be identified as U.S. Condemned and disposed of in accordance with 
Sec. 309.13.



Sec. 309.7  Livestock affected with anthrax; cleaning and disinfection 
of infected livestock pens and driveways.

    (a) Any livestock found on ante-mortem inspection to be affected 
with anthrax shall be identified as U.S. Condemned and disposed of in 
accordance with Sec. 309.13.
    (b) No other livestock of a lot in which anthrax is found on ante-
mortem inspection shall be slaughtered and presented for post-mortem 
inspection until it has been determined by a careful ante-mortem 
inspection that no anthrax infected livestock remains in the lot.
    (c) Apparently healthy livestock (other than hogs) from a lot in 
which anthrax is detected, and any apparently healthy livestock which 
have been treated with anthrax biologicals

[[Page 110]]

which do not contain living anthrax organisms, may be slaughtered and 
presented for post-mortem inspection if they have been held not less 
than 21 days following the last treatment or the last death of any 
livestock in the lot. Alternatively, if desired, all apparently healthy 
livestock of the lot may be segregated and held for treatment by a State 
licensed veterinarian under supervision of a Program employee or other 
official designated by the area supervisor. No anthrax vaccine (live 
organisms) shall be used on the premises of an official establishment.
    (d) Livestock which have been injected with anthrax vaccines (live 
organisms) within 6 weeks, and those bearing evidence of reaction to 
such treatment, such as inflammation, tumefaction, or edema at the site 
of the injection, shall be condemned on ante-mortem inspection, or such 
animals may be held under supervision of a Program employee or other 
official designated by the area supervisor until the expiration of the 
6-week period and the disappearance of any evidence of reaction to the 
treatment.
    (e) When livestock are found on ante-mortem inspection to be 
affected with anthrax, all exposed livestock pens and driveways of the 
official establishment shall be cleaned and disinfected by promptly and 
thoroughly removing and burning all straw, litter, and manure. This 
shall be followed immediately by a thorough disinfection of the exposed 
premises by soaking the ground, fences, gates, and all exposed material 
with a 5 percent solution of sodium hydroxide or commercial lye prepared 
as outlined in Sec. 310.9(e)(1) of this subchapter, or other 
disinfectant that may be approved in specific cases by the Administrator 
specifically for this purpose.



Sec. 309.8  Cattle affected with anasarca and generalized edema.

    All cattle found on ante-mortem inspection to be affected with 
anasarca in advanced stages and characterized by an extensive and 
generalized edema shall be identified as U.S. Condemned and disposed of 
in accordance with Sec. 309.13.



Sec. 309.9  Swine erysipelas.

    All hogs plainly showing on ante-mortem inspection that they are 
affected with acute swine erysipelas shall be identified as U.S. 
Condemned and disposed of in accordance with Sec. 309.13.



Sec. 309.10  Onset of parturition.

    Any livestock showing signs of the onset of parturition shall be 
withheld from slaughter until after parturition and passage of the 
placenta. Slaughter or other disposition may then be permitted if the 
animal is otherwise acceptable.



Sec. 309.11  Vaccine livestock.

    Vaccine livestock with unhealed lesions of vaccinia, accompanied 
with fever, which have not been exposed to any other infectious or 
contagious disease, are not required to be slaughtered and may be 
released for removal from the premises.



Sec. 309.12  Emergency slaughter; inspection prior to.

    In all cases of emergency slaughter, except as provided in Sec. 
311.27 of this subchapter, the animals shall be inspected immediately 
before slaughter, whether theretofore inspected or not. When the 
necessity for emergency slaughter exists, the establishment shall notify 
the inspector in charge so that such inspection may be made.



Sec. 309.13  Disposition of condemned livestock.

    (a) Except as otherwise provided in this part, livestock identified 
as U.S. Condemned shall be killed by the official establishment, if not 
already dead. Such animals shall not be taken into the official 
establishment to be slaughtered or dressed; nor shall they be conveyed 
into any department of the establishment used for edible products; but 
they shall be disposed of in the manner provided for condemned carcasses 
in part 314 of this subchapter. The official U.S. Condemned tag shall 
not be removed from, but shall remain on the carcass until it goes into 
the tank, or is otherwise disposed of as prescribed in part 314 of this 
subchapter, at which time such tag may be removed by a Program employee 
only.

[[Page 111]]

The number of such tag shall be reported to the veterinary medical 
officer by the inspector who affixed it, and also by the inspector who 
supervised the tanking of the carcass.
    (b) Any livestock condemned on account of ketosis, swine erysipelas, 
vesicular diseases, grass tetany, transport tetany, parturient paresis, 
anasarca, anaplasmosis, leptospirosis, listeriosis, or inflammatory 
condition including pneumonia, enteritis, and peritonitis may be set 
apart and held for treatment under supervision of a Program employee or 
official designated by the area supervisor. The U.S. Condemned 
identification tag will be removed by a Program employee following 
treatment under such supervision if the animal is found to be free from 
any such disease.
    (c) Livestock previously affected with listeriosis, including those 
released for slaughter after treatment under paragraph (b) of this 
section, shall be identified as U.S. Suspect.
    (d) When livestock under the provisions of this section is to be 
released for a purpose other than slaughter, the operator of the 
official establishment or the owner of the livestock shall first obtain 
permission for the movement of such livestock from the local, State, or 
Federal livestock sanitary official having jurisdiction.



Sec. 309.14  Brucellosis-reactor goats.

    Goats which have reacted to a test for brucellosis shall not be 
slaughtered in an official establishment.



Sec. 309.15  Vesicular diseases.

    (a) Immediate notification shall be given by the inspector to the 
local, State, and Federal livestock sanitary officials having 
jurisdiction when any livestock is found to be affected with a vesicular 
disease.
    (b) No livestock under quarantine by State or Federal livestock 
sanitary officials on account of a vesicular disease will be given ante-
mortem inspection. If no quarantine is invoked, or if quarantine is 
invoked and later removed, upon ante-mortem inspection, any animal found 
to be affected with vesicular exanthema or vesicular stomatitis in the 
acute stages, as evidenced by acute and active lesions or an elevated 
temperature, shall be identified as U.S. Condemned and disposed of in 
accordance with Sec. 309.13.



Sec. 309.16  Livestock suspected of having biological residues.

    (a) Except as provided by paragraph (d) of this section, livestock 
suspected of having been treated with or exposed to any substance that 
may impart a biological residue which would make the edible tissues 
unfit for human food or otherwise adulterated shall be handled in 
compliance with the provisions of this paragraph. They shall be 
identified at official establishments as ``U.S. Condemned.'' These 
livestock may be held under the custody of a Program employee, or other 
official designated by the Administrator, until metabolic processes have 
reduced the residue sufficiently to make the tissues fit for human food 
and otherwise not adulterated. When the required time has elapsed, the 
livestock, if returned for slaughter, must be re-examined on ante-mortem 
inspection. To aid in determining the amount of residue present in the 
tissues, officials of the Program may permit the slaughter of any such 
livestock for the purpose of collecting tissues for analysis for the 
residue. Such analysis may include the use of inplant screening 
procedures designed to detect the presence of antimicrobial residues in 
any species of livestock.
    (b) All carcasses and edible organs and other parts thereof, in 
which are found any biological residues which render such articles 
adulterated, shall be marked as ``U.S. Condemned'' and disposed of in 
accordance with Sec. 314.1 or Sec. 314.3 of this chapter.
    (c) [Reserved]
    (d) Calves shall not be presented for ante-mortem inspection in an 
official establishment except under the provisions of this paragraph.
    (1) Definitions. For purposes of this paragraph, the following 
definitions shall apply:
    (i) Calf. A calf up to 3 weeks of age or up to 150 pounds.
    (ii) Certified calf. A calf that the producer and all other 
subsequent custodians of the calf certify in writing has not been 
treated with any animal drug while in his or her custody or has

[[Page 112]]

been treated with one or more drugs in accordance with FDA approved 
label directions while in his or her custody and has been withheld from 
slaughter for the period(s) of time specified by those label directions.
    (iii) Healthy calf. A calf that an inspector determines shows no 
visual signs of disease or treatment of disease at ante-mortem 
inspection.
    (iv) Producer. The owner of the calf at the time of its birth.
    (v) Sick calf. A calf that an inspector on ante-mortem inspection 
determines has either signs of treatment or signs of disease.
    (vi) Veterinary medical officer. An inspector of the Program that 
has obtained a Doctor of Veterinary Medicine degree which is recognized 
by the Program.
    (2) General requirements. (i) The identity of the producer of each 
calf presented for ante-mortem inspection shall be made available by the 
official establishment to the inspection prior to the animal being 
presented for ante-mortem inspection.
    (ii) The inspector shall segregate the calves presented for ante-
mortem inspection at the establishment and identify each calf as one of 
the following: (a) Certified, (B) noncertified, or (C) previous residue 
condemnation.
    (3) Certified group. (i) For a calf to be considered certified, the 
producer and all other subsequent custodians of the calf must certify in 
writing that while the calf was in his or her custody, the calf was not 
treated with animal drugs or was treated with one or more drugs in 
accordance with FDA approved label directions and was withheld from 
slaughter for the period(s) of time specified by those label directions. 
All prior certifications must be presented with the animal at the time 
of slaughter. The certifications shall contain a list of the calves with 
accompanying identification numbers, as required by paragraph (d)(3)(ii) 
of this section, followed by the following language:

    I hereby certify that, while in my custody, from -------- to ------
-- (time period of custody), the above-listed calf or calves have not 
been treated with drugs, or have been treated with one or more drugs in 
accordance with FDA approved label directions and have been withheld 
from slaughter for the period(s) of time specified by those label 
directions. I certify that, to the best of my knowledge and belief, all 
information contained herein is true, that the information may be relied 
upon at the official establishment, and that I understand that any 
willful falsification of this certification is a felony and may result 
in a fine of up to $250,000 for an individual or up to $500,000 for an 
organization, or imprisonment for not more than 5 years, or both (21 
U.S.C. 677, 18 U.S.C. 1001 and 3571).

Executed on_____________________________________________________________
 (date of certification)

________________________________________________________________________
(signature of certifier)

________________________________________________________________________
(typed or printed name and address of certifier)

________________________________________________________________________
(business of certifier)

    (ii) Each calf must be identified by use of backtag, eartag, or 
other type of secure identification which displays a number which shall 
be recorded on all written certifications.
    (iii) The inspector shall have segregated for veterinary medical 
officer examination any certified calf which he or she determines to 
show any sign of disease or which is not identified individually. Such 
animal will be tagged as ``U.S. Suspect'' and its carcass will be 
retained on post-mortem inspection and handled in accordance with Sec. 
310.21 (c) and (d).
    (iv) The inspector shall handle the remaining carcasses of healthy 
animals in accordance with Sec. 310.21(c) and (d).
    (4) Noncertified group. On ante-mortem inspection, the inspector 
shall have segregated for veterinary medical officer examination any 
calf which he or she determines to show any sign of disease. Such animal 
will be tagged as ``U.S. Suspect'' and its carcass will be retained on 
post-mortem inspection and handled in accordance with Sec. 310.21(c). 
The inspector shall handle the remaining carcasses of healthy animals in 
accordance with Sec. 310.21(c).
    (5) Calves from producers with previous residue condemnation. On 
ante-mortem inspection, the inspector shall have segregated for 
veterinary medical officer examination any calf which he or she 
determines to show any sign of disease. Such animal will be tagged as 
``U.S. Suspect'' and its carcass will be retained on post-mortem 
inspection and handled in accordance with

[[Page 113]]

Sec. 310.21(e). The inspector shall handle the remaining carcasses of 
healthy animals in accordance with Sec. 310.21(e).
    (e) The name of each and all person(s) who sold or consigned each 
swine to the establishment shall be made available by the establishment 
to any Program employee or other authorized employee of the United 
States Department of Agriculture upon that employee's request and 
presentation of his or her official credentials. Swine identification, 
by means approved by the Animal and Plant Health Inspection Service, 
USDA, under part 71 of this title, must be maintained throughout post-
mortem inspection, in accordance with Sec. 310.23(a) of this 
subchapter.

(Recordkeeping requirements approved by the Office of Management and 
Budget under control number 0583-0053)

[36 FR 24928, Dec. 24, 1971, as amended at 44 FR 45606, Aug. 3, 1979; 44 
FR 59499, Oct. 16, 1979; 47 FR 746, Jan. 7, 1982; 47 FR 41336, Sept. 20, 
1982; 50 FR 32164, Aug. 9, 1985; 50 FR 53127, Dec. 30, 1985; 52 FR 2104, 
Jan. 20, 1987; 53 FR 40387, Oct. 14, 1988; 55 FR 7474, Mar. 2, 1990]



Sec. 309.17  Livestock used for research.

    (a) No livestock used in any research investigation involving an 
experimental biological product, drug, or chemical shall be eligible for 
slaughter at an official establishment unless:
    (1) The operator of such establishment, the sponsor of the 
investigation, or the investigator has submitted to the Program, or the 
Veterinary Services unit of the Animal and Plant Health Inspection 
Service of the Department of Agriculture or to the Environmental 
Protection Agency or to the Food and Drug Administration of the 
Department of Health, Education, and Welfare, data or a summary 
evaluation of the data which demonstrates that the use of such 
biological product, drug, or chemical will not result in the products of 
such livestock being adulterated, and a Program employee has approved 
such slaughter;
    (2) Written approval by the Deputy Administrator, Meat and Poultry 
Inspection Field Operations is furnished the area supervisor prior to 
the time of slaughter;
    (3) In the case of an animal administered any unlicensed, 
experimental veterinary biologic product regulated under the Virus-Serum 
Toxin Act (21 U.S.C. 151 et seq.), the product was prepared and 
distributed in compliance with Part 103 of the regulations issued under 
said Act (part 103 of this title), and used in accordance with the 
labeling approved under said regulations;
    (4) In the case of an animal administered any investigational drug 
regulated under the Federal Food, Drug, and Cosmetic Act, as amended (21 
U.S.C. 301 et seq.), the drug was prepared and distributed in compliance 
with the applicable provisions of part 135 of the regulations issued 
under said Act (21 CFR part 135), and used in accordance with the 
labeling approved under said regulations;
    (5) In the case of an animal subjected to any experimental economic 
poison under section 2(a) of the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended (7 U.S.C. 135 et seq.), the product was 
prepared and distributed in accordance with Sec. 362.17 of the 
regulations issued under said Act (7 CFR 362.17), and used in accordance 
with the labeling approved under said regulations.
    (6) In the case of an animal administered or subjected to any 
substance that is a food additive or pesticide chemical under the 
Federal Food, Drug, and Cosmetic Act, supra, there has been compliance 
with all tolerance limitations established by said Act and the 
regulations promulgated thereunder (21 CFR 1.1 et seq.), and all other 
restrictions and requirements imposed by said Act and said regulations 
will be complied with at the time of slaughter.
    (b) The inspector in charge may deny or withdraw the approval for 
slaughter of any livestock subject to the provision of this section when 
he deems it necessary to assure that all products prepared at the 
official establishment are free from adulteration.



Sec. 309.18  Official marks and devices for purposes of ante-mortem 
inspection.

    (a) All livestock required by this part to be identified as U.S. 
Suspects shall be tagged with a serially numbered metal ear tag bearing 
the term ``U.S. Suspect,'' except as provided in Sec. 309.2(d) and 
except that cattle affected with epithelioma of the eye,

[[Page 114]]

antinomycosis, or actinobacillosis to such an extent that the lesions 
would be readily detected on post-mortem inspection, need not be 
individually tagged on ante-mortem inspection with the U.S. Suspect tag, 
provided that such cattle are segregated and otherwise handled as U.S. 
Suspects.
    (b) In addition, identification of U.S. Suspect swine must include 
the use of tattoos specified by the inspector to maintain the identity 
of the animals through the dehairing equipment when such equipment is 
used.
    (c) All livestock required by this part to be identified as U.S. 
Condemned shall be tagged with a serially numbered metal ear tag bearing 
the term ``U.S. Condemned.''
    (d) The devices described in paragraphs (a), (b), and (c) of this 
section shall be the official devices for identification of livestock 
required to be identified as U.S. Suspect or U.S. Condemned as provided 
in this part.



PART 310_POST-MORTEM INSPECTION--Table of Contents




Sec.
310.1 Extent and time of post-mortem inspection; post-mortem inspection 
          staffing standards.
310.2 Identification of carcass with certain severed parts thereof and 
          with animal from which derived.
310.3 Carcasses and parts in certain instances to be retained.
310.4 Identification of carcasses and parts; tagging.
310.5 Condemned carcasses and parts to be so marked; tanking; 
          separation.
310.6 Carcasses and parts passed for cooking; marking.
310.7 Removal of spermatic cords, pizzles and preputial diverticuli.
310.8 Passing and marking of carcasses and parts.
310.9 Anthrax; carcasses not to be eviscerated; disposition of affected 
          carcasses; hides, hoofs, horns, hair, viscera and contents, 
          and fat; handling of blood and scalding vat water; general 
          cleanup and disinfection.
310.10 Carcasses with skin or hide on; cleaning before evisceration; 
          removal of larvae of Hypodermae, external parasites and other 
          pathological skin conditions.
310.11 Cleaning of hog carcasses before incising.
310.12 Sternum to be split; abdominal and thoracic viscera to be 
          removed.
310.13 Inflating carcasses or parts thereof; transferring caul or other 
          fat.
310.14 Handling of bruised parts.
310.15 Disposition of thyroid glands and laryngeal muscle tissue.
310.16 Disposition of lungs.
310.17 Inspection of mammary glands.
310.18 Contamination of carcasses, organs, or other parts.
310.19 Inspection of kidneys.
310.20 Saving of blood from livestock as an edible product.
310.21 Carcasses suspected of containing sulfa and antibiotic residues; 
          sampling frequency; disposition of affected carcasses and 
          parts.
310.22 Specified risk materials from cattle and their handling and 
          disposition.
310.23 Identification of carcasses and parts of swine.
310.24 [Reserved]
310.25 Contamination with microorganisms; process control verification 
          criteria and testing; pathogen reduction standards.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    Source: 35 FR 15567, Oct. 3, 1970, unless otherwise noted.



Sec. 310.1  Extent and time of post-mortem inspection; post-mortem 
inspection staffing standards.

    (a) A careful post-mortem examination and inspection shall be made 
of the carcasses and parts thereof of all livestock slaughtered at 
official establishments. Such inspection and examination shall be made 
at the time of slaughter unless, because of unusual circumstances, prior 
arrangements acceptable to the Administrator have been made in specific 
cases by the circuit supervisor for making such inspection and 
examination at a later time.
    (b)(1) The staffing standards on the basis of the number of 
carcasses to be inspected per hour are outlined in the following tables. 
Standards for multiple inspector lines are based on inspectors rotating 
through the different types of inspection stations during each shift to 
equalize the workload. The inspector in charge shall have the authority 
to require the establishment to reduce slaughter line speeds where, in 
his judgment, the inspection procedure cannot be adequately performed at 
the current line speed because of particular deficiencies in carcass 
preparation and presentation by the plant at the higher speed, or 
because the

[[Page 115]]

health condition of the particular animals indicates a need for more 
extensive inspection.
    (2) Cattle inspection. For all cattle staffing standards, an ``a'' 
in the ``Number of Inspectors by Stations'' column means that one 
inspector performs the entire inspection procedure and a ``b'' means 
that one inspector performs the head and lower carcass inspection and a 
second inspector performs the viscera and upper carcass inspection. \1\
---------------------------------------------------------------------------

    \1\ The ``Maximum Slaughter Rates'' figures listed in paragraph 
(b)(2)(i) of this section for one (a) and two (b) inspector kills are 
overstated because the time required to walk from one inspection station 
to another is not included. To determine the proper adjusted maximum 
slaughter line speed, paragraph (b)(2)(i)(A) of this section for one 
inspector kills or paragraph (b)(2)(i)(B) of this section for two 
inspector kills must be used along with their accompanying rules.
---------------------------------------------------------------------------

    (i) Inspection Using the Viscera Truck.

                           Steers and Heifers
------------------------------------------------------------------------
                                                 Number of inspectors by
                                                         stations
    Maximum slaughter rates (head per hour)     ------------------------
                                                  Head  Viscera  Carcass
------------------------------------------------------------------------
1 to 27........................................      a       a        a
28 to 56.......................................      b       b        b
57 to 84.......................................      1       1        1
85 to 86.......................................      1       2        1
87 to 143......................................      2       2        1
------------------------------------------------------------------------


                             Cows and Bulls
------------------------------------------------------------------------
                                                 Number of inspectors by
                                                         stations
    Maximum slaughter rates (head per hour)     ------------------------
                                                  Head  Viscera  Carcass
------------------------------------------------------------------------
1 to 27........................................      a       a        a
28 to 55.......................................      b       b        b
56 to 77.......................................      1       1        1
78 to 81.......................................      1       2        1
82 to 134......................................      2       2        1
------------------------------------------------------------------------

    (A) Rules for determining adjusted maximum slaughter rates for 
single-inspector kills considering walking distance according to the 
table in this subdivision: Determine the distances the inspector 
actually walks between the points shown in columns 2 through 14 of the 
following table. For each column, determine the deduction figure 
opposite the appropriate number of feet in column 1. Compute the total 
of the deduction figures for columns 2 through 14. The adjusted maximum 
rate is the maximum rate in paragraph (b)(2)(i) of this section minus 
total of the deduction figures. If the resultant number is not a whole 
number, it must be rounded off to the next lowest whole number.

[[Page 116]]



                                                                            One-Inspector Cattle Kill--Viscera Truck
                                        [Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths of cattle per hour)]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
           2  Head rack    3  Viscera    4  Low rail  5  Head rack   6  Carcass     7  Tags--    8  Viscera    9  Viscera   10  Low rail    11  Head         12         13  Head     14  Viscera
    1      and high rail  and low rail    and head     and carcass     \2\ and     brands and        and        and high      and high      rack and      Washbasin     rack and     and tags--
 Number  ------------------------------     rack           \2\        washbasin     low rail      washbasin       rail          rail         closest      and high      washbasin      brands
 of feet                               --------------------------------------------------------------------------------------------------   washbasin     rail \1\         \1\     -------------
 between   Strs.   Cows   Strs.   Cows                                                                                                   ------------------------------------------
 points    Hfrs.   Bulls  Hfrs.  Bulls  Strs.   Cows  Strs.   Cows  Strs.   Cows  Strs.   Cows  Strs.   Cows  Strs.   Cows  Strs.   Cows  Strs.   Cows  Strs.   Cows  Strs.   Cows  Strs.   Cows
                                        Hfrs.  Bulls  Hfrs.  Bulls  Hfrs.  Bulls  Hfrs.  Bulls  Hfrs.  Bulls  Hfrs.  Bulls  Hfrs.  Bulls  Hfrs.  Bulls  Hfrs.  Bulls  Hfrs.  Bulls  Hfrs.  Bulls
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
     1        0       0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0
     3        0       0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0      0    0.1      0
     5        0       0    0.1      0      0      0      0      0      0      0      0      0      0    0.1    0.1    0.1      0      0      0      0      0      0      0      0    0.2    0.1
     7        0       0    0.1    0.1    0.1    0.1      0      0      0      0    0.1    0.1    0.1    0.2    0.2    0.2    0.1    0.1      0      0      0      0      0      0    0.3    0.3
     9        0       0    0.2    0.1    0.1    0.1      0      0      0      0    0.1    0.1    0.1    0.3    0.3    0.3    0.1    0.1      0      0    0.1    0.1    0.1    0.1    0.4    0.4
    11      0.1     0.1    0.2    0.2    0.2    0.2      0      0      0      0    0.1    0.2    0.2    0.4    0.4    0.4    0.2    0.2      0      0    0.1    0.1    0.1    0.1    0.5    0.6
    13      0.1     0.1    0.3    0.2    0.2    0.2      0      0      0      0    0.2    0.2    0.2    0.5    0.5    0.5    0.2    0.2      0      0    0.1    0.1    0.1    0.1    0.6    0.7
    15      0.1     0.1    0.4    0.3    0.3    0.3      0      0      0      0    0.2    0.3    0.3    0.5    0.6    0.6    0.3    0.3      0      0    0.2    0.2    0.2    0.2    0.7    0.9
    17      0.1     0.1    0.4    0.3    0.3    0.3      0      0      0      0    0.3    0.3    0.3    0.6    0.7    0.7    0.3    0.3      0    0.1    0.2    0.2    0.2    0.2    0.9    1.0
    19      0.1     0.1    0.5    0.4    0.4    0.4      0      0      0      0    0.3    0.4    0.4    0.7    0.8    0.8    0.4    0.4      0    0.1    0.2    0.2    0.2    0.2    1.0    1.1
    21      0.2     0.2    0.5    0.4    0.4    0.4      0      0      0      0    0.3    0.4    0.4    0.8    0.9    0.8    0.4    0.4      0    0.1    0.3    0.2    0.3    0.2    1.1    1.3
    23      0.2     0.2    0.6    0.5    0.5    0.5      0      0      0      0    0.4    0.5    0.5    0.9    1.0    0.9    0.5    0.5      0    0.1    0.3    0.3    0.3    0.3    1.2    1.4
    25      0.2     0.2    0.7    0.5    0.5    0.5      0      0      0      0    0.4    0.5    0.5    1.0    1.1    1.0    0.5    0.5      0    0.1    0.3    0.3    0.3    0.3    1.3    1.5
    27      0.2     0.2    0.7    0.5    0.6    0.5      0      0      0      0    0.4    0.5    0.6    1.1    1.2    1.1    0.6    0.6      0    0.1    0.3    0.3    0.3    0.3    1.4    1.7
    29      0.2     0.2    0.8    0.6    0.6    0.6      0      0      0      0    0.5    0.6    0.6    1.2    1.3    1.2    0.6    0.6      0    0.1    0.4    0.3    0.4    0.3    1.5    1.8
    31      0.3     0.2    0.8    0.6    0.7    0.6      0      0      0      0    0.5    0.6    0.7    1.3    1.3    1.4    0.7    0.7      0    0.1    0.4    0.4    0.4    0.4    1.6    1.9
    33      0.3     0.3    0.9    0.7    0.7    0.7      0      0      0      0    0.6    0.7    0.7    1.3    1.4    1.4    0.7    0.7      0    0.1    0.4    0.4    0.4    0.4    1.7    2.1
    35      0.3     0.3    1.0    0.7    0.8    0.7      0      0      0      0    0.6    0.7    0.8    1.4    1.5    1.5    0.8    0.8      0    0.2    0.5    0.4    0.5    0.4    1.8    2.2
    37      0.3     0.3    1.0    0.8    0.8    0.8      0      0      0      0    0.6    0.8    0.8    1.5    1.6    1.6   .0.8    0.8      0    0.2    0.5    0.5    0.5    0.5    1.9    2.3
    39      0.3     0.3    1.1    0.8    0.9    0.8      0      0      0      0    0.7    0.8    0.9    1.6    1.7    1.7    0.9    0.9      0    0.2    0.5    0.5    0.5    0.5    2.0    2.4
    41      0.4     0.3    1.1    0.9    0.9    0.9      0    0.1      0    0.1    0.7    0.9    0.9    1.7    1.7    1.8    0.9    0.9      0    0.2    0.6    0.5    0.6    0.5    2.1    2.6
    43      0.4     0.4    1.2    0.9    1.0    0.9      0    0.1      0    0.1    0.7    0.9    1.0    1.8    1.8    1.9    1.0    1.0    0.1    0.2    0.6    0.5    0.6    0.5    2.2    2.7
    45      0.4     0.4    1.2    0.9    1.0    0.9      0    0.1      0    0.1    0.8    0.9    1.0    1.8    1.9    2.0    1.0    1.0    0.1    0.2    0.6    0.6    0.6    0.6    2.3    2.8
    47      0.4     0.4    1.3    1.0    1.1    1.0      0    0.1      0    0.1    0.8    1.0    1.1    1.9    2.0    2.1    1.1    1.1    0.1    0.2    0.6    0.6    0.6    0.6    2.4    2.9
    49      0.4     0.4    1.4    1.0    1.1    1.0      0    0.1      0    0.1    0.8    1.0    1.1    2.0    2.1    2.2    1.1    1.1    0.1    0.2    0.7    0.6    0.7    0.6    2.5    3.1
    51      0.5     0.5    1.4    1.1    1.2    1.1      0    0.1      0    0.1    0.9    1.1    1.2    2.1    2.2    2.2    1.2    1.2    0.1    0.3    0.7    0.7    0.7    0.7    2.6    3.2
    53      0.5     0.5    1.5    1.1    1.2    1.1      0    0.1      0    0.1    0.9    1.1    1.2    2.2    2.3    2.3    1.2    1.2    0.1    0.3    0.7    0.7    0.7    0.7    2.7    3.3
    55      0.5     0.5    1.5    1.2    1.2    1.2      0    0.1      0    0.1    1.0    1.2    1.2    2.3    2.3    2.4    1.3    1.3    0.1    0.3    0.8    0.7    0.8    0.7    2.8    3.4
    57      0.5     0.5    1.6    1.2    1.3    1.2      0    0.1      0    0.1    1.0    1.2    1.3    2.3    2.4    2.5    1.3    1.3    0.1    0.3    0.8    0.7    0.8    0.7    2.9    3.5
    59      0.5     0.5    1.6    1.3    1.3    1.3      0    0.1      0    0.1    1.0    1.3    1.3    2.4    2.5    2.6    1.4    1.4    0.1    0.3    0.8    0.8    0.8    0.8    3.0    3.6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The washbasin referred to here is the one the inspector uses while enroute from the head rack to high rail inspection.
\2\ This refers to the carcass in the bleeding area.


[[Page 117]]

    (B) Rules for determining adjusted maximum slaughter rates for two-
inspector kills considering walking distance according to the table in 
this subdivision: Determine the distances the inspectors actually walk 
between the points shown in columns 2 through 9 of the following table. 
Column 9 is used only if the condemned brands and tags the viscera 
inspector uses are kept at a location other than at the washbasin-
sterilizer. For each column, determine the deduction figure opposite the 
appropriate number of feet in column 1. Compute the total of the 
deduction figures for columns 2 through 9. Divide this total by 2. The 
adjusted maximum rate is the maximum rate in paragraph (b)(2)(i) of this 
section minus the number calculated above. If the resultant number is 
not a whole number, it must be rounded off to the next lowest whole 
number.

[[Page 118]]



                                                        Two-Inspector Cattle Kill--Viscera Truck
                    [Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths of cattle per hour)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                          Heads and low rail inspection                                              Viscera and high rail inspection
--------------------------------------------------------------------------------------------------------------------------------------------------------
    1             2                 3                 4                 5                 6                 7                 8               9 \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Head rack and     Head rack and     Washbasin and     Head rack and      Viscera and    Viscera and high    High rail and      Viscera and
 Number       washbasin       carcasses \2\       low rail          low rail         brands tags          rail            washbasin         washbasin
 of feet ------------------------------------------------------------------------    (washbasin)   -----------------------------------------------------
 between                                                                         ------------------
 points    Strs.     Cows    Strs.     Cows    Strs.     Cows    Strs.     Cows    Strs.     Cows    Strs.     Cows    Strs.     Cows    Strs.     Cows
           Hfrs.    Bulls    Hfrs.    Bulls    Hfrs.    Bulls    Hfrs.    Bulls    Hfrs.    Bulls    Hfrs.    Bulls    Hfrs.    Bulls    Hfrs.    Bulls
--------------------------------------------------------------------------------------------------------------------------------------------------------
       1        0        0        0        0        0        0        0        0        0        0        0        0        0        0        0        0
       3      0.1        0      0.1        0      0.1        0        0        0        0        0        0        0        0        0      0.1      0.2
       5      0.1      0.1      0.1      0.1      0.1      0.1      0.8      0.7      0.4      0.5      0.5      0.5      0.1      0.2      0.2      0.3
       7      0.1      0.2      0.1      0.1      0.1      0.1      1.5      1.4      0.7      0.9      1.0      0.9      0.3      0.3      0.3      0.4
       9      0.2      0.2      0.1      0.2      0.1      0.2      2.2      2.0      1.1      1.3      1.5      1.3      0.4      0.5      0.4      0.5
      11      0.2      0.3      0.1      0.2      0.2      0.2      2.8      2.7      1.4      1.7      1.9      1.8      0.5      0.6      0.4      0.6
      13      0.2      0.4      0.1      0.3      0.2      0.2      3.5      3.3      1.7      2.1      2.4      2.2      0.6      0.7      0.5      0.8
      15      0.3      0.4      0.1      0.3      0.2      0.3      4.1      3.9      2.0      2.5      2.9      2.6      0.7      0.9      0.6      0.9
      17      0.3      0.5      0.1      0.4      0.2      0.3      4.8      4.5      2.4      2.9      3.3      3.0      0.8      1.0      0.7      1.0
      19      0.3      0.6      0.2      0.4      0.3      0.4      5.4      5.1      2.7      3.3      3.7      3.4      0.9      1.2      0.7      1.2
      21      0.3      0.6      0.2      0.4      0.3      0.4      6.0      5.7      3.0      3.7      4.2      3.7      1.0      1.3      0.8      1.3
      23      0.4      0.7      0.2      0.5      0.3      0.5      6.6      6.3      3.3      4.0      4.6      4.1      1.2      1.4      0.9      1.4
      25      0.4      0.7      0.2      0.5      0.3      0.5      7.2      6.8      3.6      4.4      5.0      4.5      1.3      1.6      1.0      1.6
      27      0.4      0.8      0.2      0.6      0.4      0.5      7.8      7.4      3.9      4.7      5.4      4.9      1.4      1.7      1.0      1.7
      29      0.5      0.9      0.2      0.6      0.4      0.6      8.3      7.9      4.2      5.1      5.8      5.2      1.5      1.8      1.1      1.8
      31      0.5      0.9      0.2      0.7      0.4      0.6      8.9      8.5      4.5      5.4      6.2      5.6      1.6      2.0      1.2      2.0
      33      0.5      1.0      0.2      0.7      0.4      0.7      9.4      9.0      4.8      5.8      6.5      5.9      1.7      2.1      1.3      2.1
      35      0.6      1.1      0.3      0.8      0.5      0.7     10.0      9.5      5.0      6.1      6.9      6.3      1.8      2.2      1.3      2.3
      37      0.6      1.1      0.3      0.8      0.5      0.7     10.5     10.0      5.3      6.4      7.3      6.6      1.9      2.4      1.4      2.4
      39      0.6      1.2      0.3      0.9      0.5      0.8     11.0     10.5      5.6      6.8      7.6      6.9      2.0      2.5      1.5      2.5
      41      0.7      1.2      0.3      0.9      0.6      0.8     11.5     11.0      5.9      7.1      8.0      7.2      2.1      2.6      1.5      2.6
      43      0.7      1.3      0.3      0.9      0.6      0.9     12.0     11.4      6.1      7.4      8.3      7.6      2.2      2.8      1.6      2.8
      45      0.7      1.4      0.3      1.0      0.6      0.9     12.5     11.9      6.4      7.7      8.7      7.9      2.4      2.9      1.7      2.9
      47      0.8      1.4      0.3      1.0      0.6      1.0     13.0     12.4      6.7      8.0      9.0      8.2      2.5      3.0      1.8      3.0
      49      0.8      1.5      0.3      1.1      0.7      1.0     13.4     12.8      6.9      8.3      9.4      8.5      2.6      3.2      1.8      3.1
      51      0.8      1.6      0.3      1.1      0.7      1.0     13.9     13.3      7.2      8.6      9.7      8.8      2.7      3.3      1.9      3.3
      53      0.9      1.6      0.4      1.2      0.7      1.1     14.4     13.7      7.4      8.9     10.0      9.1      2.8      3.4      2.0      3.4
      55      0.9      1.7      0.4      1.2      0.7      1.1     14.8     14.1      7.7      9.2     10.3      9.4      2.9      3.5      2.0      3.5
      57      0.9      1.7      0.4      1.3      0.8      1.2     15.2     14.6      7.9      9.5     10.6      9.7      3.0      3.7      2.1      3.6
      59      0.9      1.8      0.4      1.3      0.8      1.2     15.7     15.0      8.2      9.7     10.9      9.9      3.1      3.8      2.2      3.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This column to be used only if brands and tags are not located at the washbasin.
\2\ This refers to the carcasses in the bleeding area.


[[Page 119]]

    (ii) Inspection Using Viscera Table, Tongue-In Presentation of 
Heads.

                           Steers and Heifers
------------------------------------------------------------------------
                                                 Number of inspectors by
                                                         stations
    Maximum slaughter rates (head per hour)     ------------------------
                                                  Head  Viscera  Carcass
------------------------------------------------------------------------
1 to 32........................................      a       a        a
33 to 58.......................................      b       b        b
59 to 84.......................................      1       1        1
85 to 86.......................................      1       2        1
87 to 143......................................      2       2        1
144 to 171.....................................      3       2        1
172 to 198.....................................      3       3        1
199 to 226.....................................      3       3        2
227 to 253.....................................      4       3        2
254 to 280.....................................      4       4        2
281 to 306.....................................      5       4        2
307 to 333.....................................      5       5        2
------------------------------------------------------------------------


                             Cows and Bulls
------------------------------------------------------------------------
                                                 Number of inspectors by
                                                         stations
    Maximum slaughter rates (head per hour)     ------------------------
                                                  Head  Viscera  Carcass
------------------------------------------------------------------------
1 to 29........................................      a       a        a
30 to 56.......................................      b       b        b
57 to 77.......................................      1       1        1
78 to 81.......................................      1       2        1
82 to 134......................................      2       2        1
135 to 159.....................................      2       3        1
160 to 187.....................................      3       3        1
188 to 213.....................................      3       4        1
214 to 234.....................................      3       4        2
235 to 264.....................................      4       4        2
265 to 289.....................................      5       4        2
290 to 314.....................................      5       5        2
------------------------------------------------------------------------

    (iii) Inspection Using Viscera Table, Tongue-Out Presentation of 
Heads.

                           Steers and Heifers
------------------------------------------------------------------------
                                                 Number of inspectors by
                                                         stations
    Maximum slaughter rates (head per hour)     ------------------------
                                                  Head  Viscera  Carcass
------------------------------------------------------------------------
1 to 32........................................      a       a        a
33 to 58.......................................      b       b        b
59 to 86.......................................      1       1        1
87 to 103......................................      1       2        1
104 to 156.....................................      2       2        1
157 to 186.....................................      2       3        1
187 to 216.....................................      3       3        1
217 to 246.....................................      3       3        2
247 to 275.....................................      3       4        2
276 to 304.....................................      4       4        2
305 to 333.....................................      4       5        2
334 to 362.....................................      5       5        2
363 to 390.....................................      5       6        2
------------------------------------------------------------------------


                             Cows and Bulls
------------------------------------------------------------------------
                                                 Number of inspectors by
                                                         stations
    Maximum slaughter rates (head per hour)     ------------------------
                                                  Head  Viscera  Carcass
------------------------------------------------------------------------
1 to 29........................................      a       a        a
30 to 56.......................................      b       b        b
57 to 79.......................................      1       1        1
80 to 98.......................................      1       2        1
99 to 147......................................      2       2        1
148 to 174.....................................      2       3        1
175 to 205.....................................      3       3        1
206 to 233.....................................      3       4        1
234 to 256.....................................      3       4        2
257 to 288.....................................      4       4        2
289 to 316.....................................      5       4        2
317 to 343.....................................      5       5        2
------------------------------------------------------------------------

    (3) Swine Inspection. The following inspection staffing standards 
are applicable to swine slaughter configurations. The inspection 
standards for all slaughter lines are based upon the observation rather 
than palpation, at the viscera inspection station, of the spleen, liver, 
heart, lungs, and mediastinal lymph nodes. In addition, for one- and 
two-inspector lines, the standards are based upon the distance walked 
(in feet) by the inspector between work stations; and for three or more 
inspector slaughter lines, upon the use of a mirror, as described in 
Sec. 307.2(m)(6), at the carcass inspection station. Although not 
required in a one- or two-inspector slaughter configuration, except in 
certain cases as determined by the inspection service, if a mirror is 
used, it must comply with the requirements of Sec. 307.2(m)(6).

          Table 1--One Inspector--Staffing Standards for Swine
------------------------------------------------------------------------
                                      Maximum inspection rates (head per
                                                     hour)
                                     -----------------------------------
                                         Market hogs     Sows and boars
  Distance walked \1\ in feet is--     (heads attached  (heads detached)
                                        or detached)   -----------------
                                     ------------------
                                      Without    With   Without    With
                                       mirror   mirror   mirror   mirror
------------------------------------------------------------------------
0 to 5..............................      140      150      131      143
6 to 10.............................      134      144      126      137
11 to 15............................      129      137      122      132
16 to 20............................      124      132      117      127
21 to 35............................      120      127      113      122
26 to 30............................      116      122      110      118
31 to 35............................      112      118      106      114
36 to 40............................      108      114      103      110
41 to 45............................      105      110      100      106
46 to 50............................      101      107       97      103
51 to 55............................       98      103       94      100
56 to 60............................       96      100       91       97
61 to 65............................       93       97       89       94
66 to 70............................       90       95       87       92

[[Page 120]]

 
71 to 75............................       88       92       85       89
76 to 80............................       86       89       82       87
81 to 85............................       84       87       80       85
86 to 90............................       82       85       79       83
91 to 95............................       80       83       77       81
96 to 100...........................       78       81       75       79
------------------------------------------------------------------------
\1\ Distance walked is the total distance that the inspector will have
  to walk between work stations during one inspection cycle (e.g.,
  between viscera, carcass, head, and wash-basin).


       Table 2--Two Inspectors--Staffing Standards for Market Hogs
------------------------------------------------------------------------
                                      Maximum inspection rates (head per
                                         hour with heads attached or
                                                  detached)
                                    ------------------------------------
   Distance walked \1\ in feet by             Line configuration
          inspector B is--          ------------------------------------
                                                                Head,\2\
                                     Carcass,\2\  Viscera,\2\   viscera
                                         head         head      carcass
                                     viscera \3\  carcass \3\     \3\
------------------------------------------------------------------------
                             Without Mirror
------------------------------------------------------------------------
0 to 5.............................     151-253      151-271     151-296
6 to 10............................     151-239      151-255     151-277
11 to 15...........................     151-226      151-240     151-260
16 to 20...........................     151-214      151-227     151-244
21 to 25...........................     151-204      151-215     151-231
------------------------------------
                               With Mirror
------------------------------------------------------------------------
0 to 5.............................     151-253      151-303     151-318
6 to 10............................     151-239      151-283     151-304
11 to 15...........................     151-226      151-265     151-289
16 to 20...........................     151-214      151-249     151-270
21 to 25...........................     151-204      151-235     151-254
------------------------------------------------------------------------
\1\ Distance walked is the total distance that Inspector B will have to
  walk between work stations during one inspection cycle (e.g., between
  viscera, carcass, and washbasin).
\2\ Inspector A.
\3\ Inspector B.

    Note: In multiple-inspector plants, the inspectors must rotate 
between all inspection positions during each shift to equalize the 
workload.

                         Table 3--Two Inspectors--Staffing Standards for Sows and Boars
----------------------------------------------------------------------------------------------------------------
                                                                   Maximum inspection rates (head per hour)
                                                             ---------------------------------------------------
                                                                              Line Configuration
                                                             ---------------------------------------------------
       Distance walked \1\ in feet by inspector B is--        Carcass,\2\  Viscera,\2\    Head,\2\     Head,\2\
                                                                  head         head       viscera      viscera
                                                              viscera,\3\  carcass,\3\  carcass,\3\  carcass,\3\
                                                                 heads        heads        heads        heads
                                                                detached     detached     detached     attached
----------------------------------------------------------------------------------------------------------------
                                                 Without Mirror
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
0 to 5..........................................................................................................
6 to 10.........................................................................................................
11 to 15........................................................................................................
16 to 20........................................................................................................
21 to 25........................................................................................................
 
                                                   With Mirror
----------------------------------------------------------------------------------------------------------------
0 to 5......................................................     144-248      144-292      144-305      144-292
6 to 10.....................................................     144-235      144-273      144-291      144-280
11 to 15....................................................     144-222      144-256      144-272      144-268
16 to 20....................................................     144-211      144-241      144-255      144-255
21 to 25....................................................     144-201      144-228      144-240      144-240
----------------------------------------------------------------------------------------------------------------
\1\ Distance walked is the total distance that Inspector B will have to walk between work stations during one
  inspection cycle (e.g., between viscera, carcass, and washbasin).
\2\ Inspector A.
\3\ Inspector B.

    Note: In multiple-inspector plants, the inspectors must rotate 
between all inspection positions during each shift to equalize the 
workload.

     Table 4--Three Inspectors or More--Staffing Standards for Swine
------------------------------------------------------------------------
                                        Number of inspectors by station
 Maximum inspection rates (head per  -----------------------------------
      hour with heads attached)         Head   Viscera  Carcass   Total
------------------------------------------------------------------------
Market hogs:
  319 to 506........................        1        1        1        3
  507 to 540........................        1        2        1        4
  541 to 859........................        2        2        1        5
  860 to 1,022......................        2        3        1        6
  1,023 to 1,106....................        3        3        1        7
Sows and boars:
  306 to 439........................        1        1        1        3
  306 to 462 \1\....................        1        1        1        3
  440 to 475........................        2        1        1        4
  476 to 752........................        2        2        1        5
  753 to 895........................        3        2        1        6
  896 to 964........................        3        3        1        7
------------------------------------------------------------------------
\1\ This rate applies if the heads of sows and boars are detached from
  the carcasses at the time of inspection.

    Note: In multiple-inspector plants, the inspectors must rotate 
between all inspection positions during each shift to equalize the 
workload.

[35 FR 15567, Oct. 3, 1970, as amended at 47 FR 33676, Aug. 4, 1982; 50 
FR 19903, May 13, 1985]

[[Page 121]]



Sec. 310.2  Identification of carcass with certain severed parts thereof 
and with animal from which derived.

    (a) The head, tail, tongue, thymus gland, and all viscera of each 
slaughtered animal, and all blood and other parts of such animal to be 
used in the preparation of meat food products or medical products, shall 
be handled in such a manner as to identify them with the rest of the 
carcass and as being derived from the particular animal involved, until 
the post-mortem examination of the carcass and parts thereof has been 
completed. Such handling shall include the retention of ear tags, 
backtags, implants, and other identifying devices affixed to the animal, 
in such a way to relate them to the carcass until the post-mortem 
examination has been completed.
    (b) The official State-Federal Department backtag on any carcass 
shall:
    (1)(i) Be removed from the hide of the animal by an establishment 
employee and placed in a clear plastic bag. The bag containing the tag 
shall be affixed to the corresponding carcass.
    (ii) The bag containing the tag shall be removed from the carcass by 
an establishment employee and presented with the viscera to the Program 
inspector at the point where such inspector conducts the viscera 
inspection.
    (2)(i) Brucellosis and tuberculosis ear tags, herd identification 
ear tags, sales tags, ear bangles, and similar identification devices 
shall be removed from the animal's hide or ear by an establishment 
employee and shall be placed in a clear plastic bag and affixed to the 
corresponding carcass.
    (ii) The bag containing the tag shall be removed from the carcass by 
an establishment employee and presented with the viscera to the Program 
inspector at the point where such inspector conducts the viscera 
inspection.
    (3) In cases where both types of devices described in paragraphs 
(b)(1) and (2) of this section are present on the same animal, both 
types may be placed in the same plastic bag or in two separate bags.
    (4) The circuit supervisor may allow the use of any alternate method 
proposed by the operator of an official establishment for handling the 
type of devices described in paragraph (b)(2) of this section if such 
alternate method would provide a ready means of identifying a specific 
carcass with the corresponding devices by a Program inspector during the 
post-mortem inspection.
    (5) Disposition and use of identifying devices.
    (i) The official State-Federal Department backtags will be collected 
by a Program inspector and used to obtain traceback information 
necessary for proper disposition of the animal or carcass and otherwise 
handled according to instructions issued to the inspectors.
    (ii) The devices described in paragraph (b)(2) of this section shall 
be collected by the Program inspector when required to obtain traceback 
information necessary for proper disposition of the animal or carcass 
and for controlling the slaughter of reactor animals. Devices not 
collected for these purposes shall be discarded after the post-mortem 
examination is complete.
    (6) Plastic bags used by the establishment for collecting 
identifying devices will be furnished by the Department.

[35 FR 15567, Oct. 3, 1970; 36 FR 12004, June 24, 1971]



Sec. 310.3  Carcasses and parts in certain instances to be retained.

    Each carcass, including all detached organs and other parts, in 
which any lesion or other condition is found that might render the meat 
or any part unfit for food purposes, or otherwise adulterated, and which 
for that reason would require a subsequent inspection, shall be retained 
by the Program employee at the time of inspection. The identity of every 
such retained carcass, detached organ, or other part shall be maintained 
until the final inspection has been completed. Retained carcasses shall 
not be washed or trimmed unless authorized by the Program employee.



Sec. 310.4  Identification of carcasses and parts; tagging.

    Such devices and methods as may be approved by the Administrator may 
be used for the temporary identification of retained carcasses, organs, 
and other parts. In all cases, the identification shall be further 
established by affixing

[[Page 122]]

``U.S. Retained'' tags as soon as practicable and before final 
inspection. These tags shall not be removed except by a Program 
employee.



Sec. 310.5  Condemned carcasses and parts to be so marked; tanking; 
separation.

    Each carcass or part which is found on final inspection to be 
unsound, unhealthful, unwholesome, or otherwise adulterated shall be 
conspicuously marked, on the surface tissues thereof, by a Program 
employee at the time of inspection, as ``U.S. Inspected and Condemned.'' 
Condemned detached organs and other parts of such character that they 
cannot be so marked shall be placed immediately in trucks or receptacles 
which shall be kept plainly marked ``U.S. Condemned,'' in letters not 
less than 2 inches high. All condemned carcasses and parts shall remain 
in the custody of a Program employee and shall be disposed of as 
required in the regulations in part 314 of this subchapter at or before 
the close of the day on which they are condemned.



Sec. 310.6  Carcasses and parts passed for cooking; marking.

    Carcasses and parts passed for cooking shall be marked conspicuously 
on the surface tissues thereof by a Program employee at the time of 
inspection, ``U.S. Passed for Cooking.'' All such carcasses and parts 
shall be cooked in accordance with part 315 of this subchapter, and 
until so cooked shall remain in the custody of a Program employee.



Sec. 310.7  Removal of spermatic cords, pizzles and preputial diverticuli.

    Spermatic cords and pizzles shall be removed from all carcasses. 
Preputial diverticuli shall be removed from hog carcasses.



Sec. 310.8  Passing and marking of carcasses and parts.

    Carcasses and parts found to be sound, healthful, wholesome, and 
otherwise not adulterated shall be passed and marked as provided in part 
316 of this subchapter. In all cases where carcasses showing localized 
lesions are passed for food or for cooking and ``U.S. Retained'' tags 
are attached to the carcasses, the affected tissues shall be removed and 
condemned before the tags are removed. ``U.S. Retained'' tags shall be 
removed only by a Program employee.



Sec. 310.9  Anthrax; carcasses not to be eviscerated; disposition of 
affected carcasses; hides, hoofs, horns, hair, viscera and contents, 
and fat; handling of blood and scalding vat water; general cleanup and disinfection.

    (a) Carcasses found before evisceration to be affected with anthrax 
shall not be eviscerated but shall be retained, condemned, and 
immediately tanked or otherwise disposed of as provided in part 314 of 
this subchapter.
    (b) All carcasses and all parts, including hides, hoofs, horns, 
hair, viscera and contents, blood, and fat of any livestock found to be 
affected with anthrax shall be condemned and immediately disposed of as 
provided in part 314 of this subchapter, except that the blood may be 
handled through the usual blood cooking and drying equipment.
    (c) Any part of any carcass that is contaminated with anthrax-
infected material through contact with soiled instruments or otherwise 
shall be immediately condemned and disposed of as provided in part 314 
of this subchapter.
    (d) The scalding vat water through which hog carcasses affected with 
anthrax have passed shall be immediately drained into the sewer and all 
parts of the scalding vat shall be cleaned and disinfected as provided 
in paragraph (e) of this section.
    (e)(1) That portion of the slaughtering department, including the 
bleeding area, scalding vat, gambrelling bench, floors, walls, posts, 
platforms, saws, cleavers, knives, and hooks, as well as employees' 
boots and aprons, contaminated through contact with anthrax-infected 
material, shall, except as provided in paragraph (e)(2) of this section 
be cleaned immediately and disinfected with one of the following

[[Page 123]]

disinfectants or other disinfectant \1\ approved specifically for this 
purpose by the Administrator:
---------------------------------------------------------------------------

    \1\ A list of disinfectants approved for this purpose is available 
upon request to the Scientific Services, Meat and Poultry Inspection, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250.
---------------------------------------------------------------------------

    (i) A 5 percent solution of sodium hydroxide or commercial lye 
containing at least 94 percent of sodium hydroxide. The solution shall 
be freshly prepared immediately before use by dissolving 2\1/2\ pounds 
of sodium hydroxide or lye in 5\1/2\ gallons of hot water and shall be 
applied as near scalding hot as possible to be most effective. (Owing to 
the extremely caustic nature of sodium hydroxide solution, precautionary 
measures such as the wearing of rubber gloves and boots to protect the 
hands and feet, and goggles to protect the eyes, should be taken by 
those engaged in the disinfection process. It is also advisable to have 
an acid solution, such as vinegar, in readiness in case any of the 
sodium hydroxide solution should come in contact with any part of the 
body.)
    (ii) A solution of sodium hypochlorite containing approximately one-
half of 1 percent (5,000 parts per million) of available chlorine. The 
solution shall be freshly prepared.
    (iii) When a disinfectant solution has been applied to equipment 
which will afterwards contact product, the equipment shall be rinsed 
with clean water before such contact.
    (2) In case anthrax infection is found in the hog slaughtering 
department, an immediate preliminary disinfection shall be made from the 
head-dropper's station to the point where the disease is detected and 
the affected carcasses shall be cut down from the rail and removed from 
the room. Upon completion of the slaughtering of the lot of hogs of 
which the anthrax-infected animals were a part, slaughtering operations 
shall cease, and a thorough cleanup and disinfection shall be made, as 
provided in paragraph (e)(1) of this section. If the slaughter of the 
lot has not been completed by the close of the day on which anthrax was 
detected, the cleanup and disinfection shall not be deferred beyond the 
close of that day.
    (3) The first and indispensable precautionary step for persons who 
have handled anthrax material is thorough cleansing of the hands and 
arms with liquid soap and running hot water. It is important that this 
step be taken immediately after exposure, before vegetative anthrax 
organisms have had time to form spores. In the cleansing, a brush or 
other appropriate appliance shall be used to insure the removal of all 
contaminating material from under and about the fingernails. This 
process of cleansing is most effective when performed in repeated cycles 
of lathering and rinsing rather than in spending the same amount of time 
in scrubbing with a single lathering. After the hands have been cleansed 
thoroughly and rinsed free of soap, they may, if desired, be immersed 
for about 1 minute in a 1:1,000 solution of bichloride of mercury, 
followed by thorough rinsing in clean running water. Supplies of 
bichloride of mercury for the purpose must be held in the custody of the 
veterinary medical officer. (As a precautionary measure, all persons 
exposed to anthrax infection should report promptly any suspicious 
condition (sore or carbuncle) or symptom to a physician, in order that 
anti-anthrax serum or other treatment may be administered as indicated.)

[35 FR 15567, Oct. 3, 1970; 36 FR 11903, June 23, 1971]



Sec. 310.10  Carcasses with skin or hide on; cleaning before evisceration; 
removal of larvae of Hypodermae, external parasites and other pathological 
skin conditions.

    When a carcass is to be dressed with the skin or hide left on, the 
skin or hide shall be thoroughly washed and cleaned before any incision 
is made for the purpose of removing any part thereof or evisceration, 
except that where calves are slaughtered by the kosher method, the heads 
shall be removed from the carcasses, before washing of the carcasses. 
The skin shall be removed at the time of post-mortem inspection from any 
calf carcass infested with the larvae of the ``oxwarble'' fly (Hypoderma 
lineata and Hypoderma bovis), or external parasites, or affected with 
other pathological skin conditions.

[[Page 124]]



Sec. 310.11  Cleaning of hog carcasses before incising.

    All hair, scurf, dirt, hoofs and claws shall be removed from hog 
carcasses, and the carcasses shall be thoroughly washed and cleaned 
before any incision is made for inspection or evisceration.



Sec. 310.12  Sternum to be split; abdominal and thoracic viscera to be 
removed.

    The sternum of each carcass shall be split and the abdominal and 
thoracic viscera shall be removed at the time of slaughter in order to 
allow proper inspection.



Sec. 310.13  Inflating carcasses or parts thereof; transferring caul or 
other fat.

    (a)(1) Establishments shall not inflate carcasses or parts of 
carcasses with air, except as set forth in paragraph (a)(2) of this 
section.
    (2)(i) Any establishment slaughtering livestock that wishes to 
inflate carcasses or parts thereof with air, using procedures other than 
the approved methods listed below, shall submit a request for approval 
for experimental testing to the Administrator. Such a request shall 
include the purpose of the use of air, a detailed description of the 
procedure for injecting the air and evidence that the procedure can be 
performed in a sanitary manner.
    (ii) The Administrator shall evaluate newly submitted procedures for 
the use of air. If the Administrator determines that any such procedure 
will likely result in wholesome, unadulterated meat product, then the 
Administrator shall approve experimental testing of the new procedure. 
In any situation where the Administrator finds a submitted procedure to 
be unlikely to result in wholesome, unadulterated meat product, the 
Administrator shall send written notification to the establishment of 
the denial of such approval. The establishment may re-submit for 
evaluation a testing procedure that has been denied, provided that 
modifications have been made to address the original reason for denial. 
The establishment also shall be afforded an opportunity to submit a 
written statement in response to the notification of denial. In those 
instances where there is a conflict of facts, a hearing, under 
applicable rules of practice, will be held to resolve the conflict.
    (iii) Final approval of an acceptable new proposed method shall be 
effectuated by modifying, through rulemaking procedures, the Federal 
regulations to include the new method.
    (iv) Uses for which approval is granted are:
    (A) Compressed air injection of cattle feet to facilitate removal of 
hair from feet intended for human consumption;
    (B) Compressed air injection under the skin of cattle heads to 
facilitate head skinning;
    (C) Compressed air injection into the skull of all livestock except 
cattle in conjunction with a captive bolt stunner to hold the animal 
still for dressing operations; or
    (D) Compressed air injected into the abdominal cavity of swine to 
facilitate the skinning operation and to minimize the loss of body fat.

The method of compressed air injection shall be a sanitary procedure 
that includes air filtration and injection needle disinfection. Air 
filtration shall consist of not less than two stages. An initial stage 
of filtration shall occur at or near the use point and shall consist of 
an aerosol or coalescing filter, capable of filtration to not more than 
0.75 micron, for the removal of oil and water. A subsequent stage of 
filtration shall occur at or near the point of needle hose attachment to 
the air line and shall be a particulate filter, capable of filtration to 
not more than 0.3 micron. The filters shall be maintained by inspecting 
regularly to assure they are working properly, and cleaned or replaced 
when necessary. The injection needle shall be disinfected by placement 
in water that is not less than 180 [deg]F. for at least 10 seconds 
immediately prior to each injection.
    (b) Transferring the caul or other fat from a fat to a lean carcass 
is prohibited.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[54 FR 36756, Sept. 5, 1989, as amended at 55 FR 29565, July 20, 1990; 
69 FR 1891, Jan. 12, 2004]

[[Page 125]]



Sec. 310.14  Handling of bruised parts.

    When only a portion of a carcass is to be condemned on account of 
slight bruises, either the bruised portion shall be removed immediately 
and disposed of in accordance with part 314 of this subchapter, or the 
carcass shall be promptly placed in a retaining room and kept until 
chilled and the bruised portion shall then be removed and disposed of as 
provided in part 314 of this subchapter.



Sec. 310.15  Disposition of thyroid glands and laryngeal muscle tissue.

    (a) Livestock thyroid glands and laryngeal muscle tissue shall not 
be used for human food.
    (b) Livestock thyroid glands and laryngeal muscle tissue may be 
distributed to pharmaceutical manufacturers for pharmaceutical use in 
accordance with Sec. 314.9 or Sec. 325.19(c) of this subchapter, if 
they are labeled in accordance with Sec. 316.13(f) of this subchapter. 
Otherwise, they shall be disposed of at the official establishment in 
accordance with Sec. 314.1 or Sec. 314.3 of this subchapter.

[53 FR 45890, Nov. 15, 1988]



Sec. 310.16  Disposition of lungs.

    (a) Livestock lungs shall not be saved for use as human food.
    (b) Lungs found to be affected with disease or pathology and lungs 
found to be adulterated with chemical or biological residue shall be 
condemned and identified as ``U.S. Inspected and Condemned.'' Condemned 
lungs may not be saved for pet food or other nonhuman food purposes. 
They shall be maintained under inspectional control and disposed of in 
accordance with Sec. Sec. 314.1 and 314.3 of this subchapter.
    (c) Lungs not condemned under paragraph (b) of this section may be 
used in the preparation of pet food or for other nonhuman food purposes 
at the official establishment, provided they are handled in the manner 
prescribed in Sec. 318.12 of this subchapter, or they may be 
distributed from the establishment in commerce, or otherwise, in 
accordance with the conditions prescribed in Sec. 325.8 of this 
subchapter for nonhuman food purposes or they may be so distributed to 
pharmaceutical manufacturers for pharmaceutical use in accordance with 
Sec. Sec. 314.9 and 325.19(b) of this subchapter, if they are labeled 
as ``Inedible [SPECIES] Lungs--for Pharmaceutical Use Only.'' Otherwise, 
they shall be disposed of at the official establishment, in accordance 
with Sec. Sec. 314.1 and 314.3 of this subchapter.

[36 FR 11639, June 17, 1971]



Sec. 310.17  Inspection of mammary glands.

    (a) Lactating mammary glands and diseased mammary glands of cattle, 
sheep, swine, and goats shall be removed without opening the milk ducts 
or sinuses. If pus or other objectionable material is permitted to come 
in contact with the carcass, the parts of the carcass thus contaminated 
shall be removed and condemned.
    (b) Nonlactating cow udders may be saved for food purposes provided 
suitable facilities for handling and inspecting them are provided. 
Examination of udders by palpation shall be done by a Program employee. 
When necessary, in the judgment of the Program employee for adequate 
inspection, the official establishment employees shall incise udders in 
sections no greater than 2 inches in thickness. All udders showing 
disease lesions shall be condemned by a Program employee. Each udder 
shall be properly identified with its respective carcass and kept 
separate and apart from other udders until its disposal has been 
accomplished in accordance with the provisions of part 311 of this 
subchapter.
    (c) Lactating mammary glands of cattle, sheep, swine, and goats 
shall not be saved for edible purposes.
    (d) The udders from cows officially designated as ``Brucellosis 
reactors'' or as ``Mastitis elimination cows'' shall be condemned.



Sec. 310.18  Contamination of carcasses, organs, or other parts.

    (a) Carcasses, organs, and other parts shall be handled in a 
sanitary manner to prevent contamination with fecal material, urine, 
bile, hair, dirt, or foreign matter; however, if contamination occurs, 
it shall be promptly removed in a manner satisfactory to the inspector.
    (b) Brains, cheek meat, and head trimmings from animals stunned by

[[Page 126]]

lead, sponge iron, or frangible bullets shall not be saved for use as 
human food but shall be handled as described in Sec. 314.1 or Sec. 
314.3 of this subchapter.



Sec. 310.19  Inspection of kidneys.

    An employee of the establishment shall open the kidney capsule and 
expose the kidneys of all livestock at the time of slaughter for the 
purpose of examination by a Program employee.



Sec. 310.20  Saving of blood from livestock as an edible product.

    Blood may be saved for edible purposes at official establishments 
provided it is derived from livestock, the carcasses of which are 
inspected and passed, and the blood is collected, defibrinated, and 
handled in a manner so as not to render it adulterated under the Federal 
Meat Inspection Act and regulations issued pursuant thereto. The 
defibrination of blood intended for human food purposes shall not be 
done with the hands. Anticoagulants may be used in accordance with 21 
CFR Chapter I, Subchapter A and Subchapter B, or by regulation in 9 CFR 
Chapter III, Subchapter A or Subchapter E.

[64 FR 72174, Dec. 23, 1999]



Sec. 310.21  Carcasses suspected of containing sulfa and antibiotic 
residues; sampling frequency; disposition of affected carcasses and parts.

    (a) Calf carcasses from animals suspected of containing biological 
residues under Sec. 309.16(d) of this subchapter shall, on post-mortem 
inspection, be handled in accordance with the provisions of this 
section.
    (b) For purposes of this section, the following definitions shall 
apply:
    (1) Calf. A calf up to 3 weeks of age or up to 150 pounds.
    (2) Certified calf. A calf that the producer and all other 
subsequent custodians of the calf certify in writing has not been 
treated with any animal drug while in his or her custody or has been 
treated with one or more drugs in accordance with FDA approved label 
directions while in his or her custody and has been withheld from 
slaughter for the period(s) of time specified by those label directions.
    (3) Healthy carcass. A carcass that an inspector determines shows no 
lesions of disease or signs of disease treatment at post-mortem 
inspection
    (4) Producer. The owner of the calf at the time of its birth.
    (5) Sick calf carcass. A calf carcass that an inspector on post-
mortem inspection determines has either signs of disease treatment or 
lesions of disease or was from an animal identified as sick on ante-
mortem.
    (6) Sign of treatment. Sign of treatment of a disease is indicated 
by leakage around jugular veins, subcutaneous, intramuscular or 
intraperitoneal injection lesions, or discoloration from particles or 
oral treatment in any part of the digestive tract.
    (7) Veterinary medical officer. An inspector of the Program that has 
obtained a Doctor of Veterinary Medicine degree which is recognized by 
the Program.
    (c) Selection of carcasses for testing. The inspector shall perform 
a swab bioassay test \1\ on:
---------------------------------------------------------------------------

    \1\ The procedures for performing the swab bioassay test are set 
forth in one of two self-instructional guides: ``Performing the CAST'' 
or ``Fast Antimicrobial Screen Test.'' These guides are available for 
review in the office of the FSIS Docket Clerk, Room 4352 South, Food 
Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250.
---------------------------------------------------------------------------

    (1) Any carcass from a calf tagged as ``U.S. Suspect'' at the time 
of ante-mortem inspection, except that calves whose carcasses are 
condemned for pathology shall not be tested for drug residues.
    (2) Any carcass which he/she finds has either lesions of disease 
which is not condemned because of these lesions or a sign of treatment 
of disease at the time of post-mortem inspection,
    (3) Any carcass of a calf from a producer whose calf or calves have 
previously been condemned for residues as prescribed in paragraph (e) of 
this section, and
    (4) Carcasses from healthy-appearing certified and noncertified 
calves, as determined by the veterinary medical officer during ante-
mortem inspection, will be selected for testing as set forth below:

[[Page 127]]



------------------------------------------------------------------------
                                                 Sampling Rate (percent
                                                   of estimated day's
                 Testing level                         slaughter)
                                               -------------------------
                                                 Certified  Noncertified
------------------------------------------------------------------------
A.............................................         100          100
B.............................................          50           50
C.............................................          20           30
(Start) D.....................................           5           10
E.............................................           2            5
F.............................................           1            2
------------------------------------------------------------------------

    (d) Testing of carcasses:
    (1) The inspector shall test all carcasses as prescribed in 
paragraph (c) of this section.
    (2) Upon initiation of this program at an establishment, the 
inspector shall begin the testing rate for carcasses from healthy-
appearing certified and noncertified calves at Level D as prescribed in 
paragraph (c)(4) of this section. The inspector shall increase the 
testing rate to the next higher level the following business day when 
three carcasses in 100 or less consecutively tested show a positive test 
result for a drug residue. The inspector shall decrease it to the next 
lower level when no more than two calves show a positive test result for 
a drug residue in either 500 calves consecutively tested or all calves 
tested over a 60 working day period.
    (3) Test results shall be determined by the veterinary medical 
officer.
    (4) The establishment may designate one or more of its employees to 
aid the inspector in performing the swab bioassay test under the 
supervision of the veterinary medical officer who shall interpret the 
results, maintain animal identification with the test unit, and ensure 
integrity of the testing program.
    (5) All carcasses and parts thereof from calves selected for testing 
shall be retained until all test results are complete.
    (6) The veterinary medical officer shall condemn all carcasses and 
parts thereof for which there are positive test results and release for 
human consumption all carcasses and parts thereof for which there are 
negative test results.
    (7) If there is a positive test result, subsequent calves from the 
producer of the calf shall be tested in accordance with paragraph (e) of 
this section. These test results will not be included in computations to 
determine an establishment's compliance record.
    (8) The veterinary medical officer may reduce inspection line rates 
when, in his/her judgment, the prescribed testing cannot be adequately 
performed within the time available because the establishment's 
compliance history dictates a need for extensive testing.
    (e) Calves from producers with a previous residue condemnation. The 
inspector shall perform a swab bioassay test on all carcasses of all 
calves in the group. The veterinary medical officer shall determine the 
test results and shall condemn any carcass and parts thereof for which 
there is a positive test result and pass for human consumption any such 
carcass and parts thereof for which there is a negative test result. All 
subsequent calves from the same producer which has previously sold or 
delivered to official establishments any carcass that was condemned 
because of drug residues must be tested according to this paragraph 
until five consecutive animals test completely free of animal drug 
residues.
    (f) If the owner or operator of an official establishment disagrees 
with the veterinary medical officer's disposition of carcasses and parts 
thereof, the owner or operator may appeal as provided in section 306.5 
of this chapter.

[50 FR 32164, Aug. 9, 1985, as amended at 52 FR 2104, Jan. 20, 1987; 55 
FR 7475, Mar. 2, 1990; 60 FR 66483, Dec. 22, 1995]



Sec. 310.22  Specified risk materials from cattle and their handling 
and disposition.

    (a) The following materials from cattle are specified risk 
materials:
    (1) The brain, skull, eyes, trigeminal ganglia, spinal cord, 
vertebral column (excluding the vertebrae of the tail, the transverse 
processes of the thoracic and lumbar vertebrae, and the wings of the 
sacrum), and dorsal root ganglia of cattle 30 months of age and older;
    (2) The tonsils of all cattle; and
    (3) The distal ileum of all cattle. The small intestine may be used 
for human food if:
    (i) It is derived from cattle that were inspected and passed in an 
official establishment in the United States or in

[[Page 128]]

a certified foreign establishment in a country listed in 9 CFR 327.2(b) 
as eligible to export meat and meat products to the United States and it 
is otherwise eligible for importation under 9 CFR 327.1(b), and
    (ii) The distal ileum is removed by a procedure that removes at 
least 80 inches of the uncoiled and trimmed small intestine as measured 
from the ceco-colic junction and progressing proximally towards the 
jejunum or by a procedure that the establishment demonstrates is 
effective in ensuring complete removal of the distal ileum.
    (b) Specified risk materials are inedible and shall not be used for 
human food.
    (c) Specified risk materials shall be disposed of in accordance with 
Sec. Sec. 314.1 or 314.3 of this subchapter.
    (d) Procedures for the removal, segregation, and disposition of 
specified risk materials.
    (1) Establishments that slaughter cattle and establishments that 
process the carcasses or parts of cattle shall develop, implement, and 
maintain written procedures for the removal, segregation, and 
disposition of specified risk materials. The establishment shall 
incorporate such procedures into its HACCP plan or in its Sanitation SOP 
or other prerequisite program.
    (2) Establishments that slaughter cattle and establishments that 
process the carcasses or parts of cattle must take appropriate 
corrective action when either the establishment or FSIS determines that 
the establishment's procedures for the removal, segregation, and 
disposition of specified risk materials, or the implementation or 
maintenance of such procedures, have failed to ensure that such 
materials are adequately and effectively removed from the carcass of 
cattle, segregated from edible materials, and disposed of in accordance 
with paragraph (c) of this section.
    (3) Establishments that slaughter cattle and establishments that 
process the carcasses or parts of cattle shall routinely evaluate the 
effectiveness of their procedures for the removal, segregation, and 
disposition of specified risk materials in preventing the use of these 
materials for human food and shall revise the procedures as necessary 
whenever any changes occur that could affect the removal, segregation, 
and disposition of specified risk materials.
    (4) Recordkeeping requirements. (i) Establishments that slaughter 
cattle and establishments that process the carcasses or parts of cattle 
shall maintain daily records sufficient to document the implementation 
and monitoring of the procedures for the removal, segregation, and 
disposition of the materials listed in paragraph (a) of this section, 
and any corrective actions taken.
    (ii) Records required by this section may be maintained on computers 
provided that the establishment implements appropriate controls to 
ensure the integrity of the electronic data.
    (iii) Records required by this section shall be retained for at 
least one year and shall be accessible to FSIS. All such records shall 
be maintained at the official establishment 48 hours following 
completion, after which they may be maintained off-site provided such 
records can be made available to FSIS within 24 hours of request.
    (e) The materials listed in paragraph (a)(1) of this section will be 
deemed to be from cattle 30 months of age and older unless the 
establishment can demonstrate that the materials are from an animal that 
was younger than 30 months of age at the time of slaughter.

[69 FR 1873, Jan. 12, 2004, as amended at 70 FR 53050, Sept. 7, 2005]



Sec. 310.23  Identification of carcasses and parts of swine.

    (a) The identification of the carcasses and parts of swine 
identified in accordance with part 71 of this title shall be made 
available to the inspector upon the inspector's request throughout post-
mortem inspection.
    (b) If the establishment fails to provide required swine 
identification, the inspector shall order the retention of swine 
caracasses at the establishment until the completion of tests to confirm 
that the carcasses are not adulterated.

[53 FR 40387, Oct. 14, 1988]

[[Page 129]]



Sec. 310.24  [Reserved]



Sec. 310.25  Contamination with microorganisms; process control 
verification criteria and testing; pathogen reduction standards.

    (a) Criteria for verifying process control; E. coli testing. (1) 
Each official establishment that slaughters livestock must test for 
Escherichia coli Biotype 1 (E.coli) Establishments that slaughter more 
than one type of livestock or both livestock and poultry, shall test the 
type of livestock or poultry slaughtered in the greatest number. The 
establishment shall:
    (i) Collect samples in accordance with the sampling techniques, 
methodology, and frequency requirements in paragraph (a)(2) of this 
section;
    (ii) Obtain analytic results in accordance with paragraph (a)(3) of 
this section; and
    (iii) Maintain records of such analytic results in accordance with 
paragraph (a)(4) of this section.
    (2) Sampling requirements.
    (i) Written procedures. Each establishment shall prepare written 
specimen collection procedures which shall identify employees designated 
to collect samples, and shall address location(s) of sampling, how 
sampling randomness is achieved, and handling of the sample to ensure 
sample integrity. The written procedure shall be made available to FSIS 
upon request.
    (ii) Sample collection. The establishment must collect samples from 
all chilled livestock carcasses, except those boned before chilling 
(hot-boned), which must be sampled after the final wash. Samples must be 
collected in the following manner;
    (A) For cattle, establishments must sponge or excise tissue from the 
flank, brisket and rump, except for hide-on calves, in which case 
establishments must take samples by sponging from inside the flank, 
inside the brisket, and inside the rump.
    (B) For sheep, goat, horse, mule, or other equine carcasses, 
establishments must sponge from the flank, brisket and rump, except for 
hide-on carcasses, in which case establishments must take samples by 
sponging from inside the flank, inside the brisket, and inside the rump.
    (C) For swine carcasses, establishments must sponge or excise tissue 
from the ham, belly and jowl areas.
    (iii) Sampling frequency. Slaughter establishments, except very low 
volume establishments as defined in paragraph (a)(2)(v) of this section, 
must take samples at a frequency proportional to the volume of 
production at the following rates:
    (A) Cattle, sheep, goas, horses, mules, and other equines: 1 test 
per 300 carcasses, but, a minimum of one sample during each week of 
operation.
    Swine: 1 test per 1,000 carcasses, but a minimum of one sample 
during each week of operation.
    (iv) Sampling frequency alternatives. An establishment operating 
under a validated HACCP plan in accordance with Sec. 417.2(b) of this 
chapter may substitute an alternative frequency for the frequency of 
sampling required under paragraph (a)(2)(iii) of this section if,
    (A) The alternative is an integral part of the establishment's 
verification procedures for its HACCP plan and,
    (B) FSIS does not determine, and notify the establishment in 
writing, that the alternative frequency is inadequate to verify the 
effectiveness of the establishment's processing controls.
    (v) Sampling in very low volume establishments. (A) Very low volume 
establishments annually slaughter no more than 6,000 cattle, 6,000 
sheep, 6,000 goats, 6,000 horses, mules or other equines, 20,000 swine, 
or a combination of livestock not exceeding 6,000 cattle and 20,000 
total of all livestock. Very low volume establishments that collect 
samples by sponging shall collect at least one sample per week, starting 
the first full week of operation after June 1 of each year, and continue 
sampling at a minimum of once each week the establishment operates until 
June 1 of the following year or until 13 samples have been collected, 
whichever comes first. Very low volume establishments collecting samples 
by excising tissue from carcasses shall collect one sample per week, 
starting the first full week of operation after June 1 of each year, and 
continue sampling at a minimum of once each week the establishment 
operates until one series of 13 tests meets the criteria set forth in 
paragraph (a)(5)(i) of this section.

[[Page 130]]

    (B) Upon the establishment's meeting requirements of paragraph 
(a)(2)(v)(A) of this section, weekly sampling and testing is optional, 
unless changes are made in establishment facilities, equipment, 
personnel or procedures that may affect the adequacy of existing process 
control measures, as determined by the establishment or FSIS. FSIS 
determinations that changes have been made requiring resumption of 
weekly testing shall be provided to the establishment in writing.
    (3) Analysis of samples. Laboratories may use any quantitative 
method for analysis of E. coli that is approved as an AOAC Official 
Method of the AOAC International (formerly the Association of Official 
Analytical Chemists) \2\ or approved and published by a scientific body 
and based on the results of a collaborative trial conducted in 
accordance with an internationally recognized protocol on collaborative 
trials and compared against the three tube Most Probable Number (MPN) 
method and agreeing with the 95 percent upper and lower confidence limit 
of the appropriate MPN index.
---------------------------------------------------------------------------

    \2\ A copy of the current edition/revision of the ``Official Methods 
of AOAC International,'' 16th edition, 3rd revision, 1997, is on file 
with the Director, Office of the Federal Register, and may be purchased 
from the Association of Official Analytical Chemists International, 
Inc., 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------

    (4) Recording of test results. The establishment shall maintain 
accurate records of all test results, in terms of CFU/cm\2\ of surface 
area sponged or excised. Results shall be recorded onto a process 
control chart or table showing at least the most recent 13 test results, 
by type of livestock slaughtered. Records shall be retained at the 
establishment for a period of 12 months and shall be made available to 
FSIS upon request.
    (5) Criteria for evaluation of test results. (i) An establishment 
excising samples from carcasses is operating within the criteria when 
the most recent E. coli test result does not exceed the upper limit (M), 
and the number of samples, if any, testing positive at levels above (m) 
is three or fewer out of the most recent 13 samples (n) taken, as 
follows:

                                   Table 1--Evaluation of E. Coli Test Results
----------------------------------------------------------------------------------------------------------------
                                                                                                       Maximum
                                                                                         Number of      number
          Type of livestock           Lower limit of marginal  Upper limit of marginal     sample     permitted
                                               range                    range              tested    in marginal
                                                                                                        range
                                      (m)....................  (M)....................          (n)          (c)
-------------------------------------
Cattle..............................  Negative a.............  100 CFU/cm \2\.........           13            3
Swine...............................  10 CFU/cm \2\..........  10,000 CFU/cm \2\......           13            3
----------------------------------------------------------------------------------------------------------------
a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of
  at least 5 cfu/cm\2\ carcass surface area.

    (ii) Establishments sponging carcasses shall evaluate E. coli test 
results using statistical process control techniques.
    (6) Failure to meet criteria. Test results that do not meet the 
criteria described in paragraph (a)(5) of this section are an indication 
that the establishment may not be maintaining process controls 
sufficient to prevent fecal contamination. FSIS shall take further 
action as appropriate to ensure that all applicable provisions of the 
law are being met.
    (7) Failure to test and record. Inspection shall be suspended in 
accordance with rules of practice that will be adopted for such 
proceedings upon a finding by FSIS that one or more provisions of 
paragraphs (a) (1)-(4) of this section have not been complied with and 
written notice of same has been provided to the establishment.
    (b) Pathogen reduction performance standard; Salmonella--(1) Raw 
meat product performance standards for Salmonella. An establishment's 
raw meat products, when sampled and tested by FSIS for Salmonella, as 
set forth in this

[[Page 131]]

section, may not test positive for Salmonella at a rate exceeding the 
applicable national pathogen reduction performance standard, as provided 
in Table 2:

                Table 2--Salmonella Performance Standards
------------------------------------------------------------------------
                                                               Maximum
                                   Performance                number of
                                    Standard     Number of    positives
        Class of product            (percent      samples     to achieve
                                  positive for  tested  (n)    Standard
                                  Salmonella)a                   (c)
------------------------------------------------------------------------
Steers/heifers..................          1.0%           82            1
Cows/bulls......................          2.7%           58            2
Ground beef.....................          7.5%           53            5
Hogs............................          8.7%           55            6
Fresh pork sausages.............        b N.A.         N.A.         N.A.
------------------------------------------------------------------------
a Performance Standards are FSIS's calculation of the national
  prevalence of Salmonella on the indicated raw product based on data
  developed by FSIS in its nationwide microbiological data collection
  programs and surveys. Copies of Reports on FSIS's Nationwide
  Microbiological Data Collection Programs and Nationwide
  Microbiological Surveys used in determining the prevalence of
  Salmonella on raw products are available in the FSIS Docket Room.
b Not available; values for fresh pork sausage will be added upon
  completion data collection programs for those products.

    (2) Enforcement. FSIS will sample and test raw meat products in an 
individual establishment on an unannounced basis to determine prevalence 
of Salmonella in such products to determine compliance with the 
standard. The frequency and timing of such testing will be based on the 
establishment's previous test results and other information concerning 
the establishment's performance. In an establishment producing more than 
one class of product subject to the pathogen reduction standard, FSIS 
may sample any or all such classes of products.\3\
---------------------------------------------------------------------------

    \3\ A copy of FSIS's ``Sample Collection Guidelines and Procedure 
for Isolation and Identification of Salmonella from Meat and Poultry 
Products'' is available for inspection in the FSIS Docket Room.
---------------------------------------------------------------------------

    (3) Noncompliance and establishment response. When FSIS determines 
that an establishment has not met the performance standard:
    (i) The establishment shall take immediate action to meet the 
standard.
    (ii) If the establishment fails to meet the standard on the next 
series of compliance tests for that product, the establishment shall 
reassess its HACCP plan for that product and take appropriate corrective 
actions.
    (iii) Failure by the establishment to act in accordance with 
paragraph (b)(3)(ii) of this section, or failure to meet the standard on 
the third consecutive series of FSIS-conducted tests for that product, 
constitutes failure to maintain sanitary conditions and failure to 
maintain an adequate HACCP plan, in accordance with part 417 of this 
chapter, for that product, and will cause FSIS to suspend inspection 
services. Such suspension will remain in effect until the establishment 
submits to the FSIS Administrator or his/her designee satisfactory 
written assurances detailing the action taken to correct the HACCP 
system and, as appropriate, other measures taken by the establishment to 
reduce the prevalence of pathogens.

[61 FR 38864, July 25, 1996, as amended at 62 FR 26217, May 13, 1997; 63 
FR 1735, Jan. 12, 1998;64 FR 66553, Nov. 29, 1999]



PART 311_DISPOSAL OF DISEASED OR OTHERWISE ADULTERATED CARCASSES AND 
PARTS--Table of Contents




Sec.
311.1 Disposal of diseased or otherwise adulterated carcasses and parts; 
          general.
311.2 Tuberculosis.
311.3 Hog cholera.
311.5 Swine erysipelas.
311.6 Diamond-skin disease.
311.7 Arthritis.
311.8 Cattle carcasses affected with anasarca or generalized edema.
311.9 Actinomycosis and actinobacillosis.
311.10 Anaplasmosis, anthrax, babesiosis, bacillary hemoglobinuria in 
          cattle, blackleg, bluetongue, hemorrhagic septicemia, 
          icterohematuria in sheep, infectious bovine rhinotracheitis, 
          leptospirosis, malignant epizootic catarrh, strangles, purpura 
          hemorrhagica, azoturia, infectious equine

[[Page 132]]

          encephalomyelitis, toxic encephalomyelitis (forage poisoning), 
          infectious anemia (swamp fever), dourine, acute influenza, 
          generalized osteoporosis, glanders (farcy), acute inflammatory 
          lameness, extensive fistula, and unhealed vaccine lesions.
311.11 Neoplasms.
311.12 Epithelioma of the eye.
311.13 Pigmentary conditions; melanosis, xanthosis, ochronosis, etc.
311.14 Abrasions, bruises, abscesses, pus, etc.
311.15 Brucellosis.
311.16 Carcasses so infected that consumption of the meat may cause food 
          poisoning.
311.17 Necrobacillosis, pyemia, and septicemia.
311.18 Caseous lymphadenitis.
311.19 Icterus.
311.20 Sexual odor of swine.
311.21 Mange or scab.
311.22 Hogs affected with urticaria, tinea tonsurans, demodex 
          follicurlorum, or erythema.
311.23 Tapeworm cysts (cysticercus bovis) in cattle.
311.24 Hogs affected with tapeworm cysts.
311.25 Parasites not transmissible to man; tapeworm cysts in sheep; 
          hydatid cysts; flukes; gid bladder-worms.
311.26 Emaciation.
311.27 Injured animals slaughtered at unusual hours.
311.28 Carcasses of young calves, pigs, kids, lambs, and foals.
311.29 Unborn and stillborn animals.
311.30 Livestock suffocated and hogs scalded alive.
311.31 Livers affected with carotenosis; livers designated as 
          ``telangiectatic,'' ``sawdust,'' or ``spotted.''
311.32 Vesicular diseases.
311.33 Listeriosis.
311.34 Anemia.
311.35 Muscular inflammation, degeneration, or infiltration.
311.36 Coccidioidal granuloma.
311.37 Odors, foreign and urine.
311.38 Meat and meat byproducts from livestock which have been exposed 
          to radiation.
311.39 Biological residues.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 15569, Oct. 3, 1970, unless otherwise noted.



Sec. 311.1  Disposal of diseased or otherwise adulterated carcasses and 
parts; general.

    (a) The carcasses or parts of carcasses of all animals slaughtered 
at an official establishment and found at the time of slaughter or at 
any subsequent inspection to be affected with any of the diseases or 
conditions named in this part shall be disposed of according to the 
section pertaining to the disease or condition: Provided, That no 
product shall be passed for human food under any such section unless it 
is found to be otherwise not adulterated. Products passed for cooking or 
refrigeration under this part must be so handled at the official 
establishment where they are initially prepared unless they are moved to 
another official establishment for such handling or in the case of 
products passed for refrigeration are moved for such refrigeration to a 
freezing facility approved by the Administrator in specific cases: 
Provided, That when so moved the products are shipped in containers 
sealed in accordance with Sec. 318.10(c) of this subchapter or in a 
sealed means of conveyance as provided in Sec. 325.7 of this 
subchapter. Owning to the fact that it is impracticable to formulate 
rules covering every case and to designate at just what stage a disease 
process or a condition results in adulteration of a product, the 
decision as to the disposal of all carcasses, organs, or other parts not 
specifically covered in this part shall be left to the veterinary 
medical officer. The veterinary medical officer shall exercise his 
judgment regarding the disposition of all carcasses or parts of 
carcasses under this part in a manner which will insure that only 
wholesome, unadulterated product is passed for human food.
    (b) In cases of doubt as to a condition, a disease, or the cause of 
a condition, or to confirm a diagnosis, representative specimens of the 
affected tissues, properly prepared and packaged, shall be sent for 
examination to one of the laboratories of the Biological Control Section 
of the Program.



Sec. 311.2  Tuberculosis.

    The following principles shall apply to the disposition of carcasses 
of livestock based on the difference in the pathogenesis of tuberculosis 
in swine, cattle, sheep, goats, and equines.
    (a) Carcasses condemned. The entire carcass of swine, cattle, sheep, 
goats, and equines shall be condemned if any of the following conditions 
occur:

[[Page 133]]

    (1) When the lesions of tuberculosis are generalized (tuberculosis 
is considered to be generalized when the lesions are distributed in a 
manner made possible only by entry of the bacilli into the systemic 
circulation);
    (2) When on ante mortem inspection the animal is observed to have a 
fever found to be associated with an active tuberculosis lesion on post 
mortem inspection;
    (3) When there is an associated cachexia;
    (4) When a tuberculosis lesion is found in any muscle or 
intermuscular tissue, or bone, or joint, or abdominal organ (excluding 
the gastrointestinal tract) or in any lymph node as a result of draining 
a muscle, bone, joint, or abdominal organ (excluding the 
gastrointestinal tract);
    (5) When the lesions are extensive in tissues of either the thoracic 
or the abdominal cavity;
    (6) When the lesions are multiple, acute, and actively progressive; 
or
    (7) When the character or extent of the lesions otherwise is not 
indicative of a localized condition.
    (b) Organs or other parts condemned. An organ or other part of a 
swine, cattle, sheep, goat, or equine carcass affected by localized 
tuberculosis shall be condemned when it contains lesions of tuberculosis 
or when the corresponding lymph node contains lesions of tuberculosis.
    (c) Carcasses of cattle passed without restriction for human food. 
Carcasses of cattle may be passed without restriction for human food 
only when the carcass of an animal not identified as a reactor to a 
tuberculin test administered by an Animal and Plant Health Inspection 
Service, State, or accredited veterinarian \1\ is found free of 
tuberculosis lesions during postmortem inspection.
---------------------------------------------------------------------------

    \1\ Such testing is conducted in the tuberculosis eradication 
program of the Animal and Plant Health Inspection Service, U.S. 
Department of Agriculture.
---------------------------------------------------------------------------

    (d) Portions of carcasses and carcasses of cattle passed for 
cooking. (1) When a cattle carcass reveals a tuberculosis lesion or 
lesions not so severe or so numerous as the lesions described in 
paragraph (a) of this section, the unaffected portion of the carcass may 
be passed for cooking in accordance with part 315 of this chapter; if 
the character and extent of the lesions indicate a localized condition, 
and if the lesions are calcified or encapsulated, and provided the 
affected organ or other part is condemned.
    (2) When the carcass of a cattle identified as a reactor to a 
tuberculin test administered by an Animal and Plant Health Inspection 
Service, State or accredited veterinarian is found free of lesions of 
tuberculosis, the carcass may be passed for cooking in accordance with 
part 315 of this chapter.
    (e) Portions of carcasses and carcasses of swine passed without 
restriction for human food. Swine carcasses found free of tuberculosis 
lesions during post mortem inspection may be passed for human food 
without restriction. When tuberculosis lesions in any swine carcass are 
localized and confined to one primary seat of infection, such as the 
cervical lymph nodes, the mesenteric lymph nodes, or the mediastinal 
lymph nodes, the unaffected portion of the carcass may be passed for 
human food without restriction after the affected organ or other part is 
condemned.
    (f) Portions of carcasses of swine passed for cooking. When the 
carcass of any swine reveals lesions more severe or more numerous than 
those described in paragraph (e) of this section, but not so severe or 
so numerous as the lesions described in paragraph (a) of this section, 
the unaffected portions of such carcass may be passed for cooking in 
accordance with part 315 of this chapter; if the character and extent of 
the lesions indicate a localized condition, and if the lesions are 
calcified or encapsulated, and provided the affected organ or other part 
is condemned.
    (g) Carcasses of sheep, goats, and equines passed without 
restriction for human food. Carcasses of sheep, goats, and equines may 
be passed without restriction for human food only if found free of 
tuberculosis lesions during post mortem inspection.
    (h) Portions of carcasses of sheep, goats, and equines passed for 
cooking. If a carcass of any sheep, goat, or equine reveals a 
tuberculosis lesion or lesions that are not so severe or so numerous as 
the lesions described in paragraph (a) of this section, the unaffected 
portion of the carcass may be passed for

[[Page 134]]

cooking in accordance with part 315 of this chapter; if the character 
and extent of the lesions indicate a localized condition, and if the 
lesions are calcified or encapsulated, and provided the affected organ 
or other part is condemned.

[37 FR 2661, Feb. 4, 1972; 38 FR 29214, Oct. 23, 1973]



Sec. 311.3  Hog cholera.

    (a) The carcasses of all hogs affected with hog cholera shall be 
condemned.
    (b) Inconclusive but suspicious symptoms of hog cholera observed 
during the ante-mortem inspection of a U.S. suspect shall be duly 
considered in connection with post-mortem findings and when the carcass 
of such a suspect shows lesions in the kidneys and the lymph nodes which 
resemble lesions of hog cholera, they shall be regarded as those of hog 
cholera and the carcass shall be condemned.
    (c) When lesions resembling those of hog cholera occur in kidneys 
and lymph nodes of carcasses of hogs which appeared normal on ante-
mortem inspection, further inspection of such carcasses shall be made 
for corroborative lesions. If on such further inspection, characteristic 
lesions of hog cholera are found in some organ or tissue in addition to 
those in the kidneys or in the lymph nodes or in both, then all lesions 
shall be regarded as those of hog cholera and the carcass shall be 
condemned. Immediate notification shall be given by the inspector to the 
official in the Veterinary Services unit of the Animal and Plant Health 
Inspection Service who has responsibility for control of swine diseases 
in the State where the swine are located.

[35 FR 15569, Oct. 3, 1970, as amended at 40 FR 27225, June 27, 1975]



Sec. 311.5  Swine erysipelas.

    Carcasses affected with swine erysipelas which is acute or 
generalized, or which show systemic change, shall be condemned.



Sec. 311.6  Diamond-skin disease.

    Carcasses of hogs affected with diamond-skin disease when localized 
and not associated with systemic change may be passed for human food 
after removal and condemnation of the affected parts, provided such 
carcasses are otherwise healthy.



Sec. 311.7  Arthritis.

    (a) Carcasses affected with arthritis which is localized and not 
associated with systemic change may be passed for human food after 
removal and condemnation of all affected parts. Affected joints with 
corresponding lymph nodes shall be removed and condemned. In order to 
avoid contamination of the meat which is passed, a joint capsule shall 
not be opened until after the affected joint is removed.
    (b) Carcasses affected with arthritis shall be condemned when there 
is evidence of systemic involvement.



Sec. 311.8  Cattle carcasses affected with anasarca or generalized edema.

    (a) Carcasses of cattle found on post-mortem inspection to be 
affected with anasarca in advanced stages and characterized by an 
extensive or well-marked generalized edema shall be condemned.
    (b) Carcasses of cattle, including their detached organs and other 
parts, found on post-mortem inspection to be affected with anasarca to a 
lesser extent than as described in paragraph (a) of this section may be 
passed for human food after removal and condemnation of the affected 
tissues, provided the lesion is localized.



Sec. 311.9  Actinomycosis and actinobacillosis.

    (a) The definition of generalization as outlined for tuberculosis in 
Sec. 311.2(a) shall apply for actinomycosis and actinobacillosis, and 
carcasses of livestock with generalized lesions of either such disease 
shall be condemned.
    (b) Carcasses of livestock in a well-nourished condition showing 
uncomplicated localized lesions of actinomycosis or actinobacillosis may 
be passed for human food after the infected organs or other infected 
parts have been removed and condemned, except as provided in paragraphs 
(c) and (d) of this section.
    (c) Heads affected with actinomycosis or actinobacillosis, including 
the tongue, shall be condemned, except that when the disease of the jaw 
is

[[Page 135]]

slight, strictly localized, and without suppuration, fistulous tracts, 
or lymph node involvement, the tongue, if free from disease, may be 
passed, or, when the disease is slight and confined to the lymph nodes, 
the head including the tongue, may be passed for human food after the 
affected nodes have been removed and condemned.
    (d) When the disease is slight and confined to the tongue, with or 
without involvement of the corresponding lymph nodes, the head may be 
passed for human food after removal and condemnation of the tongue and 
corresponding lymph nodes.



Sec. 311.10  Anaplasmosis, anthrax, bab es io sis, bacillary 
hemo glob inu ria in cattle, blackleg, blue tongue, 

hem or rhag ic sep ti cemia, ic tero hema turia in sheep, infectious 
bovine rhino tra che itis, lept o 
          spir osis, malignant epi zo otic catarrh, strangles, pur pura 
          hemor rhagica, azo turia, infectious equine enceph alo 
          myelitis, toxic enceph alo myelitis (forage poisoning), 
          infectious anemia (swamp fever), dourine, acute influenza, 
          generalized osteoporosis, glanders (farcy), acute inflammatory 
          lameness, extensive fistula, and unhealed vaccine lesions.

    (a) Carcasses of livestock affected with or showing lesions of any 
of the following named diseases or conditions shall be condemned:
    (1) Anthrax.
    (2) Blackleg.
    (3) Unhealed vaccine lesions (vaccinia).
    (4) Strangles.
    (5) Purpura hemorrhagica.
    (6) Azoturia.
    (7) Infectious equine en ceph alo my e-litis.
    (8) Toxic encephalomyelitis (forage poisoning).
    (9) Infectious anemia (swamp fever).
    (10) Dourine.
    (11) Acute influenza.
    (12) Generalized osteoporosis.
    (13) Glanders (farcy).
    (14) Acute inflammatory lameness.
    (15) Extensive fistula.
    (b) Carcasses of livestock affected with or showing lesions of any 
of the following named diseases or conditions shall be condemned, except 
when recovery has occurred to the extent that only localized lesions 
persist, in which case the carcass may be passed for human food after 
removal and condemnation of the affected organs or other parts:
    (1) Anaplasmosis.
    (2) Bacillary hemoglobinuria in cattle.
    (3) Babesiosis (piroplasmosis).
    (4) Bluetongue.
    (5) Hemorrhagic septicemia.
    (6) Icterohematuria in sheep.
    (7) Infectious bovine rhinotracheitis.
    (8) Leptospirosis.
    (9) Malignant epizootic catarrh.

[35 FR 15569, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971]



Sec. 311.11  Neoplasms.

    (a) An individual organ or other part of a carcass affected with a 
neoplasm shall be condemned. If there is evidence of metastasis or that 
the general condition of the animal has been adversely affected by the 
size, position, or nature of the neoplasm, the entire carcass shall be 
condemned.
    (b) Carcasses affected with malignant lymphoma shall be condemned.



Sec. 311.12  Epithelioma of the eye.

    (a) Carcasses of animals affected with epithelioma of the eye, or 
the orbital region shall be condemned in their entirety if one of the 
following three conditions exists:
    (1) The affection has involved the osseous structures of the head 
with extensive infection, suppuration, and necrosis;
    (2) There is metastasis from the eye, or the orbital region, to any 
lymph node including the parotid lymph node, internal organs, muscles, 
skeleton, or other structures, regardless of the extent of the primary 
tumor; or
    (3) The affection, regardless of extent, is associated with cachexia 
or evidence of absorption or secondary changes.
    (b) Carcasses of animals affected with epithelioma of the eye, or 
the orbital region, to a lesser extent than as described in paragraph 
(a) of this section may be passed for human food after removal and 
condemnation of the head, including the tongue, provided the carcass is 
otherwise normal.

[[Page 136]]



Sec. 311.13  Pigmentary conditions; melanosis, xanthosis, ochronosis, etc.

    (a) Except as provided in Sec. 311.19, carcasses of livestock 
showing generalized pigmentary deposits shall be condemned.
    (b) The affected parts of carcasses showing localized pigmentary 
deposits of such character as to be unwholesome or otherwise adulterated 
shall be removed and condemned.



Sec. 311.14  Abrasions, bruises, abscesses, pus, etc.

    All slight, well-limited abrasions on the tongue and inner surface 
of the lips and mouth, when without lymph node involvement, shall be 
carefully excised, leaving only sound, normal tissue, which may be 
passed for human food. Any organ or other part of a carcass which is 
badly bruised or which is affected by an abscess, or a suppurating sore 
shall be condemned; and when the lesions are of such character or extent 
as to affect the whole carcass, the whole carcass shall be condemned. 
Portions of carcasses which are contaminated by pus or other diseased 
material shall be condemned.



Sec. 311.15  Brucellosis.

    Carcasses affected with localized lesions of brucellosis may be 
passed for human food after the affected parts are removed and 
condemned.



Sec. 311.16  Carcasses so infected that consumption of the meat may 
cause food poisoning.

    (a) All carcasses of animals so infected that consumption of the 
products thereof may give rise to food poisoning shall be condemned. 
This includes all carcasses showing signs of:
    (1) Acute inflammation of the lungs, pleura, pericardium, 
peritoneum, or meninges.
    (2) Septicemia or pyemia, whether puerperal, traumatic, or without 
any evident cause.
    (3) Gangrenous or severe hemorrhagic enteritis or gastritis.
    (4) Acute diffuse metritis or mam mit is.
    (5) Phlebitis of the umbilical veins.
    (6) Septic or purulent traumatic pericarditis.
    (7) Any acute inflammation, abscess, or suppurating sore, if 
associated with acute nephritis, fatty and degenerated liver, swollen 
soft spleen, marked pulmonary hyperemia, general swelling of lymph 
nodes, diffuse redness of the skin, cachexia, icteric discoloration of 
the carcass or similar condition, either singly or in combination.
    (8) Salmonellosis.
    (b) Implements contaminated by contact with carcasses affected with 
any of the disease conditions mentioned in this section shall be 
thoroughly cleaned and sanitized as prescribed in part 308 of this 
subchapter. The equipment used in the dressing of such carcasses, such 
as viscera trucks or inspection tables, shall be sanitized with hot 
water having a minimum temperature of 180 [deg]F. Carcasses or parts of 
carcasses contaminated by contact with such diseased carcasses shall be 
condemned unless all contaminated tissues are removed within 2 hours.



Sec. 311.17  Necrobacillosis, pyemia, and septicemia.

    From the standpoint of meat inspection, necrobacillosis may be 
regarded as a local infection at the beginning, and carcasses in which 
the lesions are localized may be passed for human food if in a good 
state of nutrition, after those portions affected with necrotic lesions 
are removed and condemned. However, when emaciation, cloudy swelling of 
the parenchymatous tissue of organs or enlargement of the lymph nodes is 
associated with the infection, it is evident that the disease has 
progressed beyond the condition of localization to a state of toxemia, 
and the entire carcass shall therefore be condemned as both unwholesome 
and noxious. Pyemia or septicemia may intervene as a complication of the 
local necrosis, and when present the carcass shall be condemned in 
accordance with Sec. 311.16.



Sec. 311.18  Caseous lymphadenitis.

    (a) A thin carcass showing well-marked lesions in the viscera and 
the skeletal lymph nodes, or a thin carcass showing extensive lesions in 
any part shall be condemned.
    (b) A thin carcass showing well-marked lesions in the viscera with 
only

[[Page 137]]

slight lesions elsewhere or showing well-marked lesions in the skeletal 
lymph nodes with only slight lesions elsewhere may be passed for 
cooking.
    (c) A thin carcass showing only slight lesions in the skeletal lymph 
nodes and in the viscera may be passed for human food without 
restriction.
    (d) A well-nourished carcass showing well-marked lesions in the 
viscera and with only slight lesions elsewhere or showing well-marked 
lesions confined to the skeletal lymph nodes with only slight lesions 
elsewhere may be passed for human food without restriction.
    (e) A well-nourished carcass showing well-marked lesions in the 
viscera and the skeletal lymph nodes may be passed for cooking; but 
where the lesions in a well-nourished carcass are both numerous and 
extensive, it shall be condemned.
    (f) All affected organs and nodes of carcasses passed for human food 
without restriction or passed for cooking shall be removed and 
condemned.
    (g) As used in this section, the term ``thin'' does not apply to a 
carcass which is anemic or emaciated; and the term ``lesions'' refers to 
lesions of caseous lymphadenitis.



Sec. 311.19  Icterus.

    Carcasses showing any degree of icterus shall be condemned. Yellow 
fat conditions caused by nutritional factors or characteristic of 
certain breeds of livestock and yellow fat sometimes seen in sheep shall 
not be confused with icterus. Such carcasses should be passed for human 
food, if otherwise normal.



Sec. 311.20  Sexual odor of swine.

    (a) Carcasses of swine which give off a pronounced sexual odor shall 
be condemned.
    (b) The meat of swine carcasses which give off a sexual odor less 
than pronounced may be passed for use in comminuted cooked meat food 
product or for rendering. Otherwise it shall be condemned.



Sec. 311.21  Mange or scab.

    Carcasses of livestock affected with mange or scab in advanced 
stages, showing cachexia or extensive inflammation of the flesh, shall 
be condemned. When the disease is slight, the carcass may be passed 
after removal of the affected portion.



Sec. 311.22  Hogs affected with urticaria, tinea tonsurans, demodex 
fol li cur lorum, or erythema.

    Carcasses of hogs affected with urticaria (nettle rash), tinea 
tonsurans, demodex folliculorum, or erythema may be passed for human 
food after detaching and condemning the affected skin, if the carcass is 
otherwise not adulterated.



Sec. 311.23  Tapeworm cysts (cysticercus bovis) in cattle.

    (a) Except as provided in paragraph (b) of this section, carcasses 
of cattle affected with lesions of cysticercus bovis shall be disposed 
of as follows:
    (1) Carcasses of cattle displaying lesions of cysticercus bovis 
shall be condemned if the infestation is extensive or if the musculature 
is edematous or discolored. Carcasses shall be considered extensively 
infested if in addition to finding lesions in at least two of the usual 
inspection sites, namely the heart, diaphragm and its pillars, muscles 
of mastication, esophagus, tongue, and musculature exposed during normal 
dressing operations, they are found in at least two of the sites exposed 
by (i) an incision made into each round exposing the musculature in 
cross section, and (ii) a transverse incision into each forelimb 
commencing 2 or 3 inches above the point of the olecranon and extending 
to the humerus.
    (2) Carcasses of cattle showing one or more tapeworm lesions of 
cysticercus bovis but not so extensive as indicated in paragraph (a)(1) 
of this section, as determined by a careful examination, including 
examination of, but not limited to, the heart, diaphragm and its 
pillars, muscles of mastication, esophagus, tongue, and musculature 
exposed during normal dressing operations, may be passed for human food 
after removal and condemnation of the lesions with surrounding tissues: 
Provided, That the carcasses, appropriately identified by retained tags, 
are held in cold storage under positive control of a USDA Food Inspector 
at a temperature not higher than 15 [deg]F. continuously for a period of 
not less than 10 days, or in

[[Page 138]]

the case of boned meat derived from such carcasses, the meat, when in 
boxes, tierces, or other containers, appropriately identified by 
retained tags, is held under positive control of a Program Inspector at 
a temperature of not higher than 15 [deg]F. continuously for a period of 
not less than 20 days. As an alternative to retention in cold storage as 
provided in this subparagraph, such carcasses and meat may be heated 
throughout to a temperature of at least 140 [deg]F. under positive 
control of a Program Inspector.
    (b) Edible viscera and offal shall be disposed of in the same manner 
as the rest of the carcass from which they were derived unless any 
lesion of cysticercus bovis is found in these byproducts, in which case 
they shall be condemned.

[36 FR 4591, Mar. 10, 1971]



Sec. 311.24  Hogs affected with tapeworm cysts.

    Carcasses of hogs affected with tapeworm cysts (Cysticercus 
cellulosae) may be passed for cooking, unless the infestation is 
excessive, in which case the carcass shall be condemned.



Sec. 311.25  Parasites not transmissible to man; tapeworm cysts in sheep; 
hydatid cysts; flukes; gid bladder-worms.

    (a) In the disposal of carcasses, edible organs, and other parts of 
carcasses showing evidence of infestation with parasites not 
transmissible to man, the following general rules shall govern except as 
otherwise provided in this section: If the lesions are localized in such 
manner and are of such character that the parasites and the lesions 
caused by them can be completely removed, the nonaffected portion of the 
carcass, organ, or other part of the carcass may be passed for human 
food after the removal and condemnation of the affected portions. If an 
organ or other part of a carcass shows numerous lesions caused by 
parasites, or if the character of the infestation is such that complete 
extirpation of the parasitic infestation or invasion renders the part in 
any way unfit for human food, the affected part shall be condemned. If 
parasites are found to be distributed in a carcass in such a manner or 
to be of such character that their removal and the removal of the 
lesions caused by them is impracticable, no part of the carcass shall be 
passed for human food. If the infestation is excessive, the carcass 
shall be condemned. If the infestation is moderate, the carcass may be 
passed for cooking, but in case such carcass is not cooked as required 
by part 315 of this subchapter, it shall be condemned.
    (b) In the case of sheep carcasses affected with tapeworm cysts 
(Cyst i cer cus ovis, so-called sheep measles, not transmissible to 
man), such carcasses may be passed for human food after the removal and 
condemnation of the affected portions: Provided, however, That if, upon 
the final inspection of sheep carcasses retained on account of measles, 
the total number of cysts found embedded in muscular tissue, or in 
immediate relation with muscular tissue, excluding the heart, exceeds 
five, the entire carcass shall be condemned, or such carcass shall be 
heated throughout to a temperature of at least 140 [deg]F. After removal 
and condemnation of all affected portions.
    (c) Carcasses found infested with gid bladder-worms (Coenurus 
cerebralis, Multiceps multiceps) may be passed for human food after 
condemnation of the affected organ (brain or spinal cord).
    (d) Organs or other parts of carcasses infested with hydatid cysts 
(echinococus) shall be condemned.
    (e) Livers infested with flukes or fringed tapeworms shall be 
condemned.



Sec. 311.26  Emaciation.

    Carcasses of livestock too emaciated to produce wholesome meat, and 
carcasses which show a serous infiltration of muscle tissues, or a 
serous or mucoid degeneration of the fatty tissue, shall be condemned. A 
gelatinous change of the fat of the heart and kidneys of well-nourished 
carcasses and mere leanness shall not be classed as emaciation.

[35 FR 15569, Oct. 3, 1970; 36 FR 11903, June 23, 1971]



Sec. 311.27  Injured animals slaughtered at unusual hours.

    When it is necessary for humane reasons to slaughter an injured 
animal at night or on Sunday or a holiday when

[[Page 139]]

the inspector cannot be obtained, the carcass and all parts of all 
livestock except for cattle shall be kept for inspection, with the head 
and all viscera except the stomach, bladder, and intestines held by the 
natural attachments. If all parts are not so kept for inspection, the 
carcass shall be condemned. If, on inspection of a carcass slaughtered 
in the absence of an inspector, any lesion or other evidence is found 
indicating that the animal was sick or diseased, or affected with any 
other condition requiring condemnation of the animal on ante-mortem 
inspection, or if there is lacking evidence of the condition which 
rendered emergency slaughter necessary, the carcass shall be condemned. 
The parts and carcasses of cattle slaughtered in the absence of an 
inspector shall not be used for human food.

[35 FR 15569, Oct. 3, 1970, as amended at 69 FR 1874, Jan. 12, 2004]



Sec. 311.28  Carcasses of young calves, pigs, kids, lambs, and foals.

    Carcasses of young calves, pigs, kids, lambs, and foals are 
unwholesome and shall be condemned if (a) the meat has the appearance of 
being water-soaked, is loose, flabby, tears easily, and can be 
perforated with the fingers; or (b) its color is grayish-red; or (c) 
good muscular development as a whole is lacking, especially noticeable 
on the upper shank of the leg, where small amounts of serous infiltrates 
or small edematous patches are sometimes present between the muscles; or 
(d) the tissue which later develops as the fat capsule of the kidneys is 
edematous, dirty yellow, or grayish-red, tough, and intermixed with 
islands of fat.



Sec. 311.29  Unborn and stillborn animals.

    All unborn and stillborn animals shall be condemned and no hide or 
skin thereof shall be removed from the carcass within a room in which 
edible products are handled.



Sec. 311.30  Livestock suffocated and hogs scalded alive.

    All livestock which have been suffocated in any way and hogs which 
have entered the scalding vat alive shall be condemned.



Sec. 311.31  Livers affected with car o ten osis; livers designated as `
`telangiectatic,'' ``sawdust,'' or ``spotted.''

    (a) Livers affected with carotenosis shall be condemned.
    (b) Cattle livers and calf livers showing the conditions sometimes 
designated as ``telangiectatic,'' ``sawdust,'' or ``spotted'' shall be 
disposed of as follows:
    (1) When any or all of the conditions are slight in the organ, the 
whole organ shall be passed for human food without restriction.
    (2) When any or all of the conditions are more severe than slight 
and involve less than one-half of the organ, while in the remainder of 
the organ the conditions are slight or nonexistent, the remainder shall 
be passed for human food without restriction and the other portion shall 
be condemned.
    (3) When any or all of the conditions are more severe than slight 
and involve one-half or more of the organ, the whole organ shall be 
condemned.
    (4) The divisions of an organ into two parts as contemplated in this 
paragraph for disposition, shall be accomplished by one cut through the 
organ. This, of course, does not prohibit incisions which are necessary 
for inspection.
    (c) ``Telangiectatic,'' ``sawdust,'' or ``spotted'' livers and parts 
of livers which are condemned for human food may be shipped from an 
official establishment for purposes other than human food in accordance 
with Sec. 314.10 of this subchapter.



Sec. 311.32  Vesicular diseases.

    (a) Any carcass affected with vesicular disease shall be condemned 
if the condition is acute and if the extent of the condition is such 
that it affects the entire carcass or there is evidence of absorption or 
secondary change.
    (b) Any carcass affected with vesicular disease to a lesser extent 
than as described in paragraph (a) of this section may be passed for 
human food after removal and condemnation of the affected parts, if the 
carcass is otherwise healthy.

[[Page 140]]



Sec. 311.33  Listeriosis.

    Carcasses of livestock identified as U.S. Suspects because of a 
history of listeriosis shall be passed for human food after condemnation 
of the head if the carcass is otherwise normal.



Sec. 311.34  Anemia.

    Carcasses of livestock too anemic to produce wholesome meat shall be 
condemned.



Sec. 311.35  Muscular inflammation, degeneration, or infiltration.

    (a) If muscular lesions are found to be distributed in such a manner 
or to be of such character that removal is impractical, the carcass 
shall be condemned.
    (b) If muscular lesions are found to be distributed in such a manner 
or to be of such character that removal is practical, the following 
rules shall govern the disposal of the carcasses, edible organs, and 
other parts of carcasses showing such muscular lesions. If the lesions 
are localized in such a manner and are of such a character that the 
affected tissues can be removed, the nonaffected parts of the carcass 
may be passed for human food after the removal and condemnation of the 
affected portion. If a part of the carcass shows numerous lesions, or if 
the character of the lesion is such that complete extirpation is 
difficult and uncertainly accomplished, or if the lesion renders the 
part in any way unfit for human food, the part shall be condemned.
    (c) If the lesions are slight or of such character as to be 
insignificant from a standpoint of wholesomeness, the carcass or parts 
may be passed for use in the manufacture of comminuted cooked product, 
after removal and condemnation of the visibly affected portions.



Sec. 311.36  Coccidioidal granuloma.

    (a) Carcasses which are affected with generalized coccidioidal 
granuloma or which show systemic changes because of such disease shall 
be condemned.
    (b) Carcasses affected with localized lesions of this disease may be 
passed for human food after the affected parts are removed and 
condemned.



Sec. 311.37  Odors, foreign and urine.

    (a) Carcasses which give off a pronounced odor of medicinal, 
chemical, or other foreign substance shall be condemned.
    (b) Carcasses which give off a pronounced urine odor shall be 
condemned.
    (c) Carcasses, organs, or parts affected by odor to a lesser degree 
than as described in paragraphs (a) and (b) of this section and in which 
the odor can be removed by trimming or chilling may be passed for human 
food, after removal of affected parts or dissipation of the condition.



Sec. 311.38  Meat and meat byproducts from livestock which have been 
exposed to radiation.

    Meat and meat byproducts from livestock which have been administered 
radioactive material shall be condemned unless the use of the radiation 
was in conformity with a regulation or exemption in effect pursuant to 
section 409 of the Federal Food, Drug, and Cosmetic Act.



Sec. 311.39  Biological residues.

    Carcasses, organs, or other parts of carcasses of livestock shall be 
condemned if it is determined that they are adulterated because of the 
presence of any biological residues.



PART 312_OFFICIAL MARKS, DEVICES AND CERTIFICATES--Table of Contents




Sec.
312.1 General.
312.2 Official marks and devices to identify inspected and passed 
          products of cattle, sheep, swine, or goats.
312.3 Official marks and devices to identify inspected and passed equine 
          products.
312.4 Official ante-mortem inspection marks and devices.
312.5 Official seals for transportation of products.
312.6 Official marks and devices in connection with post-mortem 
          inspection and identification of adulterated products and 
          insanitary equipment and facilities.
312.7 [Reserved]
312.8 Official export inspection marks, devices, and certificates.
312.9 Official detention marks and devices.
312.10 Official mark for maintaining the identity and integrity of 
          samples.


[[Page 141]]


    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 15573, Oct. 3, 1970, unless otherwise noted.



Sec. 312.1  General.

    The marks, devices, and certificates prescribed or referenced in 
this part shall be official marks, devices, and certificates for 
purposes of the Act, and shall be used in accordance with the provisions 
of this part and the regulations cited therein.



Sec. 312.2  Official marks and devices to identify inspected and passed 
products of cattle, sheep, swine, or goats.

    (a) The official inspection legend required by part 316 of this 
subchapter to be applied to inspected and passed carcasses and parts of 
carcasses of cattle, sheep, swine and goats, meat food products in 
animal casings, and other products as approved by the Administrator, 
shall be in the appropriate form as hereinafter specified: \1\
---------------------------------------------------------------------------

    \1\ The number ``38'' is given as an example only. The establishment 
number of the official establishment where the product is prepared shall 
be used in lieu thereof.
[GRAPHIC] [TIFF OMITTED] TC11SE91.000

    For application to sheep carcasses, the loins and ribs of pork, beef 
tails, and the smaller varieties of sausage and meat food products in 
animal casings.
[GRAPHIC] [TIFF OMITTED] TC11SE91.001

    For application to calf and goat carcasses and on the larger 
varieties of sausage and meat food products in animal casings.
[GRAPHIC] [TIFF OMITTED] TC11SE91.002

    For application to beef and hog carcasses primal parts and cuts 
therefrom, beef livers, beef tongues, beef hearts, and smoked meats not 
in casings.
[GRAPHIC] [TIFF OMITTED] TC11SE91.003

    For application to burlap, muslin, cheesecloth, heavy paper, or 
other acceptable material that encloses carcasses or parts of carcasses.
    (b)(1) The official inspection legend required by part 317 of this 
subchapter to be shown on all labels for inspected and passed products 
of cattle, sheep, swine, and goats shall be in the following form \1\ 
except that it need not be of the size illustrated, provided that it is 
a sufficient size and of such color as to be conspicuously displayed and 
readily legible and the same proportions of letter size and boldness are 
maintained as illustrated:

[[Page 142]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.004

    (2) This official mark shall be applied by mechanical means and 
shall not be applied by a hand stamp.
    (3) The official inspection legend described in paragraph (b)(1) of 
this section may also be used for purposes of part 316 of this 
subchapter on shipping containers, band labels, artificial casings, and 
other articles with the approval of the Administrator.
    (c) Any brand, stamp, label, or other device approved by the 
Administrator and bearing any official mark prescribed in paragraphs (a) 
or (b) of this section shall be an official device for purposes of the 
Act.

[35 FR 15573, Oct. 3, 1970; 36 FR 12002, June 24, 1971]



Sec. 312.3  Official marks and devices to identify inspected and passed 
equine products.

    (a) The official inspection legend required by Sec. 316.12 or Sec. 
317.2 of this subchapter to identify inspected and passed horse 
carcasses and parts of carcasses, or horse meat food products shall be 
in the appropriate form as hereinafter specified: \1\
[GRAPHIC] [TIFF OMITTED] TC11SE91.005

[GRAPHIC] [TIFF OMITTED] TC11SE91.055

    (b) The official inspection legend required by Sec. 316.12 or Sec. 
317.2 of this subchapter to identify inspected and passed mule and other 
(nonhorse) equine carcasses and parts of carcasses, or equine meat food 
products shall be in whichever of the following form, is appropriate:\1\
---------------------------------------------------------------------------

    \1\ The number ``38'' is given as an example only. The establishment 
number of the official establishment where the product is prepared shall 
be used in lieu thereof.

---------------------------------------------------------------------------

[[Page 143]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.006

[GRAPHIC] [TIFF OMITTED] TC11SE91.007

    (c) Any brand, stamp, label, or other device approved by the 
Administrator and bearing any official mark prescribed in paragraphs (a) 
or (b) of this section shall be an official device for purposes of the 
Act.



Sec. 312.4  Official ante-mortem inspection marks and devices.

    The official marks and devices used in connection with ante-mortem 
inspection are those prescribed in Sec. 309.18 of this subchapter.



Sec. 312.5  Official seals for transportation of products.

    The official mark for use in sealing railroad cars or other means of 
conveyance as prescribed in part 325 of this subchapter shall be the 
inscription and a serial number as hereinafter shown \2\ and any seal 
approved by the Administrator for applying such mark shall be an 
official device for purposes of the Act. This seal shall be attached to 
the means of conveyance only by a Program employee and he shall also 
affix thereto a ``Warning Tag'' (Form MP-408-3).
---------------------------------------------------------------------------

    \2\ The number ``2135202'' is given as an example only. The serial 
number of the specific seal will be shown in lieu thereof.
[GRAPHIC] [TIFF OMITTED] TC11SE91.008


[35 FR 15573, Oct. 3, 1970, as amended at 39 FR 36000, Oct. 7, 1974; 51 
FR 37707, Oct. 24, 1986]

[[Page 144]]



Sec. 312.6  Official marks and devices in connection with post-mortem 
inspection and identification of adulterated products and insanitary 
equipment and facilities.

    (a) The official marks required by parts 310 and 416 of this chapter 
for use in post-mortem inspection and identification of adulterated 
products and insanitary equipment and facilities are:
    (1) The tag (Form MP-427) which is used to retain carcasses and 
parts of carcasses in the slaughter department; it is black and white, 
and bears the legend ``U.S. Retained.''
    (2) The ``U.S. Retained'' mark which is applied to products and 
articles as prescribed in part 310 of this subchapter by means of a 
paper tag (Form MP-35) bearing the legend ``U.S. Retained.''
    (3) The ``U.S. Rejected'' mark which is used to identify insanitary 
buildings, rooms, or equipment as prescribed in part 416, section 6, of 
this chapter and is applied by means of a paper tag (Form MP-35) bearing 
the legend ``U.S. Rejected.''
    (4) The ``U.S. Passed for Cooking'' mark is applied on products 
passed for cooking as prescribed in part 310 of this subchapter by means 
of a brand and is in the following form:
[GRAPHIC] [TIFF OMITTED] TC11SE91.009

    (5) The ``U.S. Inspected and Condemned'' mark shall be applied to 
products condemned as prescribed in part 310 by means of a brand and is 
in the following form:
[GRAPHIC] [TIFF OMITTED] TC11SE91.010

    (b) The ``U.S. Retained'' and ``U.S. Rejected'' tags, and all other 
brands, stamps, labels, and other devices approved by the Administrator 
and bearing any official mark prescribed in paragraph (a) of this 
section, shall be official devices for purposes of the Act.

[35 FR 15573, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973; 39 
FR 36000; Oct. 7, 1974; 43 FR 29268, July 7, 1978; 64 FR 36415, Oct. 20, 
1999; 65 FR 2284, Jan. 14, 2000]



Sec. 312.7  [Reserved]



Sec. 312.8  Official export inspection marks, devices, and certificates.

    (a) The official export meat inspection mark required by part 322 of 
this subchapter shall be in the following form as hereinafter specified: 
\1\
---------------------------------------------------------------------------

    \1\ The number ``529893'' is given as an example only. The number of 
the official export certificate will be shown in lieu thereof.
[GRAPHIC] [TIFF OMITTED] TC11SE91.011


Any rubber stamp approved by the Administrator, in the manner provided 
for in part 317 of this subchapter, and bearing the official mark 
prescribed in this paragraph shall be an official device for the 
purposes of the Act.
    (b) The official export certificate required by part 322 of this 
subchapter is a paper certificate form for signature by a Program 
employee, bearing a letterhead and the seal of the United States 
Department of Agriculture, with a certification that meat or meat food 
products described on the form is from animals that received ante-mortem 
and post-mortem inspection and were found sound and healthy and that it 
has been inspected and passed as provided by law and the regulations of 
the Department of Agriculture and is sound and wholesome. The 
certificate also bears a serial number such as ``No. 184432.''

[35 FR 15573, Oct. 3, 1970, as amended at 42 FR 11825, Mar. 1, 1977; 47 
FR 29823, July 9, 1982]

[[Page 145]]



Sec. 312.9  Official detention marks and devices.

    The official mark for articles and livestock detained under part 329 
of this subchapter shall be the designation ``U.S. Detained'' and the 
official device for applying such mark shall be the official ``U.S. 
Detained'' tag (FSIS Form 8400-2) as prescribed in Sec. 329.2 of this 
subchapter.

[55 FR 47842, Nov. 16, 1990]



Sec. 312.10  Official mark for maintaining the identity and integrity 
of samples.

    The official mark for use in sealing containers of samples submitted 
under any requirements in this subchapter and section 202 of the Federal 
Meat Inspection Act shall bear the designation ``Sample Seal'' 
accompanied by the official USDA logo as shown below. Any seal approved 
by the Administrator for applying such mark shall be deemed an official 
device for purposes of the Act. Such device shall be supplied to 
inspectors, compliance officers, and other designated Agency officials 
by the United States Department of Agriculture.
[GRAPHIC] [TIFF OMITTED] TC11SE91.012


[52 FR 41958, Nov. 2, 1987]



PART 313_HUMANE SLAUGHTER OF LIVESTOCK--Table of Contents




Sec.
313.1 Livestock pens, driveways and ramps.
313.2 Handling of livestock.
313.5 Chemical; carbon dioxide
313.15 Mechanical; captive bolt.
313.16 Mechanical; gunshot.
313.30 Electrical; stunning or slaughtering with electric current.
313.50 Tagging of equipment, alleyways, pens or compartments to prevent 
          inhumane slaughter or handling in connection with slaughter.
313.90 [Reserved]

    Authority: 7 U.S.C. 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 44 FR 68813, Nov. 30, 1979, unless otherwise noted.



Sec. 313.1  Livestock pens, driveways and ramps.

    (a) Livestock pens, driveways and ramps shall be maintained in good 
repair. They shall be free from sharp or protruding objects which may, 
in the opinion of the inspector, cause injury or pain to the animals. 
Loose boards, splintered or broken planking, and unnecessary openings 
where the head, feet, or legs of an animal may be injured shall be 
repaired.
    (b) Floors of livestock pens, ramps, and driveways shall be 
constructed and maintained so as to provide good footing for livestock. 
Slip resistant or waffled floor surfaces, cleated ramps and the use of 
sand, as appropriate, during winter months are examples of acceptable 
construction and maintenance.
    (c) U.S. Suspects (as defined in Sec. 301.2(xxx)) and dying, 
diseased, and disabled livestock (as defined in Sec. 301.2(y)) shall be 
provided with a covered pen sufficient, in the opinion of the inspector, 
to protect them from the adverse climatic conditions of the locale while 
awaiting disposition by the inspector.
    (d) Livestock pens and driveways shall be so arranged that sharp 
corners and direction reversal of driven animals are minimized.

[44 FR 68813, Nov. 30, 1979, as amended at 53 FR 49848, Dec. 12, 1988]



Sec. 313.2  Handling of livestock.

    (a) Driving of livestock from the unloading ramps to the holding 
pens and from the holding pens to the stunning area shall be done with a 
minimum of excitement and discomfort to the animals. Livestock shall not 
be forced to move faster than a normal walking speed.
    (b) Electric prods, canvas slappers, or other implements employed to 
drive animals shall be used as little as possible in order to minimize 
excitement

[[Page 146]]

and injury. Any use of such implements which, in the opinion of the 
inspector, is excessive, is prohibited. Electrical prods attached to AC 
house current shall be reduced by a transformer to the lowest effective 
voltage not to exceed 50 volts AC.
    (c) Pipes, sharp or pointed objects, and other items which, in the 
opinion of the inspector, would cause injury or unnecessary pain to the 
animal shall not be used to drive livestock.
    (d) Disabled livestock and other animals unable to move.
    (1) Disabled animals and other animals unable to move shall be 
separated from normal ambulatory animals and placed in the covered pen 
provided for in Sec. 313.1(c).
    (2) The dragging of disabled animals and other animals unable to 
move, while conscious, is prohibited. Stunned animals may, however, be 
dragged.
    (3) Disabled animals and other animals unable to move may be moved, 
while conscious, on equipment suitable for such purposes; e.g., stone 
boats.
    (e) Animals shall have access to water in all holding pens and, if 
held longer than 24 hours, access to feed. There shall be sufficient 
room in the holding pen for animals held overnight to lie down.
    (f) Stunning methods approved in Sec. 313.30 shall be effectively 
applied to animals prior to their being shackled, hoisted, thrown, cast, 
or cut.



Sec. 313.5  Chemical; carbon dioxide.

    The slaughtering of sheep, calves and swine with the use of carbon 
dioxide gas and the handling in connection therewith, in compliance with 
the provisions contained in this section, are hereby designated and 
approved as humane methods of slaughtering and handling of such animals 
under the Act.
    (a) Administration of gas, required effect; handling. (1) The carbon 
dioxide gas shall be administered in a chamber in accordance with this 
section so as to produce surgical anesthesia in the animals before they 
are shackled, hoisted, thrown, cast, or cut. The animals shall be 
exposed to the carbon dioxide gas in a way that will accomplish the 
anesthesia quickly and calmly, with a minimum of excitement and 
discomfort to the animals. In swine, carbon dioxide may be administered 
to induce death in the animals before they are shackled, hoisted, 
thrown, cast, or cut.
    (2) The driving or conveying of the animals to the carbon dioxide 
chamber shall be done with a minimum of excitement and discomfort to the 
animals. Delivery of calm animals to the anesthesia chamber is essential 
since the induction, or early phase, of anesthesia is less violent with 
docile animals. Among other things this requires that, in driving 
animals to the anesthesia chamber, electrical equipment be used as 
little as possible and with the lowest effective voltage.
    (3) On emerging from the carbon dioxide tunnel, the animals shall be 
in a state of surgical anesthesia and shall remain in this condition 
throughout shackling, sticking, and bleeding, except for swine in which 
death has been induced by the administration of carbon dioxide. Asphyxia 
or death from any cause shall not be produced in animals before 
bleeding, except for swine in which death has been induced by the 
administration of carbon dioxide.
    (b) Facilities and procedures--(1) General requirements for gas 
chambers and auxiliary equipment; operator. (i) The carbon dioxide gas 
shall be administered in a tunnel which is designed to permit the 
effective exposure of the animal. Two types of tunnels, based on the 
same principle, are in common use for carbon dioxide anesthesia. They 
are the ``U'' type tunnel and the ``Straight Line'' type tunnel, and are 
based on the principle that carbon dioxide gas has a higher specific 
gravity than air. The tunnels are open at both ends for entry and exit 
of animals and have a depressed central section. Anesthetizing, or, in 
the case of swine, death-inducing, carbon dioxide concentrations are 
maintained in the central sections of the tunnels. Effective anaes thet 
i zation is produced in these central sections. Animals are driven from 
holding pens through pathways constructed of large-diameter pipe or 
smooth metal and onto continuous conveyor devices that move the animals 
through the tunnels. The animals are either compartmentalized on the 
conveyors by mechanical impellers synchronized with the conveyor or they 
are otherwise prevented from

[[Page 147]]

crowding. While impellers are used to compartmentalize the animals, 
mechanically or manually operated gates are used to move the animals 
onto the conveyors. Surgically anaesthetized animals, or killed swine, 
are moved out of the tunnels by the same continuous conveyors that moved 
them into and through the carbon dioxide gas.
    (ii) Flow of animals into and through the carbon dioxide chamber is 
dependent on one operator. The operation or stoppage of the conveyor is 
entirely dependent upon this operator. It is necessary that he be 
skilled, attentive, and aware of his responsibility. Overdosages and 
death of animals can be brought about by carelessness of this 
individual.
    (2) Special requirements for gas chamber and auxiliary equipment. 
The ability of anesthetizing equipment to perform with maximum 
efficiency is dependent on its proper design and efficient mechanical 
operation. Pathways, compartments, gas chambers, and all other equipment 
used must be designed to accommodate properly the species of animals 
being anesthetized. They shall be free from pain-producing restraining 
devices. Injury of animals must be prevented by the elimination of sharp 
projections or exposed wheels or gears. There shall be no unnecessary 
holes, spaces or openings where feet or legs of animals may be injured. 
Impellers or other devices designed to mechanically move or drive 
animals or otherwise keep them in motion or compartmentalized shall be 
constructed of flexible or well padded rigid material. Power activated 
gates designed for constant flow of animals to anesthetizing equipment 
shall be so fabricated that they will not cause injury. All equipment 
involved in anesthetizing animals shall be maintained in good repair.
    (3) Gas. Maintenance of a uniform carbon dioxide concentration and 
distribution in the anesthesia chamber is a vital aspect of producing 
surgical anesthesia. This may be assured by reasonably accurate 
instruments which sample and analyze carbon dioxide gas concentration 
within the chamber throughout anesthetizing operations. Gas 
concentration shall be maintained uniform so that the degree of 
anesthesia in exposed animals will be constant. Carbon dioxide gas 
supplied to anesthesia chambers may be from controlled reduction of 
solid carbon dioxide or from a controlled liquid source. In either case 
the carbon dioxide shall be supplied at a rate sufficient to anesthetize 
adequately and uniformly the number of animals passing through the 
chamber. Sampling of gas for analysis shall be made from a 
representative place or places within the chamber and on a continuing 
basis. Gas concentrations and exposure time shall be graphically 
recorded throughout each day's operation. Neither carbon dioxide nor 
atmospheric air used in the anesthesia chambers shall contain noxious or 
irritating gases. Each day before equipment is used for anesthetizing 
animals, proper care shall be taken to mix adequately the gas and air 
within the chamber. All gas producing and control equipment shall be 
maintained in good repair and all indicators, instruments, and measuring 
devices must be available for inspection by Program inspectors during 
anesthetizing operations and at other times. An exhaust system must be 
provided so that, in case of equipment failure, non-uniform carbon 
dioxide concentrations in the gas tunnel or contamination of the ambient 
air of the establishment will be prevented.

[44 FR 68813, Nov. 30, 1979, as amended at 59 FR 21640, Apr. 26, 1994]



Sec. 313.15  Mechanical; captive bolt.

    The slaughtering of sheep, swine, goats, calves, cattle, horses, 
mules, and other equines by using captive bolt stunners and the handling 
in connection therewith, in compliance with the provisions contained in 
this section, are hereby designated and approved as humane methods of 
slaughtering and handling of such animals under the Act.
    (a) Application of stunners, required effect; handling. (1) The 
captive bolt stunners shall be applied to the livestock in accordance 
with this section so as to produce immediate unconsciousness in the 
animals before they are shackled, hoisted, thrown, cast, or cut. The 
animals shall be stunned in such a manner that they will be rendered 
unconscious with a minimum of excitement and discomfort.

[[Page 148]]

    (2) The driving of the animals to the stunning area shall be done 
with a minimum of excitement and discomfort to the animals. Delivery of 
calm animals to the stunning areas is essential since accurate placement 
of stunning equipment is difficult on nervous or injured animals. Among 
other things, this requires that, in driving animals to the stunning 
areas, electrical equipment be used as little as possible and with the 
lowest effective voltage.
    (3) Immediately after the stunning blow is delivered the animals 
shall be in a state of complete unconsciousness and remain in this 
condition throughout shackling, sticking and bleeding.
    (b) Facilities and procedures--(1) General requirements for stunning 
facilities; operator. (i) Acceptable captive bolt stunning instruments 
may be either skull penetrating or nonpenetrating. The latter type is 
also described as a concussion or mushroom type stunner. Penetrating 
instruments on detonation deliver bolts of varying diameters and lengths 
through the skull and into the brain. Unconsciousness is produced 
immediately by physical brain destruction and a combination of changes 
in intracranial pressure and acceleration concussion. Nonpenetrating or 
mushroom stunners on detonation deliver a bolt with a flattened circular 
head against the external surface of the animal's head over the brain. 
Diameter of the striking surface of the stunner may vary as conditions 
require. Unconsciousness is produced immediately by a combination of 
acceleration concussion and changes in intracranial pressures. A 
combination instrument utilizing both penetrating and non pen e trating 
principles is acceptable. Energizing of instruments may be accomplished 
by detonation of measured charges of gunpowder or accurately controlled 
compressed air. Captive bolts shall be of such size and design that, 
when properly positioned and activated, immediate unconsciousness is 
produced.
    (ii) To assure uniform unconsciousness with every blow, compressed 
air devices must be equipped to deliver the necessary constant air 
pressure and must have accurate, constantly operating air pressure 
gauges. Gauges must be easily read and conveniently located for use by 
the stunning operator and the inspector. For purposes of protecting 
employees, inspectors, and others, it is desirable that any stunning 
device be equipped with safety features to prevent injuries from 
accidental discharge. Stunning instruments must be maintained in good 
repair.
    (iii) The stunning area shall be so designed and constructed as to 
limit the free movements of animals sufficiently to allow the operator 
to locate the stunning blow with a high degree of accuracy. All chutes, 
alleys, gates and restraining mechanisms between and including holding 
pens and stunning areas shall be free from pain-producing features such 
as exposed bolt ends, loose boards, splintered or broken planking, and 
protruding sharp metal of any kind. There shall be no unnecessary holes 
or other openings where feet or legs of animals may be injured. Overhead 
drop gates shall be suitably covered on the bottom edge to prevent 
injury on contact with animals. Roughened or cleated cement shall be 
used as flooring in chutes leading to stunning areas to reduce falls of 
animals. Chutes, alleys, and stunning areas shall be so designed that 
they will comfortably accommodate the kinds of animals to be stunned.
    (iv) The stunning operation is an exacting procedure and requires a 
well-trained and experienced operator. He must be able to accurately 
place the stunning instrument to produce immediate unconsciousness. He 
must use the correct detonating charge with regard to kind, breed, size, 
age, and sex of the animal to produce the desired results.
    (2) Special requirements and prohibitions. (i) Choice of instrument 
and force required to produce immediate unconsciousness varies, 
depending on kind, breed, size, age, and sex of the animal. Young swine, 
lambs, and calves usually require less stunning force than mature 
animals of the same kind. Bulls, rams, and boars usually require skull 
penetration to produce immediate unconsciousness. Charges suitable for 
smaller kinds of livestock such as swine or for young animals are not 
acceptably interchanged for use on larger kinds or older livestock, 
respectively.
    (ii) Captive bolt stunners that deliberately inject compressed air 
into the

[[Page 149]]

cranium at the end of the penetration cycle shall not be used to stun 
cattle.

[44 FR 68813, Nov. 30, 1979, as amended at 69 FR 1891, Jan. 12, 2004]



Sec. 313.16  Mechanical; gunshot.

    The slaughtering of cattle, calves, sheep, swine, goats, horses, 
mules, and other equines by shooting with firearms and the handling in 
connection therewith, in compliance with the provisions contained in 
this section, are hereby designated and approved as humane methods of 
slaughtering and handling of such animals under the Act.
    (a) Utilization of firearms, required effect; handling. (1) The 
firearms shall be employed in the delivery of a bullet or projectile 
into the animal in accordance with this section so as to produce 
immediate unconsciousness in the animal by a single shot before it is 
shackled, hoisted, thrown, cast, or cut. The animal shall be shot in 
such a manner that they will be rendered unconscious with a minimum of 
excitement and discomfort.
    (2) The driving of the animals to the shooting areas shall be done 
with a minimum of excitement and discomfort to the animals. Delivery of 
calm animals to the shooting area is essential since accurate placement 
of the bullet is difficult in case of nervous or injured animals. Among 
other things, this requires that, in driving animals to the shooting 
areas, electrical equipment be used as little as possible and with the 
lowest effective voltage.
    (3) Immediately after the firearm is discharged and the projectile 
is delivered, the animal shall be in a state of complete unconsciousness 
and remain in this condition throughout shackling, sticking and 
bleeding.
    (b) Facilities and procedure--(1) General requirements for shooting 
facilities; operator. (i) On discharge, acceptable firearms dispatch 
free projectiles or bullets of varying sizes and diameters through the 
skull and into the brain. Unconsciousness is produced immediately by a 
combination of physical brain destruction and changes in intracranial 
pressure. Caliber of firearms shall be such that when properly aimed and 
discharged, the projectile produces immediate unconsciousness.
    (ii) To assure uniform unconsciousness of the animal with every 
discharge where small-bore firearms are employed, it is necessary to use 
one of the following type projectiles: Hollow pointed bullets; frangible 
iron plastic composition bullets; or powdered iron missiles. When 
powdered iron missiles are used, the firearms shall be in close 
proximity with the skull of the animal when fired. Firearms must be 
maintained in good repair. For purposes of protecting employees, 
inspectors and others, it is desirable that all firearms be equipped 
with safety devices to prevent injuries from accidental discharge. 
Aiming and discharging of firearms should be directed away from 
operating areas.
    (iii) The provisions contained in Sec. 313.15(b)(1)(iii) with 
respect to the stunning area also apply to the shooting area.
    (iv) The shooting operation is an exacting procedure and requires a 
well-trained and experienced operator. He must be able to accurately 
direct the projectile to produce immediate unconsciousness. He must use 
the correct caliber firearm, powder charge and type of ammunition to 
produce the desired results.
    (2) Special requirements. Choice of firearms and ammunition with 
respect to caliber and choice of powder charge required to produce 
immediate unconsciousness of the animal may vary depending on age and 
sex of the animal. In the case of bulls, rams, and boars, small bore 
firearms may be used provided they are able to produce immediate 
unconsciousness of the animals. Small bore firearms are usually 
effective for stunning other cattle, sheep, swine, and goats, and 
calves, horses, and mules.



Sec. 313.30  Electrical; stunning or slaughtering with electric current.

    The slaughtering of swine, sheep, calves, cattle, and goats with the 
use of electric current and the handling in connection therewith, in 
compliance with the provisions contained in this section, are hereby 
designated and approved as humane methods of slaughtering and handling 
of such animals under the Act.

[[Page 150]]

    (a) Administration of electric current, required effect; handling. 
(1) The electric current shall be administered so as to produce, at a 
minimum, surgical anesthesia, i.e., a state where the animal feels no 
painful sensation. The animals shall be either stunned or killed before 
they are shackled, hoisted, thrown, cast, or cut. They shall be exposed 
to the electric current in a way that will accomplish the desired result 
quickly and effectively, with a minimum of excitement and discomfort.
    (2) The driving or conveying of the animals to the place of 
application of electric current shall be done with a minimum of 
excitement and discomfort to the animals. Delivery of calm animals to 
the place of application is essential to ensure rapid and effective 
insensibility. Among other things, this requires that, in driving 
animals to the place of application, electrical equipment be used as 
little as possible and with the lowest effective voltage.
    (3) The quality and location of the electrical shock shall be such 
as to produce immediate insensibility to pain in the exposed animal.
    (4) The stunned animal shall remain in a state of surgical 
anesthesia through shackling, sticking, and bleeding.
    (b) Facilities and procedures; operator--(1) General requirements 
for operator. It is necessary that the operator of electric current 
application equipment be skilled, attentive, and aware of his or her 
responsibility.
    (2) Special requirements for electric current application equipment. 
The ability of electric current equipment to perform with maximum 
efficiency is dependent on its proper design and efficient mechanical 
operation. Pathways, compartments, current applicators, and all other 
equipment used must be designed to properly accommodate the species of 
animals being anesthetized. Animals shall be free from pain-producing 
restraining devices. Injury of animals must be prevented by the 
elimination of sharp projections or exposed wheels or gears. There shall 
be no unnecessary holes, spaces or openings where feet or legs of 
animals may be injured. Impellers or other devices designed to 
mechanically move or drive animals or otherwise keep them in motion or 
compartmentalized shall be constructed of flexible or padded material. 
Power activated gates designed for constant flow of animals shall be so 
fabricated that they will not cause injury. All equipment used to apply 
and control the electrical current shall be maintained in good repair, 
and all indicators, instruments, and measuring devices shall be 
available for inspection by Program inspectors during the operation and 
at other times.
    (3) Electric current. Each animal shall be given a sufficient 
application of electric current to ensure surgical anesthesia throughout 
the bleeding operation. Suitable timing, voltage and current control 
devices shall be used to ensure that each animal receives the necessary 
electrical charge to produce immediate unconsciousness. The current 
shall be applied so as to avoid the production of hemorrhages or other 
tissue changes which could interfere with inspection procedures.

[44 FR 68813, Nov. 30, 1979, as amended at 50 FR 25202, June 18, 1985]



Sec. 313.50  Tagging of equipment, alleyways, pens, or compartments 
to prevent inhumane slaughter or handling in connection with slaughter.

    When an inspector observes an incident of inhumane slaughter or 
handling in connection with slaughter, he/she shall inform the 
establishment operator of the incident and request that the operator 
take the necessary steps to prevent a recurrence. If the establishment 
operator fails to take such action or fails to promptly provide the 
inspector with satisfactory assurances that such action will be taken, 
the inspector shall follow the procedures specified in paragraph (a), 
(b), or (c) of this section, as appropriate.
    (a) If the cause of inhumane treatment is the result of facility 
deficiencies, disrepair, or equipment breakdown, the inspector shall 
attach a ``U.S. Rejected'' tag thereto. No equipment, alleyway, pen or 
compartment so tagged shall be used until made acceptable to the 
inspector. The tag shall not be removed by anyone other than an 
inspector. All livestock slaughtered prior to such tagging may

[[Page 151]]

be dressed, processed, or prepared under inspection.
    (b) If the cause of inhumane treatment is the result of 
establishment employee actions in the handling or moving of livestock, 
the inspector shall attach a ``U.S. Rejected'' tag to the alleyways 
leading to the stunning area. After the tagging of the alleyway, no more 
livestock shall be moved to the stunning area until the inspector 
receives satisfactory assurances from the establishment operator that 
there will not be a recurrence. The tag shall not be removed by anyone 
other than an inspector. All livestock slaughtered prior to the tagging 
may be dressed, processed, or prepared under inspection.
    (c) If the cause of inhumane treatment is the result of improper 
stunning, the inspector shall attach a ``U.S. Rejected'' tag to the 
stunning area. Stunning procedures shall not be resumed until the 
inspector receives satisfactory assurances from the establishment 
operator that there will not be a recurrence. The tag shall not be 
removed by anyone other than an inspector. All livestock slaughtered 
prior to such tagging may be dressed, processed, or prepared under 
inspection.



Sec. 313.90  [Reserved]



PART 314_HANDLING AND DISPOSAL OF CONDEMNED OR OTHER INEDIBLE PRODUCTS 
AT OFFICIAL ESTABLISHMENTS--Table of Contents




Sec.
314.1 Disposition of condemned products at official establishments 
          having tanking facilities; sealing of tanks.
314.2 Tanking and other facilities for inedible products to be separate 
          from edible product facilities.
314.3 Disposition of condemned products at official establishments 
          having no tanking facilities.
314.4 Suppression of odors in preparing inedible products.
314.5 Inedible rendered fats prepared at official establishments.
314.6 Inedible fats from outside official establishments.
314.7 Carcasses of livestock condemned on ante-mortem inspection not to 
          pass through edible product areas.
314.8 Dead animal carcasses.
314.9 Specimens for educational, research, and other nonfood purposes; 
          permits for, required.
314.10 Livers condemned because of parasitic infestation and for other 
          causes; conditions for disposal for purposes other than human 
          food.
314.11 Handling of certain condemned products for purposes other than 
          human food.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 15575, Oct. 3, 1970, unless otherwise noted.



Sec. 314.1  Disposition of condemned products at official establishments 
having tanking facilities; sealing of tanks.

    (a) Carcasses, parts of carcasses, and other products condemned at 
official establishments having facilities for tanking shall, except as 
provided in paragraph (c) of this section or elsewhere in this part, be 
disposed of by tanking as follows:
    (1) The lower opening of the tank shall first be sealed securely by 
a Program employee, except when permanently connected with a blow line; 
then the condemned products shall be placed in the tank in his presence, 
after which the upper opening shall also be sealed securely by such 
employee, who shall then see that the contents of the tank are subjected 
to sufficient heating for sufficient time to effectively destroy the 
contents for human food purposes.
    (2) The use of equipment such as crushers or hashers for pretanking 
preparation of condemned products in the inedible products department 
has been found to give inedible character and appearance to the 
material. Accordingly, if condemned products are so crushed or hashed, 
conveying systems, rendering tanks, and other equipment used in the 
further handling of crushed or hashed material need not be locked or 
sealed during the tanking operations. If the rendering tanks or other 
equipment contain condemned material not so crushed or hashed, the 
equipment shall be sealed as prescribed in paragraph (a)(1) of this 
section. If the crushed or hashed material is not rendered in the 
establishment where produced, it shall be denatured as provided for in 
Sec. 314.3 before leaving such establishment.

[[Page 152]]

    (b) The seals of tanks shall be broken only by a Program employee 
and only after the contents of the tanks have been treated as provided 
in paragraph (a) of this section. The rendered fat derived from 
condemned material shall be held until a Program employee shall have had 
an opportunity to determine whether it conforms with the requirements of 
this section. Samples shall be taken by Program employees as often as is 
necessary to determine whether the rendered fat is effectually 
denatured.
    (c) Carcasses of animals condemned under Sec. 309.3 of this 
subchapter may be disposed of as provided in Sec. 314.3, in lieu of 
tanking, with the approval of the inspector.



Sec. 314.2  Tanking and other facilities for inedible products to be 
separate from edible product facilities.

    All tanks and equipment used for rendering, otherwise preparing, or 
storing inedible products must be in rooms or compartments separate from 
those used for preparing or storing edible products. There may be a 
connection between rooms or compartments containing inedible products 
and those containing edible products as long as it does not cause the 
adulteration of edible product or create insanitary conditions.

[64 FR 56416, Oct. 20, 1999]



Sec. 314.3  Disposition of condemned products at official establishments 
having no tanking facilities.

    (a) Carcasses, parts of carcasses, and other products condemned at 
an official establishment which has no facilities for tanking shall, 
except as provided in paragraph (b) of this section or elsewhere in this 
part, be destroyed in the presence of an inspector by incineration, or 
denatured with crude carbolic acid, or cresylic disinfectant, or a 
formula consisting of one part FD&C No. 3 green coloring, 40 parts 
water, 40 parts liquid detergent, and 40 parts oil of citronella or any 
other proprietary material approved by the Administrator in specific 
cases. When such product is to be denatured, it shall be freely slashed 
before the denaturing agent is applied, except that, in the case of dead 
animals that have not been dressed, the denaturant may be applied by 
injection. The denaturant must be deposited in all portions of the 
carcass or product to the extent necessary to preclude its use for food 
purposes.
    (b) All carcasses and parts condemned on account of anthrax, as 
identified in Sec. 310.9(b) of this subchapter, at official 
establishments which are not equipped with tanking facilities shall be 
disposed of by (1) complete incineration, or (2) by thorough denaturing 
with crude carbolic acid, or cresylic disinfectant, and then disposed of 
in accordance with the requirements of the particular State or municipal 
authorities, who shall be notified immediately by the area supervisor.



Sec. 314.4  Suppression of odors in preparing inedible products.

    Tanks, fertilizer driers, and other equipment used in the 
preparation of inedible product must be operated in a manner that will 
suppress odors incident to such preparation which could adulterate 
edible product or create insanitary conditions.

[64 FR 56416, Oct. 20, 1999]



Sec. 314.5  Inedible rendered fats prepared at official establishments.

    Except as provided in Sec. 325.11(b) of this subchapter, rendered 
animal fat derived from condemned or other inedible materials at 
official establishments shall be denatured to effectually distinguish it 
from an edible product, either with low grade offal during the rendering 
or by adding to, and mixing thoroughly with, such fat, denaturing oil, 
No. 2 fuel oil, or brucine dissolved in a mixture of alcohol and pine 
oil or oil of rosemary, and may be shipped in commerce in accordance 
with Sec. 325.11(c) of this subchapter.

[35 FR 15575, Oct. 3, 1970, as amended at 53 FR 24679, June 30, 1988]



Sec. 314.6  Inedible fats from outside official establishments.

    Except as provided in Sec. 325.11(b) of this subchapter, inedible 
fats from outside the premises of any official establishment shall not 
be received into an official establishment except into the

[[Page 153]]

tank room provided for inedible products, and then only when they have 
been denatured in accordance with Sec. 314.5 and are marked in 
accordance with Sec. 316.15 of this subchapter, and when their receipt 
into the tank room produces no insanitary condition on the premises; nor 
shall such fats be received in such volume as interferes with prompt 
disposal of condemned or other inedible material produced at the 
establishment. When received, they shall not enter any room or 
compartment used for edible products.

[35 FR 15575, Oct. 3, 1970, as amended at 53 FR 24679, June 30, 1988]



Sec. 314.7  Carcasses of livestock condemned on ante-mortem inspection 
not to pass through edible product areas.

    Carcasses of livestock which have been condemned on ante-mortem 
inspection shall not be taken through rooms or compartments in which an 
edible product is prepared, handled, or stored.



Sec. 314.8  Dead animal carcasses.

    (a) With the exception of dead livestock which have died en route 
and are received with livestock for slaughter at an official 
establishment, no dead animal or part of the carcass of any livestock 
that died otherwise than by slaughter may be brought on the premises of 
an official establishment unless advance permission therefore is 
obtained from the circuit supervisor.
    (b) Under no circumstances shall the carcasses of any animal which 
has died otherwise than by slaughter, or any part thereof, be brought 
into any room or compartment in which any edible product is prepared, 
handled, or stored.



Sec. 314.9  Specimens for educational, research, and other nonfood 
purposes; permits for, required.

    (a) Specimens of condemned or other inedible materials, including 
embryos and specimens of animal parasites, may be released for 
educational, research, or other nonfood purposes under permit issued by 
the inspector in charge: Provided, That the person desiring such 
specimens makes a written application to the inspector in charge for 
such permit on Form MP-403-10 and arranges with and receives permission 
from the official establishment to obtain the specimens. Permits shall 
be issued for a period not longer than 1 year. The permit may be revoked 
by the inspector in charge if the specimens are not used as stated in 
the application, or if the collection or handling of the specimens 
interferes with inspection or the maintenance of sanitary conditions in 
the establishment.
    (b) The specimens referred to in paragraph (a) of this section shall 
be collected and handled only at such time and place and in such manner 
as not to interfere with the inspection or to cause any objectionable 
condition and shall be identified as inedible when they leave the 
establishment.

[35 FR 15575, Oct. 3, 1970, as amended at 38 FR 18665, July 13, 1973; 39 
FR 36000, Oct. 7, 1974]



Sec. 314.10  Livers condemned because of parasitic infestation and for 
other causes; conditions for disposal for purposes other than human food.

    (a) Livers condemned on account of hydatid cysts shall be disposed 
of by tanking pursuant to the provisions of Sec. 314.1 of this 
subchapter if condemned at official establishments having facilities for 
tanking; otherwise they shall be destroyed pursuant to the provisions of 
Sec. 314.3 of this subchapter.
    (b) Livers condemned because of parasites other than hydatid cysts; 
and livers condemned because of telangiectasis, angioma, ``sawdust'' 
condition, cirrhosis, carotenosis, or other nonmalignant change, benign 
abscesses, or contamination, when these conditions are not associated 
with infectious diseases in the carcasses, may be shipped from an 
official establishment only for purposes other than human food, and only 
if all tissue affected with abscesses is removed and destroyed within 
the establishment, and all livers are processed and denatured, with any 
agent prescribed in Sec. 325.13(a)(1) or (2) or (5), and in accordance 
with Sec. 325.13(a)(6) of this subchapter. This provision for movement 
from an official establishment is made solely under the Federal Meat 
Inspection Act and is not intended to relieve or modify any other 
applicable requirements under any other law regarding

[[Page 154]]

the movement of such articles, for purposes other than use as human 
food.
    (c) Livers condemned because of conditions described in paragraph 
(b) of this section shall be in containers plainly marked ``inedible''.

[41 FR 23701, June 11, 1976]



Sec. 314.11  Handling of certain condemned products for purposes other 
than human food.

    Condemned carcasses of animals affected with one or more of the 
following conditions may be shipped from an official establishment only 
for purposes other than human food and only if permission therefor is 
obtained from the circuit supervisor: Anasarca, Ocular Squamous Cell 
Carcinoma (after removal of neoplastic tissue), emaciation, eosinophilic 
myositis, immaturity, nonseptic bruises and injuries, and 
sarcosporidiosis. This provision also applies to unborn calves and to 
products such as paunches and udders when they have not been handled as 
required under this subchapter for products for human food purposes; 
provided, such articles have not been condemned for other pathological 
reasons. Such permission will be granted only if all parts to be so used 
will be promptly handled, freely slashed and adequately identified as 
required by Sec. 325.13(a)(2) of this subchapter. The slashing, 
identification and packing of the product shall be accomplished in an 
inedible product area under the supervision of an inspector. Facilities 
must be adequate so that the carcasses or parts saved under these 
provisions are not contaminated with pus, manure, septic, or toxic 
materials, or similar substances. The operation must not result in 
unsanitary conditions within the establishment.

[35 FR 15575, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 36 
FR 11903, June 23, 1971]



PART 315_RENDERING OR OTHER DISPOSAL OF CARCASSES AND PARTS PASSED FOR 
COOKING--Table of Contents




Sec.
315.1 Carcasses and parts passed for cooking; rendering into lard or 
          tallow.
315.2 Carcasses and parts passed for cooking; utilization for food 
          purposes after cooking.
315.3 Disposal of products passed for cooking if not handled according 
          to this part.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



Sec. 315.1  Carcasses and parts passed for cooking; rendering into lard 
or tallow.

    Carcasses and parts passed for cooking may be rendered into lard in 
accordance with Sec. 319.702 of this subchapter or rendered into 
tallow, provided such rendering is done in the following manner:
    (a) When closed rendering equipment is used, the lower opening, 
except when permanently connected with a blowline, shall first be sealed 
securely by a Program employee; then the carcasses or parts shall be 
placed in such equipment in his presence, after which the upper opening 
shall be securely sealed by such employee. When the product passed for 
cooking in the tank does not consist of a carcass or whole primal part, 
the requirements for sealing shall be at the discretion of the circuit 
supervisor. Such carcasses and parts shall be cooked for a time 
sufficient to render them effectually into lard or tallow, provided all 
parts of the products are heated to a temperature not lower than 170 
[deg]F. for a period of not less than 30 minutes.
    (b) At establishments not equipped with closed rendering equipment 
for rendering carcasses and parts passed for cooking into lard and 
tallow, such carcasses or parts may be rendered in open kettles under 
the direct supervision of a Program employee. Such rend ering shall be 
done during regular hours of work and in compliance with the 
requirements as to temperature and time specified in paragraph (a) of 
this section.

[35 FR 15577, Oct. 3, 1970, as amended at 43 FR 25420, June 13, 1978]



Sec. 315.2  Carcasses and parts passed for cooking; utilization for food 
purposes after cooking.

    Carcasses and parts passed for cooking may be used for the 
preparation of meat food products, provided all such carcasses or parts 
are heated to a temperature not lower than 170 [deg]F. for a

[[Page 155]]

period of not less than 30 minutes either before being used in or during 
the preparation of the finished product.

[37 FR 2661, Feb. 4, 1972]



Sec. 315.3  Disposal of products passed for cooking if not handled according 
to this part.

    Products passed for cooking if not handled and processed in 
accordance with the provisions of this part, shall be disposed of in 
accordance with Sec. 314.1 or Sec. 314.3 of this subchapter.

[35 FR 15577, Oct. 3, 1970. Redesignated at 37 FR 2661, Feb. 4, 1972]



PART 316_MARKING PRODUCTS AND THEIR CONTAINERS--Table of Contents




Sec.
316.1 Authorization required to make devices bearing official marks.
316.2 Approval required for official marks.
316.3 Use of official marks prohibited except under supervision of 
          Program employee; removal of official marks, when required.
316.4 Marking devices; to be furnished by official establishments; 
          control of.
316.5 Branding ink; to be furnished by official establishments; approval 
          by Program; color.
316.6 Products not to be removed from official establishments unless 
          marked in accordance with the regulations.
316.7 Marking devices not to be false or misleading; style and size of 
          lettering; approval required.
316.8 Unmarked inspected products; moved between official 
          establishments; moved in commerce.
316.9 Products to be marked with official marks.
316.10 Marking of meat food products with official inspection legend and 
          ingredient statement.
316.11 Special markings for certain meat food products.
316.12 Marking of equine carcasses and parts thereof.
316.13 Marking of outside containers.
316.14 Marking tank cars and tank trucks used in transportation of 
          edible products.
316.15 Marking outside containers of inedible grease, etc.
316.16 Custom prepared products to be marked ``Not for Sale.''

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 15577, Oct. 3, 1970, unless otherwise noted.



Sec. 316.1  Authorization required to make devices bearing official marks.

    No brand manufacturer, printer or other person shall cast, print, 
lithograph, or otherwise make or cause to be made any device containing 
any official mark or simulation thereof without prior written authority 
therefor from the Administrator as provided for in part 317 of this 
subchapter.



Sec. 316.2  Approval required for official marks.

    No device containing any official mark shall be made or caused to be 
made for use on any product until it has been approved by the 
Administrator as provided for in part 317 of this subchapter.



Sec. 316.3  Use of official marks prohibited except under supervision of 
Program employee; removal of official marks, when required.

    (a) No person shall affix or place, or cause to be affixed or 
placed, the official inspection legend or any other official mark, or 
any abbreviation or simulation of any official mark, to or on any 
product, or container thereof, except under the supervision of a Program 
employee, or as authorized by part 317 of this subchapter in connection 
with the manufacture of containers.
    (b) No person shall fill, or cause to be filled, in whole or in 
part, with any product, any container bearing or intended to bear any 
official mark, or any abbreviation or simulation of any official mark, 
except under the supervision of a Program employee.
    (c) Product bearing any official mark shall not be canned, cooked, 
cured, smoked, salted, packed, rend ered, or otherwise prepared by any 
person for commercial purposes unless:
    (1) Such preparation is performed at an official establishment; or
    (2) Such preparation is conducted under State or other governmental 
inspection and the prepared product is marked to show that fact; or
    (3) The official marks are removed, defaced, or otherwise destroyed 
before or during such preparation; or
    (4) The preparation of the product consists solely of cutting up 
operations at any establishment exempted from

[[Page 156]]

inspection under paragraph 301(c)(2) of the Act or equal provisions of a 
law of a State or organized Territory or at any establishment in an 
unorganized Territory exempted under paragraph 23(b) of the Act.



Sec. 316.4  Marking devices; to be furnished by official establishments; 
control of.

    (a) The operator of each official establishment or official import 
inspection establishment shall furnish such ink brands, burning brands, 
and any other device for marking products with official marks as the 
Administrator may determine is necessary for marking products at such 
establishment. The official inspection legend on such a device shall be 
as prescribed in part 312 of this subchapter.
    (b) All official devices for marking products with the official 
inspection legend, or other official inspection marks, including self-
locking seals, shall be used only under supervision of a Program 
employee, and, when not in use for marking shall be kept locked in 
properly equipped locks or compartments, the keys of which shall not 
leave the possession of a Program employee, or the locker or compartment 
shall be sealed with an official seal of the Department as prescribed in 
part 312 of this subchapter.

[35 FR 15577, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971; 46 
FR 38072, July 24, 1981]



Sec. 316.5  Branding ink; to be furnished by official establishments; 
approval by Program; color.

    (a) The operator of each official establishment shall furnish all 
ink for marking products with the official marks at such establishment. 
Such ink must be made with harmless ingredients that are approved for 
the purpose by the Administrator. Samples of inks shall be submitted to 
the Program laboratory from time to time as may be deemed necessary by 
the inspector in charge.
    (b) Only ink approved for the purpose shall be used to apply ink 
brands bearing official marks to carcasses of cattle, sheep, swine, or 
goats and fresh meat cuts derived therefrom. Any ink containing F.D. & 
C. Violet No. 1 shall not be considered an approved ink within the 
meaning of this paragraph.
    (c) Green ink shall not be used to apply marks to carcasses of 
cattle, sheep, swine, or goats or fresh meat cuts derived therefrom.
    (d) Except as provided in paragraphs (b) and (c) of this section, 
branding ink of any color, approved for the purpose by the Administrator 
in specific cases, may be used to apply ink brands, bearing official 
marks, to processed meat cuts derived from cattle, sheep, swine, or 
goats.
    (e) Only green ink approved for the purpose shall be used to apply 
ink brands bearing official marks to carcasses and parts of carcasses 
and meat cuts derived from horses, mules, and other equines.
    (f) Ink used must assure legibility and permanence of the markings 
and the color of ink shall provide acceptable contrast with the color of 
the product to which it is applied.

[35 FR 15577, Oct. 3, 1970, as amended at 38 FR 9088, Apr. 10, 1973]



Sec. 316.6  Products not to be removed from official establishments 
unless marked in accordance with the regulations.

    No person shall remove or cause to be removed from an official 
establishment any products which the regulations in this subchapter 
require to be marked in any way unless they are clearly and legibly 
marked in compliance with such regulations.



Sec. 316.7  Marking devices not to be false or misleading; style and 
size of lettering; approval required.

    No brand or other marking device shall be false or misleading. The 
letters and figures thereon shall be of such style and type as will make 
a clear and legible impression. All markings to be applied to products 
in an official establishment shall be approved prior to use by the 
Administrator as provided for in Sec. 317.3 of this subchapter, except 
that official markings prescribed by the Federal meat grading 
regulations (7 CFR 53.19) need not be submitted to the Administrator for 
approval.

[[Page 157]]



Sec. 316.8  Unmarked inspected products; moved between official 
establishments; moved in commerce.

    (a) Unmarked products which have been inspected and passed but do 
not bear the official inspection legend may be transported in compliance 
with part 325 of this subchapter from one official establishment to 
another official establishment, for further processing, in a railroad 
car, truck, or other closed container, if the railroad car, truck, or 
container is sealed with an official seal of the Department (as 
prescribed in part 312 of this subchapter) bearing the official 
inspection legend.
    (b) Products which have been inspected and passed but do not bear 
the official inspection legend may be removed from an official 
establishment in closed containers bearing the official inspection 
legend and all other information required by this part and part 317 of 
this subchapter: Provided, That upon removal from such closed container 
the product may not be further transported in commerce unless such 
removal is made under the supervision of a Program employee and such 
product is reinspected by a Program employee and packed under his 
supervision in containers bearing the official inspection legend and all 
other information required by this part and part 317 of this subchapter: 
And provided further, That unmarked product shall not be brought into an 
official establishment in an open container.



Sec. 316.9  Products to be marked with official marks.

    (a) Each carcass which has been inspected and passed in an official 
establishment shall be marked at the time of inspection with the 
official inspection legend containing the number of the official 
establishment.
    (b) Except as provided otherwise in Sec. 316.8, each primal part of 
a carcass and each liver, beef tongue, and beef heart which has been 
inspected and passed shall be marked with the official inspection legend 
containing the number of the official establishment before it leaves the 
establishment in which it is first inspected and passed, and each such 
inspected and passed product shall be marked with the official 
inspection legend containing the number of the official establishment 
where it was last prepared. Additional official marks of inspection may 
be applied to products as desired to meet local conditions. Primal parts 
are the wholesale cuts of carcasses as customarily distributed to 
retailers. The round, flank, loin, rib, plate, brisket, chuck, and shank 
are primal parts of beef carcasses. Veal, mutton, and goat primal parts 
are the leg; flank, loin, rack, breast, and shoulder. The ham, belly, 
loin, shoulder, and jowl are pork primal parts. Equine primal parts are 
the round, flank, loin, rib, plate, brisket, chuck, and shank.
    (c) Beef livers shall be marked with the official inspection legend 
containing the number of the official establishment, at which the cattle 
involved were slaughtered, on the convex surface of the thickest portion 
of the organ.
    (d) Inspected and passed parts of carcasses which are not marked 
with the official inspection legend under this section shall not enter 
any official establishment or be sold, transported, or offered for sale 
or transportation, in commerce, except as provided in Sec. 316.8.

[35 FR 15577, Oct. 3, 1970, as amended at 36 FR 23720, Dec. 14, 1971]



Sec. 316.10  Marking of meat food products with official inspection legend 
and ingredient statement.

    (a) Inspected and passed sausages and other products in casings or 
in link form, of the ordinary ``ring'' variety or larger shall be marked 
with the official inspection legend and list of ingredients in 
accordance with part 317 of this subchapter. The official marks required 
by this section shall be branded near each end of the sausage or similar 
product prepared in casings when the product is of a size larger than 
that customarily sold at retail intact.
    (b) Inspected and passed sausage and other products, in casings or 
in link form, of the smaller varieties, shall bear one or more official 
inspection legends and one or more lists of ingredients in accordance 
with part 317 of this subchapter on each kilogram (2.205 lbs.) of 
product, except where such products leave the official establishment 
completely enclosed in properly labeled immediate containers having a

[[Page 158]]

capacity of 5 kilograms (11.025 lbs.) or less and containing a single 
kind of product: Provided, That such products in properly labeled closed 
containers exceeding 5 kilograms (11.025 lbs.) capacity, when shipped to 
another official establishment for further processing or to a 
governmental agency, need only have the official inspection legend and 
list of ingredients shown twice throughout the contents of the 
container. When such products are shipped to another official 
establishment for further processing, the inspector in charge at the 
point of origin shall identify the shipment to the inspector in charge 
at destination by means of Form MP 408-1.
    (c) The list of ingredients may be applied by stamping, printing, 
using paper bands, tags, or tissue strips, or other means approved by 
the Administrator in specific cases.
    (d) All cured products shall be marked with the list of ingredients 
in accordance with part 317 of this subchapter.

[35 FR 15577, Oct. 3, 1970, as amended at 37 FR 16863, Aug. 22, 1972; 38 
FR 4385, Feb. 14, 1973; 39 FR 36000, Oct. 7, 1974; 44 FR 67088, Nov. 23, 
1979]



Sec. 316.11  Special markings for certain meat food products.

    (a) Meat food products prepared in casing or link form (whether or 
not thereafter subdivided), other than sausage, which possess the 
characteristics of or resemble sausage, shall bear on each link or piece 
the word ``imitation'' prominently displayed: Provided, That the 
following need not be so marked if they bear on each link or piece the 
name of the product in accordance with Sec. 317.2 of this subchapter: 
Such products as coppa, capocollo, lachschinken, bacon, pork loins, pork 
shoulder butts, and similar cuts of meat which are prepared without 
added substance other than curing materials or condiments; meat rolls, 
bockwurst, and similar products which do not contain cereal or 
vegetables; headcheese, souse, sulze, scrapple, blood pudding, and liver 
pudding; and other products such as loaves, chili con carne, and meat 
and cheese products when prepared with sufficient cheese to give 
definite characteristics to the finished products: And provided further, 
That imitation sausage packed in properly labeled containers having a 
capacity of 3 pounds or less and of a kind usually sold at retail 
intact, need not bear the word ``imitation'' on each link or piece if no 
other marking or labeling is applied directly to the product.
    (b) When cereal, vegetable starch, starchy vegetable flour, soy 
flour, soy protein concentrate, isolated soy protein, dried milk, nonfat 
dry milk, or calcium reduced dried skim milk is added to sausage in 
casing or in link form within the limits prescribed in part 319 of this 
subchapter, the products shall be marked with the name of each added 
ingredient, as for example ``cereal added,'' ``potato flour added,'' 
``cereal and potato flour added,'' ``soy flour added,'' ``isolated soy 
protein added,'' ``nonfat dry milk added,'' ``calcium reduced dried skim 
milk added,'' or ``cereal and nonfat dry milk added,'' as the case may 
be.
    (c)(1) When product is placed in a casing to which artificial 
coloring is thereafter applied, as permitted in part 318 of this 
subchapter, the product shall be legibly and conspicuously marked by 
stamping or printing on the casing the words ``artificially colored.''
    (2) If a casing is removed from product at an official establishment 
and there is evidence of artificial coloring on the surface of the 
product, the product from which the casing has been removed shall be 
marked by stamping directly thereon the words ``artificially colored.''
    (3) The casing containing product need not be marked to show that it 
is colored if it is colored prior to its use as a covering for the 
product, and the coloring is of a kind and so applied as not to be 
transferable to the product and not to be misleading or deceptive in any 
respect.
    (d) When an approved artificial smoke flavoring or an approved smoke 
flavoring is added to the formula of any meat food product as permitted 
in part 318 of this subchapter, the product shall be legibly and 
conspicuously marked with the words ``Artificial Smoke Flavoring Added'' 
or ``Smoke Flavoring Added,'' whichever may be applicable.

[[Page 159]]

    (e) Subject to the provisions in paragraph (a) of this section, in 
the case of sausage of the smaller varieties, the markings prescribed in 
this section may be limited to links bearing the official inspection 
legend, and such markings shall not be required if the sausages are 
packed in properly labeled containers having a capacity of 3 pounds or 
less and of a kind usually sold at retail intact. Further, all markings 
otherwise required by this section (except those required by paragraph 
(a) of this section) may be omitted from the casings of sausage and 
other meat food products when these products are to be processed in 
sealed metal containers properly labeled in accordance with the 
requirements in part 317 of this subchapter.
    (f) When an approved antioxidant is added to any meat food product 
as permitted in parts 318 and 319 of this subchapter, the products shall 
be legibly and conspicuously marked in an approved manner identifying 
the specific antioxidant used by its common name or approved 
abbreviation and the purpose for which it is added, such as, ``BHA, BHT, 
and Propylgallate added to help protect flavor.''
    (g) Sausage of the dry varieties treated with potassium sorbate or 
propylparaben (propyl p-hy drox y ben zoate) as permitted by part 318 of 
this subchapter shall be marked as prescribed in Sec. 317.8(b)(28) of 
this subchapter).



Sec. 316.12  Marking of equine carcasses and parts thereof.

    (a) All inspected and passed equine carcasses and parts thereof 
prepared at any establishment shall be conspicuously marked at the time 
of inspection with the official inspection legend as prescribed in Sec. 
312.3 of this subchapter and with other information prescribed for 
marking products in this part.
    (b) All equine carcasses and meat and other parts thereof shall be 
marked to show the kinds of animals from which they were derived, before 
the products are sold, transported, offered for sale or transportation, 
or received for transportation in commerce.



Sec. 316.13  Marking of outside containers.

    (a) Except as otherwise provided in part 325 of this subchapter, 
when any inspected and passed product for domestic commerce is moved 
from an official establishment, the outside container shall bear an 
official inspection legend as prescribed in part 312 of this subchapter.
    (b) When any product prepared in an official establishment for 
domestic commerce has been inspected and passed and is enclosed in a 
cloth or other wrapping, such wrapping shall bear the official 
inspection legend and official establishment number applied by the 
approved 2\1/2\-inch rubber brand in the form prescribed in part 312 of 
this subchapter: Provided, That the rubber brand may be omitted if the 
official inspection legend and official establishment number on the 
product itself are clearly legible through the wrapping or the wrapping 
is labeled in accordance with part 317 of this subchapter: Provided 
further, That plain unprinted wrappings, such as stockinettes, 
cheesecloth, paper, and crinkled paper bags, for properly marked 
products, which are used solely to protect the product against soiling 
or excessive drying during transportation or storage, need not bear the 
official inspection legend.
    (c) The outside containers of products for export shall be marked in 
compliance with part 322 of this subchapter as well as this part.
    (d) Slack barrels used as outside containers of products shall have 
a cloth or paper top covering bearing the official inspection legend 
containing the official establishment number. At the time of removal of 
the covering, the official inspection legend shall be destroyed.
    (e) The outside containers of any product which has been inspected 
and passed for cooking, pork which has been refrigerated as provided in 
Sec. 318.10(c) of this subchapter, and beef which has been inspected 
and passed for refrigeration shall bear the markings and tag prescribed 
in Sec. 325.7(b) of this subchapter.
    (f) The outside containers of glands and organs which are not used 
for human food purposes, such as those described in Sec. 325.19 of this 
subchapter,

[[Page 160]]

shall be plainly marked with the phrase ``For pharmaceutical purposes,'' 
``For organotherapeutic purposes'' or ``For technical purposes,'' as 
appropriate, with no reference to inspection, and need not bear other 
markings otherwise required under the regulations in this subchapter.
    (g) Stencils, box dies, labels, and brands may be used on shipping 
containers of properly labeled products and on such immediate 
containers, of properly marked products, as tierces, barrels, drums, 
boxes, crates, and large-size fiber-board containers, without approval 
as provided for in Sec. 317.3 of this subchapter: Provided, That the 
stencils, box dies, labels, and brands are not false or misleading and 
are approved by the inspector in charge. The official inspection legend 
for use with such markings shall be approved by the Administrator as 
provided for in part 317 of this subchapter.
    (h) The outside containers of livers prepared as described in Sec. 
314.10(b), shall be marked as prescribed in Sec. 314.10(c) of this 
subchapter.
    (i) The outside containers of any equine product shall be marked to 
show the kinds of animals from which derived, when the products are 
sold, transported, offered for sale or transported, or received for 
transportation in commerce.

[35 FR 15577, Oct. 3, 1970, as amended at 43 FR 29268, July 7, 1978]



Sec. 316.14  Marking tank cars and tank trucks used in transportation 
of edible products.

    Each tank car and each tank truck carrying inspected and passed 
product from an official establishment shall bear a label containing the 
name of the product in accordance with Sec. 317.2 of this subchapter, 
the official inspection legend containing the number of the official 
establishment and the words ``date of loading,'' followed by a suitable 
space in which the date the tank car or tank truck is loaded shall be 
inserted. The label shall be located conspicuously and shall be printed 
on material of such character and so affixed as to preclude detachment 
or effacement upon exposure to the weather. Before the car or truck is 
removed from the place where it is unloaded, the carrier shall remove or 
obliterate such label.

[53 FR 28634, July 29, 1988]



Sec. 316.15  Marking outside containers of inedible grease, etc.

    (a) Outside containers of inedible grease, inedible tallow, or other 
inedible animal fat, or mixture of any such articles, resulting from 
operations at any official establishment shall be marked conspicuously 
with the word ``inedible'' prior to removal from the point of filling. 
Containers, such as tierces, barrels, and half barrels shall have both 
ends painted white with durable paint, if necessary, to provide a 
contrasting background, and the word ``inedible'' shall be marked 
thereon in letters not less than 2 inches high, while on tank cars and 
tank trucks the letters shall be not less than 4 inches high.
    (b) Inspected rendered animal fat which is intended not to be used 
for human food may also be marked ``inedible'' if handled as provided in 
paragraph (a) of this section and part 314 of this subchapter.



Sec. 316.16  Custom prepared products to be marked ``Not for Sale.''

    Carcasses and parts therefrom that are prepared on a custom basis 
under Sec. 303.1(a)(2) of this subchapter shall be marked at the time 
of preparation with the term ``Not for Sale'' in letters at least three-
eighths inch in height, except that such products need not be so marked 
if in immediate containers properly labeled in accordance with the 
regulations in Sec. 317.16 of this subchapter. Ink used for marking 
such products must comply with the requirements of Sec. 316.5.

[35 FR 15577, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973]



PART 317_LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents




                            Subpart A_General

Sec.
317.1 Labels required; supervision by Program employee.
317.2 Labels: definition; required features.

[[Page 161]]

317.3 Approval of abbreviations of marks of inspection; preparation of 
          marking devices bearing inspection legend without advance 
          approval prohibited; exception.
317.4 Labeling approval.
317.5 Generically approved labeling.
317.6 Approved labels to be used only on products to which they are 
          applicable.
317.7 Products for foreign commerce; printing labels in foreign language 
          permissible; other deviations.
317.8 False or misleading labeling or practices generally; specific 
          prohibitions and requirements for labels and containers.
317.9 Labeling of equine products.
317.10 Reuse of official inspection marks; reuse of containers bearing 
          official marks, labels, etc.
317.11 Labeling, filling of containers, handling of labeled products to 
          be only in compliance with regulations.
317.12 Relabeling products; requirements.
317.13 Storage and distribution of labels and containers bearing 
          official marks.
317.14-317.15 [Reserved]
317.16 Labeling and containers of custom prepared products.
317.17 Interpretation and statement of labeling policy for cured 
          products; special labeling requirements concerning nitrate and 
          nitrite.
317.18 Quantity of contents labeling.
317.19 Definitions and procedures for determining net weight compliance.
317.20 Scale requirements for accurate weights, repairs, adjustments, 
          and replacement after inspection.
317.21 Scales: testing of.
317.22 Handling of failed product.
317.23 [Reserved]
317.24 Packaging materials.

                      Subpart B_Nutrition Labeling

317.300 Nutrition labeling of meat or meat food products.
317.301 [Reserved]
317.302 Location of nutrition information.
317.303-317.307 [Reserved]
317.308 Labeling of meat or meat food products with number of servings.
317.309 Nutrition label content.
317.310-317.311 [Reserved]
317.312 Reference amounts customarily consumed per eating occasion.
317.313 Nutrient content claims; general principles.
317.314-317.342 [Reserved]
317.343 Significant participation for voluntary nutrition labeling.
317.344 Identification of major cuts of meat products.
317.345 Guidelines for voluntary nutrition labeling of single-
          ingredient, raw products.
317.346-317.353 [Reserved]
317.354 Nutrient content claims for ``good source,'' ``high,'' and 
          ``more''.
317.355 [Reserved]
317.356 Nutrient content claims for ``light'' or ``lite''.
317.357-317.359 [Reserved]
317.360 Nutrient content claims for calorie content.
317.361 Nutrient content claims for the sodium content.
317.362 Nutrient content claims for fat, fatty acids, and cholesterol 
          content.
317.363 Nutrient content claims for ``healthy''.
317.364-317.368 [Reserved]
317.369 Labeling applications for nutrient content claims.
317.370-317.379 [Reserved]
317.380 Label statements relating to usefulness in reducing or 
          maintaining body weight.
317.381-317.399 [Reserved]
317.400 Exemption from nutrition labeling.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    Source: 35 FR 15580, Oct. 3, 1970, unless otherwise noted.



                            Subpart A_General



Sec. 317.1  Labels required; supervision by Program employee.

    (a) When, in an official establishment, any inspected and passed 
product is placed in any receptacle or covering constituting an 
immediate container, there shall be affixed to such container a label as 
described in Sec. 317.2 except that the following do not have to bear 
such a label.
    (1) Wrappings of dressed carcasses and primal parts in an 
unprocessed state, bearing the official inspection legend, if such 
wrappings are intended solely to protect the product against soiling or 
excessive drying during transportation or storage, and the wrappings 
bear no information except company brand names, trade marks, or code 
numbers which do not include any information required by Sec. 317.2;
    (2) Uncolored transparent coverings, such as cellophane, which bear 
no written, printed, or graphic matter and which enclose any unpackaged 
or packaged product bearing all markings required by part 316 of this 
subchapter which are clearly legible through such coverings;

[[Page 162]]

    (3) Animal and transparent artificial casings bearing only the 
markings required by part 316 of this subchapter;
    (4) Stockinettes used as ``operative devices'', such as those 
applied to cured meats in preparation for smoking, whether or not such 
stockinettes are removed following completion of the operations for 
which they were applied;
    (5) Containers such as boil-in bags, trays of frozen dinners, and 
pie pans which bear no information except company brand names, 
trademarks, code numbers, directions for preparation and serving 
suggestions, and which are enclosed in a consumer size container that 
bears a label as described in Sec. 317.2;
    (6) Containers of products passed for cooking or refrigeration and 
moved from an official establishment under Sec. 311.1 of this 
subchapter.
    (b) Folders and similar coverings made of paper or similar 
materials, whether or not they completely enclose the product and which 
bear any written, printed, or graphic matter, shall bear all features 
required on a label for an immediate container.
    (c) No covering or other container which bears or is to bear a label 
shall be filled, in whole or in part, except with product which has been 
inspected and passed in compliance with the regulations in this 
subchapter, which is not adulterated and which is strictly in accordance 
with the statements on the label. No such container shall be filled, in 
whole or in part, and no label shall be affixed thereto, except under 
supervision of a Program employee.



Sec. 317.2  Labels: definition; required features.

    (a) A label within the meaning of this part shall mean a display of 
any printing, lithographing, embossing, stickers, seals, or other 
written, printed, or graphic matter upon the immediate container (not 
including package liners) of any product.
    (b) Any word, statement, or other information required by this part 
to appear on the label must be prominently placed thereon with such 
conspicuousness (as compared with other words, statements, designs, or 
devices, in the labeling) and in such terms as to render it likely to be 
read and understood by the ordinary individual under customary 
conditions of purchase and use. In order to meet this requirement, such 
information must appear on the principal display panel except as 
otherwise permitted in this part. Except as provided in Sec. 317.7, all 
words, statements, and other information required by or under authority 
of the Act to appear on the label or labeling shall appear thereon in 
the English language: Provided, however, That in the case of products 
distributed solely in Puerto Rico, Spanish may be substituted for 
English for all printed matter except the USDA inspection legend.
    (c) Labels of all products shall show the following information on 
the principal display panel (except as otherwise permitted in this 
part), in accordance with the requirements of this part or, if 
applicable, part 319 of this subchapter:
    (1) The name of the product, which in the case of a product which 
purports to be or is represented as a product for which a definition and 
standard of identity or composition is prescribed in part 319 of this 
subchapter, shall be the name of the food specified in the standard, and 
in the case of any other product shall be the common or usual name of 
the food, if any there be, and if there is none, a truthful descriptive 
designation, as prescribed in paragraph (e) of this section;
    (2) If the product is fabricated from two or more ingredients, the 
word ``ingredients'' followed by a list of the ingredients as prescribed 
in paragraph (f) of this section;
    (3) The name and place of business of the manufacturer, packer, or 
distributor for whom the product is prepared, as prescribed in paragraph 
(g) of this section;
    (4) An accurate statement of the net quantity of contents, as 
prescribed in paragraph (h) of this section;
    (5) An official inspection legend and, except as otherwise provided 
in paragraph (i) of this section, the number of the official 
establishment, in the form required by part 312 of this subchapter;
    (6) Any other information required by the regulations in this part 
or part 319 of this subchapter.
    (d) The principal display panel shall be the part of a label that is 
most likely to be displayed, presented, shown, or

[[Page 163]]

examined under customary conditions of display for sale. Where packages 
bear alternate principal display panels, information required to be 
placed on the principal display panel shall be duplicated on each 
principal display panel. The principal display panel shall be large 
enough to accommodate all the mandatory label information required to be 
placed thereon by this part and part 319 of this subchapter with clarity 
and conspicuousness and without obscuring of such information by designs 
or vignettes or crowding. In determining the area of the principal 
display panel, exclude tops, bottoms, flanges at tops and bottoms of 
cans, and shoulders and necks of bottles or jars. The principal display 
panel shall be:
    (1) In the case of a rectangular package, one entire side, the area 
of which is at least the product of the height times the width of that 
side.
    (2) In the case of a cylindrical or nearly cylindrical container:
    (i) An area that is 40 percent of the product of the height of the 
container times the circumference of the container, or
    (ii) A panel, the width of which is one-third of the circumference 
and the height of which is as high as the container: Provided, however, 
That if there is immediately to the right or left of such principal 
display panel, a panel which has a width not greater than 20 percent of 
the circumference and a height as high as the container, and which is 
reserved for information prescribed in paragraphs (c) (2), (3), and (5), 
such panel shall be known as the ``20 percent panel'' and such 
information may be shown on that panel in lieu of showing it on the 
principal display panel.
    (3) In the case of a container of any other shape, 40 percent of the 
total surface of the container.
    (e) Any descriptive designation used as a product name for a product 
which has no common or usual name shall clearly and completely identify 
the product. Product which has been prepared by salting, smoking, 
drying, cooking, chopping, or otherwise shall be so described on the 
label unless the name of the product implies, or the manner of packaging 
shows that the product was subjected to such preparation. The 
unqualified terms ``meat,'' ``meat byproduct,'' ``meat food product,'' 
and terms common to the meat industry but not common to consumers such 
as ``picnic,'' ``butt,'' ``cala,'' ``square,'' ``loaf,'' ``spread,'' 
``delight,'' ``roll,'' ``plate,'' ``luncheon,'' and ``daisy'' shall not 
be used as names of a product unless accompanied with terms descriptive 
of the product or with a list of ingredients, as deemed necessary in any 
specific case by the Administrator in order to assure that the label 
will not be false or misleading.
    (f)(1) The list of ingredients shall show the common or usual names 
of the ingredients arranged in the descending order of predominance, 
except as otherwise provided in this paragraph.
    (i) The terms spice, natural flavor, natural flavoring, flavor and 
flavoring may be used in the following manner:
    (A) The term ``spice'' means any aromatic vegetable substance in the 
whole, broken, or ground form, with the exceptions of onions, garlic and 
celery, whose primary function in food is seasoning rather than 
nutritional and from which no portion of any volatile oil or other 
flavoring principle has been removed. Spices include the spices listed 
in 21 CFR 182.10, and 184.
    (B) The term ``natural flavor,'' ``natural flavoring,'' ``flavor'' 
or ``flavoring'' means the essential oil, oleoresin, essence or 
extractive, protein hydrolysate, distillate, or any product or roasting, 
heating or enzymolysis, which contains the flavoring constituents 
derived from a spice, fruit or fruit juice, vegetable or vegetable 
juice, edible yeast, herb, bark, bud, root, leaf or any other edible 
portion of a plant, meat, seafood, poultry, eggs, dairy products, or 
fermentation products thereof, whose primary function in food is 
flavoring rather than nutritional. Natural flavors include the natural 
essence or extractives obtained from plants listed in 21 CFR 182.10, 
182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR 
172.510. The term natural flavor, natural flavoring, flavor or flavoring 
may also be used to designate spices, powered onion, powdered garlic, 
and powdered celery.

[[Page 164]]

    (ii) The term ``corn syrup'' may be used to designate either corn 
syrup or corn syrup solids.
    (iii) The term ``animal and vegetable fats'' or ``vegetable and 
animal fats'' may be used to designate the ingredients of mixtures of 
such edible fats in product designated ``compound'' or ``shortening.'' 
``Animal fats'' as used herein means fat derived from inspected and 
passed cattle, sheep, swine, or goats.
    (iv) When a product is coated with pork fat, gelatin, or other 
approved substance and a specific declaration of such coating appears 
contiguous to the name of the product, the ingredient statement need not 
make reference to the ingredients of such coating.
    (v) When two meat ingredients comprise at least 70 percent of the 
meat and meat byproduct ingredients of a formula and when neither of the 
two meat ingredients is less than 30 percent by weight of the total meat 
and meat byproducts used, such meat ingredients may be interchanged in 
the formula without a change being made in the ingredients statement on 
labeling materials: Provided, That the word ``and'' in lieu of a comma 
shall be shown between the declaration of such meat ingredients in the 
statement of ingredients.
    (vi)(A) Product ingredients which are present in individual amounts 
of 2 percent or less by weight may be listed in the ingredients 
statement in other than descending order of predominance: Provided, That 
such ingredients are listed by their common or usual names at the end of 
the ingredients statement and preceded by a quantifying statement, such 
as ``Contains ---------- percent of ---------- ,'' ``Less than --------
-- percent of ---------- .'' The percentage of the ingredient(s) shall 
be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 
percent, or 0.5 percent, as appropriate. No ingredient to which the 
quantifying statement applies may be present in an amount greater than 
the stated threshold. Such a quantifying statement may also be utilized 
when an ingredients statement contains a listing of ingredients by 
individual components. Each component listing may utilize the required 
quantifying statement at the end of each component ingredients listing.
    (B) Such ingredients may be adjusted in the product formulation 
without a change being made in the ingredients statement on the 
labeling, provided that the adjusted amount complies with Sec. 
318.7(c)(4) and part 319 of this subchapter, and does not exceed the 
amount shown in the quantifying statement. Any such adjustments to the 
formulation shall be provided to the inspector-in-charge.
    (2) On containers of frozen dinners, entrees, pizzas, and similar 
consumer packaged products in cartons the ingredient statement may be 
placed on the front riser panel: Provided, That the words ``see 
ingredients'' followed immediately by an arrow is placed on the 
principal display panel immediately above the location of such statement 
without intervening print or designs.
    (3) The ingredient statement may be placed on the 20 percent panel 
adjacent to the principal display panel and reserved for required 
information, in the case of a cylindrical or nearly cylindrical 
container.
    (4) The ingredients statement may be placed on the information 
panel, except as otherwise permitted in this subchapter.
    (g)(1) The name or trade name of the person that prepared the 
product may appear as the name of the manufacturer or packer without 
qualification on the label. Otherwise the name of the distributor of the 
product shall be shown with a phrase such as ``Prepared for * * *''. The 
place of business of the manufacturer, packer, or distributor shall be 
shown on the label by city, State, and postal ZIP code when such 
business is listed in a telephone or city directory, and if not listed 
in such directory, then the place of business shall be shown by street 
address, city, State, and postal ZIP code.
    (2) The name and place of business of the manufacturer, packer, or 
distributor may be shown:
    (i) On the principal display panel, or
    (ii) On the 20 percent panel adjacent to the principal display panel 
and reserved for required information, in the case of a cylindrical or 
nearly cylindrical container, or

[[Page 165]]

    (iii) On the front riser panel of frozen food cartons, or
    (iv) On the information panel.
    (h)(1) The statement of net quantity of contents shall appear on the 
principal display panel of all containers to be sold at retail intact, 
in conspicuous and easily legible boldface print or type in distinct 
contrast to other matter on the container, and shall be declared in 
accordance with the provisions of this paragraph.
    (2) The statement as it is shown on a label shall not be false or 
misleading and shall express an accurate statement of the quantity of 
contents of the container. Reasonable variations caused by loss or gain 
of moisture during the course of good distribution practices or by 
unavoidable deviations in good manufacturing practices will be 
recognized. Variations from stated quantity of contents shall be as 
provided in Sec. 317.19. The statement shall not include any term 
qualifying a unit of weight, measure, or count such as ``jumbo quart,'' 
``full gallon,'' ``giant quart,'' ``when packed,'' ``minimum,'' or words 
of similar importance.
    (3) The statement shall be placed on the principal display panel 
within the bottom 30 percent of the area of the panel in lines generally 
parallel to the base: Provided, That on packages having a principal 
display panel of 5 square inches or less, the requirement for placement 
within the bottom 30 percent of the area of the label panel shall not 
apply when the statement meets the other requirements of this paragraph 
(h). In any case, the statement may appear in more than one line. The 
terms ``net weight'' or ``net wt.'' shall be used when stating the net 
quantity of contents in terms of weight, and the term ``net contents'' 
or ``content'' when stating the net quantity of contents in terms of 
fluid measure.
    (4) Except as provided in Sec. 317.7, the statement shall be 
expressed in terms of avoirdupois weight or liquid measure. Where no 
general consumer usage to the contrary exists, the statement shall be in 
terms of liquid measure, if the product is liquid, or in terms of weight 
if the product is solid, semi solid viscous or a mixture of solid and 
liquid. For example, a declaration of \3/4\-pound avoirdupois weight 
shall be expressed as ``Net Wt. 12 oz.'' except as provided for in 
paragraph (h)(5) of this section for random weight packages; a 
declaration of 1\1/2\ pounds avoirdupois weight shall be expressed as 
``Net Wt. 24 oz. (1 lb. 8 oz.),'' ``Net Wt. 24 oz. (1\1/2\ lb.),'' or 
``Net Wt. 24 oz. (1.5 lbs.).''
    (5) On packages containing 1 pound or 1 pint and less than 4 pounds 
or 1 gallon, the statement shall be expressed as a dual declaration both 
in ounces and (immediately thereafter in parentheses) in pounds, with 
any remainder in terms of ounces or common or decimal fraction of the 
pound, or in the case of liquid measure, in the largest whole units with 
any remainder in terms of fluid ounces or common or decimal fractions of 
the pint or quart, except that on random weight packages the statement 
shall be expressed in terms of pounds and decimal fractions of the 
pound, for packages over 1 pound, and for packages which do not exceed 1 
pound the statement may be in decimal fractions of the pound in lieu of 
ounces. Paragraph (h)(9) of this section permits certain exceptions from 
the provisions of this paragraph for margarine packages, random weight 
consumer size packages, and packages of less than \1/2\ ounce net 
weight. Pargraph (h)(12) of this section permits certain exceptions from 
the provision of this paragraph for multi-unit packages.
    (6) The statement shall be in letters and numerals in type size 
established in relationship to the area of the principal display panel 
of the package and shall be uniform of all packages of substantially the 
same size by complying with the following type specifications:
    (i) Not less than one-sixteenth inch in height on packages, the 
principal display panel of which has an area of 5 square inches or less;
    (ii) Not less than one-eighth inch in height on packages, the 
principal display panel of which has an area of more than 5 but not more 
than 25 square inches;
    (iii) Not less than three-sixteenths inch in height on packages, the 
principal display panel of which has an area of more than 25 but not 
more than 100 square inches;

[[Page 166]]

    (iv) Not less than one-quarter inch in height on packages, the 
principal display panel of which has an area of more than 100 but not 
more than 400 square inches.
    (v) Not less than one-half inch in height on packages, the principal 
display panel of which has an area of more than 400 square inches.
    (7) The ratio of height to width of letters and numerals shall not 
exceed a differential of 3 units to 1 unit (no more than 3 times as high 
as it is wide). Heights pertain to upper case or capital letters. When 
upper and lower case or all lower case letters are used, it is the lower 
case letter ``o'' or its equivalent that shall meet the minimum 
standards. When fractions are used, each component numeral shall meet 
one-half the height standards.
    (8) The statement shall appear as a distinct item on the principal 
display panel and shall be separated by a space at least equal to the 
height of the lettering used in the statement from other printed label 
information appearing above or below the statement and by a space at 
least equal to twice the width of the letter ``N'' of the style of type 
used in the quantity of contents statement from other printed label 
information appearing to the left or right of the statement. It shall 
not include any term qualifying a unit of weight, measure, or count such 
as, ``jumbo quart,'' ``full gallon,'' ``giant quart,'' ``when packed,'' 
``Minimum'' or words of similar import.
    (9) The following exemptions from the requirements contained in this 
paragraph (h) are hereby established:
    (i) Individually wrapped, random weight consumer size packages 
shipped in bulk containers (as specified in paragraph (h)(11) of this 
section) and meat products that are subject to shrinkage through 
moisture loss during good distribution practices and are designated as 
gray area type of products as defined under Sec. 317.19 need not bear a 
net weight statement when shipped from an official establishment, 
provided that a net weight shipping statement which meets the 
requirements of paragraph (h)(2) of this section is applied to their 
shipping container prior to shipping it from the official establishment. 
Net weight statements so applied to the shipping container are exempt 
from the type size, dual declaration, and placement requirements of this 
paragraph, if an accurate statement of net weight is shown conspicuously 
on the principal display panel of the shipping container. The net weight 
also shall be applied directly to random weight consumer size packages 
prior to retail display and sale. The net weight statement on random 
weight consumer size packages for retail sale shall be exempt from the 
type size, dual declaration, and placement requirements of this 
paragraph, if an accurate statement of net weight is shown conspicuously 
on the principal display panel of the package.
    (ii) Individually wrapped and labeled packages of less than \1/2\ 
ounce net weight and random weight consumer size packages shall be 
exempt from the requirements of this paragraph if they are in a shipping 
container and the statement of net quantity of contents on the shipping 
container meets the requirements of paragraph (h)(2) of this section;
    (iii) Individually wrapped and labeled packages of less than \1/2\ 
ounce net weight bearing labels declaring net weight, price per pound, 
and total price, shall be exempt from the type size, dual declaration, 
and placement requirements of this paragraph, if an accurate statement 
of net weight is shown conspicuously on the principal display panel of 
the package.
    (iv) Margarine in 1 pound rectangular packages (except packages 
containing whipped or soft margarine or packages that contain more than 
four sticks) is exempt from the requirements of paragraphs (h) (3) and 
(5) of this section regarding the placement of the statement of the net 
quantity of contents within the bottom 30 percent of the principal 
display panel and that the statement be expressed both in ounces and in 
pounds, if the statement appears as ``1 pound'' or ``one pound'' in a 
conspicuous manner on the principal display panel.
    (v) Sliced shingle packed bacon in rectangular packages is exempt 
from the requirements of paragraphs (h)(3) and (h)(5) of this section 
regarding the placement of the statement of the net quantity of contents 
within the bottom

[[Page 167]]

30 percent of the principal display panel, and that the statement be 
expressed both in ounces and in pounds, if the statement appears in a 
conspicuous manner on the principal display panel.
    (10) Labels for containers which bear any representation as to the 
number of servings contained therein shall bear, contiguous to such 
representation, and in the same size type as is used for such 
representation, a statement of the net quantity of each such serving.
    (11) As used in this section, a ``random weight consumer size 
package'' is one which is one of a lot, shipment or delivery of packages 
of the same product with varying weights and with no fixed weight 
pattern.
    (12) On a multiunit retail package, a statement of the net quantity 
of contents shall appear on the outside of the package and shall include 
the number of individual units, the quantity of each individual unit, 
and in parentheses, the total net quantity of contents of the multiunit 
package in terms of avoirdupois or fluid ounces, except that such 
declaration of total quantity need not be followed by an additional 
parenthetical declaration in terms of the largest whole units and 
subdivisions thereof, as required by paragraph (h)(5) of this section. 
For the purposes of this section, ``multi unit retail package'' means a 
package containing two or more individually packaged units of the 
identical commodity and in the same quantity, with the individual 
packages intended to be sold as part of the multiunit retail package but 
capable of being individually sold in full compliance with all 
requirements of the regulations in this part. Open multiunit retail 
packages that do not obscure the number of units and the labeling 
thereon are not subject to this paragraph if the labeling of each 
individual unit complies with the requirements of paragraphs (h) (2), 
(3), (6), and (8) of this section.
    (i) The official establishment number of the official establishment 
in which the product was processed under inspection shall be placed as 
follows:
    (1) Within the official inspection legend in the form required by 
part 312 of this subchapter; or
    (2) Outside the official inspection legend elsewhere on the exterior 
of the container or its labeling, e.g., the lid of a can, if shown in a 
prominent and legible manner in a size sufficient to insure easy 
visibility and recognition and accompanied by the prefix ``EST''; or
    (3) Off the exterior of the container, e.g., on a metal clip used to 
close casings or bags, or on the back of a paper label of a canned 
product, or on other packaging or labeling material in the container, 
e.g., on aluminum pans and trays placed within containers, when a 
statement of its location is printed contiguous to the official 
inspection legend, such as ``EST. No. on Metal Clip'' or ``Est. No. on 
Pan'', if shown in a prominent and legible manner in a size sufficient 
to insure easy visibility and recognition; or
    (4) On an insert label placed under a transparent covering if 
clearly visible and legible and accompanied by the prefix ``EST''.
    (j) Labels of any product within any of the following paragraphs 
shall show the information required by such paragraph for such product:
    (1) A label for product which is an imitation of another food shall 
bear the word ``imitation'' immediately preceding the name of the food 
imitated and in the same size and style of lettering as in that name and 
immediately thereafter the word ``ingredients:'' and the names of the 
ingredients arranged in the order of their predominance.
    (2) If a product purports to be or is represented for any special 
dietary use by man, its label shall bear a statement concerning its 
vitamin, mineral, and other dietary properties upon which the claim for 
such use is based in whole or in part and shall be in conformity with 
regulations (21 CFR part 125) established pursuant to sections 403, and 
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).
    (3) When an artificial smoke flavoring or a smoke flavoring is added 
as an ingredient in the formula of a meat food product, as permitted in 
part 318 of this subchapter, there shall appear on the label, in 
prominent letters and contiguous to the name of the product, a statement 
such as ``Artificial Smoke Flavoring Added'' or ``Smoke Flavoring 
Added,'' as may be applicable, and the ingredient statement shall

[[Page 168]]

identify any artificial smoke flavoring or smoke flavoring so added as 
an ingredient in the formula of the meat food product.
    (4) When any other artificial flavoring is permitted under part 318 
of this subchapter to be added to a product, the ingredient statement 
shall identify it as ``Artificial Flavoring.''
    (5) When artificial coloring is added to edible fats as permitted 
under part 318 of this subchapter such substance shall be declared on 
the label in a prominent manner and contiguous to the name of the 
product by the words ``Artificially colored'' or ``Artificial coloring 
added'' or ``With added artificial coloring.'' When natural coloring 
such as annatto is added to edible fats as permitted under part 318 of 
this subchapter, such substance shall be declared on the label in the 
same manner by a phrase such as ``Colored with annatto.''
    (6) When product is placed in a casing to which artificial coloring 
is applied as permitted under part 318 of this subchapter, there shall 
appear on the label, in a prominent manner and contiguous to the name of 
the product, the words, ``Artificially colored.''
    (7) If a casing is removed from product at an official establishment 
and there is evidence of artificial coloring on the surface of the 
product, there shall appear on the label, in a prominent manner and 
contiguous to the name of product, the words ``Artificially colored.''
    (8) When a casing is colored prior to its use as a covering for 
product and the color is not transferred to the product enclosed in the 
casing, no reference to color need appear on the label but no such 
casing may be used if it is misleading or deceptive with respect to 
color, quality, or kind of product, or otherwise.
    (9) Product which bears or contains any other artificial coloring, 
as permitted under part 318 of this subchapter, shall bear a label 
stating that fact on the immediate container or if there is none, on the 
product.
    (10) When an antioxidant is added to product as permitted under part 
318 of this subchapter, there shall appear on the label in prominent 
letters and contiguous to the name of the product, a statement 
identifying the officially approved specific antioxidant by its common 
name or abbreviation thereof and the purpose for which it is added, such 
as, ``BHA, BHT, and Propylgallate added to help protect flavor.''
    (11) Containers of meat packed in borax or other preservative for 
export to a foreign country which permits the use of such preservative 
shall, at the time of packing, be marked ``for export,'' followed on the 
next line by the words ``packed in preservative,'' or such equivalent 
statement as may be approved for this purpose by the Administrator and 
directly beneath this there shall appear the word ``establishment'' or 
abbreviation thereof, followed by the number of the establishment at 
which the product is packed. The complete statement shall be applied in 
a conspicuous location and in letters not less than 1 inch in height.
    (12) Containers of other product packed in, bearing, or containing 
any chemical preservative shall bear a label stating that fact.
    (13)(i) On the label of any ``Mechanically Separated (Species)'' 
described in Sec. 319.5(a) of this subchapter, the name of such product 
shall be followed immediately by the phrase ``for processing'' unless 
such product has a protein content of not less than 14 percent and a fat 
content of not more than 30 percent.
    (ii) When any ``Mechanically Separated (Species)'' described in 
Sec. 319.5 of this subchapter is used as an ingredient in the 
preparation of a meat food product and such ``Mechanically Separated 
(Species)'' contributes 20 mg or more of calcium to a serving of such 
meat food product, the label of such meat food product shall state the 
calcium content of such meat food product, determined and expressed as 
the percentage of the U.S. Recommended Daily Allowance (U.S. RDA) in a 
serving in accordance with 21 CFR 101.9(b)(1), (c)(7) (i) and (iv), and 
(e), as part of any nutrition information included on such label, or if 
such meat food product does not bear nutrition labeling information, as 
part of a prominent statement in immediate conjunction with the list of 
ingredients, as follows: ``A ------ serving contains ----% of the U.S. 
RDA of calcium'', with the blanks to be filled in,

[[Page 169]]

respectively, with the quantity of such product that constitutes a 
serving and the amount of calcium provided by such serving: Provided, 
That, calcium content need not be stated where (a) the percent of the 
U.S. RDA of calcium to be declared would not differ from the percent of 
the U.S. RDA that would be declared if the meat food product contained 
only hand deboned ingredients or (b) the calcium content of a serving of 
the meat food product would be 20 percent of the U.S. RDA or more if the 
meat food product contained only hand deboned ingredients.
    (k) Packaged products which require special handling to maintain 
their wholesome condition shall have prominently displayed on the 
principal display panel of the label the statement: ``Keep 
Refrigerated,'' ``Keep Frozen,'' ``Perishable Keep Under 
Refrigeration,'' or such similar statement as the Administrator may 
approve in specific cases. Products that are distributed frozen during 
distribution and thawed prior to or during display for sale at retail 
shall bear the statement on the shipping container: ``Keep Frozen.'' The 
consumer-size containers for such products shall bear the statement 
``Previously Handled Frozen for Your Protection, Refreeze or Keep 
Refrigerated.'' For all perishable canned products the statement shall 
be shown in upper case letters one-fourth inch in height for containers 
having a net weight of 3 pounds or less, and for containers having a net 
weight over 3 pounds, the statement shall be in upper case letters at 
least one-half inch in height.
    (l) Safe handling instructions shall be provided for: All meat and 
meat products of cattle, swine, sheep, goat, horse, other equine that do 
not meet the requirements contained in Sec. 318.17, or that have not 
undergone other processing that would render them ready-to-eat; and all 
comminuted meat patties not heat processed in a manner that conforms to 
the time and temperature combinations in the Table for Permitted Heat-
Processing Temperature/Time Combinations For Fully-Cooked Patties in 
Sec. 318.23, except as exempted under paragraph (l)(4) of this section.
    (1)(i) Safe handling instructions shall accompany every meat or meat 
product, specified in this paragraph (l) destined for household 
consumers, hotels, restaurants, or similar institutions and shall appear 
on the label. The information shall be in lettering no smaller than one-
sixteenth of an inch in size and shall be prominently placed with such 
conspicuousness (as compared with other words, statements, designs or 
devices in the labeling) as to render it likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use.
    (ii) The safe handling information shall be presented on the label 
under the heading ``Safe Handling Instructions'' which shall be set in 
type size larger than the print size of the rationale statement and 
handling statements as discussed in paragraphs (l)(2) and (l)(3) of this 
section. The safe handling information shall be set off by a border and 
shall be one color type printed on a single color contrasting background 
whenever practical.
    (2) The labels of the meat and meat products specified in this 
paragraph (l) shall include the following rationale statement as part of 
the safe handling instructions, ``This product was prepared from 
inspected and passed meat and/or poultry. Some food products may contain 
bacteria that could cause illness if the product is mishandled or cooked 
improperly. For your protection, follow these safe handling 
instructions.'' This statement shall be placed immediately after the 
heading and before the safe handling statements.
    (3) Meat and meat products, specified in this paragraph (l), shall 
bear the labeling statements:
    (i) Keep refrigerated or frozen. Thaw in refrigerator or microwave. 
(Any portion of this statement that is in conflict with the product's 
specific handling instructions, may be omitted, e.g., instructions to 
cook without thawing.) (A graphic illustration of a refrigerator shall 
be displayed next to the statement.);
    (ii) Keep raw meat and poultry separate from other foods. Wash 
working surfaces (including cutting boards), utensils, and hands after 
touching raw

[[Page 170]]

meat or poultry. (A graphic illustration of soapy hands under a faucet 
shall be displayed next to the statement.);
    (iii) Cook thoroughly. (A graphic illustration of a skillet shall be 
displayed next to the statement.); and
    (iv) Keep hot foods hot. Refrigerate leftovers immediately or 
discard. (A graphic illustration of a thermometer shall be displayed 
next to the statement.)
    (4) Meat or meat products intended for further processing at another 
official establishment are exempt from the requirements prescribed in 
paragraphs (l)(1) through (l)(3) of this section.
    (m)(1) The information panel is that part of a label that is the 
first surface to the right of the principal display panel as observed by 
an individual facing the principal display panel, with the following 
exceptions:
    (i) If the first surface to the right of the principal display panel 
is too small to accommodate the required information or is otherwise 
unusable label space, e.g., folded flaps, tear strips, opening flaps, 
heat-sealed flaps, the next panel to the right of this part of the label 
may be used.
    (ii) If the package has one or more alternate principal display 
panels, the information panel is to the right of any principal display 
panel.
    (iii) If the top of the container is the principal display panel and 
the package has no alternate principal display panel, the information 
panel is any panel adjacent to the principal display panel.
    (2) (i) Except as otherwise permitted in this part, all information 
required to appear on the principal display panel or permitted to appear 
on the information panel shall appear on the same panel unless there is 
insufficient space. In determining the sufficiency of the available 
space, except as otherwise prescribed in this part, any vignettes, 
designs, and any other nonmandatory information shall not be considered. 
If there is insufficient space for all required information to appear on 
a single panel, it may be divided between the principal display panel 
and the information panel, provided that the information required by any 
given provision of this part, such as the ingredients statement, is not 
divided and appears on the same panel.
    (ii) All information appearing on the information panel pursuant to 
this section shall appear in one place without intervening material, 
such as designs or vignettes.

[35 FR 15580, Oct. 3, 1970]

    Editorial Note: For Federal Register citations affecting Sec. 
317.2, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 317.3  Approval of abbreviations of marks of inspection; preparation 
of marking devices bearing inspection legend without advance approval 
prohibited; exception.

    (a) The Administrator may approve and authorize the use of 
abbreviations of marks of inspection under the regulations in this 
subchapter. Such abbreviations shall have the same force and effect as 
the respective marks for which they are authorized abbreviations.
    (b) Except for the purposes of preparing and submitting a sample or 
samples of the same to the Administrator for approval, no brand 
manufacturer, printer, or other person shall cast, print, lithograph, or 
otherwise make any marking device containing any official mark or 
simulation thereof, or any label bearing any such mark or simulation, 
without the written authority therefor of the Administrator. However, 
when any such sample label, or other marking device, is approved by the 
Administrator, additional supplies of the approved label, or marking 
device, may be made for use in accordance with the regulations in this 
subchapter, without further approval by the Administrator. The 
provisions of this paragraph apply only to labels, or other marking 
devices, bearing or containing an official inspection legend shown in 
Sec. 312.2(b), Sec. 312.3(a) (only the legend appropriate for horse 
meat food products) or Sec. 312.3(b) (only the legend appropriate for 
other (nonhorse) equine meat food products), or any abbreviations, copy 
or representation thereof.
    (c) No brand manufacturer or other person shall cast or otherwise 
make, without an official certificate issued in quadruplicate by a 
Program employee,

[[Page 171]]

a brand or other marking device containing an official inspection 
legend, or simulation thereof, shown in Sec. 312.2(a), Sec. 312.3(a) 
(only the legend appropriate for horse carcasses and parts of horse 
carcasses), Sec. 312.3(b) (only the legend appropriate for other equine 
(nonhorse) carcasses and parts of other (nonhorse) equine carcasses) or 
Sec. 312.7(a).
    (1) The certificate is a Food Safety and Inspection Service form for 
signature by a Program employee and the official establishment ordering 
the brand or other marking device, bearing a certificate serial number 
and a letterhead and the seal of the United States Department of 
Agriculture. The certificate authorizes the making of only the brands or 
other marking devices of the type and quantity listed on the 
certificate.
    (2) After signing the certificate, the Program employee and the 
establishment shall each keep a copy, and the remaining two copies shall 
be given to the brand or other marking device manufacturer.
    (3) The manufacturer of the brands or other marking devices shall 
engrave or otherwise mark each brand or other marking device with a 
permanent identifying serial number unique to it. The manufacturer shall 
list on each of the two copies of the certificate given to the 
manufacturer the number of each brand or other marking device authorized 
by the certificate. The manufacturer shall retain one copy of the 
certificate for the manufacturer's records and return the remaining copy 
with the brands or other marking devices to the Program employee whose 
name and address are given on the certificate as the recipient.
    (4) In order that all such brands or other marking devices bear 
identifying numbers, within one year after June 24, 1985, an 
establishment shall either replace each such brand or other marking 
device which does not bear an identifying number, or, under the 
direction of the inspector-in-charge, mark such brand or other marking 
device with a permanent identifying number.

(Recordkeeping requirements approved by the Office of Management and 
Budget under control number 0583-0015)

[35 FR 15580, Oct. 3, 1970, as amended at 50 FR 21422, May 24, 1985]



Sec. 317.4  Labeling approval.

    (a) No final labeling shall be used on any product unless the sketch 
labeling of such final labeling has been submitted for approval to the 
Food Labeling Division, Regulatory Programs, Food Safety and Inspection 
Service, and approved by such division, accompanied by FSIS form, 
Application for Approval of Labels, Marking, and Devices, except for 
generically approved labeling authorized for use in Sec. 317.5(b). The 
management of the official establishment or establishment certified 
under a foreign inspection system, in accordance with part 327 of this 
subchapter, must maintain a copy of all labeling used, along with the 
product formulation and processing procedure, in accordance with part 
320 of this subchapter. Such records shall be made available to any duly 
authorized representative of the Secretary upon request.
    (b) The Food Labeling Division shall permit submission for approval 
of only sketch labeling, as defined in Sec. 317.4(d), for all products, 
except as provided in Sec. 317.5(b) (2)-(9) and except for temporary 
use of final labeling as prescribed in paragraph (f) of this section.
    (c) All labeling required to be submitted for approval as set forth 
in Sec. 317.4(a) shall be submitted in duplicate to the Food Labeling 
Division, Regulatory Programs, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250. A parent company for a 
corporation may submit only one labeling application (in duplicate form) 
for a product produced in other establishments that are owned by the 
corporation.
    (d) ``Sketch'' labeling is a printer's proof or equivalent which 
clearly shows all labeling features, size, location, and indication of 
final color, as specified in Sec. 317.2. FSIS will accept sketches that 
are hand drawn, computer generated or other reasonable facsimiles that 
clearly reflect and project the final version of the labeling. 
Indication of final color may be met by: submission of a color sketch, 
submission of a sketch which indicates by descriptive language the final 
colors, or submission with the sketch of previously approved final 
labeling that indicates the final colors.

[[Page 172]]

    (e) Inserts, tags, liners, pasters, and like devices containing 
printed or graphic matter and for use on, or to be placed within, 
containers and coverings of product shall be submitted for approval in 
the same manner as provided for labeling in Sec. 317.4(a), except that 
such devices which contain no reference to product and bear no 
misleading feature shall be used without submission for approval as 
prescribed in Sec. 317.5(b)(7).
    (f)(1) Consistent with the requirements of this section, temporary 
approval for the use of a final label or other final labeling that may 
otherwise be deemed deficient in some particular may be granted by the 
Food Labeling Division. Temporary approvals may be granted for a period 
not to exceed 180 calendar days, under the following conditions:
    (i) The proposed labeling would not misrepresent the product;
    (ii) The use of the labeling would not present any potential health, 
safety, or dietary problems to the consumer;
    (iii) Denial of the request would create undue economic hardship; 
and
    (iv) An unfair competitive advantage would not result from the 
granting of the temporary approval.
    (2) Extensions of temporary approvals may also be granted by the 
Food Labeling Division provided that the applicant demonstrates that new 
circumstances, meeting the above criteria, have developed since the 
original temporary approval was granted.
    (g) The inspector-in-charge shall approve meat carcass ink brands 
and meat food product ink and burning brands, which comply with parts 
312 and 316 of this subchapter.

[60 FR 67454, Dec. 29, 1995]



Sec. 317.5  Generically approved labeling.

    (a)(1) An official establishment or an establishment certified under 
a foreign inspection system, in accordance with part 327 of this 
subchapter, is authorized to use generically approved labeling, as 
defined in paragraph (b) of this section, without such labeling being 
submitted for approval to the Food Safety and Inspection Service in 
Washington or the field, provided the labeling is in accordance with 
this section and shows all mandatory features in a prominent manner as 
required in Sec. 317.2, and is not otherwise false or misleading in any 
particular.
    (2) The Food Safety and Inspection Service shall select samples of 
generically approved labeling from the records maintained by official 
establishments and establishments certified under foreign inspection 
systems, in accordance with part 327 of this subchapter, as required in 
Sec. 317.4, to determine compliance with labeling requirements. Any 
finding of false or misleading labeling shall institute the proceedings 
prescribed in Sec. 335.12.
    (b) Generically approved labeling is labeling which complies with 
the following:
    (1) Labeling for a product which has a product standard as specified 
in part 319 of this subchapter or the Standards and Labeling Policy Book 
and which does not contain any special claims, such as quality claims, 
nutrient content claims, health claims, negative claims, geographical 
origin claims, or guarantees, or which is not a domestic product labeled 
in a foreign language;
    (2) Labeling for single-ingredient products (such as beef steak or 
lamb chops) which does not contain any special claims, such as quality 
claims, nutrient content claims, health claims, negative claims, 
geographical origin claims, or guarantees, or which is not a domestic 
product labeled with a foreign language;
    (3) Labeling for containers of products sold under contract 
specifications to Federal Government agencies, when such product is not 
offered for sale to the general public, provided that the contract 
specifications include specific requirements with respect to labeling, 
and are made available to the inspector-in-charge;
    (4) Labeling for shipping containers which contain fully labeled 
immediate containers, provided such labeling complies with Sec. 316.13;
    (5) Labeling for products not intended for human food, provided they 
comply with part 325 of this subchapter;
    (6) Meat inspection legends, which comply with parts 312 and 316 of 
this subchapter;
    (7) Inserts, tags, liners, pasters, and like devices containing 
printed or

[[Page 173]]

graphic matter and for use on, or to be placed within containers, and 
coverings of products, provided such devices contain no reference to 
product and bear no misleading feature;
    (8) Labeling for consumer test products not intended for sale; and
    (9) Labeling which was previously approved by the Food Labeling 
Division as sketch labeling, and the final labeling was prepared without 
modification or with the following modifications:
    (i) All features of the labeling are proportionately enlarged or 
reduced, provided that all minimum size requirements specified in 
applicable regulations are met and the labeling is legible;
    (ii) The substitution of any unit of measurement with its 
abbreviation or the substitution of any abbreviation with its unit of 
measurement, e.g., ``lb.'' for ``pound,'' or ``oz.'' for ``ounce,'' or 
of the word ``pound'' for ``lb.'' or ``ounce'' for ``oz.'';
    (iii) A master or stock label has been approved from which the name 
and address of the distributor are omitted and such name and address are 
applied before being used (in such case, the words ``prepared for'' or 
similar statement must be shown together with the blank space reserved 
for the insertion of the name and address when such labels are offered 
for approval);
    (iv) Wrappers or other covers bearing pictorial designs, emblematic 
designs or illustrations, e.g., floral arrangements, illustrations of 
animals, fireworks, etc. are used with approved labeling (the use of 
such designs will not make necessary the application of labeling not 
otherwise required);
    (v) A change in the language or the arrangement of directions 
pertaining to the opening of containers or the serving of the product;
    (vi) The addition, deletion, or amendment of a dated or undated 
coupon, a cents-off statement, cooking instructions, packer product code 
information, or UPC product code information;
    (vii) Any change in the name or address of the packer, manufacturer 
or distributor that appears in the signature line;
    (viii) Any change in the net weight, provided the size of the net 
weight statement complies with Sec. 317.2;
    (ix) The addition, deletion, or amendment of recipe suggestions for 
the product;
    (x) Any change in punctuation;
    (xi) Newly assigned or revised establishment numbers for a 
particular establishment for which use of the labeling has been approved 
by the Food Labeling Division, Regulatory Programs;
    (xii) The addition or deletion of open dating information;
    (xiii) A change in the type of packaging material on which the label 
is printed;
    (xiv) Brand name changes, provided that there are no design changes, 
the brand name does not use a term that connotes quality or other 
product characteristics, the brand name has no geographic significance, 
and the brand name does not affect the name of the product;
    (xv) The deletion of the word ``new'' on new product labeling;
    (xvi) The addition, deletion, or amendment of special handling 
statements, provided that the change is consistent with Sec. 317.2(k);
    (xvii) The addition of safe handling instructions as required by 
Sec. 317.2(l);
    (xviii) Changes reflecting a change in the quantity of an ingredient 
shown in the formula without a change in the order of predominance shown 
on the label, provided that the change in quantity of ingredients 
complies with any minimum or maximum limits for the use of such 
ingredients prescribed in parts 318 and 319 of this subchapter;
    (xix) Changes in the color of the labeling, provided that sufficient 
contrast and legibility remain;
    (xx) A change in the product vignette, provided that the change does 
not affect mandatory labeling information or misrepresent the content of 
the package;
    (xxi) A change in the establishment number by a corporation or 
parent company for an establishment under its ownership;
    (xxii) Changes in nutrition labeling that only involve quantitative 
adjustments to the nutrition labeling information, except for serving 
sizes, provided the nutrition labeling information maintains its 
accuracy and consistency;

[[Page 174]]

    (xxiii) Deletion of any claim, and the deletion of non-mandatory 
features or non-mandatory information; and
    (xxiv) The addition or deletion of a direct translation of the 
English language into a foreign language for products marked ``for 
export only.''

[60 FR 67455, Dec. 29, 1995]



Sec. 317.6  Approved labels to be used only on products to which they 
are applicable.

    Labels shall be used only on products for which they are approved, 
and only if they have been approved for such products in accordance with 
Sec. 317.3: Provided, That existing stocks of labels approved prior to 
the effective date of this section and the quantity of which has been 
identified to the circuit supervisor as being in storage on said date at 
the official establishment or other identified warehouse for the account 
of the operator of the official establishment may be used until such 
stocks are exhausted, but not later than 1 year after the effective date 
of this section unless such labels conform to all the requirements of 
this part and part 319 of this subchapter. The Administrator may upon 
the show of good cause grant individual extension of time as he deems 
necessary.



Sec. 317.7  Products for foreign commerce; printing labels in foreign 
language permissible; other deviations.

    Labels to be affixed to packages of products for foreign commerce 
may be printed in a foreign language and may show the statement of the 
quantity of contents in accordance with the usage of the country to 
which exported and other deviations from the form of labeling required 
under this part may be approved for such product by the Administrator in 
specific cases: Provided,
    (a) That the proposed labeling accords to the specifications of the 
foreign purchaser,
    (b) That it is not in conflict with the laws of the country to which 
the product is intended for export, and
    (c) That the outside container is labeled to show that it is 
intended for export; but if such product is sold or offered for sale in 
domestic commerce, all the requirements of this subchapter apply. The 
inspection legend and the establishment number shall in all cases appear 
in English but in addition, may appear literally translated in a foreign 
language.



Sec. 317.8  False or misleading labeling or practices generally; specific 
prohibitions and requirements for labels and containers.

    (a) No product or any of its wrappers, packaging, or other 
containers shall bear any false or misleading marking, label, or other 
labeling and no statement, word, picture, design, or device which 
conveys any false impression or gives any false indication of origin or 
quality or is otherwise false or misleading shall appear in any marking 
or other labeling. No product shall be wholly or partly enclosed in any 
wrapper, packaging, or other container that is so made, formed, or 
filled as to be misleading.
    (b) The labels and containers of product shall comply with the 
following provisions, as applicable:
    (1) Terms having geographical significance with reference to a 
locality other than that in which the product is prepared may appear on 
the label only when qualified by the word ``style,'' ``type,'' or 
``brand,'' as the case may be, in the same size and style of lettering 
as in the geographical term, and accompanied with a prominent qualifying 
statement identifying the country, State, Territory, or locality in 
which the product is prepared, using terms appropriate to effect the 
qualification. When the word ``style'' or ``type'' is used, there must 
be a recognized style or type of product identified with and peculiar to 
the area represented by the geographical term and the product must 
possess the characteristics of such style or type, and the word 
``brand'' shall not be used in such a way as to be false or misleading: 
Provided, That a geographical term which has come into general usage as 
a trade name and which has been approved by the Administrator as being a 
generic term may be used without the qualifications provided for in this 
paragraph. The terms ``frankfurter,'' ``vienna,'' ``bologna,'' ``lebanon 
bologna,'' ``braunschweiger,'' ``thuringer,'' ``genoa,'' ``leona,'' 
``berliner,'' ``holstein,'' ``goteborg,'' ``milan,'' ``polish,''

[[Page 175]]

``italian,'' and their modifications, as applied to sausages, the terms 
``brunswick'' and ``irish'' as applied to stews and the term ``boston'' 
as applied to pork shoulder butts need not be accompanied with the word 
``style,'' ``type,'' or ``brand,'' or a statement identifying the 
locality in which the product is prepared.
    (2) Such terms as ``farm'' or ``country'' shall not be used on 
labels in connection with products unless such products are actually 
prepared on the farm or in the country: Provided, That if the product is 
prepared in the same way as on the farm or in the country these terms, 
if qualified by the word ``style'' in the same size and style of 
lettering, may be used: Provided further, That the term ``farm'' may be 
used as part of a brand designation when qualified by the word ``brand'' 
in the same size and style of lettering, and followed with a statement 
identifying the locality in which the product is prepared: And Provided 
further, That the provisions of this paragraph shall not apply to 
products prepared in accordance with Sec. 319.106 of this subchapter. 
Sausage containing cereal shall not be labeled ``farm style'' or 
``country style,'' and lard not rendered in an open kettle shall not be 
designated as ``farm style'' or ``country style.''
    (3) The requirement that the label shall contain the name and place 
of business of the manufacturer, packer, or distributor shall not 
relieve any establishment from the requirement that its label shall not 
be misleading in any particular.
    (4) The term ``spring lamb'' or ``genuine spring lamb'' is 
applicable only to carcasses of new-crop lambs slaughtered during the 
period beginning in March and terminating not beyond the close of the 
week containing the first Monday in October.
    (5)(i) Coverings shall not be of such color, design, or kind as to 
be misleading with respect to color, quality, or kind of product to 
which they are applied. For example, transparent or semitransparent 
coverings for such articles as sliced bacon or fresh (uncooked) meat and 
meat food products shall not bear lines or other designs of red or other 
color which give a false impression of leanness of the product. 
Transparent or semitransparent wrappers, casings, or coverings for use 
in packaging cured, cured and smoked, or cured and cooked sausage 
products, and sliced ready-to-eat meat food products may be color tinted 
or bear red designs on 50 percent of such wrapper or covering: Provided, 
That the transparent or semitransparent portion of the principal display 
panel is free of color tinting and red designs: And provided further, 
That the principal display panel provides at least 20 percent 
unobstructed clear space, consolidated in one area so that the true 
nature and color of the product is visible to the consumer.
    (ii) Packages for sliced bacon that have a transparent opening shall 
be designed to expose, for viewing, the cut surface of a representative 
slice. Packages for sliced bacon which meet the following specifications 
will be accepted as meeting the requirements of this subparagraph 
provided the enclosed bacon is positioned so that the cut surface of the 
representative slice can be visually examined:
    (a) For shingle-packed sliced bacon, the transparent window shall be 
designed to reveal at least 70 percent of the length (longest dimension) 
of the representative slice, and this window shall be at least 1\1/2\ 
inches wide. The transparent window shall be located not more than five-
eighths inch from the top or bottom edge of a 1-pound or smaller package 
and not more than three-fourths inch from either the top or bottom edge 
of a package larger than 1 pound.
    (b) For stack-packed sliced bacon, the transparent window shall be 
designed to reveal at least 70 percent of the length (longest dimension) 
of the representative slice and be at least 1\1/2\ inches wide.
    (6) The word ``fresh'' shall not be used on labels to designate 
product which contains any sodium nitrate, sodium nitrite, potassium 
nitrate, or potassium nitrite, or which has been salted for 
preservation.
    (7)(i) No ingredient shall be designated on the label as a spice, 
flavoring, or coloring unless it is a spice, flavoring, or coloring, as 
the case may

[[Page 176]]

be. An ingredient that is both a spice and a coloring, or both a 
flavoring and a coloring, shall be designated as ``spice and coloring'', 
or ``flavoring and coloring'', as the case may be, unless such 
ingredient is designated by its common or usual name.
    (ii) Any ingredient not designated in Sec. 317.2(f)(1)(i) of this 
part whose function is flavoring, either in whole or in part, must be 
designated by its common or usual name. Those ingredients which are of 
livestock and poultry origin must be designated by names that include 
the species and livestock and poultry tissues from which the ingredients 
are derived.
    (8) As used on labels of product, the term ``gelatin'' shall mean 
(i) the jelly prepared in official establishments by cooking pork skins, 
tendons, or connective tissue from inspected and passed product, and 
(ii) dry commercial gelatin or the jelly resulting from its use.
    (9) Product (other than canned product) labeled with the term 
``loaf'' as part of its name:
    (i) If distributed from the official establishment in consumer size 
containers may be in any shape;
    (ii) If distributed in a container of a size larger than that sold 
intact at retail the product shall be prepared in rectangular form, or 
as in paragraph (b)(9)(iii) of this section;
    (iii) If labeled as an ``Old Fashioned Loaf'' shall be prepared in a 
traditional form, such as rectangular with rounded top or circular with 
flat bottom and rounded top.
    (10) The term ``baked'' shall apply only to product which has been 
cooked by the direct action of dry heat and for a sufficient time to 
permit the product to assume the characteristics of a baked article, 
such as the formation of a brown crust on the surface, rendering out of 
surface fat, and the caramelization of the sugar if applied. Baked 
loaves shall be heated to a temperature of at least 160 [deg]F. and 
baked pork cuts shall be heated to an internal temperature of at least 
170 [deg]F.
    (11) When products such as loaves are browned by dipping in hot 
edible oil or by a flame, the label shall state such fact, e.g., by the 
words ``Browned in Hot Cottonseed Oil'' or ``Browned by a Flame,'' as 
the case may be, appearing as part of the product name.
    (12) The term ``meat'' and the names of particular kinds of meat, 
such as beef, veal, mutton, lamb, and pork, shall not be used in such 
manner as to be false or misleading.
    (13) The word ``ham,'' without any prefix indicating the species of 
animal from which derived, shall be used in labeling only in connection 
with the hind legs of swine. Ham shanks as such or ham shank meat as 
such or the trimmings accruing in the trimming and shaping of hams shall 
not be labeled ``ham'' or ``ham meat'' without qualification. When used 
in connection with a chopped product the term ``ham'' or ``ham meat'' 
shall not include the skin.
    (14) The terms ``shankless'' and ``hockless'' shall apply only to 
hams and pork shoulders from which the shank or hock has been completely 
removed, thus eliminating the entire tibia and fibula, or radius and 
ulna, respectively, together with the overlying muscle, skin, and other 
tissue.
    (15) Such terms as ``meat extract'' or ``extract of beef'' without 
qualification shall not be used on labels in connection with products 
prepared from organs or other parts of the carcass, other than fresh 
meat. Extracts prepared from any parts of the carcass other than fresh 
meat may be properly labeled as extracts with the true name of the parts 
from which prepared. In the case of extract in fluid form, the word 
``fluid'' shall also appear on the label, as, for example, ``fluid 
extract of beef.''
    (16) [Reserved]
    (17) When any product is enclosed in a container along with a 
packing substance such as brine, vinegar, or agar jelly, a declaration 
of the packing substance shall be printed prominently on the label as 
part of the name of the product, as for example, ``frankfurts packed in 
brine,'' ``lamb tongue packed in vinegar,'' or ``beef tongue packed in 
agar jelly,'' as the case may be. The packing substance shall not be 
used in such a manner as will result in the container being so filled as 
to be misleading.
    (18) ``Leaf lard'' is lard prepared from fresh leaf fat.

[[Page 177]]

    (19) When lard or hardened lard is mixed with rendered pork fat or 
hardened rendered pork fat, the mixture shall be designated as 
``rendered pork fat'' or ``hardened rendered pork fat,'' as the case may 
be.
    (20) Oil, stearin, or stock obtained from beef or mutton fats 
rendered at a temperature above 170 [deg]F. shall not be designated as 
``oleo oil,'' ``oleo stearin,'' or ``oleo stock,'' respectively.
    (21) When not more than 20 percent of beef fat, mutton fat, oleo 
stearin, vegetable stearin, or hardened vegetable fat is mixed with lard 
or with rendered pork fat, there shall appear on the label, contiguous 
to and in the same size and style of lettering as the name of the 
product, the words ``beef fat added,'' ``mutton fat added,'' ``oleo 
stearin added,'' ``vegetable stearin added,'' or ``hardened vegetable 
fat added,'' as the case may be. If more than 20 percent is added, the 
product name shall refer to the particular animal fat or fats used, such 
as, ``Lard and Beef Fat.'' The designation ``vegetable fat'' is 
applicable to vegetable oil, vegetable stearin, or a combination of such 
oil and stearin, whereas the designations ``vegetable oil'' and 
``vegetable stearin'' shall be applicable only to the oil and the 
stearin respectively, when used in meat food products.
    (22) Cooked, cured, or pickled pigs feet, pigs knuckles, and similar 
products, shall be labeled to show that the bones remain in the product, 
if such is the case. The designation ``semi-boneless'' shall not be used 
if less than 50 percent of the total weight of bones has been removed.
    (23) When monoglycerides, diglycerides, and/or polyglycerol esters 
of fatty acids are added to rendered animal fat or a combination of such 
fat and vegetable fat, there shall appear on the label in a prominent 
manner and contiguous to the name of the product a statement such as 
``With Monoglycerides and Diglycerides Added,'' or ``With Diglycerides 
and Monoglycerides,'' or ``With Polyglyc erol Esters of Fatty Acids'' as 
the case may be.
    (24) Section 407 of the Federal Food, Drug, and Cosmetic Act 
contains provisions with respect to colored margarine or colored 
oleomargarine (21 U.S.C. 347) which are set forth herein as footnote. 
\1\
---------------------------------------------------------------------------

    \1\ ``Sec. 407(a) Colored oleomargarine or colored margarine which 
is sold in the same State or Territory in which it is produced shall be 
subject in the same manner and to the same extent to the provisions of 
this Act as if it had been introduced in interstate commerce.
    (b) No person shall sell, or offer for sale, colored oleomargarine 
or colored margarine unless--
    (1) Such oleomargarine or margarine is packaged,
    (2) The net weight of the contents of any package sold in a retail 
establishment is one pound or less,
    (3) There appears on the label of the package (A) The word 
`oleomargarine' or `margarine' in type or lettering at least as large as 
any other type or lettering on such label, and (B) A full and accurate 
statement of all the ingredients contained in such oleomargarine, or 
margarine, and
    (4) Each part of the contents of the package is contained in a 
wrapper which bears the word `oleomargarine' or `margarine' in type or 
lettering not smaller than 20-point type.
    The requirements of this subsection shall be in addition to and not 
in lieu of any of the other requirements of this Act.
    (c) No person shall possess in a form ready for serving colored 
oleomargarine or colored margarine at a public eating place unless a 
notice that oleomargarine or margarine is served is displayed 
prominently and conspicuously in such place and in such manner as to 
render it likely to be read and understood by the ordinary individual 
being served in such eating place or is printed or is otherwise set 
forth on the menu in type or lettering not smaller than that normally 
used to designate the serving of other food items. No person shall serve 
colored oleomargarine or colored margarine at a public eating place, 
whether or not any charge is made therefor, unless (1) each separate 
serving bears or is accompanied by labeling identifying it as 
oleomargarine or margarine, or (2) each separate serving thereof is 
triangular in shape.
    (d) Colored oleomargarine or colored margarine when served with 
meals at a public eating place shall at the time of such service be 
exempt from the labeling requirements of section 343 of this Act (except 
subsection (a) and (f) of section 343 of this title) if it complies with 
the requirements of subsection (b) of this section.
    (e) For the purpose of this section colored oleomargarine or colored 
margarine is oleomargarine or margarine having a tint or shade 
containing more than one and six tenths degrees of yellow or of yellow 
and red collectively, but with an excess of yellow over red, measured in 
terms of Lovibond tintometer scale or its equivalent'' (21 U.S.C. 347).

---------------------------------------------------------------------------

[[Page 178]]

    (25) When approved proteolytic enzymes as permitted in part 318 of 
this subchapter are used on steaks or other raw meat cuts, there shall 
appear on the label, in a prominent manner, contiguous to the product 
name, the statement, ``Tenderized with [approved enzyme],'' to indicate 
the use of such enzymes. Any other approved substance which may be used 
in the solution shall also be included in the statement.
    When approved inorganic chlorides as permitted in part 318 of this 
subchapter are used on steaks or other raw meat cuts there shall appear 
on the label in a prominent manner, contiguous to the product name, the 
statement, ``Tenderized with (names of approved inorganic chloride(s))'' 
to indicate the use of such inorganic chlorides. Any other approved 
substance which may be in the solution shall also be included in the 
statement.
    (26) When dimethylpolysiloxan is added as an antifoaming agent to 
rendered fats, its presence shall be declared on the label contiguous to 
the name of the product. Such declaration shall read 
``Dimethylpolysiloxan Added.''
    (27) When pizzas are formulated with crust containing calcium 
propionate or sodium propionate, there shall appear on the label 
contiguous to the name of the product the statement ``-------- added to 
retard spoilage of crust'' preceded by the name of the preservative.
    (28) Sausage of the dry varieties treated with potassium sorbate or 
propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of 
this subchapter, shall be marked or labeled with a statement disclosing 
such treatment and the purpose thereof, such as ``dipped in a potassium 
sorbate solution to retard mold growth.''
    (29) Meat of goats shall be identified as goat meat or chevon.
    (30) The term ``Chitterlings'' shall apply to the large intestines 
of swine, or young bovine animals when preceded with the word ``Calf'' 
or ``Veal.'' Meat food products that contain chitterlings or calf or 
veal chitterlings, in accordance with Sec. 318.6(b)(8) of this 
subchapter shall be identified with product names that refer to such 
ingredients, as for instance, ``Chitterling Loaf,'' ``Chitterling Pie,'' 
or ``Calf Chitterlings and Gravy,'' and shall be packed in containers 
having a capacity of 3 pounds or less and of a kind usually sold at 
retail intact and bearing such other information as is required by this 
part.
    (31) Products that contain blood from livestock as permitted by part 
318 of this subchapter shall be labeled with a name that includes the 
term ``blood,'' and the specific kind of blood shall be declared in the 
ingredient statement, e.g., ``Swine blood,'' in the manner required by 
this part.
    (32) A calendar date may be shown on labeling when declared in 
accordance with the provisions of this subparagraph:
    (i) The calendar date shall express the month of the year and the 
day of the month for all products and also the year in the case of 
products hermetically sealed in metal or glass containers, dried or 
frozen products, or any other products that the Administrator finds 
should be labeled with the year because the distribution and marketing 
practices with respect to such products may cause a label without a year 
identification to be misleading.
    (ii) Immediately adjacent to the calendar date shall be a phrase 
explaining the meaning of such date, in terms of ``packing'' date, 
``sell by'' date, or ``use before'' date, with or without a further 
qualifying phrase, e.g., ``For Maximum Freshness'' or ``For Best 
Quality'', and such phrases shall be approved by the Administrator as 
prescribed in Sec. 317.4.
    (33) [Reserved]
    (34) The terms ``All,'' ``Pure,'' ``100%,'' and terms of similar 
connotation shall not be used on labels for products to identify 
ingredient content, unless the product is prepared solely from a single 
ingredient.
    (35) When agar-agar is used in canned jellied meat food products, as 
permitted in part 318 of this subchapter, there shall appear on the 
label in a prominent manner, contiguous to the product name, a statement 
to indicate the use of agar-agar.

[[Page 179]]

    (36) When sodium alginate, calcium carbonate, and lactic acid and 
calcium carbonate (or glucono delta-lactone) are used together in a dry 
binding matrix in restructured, formed meat food products, as permitted 
in part 318 of this subchapter, there shall appear on the label 
contiguous to the product name, a statement to indicate the use of 
sodium alginate, calcium carbonate and lactic acid and calcium carbonate 
(or glucono delta-lactone).
    (37) The labels of sausages encased in natural casings made from 
meat or poultry viscera shall identify the type of meat or poultry from 
which the casings were derived, if the casings are from a different type 
of meat or poultry than the encased meat or poultry. The identity of the 
casing, if required, may be placed on the principal display panel or in 
the ingredient statement. Establishments producing, manufacturing, or 
using natural sausage casings are to maintain records documenting the 
meat or poultry source in accordance with part 320 of this chapter.
    (38) The labels of sausages encased in regenerated collagen casings 
shall disclose this fact on the product label. The fact that the sausage 
is encased in collagen may be placed on the principal display panel or 
in the ingredient statement.
    (39) When transglutaminase enzyme is used to bind pieces of meat to 
form a cut of meat, or to reform a piece of meat from a multiple cuts, 
there shall appear on the label, as part of the product name, a 
statement that indicates that the product has been ``formed'' or 
``reformed,'' in addition to other preparation steps, e.g., ``Formed 
Beef Tenderloin'' or ``Reformed and Shaped Beef Tenderloin.''
    (40) Products identified as ``pizza'' that list a meat component as 
part of the product name must bear a parenthetical statement contiguous 
to the ingredients statement that conveys the percent of the cooked, 
cured, or dried meat component in the product. This paragraph shall 
expire on October 30, 2006.

[35 FR 15580, Oct. 3, 1970]

    Editorial Note: For Federal Register citations affecting Sec. 
317.8, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.

    Effective Date Note: At 68 FR 44870, July 31, 2003, Sec. 317.8 was 
amended by adding paragraph (b)(40), effective Oct. 22, 2003, through 
Oct. 24, 2006.



Sec. 317.9  Labeling of equine products.

    The immediate containers of any equine products shall be labeled to 
show the kinds of animals from which derived when the products are sold, 
transported, offered for sale or transportation or received for 
transportation in commerce.



Sec. 317.10  Reuse of official inspection marks; reuse of containers 
bearing official marks, labels, etc.

    (a) No official inspection legend or other official mark which has 
been previously used shall be used again for the identification of any 
product, except as provided for in paragraph (b) of this section.
    (b) All stencils, marks, labels, or other labeling on previously 
used containers, whether relating to any product or otherwise, shall be 
removed or obliterated before such containers are used for any product, 
unless such labeling correctly indicates the product to be packed 
therein and such containers are refilled under the supervision of a 
Program employee.



Sec. 317.11  Labeling, filling of containers, handling of labeled 
products to be only in compliance with regulations.

    (a) No person shall in any official establishment apply or affix, or 
cause to be applied or affixed, any label to any product prepared or 
received in such establishment, or to any container thereof, or fill any 
container at such an establishment, except in compliance with the 
regulations in this subchapter.
    (b) No covering or other container shall be filled, in whole or in 
part, at any official establishment with any product unless it has been 
inspected and passed in compliance with the regulations in this 
subchapter, is not adulterated, and is strictly in accordance with the 
statements on the label, and such filling is done under the supervision 
of a Program employee.

[[Page 180]]

    (c) No person shall remove, or cause to be removed from an official 
establishment any product bearing a label unless such label is in 
compliance with the regulations in this subchapter, or any product not 
bearing a label required by such regulations.



Sec. 317.12  Relabeling products; requirements.

    When it is claimed by an official establishment that any of its 
products which bore labels bearing official marks has been transported 
to a location other than an official establishment, and it is desired to 
relabel the product because the labels have become mutilated or 
otherwise damaged, a request for relabeling the product shall be sent to 
the Administrator, accompanied with a statement of the reasons therefor. 
Labeling material intended for relabeling inspected and passed product 
shall not be transported from an official establishment until permission 
has been received from the Administrator. The relabeling of inspected 
and passed product with labels bearing any official marks shall be done 
under the supervision of a Program inspector. The official establishment 
shall reimburse the Program, in accordance with the regulations of the 
Department, for any cost involved in supervising the relabeling of such 
product.



Sec. 317.13  Storage and distribution of labels and containers bearing 
official marks.

    Labels, wrappers, and containers bearing any official marks, with or 
without the establishment number, may be transported from one official 
establishment to any other official establishment provided such 
shipments are made with the prior authorization of the inspector in 
charge at point of origin, who will notify the inspector in charge at 
destination concerning the date of shipment, quantity, and type of 
labeling material involved. No such material shall be used at the 
establishment to which it is shipped unless such use conforms with the 
requirements of this subchapter.



Sec. Sec. 317.14-317.15  [Reserved]



Sec. 317.16  Labeling and containers of custom prepared products.

    Products that are custom prepared under Sec. 303.1(a)(2) of this 
subchapter must be packaged immediately after preparation and must be 
labeled (in lieu of information otherwise required by this part 317) 
with the words ``Not For Sale'' in lettering not less than three-eighth 
inch in height. Such exempted custom prepared products or their 
containers may bear additional labeling provided such labeling is not 
false or misleading.

[37 FR 4071, Feb. 26, 1972]



Sec. 317.17  Interpretation and statement of labeling policy for cured 
products; special labeling requirements concerning nitrate and nitrite.

    (a) With respect to sections 1(n) (7), (9), and (12) of the Act and 
Sec. 317.2, any substance mixed with another substance to cure a 
product must be identified in the ingredients statement on the label of 
such product. For example, curing mixtures composed of such ingredients 
as water, salt, sugar, sodium phosphate, sodium nitrate, and sodium 
nitrite or other permitted substances which are added to any product, 
must be identified on the label of the product by listing each such 
ingredient in accordance with the provisions of Sec. 317.2.
    (b) Any product, such as bacon and pepperoni, which is required to 
be labeled by a common or usual name or descriptive name in accordance 
with Sec. 317.2(c)(1) and to which nitrate or nitrite is permitted or 
required to be added may be prepared without nitrate or nitrite and 
labeled with such common or usual name or descriptive name when 
immediately preceded with the term ``Uncured'' as part of the product 
name in the same size and style of lettering as the product name, 
provided that the product is found by the Administrator to be similar in 
size, flavor, consistency, and general appearance to such product as 
commonly prepared with nitrate or nitrite, or both.
    (c)(1) Products described in paragraph (b) of this section or Sec. 
319.2 of

[[Page 181]]

this subchapter, which contain no nitrate or nitrite shall bear the 
statement ``No Nitrate or Nitrite Added.'' This statement shall be 
adjacent to the product name in lettering of easily readable style and 
at least one-half the size of the product name.
    (2) Products described in paragraph (b) of this section and Sec. 
319.2 of this subchapter shall bear, adjacent to the product name in 
lettering of easily readable style and at least one-half the size of the 
product name, the statement ``Not Preserved--Keep Refrigerated Below 40 
[deg]F. At All Times'' unless they have been thermally processed to 
Fo 3 or more; they have been fermented or pickled to pH of 
4.6 or less; or they have been dried to a water activity of 0.92 or 
less.
    (3) Products described in paragraph (b) of this section and Sec. 
319.2 of this subchapter shall not be subject to the labeling 
requirements of paragraphs (b) and (c) of this section if they contain 
an amount of salt sufficient to achieve a brine concentration of 10 
percent or more.

[37 FR 16863, Aug. 22, 1972, as amended at 44 FR 48961, Aug. 21, 1979]



Sec. 317.18  Quantity of contents labeling.

    Sections 317.18 through 317.22 of this part prescribe the procedures 
to be followed for determining net weight compliance and prescribe the 
reasonable variations from the declared net weight on the labels of 
immediate containers of products in accordance with Sec. 317.2(h) of 
this part.

[55 FR 49834, Nov. 30, 1990]



Sec. 317.19  Definitions and procedures for determining net weight 
compliance.

    (a) For the purpose of Sec. Sec. 317.18 through 317.22 of this 
part, the reasonable variations allowed, definitions, and procedures to 
be used in determining net weight and net weight compliance are 
described in the National Institute of Standards and Technology (NIST) 
Handbook 133, ``Checking the Net Contents of Packaged Goods,'' Third 
Edition, September 1988, and Supplements 1, 2, 3, and 4 dated September 
1990, October 1991, October 1992, and October 1994, respectively, which 
are incorporated by reference, with the exception of the NIST Handbook 
133 and Supplements 1, 3, and 4 requirements listed in paragraphs (b) 
and (c) of this section. Those provisions incorporated by reference 
herein, are considered mandatory requirements. This incorporation was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. (These materials are incorporated as 
they exist on the date of approval.) A notice of any change in the 
Handbook cited herein will be published in the Federal Register. Copies 
may be purchased from the Superintendent of Documents, U.S. Government 
Printing Office, Washington, DC 20402. It is also available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
    (b) The following NBS Handbook 133 requirements are not incorporated 
by reference.

                    Chapter 2--General Considerations

2.13.1 Polyethylene Sheeting and Film
2.13.2 Textiles
2.13.3 Mulch

        Chapter 3--Methods of Test for Packages Labeled by Weight

3.11. Aerosol Packages
3.14. Glazed Raw Seafood and Fish
3.15. Canned Coffee
3.16. Borax
3.17. Flour

        Chapter 4--Methods of Test for Packages Labeled by Volume

4.7. Milk
4.8. Mayonnaise and Salad Dressing
4.9. Paint, Varnish, and Lacquers--Nonaerosol
4.11. Peat Moss
4.12. Bark Mulch
4.15. Ice Cream Novelties

Chapter 5--Methods of Test for Packages Labeled by Count, Length, Area, 
                Thickness, or Combinations of Quantities

5.4. Polyethylene Sheeting
5.5. Paper Plates
5.6. Sanitary Paper Products
5.7. Pressed and Blown Glass Tumblers and Stemware

[[Page 182]]

              Appendix D: Package Net Contents Regulations

D.1.1. U.S. Department of Health and Human Services, Food and Drug 
Administration
D.1.2. Department of Agriculture, Food Safety and Inspection Service
D.1.3. Federal Trade Commission
D.1.4. Environmental Protection Agency
D.1.5. U.S. Department of the Treasury, Bureau of Alcohol, Tobacco, and 
Firearms

    (c) The following requirements of Supplement 1, dated September 
1990, Supplement 3, dated October 1992, and Supplement 4, dated 1994, of 
NIST Handbook 133 are not incorporated by reference.

                              Supplement 1

                    Chapter 2 General Considerations

2.13.1. Polyethylene Sheeting and Film
2.13.2. Textiles
2.13.3. Mulch

        Chapter 3 Methods of Test for Packages Labeled by Weight

3.11.4. Exhausting the Aerosol Container

        Chapter 4 Methods of Test for Packages Labeled by Volume

4.6.4. Method D: Determining the Net Contents of Compressed Gas in 
Cylinders
4.7. Milk
4.16. Fresh Oysters Labeled by Volume

 Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area, 
                Thickness, or Combinations of Quantities

5.4. Polyethylene Sheeting

                              Supplement 3

        Chapter 3 Methods of Test for Packages Labeled by Weight

3.17. Flour and Dry Pet Food

 Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area, 
                 Thickness, or Combination of Quantities

5.4. Polyethylene Sheeting
5.5. Paper Plates
5.8. Baler Twine

Appendix A. Forms and Worksheets

                              Supplement 4

3.11 Aerosol Packages
3.11.1 Equipment
3.11.2 Preparation for Test
3.11.3 The Determination of Net Contents: Part 1
3.11.4 Exhausting the Aerosol Container
3.11.5 The Determination of Net Contents: Part 2

Appendix A. Report Forms

[55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, March 9, 1995]



Sec. 317.20  Scale requirements for accurate weights, repairs, 
adjustments, and replacement after inspection.

    (a) All scales used to weigh meat products sold or otherwise 
distributed in commerce in federally inspected meat establishments shall 
be installed, maintained and operated to insure accurate weights. Such 
scales shall meet the applicable requirements contained in National 
Institute of Standards and Technology Handbook 44, ``Specifications, 
Tolerances, and Other Technical Requirements for Weighing and Measuring 
Devices'', 1999 Edition, November 1998, which is incorporated by 
reference. This incorporation was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
(These materials are incorporated as they exist on the date of 
approval.) Copies may be purchased from the Superintendent of Documents, 
U.S. Government Printing Office, Washington, DC 20402. It is also 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (b) All scales used to weigh meat products sold or otherwise 
distributed in commerce or in States designated under section 301(c) of 
the Federal Meat Inspection Act, shall be of sufficient capacity to 
weigh the entire unit and/or package.
    (c) No scale shall be used at a federally inspected establishment to 
weigh meat products unless it has been found upon test and inspection, 
as specified in NIST Handbook 44, to provide accurate weight. If a scale 
is reinspected or retested and found to be inaccurate, or if any 
repairs, adjustments or replacements are made to a scale, it shall not 
be used until it has been inspected and tested by a USDA official, or a 
State or local government weights and measures official, or State 
registered or licensed scale repair firm or person, and

[[Page 183]]

it must meet all accuracy requirements as specified in NIST Handbook 44. 
If a USDA inspector has put a retain tag on a scale it can only be 
removed by a USDA inspector. As long as the tag is on the scale, it 
shall not be used.

[55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, Mar. 9, 1995; 64 
FR 53187, Oct. 1, 1999]



Sec. 317.21  Scales: testing of.

    (a) The operator of each official establishment that weighs meat 
food products shall cause such scales to be tested for accuracy, in 
accordance with the technical requirements of NIST Handbook 44, at least 
once during the calendar year. In cases where the scales are found not 
to maintain accuracy between tests, more frequent tests may be required 
and monitored by an authorized USDA program official.
    (b) The operator of each official establishment shall display on or 
near each scale a valid certification of the scale's accuracy from a 
State or local government's weights and measures authority or from a 
State registered or licensed scale repair firm or person, or shall have 
alternative documented procedures showing that the scale has been tested 
for accuracy in accordance with the requirements of NIST Handbook 44.

[55 FR 49834, Nov. 30, 1990, as amended at 62 FR 45024, Aug. 25, 1997; 
65 FR 34389, May 30, 2000; 66 FR 52486, Oct. 16, 2001]



Sec. 317.22  Handling of failed product.

    Any lot of product which is found to be out of compliance with net 
weight requirements upon testing in accordance with Sec. 317.19 shall 
be handled as follows:
    (a) A lot tested in an official establishment and found not to 
comply with net weight requirements may be reprocessed and must be 
reweighed and remarked to satisfy the net weight requirements of this 
section and be reinspected, in accordance with the requirements of this 
part.
    (b) A lot tested outside of an official establishment and found not 
to comply with net weight requirements must be reweighed and remarked 
with a proper net weight statement, provided that such reweighing and 
remarking shall not deface, cover, or destroy any other marking or 
labeling required under this subchapter and the net quantity of contents 
is shown with the same prominence as the most conspicuous feature of a 
label.

[55 FR 49834, Nov. 30, 1990]



Sec. 317.23  [Reserved]



Sec. 317.24  Packaging materials.

    (a) Edible products may not be packaged in a container which is 
composed in whole or in part of any poisonous or deleterious substances 
which may render the contents adulterated or injurious to health. All 
packaging materials must be safe for their intended use within the 
meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as 
amended (FFDCA).
    (b) Packaging materials entering the official establishment must be 
accompanied or covered by a guaranty, or statement of assurance, from 
the packaging supplier under whose brand name and firm name the material 
is marketed to the official establishment. The guaranty shall state that 
the material's intended use complies with the FFDCA and all applicable 
food additive regulations. The guaranty must identify the material, 
e.g., by the distinguishing brand name or code designation appearing on 
the packaging material shipping container; must specify the applicable 
conditions of use, including temperature limits and any other pertinent 
limits specified under the FFDCA and food additive regulations; and must 
be signed by an authorized official of the supplying firm. The guaranty 
may be limited to a specific shipment of an article, in which case it 
may be part of or attached to the invoice covering such shipment, or it 
may be general and continuing, in which case, in its application to any 
article or other shipment of an article, it shall be considered to have 
been given at the date such article was shipped by the person who gives 
the guaranty. Guaranties consistent with the Food and Drug 
Administration's regulations regarding such guaranties (21 CFR 7.12 and 
7.13) will be acceptable. The management of the establishment must 
maintain a file containing guaranties for all food contact packaging 
materials in the establishment.

[[Page 184]]

The file shall be made available to Program inspectors or other 
Department officials upon request. While in the official establishment, 
the identity of all packaging materials must be traceable to the 
applicable guaranty.
    (c) The guaranty by the packaging supplier will be accepted by 
Program inspectors to establish that the use of material complies with 
the FFDCA and all applicable food additive regulations.
    (d) The Department will monitor the use of packaging material in 
official establishments to assure that the requirements of paragraph (a) 
of this section are met, and may question the basis for any guaranty 
described under paragraph (b) of this section. Official establishments 
and packaging suppliers providing written guaranties to those official 
establishments will be permitted an opportunity to provide information 
tm designated Department officials as needed to verify the basis for any 
such guaranty. The required information will include, but is not limited 
to, manufacturing firm's name, trade name or code designation for the 
material, complete chemical composition, and use. Selection of a 
material for review does not in itself affect a material's 
acceptability. Materials may continue to be used during the review 
period. However, if information requested from the supplier is not 
provided within the time indicated in the request--a minimum of 30 
days--any applicable guaranty shall cease to be effective, and approval 
to continue using the specified packaging material in official 
establishments may be denied. The Administrator may extend this time 
where reasonable grounds for extension are shown, as, for example, where 
data must be obtained from suppliers.
    (e) The Administrator may disapprove for use in official 
establishments packaging materials whose use cannot be confirmed as 
complying with FFDCA and applicable food additive regulations. Before 
approval to use a packaging material is finally denied by the 
Administrator, the affected official establishment and the supplier of 
the material shall be given notice and the opportunity to present their 
views to the Administrator. If the official establishment and the 
supplier do not accept the Administrator's determination, a hearing in 
accordance with applicable rules of practice will be held to resolve 
such dispute. Approval to use the materials pending the outcome of the 
presentation of views or hearing shall be denied if the Administrator 
determines that such use may present an imminent hazard to public 
health.
    (f) Periodically, the Administrator will issue to inspectors a 
listing, by distinguishing brand name or code designation, of packaging 
materials that have been reviewed and that fail to meet the requirements 
of paragraph (a) of this section. Listed materials will not be permitted 
for use in official establishments. If a subsequent review of any 
material indicates that it meets the requirements of paragraph (a), the 
material will be deleted from the listing.
    (g) Nothing in this section shall affect the authority of Program 
inspectors to refuse a specific material if he/she determines the 
material may render products adulterated or injurious to health.

[49 FR 2235, Jan. 19, 1984. Redesignated at 55 FR 49833, Nov. 30, 1990]



                      Subpart B_Nutrition Labeling

    Source: 58 FR 664, Jan. 6, 1993, unless otherwise noted.



Sec. 317.300  Nutrition labeling of meat or meat food products.

    (a) Nutrition labeling shall be provided for all meat or meat food 
products intended for human consumption and offered for sale, except 
single-ingredient, raw products, in accordance with the requirements of 
Sec. 317.309; except as exempted under Sec. 317.400 of this subpart.
    (b) Nutrition labeling may be provided for single-ingredient, raw 
meat or meat food products in accordance with the requirements of 
Sec. Sec. 317.309 and 317.345. Significant participation in voluntary 
nutrition labeling shall be measured by the Agency in accordance with 
Sec. Sec. 317.343 and 317.344 of this subpart.

[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]

[[Page 185]]



Sec. 317.301  [Reserved]



Sec. 317.302  Location of nutrition information.

    (a) Nutrition information on a label of a packaged meat or meat food 
product shall appear on the label's principal display panel or on the 
information panel, except as provided in paragraphs (b) and (c) of this 
section.
    (b) Nutrition information for gift packs may be shown at a location 
other than on the product label, provided that the labels for these 
products bear no nutrition claim. In lieu of on the product label, 
nutrition information may be provided by alternate means such as product 
label inserts.
    (c) Meat or meat food products in packages that have a total surface 
area available to bear labeling greater than 40 square inches but whose 
principal display panel and information panel do not provide sufficient 
space to accommodate all required information may use any alternate 
panel that can be readily seen by consumers for the nutrition 
information. In determining the sufficiency of available space for the 
nutrition information, the space needed for vignettes, designs, and 
other nonmandatory label information on the principal display panel may 
be considered.

[58 FR 664, Jan. 6, 1993, as amended at 59 FR 40213, Aug. 8, 1994; 60 FR 
176, Jan. 3, 1995]



Sec. Sec. 317.303-317.307  [Reserved]



Sec. 317.308  Labeling of meat or meat food products with number of 
servings.

    The label of any package of a meat or meat food product that bears a 
representation as to the number of servings contained in such package 
shall meet the requirements of Sec. 317.2(h)(10).

[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]



Sec. 317.309  Nutrition label content.

    (a) All nutrient and food component quantities shall be declared in 
relation to a serving as defined in this section.
    (b)(1) The term ``serving'' or ``serving size'' means an amount of 
food customarily consumed per eating occasion by persons 4 years of age 
or older, which is expressed in a common household measure that is 
appropriate to the product. When the product is specially formulated or 
processed for use by infants or by toddlers, a serving or serving size 
means an amount of food customarily consumed per eating occasion by 
infants up to 12 months of age or by children 1 through 3 years of age, 
respectively.
    (2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of 
this section and for products that are intended for weight control and 
are available only through a weight-control or weight-maintenance 
program, serving size declared on a product label shall be determined 
from the ``Reference Amounts Customarily Consumed Per Eating Occasion--
General Food Supply'' (Reference Amount(s)) that appear in Sec. 
317.312(b) using the procedures described in this paragraph (b). For 
products that are both intended for weight control and available only 
through a weight-control program, a manufacturer may determine the 
serving size that is consistent with the meal plan of the program. Such 
products must bear a statement, ``for sale only through the ------ 
program'' (fill in the blank with the name of the appropriate weight-
control program, e.g., Smith's Weight Control), on the principal display 
panel. However, the Reference Amounts in Sec. 317.312(b) shall be used 
for purposes of evaluating whether weight-control products that are 
available only through a weight-control program qualify for nutrition 
claims.
    (3) The declaration of nutrient and food component content shall be 
on the basis of the product ``as packaged'' for all products, except 
that single-ingredient, raw products may be declared on the basis of the 
product ``as consumed'' as set forth in Sec. 317.345(a)(1). In addition 
to the required declaration on the basis of ``as packaged'' for products 
other than single-ingredient, raw products, the declaration may also be 
made on the basis of ``as consumed,'' provided that preparation and 
cooking instructions are clearly stated.
    (4) For products in discrete units (e.g., hot dogs, and individually 
packaged products within a multi-serving package), and for products 
which consist of two or more foods packaged and

[[Page 186]]

presented to be consumed together where the ingredient represented as 
the main ingredient is in discrete units (e.g., beef fritters and 
barbecue sauce), the serving size shall be declared as follows:
    (i) If a unit weighs 50 percent or less of the Reference Amount, the 
serving size shall be the number of whole units that most closely 
approximates the Reference Amount for the product category.
    (ii) If a unit weighs more than 50 percent but less than 67 percent 
of the Reference Amount, the manufacturer may declare one unit or two 
units as the serving size.
    (iii) If a unit weighs 67 percent or more but less than 200 percent 
of the Reference Amount, the serving size shall be one unit.
    (iv) If a unit weighs 200 percent or more of the Reference Amount, 
the manufacturer may declare one unit as the serving size if the whole 
unit can reasonably be consumed at a single eating occasion.
    (v) For products that have Reference Amounts of 100 grams (or 
milliliter) or larger and are individual units within a multi-serving 
package, if a unit contains more than 150 percent but less than 200 
percent of the Reference Amount, the manufacturer may decide whether to 
declare the individual unit as 1 or 2 servings.
    (vi) For products which consist of two or more foods packaged and 
presented to be consumed together where the ingredient represented as 
the main ingredient is in discrete units (e.g., beef fritters and 
barbecue sauce), the serving size may be the number of discrete units 
represented as the main ingredient plus proportioned minor ingredients 
used to make the Reference Amount for the combined product as determined 
in Sec. 317.312(c).
    (vii) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving containers), 
the serving size shall be 1 unit.
    (5) For products in large discrete units that are usually divided 
for consumption (e.g., pizza), for unprepared products where the entire 
contents of the package is used to prepare large discrete units that are 
usually divided for consumption (e.g. pizza kit), and for products which 
consist of two or more foods packaged and presented to be consumed 
together where the ingredient represented as the main ingredient is a 
large discrete unit usually divided for consumption, the serving size 
shall be the fractional slice of the ready-to-eat product (e.g., \1/8\ 
quiche, \1/4\ pizza) that most closely approximates the Reference Amount 
for the product category. The serving size may be the fraction of the 
package used to make the Reference Amount for the unprepared product 
determined in Sec. 317.312(d) or the fraction of the large discrete 
unit represented as the main ingredient plus proportioned minor 
ingredients used to make the Reference Amount of the combined product 
determined in Sec. 317.312(c). In expressing the fractional slice, 
manufacturers shall use \1/2\, \1/3\, \1/4\, \1/5\, \1/6\, or smaller 
fractions that can be generated by further division by 2 or 3.
    (6) For nondiscrete bulk products (e.g., whole roast beef, marinated 
beef tenderloin, large can of chili), and for products which consist of 
two or more foods packaged and presented to be consumed together where 
the ingredient represented as the main ingredient is a bulk product 
(e.g., roast beef and gravy), the serving size shall be the amount in 
household measure that most closely approximates the Reference Amount 
for the product category and may be the amount of the bulk product 
represented as the main ingredient plus proportioned minor ingredients 
used to make the Reference Amount for the combined product determined in 
Sec. 317.312(c).
    (7) For labeling purposes, the term ``common household measure'' or 
``common household unit'' means cup, tablespoon, teaspoon, piece, slice, 
fraction (e.g., \1/4\ pizza), ounce (oz), or other common household 
equipment used to package food products (e.g., jar or tray). In 
expressing serving size in household measures, except as specified in 
paragraphs (b)(7)(iv), (v), and (vi) of this section, the following 
rules shall be used:

[[Page 187]]

    (i) Cups, tablespoons, or teaspoons shall be used wherever possible 
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup 
increments, tablespoons in whole number of tablespoons for quantities 
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp), 
1, 1\1/3\, 1\1/2\, or 1 \2/3\ tbsp for quantities less than 2 tbsp but 
greater than or equal to 1 tbsp, and teaspoons in whole number of 
teaspoons for quantities less than 1 tbsp but greater than or equal to 1 
teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 1 
tsp.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If cups, tablespoons and teaspoons, or units such as piece, 
slice, tray, jar, or fraction are not applicable, ounces may be used. 
Ounce measurements shall be expressed in 0.5-ounce increments most 
closely approximating the Reference Amount with rounding indicated by 
the use of the term ``about'' (e.g., about 2.5 ounces).
    (iv) A description of the individual container or package shall be 
used for single-serving containers and for individually packaged 
products within multi-serving containers (e.g., can, box, package, meal, 
or dinner). A description of the individual unit shall be used for other 
products in discrete units (e.g., chop, slice, link, or patty).
    (v) For unprepared products where the entire contents of the package 
is used to prepare large discrete units that are usually divided for 
consumption (e.g., pizza kit), the fraction or portion of the package 
may be used.
    (vi) For products that consist of two or more distinct ingredients 
or components packaged and presented to be consumed together (e.g., ham 
with a glaze packet), the nutrition information may be declared for each 
component or as a composite. The serving size may be provided in 
accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6) 
of this section.
    (vii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz 
in weight means 28 grams (g).
    (viii) When a serving size, determined from the Reference Amount in 
Sec. 317.312(b) and the procedures described in this section, falls 
exactly half way between two serving sizes (e.g., 2.5 tbsp), 
manufacturers shall round the serving size up to the next incremental 
size.
    (8) A product that is packaged and sold individually and that 
contains less than 200 percent of the applicable Reference Amount shall 
be considered to be a single-serving container, and the entire content 
of the product shall be labeled as one serving, except for products that 
have Reference Amounts of 100 g (or mL) or larger, manufacturers may 
decide whether a package that contains more than 150 percent but less 
than 200 percent of the Reference Amount is 1 or 2 servings. Packages 
sold individually that contain 200 percent or more of the applicable 
Reference Amount may be labeled as a single-serving if the entire 
content of the package can reasonably be consumed at a single-eating 
occasion.
    (9) A label statement regarding a serving shall be the serving size 
expressed in common household measures as set forth in paragraphs (b)(2) 
through (b)(8) of this section and shall be followed by the equivalent 
metric quantity in parenthesis (fluids in milliliters and all other 
foods in grams), except for single-serving containers.
    (i) For a single-serving container, the parenthetical metric 
quantity, which will be presented as part of the net weight statement on 
the principal display panel, is not required except where nutrition 
information is required on a drained weight basis according to paragraph 
(b)(11) of this section. However, if a manufacturer voluntarily provides 
the metric quantity on products that can be sold as single-servings, 
then the numerical value provided as part of the serving size 
declaration must be identical to the metric quantity declaration 
provided as part of the net quantity of contents statement.
    (ii) The gram or milliliter quantity equivalent to the household 
measure should be rounded to the nearest whole number except for 
quantities that are less than 5 g (mL). The gram (mL) quantity between 2 
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) 
quantity less than 2 g

[[Page 188]]

(mL) should be expressed in 0.1-g (mL) increments.
    (iii) In addition, serving size may be declared in ounce, in 
parenthesis, following the metric measure separated by a slash where 
other common household measures are used as the primary unit for serving 
size, e.g., 1 slice (28 g/1 oz) for sliced bologna. The ounce quantity 
equivalent to the metric quantity should be expressed in 0.1-oz 
increments.
    (iv) If a manufacturer elects to use abbreviations for units, the 
following abbreviations shall be used: tbsp for tablespoon, tsp for 
teaspoon, g for gram, mL for milliliter, and oz for ounce.
    (10) Determination of the number of servings per container shall be 
based on the serving size of the product determined by following the 
procedures described in this section.
    (i) The number of servings shall be rounded to the nearest whole 
number except for the number of servings between 2 and 5 servings and 
random weight products. The number of servings between 2 and 5 servings 
shall be rounded to the nearest 0.5 serving. Rounding should be 
indicated by the use of the term ``about'' (e.g., about 2 servings; 
about 3.5 servings).
    (ii) When the serving size is required to be expressed on a drained 
solids basis and the number of servings varies because of a natural 
variation in unit size (e.g., pickled pigs feet), the manufacturer may 
state the typical number of servings per container (e.g., usually 5 
servings).
    (iii) For random weight products, a manufacturer may declare 
``varied'' for the number of servings per container provided the 
nutrition information is based on the Reference Amount expressed in 
ounces. The manufacturer may provide the typical number of servings in 
parenthesis following the ``varied'' statement (e.g., varied 
(approximately 8 servings per pound)).
    (iv) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving containers), 
the number of servings shall be the number of individual packages within 
the total package.
    (v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by multiplying 
the number of individual multi-serving units in the total package by the 
number of servings in each individual unit.
    (11) The declaration of nutrient and food component content shall be 
on the basis of product as packaged or purchased with the exception of 
products that are packed or canned in water, brine, or oil but whose 
liquid packing medium is not customarily consumed. Declaration of the 
nutrient and food component content of products that are packed in 
liquid which is not customarily consumed shall be based on the drained 
solids.
    (12) The serving size for meal-type products and main-dish products 
as defined in Sec. 317.313(l) and Sec. 317.313(m) in single-serving 
containers will be the entire edible content of the package. Serving 
size for meal-type products and main-dish products in multi-serve 
containers will be based on the reference amount applicable to the 
product in Sec. 317.312(b) if the product is listed in Sec. 
317.312(b). Serving size for meal-type products and main-dish products 
in multi-serve containers that are not listed in Sec. 317.312(b) will 
be based on the reference amount according to Sec. 317.312(c), (d), and 
(e).
    (13) Another column of figures may be used to declare the nutrient 
and food component information in the same format as required by Sec. 
317.309(e),
    (i) Per 100 grams, 100 milliliters, or 1 ounce of the product as 
packaged or purchased.
    (ii) Per one unit if the serving size of a product in discrete units 
in a multi-serving container is more than one unit.
    (14) If a product consists of assortments of meat or meat food 
products (e.g., variety packs) in the same package, nutrient content 
shall be expressed on the entire package contents or on each individual 
product.
    (15) If a product is commonly combined with other ingredients or is 
cooked or otherwise prepared before eating, and directions for such 
combination or preparations are provided,

[[Page 189]]

another column of figures may be used to declare the nutrient contents 
on the basis of the product as consumed for the product alone (e.g., a 
cream soup mix may be labeled with one set of Daily Values for the dry 
mix (per serving), and another set for the serving of the final soup 
when prepared (e.g., per serving of cream soup mix and 1 cup of vitamin 
D fortified whole milk)): Provided, That the type and quantity of the 
other ingredients to be added to the product by the user and the 
specific method of cooking and other preparation shall be specified 
prominently on the label.
    (c) The declaration of nutrition information on the label or in 
labeling of a meat or meat food product shall contain information about 
the level of the following nutrients, except for those nutrients whose 
inclusion, and the declaration of amounts, is voluntary as set forth in 
this paragraph. No nutrients or food components other than those listed 
in this paragraph as either mandatory or voluntary may be included 
within the nutrition label. Except as provided for in paragraph (f) or 
(g) of this section, nutrient information shall be presented using the 
nutrient names specified and in the following order in the formats 
specified in paragraph (d) or (e) of this section.
    (1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A 
statement of the caloric content per serving, expressed to the nearest 
5-calorie increment up to and including 50 calories, and 10-calorie 
increment above 50 calories, except that amounts less than 5 calories 
may be expressed as zero. Energy content per serving may also be 
expressed in kilojoule units, added in parenthesis immediately following 
the statement of the caloric content.
    (i) Caloric content may be calculated by the following methods. 
Where either specific or general food factors are used, the factors 
shall be applied to the actual amount (i.e., before rounding) of food 
components (e.g., fat, carbohydrate, protein, or ingredients with 
specific food factors) present per serving.
    (A) Using specific Atwater factors (i.e., the Atwater method) given 
in Table 13, page 25, ``Energy Value of Foods--Basis and Derivation,'' 
by A. L. Merrill and B. K. Watt, United States Department of Agriculture 
(USDA), Agriculture Handbook No. 74 (Slightly revised February 1973), 
which is incorporated by reference. Table 13 of the ``Energy Value of 
Foods--Basis and Derivation,'' Agriculture Handbook No. 74 is 
incorporated as it exists on the date of approval. This incorporation by 
reference was approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for 
inspection at the office of the FSIS Docket Clerk, Room 3171, South 
Building, 14th and Independence Avenue, SW., Washington, DC, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. Copies of the incorporation by 
reference are available from the Product Assessment Division, Regulatory 
Programs, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Room 329, West End Court Building, Washington, DC 20250-
3700;
    (B) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate, and total fat, respectively, as described 
in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), 
pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture 
Handbook No. 74 is incorporated as it exists on the date of approval. 
This incorporation by reference was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
(The availability of this incorporation by reference is given in 
paragraph (c)(1)(i)(A) of this section.);
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate less the amount of insoluble dietary fiber, 
and total fat, respectively, as described in USDA's Agriculture Handbook 
No. 74 (Slightly revised February 1973), pages 9-11, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. (The availability of this incorporation by reference is given 
in paragraph (c)(1)(i)(A) of this section.); or

[[Page 190]]

    (D) Using data for specific food factors for particular foods or 
ingredients approved by the Food and Drug Administration (FDA) and 
provided in parts 172 or 184 of 21 CFR, or by other means, as 
appropriate.
    (ii) ``Calories from fat'': A statement of the caloric content 
derived from total fat as defined in paragraph (c)(2) of this section 
per serving, expressed to the nearest 5-calorie increment, up to and 
including 50 calories, and the nearest 10-calorie increment above 50 
calories, except that label declaration of ``calories from fat'' is not 
required on products that contain less than 0.5 gram of fat per serving 
and amounts less than 5 calories may be expressed as zero. This 
statement shall be declared as provided in paragraph (d)(5) of this 
section.
    (iii) ``Calories from saturated fat'' or ``Calories from saturated'' 
(VOLUNTARY): A statement of the caloric content derived from saturated 
fat as defined in paragraph (c)(2)(i) of this section per serving may be 
declared voluntarily, expressed to the nearest 5-calorie increment, up 
to and including 50 calories, and the nearest 10-calorie increment above 
50 calories, except that amounts less than 5 calories may be expressed 
as zero. This statement shall be indented under the statement of 
calories from fat as provided in paragraph (d)(5) of this section.
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat per serving defined as total lipid fatty acids and 
expressed as triglycerides. Amounts shall be expressed to the nearest 
0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content shall be expressed as zero.
    (i) ``Saturated fat'' or ``Saturated'': A statement of the number of 
grams of saturated fat per serving defined as the sum of all fatty acids 
containing no double bonds, except that label declaration of saturated 
fat content information is not required for products that contain less 
than 0.5 gram of total fat per serving if no claims are made about fat 
or cholesterol content, and if ``calories from saturated fat'' is not 
declared. Saturated fat content shall be indented and expressed as grams 
per serving to the nearest 0.5 (\1/2\)-gram increment below 5 grams and 
to the nearest gram increment above 5 grams. If the serving contains 
less than 0.5 gram, the content shall be expressed as zero.
    (A) ``Stearic Acid'' (VOLUNTARY): A statement of the number of grams 
of stearic acid per serving may be declared voluntarily, except that 
when a claim is made about stearic acid, label declaration shall be 
required. Stearic acid content shall be indented under saturated fat and 
expressed to the nearest 0.5 (\1/2\)-gram increment below 5 grams and 
the nearest gram increment above 5 grams. If the serving contains less 
than 0.5 gram, the content shall be expressed as zero.
    (B) [Reserved]
    (ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A 
statement of the number of grams of polyunsaturated fat per serving 
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may 
be declared voluntarily, except that when monounsaturated fat is 
declared, or when a claim about fatty acids or cholesterol is made on 
the label or in labeling of a product other than one that meets the 
criteria in Sec. 317.362(b)(1) for a claim for ``fat free,'' label 
declaration of polyunsaturated fat is required. Polyunsaturated fat 
content shall be indented and expressed as grams per serving to the 
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content shall be expressed as zero.
    (iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A 
statement of the number of grams of monounsaturated fat per serving 
defined as cis-monounsaturated fatty acids may be declared voluntarily, 
except that when polyunsaturated fat is declared, or when a claim about 
fatty acids or cholesterol is made on the label or in labeling of a 
product other than one that meets the criteria in Sec. 317.362(b)(1) 
for a claim for ``fat free,'' label declaration of monounsaturated fat 
is required. Monounsaturated fat content shall be indented and expressed 
as grams per serving to the nearest 0.5 (\1/2\)-gram increment below 5 
grams and to the nearest gram increment above 5 grams. If the serving 
contains less than

[[Page 191]]

0.5 gram, the content shall be expressed as zero.
    (3) ``Cholesterol'': A statement of the cholesterol content per 
serving expressed in milligrams to the nearest 5-milligram increment, 
except that label declaration of cholesterol information is not required 
for products that contain less than 2 milligrams of cholesterol per 
serving and make no claim about fat, fatty acids, or cholesterol 
content, or such products may state the cholesterol content as zero. If 
the product contains 2 to 5 milligrams of cholesterol per serving, the 
content may be stated as ``less than 5 milligrams.''
    (4) ``Sodium'': A statement of the number of milligrams of sodium 
per serving expressed as zero when the serving contains less than 5 
milligrams of sodium, to the nearest 5-milligram increment when the 
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-
milligram increment when the serving contains greater than 140 
milligrams.
    (5) ``Potassium'' (VOLUNTARY): A statement of the number of 
milligrams of potassium per serving may be declared voluntarily, except 
that when a claim is made about potassium content, label declaration 
shall be required. Potassium content shall be expressed as zero when the 
serving contains less than 5 milligrams of potassium, to the nearest 5-
milligram increment when the serving contains 5 to 140 milligrams of 
potassium, and to the nearest 10-milligram increment when the serving 
contains greater than 140 milligrams.
    (6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement 
of the number of grams of total carbohydrate per serving expressed to 
the nearest gram, except that if a serving contains less than 1 gram, 
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may 
be used as an alternative, or, if the serving contains less than 0.5 
gram, the content may be expressed as zero. Total carbohydrate content 
shall be calculated by subtraction of the sum of the crude protein, 
total fat, moisture, and ash from the total weight of the product. This 
calculation method is described in USDA's Agriculture Handbook No. 74 
(Slightly revised February 1973), pages 2 and 3, which is incorporated 
by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated 
as it exists on the date of approval. This incorporation by reference 
was approved by the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this 
incorporation by reference is given in paragraph (c)(1)(i)(A) of this 
section.)
    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber per serving, indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, declaration of 
dietary fiber is not required, or, alternatively, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and 
if the serving contains less than 0.5 gram, the content may be expressed 
as zero.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber per serving may be declared voluntarily 
except when a claim is made on the label or in labeling about soluble 
fiber, label declaration shall be required. Soluble fiber content shall 
be indented under dietary fiber and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of 
grams of insoluble dietary fiber per serving may be declared voluntarily 
except when a claim is made on the label or in labeling about insoluble 
fiber, label declaration shall be required. Insoluble fiber content 
shall be indented under dietary fiber and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (ii) ``Sugars'': A statement of the number of grams of sugars per 
serving, except that label declaration of sugars content is not required 
for products

[[Page 192]]

that contain less than 1 gram of sugars per serving if no claims are 
made about sweeteners, sugars, or sugar alcohol content. Sugars shall be 
defined as the sum of all free mono- and disaccharides (such as glucose, 
fructose, lactose, and sucrose). Sugars content shall be indented and 
expressed to the nearest gram, except that if a serving contains less 
than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 
1 gram'' may be used as an alternative, and if the serving contains less 
than 0.5 gram, the content may be expressed as zero.
    (iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols per serving may be declared voluntarily on the 
label, except that when a claim is made on the label or in labeling 
about sugar alcohol or sugars when sugar alcohols are present in the 
product, sugar alcohol content shall be declared. For nutrition labeling 
purposes, sugar alcohols are defined as the sum of saccharide 
derivatives in which a hydroxyl group replaces a ketone or aldehyde 
group and whose use in the food is listed by FDA (e.g., mannitol or 
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of 
the term ``sugar alcohol,'' the name of the specific sugar alcohol 
(e.g., ``xylitol'') present in the product may be used in the nutrition 
label, provided that only one sugar alcohol is present in the product. 
Sugar alcohol content shall be indented and expressed to the nearest 
gram, except that if a serving contains less than 1 gram, the statement 
``Contains less then 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number 
of grams of other carbohydrate per serving may be declared voluntarily. 
Other carbohydrate shall be defined as the difference between total 
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, 
except that if sugar alcohol is not declared (even if present), it shall 
be defined as the difference between total carbohydrate and the sum of 
dietary fiber and sugars. Other carbohydrate content shall be indented 
and expressed to the nearest gram, except that if a serving contains 
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less 
than 1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero.
    (7) ``Protein'': A statement of the number of grams of protein per 
serving expressed to the nearest gram, except that if a serving contains 
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less 
than 1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero. When the 
protein in products represented or purported to be for adults and 
children 4 or more years of age has a protein quality value that is a 
protein digestibility-corrected amino acid score of less than 20 
expressed as a percent, or when the protein in a product represented or 
purported to be for children greater than 1 but less than 4 years of age 
has a protein quality value that is a protein digestibility-corrected 
amino acid score of less than 40 expressed as a percent, either of the 
following shall be placed adjacent to the declaration of protein content 
by weight: The statement ``not a significant source of protein,'' or a 
listing aligned under the column headed ``Percent Daily Value'' of the 
corrected amount of protein per serving, as determined in paragraph 
(c)(7)(ii) of this section, calculated as a percentage of the Daily 
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, 
for protein and expressed as percent of Daily Value. When the protein 
quality in a product as measured by the Protein Efficiency Ratio (PER) 
is less than 40 percent of the reference standard (casein) for a product 
represented or purported to be for infants, the statement ``not a 
significant source of protein'' shall be placed adjacent to the 
declaration of protein content. Protein content may be calculated on the 
basis of the factor of 6.25 times the nitrogen content of the food as 
determined by appropriate methods of analysis in accordance with Sec. 
317.309(h), except when the procedure for a specific food requires 
another factor.

[[Page 193]]

    (i) A statement of the corrected amount of protein per serving, as 
determined in paragraph (c)(7)(ii) of this section, calculated as a 
percentage of the RDI or DRV for protein, as appropriate, and expressed 
as percent of Daily Value, may be placed on the label, except that such 
a statement shall be given if a protein claim is made for the product, 
or if the product is represented or purported to be for infants or 
children under 4 years of age. When such a declaration is provided, it 
shall be placed on the label adjacent to the statement of grams of 
protein and aligned under the column headed ``Percent Daily Value,'' and 
expressed to the nearest whole percent. However, the percentage of the 
RDI for protein shall not be declared if the product is represented or 
purported to be for infants and the protein quality value is less than 
40 percent of the reference standard.
    (ii) The corrected amount of protein (grams) per serving for 
products represented or purported to be for adults and children 1 or 
more years of age is equal to the actual amount of protein (grams) per 
serving multiplied by the amino acid score corrected for protein 
digestibility. If the corrected score is above 1.00, then it shall be 
set at 1.00. The protein digestibility-corrected amino acid score shall 
be determined by methods given in sections 5.4.1, 7.2.1, and 8 in 
``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert 
Consultation on Protein Quality Evaluation,'' Rome, 1990, which is 
incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the ``Report 
of the Joint FAO/WHO Expert Consultation on Protein Quality 
Evaluation,'' as published by the Food and Agriculture Organization of 
the United Nations/World Health Organization, is incorporated as it 
exists on the date of approval. This incorporation by reference was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the 
office of the FSIS Docket Clerk, Room 3171, South Building, 14th and 
Independence Avenue, SW., Washington, DC, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. Copies of the incorporation by reference are available 
from the Product Assessment Division, Regulatory Programs, Food Safety 
and Inspection Service, U.S. Department of Agriculture, Room 329, West 
End Court Building, Washington, DC 20250-3700. For products represented 
or purported to be for infants, the corrected amount of protein (grams) 
per serving is equal to the actual amount of protein (grams) per serving 
multiplied by the relative protein quality value. The relative protein 
quality value shall be determined by dividing the subject product's 
protein PER value by the PER value for casein. If the relative protein 
value is above 1.00, it shall be set at 1.00.
    (iii) For the purpose of labeling with a percent of the DRV or RDI, 
a value of 50 grams of protein shall be the DRV for adults and children 
4 or more years of age, and the RDI for protein for children less than 4 
years of age, infants, pregnant women, and lactating women shall be 16 
grams, 14 grams, 60 grams, and 65 grams, respectively.
    (8) Vitamins and minerals: A statement of the amount per serving of 
the vitamins and minerals as described in this paragraph, calculated as 
a percent of the RDI and expressed as percent of Daily Value.
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d) through (g) of this section, products 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women shall use the RDI's 
that are specified for the intended group. For products represented or 
purported to be for use by both infants and children under 4 years of 
age, the percent of Daily Value shall be presented by separate 
declarations according to paragraph (e) of this section based on the RDI 
values for infants from birth to 12 months of age and for children under 
4 years of age. Similarly, the percent of Daily Value based on both the 
RDI values for pregnant women and for lactating women shall be declared 
separately on products represented or purported to be for use by

[[Page 194]]

both pregnant and lactating women. When such dual declaration is used on 
any label, it shall be included in all labeling, and equal prominence 
shall be given to both values in all such labeling. All other products 
shall use the RDI for adults and children 4 or more years of age.
    (ii) The declaration of vitamins and minerals as a percent of the 
RDI shall include vitamin A, vitamin C, calcium, and iron, in that 
order, and shall include any of the other vitamins and minerals listed 
in paragraph (c)(8)(iv) of this section when they are added, or when a 
claim is made about them. Other vitamins and minerals need not be 
declared if neither the nutrient nor the component is otherwise referred 
to on the label or in labeling or advertising and the vitamins and 
minerals are:
    (A) Required or permitted in a standardized food (e.g., thiamin, 
riboflavin, and niacin in enriched flour) and that standardized food is 
included as an ingredient (i.e., component) in another product; or
    (B) Included in a product solely for technological purposes and 
declared only in the ingredients statement. The declaration may also 
include any of the other vitamins and minerals listed in paragraph 
(c)(8)(iv) of this section when they are naturally occurring in the 
food. The additional vitamins and minerals shall be listed in the order 
established in paragraph (c)(8)(iv) of this section.
    (iii) The percentages for vitamins and minerals shall be expressed 
to the nearest 2-percent increment up to and including the 10-percent 
level, the nearest 5-percent increment above 10 percent and up to and 
including the 50-percent level, and the nearest 10-percent increment 
above the 50-percent level. Amounts of vitamins and minerals present at 
less than 2 percent of the RDI are not required to be declared in 
nutrition labeling but may be declared by a zero or by the use of an 
asterisk (or other symbol) that refers to another asterisk (or symbol) 
that is placed at the bottom of the table and that is followed by the 
statement ``Contains less than 2 percent of the Daily Value of this 
(these) nutrient (nutrients).'' Alternatively, if vitamin A, vitamin C, 
calcium, or iron is present in amounts less than 2 percent of the RDI, 
label declaration of the nutrient(s) is not required if the statement 
``Not a significant source of ------ (listing the vitamins or minerals 
omitted)'' is placed at the bottom of the table of nutrient values.
    (iv) The following RDI's and nomenclature are established for the 
following vitamins and minerals which are essential in human nutrition:

Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1.0 gram
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 0.4 milligram
Vitamin B12, 6 micrograms
Biotin, 0.3 milligram
Pantothenic acid, 10 milligrams
Phosphorus, 1.0 gram
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Copper, 2.0 milligrams

    (v) The following synonyms may be added in parenthesis immediately 
following the name of the nutrient or dietary component:

Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folacin
Calories--Energy
    (vi) A statement of the percent of vitamin A that is present as 
beta-carotene may be declared voluntarily. When the vitamins and 
minerals are listed in a single column, the statement shall be indented 
under the information on vitamin A. When vitamins and minerals are 
arrayed horizontally, the statement of percent shall be presented in 
parenthesis following the declaration of vitamin A and the percent of 
Daily Value of vitamin A in the product (e.g., ``Percent Daily Value: 
Vitamin A 50 (90 percent as beta-carotene)''). When declared, the 
percentages shall be expressed in the same increments as are provided 
for vitamins and minerals in paragraph (c)(8)(iii) of this section.

[[Page 195]]

    (9) For the purpose of labeling with a percent of the DRV, the 
following DRV's are established for the following food components based 
on the reference caloric intake of 2,000 calories:

------------------------------------------------------------------------
            Food component                 Unit of measurement      DRV
------------------------------------------------------------------------
Fat...................................  grams (g)...............      65
Saturated fatty acids.................  do......................      20
Cholesterol...........................  milligrams (mg).........     300
Total carbohydrate....................  grams (g)...............     300
Fiber.................................  do......................      25
Sodium................................  milligrams (mg).........   2,400
Potassium.............................  do......................   3,500
Protein...............................  grams (g)...............      50
------------------------------------------------------------------------

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on products in the following format, except 
on products on which dual columns of nutrition information are declared 
as provided for in paragraph (e) of this section, on those products on 
which the simplified format is permitted to be used as provided for in 
paragraph (f) of this section, on products for infants and children less 
than 4 years of age as provided for in Sec. 317.400(c), and on products 
in packages that have a total surface area available to bear labeling of 
40 or less square inches as provided for in paragraph (g) of this 
section.
    (i) The nutrition information shall be set off in a box by use of 
hairlines and shall be all black or one color type, printed on a white 
or other neutral contrasting background whenever practical.
    (ii) All information within the nutrition label shall utilize:
    (A) A single easy-to-read type style,
    (B) Upper and lower case letters,
    (C) At least one point leading (i.e., space between two lines of 
text) except that at least four points leading shall be utilized for the 
information required by paragraphs (d)(7) and (d)(8) of this section, 
and
    (D) Letters should never touch.
    (iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and 
(d)(8) of this section shall be in type size no smaller than 8 point. 
Except for the heading ``Nutrition Facts,'' the information required in 
paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other 
information contained within the nutrition label shall be in type size 
no smaller than 6 point. When provided, the information described in 
paragraph (d)(10) of this section shall also be in type no smaller than 
6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) 
of this section (i.e., ``Nutrition Facts,'' ``Amount per Serving,'' and 
``% Daily Value*''), the names of all nutrients that are not indented 
according to requirements of paragraph (c) of this section (i.e., 
Calories, Total fat, Cholesterol, Sodium, Potassium, Total carbohydrate, 
and Protein), and the percentage amounts required by paragraph 
(d)(7)(ii) of this section shall be highlighted by bold or extra bold 
type or other highlighting (reverse printing is not permitted as a form 
of highlighting) that prominently distinguishes it from other 
information. No other information shall be highlighted.
    (v) A hairline rule that is centered between the lines of text shall 
separate ``Amount Per Serving'' from the calorie statements required in 
paragraph (d)(5) of this section and shall separate each nutrient and 
its corresponding percent of Daily Value required in paragraphs 
(d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent 
of Daily Value above and below it.
    (2) The information shall be presented under the identifying heading 
of ``Nutrition Facts'' which shall be set in a type size larger than all 
other print size in the nutrition label and, except for labels presented 
according to the format provided for in paragraph (d)(11) of this 
section, unless impractical, shall be set the full width of the 
information provided under paragraph (d)(7) of this section.
    (3) Information on serving size shall immediately follow the 
heading. Such information shall include:
    (i) ``Serving Size'': A statement of the serving size as specified 
in paragraph (b)(9) of this section.
    (ii) ``Servings Per Container'': The number of servings per 
container, except that this statement is not required on single-serving 
containers as defined in paragraph (b)(8) of this section.
    (4) A subheading ``Amount Per Serving'' shall be separated from 
serving size information by a bar.
    (5) Information on calories shall immediately follow the heading 
``Amount Per Serving'' and shall be declared in

[[Page 196]]

one line, leaving sufficient space between the declaration of 
``Calories'' and ``Calories from fat'' to allow clear differentiation, 
or, if ``Calories from saturated fat'' is declared, in a column with 
total ``Calories'' at the top, followed by ``Calories from fat'' 
(indented), and ``Calories from saturated fat'' (indented).
    (6) The column heading ``% Daily Value,'' followed by an asterisk 
(e.g., ``% Daily Value*''), shall be separated from information on 
calories by a bar. The position of this column heading shall allow for a 
list of nutrient names and amounts as described in paragraph (d)(7) of 
this section to be to the left of, and below, this column heading. The 
column headings ``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may 
be substituted for ``% Daily Value.''
    (7) Except as provided for in paragraph (g) of this section, and 
except as permitted by Sec. 317.400(d)(2), nutrient information for 
both mandatory and any voluntary nutrients listed in paragraph (c) of 
this section that are to be declared in the nutrition label, except 
vitamins and minerals, shall be declared as follows:
    (i) The name of each nutrient, as specified in paragraph (c) of this 
section, shall be given in a column and followed immediately by the 
quantitative amount by weight for that nutrient appended with a ``g'' 
for grams or ``mg'' for milligrams.
    (ii) A listing of the percent of the DRV as established in 
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a 
column aligned under the heading ``% Daily Value'' established in 
paragraph (d)(6) of this section with the percent expressed to the 
nearest whole percent for each nutrient declared in the column described 
in paragraph (d)(7)(i) of this section for which a DRV has been 
established, except that the percent for protein may be omitted as 
provided in paragraph (c)(7) of this section. The percent shall be 
calculated by dividing either the amount declared on the label for each 
nutrient or the actual amount of each nutrient (i.e., before rounding) 
by the DRV for the nutrient, except that the percent for protein shall 
be calculated as specified in paragraph (c)(7)(ii) of this section. The 
numerical value shall be followed by the symbol for percent (i.e., %).
    (8) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, 
Iron 4%) or may be listed in two columns, except that when more than 
four vitamins and minerals are declared, they may be declared vertically 
with percentages listed under the column headed ``% Daily Value.''
    (9) A footnote, preceded by an asterisk, shall be placed beneath the 
list of vitamins and minerals and shall be separated from that list by a 
hairline.
    (i) The footnote shall state: Percent Daily Values are based on a 
2,000 calorie diet. Your daily values may be higher or lower depending 
on your calorie needs.

----------------------------------------------------------------------------------------------------------------
                                              Calories:                  2,000                    2,500
----------------------------------------------------------------------------------------------------------------
Total fat............................  Less than..............  65 g...................  80 g
Saturated fat........................  Less than..............  20 g...................  25 g
Cholesterol..........................  Less than..............  300 mg.................  300 mg
Sodium...............................  Less than..............  2,400 mg...............  2,400 mg
Total carbohydrate...................  .......................  300 g..................  375 g
Dietary fiber........................  .......................  25 g...................  30 g
----------------------------------------------------------------------------------------------------------------

    (ii) If the percent of Daily Value is given for protein in the 
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of 
this section, protein shall be listed under dietary fiber, and a value 
of 50 g shall be inserted on the same line in the column headed 
``2,000'' and value of 65 g in the column headed ``2,500.''
    (iii) If potassium is declared in the column described in paragraph 
(d)(7)(i) of this section, potassium shall be listed under sodium and 
the DRV established in paragraph (c)(9) of this section shall be 
inserted on the same line in the numeric columns.
    (iv) The abbreviations established in paragraph (g)(2) of this 
section may be used within the footnote.
    (10) Caloric conversion information on a per-gram basis for fat, 
carbohydrate, and protein may be presented beneath the information 
required in paragraph (d)(9), separated from that information by a 
hairline. This information may be presented horizontally

[[Page 197]]

(i.e., ``Calories per gram: Fat 9, Carbohydrate 4, Protein 4'') or 
vertically in columns.
    (11)(i) If the space beneath the information on vitamins and 
minerals is not adequate to accommodate the information required in 
paragraph (d)(9) of this section, the information required in paragraph 
(d)(9) may be moved to the right of the column required in paragraph 
(d)(7)(ii) of this section and set off by a line that distinguishes it 
and sets it apart from the percent of Daily Value information. The 
caloric conversion information provided for in paragraph (d)(10) of this 
section may be presented beneath either side or along the full length of 
the nutrition label.
    (ii) If the space beneath the mandatory declaration of iron is not 
adequate to accommodate any remaining vitamins and minerals to be 
declared or the information required in paragraph (d)(9) of this 
section, the remaining information may be moved to the right and set off 
by a line that distinguishes it and sets it apart from the percent of 
Daily Value information given to the left. The caloric conversion 
information provided for in paragraph (d)(10) of this section may be 
presented beneath either side or along the full length of the nutrition 
label.
    (iii) If there is not sufficient continuous vertical space (i.e., 
approximately 3 inches) to accommodate the required components of the 
nutrition label up to and including the mandatory declaration of iron, 
the nutrition label may be presented in a tabular display in which the 
footnote required by paragraph (d)(9) of the section is given to the far 
right of the label, and additional vitamins and minerals beyond the four 
that are required (i.e., vitamin A, vitamin C, calcium, and iron) are 
arrayed horizontally following declarations of the required vitamins and 
minerals.
    (12) The following sample label illustrates the provisions of 
paragraph (d) of this section:

[[Page 198]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.013

    (13)(i) Nutrition labeling on the outer label of packages of meat or 
meat food products that contain two or more products in the same 
packages (e.g., variety packs) or of packages that are used 
interchangeably for the same type of food (e.g., meat salad containers) 
may use an aggregate display.
    (ii) Aggregate displays shall comply with format requirements of 
paragraph

[[Page 199]]

(d) of this section to the maximum extent possible, except that the 
identity of each food shall be specified to the right of the ``Nutrition 
Facts'' title, and both the quantitative amount by weight (i.e., g/mg 
amounts) and the percent Daily Value for each nutrient shall be listed 
in separate columns under the name of each food.
    (14) When nutrition labeling appears in a second language, the 
nutrition information may be presented in a separate nutrition label for 
each language or in one nutrition label with the information in the 
second language following that in English. Numeric characters that are 
identical in both languages need not be repeated (e.g., ``Protein/
Proteinas 2 g''). All required information must be included in both 
languages.
    (e) Nutrition information may be presented for two or more forms of 
the same product (e.g., both ``raw'' and ``cooked'') or for common 
combinations of foods as provided for in paragraph (b) of this section, 
or for different units (e.g., per 100 grams) as provided for in 
paragraph (b) of this section, or for two or more groups for which RDI's 
are established (e.g., both infants and children less than 4 years of 
age) as provided for in paragraph (c)(8)(i) of this section. When such 
dual labeling is provided, equal prominence shall be given to both sets 
of values. Information shall be presented in a format consistent with 
paragraph (d) of this section, except that:
    (1) Following the subheading of ``Amount Per Serving,'' there shall 
be two or more column headings accurately describing the forms of the 
same product (e.g., ``raw'' and ``roasted''), the combinations of foods, 
the units, or the RDI groups that are being declared. The column 
representing the product as packaged and according to the label serving 
size based on the Reference Amount in Sec. 317.312(b) shall be to the 
left of the numeric columns.
    (2) When the dual labeling is presented for two or more forms of the 
same product, for combinations of foods, or for different units, total 
calories and calories from fat (and calories from saturated fat, when 
declared) shall be listed in a column and indented as specified in 
paragraph (d)(5) of this section with quantitative amounts declared in 
columns aligned under the column headings set forth in paragraph (e)(1) 
of this section.
    (3) Quantitative information by weight required in paragraph 
(d)(7)(i) of this section shall be specified for the form of the product 
as packaged and according to the label serving size based on the 
Reference Amount in Sec. 317.312(b).
    (i) Quantitative information by weight may be included for other 
forms of the product represented by the additional column(s) either 
immediately adjacent to the required quantitative information by weight 
for the product as packaged and according to the label serving size 
based on the Reference Amount in Sec. 317.312(b) or as a footnote.
    (A) If such additional quantitative information is given immediately 
adjacent to the required quantitative information, it shall be declared 
for all nutrients listed and placed immediately following and 
differentiated from the required quantitative information (e.g., 
separated by a comma). Such information shall not be put in a separate 
column.
    (B) If such additional quantitative information is given in a 
footnote, it shall be declared in the same order as the nutrients are 
listed in the nutrition label. The additional quantitative information 
may state the total nutrient content of the product identified in the 
second column or the nutrient amounts added to the product as packaged 
for only those nutrients that are present in different amounts than the 
amounts declared in the required quantitative information. The footnote 
shall clearly identify which amounts are declared. Any subcomponents 
declared shall be listed parenthetically after principal components 
(e.g., \1/2\ cup skim milk contributes an additional 40 calories, 65 mg 
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
    (ii) Total fat and its quantitative amount by weight shall be 
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'') 
referring to another asterisk (or symbol) at the bottom of the nutrition 
label identifying the form(s) of the product for which quantitative 
information is presented.

[[Page 200]]

    (4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this 
section shall be presented under the subheading ``% DAILY VALUE'' and in 
columns directly under the column headings set forth in paragraph (e)(1) 
of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:

[[Page 201]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.014

    (f)(1) Nutrition information may be presented in a simplified format 
as set forth herein when any required nutrients, other than the core 
nutrients

[[Page 202]]

(i.e., calories, total fat, sodium, total carbohydrate, and protein), 
are present in insignificant amounts. An insignificant amount shall be 
defined as that amount that may be rounded to zero in nutrition 
labeling, except that for total carbohydrate, dietary fiber, sugars and 
protein, it shall be an amount less than 1 gram.
    (2) The simplified format shall include information on the following 
nutrients:
    (i) Total calories, total fat, total carbohydrate, sodium, and 
protein;
    (ii) Any of the following that are present in more than 
insignificant amounts: Calories from fat, saturated fat, cholesterol, 
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
    (iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of 
this section when they are added in fortified or fabricated foods.
    (3) Other nutrients that are naturally present in the product in 
more than insignificant amounts may be voluntarily declared as part of 
the simplified format.
    (4) Any required nutrient, other than a core nutrient, that is 
present in an insignificant amount may be omitted from the tabular 
listing, provided that the following statement is included at the bottom 
of the nutrition label, ``Not a significant source of --------.'' The 
blank shall be filled in with the appropriate nutrient or food 
component. Alternatively, amounts of vitamins and minerals present in 
insignificant amounts may be declared by the use of an asterisk (or 
symbol) that is placed at the bottom of the table of nutrient values and 
that is followed by the statement ``Contains less than 2 percent of the 
Daily Value of this (these) nutrient (nutrients).''
    (5) Except as provided for in paragraph (g) of this section and in 
Sec. 317.400(c) and (d), nutrient information declared in the 
simplified format shall be presented in the same manner as specified in 
paragraphs (d) or (e) of this section, except that the footnote required 
in paragraph (d)(9) of this section is not required. When the footnote 
is omitted, an asterisk shall be placed at the bottom of the label 
followed by the statement ``Percent Daily Values are based on a 2,000 
calorie diet'' and, if the term ``Daily Value'' is not spelled out in 
the heading, a statement that ``DV'' represents ``Daily Value.''
    (g) Foods in packages that have a total surface area available to 
bear labeling of 40 or less square inches may modify the requirements of 
paragraphs (c) through (f) of this section and Sec. 317.302(a) by one 
or more of the following means:
    (1)(i) Presenting the required nutrition information in a tabular or 
linear (i.e., string) fashion, rather than in vertical columns if the 
product has a total surface area available to bear labeling of less than 
12 square inches, or if the product has a total surface area available 
to bear labeling of 40 or less square inches and the package shape or 
size cannot accommodate a standard vertical column or tabular display on 
any label panel. Nutrition information may be given in a linear fashion 
only if the package shape or size will not accommodate a tabular 
display.
    (ii) When nutrition information is given in a linear display, the 
nutrition information shall be set off in a box by the use of a 
hairline. The percent Daily Value is separated from the quantitative 
amount declaration by the use of parenthesis, and all nutrients, both 
principal components and subcomponents, are treated similarly. Bolding 
is required only on the title ``Nutrition Facts'' and is allowed for 
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
    (2) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb

    (3) Omitting the footnote required in paragraph (d)(9) of this 
section and

[[Page 203]]

placing another asterisk at the bottom of the label followed by the 
statement ``Percent Daily Values are based on a 2,000 calorie diet'' 
and, if the term ``Daily Value'' is not spelled out in the heading, a 
statement that ``DV'' represents ``Daily Value.''
    (4) Presenting the required nutrition information on any other label 
panel.
    (h) Compliance with this section shall be determined as follows:
    (1) A production lot is a set of food production consumer units that 
are from one production shift. Alternatively, a collection of consumer 
units of the same size, type, and style produced under conditions as 
nearly uniform as possible, designated by a common container code or 
marking, constitutes a production lot.
    (2) The sample for nutrient analysis shall consist of a composite of 
a minimum of six consumer units, each from a production lot. 
Alternatively, the sample for nutrient analysis shall consist of a 
composite of a minimum of six consumer units, each randomly chosen to be 
representative of a production lot. In each case, the units may be 
individually analyzed and the results of the analyses averaged, or the 
units would be composited and the composite analyzed. In both cases, the 
results, whether an average or a single result from a composite, will be 
considered by the Agency to be the nutrient content of a composite. All 
analyses shall be performed by appropriate methods and procedures used 
by the Department for each nutrient in accordance with the ``Chemistry 
Laboratory Guidebook,'' or, if no USDA method is available and 
appropriate for the nutrient, by appropriate methods for the nutrient in 
accordance with the 1990 edition of the ``Official Methods of Analysis'' 
of the AOAC International, formerly Association of Official Analytical 
Chemists, 15th ed., which is incorporated by reference, unless a 
particular method of analysis is specified in Sec. 317.309(c), or, if 
no USDA, AOAC, or specified method is available and appropriate, by 
other reliable and appropriate analytical procedures as so determined by 
the Agency. The ``Official Methods of Analysis'' is incorporated as it 
exists on the date of approval. This incorporation by reference was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC 
International, 2200 Wilson Blvd., suite 400, Arlington, VA 22201. It is 
also available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (3) Two classes of nutrients are defined for purposes of compliance:
    (i) Class I. Added nutrients in fortified or fabricated foods; and
    (ii) Class II. Naturally occurring (indigenous) nutrients. If any 
ingredient which contains a naturally occurring (indigenous) nutrient is 
added to a food, the total amount of such nutrient in the final food 
product is subject to Class II requirements unless the same nutrient is 
also added, which would make the total amount of such nutrient subject 
to Class I requirements.
    (4) A product with a label declaration of a vitamin, mineral, 
protein, total carbohydrate, dietary fiber, other carbohydrate, 
polyunsaturated or monounsaturated fat, or potassium shall be deemed to 
be misbranded under section 1(n) of the Federal Meat Inspection Act (21 
U.S.C. 601(n)(1)) unless it meets the following requirements:
    (i) Class I vitamin, mineral, protein, dietary fiber, or potassium. 
The nutrient content of the composite is at least equal to the value for 
that nutrient declared on the label.
    (ii) Class II vitamin, mineral, protein, total carbohydrate, dietary 
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or 
potassium. The nutrient content of the composite is at least equal to 80 
percent of the value for that nutrient declared on the label; Provided, 
That no regulatory action will be based on a determination of a nutrient 
value which falls below this level by an amount less than the 
variability generally recognized for the analytical method used in that 
product at the level involved, and inherent nutrient variation in a 
product.
    (5) A product with a label declaration of calories, sugars, total 
fat, saturated

[[Page 204]]

fat, cholesterol, or sodium shall be deemed to be misbranded under 
section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) if 
the nutrient content of the composite is greater than 20 percent in 
excess of the value for that nutrient declared on the label; Provided, 
That no regulatory action will be based on a determination of a nutrient 
value which falls above this level by an amount less than the 
variability generally recognized for the analytical method used in that 
product at the level involved, and inherent nutrient variation in a 
product.
    (6) The amount of a vitamin, mineral, protein, total carbohydrate, 
dietary fiber, other carbohydrate, polyunsaturated or monounsaturated 
fat, or potassium may vary over labeled amounts within good 
manufacturing practice. The amount of calories, sugars, total fat, 
saturated fat, cholesterol, or sodium may vary under labeled amounts 
within good manufacturing practice.
    (7) Compliance will be based on the metric measure specified in the 
label statement of serving size.
    (8) The management of the establishment must maintain records to 
support the validity of nutrient declarations contained on product 
labels. Such records shall be made available to the inspector or any 
duly authorized representative of the Agency upon request.
    (9) The compliance provisions set forth in paragraph (h) (1) through 
(8) of this section shall not apply to single-ingredient, raw meat 
(including ground beef) products, including those that have been 
previously frozen, when nutrition labeling is based on the most current 
representative data base values contained in USDA's National Nutrient 
Data Bank or its published form, the Agriculture Handbook No. 8 series 
available from the Government Printing Office.

(Paperwork requirements were approved by the Office of Management and 
Budget under control number 0583-0088)

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993; 58 FR 47627, Sept. 
10, 1993; 59 FR 45194, Sept. 1, 1994; 60 FR 176, Jan. 3, 1995; 69 FR 
58801, Oct. 1, 2004]



Sec. Sec. 317.310-317.311  [Reserved]



Sec. 317.312  Reference amounts customarily consumed per eating occasion.

    (a) The general principles followed in arriving at the reference 
amounts customarily consumed per eating occasion (Reference Amount(s)), 
as set forth in paragraph (b) of this section, are:
    (1) The Reference Amounts are calculated for persons 4 years of age 
or older to reflect the amount of food customarily consumed per eating 
occasion by persons in this population group. These Reference Amounts 
are based on data set forth in appropriate national food consumption 
surveys.
    (2) The Reference Amounts are calculated for an infant or child 
under 4 years of age to reflect the amount of food customarily consumed 
per eating occasion by infants up to 12 months of age or by children 1 
through 3 years of age, respectively. These Reference Amounts are based 
on data set forth in appropriate national food consumption surveys. Such 
Reference Amounts are to be used only when the product is specially 
formulated or processed for use by an infant or by a child under 4 years 
of age.
    (3) An appropriate national food consumption survey includes a large 
sample size representative of the demographic and socioeconomic 
characteristics of the relevant population group and must be based on 
consumption data under actual conditions of use.
    (4) To determine the amount of food customarily consumed per eating 
occasion, the mean, median, and mode of the consumed amount per eating 
occasion were considered.
    (5) When survey data were insufficient, FSIS took various other 
sources of information on serving sizes of food into consideration. 
These other sources of information included:
    (i) Serving sizes used in dietary guidance recommendations or 
recommended by other authoritative systems or organizations;
    (ii) Serving sizes recommended in comments;
    (iii) Serving sizes used by manufacturers and grocers; and
    (iv) Serving sizes used by other countries.

[[Page 205]]

    (6) Because they reflect the amount customarily consumed, the 
Reference Amount and, in turn, the serving size declared on the product 
label are based on only the edible portion of food, and not bone, seed, 
shell, or other inedible components.
    (7) The Reference Amount is based on the major intended use of the 
product (e.g., a mixed dish measurable with a cup as a main dish and not 
as a side dish).
    (8) The Reference Amounts for products that are consumed as an 
ingredient of other products, but that may also be consumed in the form 
in which they are purchased (e.g., ground beef), are based on use in the 
form purchased.
    (9) FSIS sought to ensure that foods that have similar dietary 
usage, product characteristics, and customarily consumed amounts have a 
uniform Reference Amount.
    (b) The following Product Categories and Reference Amounts shall be 
used as the basis for determining serving sizes for specific products:

  Table 1--Reference Amounts Customarily Consumed per Eating Occasion--
                    Infant and Toddler Foods \1,2,3\
------------------------------------------------------------------------
                                                               Reference
                      Product category                          amount
------------------------------------------------------------------------
Infant & Toddler Foods:
  Dinner Dry Mix............................................        15 g
  Dinner, ready-to-serve, strained type.....................        60 g
  Dinner, soups, ready-to-serve junior type.................       110 g
  Dinner, stew or soup ready-to-serve toddlers..............       170 g
  Plain meats and meat sticks, ready-to-serve...............        55 g
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
  eating occasion and were primarily derived from the 1977-1978 and the
  1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the Reference
  Amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (i.e., heat and serve). If not listed separately, the
  Reference Amount for the unprepared form (e.g., dehydrated cereal) is
  the amount required to make one Reference Amount of the prepared form.
\3\ Manufacturers are required to convert the Reference Amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures established by regulation.


  Table 2--Reference Amounts Customarily Consumed Per Eating Occasion--
                     General Food Supply \1,2,3,4,5\
------------------------------------------------------------------------
                                   Reference amount    Reference amount
        Product category        ----------------------------------------
                                    Ready-to-serve       Ready-to-cook
------------------------------------------------------------------------
Egg mixtures, (western style     110 g                n/a.
 omelet, souffle, egg foo young.
Lard, margarine, shortening....  1 tbsp               n/a.
Salad and potato toppers; e.g.,  7 g                  n/a.
 bacon bits.
Bacon (bacon, beef breakfast     15 g                 54 g=bacon. 30 g =
 strips, pork breakfast strips,                        breakfast strips.
 pork rinds).
Dried; e.g., jerky, dried beef,  30 g                 n/a.
 Parma ham sausage products
 with a moisture/protein ratio
 of less than 2:1; e.g.,
 pepperoni.
Snacks; e.g., meat snack food    30 g                 n/a.
 sticks.
Luncheon meat, bologna,          55 g                 n/a.
 Canadian style bacon, pork
 pattie crumbles, beef pattie
 crumbles, blood pudding,
 luncheon loaf, old fashioned
 loaf, berlinger, bangers,
 minced luncheon roll,
 thuringer, liver sausage,
 mortadella, uncured sausage
 (franks), ham and cheese loaf,
 P&P loaf, scrapple souse, head
 cheese, pizza loaf, olive
 loaf, pate, deviled ham,
 sandwich spread, teawurst,
 cervelet, Lebanon bologna,
 potted meat food product, taco
 fillings, meat pie fillings.
Linked meat sausage products,    55 g                 n/a. 75 g=uncooked
 Vienna sausage, frankfurters,                         sausage.
 pork sausage, imitation
 frankfurters, bratwurst,
 kielbasa, Polish sausage,
 summer sausage, mettwurst,
 smoked country sausage, smoked
 sausage, smoked or pickled
 meat, pickled pigs feet.
Entrees without sauce, cuts of   85 g                 114 g.
 meat including marinated,
 tenderized, injected cuts of
 meat, beef patty, corn dog,
 croquettes, fritters, cured
 ham, dry cured ham, dry cured
 cappicola, corned beef,
 pastrami, country ham, pork
 shoulder picnic, meatballs,
 pureed adult foods.
Canned meats, canned beef,       55 g                 n/a.
 canned pork. \4\.
Entrees with sauce, barbecued    140 g                n/a.
 meats in sauce.
Mixed dishes NOT measurable      140 g (plus 55 g     n/a.
 with a cup; \5\ e.g., burrito,   for products with
 egg roll, enchilada, pizza,      sauce toppings)
 pizza roll, quiche, all types
 of sandwiches, cracker and
 meat lunch type packages,
 gyro, stromboli, burger on a
 bun, frank on a bun, calzone,
 taco, pockets stuffed with
 meat, foldovers, stuffed
 vegetables with meat, shish
 kabobs, empanada.
Mixed dishes measurable with a   1 cup                n/a.
 cup; e.g., meat casserole,
 macaroni and cheese with meat,
 pot pie, spaghetti with sauce,
 meat chili, chili with beans,
 meat hash, creamed chipped
 beef, beef ravioli in sauce,
 beef stroganoff, Brunswick
 stew, goulash, meat stew,
 ragout, meat lasagna, meat
 filled pasta.
Salads--pasta or potato, potato  140 g                n/a.
 salad with bacon, macaroni and
 meat salad.
Salads--all other meat, salads,  100 g                n/a.
 ham salad.
Soups--all varieties...........  245 g                n/a.

[[Page 206]]

 
Major main entree type sauce;    125 g                n/a.
 e.g., spaghetti sauce with
 meat, spaghetti sauce with
 meatballs.
Minor main entree sauce; e.g.,   \1/4\ cup            n/a.
 pizza sauce with meat, gravy.
Seasoning mixes dry, bases,      ...................  ..................
 extracts, dried broths and
 stock/juice, freeze dry trail
 mix products with meat..
As reconstituted:
  Amount to make one Reference
   Amount of the final dish;
   e.g.,
    Gravy......................  \1/4\ cup            n/a.
    Major main entree type       125 g                n/a.
     sauce.
    Soup.......................  245 g                n/a.
    Entree measurable with a     1 cup                n/a.
     cup.
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
  eating occasion and were primarily derived from the 1977-78 and the
  1987-88 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture.
\2\ Manufacturers are required to convert the Reference Amounts to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures established by regulation.
\3\ Examples listed under Product Category are not all inclusive or
  exclusive. Examples are provided to assist manufacturers in
  identifying appropriate product Reference Amount.
\4\ If packed or canned in liquid, the Reference Amount is for the
  drained solids, except for products in which both the solids and
  liquids are customarily consumed.
\5\ Pizza sauce is part of the pizza and is not considered to be sauce
  topping.

    (c) For products that have no Reference Amount listed in paragraph 
(b) of this section for the unprepared or the prepared form of the 
product and that consist of two or more foods packaged and presented to 
be consumed together (e.g., lunch meat with cheese and crackers), the 
Reference Amount for the combined product shall be determined using the 
following rules:
    (1) For bulk products, the Reference Amount for the combined product 
shall be the Reference Amount, as established in paragraph (b) of this 
section, for the ingredient that is represented as the main ingredient 
plus proportioned amounts of all minor ingredients.
    (2) For products where the ingredient represented as the main 
ingredient is one or more discrete units, the Reference Amount for the 
combined product shall be either the number of small discrete units or 
the fraction of the large discrete unit that is represented as the main 
ingredient that is closest to the Reference Amount for that ingredient 
as established in paragraph (b) of this section plus proportioned 
amounts of all minor ingredients.
    (3) If the Reference Amounts are in compatible units, they shall be 
summed (e.g., ingredients in equal volumes such as tablespoons). If the 
Reference Amounts are in incompatible units, the weights of the 
appropriate volumes should be used (e.g., grams of one ingredient plus 
gram weight of tablespoons of a second ingredient).
    (d) If a product requires further preparation, e.g., cooking or the 
addition of water or other ingredients, and if paragraph (b) of this 
section provides a Reference Amount for the product in the prepared 
form, then the Reference Amount for the unprepared product shall be 
determined using the following rules:
    (1) Except as provided for in paragraph (d)(2) of this section, the 
Reference Amount for the unprepared product shall be the amount of the 
unprepared product required to make the Reference Amount for the 
prepared product as established in paragraph (b) of this section.
    (2) For products where the entire contents of the package is used to 
prepare one large discrete unit usually divided for consumption, the 
Reference Amount for the unprepared product shall be the amount of the 
unprepared product required to make the fraction of the large discrete 
unit closest to the Reference Amount for the prepared product as 
established in paragraph (b) of this section.
    (e) The Reference Amount for an imitation or substitute product or 
altered product as defined in Sec. 317.313(d), such as a ``low 
calorie'' version, shall be the

[[Page 207]]

same as for the product for which it is offered as a substitute.
    (f) The Reference Amounts set forth in paragraphs (b) through (e) of 
this section shall be used in determining whether a product meets the 
criteria for nutritional claims. If the serving size declared on the 
product label differs from the Reference Amount, and the product meets 
the criteria for the claim only on the basis of the Reference Amount, 
the claim shall be followed by a statement that sets forth the basis on 
which the claim is made. That statement shall include the Reference 
Amount as it appears in paragraph (b) of this section followed, in 
parentheses, by the amount in common household measure if the Reference 
Amount is expressed in measures other than common household measures.
    (g) The Administrator, on his or her own initiative or on behalf of 
any interested person who has submitted a labeling application, may 
issue a proposal to establish or amend a Product Category or Reference 
Amount identified in paragraph (b) of this section.
    (1) Labeling applications and supporting documentation to be filed 
under this section shall be submitted in quadruplicate, except that the 
supporting documentation may be submitted on a computer disc copy. If 
any part of the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
labeling application shall state the applicant's post office address.
    (2) Pertinent information will be considered as part of an 
application on the basis of specific reference to such information 
submitted to and retained in the files of the Food Safety and Inspection 
Service. However, any reference to unpublished information furnished by 
a person other than the applicant will not be considered unless use of 
such information is authorized (with the understanding that such 
information may in whole or part be subject to release to the public) in 
a written statement signed by the person who submitted it. Any reference 
to published information should be accompanied by reprints or 
photostatic copies of such references.
    (3) The availability for public disclosure of labeling applications, 
along with supporting documentation, submitted to the Agency under this 
section will be governed by the rules specified in subchapter D, title 
9.
    (4) Data accompanying the labeling application, such as food 
consumption data, shall be submitted on separate sheets, suitably 
identified. If such data has already been submitted with an earlier 
labeling application from the applicant, the present labeling 
application must provide the data.
    (5) The labeling application must be signed by the applicant or by 
his or her attorney or agent, or (if a corporation) by an authorized 
official.
    (6) The labeling application shall include a statement signed by the 
person responsible for the labeling application, that to the best of his 
or her knowledge, it is a representative and balanced submission that 
includes unfavorable information, as well as favorable information, 
known to him or her pertinent to the evaluation of the labeling 
application.
    (7) Labeling applications for a new Reference Amount and/or Product 
Category shall be accompanied by the following data which shall be 
submitted in the following form to the Director, Food Labeling Division, 
Regulatory Programs, Food Safety and Inspection Service, Washington, DC 
20250:

________________________________________________________________________
(Date)

    The undersigned, ------------ submits this labeling application 
pursuant to 9 CFR 317.312 with respect to Reference Amount and/or 
Product Category.
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement of the objective of the labeling application;
    (ii) A description of the product;
    (iii) A complete sample product label including nutrition label, 
using the format established by regulation;
    (iv) A description of the form in which the product will be 
marketed;
    (v) The intended dietary uses of the product with the major use 
identified (e.g., ham as a luncheon meat);
    (vi) If the intended use is primarily as an ingredient in other 
foods, list of foods or food categories in which the product will be 
used as an ingredient with information on the prioritization of the use;

[[Page 208]]

    (vii) The population group for which the product will be offered for 
use (e.g., infants, children under 4 years of age);
    (viii) The names of the most closely-related products (or in the 
case of foods for special dietary use and imitation or substitute foods, 
the names of the products for which they are offered as substitutes);
    (ix) The suggested Reference Amount (the amount of edible portion of 
food as consumed, excluding bone, skin or other inedible components) for 
the population group for which the product is intended with full 
description of the methodology and procedures that were used to 
determine the suggested Reference Amount. In determining the Reference 
Amount, general principles and factors in paragraph (a) of this section 
should be followed.
    (x) The suggested Reference Amount shall be expressed in metric 
units. Reference Amounts for foods shall be expressed in grams except 
when common household units such as cups, tablespoons, and teaspoons are 
more appropriate or are more likely to promote uniformity in serving 
sizes declared on product labels. For example, common household measures 
would be more appropriate if products within the same category differ 
substantially in density such as mixed dishes measurable with a cup.
    (A) In expressing the Reference Amount in grams, the following 
general rules shall be followed:
    (1) For quantities greater than 10 grams, the quantity shall be 
expressed in nearest 5 grams increment.
    (2) For quantities less than 10 grams, exact gram weights shall be 
used.
    (B) [Reserved]
    (xi) A labeling application for a new subcategory of food with its 
own Reference Amount shall include the following additional information:
    (A) Data that demonstrate that the new subcategory of food will be 
consumed in amounts that differ enough from the Reference Amount for the 
parent category to warrant a separate Reference Amount. Data must 
include sample size, and the mean, standard deviation, median, and modal 
consumed amount per eating occasion for the product identified in the 
labeling application and for other products in the category. All data 
must be derived from the same survey data.
    (B) Documentation supporting the difference in dietary usage and 
product characteristics that affect the consumption size that 
distinguishes the product identified in the labeling application from 
the rest of the products in the category.
    (xii) In conducting research to collect or process food consumption 
data in support of the labeling application, the following general 
guidelines should be followed.
    (A) Sampled population selected should be representative of the 
demographic and socioeconomic characteristics of the target population 
group for which the food is intended.
    (B) Sample size (i.e., number of eaters) should be large enough to 
give reliable estimates for customarily consumed amounts.
    (C) The study protocol should identify potential biases and describe 
how potential biases are controlled for or, if not possible to control, 
how they affect interpretation of results.
    (D) The methodology used to collect or process data including study 
design, sampling procedures, materials used (e.g., questionnaire, 
interviewer's manual), procedures used to collect or process data, 
methods or procedures used to control for unbiased estimates, and 
procedures used to correct for nonresponse, should be fully documented.
    (xiii) A statement concerning the feasibility of convening 
associations, corporations, consumers, and other interested parties to 
engage in negotiated rulemaking to develop a proposed rule.

 Yours very truly,

 Applicant______________________________________________________________

 By_____________________________________________________________________
 (Indicate authority)

    (8) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (9) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (10) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
Reference Amount and/or Product Category is false or misleading. The 
notification letter shall inform the applicant that the applicant may 
submit a written statement by way of answer to the notification, and 
that the applicant shall have the right to request a hearing with 
respect to

[[Page 209]]

the merits or validity of the Administrator's decision to deny the use 
of the proposed Reference Amount and/or Product Category.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (11) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish in the Federal Register a 
proposed rule to amend the regulations to authorize the use of the 
Reference Amount and/or Product Category. The proposal shall also 
summarize the labeling application, including where the supporting 
documentation can be reviewed. The Administrator's proposed rule shall 
seek comment from consumers, the industry, consumer and industry groups, 
and other interested persons on the labeling application and the use of 
the proposed Reference Amount and/or Product Category. After public 
comment has been received and reviewed by the Agency, the Administrator 
shall make a determination on whether the proposed Reference Amount and/
or Product Category shall be approved for use on the labeling of meat 
food products.
    (i) If the Reference Amount and/or Product Category is denied by the 
Administrator, the Agency shall notify the applicant, in writing, of the 
basis for the denial, including the reason why the Reference Amount and/
or Product Category on the labeling was determined by the Agency to be 
false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed Reference 
Amount and/or Product Category.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of an answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the Reference Amount and/or Product Category is approved, 
the Agency shall notify the applicant, in writing, and shall also 
publish in the Federal Register a final rule amending the regulations to 
authorize the

[[Page 210]]

use of the Reference Amount and/or Product Category.

(Paperwork requirements were approved by the Office of Management and 
Budget under control number 0583-0088)

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993 as amended at 58 FR 
47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3, 
1995]



Sec. 317.313  Nutrient content claims; general principles.

    (a) This section applies to meat or meat food products that are 
intended for human consumption and that are offered for sale.
    (b) A claim which, expressly or by implication, characterizes the 
level of a nutrient (nutrient content claim) of the type required in 
nutrition labeling pursuant to Sec. 317.309, may not be made on a label 
or in labeling of that product unless the claim is made in accordance 
with the applicable provisions in this subpart.
    (1) An expressed nutrient content claim is any direct statement 
about the level (or range) of a nutrient in the product, e.g., ``low 
sodium'' or ``contains 100 calories.''
    (2) An implied nutrient content claim is any claim that:
    (i) Describes the product or an ingredient therein in a manner that 
suggests that a nutrient is absent or present in a certain amount (e.g., 
``high in oat bran''); or
    (ii) Suggests that the product, because of its nutrient content, may 
be useful in maintaining healthy dietary practices and is made in 
association with an explicit claim or statement about a nutrient (e.g., 
``healthy, contains 3 grams (g) of fat'').
    (3) Except for claims regarding vitamins and minerals described in 
paragraph (q)(3) of this section, no nutrient content claims may be made 
on products intended specifically for use by infants and children less 
than 2 years of age unless the claim is specifically provided for in 
subpart B of this part.
    (4) Reasonable variations in the spelling of the terms defined in 
applicable provisions in this subpart and their synonyms are permitted 
provided these variations are not misleading (e.g., ``hi'' or ``lo'').
    (c) Information that is required or permitted by Sec. 317.309 to be 
declared in nutrition labeling, and that appears as part of the 
nutrition label, is not a nutrient content claim and is not subject to 
the requirements of this section. If such information is declared 
elsewhere on the label or in labeling, it is a nutrient content claim 
and is subject to the requirements for nutrient content claims.
    (d) A ``substitute'' product is one that may be used interchangeably 
with another product that it resembles, i.e., that it is 
organoleptically, physically, and functionally (including shelf life) 
similar to, and that it is not nutritionally inferior to unless it is 
labeled as an ``imitation.''
    (1) If there is a difference in performance characteristics that 
materially limits the use of the product, the product may still be 
considered a substitute if the label includes a disclaimer adjacent to 
the most prominent claim as defined in paragraph (j)(2)(iii) of this 
section, informing the consumer of such difference (e.g., ``not 
recommended for frying'').
    (2) This disclaimer shall be in easily legible print or type and in 
a size no less than that required by Sec. 317.2(h) for the net quantity 
of contents statement, except where the size of the claim is less than 
two times the required size of the net quantity of contents statement, 
in which case the disclaimer statement shall be no less than one-half 
the size of the claim but no smaller than \1/16\-inch minimum height, 
except as permitted by Sec. 317.400(d)(2).
    (e)(1) Because the use of a ``free'' or ``low'' claim before the 
name of a product implies that the product differs from other products 
of the same type by virtue of its having a lower amount of the nutrient, 
only products that have been specially processed, altered, formulated, 
or reformulated so as to lower the amount of the nutrient in the 
product, remove the nutrient from the product, or not include the 
nutrient in the product, may bear such a claim (e.g., ``low sodium beef 
noodle soup'').
    (2) Any claim for the absence of a nutrient in a product, or that a 
product is low in a nutrient when the product has not been specially 
processed, altered,

[[Page 211]]

formulated, or reformulated to qualify for that claim shall indicate 
that the product inherently meets the criteria and shall clearly refer 
to all products of that type and not merely to the particular brand to 
which the labeling attaches (e.g., ``lard, a sodium free food'').
    (f) A nutrient content claim shall be in type size and style no 
larger than two times that of the statement of identity and shall not be 
unduly prominent in type style compared to the statement of identity.
    (g) Labeling information required in Sec. Sec. 317.313, 317.354, 
317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is not 
otherwise specified, is required to be in letters and/or numbers no less 
than \1/16\ inch in height, except as permitted by Sec. 317.400(d)(2).
    (h) [Reserved]
    (i) Except as provided in Sec. 317.309 or in paragraph (q)(3) of 
this section, the label or labeling of a product may contain a statement 
about the amount or percentage of a nutrient if:
    (1) The use of the statement on the product implicitly characterizes 
the level of the nutrient in the product and is consistent with a 
definition for a claim, as provided in subpart B of this part, for the 
nutrient that the label addresses. Such a claim might be, ``less than 10 
g of fat per serving;''
    (2) The use of the statement on the product implicitly characterizes 
the level of the nutrient in the product and is not consistent with such 
a definition, but the label carries a disclaimer adjacent to the 
statement that the product is not ``low'' in or a ``good source'' of the 
nutrient, such as ``only 200 milligrams (mg) sodium per serving, not a 
low sodium product.'' The disclaimer must be in easily legible print or 
type and in a size no less than required by Sec. 317.2(h) for the net 
quantity of contents, except where the size of the claim is less than 
two times the required size of the net quantity of contents statement, 
in which case the disclaimer statement shall be no less than one-half 
the size of the claim but no smaller than \1/16\-inch minimum height, 
except as permitted by Sec. 317.400(d)(2);
    (3) The statement does not in any way implicitly characterize the 
level of the nutrient in the product and it is not false or misleading 
in any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which 
case no disclaimer is required.
    (4) ``Percent fat free'' claims are not authorized by this 
paragraph. Such claims shall comply with Sec. 317.362(b)(6).
    (j) A product may bear a statement that compares the level of a 
nutrient in the product with the level of a nutrient in a reference 
product. These statements shall be known as ``relative claims'' and 
include ``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more'' 
claims.
    (1) To bear a relative claim about the level of a nutrient, the 
amount of that nutrient in the product must be compared to an amount of 
nutrient in an appropriate reference product as specified in this 
paragraph (j).
    (i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the 
reference product may be a dissimilar product within a product category 
that can generally be substituted for one another in the diet or a 
similar product.
    (B) For ``light,'' ``reduced,'' and ``added'' claims, the reference 
product shall be a similar product, and
    (ii)(A) For ``light'' claims, the reference product shall be 
representative of the type of product that includes the product that 
bears the claim. The nutrient value for the reference product shall be 
representative of a broad base of products of that type; e.g., a value 
in a representative, valid data base; an average value determined from 
the top three national (or regional) brands, a market basket norm; or, 
where its nutrient value is representative of the product type, a market 
leader. Firms using such a reference nutrient value as a basis for a 
claim, are required to provide specific information upon which the 
nutrient value was derived, on request, to consumers and appropriate 
regulatory officials.
    (B) For relative claims other than ``light,'' including ``less'' and 
``more'' claims, the reference product may be the same as that provided 
for ``light'' in paragraph (j)(1)(ii)(A) of this section or it may be 
the manufacturer's regular product, or that of another manufacturer, 
that has been offered for sale to the public on a regular basis for a

[[Page 212]]

substantial period of time in the same geographic area by the same 
business entity or by one entitled to use its trade name, provided the 
name of the competitor is not used on the labeling of the product. The 
nutrient values used to determine the claim when comparing a single 
manufacturer's product to the labeled product shall be either the values 
declared in nutrition labeling or the actual nutrient values, provided 
that the resulting labeling is internally consistent (i.e., that the 
values stated in the nutrition information, the nutrient values in the 
accompanying information, and the declaration of the percentage of 
nutrient by which the product has been modified are consistent and will 
not cause consumer confusion when compared), and that the actual 
modification is at least equal to the percentage specified in the 
definition of the claim.
    (2) For products bearing relative claims:
    (i) The label or labeling must state the identity of the reference 
product and the percent (or fraction) of the amount of the nutrient in 
the reference product by which the nutrient has been modified, (e.g., 
``50 percent less fat than `reference product' '' or ``\1/3\ fewer 
calories than `reference product' ''); and
    (ii) This information shall be immediately adjacent to the most 
prominent claim in easily legible boldface print or type, in distinct 
contrast to other printed or graphic matter, that is no less than that 
required by Sec. 317.2(h) for net quantity of contents, except where 
the size of the claim is less than two times the required size of the 
net quantity of contents statement, in which case the referral statement 
shall be no less than one-half the size of the claim, but no smaller 
than \1/16\-inch minimum height, except as permitted by Sec. 
317.400(d)(2).
    (iii) The determination of which use of the claim is in the most 
prominent location on the label or labeling will be made based on the 
following factors, considered in order:
    (A) A claim on the principal display panel adjacent to the statement 
of identity;
    (B) A claim elsewhere on the principal display panel;
    (C) A claim on the information panel; or
    (D) A claim elsewhere on the label or labeling.
    (iv) The label or labeling must also bear:
    (A) Clear and concise quantitative information comparing the amount 
of the subject nutrient in the product per labeled serving size with 
that in the reference product; and
    (B) This statement shall appear adjacent to the most prominent claim 
or to the nutrition information.
    (3) A relative claim for decreased levels of a nutrient may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the requirement for a ``low'' claim for that 
nutrient.
    (k) The term ``modified'' may be used in the statement of identity 
of a product that bears a relative claim that complies with the 
requirements of this part, followed immediately by the name of the 
nutrient whose content has been altered (e.g., ``modified fat `product' 
''). This statement of identity must be immediately followed by the 
comparative statement such as ``contains 35 percent less fat than 
`reference product'.'' The label or labeling must also bear the 
information required by paragraph (j)(2) of this section in the manner 
prescribed.
    (l) For purposes of making a claim, a ``meal-type'' product will be 
defined as a product that:
    (1) Makes a major contribution to the diet by:
    (i) Weighing at least 10 ounces per labeled serving; and
    (ii) Containing not less than three 40 gram portions of food, or 
combinations of foods, from two or more of the following four food 
groups, except as noted in paragraph (l)(1)(ii)(E) of this section:
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (l)(1)(ii)(A) through (D) of this section, that 
are in

[[Page 213]]

the sauces), gravies, condiments, relishes, pickles, olives, jams, 
jellies, syrups, breadings, or garnishes; and
    (2) Is represented as, or is in the form commonly understood to be, 
a breakfast, lunch, dinner, meal, or entre. Such representations may be 
made by statements, photographs, or vignettes.
    (m) For purposes of making a claim, a main-dish product will be 
defined as a food that:
    (1) Makes a major contribution to the meal by:
    (i) Weighing at least 6 ounces per labeled serving; and
    (ii) Containing not less than 40 grams of food, or combinations of 
foods, from two or more of the following four food groups, except as 
noted in paragraph (m)(1)(ii)(E) of this section.
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (m)(l)(ii)(A) through (D) of this section, that 
are in the sauces), gravies, condiments, relishes, pickles, olives, 
jams, jellies, syrups, breadings, or garnishes; and
    (3) Is represented as, or is in a form commonly understood to be, a 
main dish (e.g., not a beverage or dessert). Such representations may be 
made by statements, photographs, or vignettes.
    (n) Nutrition labeling in accordance with Sec. 317.309, shall be 
provided for any food for which a nutrient content claim is made.
    (o) Compliance with requirements for nutrient content claims shall 
be in accordance with Sec. 317.309(h).
    (p)(1) Unless otherwise specified, the reference amount customarily 
consumed set forth in Sec. 317.312(b) through (e) shall be used in 
determining whether a product meets the criteria for a nutrient content 
claim. If the serving size declared on the product label differs from 
the reference amount customarily consumed, and the amount of the 
nutrient contained in the labeled serving does not meet the maximum or 
minimum amount criterion in the definition for the descriptor for that 
nutrient, the claim shall be followed by the criteria for the claim as 
required by Sec. 317.312(f) (e.g., ``very low sodium, 35 mg or less per 
55 grams'').
    (2) The criteria for the claim shall be immediately adjacent to the 
most prominent claim in easily legible print or type and in a size that 
is no less than that required by Sec. 317.2(h) for net quantity of 
contents, except where the size of the claim is less than two times the 
required size of the net quantity of contents statement, in which case 
the criteria statement shall be no less than one-half the size of the 
claim but no smaller than \1/16\-inch minimum height, except as 
permitted by Sec. 317.400(d)(2).
    (q) The following exemptions apply:
    (1) Nutrient content claims that have not been defined by regulation 
and that appear as part of a brand name that was in use prior to 
November 27, 1991, may continue to be used as part of that brand name, 
provided they are not false or misleading under section 1(n) of the Act 
(21 U.S.C. 601(n)(1)).
    (2) [Reserved]
    (3) A statement that describes the percentage of a vitamin or 
mineral in the food, including foods intended specifically for use by 
infants and children less than 2 years of age, in relation to a 
Reference Daily Intake (RDI) as defined in Sec. 317.309 may be made on 
the label or in the labeling of a food without a regulation authorizing 
such a claim for a specific vitamin or mineral.
    (4) The requirements of this section do not apply to infant formulas 
and medical foods, as described in 21 CFR 101.13(q)(4).
    (5) [Reserved]
    (6) Nutrient content claims that were part of the name of a product 
that was subject to a standard of identity as of November 27, 1991, are 
not subject to the requirements of paragraph (b) of this section whether 
or not they meet the definition of the descriptive term.
    (7) Implied nutrient content claims may be used as part of a brand 
name, provided that the use of the claim has been authorized by FSIS. 
Labeling applications requesting approval of such a claim may be 
submitted pursuant to Sec. 317.369.

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 
FR 47627, Sept. 10, 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, Sept. 
1, 1994; 60 FR 187, Jan. 3, 1995; 69 FR 58801, Oct. 1, 2004]

[[Page 214]]



Sec. Sec. 317.314-317.342  [Reserved]



Sec. 317.343  Significant participation for voluntary nutrition labeling.

    (a) In evaluating significant participation for voluntary nutrition 
labeling, FSIS will consider only the major cuts of single-ingredient, 
raw meat products, as identified in Sec. 317.344, including those that 
have been previously frozen.
    (b) FSIS will judge a food retailer to be participating at a 
significant level if the retailer provides nutrition labeling 
information for at least 90 percent of the major cuts of single-
ingredient, raw meat products, listed in Sec. 317.344, that it sells, 
and if the nutrition label is consistent in content and format with the 
mandatory program, or nutrition information is displayed at point-of-
purchase in an approriate manner.
    (c) To determine whether there is significant participation by 
retailers under the voluntary nutrition labeling guidelines, FSIS will 
select a representative sample of companies allocated by type and size.
    (d) FSIS will find that significant participation by food retailers 
exists if at least 60 percent of all companies that are evaluated are 
participating in accordance with the guidelines.
    (e) FSIS will evaluate significant participation of the voluntary 
program every 2 years beginning in May 1995.
    (1) If significant participation is found, the voluntary nutrition 
labeling guidelines shall remain in effect.
    (2) If significant participation is not found, FSIS shall initiate 
rulemaking to require nutrition labeling on those products under the 
voluntary program.



Sec. 317.344  Identification of major cuts of meat products.

    The major cuts of single-ingredient, raw meat products are: Beef 
chuck blade roast, beef loin top loin steak, beef rib roast large end, 
beef round eye round steak, beef round top round steak, beef round tip 
roast, beef chuck arm pot roast, beef loin sirloin steak, beef round 
bottom round steak, beef brisket (whole, flat half, or point half), beef 
rib steak small end, beef loin tenderloin steak, ground beef regular 
without added seasonings, ground beef about 17% fat, pork loin chop, 
pork loin country style ribs, pork loin top loin chop boneless, pork 
loin rib chop, pork spareribs, pork loin tenderloin, pork loin sirloin 
roast, pork shoulder blade steak, pork loin top roast boneless, ground 
pork, lamb shank, lamb shoulder arm chop, lamb shoulder blade chop, lamb 
rib roast, lamb loin chop, lamb leg (whole, sirloin half, or shank 
half), veal shoulder arm steak, veal shoulder blade steak, veal rib 
roast, veal loin chop, and veal cutlets.

[58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994]



Sec. 317.345  Guidelines for voluntary nutrition labeling of 
single-ingredient, raw products.

    (a) Nutrition information on the cuts of single-ingredient, raw meat 
products, including those that have been previously frozen, shall be 
provided in the following manner:
    (1) If a retailer or manufacturer chooses to provide nutrition 
information on the label of these products, these products shall be 
subject to all requirements of the mandatory nutrition labeling program, 
except that nutrition labeling may be declared on the basis of either 
``as consumed'' or ``as packaged.'' In addition, the declaration of the 
number of servings per container need not be included in nutrition 
labeling of single-ingredient, raw meat products (including ground 
beef), including those that have been previously frozen.
    (2) A retailer may choose to provide nutrition information at the 
point-of-purchase, such as by posting a sign, or by making the 
information readily available in brochures, notebooks, or leaflet form 
in close proximity to the food. The nutrition labeling information may 
also be supplemented by a video, live demonstration, or other media. If 
a nutrition claim is made on point-of-purchase materials all of the 
requirements of the mandatory nutrition labeling program apply. However, 
if only nutrition information--and not a nutrition claim--is supplied on 
point-of-purchase materials:
    (i) The requirements of the mandatory nutrition labeling program 
apply, but the nutrition information may be supplied on an ``as 
packaged'' or ``as consumed,'' basis;

[[Page 215]]

    (ii) The listing of percent of Daily Value for the nutrients (except 
vitamins and minerals specified in Sec. 317.309(c)(8)) and footnote 
required by Sec. 317.309(d)(9) may be omitted; and
    (iii) The point-of-purchase materials are not subject to any of the 
format requirements.
    (b) [Reserved]
    (c) The declaration of nutrition information may be presented in a 
simplified format as specified in Sec. 317.309(f) for the mandatory 
nutrition labeling program.
    (d) The nutrition label data should be based on either the raw or 
cooked edible portions of meat cuts with external cover fat at trim 
levels reflecting current marketing practices. If data are based on 
cooked portions, the methods used to cook the products must be specified 
and should be those which do not add nutrients from other ingredients 
such as flour, breading, and salt. Additional nutritional data may be 
presented on an optional basis for the raw or cooked edible portions of 
the separable lean of meat cuts.
    (e) Nutrient data that are the most current representative data base 
values contained in USDA's National Nutrient Data Bank or its published 
form, the Agriculture Handbook No. 8 series, may be used for nutrition 
labeling of single-ingredient, raw meat products (including ground 
beef), including those that have been previously frozen. These data may 
be composite data that reflect different quality grades of beef or other 
variables affecting nutrient content. Alternatively, data that reflect 
specific grades or other variables may be used, except that if data are 
used on labels attached to a product which is labeled as to grade of 
meat or other variables, the data must represent the product in the 
package when such data are contained in the representative data base. 
When data are used on labels attached to a product, the data must 
represent the edible meat tissues present in the package.
    (f) If the nutrition information is in accordance with paragraph (e) 
of this section, a nutrition label or labeling will not be subject to 
the Agency compliance review under Sec. 317.309(h), unless a nutrition 
claim is made on the basis of the representative data base values.
    (g) Retailers may use data bases that they believe reflect the 
nutrient content of single-ingredient, raw meat products (including 
ground beef), including those that have been previously frozen; however, 
such labeling shall be subject to the compliance procedures of paragraph 
(e) of this section and the requirements specified in this subpart for 
the mandatory nutrition labeling program.

[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 60 
FR 189, Jan. 3, 1995]



Sec. Sec. 317.346-317.353  [Reserved]



Sec. 317.354  Nutrient content claims for ``good source,'' ``high,'' 
and ``more.''

    (a) General requirements. Except as provided in paragraph (e) of 
this section, a claim about the level of a nutrient in a product in 
relation to the Reference Daily Intake (RDI) or Daily Reference Value 
(DRV) established for that nutrient (excluding total carbohydrate) in 
Sec. 317.309(c), may only be made on the label or in labeling of the 
product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or 
``excellent source of'' may be used on the label or in labeling of 
products, except meal-type products as defined in Sec. 317.313(l), and 
main-dish products as defined in Sec. 317.313(m) provided that the 
product contains 20 percent or more of the RDI or the DRV per reference 
amount customarily consumed.
    (2) The terms defined in paragraph (b)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), and main-dish product as defined in Sec. 317.313(m) 
provided that:
    (i) The product contains a food that meets the definition of 
``high'' in paragraph (b)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the

[[Page 216]]

claim (e.g., ``the serving of broccoli in this meal is high in vitamin 
C'').
    (c) ``Good Source'' claims. (1) The terms ``good source,'' 
``contains,'' or ``provides'' may be used on the label or in labeling of 
products, except meal-type products as described in Sec. 317.313(l), 
and main-dish products as defined in Sec. 317.313(m) provided that the 
product contains 10 to 19 percent of the RDI or the DRV per reference 
amount customarily consumed.
    (2) The terms defined in paragraph (c)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), and main-dish product as defined in Sec. 317.313(m) 
provided that:
    (i) The product contains a food that meets the definition of ``good 
source'' in paragraph (c)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., ``the serving of sweet potatoes in this meal 
is a good source of fiber'').
    (d) Fiber claims. (1) If a nutrient content claim is made with 
respect to the level of dietary fiber, i.e., that the product is high in 
fiber, a good source of fiber, or that the product contains ``more'' 
fiber, and the product is not ``low'' in total fat as defined in Sec. 
317.362(b)(2) or, in the case of a meal-type product or a main-dish 
product, is not ``low'' in total fat as defined in Sec. 317.362(b)(3), 
then the labeling shall disclose the level of total fat per labeled 
serving size (e.g., ``contains 12 grams (g) of fat per serving''); and
    (2) The disclosure shall appear in immediate proximity to such claim 
and be in a type size no less than one-half the size of the claim.
    (e) ``More'' claims. (1) A relative claim using the terms ``more'' 
and ``added'' may be used on the label or in labeling to describe the 
level of protein, vitamins, minerals, dietary fiber, or potassium in a 
product, except meal-type products as defined in Sec. 317.313(l), and 
main-dish products as defined in Sec. 317.313(m) provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per reference amount 
customarily consumed than an appropriate reference product as described 
in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber than `reference 
product' ''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``fiber content of `reference product' 
is 1 g per serving; `this product' contains 4 g per serving'').
    (2) A relative claim using the terms ``more'' and ``added'' may be 
used on the label or in labeling to describe the level of protein, 
vitamins, minerals, dietary fiber, or potassium in meal-type products as 
defined in Sec. 317.313(l), and main-dish products as defined in Sec. 
317.313(m) provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per 100 g of product than an 
appropriate reference product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber per 3 ounces 
(oz) than does `reference product' ''), and
    (B) Quantitative information comparing the level of the nutrient in 
the meal-type product or a main-dish product per specified weight with 
that of the reference product that it replaces is declared adjacent to 
the most prominent claim or to the nutrition information (e.g., ``fiber 
content of `reference

[[Page 217]]

product' is 2 g per 3 oz; `this product' contains 5 g per 3 oz'').

[60 FR 189, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]



Sec. 317.355  [Reserved]



Sec. 317.356  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. A claim using the terms ``light'' or 
``lite'' to describe a product may only be made on the label or in 
labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) ``Light'' claims. The terms ``light'' or ``lite'' may be used on 
the label or in labeling of products, except meal-type products as 
defined in Sec. 317.313(l) and main-dish products as defined in Sec. 
317.313(m), without further qualification, provided that:
    (1) If the product derives 50 percent or more of its calories from 
fat, its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to an appropriate reference product 
as described in Sec. 317.313(j)(1); or
    (2) If the product derives less than 50 percent of its calories from 
fat:
    (i) The number of calories is reduced by at least one-third (33\1/3\ 
percent) per reference amount customarily consumed compared to an 
appropriate reference product as described in Sec. 317.313(j)(1); or
    (ii) Its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to the appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (3) As required in Sec. 317.313(j)(2) for relative claims:
    (i) The identity of the reference product and the percent (or 
fraction) that the calories and the fat were reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``\1/3\ 
fewer calories and 50 percent less fat than the market leader''); and
    (ii) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference product that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``lite `this 
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving''); and
    (iii) If the labeled product contains less than 40 calories or less 
than 3 g fat per reference amount customarily consumed, the percentage 
reduction for that nutrient need not be declared.
    (4) A ``light'' claim may not be made on a product for which the 
reference product meets the definition of ``low fat'' and ``low 
calorie.''
    (c)(1)(i) A product for which the reference product contains 40 
calories or less and 3 g fat or less per reference amount customarily 
consumed may use the terms ``light'' or ``lite'' without further 
qualification if it is reduced by 50 percent or more in sodium content 
compared to the reference product; and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50 percent less 
sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., ``lite `this product'--500 milligrams (mg) sodium per 
serving; regular `reference product'--1,000 mg sodium per serving'').
    (2)(i) A product for which the reference product contains more than 
40 calories or more than 3 g fat per reference amount customarily 
consumed may use the terms ``light in sodium'' or ``lite in sodium'' if 
it is reduced by 50 percent or more in sodium content compared to the 
reference product, provided that ``light'' or ``lite'' is presented in 
immediate proximity with ``in sodium'' and the entire term is presented 
in uniform type size, style, color, and prominence; and

[[Page 218]]

    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50 percent less 
sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., or ``lite `this product'--170 mg sodium per serving; 
regular `reference product'--350 mg per serving'').
    (3) Except for meal-type products as defined in Sec. 317.313(l) and 
main-dish products as defined in Sec. 317.313(m), a ``light in sodium'' 
claim may not be made on a product for which the reference product meets 
the definition of ``low in sodium.''
    (d)(1) The terms ``light'' or ``lite'' may be used on the label or 
in labeling of a meal-type product as defined in Sec. 317.313(l) and 
main-dish product as defined in Sec. 317.313(m), provided that:
    (i) The product meets the definition of:
    (A) ``Low in calories'' as defined in Sec. 317.360(b)(3); or
    (B) ``Low in fat'' as defined in Sec. 317.362(b)(3); and
    (ii)(A) A statement appears on the principal display panel that 
explains whether ``light'' is used to mean ``low fat,'' ``low 
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
    (B) The accompanying statement is no less than one-half the type 
size of the ``light'' or ``lite'' claim.
    (2)(i) The terms ``light in sodium'' or ``lite in sodium'' may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that the product meets the definition of ``low in sodium'' as 
defined in Sec. 317.361(b)(5)(i); and
    (ii) ``Light'' or ``lite'' and ``in sodium'' are presented in 
uniform type size, style, color, and prominence.
    (3) The term ``light'' or ``lite'' may be used in the brand name of 
a product to describe the sodium content, provided that:
    (i) The product is reduced by 50 percent or more in sodium content 
compared to the reference product;
    (ii) A statement specifically stating that the product is ``light in 
sodium'' or ``lite in sodium'' appears:
    (A) Contiguous to the brand name; and
    (B) In uniform type size, style, color, and prominence as the 
product name; and
    (iii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim; and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information.
    (e) Except as provided in paragraphs (b) through (d) of this 
section, the terms ``light'' or ``lite'' may not be used to refer to a 
product that is not reduced in fat by 50 percent, or, if applicable, in 
calories by \1/3\ or, when properly qualified, in sodium by 50 percent 
unless:
    (1) It describes some physical or organoleptic attribute of the 
product such as texture or color and the information (e.g., ``light in 
color'' or ``light in texture'') so stated, clearly conveys the nature 
of the product; and
    (2) The attribute (e.g., ``color'' or ``texture'') is in the same 
style, color, and at least one-half the type size as the word ``light'' 
and in immediate proximity thereto.
    (f) If a manufacturer can demonstrate that the word ``light'' has 
been associated, through common use, with a particular product to 
reflect a physical or organoleptic attribute to the point where it has 
become part of the statement of identity, such use of the term ``light'' 
shall not be considered a nutrient content claim subject to the 
requirements in this part.
    (g) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is

[[Page 219]]

normally added to the reference product as described in Sec. 
317.313(j)(1)(i)(B) and (j)(1)(ii)(B), provided that if the product is 
not ``low in sodium'' as defined in Sec. 317.361(b)(4), the statement 
``not a low sodium food,'' shall appear adjacent to the nutrition 
information and the information required to accompany a relative claim 
shall appear on the label or labeling as specified in Sec. 
317.313(j)(2).

[60 FR 189, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]



Sec. Sec. 317.357-317.359  [Reserved]



Sec. 317.360  Nutrient content claims for calorie content.

    (a) General requirements. A claim about the calorie or sugar content 
of a product may only be made on the label or in labeling of the product 
if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) Calorie content claims. (1) The terms ``calorie free,'' ``free 
of calories,'' ``no calories,'' ``zero calories,'' ``without calories,'' 
``trivial source of calories,'' ``negligible source of calories,'' or 
``dietarily insignificant source of calories'' may be used on the label 
or in labeling of products, provided that:
    (i) The product contains less than 5 calories per reference amount 
customarily consumed and per labeled serving size; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low calorie,'' ``few calories,'' ``contains a small 
amount of calories,'' ``low source of calories,'' or ``low in calories'' 
may be used on the label or in labeling of products, except meal-type 
products as defined in Sec. 317.313(l) and main-dish products as 
defined in Sec. 317.313(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does 
not provide more than 40 calories per reference amount customarily 
consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and does not provide more than 40 calories per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 317.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains 120 calories or less per 100 g of product; 
and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the calorie content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which it attaches.
    (4) The terms ``reduced calorie,'' ``reduced in calories,'' 
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower 
in calories'' may be used on the label or in labeling of products, 
except meal-type products as defined in Sec. 317.313(l) and main-dish 
products as defined in Sec. 317.313(m), provided that:
    (i) The product contains at least 25 percent fewer calories per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:

[[Page 220]]

    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., lower 
calorie `product'--``33\1/3\ percent fewer calories than our regular 
`product' ''); and
    (B) Quantitative information comparing the level of calories in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``calorie content has been reduced from 150 
to 100 calories per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of products if the reference product 
meets the definition for ``low calorie.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains at least 25 percent fewer calories per 100 
g of product than an appropriate reference product as described in Sec. 
317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``calorie 
reduced `product', 25% less calories per ounce (oz) (or 3 oz) than our 
regular `product' ''); and
    (B) Quantitative information comparing the level of calories in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``calorie content has been reduced from 110 
calories per 3 oz to 80 calories per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of products if the reference product 
meets the definition for ``low calorie.''
    (c) Sugar content claims. (1) Terms such as ``sugar free,'' ``free 
of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,'' 
``sugarless,'' ``trivial source of sugar,'' ``negligible source of 
sugar,'' or ``dietarily insignificant source of sugar'' may reasonably 
be expected to be regarded by consumers as terms that represent that the 
product contains no sugars or sweeteners, e.g., ``sugar free,'' or ``no 
sugar,'' as indicating a product which is low in calories or 
significantly reduced in calories. Consequently, except as provided in 
paragraph (c)(2) of this section, a product may not be labeled with such 
terms unless:
    (i) The product contains less than 0.5 g of sugars, as defined in 
Sec. 317.309(c)(6)(ii), per reference amount customarily consumed and 
per labeled serving size or, in the case of a meal-type product or a 
main-dish product, less than 0.5 g of sugars per labeled serving size;
    (ii) The product contains no ingredient that is a sugar or that is 
generally understood by consumers to contain sugars unless the listing 
of the ingredient in the ingredients statement is followed by an 
asterisk that refers to the statement below the list of ingredients, 
which states: ``Adds a trivial amount of sugar,'' ``adds a negligible 
amount of sugar,'' or ``adds a dietarily insignificant amount of 
sugar;'' and
    (iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or 
bears a relative claim of special dietary usefulness labeled in 
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this 
section; or
    (B) Such term is immediately accompanied, each time it is used, by 
either the statement ``not a reduced calorie product,'' ``not a low 
calorie product,'' or ``not for weight control.''
    (2) The terms ``no added sugar,'' ``without added sugar,'' or ``no 
sugar added'' may be used only if:
    (i) No amount of sugars, as defined in Sec. 317.309(c)(6)(ii), or 
any other ingredient that contains sugars that functionally substitute 
for added sugars is added during processing or packaging;
    (ii) The product does not contain an ingredient containing added 
sugars such as jam, jelly, or concentrated fruit juice;
    (iii) The sugars content has not been increased above the amount 
present in the ingredients by some means such as

[[Page 221]]

the use of enzymes, except where the intended functional effect of the 
process is not to increase the sugars content of a product, and a 
functionally insignificant increase in sugars results;
    (iv) The product that it resembles and for which it substitutes 
normally contains added sugars; and
    (v) The product bears a statement that the product is not ``low 
calorie'' or ``calorie reduced'' (unless the product meets the 
requirements for a ``low'' or ``reduced calorie'' product) and that 
directs consumers' attention to the nutrition panel for further 
information on sugar and calorie content.
    (3) Paragraph (c)(1) of this section shall not apply to a factual 
statement that a product, including products intended specifically for 
infants and children less than 2 years of age, is unsweetened or 
contains no added sweeteners in the case of a product that contains 
apparent substantial inherent sugar content, e.g., juices.
    (4) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar 
reduced,'' ``less sugar,'' ``lower sugar,'' or ``lower in sugar'' may be 
used on the label or in labeling of products, except meal-type products 
as defined in Sec. 317.313(l) and main-dish products as defined in 
Sec. 317.313(m), provided that:
    (i) The product contains at least 25 percent less sugars per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``this 
product contains 25 percent less sugar than our regular product''); and
    (B) Quantitative information comparing the level of the sugar in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sugar content has been lowered from 8 g 
to 6 g per serving'').
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains at least 25 percent less sugars per 100 g 
of product than an appropriate reference product as described in Sec. 
317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``reduced 
sugar `product'--25% less sugar than our regular `product' ''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sugar content has been reduced from 17 g 
per 3 oz to 13 g per 3 oz'').

[60 FR 191, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]



Sec. 317.361  Nutrient content claims for the sodium content.

    (a) General requirements. A claim about the level of sodium in a 
product may only be made on the label or in labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) Sodium content claims. (1) The terms ``sodium free,'' ``free of 
sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' ``trivial 
source of sodium,'' ``negligible source of sodium,'' or ``dietarily 
insignificant source of sodium'' may be used on the label or in labeling 
of products, provided that:
    (i) The product contains less than 5 milligrams (mg) of sodium per 
reference amount customarily consumed and per labeled serving size or, 
in the case of a meal-type product or a main-

[[Page 222]]

dish product, less than 5 mg of sodium per labeled serving size;
    (ii) The product contains no ingredient that is sodium chloride or 
is generally understood by consumers to contain sodium unless the 
listing of the ingredient in the ingredients statement is followed by an 
asterisk that refers to the statement below the list of ingredients, 
which states: ``Adds a trivial amount of sodium,'' ``adds a negligible 
amount of sodium'' or ``adds a dietarily insignificant amount of 
sodium''; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``very low sodium'' or ``very low in sodium'' may be 
used on the label or in labeling of products, except meal-type products 
as defined in Sec. 317.313(l) and main-dish products as defined in 
Sec. 317.313(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and 
contains 35 mg or less sodium per reference amount customarily consumed; 
or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 35 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 317.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains 35 mg or less of sodium per 100 g of 
product; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``low sodium,'' ``low in sodium,'' ``little sodium,'' 
``contains a small amount of sodium,'' or ``low source of sodium'' may 
be used on the label and in labeling of products, except meal-type 
products as defined in Sec. 317.313(l) and main-dish products as 
defined in Sec. 317.313(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tbsp and contains 140 mg or less 
sodium per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 140 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 317.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains 140 mg or less sodium per 100 g of product; 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or

[[Page 223]]

reformulation to lower the sodium content, it is labeled to clearly 
refer to all products of its type and not merely to the particular brand 
to which the label attaches.
    (6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium 
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium'' may 
be used on the label or in labeling of products, except meal-type 
products as defined in Sec. 317.313(l) and main-dish products as 
defined in Sec. 317.313(m), provided that:
    (i) The product contains at least 25 percent less sodium per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium differs between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``reduced 
sodium `product', 50 percent less sodium than regular `product' ''); and
    (B) Quantitative information comparing the level of sodium in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sodium content has been lowered from 300 
to 150 mg per serving'').
    (iii) Claims described in paragraph (b)(6) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low sodium.''
    (7) The terms defined in paragraph (b)(6) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains at least 25 percent less sodium per 100 g 
of product than an appropriate reference product as described in Sec. 
317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium differs between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``reduced 
sodium `product'--30% less sodium per 3 oz than our `regular product' 
''); and
    (B) Quantitative information comparing the level of sodium in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sodium content has been reduced from 220 
mg per 3 oz to 150 mg per 3 oz'').
    (iii) Claims described in paragraph (b)(7) of this section may not 
be made on the label or in labeling of products if the nutrient content 
of the reference product meets the definition for ``low sodium.''
    (c) The term ``salt'' is not synonymous with ``sodium.'' Salt refers 
to sodium chloride. However, references to salt content such as 
``unsalted,'' ``no salt,'' ``no salt added'' are potentially misleading.
    (1) The term ``salt free'' may be used on the label or in labeling 
of products only if the product is ``sodium free'' as defined in 
paragraph (b)(1) of this section.
    (2) The terms ``unsalted,'' ``without added salt,'' and ``no salt 
added'' may be used on the label or in labeling of products only if:
    (i) No salt is added during processing;
    (ii) The product that it resembles and for which it substitutes is 
normally processed with salt; and
    (iii) If the product is not sodium free, the statement, ``not a 
sodium free product'' or ``not for control of sodium in the diet'' 
appears adjacent to the nutrition information of the product bearing the 
claim.
    (3) Paragraph (c)(2) of this section shall not apply to a factual 
statement that a product intended specifically for infants and children 
less than 2 years of age is unsalted, provided such statement refers to 
the taste of the product and is not false or otherwise misleading.

[60 FR 192, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]

[[Page 224]]



Sec. 317.362  Nutrient content claims for fat, fatty acids, and 
cholesterol content.

    (a) General requirements. A claim about the level of fat, fatty 
acid, and cholesterol in a product may only be made on the label or in 
labeling of products if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) Fat content claims. (1) The terms ``fat free,'' ``free of fat,'' 
``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial source 
of fat,'' ``negligible source of fat,'' or ``dietarily insignificant 
source of fat'' may be used on the label or in labeling of products, 
provided that:
    (i) The product contains less than 0.5 gram (g) of fat per reference 
amount customarily consumed and per labeled serving size or, in the case 
of a meal-type product or a main-dish product, less than 0.5 g of fat 
per labeled serving size;
    (ii) The product contains no added ingredient that is a fat or is 
generally understood by consumers to contain fat unless the listing of 
the ingredient in the ingredients statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which 
states: ``Adds a trivial amount of fat,'' ``adds a negligible amount of 
fat,'' or ``adds a dietarily insignificant amount of fat''; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label attaches.
    (2) The terms ``low fat,'' ``low in fat,'' ``contains a small amount 
of fat,'' ``low source of fat,'' or ``little fat'' may be used on the 
label and in labeling of products, except meal-type products as defined 
in Sec. 317.313(l) and main-dish products as defined in Sec. 
317.313(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g 
or less of fat per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 3 g or less of fat per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec. 317.309(f)(1), 
of all nutrients per reference amount customarily consumed, the per-50-g 
criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains 3 g or less of total fat per 100 g of 
product and not more than 30 percent of calories from fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label attaches.
    (4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,'' 
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the 
label or in labeling of products, except meal-type products as defined 
in Sec. 317.313(l) and main-dish products as defined in Sec. 
317.313(m), provided that:
    (i) The product contains at least 25 percent less fat per reference 
amount customarily consumed than an appropriate reference product as 
described in Sec. 317.313(j)(1); and

[[Page 225]]

    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two products are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
fat--50 percent less fat than our regular `product' ''); and
    (B) Quantitative information comparing the level of fat in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``fat content has been reduced from 8 g to 
4 g per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low fat.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains at least 25 percent less fat per 100 g of 
product than an appropriate reference product as described in Sec. 
317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two products are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
fat `product', 33 percent less fat per 3 oz than our regular `product' 
''); and
    (B) Quantitative information comparing the level of fat in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent such claim or to the 
nutrition information (e.g., ``fat content has been reduced from 8 g per 
3 oz to 5 g per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low fat.''
    (6) The term ``------ percent fat free'' may be used on the label or 
in labeling of products, provided that:
    (i) The product meets the criteria for ``low fat'' in paragraph 
(b)(2) or (b)(3) of this section;
    (ii) The percent declared and the words ``fat free'' are in uniform 
type size; and
    (iii) A ``100 percent fat free'' claim may be made only on products 
that meet the criteria for ``fat free'' in paragraph (b)(1) of this 
section, that contain less than 0.5 g of fat per 100 g, and that contain 
no added fat.
    (iv) A synonym for ``------ percent fat free'' is ``------ percent 
lean.''
    (c) Fatty acid content claims. (1) The terms ``saturated fat free,'' 
``free of saturated fat,'' ``no saturated fat,'' ``zero saturated fat,'' 
``without saturated fat,'' ``trivial source of saturated fat,'' 
``negligible source of saturated fat,'' or ``dietarily insignificant 
source of saturated fat'' may be used on the label or in labeling of 
products, provided that:
    (i) The product contains less than 0.5 g of saturated fat and less 
than 0.5 g trans fatty acids per reference amount customarily consumed 
and per labeled serving size or, in the case of a meal-type product or a 
main-dish product, less than 0.5 g of saturated fat and less than 0.5 g 
trans fatty acids per labeled serving size;
    (ii) The product contains no ingredient that is generally understood 
by consumers to contain saturated fat unless the listing of the 
ingredient in the ingredients statement is followed by an asterisk that 
refers to the statement below the list of ingredients, which states: 
``Adds a trivial amount of saturated fat,'' ``adds a negligible amount 
of saturated fat,'' or ``adds a dietarily insignificant amount of 
saturated fat;'' and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low in saturated fat,'' ``low saturated fat,'' 
``contains a small amount of saturated fat,'' ``low source

[[Page 226]]

of saturated fat,'' or ``a little saturated fat'' may be used on the 
label or in labeling of products, except meal-type products as defined 
in Sec. 317.313(l) and main-dish products as defined in Sec. 
317.313(m), provided that:
    (i) The product contains 1 g or less of saturated fat per reference 
amount customarily consumed and not more than 15 percent of calories 
from saturated fat; and
    (ii) If the product meets these conditions without benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (c)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains 1 g or less of saturated fat per 100 g and 
less than 10 percent calories from saturated fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced saturated fat,'' ``reduced in saturated 
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower 
saturated fat,'' or ``lower in saturated fat'' may be used on the label 
or in labeling of products, except meal-type products as defined in 
Sec. 317.313(l) and main-dish products as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains at least 25 percent less saturated fat per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat `product', contains 50 percent less saturated 
fat than the national average for `product' ''); and
    (B) Quantitative information comparing the level of saturated fat in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``saturated fat reduced from 3 g to 1.5 
g per serving'').
    (iii) Claims described in paragraph (c)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low saturated fat.''
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains at least 25 percent less saturated fat per 
100 g of product than an appropriate reference product as described in 
Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat `product','' ``50 percent less saturated fat 
than our regular `product' ''); and
    (B) Quantitative information comparing the level of saturated fat in 
the product per specified weight with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``saturated fat content has been reduced 
from 2.5 g per 3 oz to 1.5 g per 3 oz'').
    (iii) Claims described in paragraph (c)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low saturated fat.''
    (d) Cholesterol content claims. (1) The terms ``cholesterol free,'' 
``free of cholesterol,'' ``zero cholesterol,'' ``without cholesterol,'' 
``no cholesterol,'' ``trivial source of cholesterol,'' ``negligible

[[Page 227]]

source of cholesterol,'' or ``dietarily insignificant source of 
cholesterol'' may be used on the label or in labeling of products, 
provided that:
    (i) The product contains less than 2 milligrams (mg) of cholesterol 
per reference amount customarily consumed and per labeled serving size 
or, in the case of a meal-type product as defined in Sec. 317.313(l) 
and main-dish product as defined in Sec. 317.313(m), less than 2 mg of 
cholesterol per labeled serving size;
    (ii) The product contains no ingredient that is generally understood 
by consumers to contain cholesterol, unless the listing of the 
ingredient in the ingredients statement is followed by an asterisk that 
refers to the statement below the list of ingredients, which states: 
``Adds a trivial amount of cholesterol,'' ``adds a negligible amount of 
cholesterol,'' or ``adds a dietarily insignificant amount of 
cholesterol'';
    (iii) The product contains 2 g or less of saturated fat per 
reference amount customarily consumed or, in the case of a meal-type 
product as defined in Sec. 317.313(l) and main-dish product as defined 
in Sec. 317.313(m), 2 g or less of saturated fat per labeled serving 
size; and
    (iv) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which it attaches; or
    (v) If the product meets these conditions only as a result of 
special processing, alteration, formulation, or reformulation, the 
amount of cholesterol is reduced by 25 percent or more from the 
reference product it replaces as described in Sec. 317.313(j)(1) and 
for which it substitutes as described in Sec. 317.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``cholesterol free 
`product', contains 100 percent less cholesterol than `reference 
product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``contains no cholesterol compared with 
30 mg in one serving of `reference product' '').
    (2) The terms ``low in cholesterol,'' ``low cholesterol,'' 
``contains a small amount of cholesterol,'' ``low source of 
cholesterol,'' or ``little cholesterol'' may be used on the label or in 
labeling of products, except meal-type products as defined in Sec. 
317.313(l) and main-dish products as defined in Sec. 317.313(m), 
provided that:
    (i)(A) If the product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tbsp:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed; and
    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed; or
    (B) If the product has a reference amount customarily consumed of 30 
g or less or 2 tbsp or less:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec. 317.309(f)(1), 
of all nutrients per reference amount customarily consumed, the per-50-g 
criterion refers to the ``as prepared'' form); and
    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed.
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches; or
    (iii) If the product contains 20 mg or less of cholesterol only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is reduced by 25 percent or more from the 
reference product it replaces as described in Sec. 317.313(j)(1) and

[[Page 228]]

for which it substitutes as described in Sec. 317.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``low 
cholesterol `product', contains 85 percent less cholesterol than our 
regular `product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 30 mg to 5 
mg per serving'').
    (3) The terms defined in paragraph (d)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product contains 20 mg or less of cholesterol per 100 g of 
product;
    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,'' 
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' or 
``lower in cholesterol'' may be used on the label or in labeling of 
products or products that substitute for those products as specified in 
Sec. 317.313(d), excluding meal-type products as defined in Sec. 
317.313(l) and main-dish products as defined in Sec. 317.313(m), 
provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec. 317.313(j)(1) and 
for which it substitutes as described in Sec. 317.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;
    (ii) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed; and
    (iii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25 percent 
less cholesterol than `reference product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 55 mg to 30 
mg per serving'').
    (iv) Claims described in paragraph (d)(4) of this section may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the definition for ``low cholesterol.''
    (5) The terms defined in paragraph (d)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 
provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec. 317.313(j)(1) and 
for which it substitutes as described in Sec. 317.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;
    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25% less 
cholesterol than `reference product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that

[[Page 229]]

of the reference product that it replaces is declared adjacent to the 
most prominent claim or to the nutrition information (e.g., 
``cholesterol content has been reduced from 35 mg per 3 oz to 25 mg per 
3 oz).
    (iv) Claims described in paragraph (d)(5) of this section may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the definition for ``low cholesterol.''
    (e) ``Lean'' and ``Extra Lean'' claims. (1) The term ``lean'' may be 
used on the label or in labeling of a product, provided that the product 
contains less than 10 g of fat, 4.5 g or less of saturated fat, and less 
than 95 mg of cholesterol per 100 g of product and per reference amount 
customarily consumed for individual foods, and per 100 g of product and 
per labeled serving size for meal-type products as defined in Sec. 
317.313(l) and main-dish products as defined in Sec. 317.313(m).
    (2) The term ``extra lean'' may be used on the label or in labeling 
of a product, provided that the product contains less than 5 g of fat, 
less than 2 g of saturated fat, and less than 95 mg of cholesterol per 
100 g of product and per reference amount customarily consumed for 
individual foods, and per 100 g of product and per labeled serving size 
for meal-type products as defined in Sec. 317.313(l) and main-dish 
products as defined in Sec. 317.313(m).

[60 FR 193, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]



Sec. 317.363  Nutrient content claims for ``healthy.''

    (a) The term ``healthy,'' or any other derivative of the term 
``health,'' may be used on the labeling of any meat or meat food 
product, provided that the product is labeled in accordance with Sec. 
317.309 and Sec. 317.313.
    (b)(1) The product shall meet the requirements for ``low fat'' and 
``low saturated fat,'' as defined in Sec. 317.362, except that single-
ingredient, raw products may meet the total fat and saturated fat 
criteria for ``extra lean'' in Sec. 317.362.
    (2) The product shall not contain more than 60 milligrams (mg) of 
cholesterol per reference amount customarily consumed, per labeled 
serving size, and, only for foods with reference amounts customarily 
consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50 
g, and, for dehydrated products that must be reconstituted with water or 
a diluent containing an insignificant amount, as defined in Sec. 
317.309(f)(1), of all nutrients, the per-50-g criterion refers to the 
prepared form, except that:
    (i) A main-dish product, as defined in Sec. 317.313(m), and a meal-
type product, as defined in Sec. 317.313(l), and including meal-type 
products that weigh more than 12 ounces (oz) per serving (container), 
shall not contain more than 90 mg of cholesterol per labeled serving 
size; and
    (ii) Single-ingredient, raw products may meet the cholesterol 
criterion for ``extra lean''in Sec. 317.362.
    (3) The product shall not contain more than 360 mg of sodium, except 
that it shall not contain more than 480 mg of sodium effective through 
January 1, 2006, per reference amount customarily consumed, per labeled 
serving size, and, only for foods with reference amounts customarily 
consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for 
dehydrated products that must be reconstituted with water or a diluent 
containing an insignificant amount, as defined in Sec. 317.309(f)(1), 
of all nutrients, the per-50-g criterion refers to the prepared form, 
except that:
    (i) A main-dish product, as defined in Sec. 317.313(m), and a meal-
type product, as defined in Sec. 317.313(l), and including meal-type 
products that weigh more than 12 oz per serving (container), shall not 
contain more than 480 mg of sodium, except that it shall not contain 
more than 600 mg of sodium effective through January 1, 2006, per 
labeled serving size; and
    (ii) The requirements of this paragraph (b)(3) do not apply to 
single-ingredient, raw products.
    (4) The product shall contain 10 percent or more of the Reference 
Daily Intake or Daily Reference Value as defined in Sec. 317.309 for 
vitamin A, vitamin C, iron, calcium, protein, or fiber per reference 
amount customarily consumed prior to any nutrient addition, except that:
    (i) A main-dish product, as defined in Sec. 317.313(m), and 
including main-dish

[[Page 230]]

products that weigh less than 10 oz per serving (container), shall meet 
the level for two of the nutrients per labeled serving size; and
    (ii) A meal-type product, as defined in Sec. 317.313(l), shall meet 
the level for three of the nutrients per labeled serving size.

[59 FR 24228, May 10, 1994, as amended at 60 FR 196, Jan. 3, 1995; 63 FR 
7281, Feb. 13, 1998; 64 FR 72492, Dec. 28, 1999; 68 FR 463, Jan. 6, 
2003; 69 FR 58802, Oct. 1, 2004]



Sec. Sec. 317.364-317.368  [Reserved]



Sec. 317.369  Labeling applications for nutrient content claims.

    (a) This section pertains to labeling applications for claims, 
express or implied, that characterize the level of any nutrient required 
to be on the label or in labeling of product by this subpart.
    (b) Labeling applications included in this section are:
    (1) Labeling applications for a new (heretofore unauthorized) 
nutrient content claim,
    (2) Labeling applications for a synonymous term (i.e., one that is 
consistent with a term defined by regulation) for characterizing the 
level of a nutrient, and
    (3) Labeling applications for the use of an implied claim in a brand 
name.
    (c) Labeling applications and supporting documentation to be filed 
under this section shall be submitted in quadruplicate, except that the 
supporting documentation may be submitted on a computer disc copy. If 
any part of the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
labeling application shall state the applicant's post office address.
    (d) Pertinent information will be considered as part of an 
application on the basis of specific reference to such information 
submitted to and retained in the files of the Food Safety and Inspection 
Service. However, any reference to unpublished information furnished by 
a person other than the applicant will not be considered unless use of 
such information is authorized (with the understanding that such 
information may in whole or part be subject to release to the public) in 
a written statement signed by the person who submitted it. Any reference 
to published information should be accompanied by reprints or 
photostatic copies of such references.
    (e) If nonclinical laboratory studies accompany a labeling 
application, the applicant shall include, with respect to each 
nonclinical study included with the application, either a statement that 
the study has been, or will be, conducted in compliance with the good 
laboratory practice regulations as set forth in part 58 of chapter 1, 
title 21, or, if any such study was not conducted in compliance with 
such regulations, a brief statement of the reason for the noncompliance.
    (f) If clinical investigations accompany a labeling application, the 
applicant shall include, with respect to each clinical investigation 
included with the application, either a statement that the investigation 
was conducted in compliance with the requirements for institutional 
review set forth in part 56 of chapter 1, title 21, or was not subject 
to such requirements in accordance with Sec. 56.194 or Sec. 56.105, 
and that it was conducted in compliance with the requirements for 
informed consents set forth in part 50 of chapter 1, title 21.
    (g) The availability for public disclosure of labeling applications, 
along with supporting documentation, submitted to the Agency under this 
section will be governed by the rules specified in subchapter D, title 
9.
    (h) The data specified under this section to accompany a labeling 
application shall be submitted on separate sheets, suitably identified. 
If such data has already been submitted with an earlier labeling 
application from the applicant, the present labeling application must 
provide the data.
    (i) The labeling application must be signed by the applicant or by 
his or her attorney or agent, or (if a corporation) by an authorized 
official.
    (j) The labeling application shall include a statement signed by the 
person responsible for the labeling application, that to the best of his 
or her knowledge, it is a representative and balanced submission that 
includes unfavorable information, as well as favorable information, 
known to him or her

[[Page 231]]

pertinent to the evaluation of the labeling application.
    (k)(1) Labeling applications for a new nutrient content claim shall 
be accompanied by the following data which shall be submitted in the 
following form to the Director, Food Labeling Division, Regulatory 
Programs, Food Safety and Inspection Service, Washington, DC 20250.

________________________________________________________________________
(Date)

    The undersigned, ----------, submits this labeling application 
pursuant to 9 CFR 317.369 with respect to (statement of the claim and 
its proposed use).
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement identifying the nutrient content claim and the 
nutrient that the term is intended to characterize with respect to the 
level of such nutrient. The statement shall address why the use of the 
term as proposed will not be misleading. The statement shall provide 
examples of the nutrient content claim as it will be used on labels or 
labeling, as well as the types of products on which the claim will be 
used. The statement shall also specify the level at which the nutrient 
must be present or what other conditions concerning the product must be 
met for the appropriate use of the term in labels or labeling, as well 
as any factors that would make the use of the term inappropriate.
    (ii) A detailed explanation supported by any necessary data of why 
use of the food component characterized by the claim is of importance in 
human nutrition by virtue of its presence or absence at the levels that 
such claim would describe. This explanation shall also state what 
nutritional benefit to the public will derive from use of the claim as 
proposed and why such benefit is not available through the use of 
existing terms defined by regulation. If the claim is intended for a 
specific group within the population, the analysis shall specifically 
address nutritional needs of such group, and scientific data sufficient 
for such purpose, and data and information to the extent necessary to 
demonstrate that consumers can be expected to understand the meaning of 
the term under the proposed conditions of use.
    (iii) Analytical data that demonstrates the amount of the nutrient 
that is present in the products for which the claim is intended. The 
assays should be performed on representative samples in accordance with 
317.309(h). If no USDA or AOAC methods are available, the applicant 
shall submit the assay method used, and data establishing the validity 
of the method for assaying the nutrient in the particular food. The 
validation data shall include a statistical analysis of the analytical 
and product variability.
    (iv) A detailed analysis of the potential effect of the use of the 
proposed claim on food consumption, and any corresponding changes in 
nutrient intake. The analysis shall specifically address the intake of 
nutrients that have beneficial and negative consequences in the total 
diet. If the claim is intended for a specific group within the 
population, the analysis shall specifically address the dietary 
practices of such group, and shall include data sufficient to 
demonstrate that the dietary analysis is representative of such group.

 Yours very truly,

 Applicant______________________________________________________________

 By_____________________________________________________________________
 (Indicate authority)

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
nutrient content claim is false or misleading. The notification letter 
shall inform the applicant that the applicant may submit a written 
statement by way of answer to the notification, and that the applicant 
shall have the right to request a hearing with respect to the merits or 
validity of the Administrator's decision to deny the use of the proposed 
nutrient content claim.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the

[[Page 232]]

Administrator shall file with the Hearing Clerk of the Department the 
notification, answer, and the request for a hearing, which shall 
constitute the complaint and answer in the proceeding, which shall 
thereafter be conducted in accordance with the Department's Uniform 
Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish in the Federal Register a 
proposed rule to amend the regulations to authorize the use of the 
nutrient content claim. The proposal shall also summarize the labeling 
application, including where the supporting documentation can be 
reviewed. The Administrator's proposed rule shall seek comment from 
consumers, the industry, consumer and industry groups, and other 
interested persons on the labeling application and the use of the 
proposed nutrient content claim. After public comment has been received 
and reviewed by the Agency, the Administrator shall make a determination 
on whether the proposed nutrient content claim shall be approved for use 
on the labeling of meat and meat food products.
    (i) If the claim is denied by the Administrator, the Agency shall 
notify the applicant, in writing, of the basis for the denial, including 
the reason why the claim on the labeling was determined by the Agency to 
be false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed nutrient 
content claim.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make final determination for the Secretary. Any such 
determination by the Secretary shall be conclusive unless, within 30 
days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the claim is approved, the Agency shall notify the 
applicant, in writing, and shall also publish in the Federal Register a 
final rule amending the regulations to authorize the use of the claim.
    (l)(1) Labeling applications for a synonymous term shall be 
accompanied by the following data which shall be submitted in the 
following form to the Director, Food Labeling Division, Regulatory 
Programs, Food Safety and Inspection Service, Washington, DC 20250:

________________________________________________________________________
(Date)

    The undersigned, ------------ submits this labeling application 
pursuant to 9 CFR 317.369 with respect to (statement of the synonymous 
term and its proposed use in a nutrient content claim that is consistent 
with an existing term that has been defined under subpart B of part 
317).
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement identifying the synonymous term, the existing term 
defined by a regulation with which the synonymous term

[[Page 233]]

is claimed to be consistent, and the nutrient that the term is intended 
to characterize the level of. The statement shall address why the use of 
the synonymous term as proposed will not be misleading. The statement 
shall provide examples of the nutrient content claim as it will be used 
on labels or labeling, as well as the types of products on which the 
claim will be used. The statement shall also specify whether any 
limitations not applicable to the use of the defined term are intended 
to apply to the use of the synonymous term.
    (ii) A detailed explanation supported by any necessary data of why 
use of the proposed term is requested, including whether the existing 
defined term is inadequate for the purpose of effectively characterizing 
the level of a nutrient. This explanation shall also state what 
nutritional benefit to the public will derive from use of the claim as 
proposed, and why such benefit is not available through the use of 
existing terms defined by regulation. If the claim is intended for a 
specific group within the population, the analysis shall specifically 
address nutritional needs of such group, scientific data sufficient for 
such purpose, and data and information to the extent necessary to 
demonstrate that consumers can be expected to understand the meaning of 
the term under the proposed conditions of use.

 Yours very truly,

 Applicant______________________________________________________________

 By_____________________________________________________________________
 (Indicate authority)

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
synonymous term is false or misleading. The notification letter shall 
inform the applicant that the applicant may submit a written statement 
by way of answer to the notification, and that the applicant shall have 
the right to request a hearing with respect to the merits or validity of 
the Administrator's decision to deny the use of the proposed synonymous 
term.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the claim is approved, the Agency shall notify the applicant, 
in writing, and shall publish in the Federal Register a notice informing 
the public that the synonymous term has been approved for use.
    (m)(1) Labeling applications for the use of an implied nutrient 
content claim in a brand name shall be accompanied by the following data 
which shall be submitted in the following form to the Director, Food 
Labeling Division, Regulatory Programs, Food Safety and Inspection 
Service, Washington, DC 20250:

________________________________________________________________________
(Date)

    The undersigned, ------------ submits this labeling application 
pursuant to 9 CFR 317.369 with respect to (statement of the implied 
nutrient content claim and its proposed use in a brand name).

[[Page 234]]

    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement identifying the implied nutrient content claim, the 
nutrient the claim is intended to characterize, the corresponding term 
for characterizing the level of such nutrient as defined by a 
regulation, and the brand name of which the implied claim is intended to 
be a part. The statement shall address why the use of the brand-name as 
proposed will not be misleading. The statement shall provide examples of 
the types of products on which the brand name will appear. It shall also 
include data showing that the actual level of the nutrient in the food 
would qualify the label of the product to bear the corresponding term 
defined by regulation. Assay methods used to determine the level of a 
nutrient shall meet the requirements stated under labeling application 
format in paragraph (k)(1)(iii) of this section.
    (ii) A detailed explanation supported by any necessary data of why 
use of the proposed brand name is requested. This explanation shall also 
state what nutritional benefit to the public will derive from use of the 
brand name as proposed. If the branded product is intended for a 
specific group within the population, the analysis shall specifically 
address nutritional needs of such group and scientific data sufficient 
for such purpose.

 Yours very truly,

 Applicant______________________________________________________________

 By_____________________________________________________________________

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
implied nutrient content claim is false or misleading. The notification 
letter shall inform the applicant that the applicant may submit a 
written statement by way of answer to the notification, and that the 
applicant shall have the right to request a hearing with respect to the 
merits or validity of the Administrator's decision to deny the use of 
the proposed implied nutrient content claim.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish a notice of the labeling 
application in the Federal Register seeking comment on the use of the 
implied nutrient content claim. The notice shall also summarize the 
labeling application, including where the supporting documentation can 
be reviewed. The Administrator's notice shall seek comment from 
consumers, the industry, consumer and industry groups, and other 
interested persons on the labeling application and the use of the 
implied nutrient content claim. After public comment has been received 
and reviewed by the Agency, the Administrator shall make a determination 
on whether the implied nutrient content

[[Page 235]]

claim shall be approved for use on the labeling of meat food products.
    (i) If the claim is denied by the Administrator, the Agency shall 
notify the applicant, in writing, of the basis for the denial, including 
the reason why the claim on the labeling was determined by the Agency to 
be false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed implied 
nutrient content claim.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the claim is approved, the Agency shall notify the 
applicant, in writing, and shall also publish in the Federal Register a 
notice informing the public that the implied nutrient content claim has 
been approved for use.

(Paperwork requirements were approved by the Office of Management and 
Budget under control number 0583-0088)

[58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994; 60 
FR 196, Jan. 3, 1995]



Sec. Sec. 317.370-317.379  [Reserved]



Sec. 317.380  Label statements relating to usefulness in reducing or 
maintaining body weight.

    (a) General requirements. Any product that purports to be or is 
represented for special dietary use because of usefulness in reducing 
body weight shall bear:
    (1) Nutrition labeling in conformity with Sec. 317.309 of this 
subpart, unless exempt under that section, and
    (2) A conspicuous statement of the basis upon which the product 
claims to be of special dietary usefulness.
    (b) Nonnutritive ingredients. (1) Any product subject to paragraph 
(a) of this section that achieves its special dietary usefulness by use 
of a nonnutritive ingredient (i.e., one not utilized in normal 
metabolism) shall bear on its label a statement that it contains a 
nonnutritive ingredient and the percentage by weight of the nonnutritive 
ingredient.
    (2) A special dietary product may contain a nonnutritive sweetener 
or other ingredient only if the ingredient is safe for use in the 
product under the applicable law and regulations of this chapter. Any 
product that achieves its special dietary usefulness in reducing or 
maintaining body weight through the use of a nonnutritive sweetener 
shall bear on its label the statement required by paragraph (b)(1) of 
this section, but need not state the percentage by weight of the 
nonnutritive sweetener. If a nutritive sweetener(s) as well as 
nonnutritive sweetener(s) is added, the statement shall indicate the 
presence of both types of sweetener; e.g., ``Sweetened with nutritive 
sweetener(s) and nonnutritive sweetener(s).''
    (c) ``Low calorie'' foods. A product purporting to be ``low 
calorie'' must comply with the criteria set forth for such foods in 
Sec. 317.360.
    (d) ``Reduced calorie'' foods and other comparative claims. A 
product purporting to be ``reduced calorie'' or otherwise containing 
fewer calories than a reference food must comply with the criteria set 
forth for such foods in Sec. 317.360(b) (4) and (5).
    (e) ``Label terms suggesting usefulness as low calorie or reduced 
calorie foods''. (1) Except as provided in paragraphs

[[Page 236]]

(e)(2) and (e)(3) of this section, a product may be labeled with terms 
such as ``diet,'' ``dietetic,'' ``artificially sweetened,'' or 
``sweetened with nonnutritive sweetener'' only if the claim is not false 
or misleading, and the product is labeled ``low calorie'' or ``reduced 
calorie'' or bears another comparative calorie claim in compliance with 
the applicable provisions in this subpart.
    (2) Paragraph (e)(1) of this section shall not apply to any use of 
such terms that is specifically authorized by regulation governing a 
particular food, or, unless otherwise restricted by regulation, to any 
use of the term ``diet'' that clearly shows that the product is offered 
solely for a dietary use other than regulating body weight, e.g., ``for 
low sodium diets.''
    (3) Paragraph (e)(1) of this section shall not apply to any use of 
such terms on a formulated meal replacement or other product that is 
represented to be of special dietary use as a whole meal, pending the 
issuance of a regulation governing the use of such terms on foods.
    (f) ``Sugar free'' and ``no added sugar''. Criteria for the use of 
the terms ``sugar free'' and ``no added sugar'' are provided for in 
Sec. 317.360(c).

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 
FR 47627, Sept. 10, 1993; 58 FR 66075, Dec. 17, 1993; 60 FR 196, Jan. 3, 
1995]



Sec. Sec. 317.381-317.399  [Reserved]



Sec. 317.400  Exemption from nutrition labeling.

    (a) The following meat or meat food products are exempt from 
nutrition labeling:
    (1) Food products produced by small businesses provided that the 
labels for these products bear no nutrition claims or nutrition 
information,
    (i) A food product, for the purposes of the small business 
exemption, is defined as a formulation, not including distinct flavors 
which do not significantly alter the nutritional profile, sold in any 
size package in commerce.
    (ii) For purposes of this paragraph, a small business is any single-
plant facility or multi-plant company/firm that employs 500 or fewer 
people and produces no more than the following amounts of pounds of the 
product qualifying the firm for exemption from this subpart:
    (A) During the first year of implementation of nutrition labeling, 
from July 1994 to July 1995, 250,000 pounds or less,
    (B) During the second year of implementation of nutrition labeling, 
from July 1995 to July 1996, 175,000 pounds or less, and
    (C) During the third year of implementation and subsequent years 
thereafter, 100,000 pounds or less.
    (iii) For purposes of this paragraph, calculation of the amount of 
pounds shall be based on the most recent 2-year average of business 
activity. Where firms have been in business less than 2 years or where 
products have been produced for less than 2 years, reasonable estimates 
must indicate that the annual pounds produced will not exceed the 
amounts specified.
    (2) Products intended for further processing, provided that the 
labels for these products bear no nutrition claim or nutrition 
information,
    (3) Products that are not for sale to consumers, provided that the 
labels for these products bear no nutrition claims or nutrition 
information,
    (4) Products in small packages that are individually wrapped 
packages of less than \1/2\ ounce net weight, provided that the labels 
for these products bear no nutrition claims or nutrition information,
    (5) Products custom slaughtered or prepared,
    (6) Products intended for export, and
    (7) The following products prepared and served or sold at retail 
provided that the labels or the labeling of these products bear no 
nutrition claims or nutrition information:
    (i) Ready-to-eat products that are packaged or portioned at a retail 
store or similar retail-type establishment; and
    (ii) Multi-ingredient products (e.g., sausage) processed at a retail 
store or similar retail-type establishment.
    (b) Restaurant menus generally do not constitute labeling or fall 
within the scope of these regulations.
    (c)(1) Foods represented to be specifically for infants and children 
less than

[[Page 237]]

2 years of age shall bear nutrition labeling as provided in paragraph 
(c)(2) of this section, except such labeling shall not include calories 
from fat, calories from saturated fat, saturated fat, stearic acid, 
polyunsaturated fat, monounsaturated fat, and cholesterol.
    (2) Foods represented or purported to be specifically for infants 
and children less than 4 years of age shall bear nutrition labeling 
except that:
    (i) Such labeling shall not include declarations of percent of Daily 
Value for total fat, saturated fat, cholesterol, sodium, potassium, 
total carbohydrate, and dietary fiber;
    (ii) Nutrient names and quantitative amounts by weight shall be 
presented in two separate columns;
    (iii) The heading ``Percent Daily Value'' required in Sec. 
317.309(d)(6) shall be placed immediately below the quantitative 
information by weight for protein;
    (iv) The percent of the Daily Value for protein, vitamins, and 
minerals shall be listed immediately below the heading ``Percent Daily 
Value''; and
    (v) Such labeling shall not include the footnote specified in Sec. 
317.309(d)(9).
    (d)(1) Products in packages that have a total surface area available 
to bear labeling of less than 12 square inches are exempt from nutrition 
labeling, provided that the labeling for these products bear no 
nutrition claims or other nutrition information. The manufacturer, 
packer, or distributor shall provide, on the label of packages that 
qualify for and use this exemption, an address or telephone number that 
a consumer can use to obtain the required nutrition information (e.g., 
``For nutrition information call 1-800-123-4567'').
    (2) When such products bear nutrition labeling, either voluntarily 
or because nutrition claims or other nutrition information is provided, 
all required information shall be in a type size no smaller than 6 point 
or all upper case type of \1/16\-inch minimum height, except that 
individual serving-size packages of meat products that have a total area 
available to bear labeling of 3 square inches or less may provide all 
required information in a type size no smaller than \1/32\-inch minimum 
height.

[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59 
FR 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995]



PART 318_ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION 
OF PRODUCTS--Table of Contents




                            Subpart A_General

Sec.
318.1 Products and other articles entering official establishments.
318.2 Reinspection, retention, and disposal of meat and poultry products 
          at official establishments.
318.3 Designation of places of receipt of products and other articles 
          for reinspection.
318.4 Preparation of products to be officially supervised; 
          responsibilities of official establishments; plant operated 
          quality control.
318.5 Requirements concerning procedures.
318.6 Requirements concerning ingredients and other articles used in 
          preparation of products.
318.8 Preservatives and other substances permitted in product for export 
          only; handling; such product not to be used for domestic food 
          purposes.
318.9 Samples of products, water, dyes, chemicals, etc., to be taken for 
          examination.
318.10 Prescribed treatment of pork and products containing pork to 
          destroy trichinae.
318.11 [Reserved]
318.12 Manufacture of dog food or similar uninspected article at 
          official establishments.
318.13 Mixtures containing product but not amendable to the Act.
318.14 Adulteration of product by polluted water; procedure for 
          handling.
318.15 Tagging chemicals, preservatives, cereals, spices, etc., ``U.S. 
          retained.''
318.16 Pesticide chemicals and other residues in products.
318.17 Requirements for the production of cooked beef, roast beef, and 
          cooked corned beef products.
318.18 Handling of certain material for mechanical processing.
318.19 Compliance procedure for cured pork products.
318.20 Use of animal drugs.
318.21 Accreditation of chemistry laboratories.
318.22 Determination of added water in cooked sausages.

[[Page 238]]

318.23 Heat-processing and stabilization requirements for uncured meat 
          patties.
318.24 Product prepared using advanced meat/bone separation machinery; 
          process control.

Subparts B-F [Reserved]

                  Subpart G_Canning and Canned Products

318.300 Definitions.
318.301 Containers and closures.
318.302 Thermal processing.
318.303 Critical factors and the application of the process schedule.
318.304 Operations in the thermal processing area.
318.305 Equipment and procedures for heat processing systems.
318.306 Processing and production records.
318.307 Record review and maintenance.
318.308 Deviations in processing.
318.309 Finished product inspection.
318.310 Personnel and training.
318.311 Recall procedure.

    Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53.



                            Subpart A_General

    Source: 35 FR 15586, Oct. 3, 1970, unless otherwise noted.



Sec. 318.1  Products and other articles entering official establishments.

    (a) Except as otherwise provided in paragraphs (g) and (h) of this 
section or Sec. 318.12, no product shall be brought into an official 
establishment unless it has been prepared only in an official 
establishment and previously inspected and passed by a Program employee, 
and is identified by an official inspection legend as so inspected and 
passed. Notwithstanding the foregoing provisions of this subparagraph, 
product imported in accordance with part 327 of this subchapter and not 
prepared in the United States outside an official establishment, may 
enter any official establishment subject in other respects to the same 
restrictions as apply to domestic product. Products received in an 
official establishment during the Program employees absence shall be 
identified and maintained in a manner acceptable to such employee. 
Product entering any official establishment shall not be used or 
prepared thereat until it has been reinspected in accordance with Sec. 
318.2. Any product originally prepared at any official establishment may 
not be returned into any part of such establishment, except the 
receiving area approved under Sec. 318.3, until it has been reinspected 
by the inspector.
    (b) No slaughtered poultry or poultry product shall be brought into 
an official establishment unless it has been (1) previously inspected 
and passed and is identified as such in accordance with the requirements 
of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and the 
regulations thereunder, and has not been prepared other than in an 
establishment inspected under said Act, or (2) has been inspected and 
passed and is identified as such in accordance with the requirements of 
a State law.
    (c) Every article for use as an ingredient in the preparation of 
meat food products, when entering any official establishment and at all 
times while it is in such establishment, shall bear a label showing the 
name of the article, the amount or percentage therein of any substances 
restricted by this part or part 317 of this subchapter, and a list of 
ingredients in the article if composed of two or more ingredients: 
Provided, That in the case of articles received in tank car lots, only 
one such label shall be used to identify each lot. In addition, the 
label must show the name and address of the shipper.
    (d) To ensure the safe use of preparations used in hog scalding 
water or in the denuding of tripe, the label or labeling on containers 
of such preparations shall bear adequate directions to ensure use in 
compliance with any limitations prescribed in 21 CFR Chapter I, 
Subchapter A or Subchapter B, or 9 CFR Chapter III, Subchapter A or 
Subchapter E.
    (e) Dyes, chemicals, or other substances the use of which is 
restricted to certain products may be brought into or kept in an 
official establishment only if such products are prepared thereat. No 
prohibited dye, chemical, preservative, or other substance shall be 
brought into or kept in an official establishment.
    (f) [Reserved]
    (g) Glands and organs, such as cotyledons, ovaries, prostate glands,

[[Page 239]]

tonsils, spinal cords, and detached lymphatic, pineal, pituitary, 
parathyroid, suprarenal, pancreatic and thyroid glands, used in 
preparing pharmaceutical, organotherapeutic, or technical products and 
which are not used as human food (whether or not prepared at official 
establishments) may be brought into and stored in edible product 
departments of inspected establishments if packaged in suitable 
containers so that the presence of such glands and organ will in no way 
interfere with the maintenance of sanitary conditions or constitute an 
interference with inspection. Glands or organs which are regarded as 
human food products, such as livers, testicles, and thymus glands, may 
be brought into official establishments for pharmaceutical, 
organotherapeutic or technical purposes, only if U.S. inspected and 
passed and so identified. Lungs and lung lobes derived from livestock 
slaughtered in any establishment may not be brought into any official 
establishment except as provided in Sec. 318.12(a).
    (h)(1) Carcasses of game animals, and carcasses derived from the 
slaughter by any person of livestock of his own raising in accordance 
with the exemption provisions of paragraph 23(a) of the Act, and parts 
of such carcasses, may be brought into an official establishment for 
preparation, packaging, and storing in accordance with the provisions of 
Sec. 303.1(a)(2) of this subchapter.
    (2) Meat, meat byproducts, and meat food products bearing official 
marks showing that they were inspected and passed under State inspection 
in any State not designated in Sec. 331.2 of this subchapter may be 
received by official establishments for storage and distribution solely 
in intrastate commerce. The presence of such State inspected products 
must not create any unsanitary condition or otherwise result in 
adulteration of any products at the official establishment or interfere 
with the conduct of inspection under this subchapter. In addition, such 
State inspected products must be stored separately and apart from the 
federally inspected products in the official establishment.
    (i) The operator of the official establishment shall furnish such 
information as is necessary to determine the origin of any product or 
other article entering the official establishment. Such information 
shall include, but is not limited to, the name and address of the seller 
or supplier, transportation company, agent, or broker involved in the 
sale or delivery of the product or article in question.
    (j) Any product or any poultry or poultry product or other article 
that is brought into an official establishment contrary to any provision 
of this section may be required by the Administrator to be removed 
immediately from such establishment by the operator thereof, and failure 
to comply with such requirement shall be deemed a violation of this 
regulation. If any slaughtered poultry or poultry products or other 
articles are received at an official establishment and are suspected of 
being adulterated or misbranded under the Poultry Products Inspection 
Act or the Federal Food, Drug, and Cosmetic Act, or applicable State 
laws, the appropriate governmental authorities will be notified.

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 38 
FR 5152, Feb. 26, 1973; 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10, 
1984; 64 FR 72174, Dec. 23, 1999]



Sec. 318.2  Reinspection, retention, and disposal of meat and poultry 
products at official establishments.

    (a) All products and all slaughtered poultry and poultry products 
brought into any official establishment shall be identified by the 
operator of the official establishment at the time of receipt at the 
official establishment and shall be subject to reinspection by a Program 
employee at the official establishment in such manner and at such times 
as may be deemed necessary to assure compliance with the regulations in 
this subchapter.
    (b) All products, whether fresh, cured, or otherwise prepared, even 
though previously inspected and passed, shall be reinspected by Program 
employees as often as they may deem necessary in order to ascertain that 
they are not adulterated or misbranded at the time they enter or leave 
official establishments and that the requirements of the regulations in 
this subchapter are complied with.

[[Page 240]]

    (c) Reinspection may be accomplished through use of statistically 
sound sampling plans that assure a high level of confidence. The circuit 
supervisor shall designate the type of plan and the program employee 
shall select the specific plan to be used in accordance with 
instructions issued by the Administrator. \1\
---------------------------------------------------------------------------

    \1\ Further information concerning sampling plans which have been 
adopted for specific products may be obtained from the Circuit 
Supervisors of Program circuits. These sampling plans are developed for 
individual products by the Washington staff and will be distributed for 
field use as they are developed. The type of plan applicable depends on 
factors such as whether the product is in containers, stage of 
preparation, and procedures followed by the establishment operator. The 
specific plan applicable depends on the kind of product involved, such 
as liver, oxtails, etc.
---------------------------------------------------------------------------

    (d) A U.S. retained tag shall be placed by a Program employee at the 
time of reinspection at any official establishment on all products which 
are suspected on such reinspection of being adulterated or misbranded, 
and such products shall be held for further inspection. Such tags shall 
be removed only by authorized Program employees. When further inspection 
is made, if the product is found to be adulterated, all official 
inspection legends or other official marks for which the product is 
found to be ineligible under the regulations in this subchapter, shall 
be removed or defaced and the product will be subject to condemnation 
and disposal in accordance with part 314 of this subchapter, except that 
a determination regarding adulteration may be deferred if a product has 
become soiled or unclean by falling on the floor or in any other 
accidental way or if the product is affected with any other condition 
which the inspector deems capable of correction, in which case the 
product shall be cleaned (including trimming if necessary) or otherwise 
handled in a manner approved by the inspector to assure that it will not 
be adulterated or misbranded and shall then be presented for 
reinspection and disposal in accordance with this section. If upon final 
inspection, the product is found to be neither adulterated nor 
misbranded, the inspector shall remove the U.S. retained tag. If a 
product is found upon reinspection to be misbranded, it shall be held 
under a U.S. retained tag, or a U.S. detention tag as provided in part 
329 of this subchapter, pending correction of the misbranding or 
issuance of an order under section 7 of the Act to withhold from use the 
labeling or container of the product, or the institution of a judicial 
seizure action under section 403 of Act or other appropriate action. The 
inspector shall make a complete record of each transaction under this 
paragraph and shall report his action to the area supervisor.

[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]



Sec. 318.3  Designation of places of receipt of products and other 
articles for reinspection.

    Every official establishment shall designate, with the approval of 
the circuit supervisor, a dock or place at which products and other 
articles subject to reinspection under Sec. 318.2 shall be received, 
and such products and articles shall be received only at such dock or 
place.



Sec. 318.4  Preparation of products to be officially supervised; 
responsibilities of official establishments; plant operated quality control.

    (a) All processes used in curing, pickling, rendering, canning, or 
otherwise preparing any product in official establishments shall be 
supervised by Program employees unless such preparation is conducted as 
a custom operation exempted from inspection under Sec. 303.1(a)(2) of 
this subchapter in any official establishment or consists of operations 
that are exempted from inspection under Sec. 303.1(d) of this 
subchapter and are conducted in a retail store in an establishment 
subject to inspection only because the State or Territory in which the 
establishment is located is designated under paragraph 301(c) of the 
Act. No fixtures or appliances, such as tables, trucks, trays, tanks, 
vats, machines, implements, cans, or containers of any kind, shall be 
used unless they are of such materials and construction as will not 
contaminate or otherwise adulterate the product and are clean and 
sanitary. All steps in the preparation of edible products shall be

[[Page 241]]

conducted carefully and with strict cleanliness in rooms or compartments 
separate from those used for inedible products.
    (b) It shall be the responsibility of the operator of every official 
establishment to comply with the Act and the regulations in this 
subchapter. In order to carry out this responsibility effectively, the 
operator of the establishment shall institute appropriate measures to 
assure the maintenance of the establishment and the preparation, 
marking, labeling, packaging and other handling of its products strictly 
in accordance with the sanitary and other requirements of this 
subchapter. The effectiveness of such measures will be subject to review 
by the Department.
    (c) Applying for Total Plant Quality Control. Any owner or operator 
of an official establishment preparing meat food product who has a total 
plant quality control system or plan for controlling such product, after 
ante-mortem and post-mortem inspection, through all stages of 
preparation, may request the Administrator to evaluate it to determine 
whether or not that system is adequate to result in product being in 
compliance with the requirements of the Act and therefore qualify as a 
U.S. Department of Agriculture (USDA) Total Plant Quality Control 
Establishment. Such a request shall, as a minimum, include:
    (1) A letter to the Administrator from the establishment owner of 
operator stating the company's basis and purpose for seeking an approved 
quality control system and willingness to adhere to the requirements of 
the system as approved by the Department; that all the establishment's 
data, analyses, and information generated by its quality control system 
will be maintained to enable the Department to monitor compliance and 
available to Department personnel; that plant quality control personnel 
will have authority to halt production or shipping of product in cases 
where the submitted quality control system requires it; and that the 
owner or operator (or his/her designee) will be available for 
consultation at any time Department personnel consider it necessary.
    (2) In the case of an establishment having one or more full-time 
persons whose primary duties are related to the quality control system, 
an organizational chart showing that such people ultimately report to an 
establishment official whose quality control responsibilities are 
independent of or not predominantly production responsibilities. In the 
case of an establishment which does not have full-time quality control 
personnel, information indicating the nature of the duties and 
responsibilities of the person who will be responsible for the quality 
control system.
    (3) A list identifying those parts and sections of the Federal meat 
inspection regulations which are applicable to the operations of the 
establishment applying for approval of a quality control system. This 
list shall also identify which part of the quality control system will 
serve to maintain compliance with the applicable regulations.
    (4) Detailed information concerning the manner in which the system 
will function. Such information should include, but not necessarily be 
limited to, questions of raw material control, the critical check or 
control points, the nature and frequency of tests to be made, the nature 
of charts and other records that will be used, the length of time such 
charts and records will be maintained in the custody of the official 
establishment, the nature of deficiencies the quality control system is 
designed to identify and control, the parameters or limits which will be 
used, and the points at which corrective action will occur and the 
nature of such corrective action--ranging from least to most severe: 
Provided, That, subsequent to approval of the total plant quality 
control system by the Administrator, the official establishment may 
produce a new product for test marketing provided labeling for the 
product has been approved by the Administrator, the inspector in charge 
has determined that the procedures for preparing the product will assure 
that all Federal requirements are met, and the production for test 
marketing does not exceed 6 months. Such new product shall not be 
produced at that establishment after the 6-month period unless approval 
of the quality control system for that product has been received from 
the Administrator.

[[Page 242]]

    (d) [Reserved]
    (e) Evaluation and Approval of Total Plant Quality Control. (1) The 
Administrator shall evaluate the material presented in accordance with 
the provisions of paragraph (c) of this section. If it is determined by 
the Administrator, on the basis of the evaluation, that the total 
quality control system will result in finished products controlled in 
this manner being in full compliance with the requirements of the Act 
and regulations thereunder, the total quality control system will be 
approved and plans will be made for implementation under departmental 
supervision.
    (2) In any situation where the system is found by the Administrator 
to be unacceptable, formal notification shall be given to the applicant 
of the basis for the denial. The applicant will be afforded an 
opportunity to modify the system in accordance with the notification. 
The applicant shall also be afforded an opportunity to submit a written 
statement in response to this notification of denial and a right to 
request a hearing with respect to the merits or validity of the denial. 
If the applicant requests a hearing and the Administrator, after review 
of the answer, determines the initial determination to be correct, he 
shall file with the Hearing Clerk of the Department the notification, 
answer and the request for hearing, which shall constitute the complaint 
and answer in the proceeding, which shall thereafter be conducted in 
accordance with Rules of Practice which shall be adopted for this 
proceeding.
    (3) The establishment owner or operator shall be responsible for the 
effective operation of the approved total plant quality control system 
to assure compliance with the requirements of the Act and regulations 
thereunder. The Secretary shall continue to provide the Federal 
inspection necessary to carry out his responsibilities under the Act.
    (f) Labeling Logo. Owners and operators of official establishments 
having a total plant quality control system approved under the 
provisions of paragraph (c) of this section, may only use, as a part of 
any labeling, the following logo. Any labeling bearing the logo and any 
wording of explanation with respect to this logo shall be approved as 
required by parts 316 and 317 of this subchapter.
[GRAPHIC] [TIFF OMITTED] TC11SE91.015

    (g) Termination of Total Plant Quality Control. (1) The approval of 
a total plant quality control system may be terminated at any time by 
the owner or operator of the official establishment upon written notice 
to the Administrator.
    (2) The approval of a total plant quality control system may be 
terminated upon the establishment's receipt of a written notice from the 
Administrator under the following conditions:
    (i) If adulterated or misbranded meat food product is found by the 
Administrator to have been prepared for or distributed in commerce by 
the subject establishment. In such case, opportunity will be provided to 
the establishment owner or operator to present views to the 
Administrator within 30 days of the date of terminating the approval. In 
those instances where there is conflict of facts, a hearing, under 
applicable Rules of Practice, will be provided to the establishment 
owner or operator to resolve the conflict. The Administrator's 
termination of approval shall remain in effect pending the final 
determination of the proceeding.
    (ii) If the establishment fails to comply with the quality control 
system or program to which it has agreed after being notified by letter 
from the Administrator or his designee. Prior to such termination, 
opportunity will be provided to the establishment owner or

[[Page 243]]

operator to present views to the Administrator within 30 days of the 
date of the letter. In those instances where there is a conflict of 
facts, a hearing, under applicable Rules of Practice, will be provided 
to the establishment owner or operator to resolve the conflict. The 
Administrator's termination of quality control approval shall remain in 
effect pending the final determination of the proceeding.
    (3) If approval of the total establishment quality control system 
has been terminated in accordance with the provisions of this section, 
an application and request for approval of the same or a modified total 
establishment quality control system will not be evaluated by the 
Administrator for at least 6 months from the termination date.
    (h)(1) Operating Schedule Under Total Plant Quality Control. An 
official establishment with an approved total plant quality control 
system may request approval for an operating schedule of up to 12 
consecutive hours per shift. Permission will be granted provided that:
    (i) The official establishment has satisfactorily operated under a 
total plant quality control system for at least 1 year.
    (ii) All products prepared and packaged, or processed after the end 
of 8 hours of inspection shall only be a continuation of the processing 
monitored by the inspector and being conducted during the last hour of 
inspection.
    (iii) All immediate containers of products prepared and packaged 
shall bear code marks that are unique to any period of production beyond 
the 8 hours of inspection. The form of such code marks will remain 
constant from day to day, and a facsimile of the code marks and their 
meaning shall be provided to the inspector.
    (2) Application. Applications shall be submitted to the Regional 
Director and shall specify how the conditions in Sec. 318.4(h)(1) have 
been or will be met.
    (3) Monitoring by Inspectors. In order to verify that an 
establishment is preparing and shipping product in accordance with the 
approved total plant quality control system and the Act and regulations 
after the 8 hours of inspection, the official establishment may be 
provided overtime inspection services at the discretion of the circuit 
supervisor and charged for such services.

(Reporting requirements were approved by the Office of Management and 
Budget under control number 0583-0015)

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45 
FR 54322, Aug. 15, 1980; 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug. 
25, 1997; 62 FR 54759, Oct. 22, 1997; 65 FR 34389, May 30, 2000]



Sec. 318.5  Requirements concerning procedures.

    (a)(1) Care shall be taken to assure that product is not adulterated 
when placed in freezers. If there is doubt as to the soundness of any 
frozen product, the inspector will require the defrosting and 
reinspection of a sufficient quantity thereof to determine its actual 
condition.
    (2) Frozen product may be defrosted in water or pickle in a manner 
and with the use of facilities which are acceptable to the inspector. 
Before such product is defrosted, a careful examination shall be made to 
determine its condition. If necessary, this examination shall include 
defrosting of representative samples by means other than in water or 
pickle.
    (b) Product, such as pork tenderloins, brains, sweetbreads, stew, or 
chop suey, shall not be packed in hermetically sealed metal or glass 
containers, unless subsequently heat processed or otherwise treated to 
preserve the product in a manner approved by the Administrator in 
specific cases.
    (c) Care shall be taken to remove bones and parts of bones from 
product which is intended for chopping.
    (d) Heads for use in the preparation of meat food products shall be 
split and the bodies of the teeth, the turbinated and ethmoid bones, ear 
tubes, and horn butts removed, and the heads then thoroughly cleaned.
    (e) Kidneys for use in the preparation of meat food products shall 
first be freely sectioned and then thoroughly soaked and washed. All 
detached kidneys, including beef kidneys with detached kidney fat, shall 
be inspected before being used in or shipped from the official 
establishment.
    (f) Cattle paunches and hog stomachs for use in the preparation of 
meat food products shall be thoroughly cleaned

[[Page 244]]

on all surfaces and parts immediately after being emptied of their 
contents, which shall follow promptly their removal from the carcasses.
    (g) Clotted blood shall be removed from hog hearts before they are 
shipped from the official establishment or used in the preparation of 
meat food products.
    (h) Beef rounds, beef bungs, beef middles, beef bladders, calf 
rounds, hog bungs, hog middles, and hog stomachs which are to be used as 
containers of any meat food product shall be presented for inspection, 
turned with the fat surface exposed.
    (i) Portions of casings which show infection with Oesophagostomum or 
other nodule-producing parasite, and weasands infected with the larvae 
of Hypoderma lineatum, shall be rejected, except that when the 
infestation is slight and the nodules and larvae are removed, the casing 
or weasand may be passed.

[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]



Sec. 318.6  Requirements concerning ingredients and other articles used 
in preparation of products.

    (a) All ingredients and other articles used in the preparation of 
any product shall be clean, sound, healthful, wholesome, and otherwise 
such as will not result in the product being adulterated. Official 
establishments shall furnish inspectors accurate information on all 
procedures involved in product preparation including product composition 
and any changes in such procedures essential for inspectional control of 
the product.
    (b)(1) The only animal casings that may be used as containers of 
product are those from sheep, swine, or goats. Casings from cattle may 
be used as containers of products. However, if casings from cattle are 
derived from the small intestine, the small intestine must comply with 
the requirements in 9 CFR 310.22(a)(3). Establishments that use casings 
derived from the small intestine of cattle as containers for products 
must demonstrate, through documentation, that the small intestine from 
which the casing was derived complies with the requirements in 9 CFR 
310.22(a)(3).
    (2) Casings for products shall be carefully inspected by Program 
employees. Only those casings which have been carefully washed and 
thoroughly flushed with clean water immediately before stuffing and are 
suitable for containers, are clean, and are passed on such inspection 
shall be used, except that preflushed animal casings packed in salt or 
salt and glycerine solution or other approved medium may be used without 
additional flushing provided they are found to be clean and otherwise 
acceptable and are thoroughly rinsed before use.
    (3) Hog and sheep casings intended for use as containers of product 
may be treated by soaking in or applying thereto sound, fresh pineapple 
juice or papain or bromelin or pancreatic extract to permit the enzymes 
contained in these substances to act on the casings to make them less 
resistant. The casings shall be handled in a clean and sanitary manner 
throughout and the treatment shall be followed by washing and flushing 
the casings with water sufficiently to effectively remove the substance 
used and terminate the enzymatic action.
    (4) On account of the invariable presence of bone splinters, 
detached spinal cords shall not be used in the preparation of edible 
product other than for rendering where they constitute a suitable raw 
material. Detached spinal cords from cattle 30 months of age and older 
shall not be used as raw materials for edible rendering.
    (5) Testicles if handled as an edible product may be shipped from 
the official establishment as such, but they shall not be used as an 
ingredient of a meat food product.
    (6) Tonsils shall be removed and shall not be used as ingredients of 
meat food products.
    (7) Blood from livestock prepared in accordance with Sec. 310.20 of 
this subchapter may be used as an ingredient of a meat food product for 
which a standard is prescribed in part 319 of this subchapter, if 
permitted by such standard, and may be used in any meat food product for 
which no such standard is prescribed in part 319 of this subchapter if 
it is a common and usual ingredient of such product.

[[Page 245]]

    (8) Intestines shall not be used as ingredients in any meat food 
product for which a standard is prescribed in part 319 of this 
subchapter and shall not be used in other products unless the products 
are labeled in accordance with Sec. 317.8(b)(3) of this subchapter. 
When small intestine from cattle is used in a meat food product or for 
edible rendering, it must comply with the requirements in 9 CFR 
310.22(a)(3).
    (9) Poultry products and egg products (other than shell eggs) which 
are intended for use as ingredients of meat food products shall be 
considered acceptable for such use only when identified as having been 
inspected and passed for wholesomeness by the Department under the 
regulations in 7 CFR part 59 or 9 CFR part 362 or 381 and when found to 
be sound and otherwise acceptable when presented for use. Poultry 
products and egg products (other than shell eggs) which have not been so 
inspected and passed for wholesomeness shall not be used in the 
preparation of such meat food products.
    (10) Dry milk products which are intended for use as ingredients of 
meat food products shall be considered acceptable for such use only when 
produced in a plant approved by the Department under the regulations in 
7 CFR part 58, and when found to be sound and otherwise acceptable when 
presented for use. Dry milk products prepared in a plant not so approved 
shall not be used in the preparation of such meat food products.
    (11) [Reserved]
    (12) Ingredients for use in any product may not bear or contain any 
pesticide chemical or other residues in excess of level permitted in 
Sec. 318.16.
    (13) Use of ``Mechanically Separated (Kind of Poultry),'' as defined 
in Sec. 381.173 of this chapter, in the preparation of meat food 
products shall accord with Sec. 381.174 and all other applicable 
provisions of this subchapter.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 14368, June 1, 1973; 38 
FR 29214, Oct. 23, 1973; 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June 
11, 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, 1985; 60 FR 55982, 
Nov. 3, 1995; 69 FR 1874, Jan. 12, 2004; 70 FR 53050, Sept. 7, 2005]



Sec. 318.8  Preservatives and other substances permitted in product 
for export only; handling; such product not to be used for domestic food purposes.

    (a) Preservatives and other substances not permitted in domestic 
product under the regulations in this subchapter may be used in the 
preparation and packing of product intended for export provided the 
product (1) accords to the specifications or directions of the foreign 
purchaser; (2) is not in conflict with the laws of the country to which 
it is intended for export; and (3) is labeled on the outside container 
to show that it is intended for export, and is otherwise labeled as 
required by this subchapter for such export product.
    (b) The preparation and packing of export product as provided for in 
paragraph (a) of this section shall be done in a manner acceptable to 
the inspector in charge so that the identity of the export product is 
maintained conclusively and the preparation of domestic product is 
adequately protected. The preservatives and other substances not 
permitted in domestic product shall be stored in a room or compartment 
separate from areas used to store other supplies and shall be held under 
Program lock. Use of the preservatives or other substances shall be 
under the direct supervision of a Program employee.
    (c) The packing of all articles under paragraph (a) of this section 
shall be conducted under the direct supervision of a Program employee.
    (d) No article prepared or packed for export under paragraph (a) of 
this section shall be sold or offered for sale for domestic use or 
consumption, but unless exported shall be destroyed for food purposes 
under the direct supervision of a Program employee.
    (e) The contents of the container of any article prepared or packed 
for export under paragraph (a) of this section shall not be removed, in 
whole or in part, from such container prior to exportation, except under 
the supervision of a Program employee. If such contents are removed 
prior to exportation, then the article shall be either repacked, in 
accordance with the provisions of paragraphs (b) and (c) of this

[[Page 246]]

section, or destroyed for food purposes under the direct supervision of 
a Program employee.
    (f) Permission must be obtained from the Administrator before meats 
packed in borax are shipped from one official establishment to another 
or to an unofficial establishment for storage, except such meat prepared 
for the account of Federal agencies.
    (g) At all times, the identity of meat to which borax has been added 
shall be effectively maintained. In no case shall such meat, nor any 
trimmings or fat derived from such meat, whether unwashed or washed, or 
otherwise treated, be diverted to domestic use.
    (h) Salt used for bulking meat previously packed in borax may not 
again be used in an edible products department other than in connection 
with the packing of meat in borax. Only metal equipment should be used 
for handling such meat. Particularly effective cleansing will be 
required if wooden equipment such as trucks, washing vats, etc., is 
used. Boxes from which boraxed meat has been removed may be used for 
repacking meat in borax, but their use as containers for other meat will 
be dependent upon the effective removal of all traces of borax.
    (i) The following instructions pertain to export cured pork packed 
in borax for the account of Federal agencies. The meat may be packed in 
borax in a room in which there is borax-free meat, provided proper care 
is taken to see that the borax-free meat is not affected by the borax. 
Under the same condition, meat packed in borax may be received, 
unpacked, defrosted, soaked, washed, smoked, and repacked in a room 
where there is other meat. However, meat originally packed in borax 
shall at all times be subject to the restrictions of meat so packed, 
even though repacked without borax. After packing or repacking, borax 
packed meat may be stored in a room with meat not packed in borax, 
provided a reasonable degree of separation is maintained between the two 
classes of product.

[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 38 
FR 29214, Oct. 23, 1973]



Sec. 318.9  Samples of products, water, dyes, chemicals, etc., to be 
taken for examination.

    Samples of products, water, dyes, chemicals, preservatives, spices, 
or other articles in any official establishment shall be taken, without 
cost to the Program, for examination, as often as may be deemed 
necessary for the efficient conduct of the inspection.



Sec. 318.10  Prescribed treatment of pork and products containing pork 
to destroy trichinae.

    (a)(1) All forms of fresh pork, including fresh unsmoked sausage 
containing pork muscle tissue, and pork such as bacon and jowls, other 
than those covered by paragraph (b) of this section, are classed as 
products that are customarily well cooked in the home or elsewhere 
before being served to the consumer. Therefore, the treatment of such 
products for the destruction of trichinae is not required.
    (2) Pork from carcasses or carcass parts that have been found free 
of trichinae as described under paragraph (e) or (f) of this section is 
not required to be treated for the destruction of trichinae.
    (b) Products named in this paragraph, and products of the character 
hereof, containing pork muscle tissue (not including pork hearts, pork 
stomachs, and pork livers), or the pork muscle tissue which forms an 
ingredient of such products, shall be effectively heated, refrigerated, 
or cured to destroy any possible live trichinae, as prescribed in this 
section at the official establishment where such products are prepared: 
Bologna, frankfurter, vienna, and other cooked sausage; smoked sausage; 
knoblauch sausage; mortadella; all forms of summer or dried sausage, 
including mettwurst; flavored pork sausages such as those containing 
wine or similar flavoring materials; cured pork sausage; sausage 
containing cured and/or smoked pork; cooked loaves; roasted, baked, 
boiled, or cooked hams, pork shoulders, or pork shoulder picnics; 
Italian-style hams; Westphalia-style hams; smoked boneless pork shoulder 
butts; cured meat rolls; capocollo (capicola, capacola); coppa; fresh or 
cured boneless pork shoulder butts, hams, loins, shoulders, shoulder

[[Page 247]]

picnics, and similar pork cuts, in casings or other containers in which 
ready-to-eat delicatessen articles are customarily enclosed (excepting 
Scotch-style hams); breaded pork products; cured boneless pork loins; 
boneless back bacon; bacon used for wrapping around patties, steaks and 
similar products; and smoked pork cuts such as hams, shoulders, loins, 
and pork shoulder picnics (excepting smoked hams, and smoked pork 
shoulder picnics which are specially prepared for distribution in 
tropical climates or smoked hams delivered to the Armed Services); 
ground meat mixtures containing pork and beef, veal, lamb, mutton, or 
goat meat and other product consisting of mixtures of pork and other 
ingredients, which the Administrator determines at the time the labeling 
for the product is submitted for approval in accordance with part 317 of 
the regulations in this subchapter or upon subsequent reevaluation of 
the product, would be prepared in such a manner that the product might 
be eaten rare or without thorough cooking because of the appearance of 
the finished product or otherwise. Cured boneless pork loins shall be 
subjected to prescribed treatment for destruction of trichinae prior to 
being shipped from the establishment where cured.
    (c) The treatment shall consist of heating, refrigerating, or 
curing, as follows:
    (1) Heating. (i) All parts of the pork muscle tissue shall be heated 
according to one of the time and temperature combinations in the 
following table:

------------------------------------------------------------------------
           Minimum internal temperature
--------------------------------------------------
                                         Degrees        Minimum time
          Degrees fahrenheit           centigrade
------------------------------------------------------------------------
120..................................       49.0   21 hours.
122..................................       50.0   9.5 hours.
124..................................       51.1   4.5 hours.
126..................................       52.2   2 hours.
128..................................       53.4   1 hour.
130..................................       54.5   30 minutes.
132..................................       55.6   15 minutes.
134..................................       56.7   6 minutes.
136..................................       57.8   3 minutes.
138..................................       58.9   2 minutes.
140..................................       60.0   1 minute.
142..................................       61.1   1 minute.
144..................................       62.2   Instant.
------------------------------------------------------------------------

    (ii) Time and temperature shall be monitored by a calibrated 
recording instrument that meets the requirements of paragraph (d) of 
this section, except for paragraph (c)(1)(iv).
    (iii) The time to raise product temperature from 60 [deg]F. to 120 
[deg]F shall not exceed 2 hours unless the product is cured or 
fermented.
    (iv) Time, in combination with temperatures of 138 [deg]F to 143 
[deg]F, need not be monitored if the product's minimum thickness exceeds 
2 inches (5.1 cm) and refrigeration of the product does not begin within 
5 minutes of attaining 138 [deg]F (58.9 [deg]C).
    (v) The establishment shall use procedures which insure the proper 
heating of all parts of the product. It is important that each piece of 
sausage, each ham, and other product treated by heating in water be kept 
entirely submerged throughout the heating period; and that the largest 
pieces in a lot, the innermost links of bunched sausage or other massed 
articles, and pieces placed in the coolest part of a heating cabinet or 
compartment or vat be included in the temperature tests.
    (2) Refrigerating. At any stage of preparation and after preparatory 
chilling to a temperature of not above 40 [deg]F. or preparatory 
freezing, all parts of the muscle tissue of pork or product containing 
such tissue shall be subjected continuously to a temperature not higher 
than one of those specified in table 1, the duration of such 
refrigeration at the specified temperature being dependent on the 
thickness of the meat or inside dimensions of the container.

      Table 1--Required Period of Freezing at Temperature Indicated
------------------------------------------------------------------------
   Temperature [deg]F.        Group 1 (Days)          Group 2 (Days)
------------------------------------------------------------------------
                5                       20                      30
              -10                       10                      20
              -20                        6                      12
------------------------------------------------------------------------

    (i) Group 1 comprises product in separate pieces not exceeding 6 
inches in thickness, or arranged on separate racks with the layers not 
exceeding 6 inches in depth, or stored in crates or boxes not exceeding 
6 inches in depth, or stored as solidly frozen blocks not exceeding 6 
inches in thickness.
    (ii) Group 2 comprises product in pieces, layers, or within 
containers, the

[[Page 248]]

thickness of which exceeds 6 inches but not 27 inches, and product in 
containers including tierces, barrels, kegs, and cartons having a 
thickness not exceeding 27 inches.
    (iii) The product undergoing such refrigeration or the containers 
thereof shall be so spaced while in the freezer as will insure a free 
circulation of air between the pieces of meat, layers, blocks, boxes, 
barrels, and tierces in order that the temperature of the meat 
throughout will be promptly reduced to not higher than 5 [deg]F., -10 
[deg]F., or -20 [deg]F., as the case may be.
    (iv) In lieu of the methods prescribed in Table 1, the treatment may 
consist of commercial freeze drying or controlled freezing, at the 
center of the meat pieces, in accordance with the times and temperatures 
specified in Table 2.

    Table 2--Alternate Periods of Freezing at Temperatures Indicated
------------------------------------------------------------------------
           Maximum internal temperature
--------------------------------------------------
                                         Degrees        Minimum Time
          Degrees Fahrenheit           centigrade
------------------------------------------------------------------------
 0...................................       -17.8  106 hours.
-5...................................       -20.6  82 hours.
-10..................................       -23.3  63 hours.
-15..................................       -26.1  48 hours.
-20..................................       -28.9  35 hours.
-25..................................       -31.7  22 hours.
-30..................................       -34.5  8 hours.
-35..................................       -37.2  \1/2\ hour.
------------------------------------------------------------------------

    (v) During the period of refrigeration the product shall be kept 
separate from other products and in the custody of the Program in rooms 
or compartments equipped and made secure with an official Program lock 
or seal. The rooms or compartments containing product undergoing 
freezing shall be equipped with accurate thermometers placed at or above 
the highest level at which the product undergoing treatment is stored 
and away from refrigerating coils. After completion of the prescribed 
freezing of pork to be used in the preparation of product covered by 
paragraph (b) of this section the pork shall be kept under close 
supervision of an inspector until it is prepared in finished form as one 
of the products enumerated in paragraph (b) of this section or until it 
is transferred under Program control to another official establishment 
for preparation in such finished form.
    (vi) Pork which has been refrigerated as specified in this 
subparagraph may be transferred in sealed railroad cars, sealed 
motortrucks, sealed trailers, or sealed closed containers to another 
official establishment at the same or another location, for use in the 
preparation of product covered by paragraph (b) of this section. Such 
vehicles and containers shall be sealed and transported between official 
establishments in accordance with Sec. 325.7 of this subchapter.
    (3) Curing--(i) Sausage. The sausage may be stuffed in animal 
casings, hydrocellulose casings, or cloth bags. During any stage of 
treating the sausage for the destruction of live trichinae, except as 
provided in Method 5, these coverings shall not be coated with paraffin 
or like substance, nor shall any sausage be washed during any prescribed 
period of drying. In the preparation of sausage, one of the following 
methods may be used:

    Method No. 1. The meat shall be ground or chopped into pieces not 
exceeding three-fourths of an inch in diameter. A dry-curing mixture 
containing not less than 3\1/3\ pounds of salt to each hundredweight of 
the unstuffed sausage shall be thoroughly mixed with the ground or 
chopped meat. After being stuffed, sausage having a diameter not 
exceeding 3\1/2\ inches, measured at the time of stuffing, shall be held 
in a drying room not less than 20 days at a temperature not lower than 
45 [deg]F., except that in sausage of the variety known as pepperoni, if 
in casings not exceeding 1\3/8\ inches in diameter measured at the time 
of stuffing, the period of drying may be reduced to 15 days. In no case, 
however, shall the sausage be released from the drying room in less than 
25 days from the time the curing materials are added, except that 
sausage of the variety known as pepperoni, if in casings not exceeding 
the size specified, may be released at the expiration of 20 days from 
the time the curing materials are added. Sausage in casings exceeding 
3\1/2\ inches, but not exceeding 4 inches, in diameter at the time of 
stuffing, shall be held in a drying room not less than 35 days at a 
temperature not lower than 45 [deg]F., and in no case shall the sausage 
be released from the drying room in less than 40 days from the time the 
curing materials are added to the meat.
    Method No. 2. The meat shall be ground or chopped into pieces not 
exceeding three-fourths of an inch in diameter. A dry-curing mixture 
containing not less than 3\1/3\ pounds

[[Page 249]]

of salt to each hundredweight of the unstuffed sausage shall be 
thoroughly mixed with the ground or chopped meat. After being stuffed, 
sausage having a diameter not exceeding 3\1/2\ inches, measured at the 
time of stuffing, shall be smoked not less than 40 hours at a 
temperature not lower than 80 [deg]F., and finally held in a drying room 
not less than 10 days at a temperature not lower than 45 [deg]F. In no 
case, however, shall the sausage be released from the drying room in 
less than 18 days from the time the curing materials are added to the 
meat. Sausage exceeding 3\1/2\ inches, but not exceeding 4 inches, in 
diameter at the time of stuffing, shall be held in a drying room, 
following smoking as above indicated, not less than 25 days at a 
temperature not lower than 45 [deg]F., but in no case shall the sausage 
be released from the drying room in less than 33 days from the time the 
curing materials are added to the meat.
    Method No. 3. The meat shall be ground or chopped into pieces not 
exceeding three-fourths of an inch in diameter. A dry-curing mixture 
containing not less than 3\1/3\ pounds of salt to each hundredweight of 
the unstuffed sausage shall be thoroughly mixed with the ground or 
chopped meat. After admixture with the salt and other curing materials 
and before stuffing, the ground or chopped meat shall be held at a 
temperature not lower than 34 [deg]F. for not less than 36 hours. After 
being stuffed, the sausage shall be held at a temperature not lower than 
34 [deg]F. for an additional period of time sufficient to make a total 
of not less than 144 hours from the time the curing materials are added 
to the meat, or the sausage shall be held for the time specified in a 
pickle-curing medium of not less than 50[deg] strength (salometer 
reading) at a temperature not lower than 44 [deg]F. Finally, sausage 
having a diameter not exceeding 3\1/2\ inches, measured at the time of 
stuffing, shall be smoked for not less than 12 hours. The temperature of 
the smokehouse during this period at no time shall be lower than 90 
[deg]F.; and for 4 consecutive hours of this period the smokehouse shall 
be maintained at a temperature not lower than 128 [deg]F. Sausage 
exceeding 3\1/2\ inches, but not exceeding 4 inches, in diameter at the 
time of stuffing shall be smoked, following the prescribed curing, for 
not less than 15 hours. The temperature of the smokehouse during the 15-
hour period shall at no time be lower than 90 [deg]F., and for 7 
consecutive hours of this period the smokehouse shall be maintained at a 
temperature not lower than 128 [deg]F. In regulating the temperature of 
the smokehouse for the treatment of sausage under this method, the 
temperature of 128 [deg]F. shall be attained gradually during a period 
of not less than 4 hours.
    Method No. 4. The meat shall be ground or chopped into pieces not 
exceeding one-fourth of an inch in diameter. A dry-curing mixture 
containing not less than 2\1/2\ pounds of salt to each hundredweight of 
the unstuffed sausage shall be thoroughly mixed with the ground or 
chopped meat. After admixture with the salt and other curing materials 
and before stuffing, the ground or chopped sausage shall be held as a 
compact mass, not more than 6 inches in depth, at a temperature not 
lower than 36 [deg]F. for not less than 10 days. At the termination of 
the holding period, the sausage shall be stuffed in casings or cloth 
bags not exceeding 3\1/3\ inches in diameter, measured at the time of 
stuffing. After being stuffed, the sausage shall be held in a drying 
room at a temperature not lower than 45 [deg]F. for the remainder of a 
35-day period, measured from the time the curing materials are added to 
the meat. At any time after stuffing, if the establishment operator 
deems it desirable, the product may be heated in a water bath for a 
period not to exceed 3 hours at a temperature not lower than 85 [deg]F., 
or subjected to smoking at a temperature not lower than 80 [deg]F., or 
the product may be both heated and smoked as specified. The time 
consumed in heating and smoking, however, shall be in addition to the 
35-day holding period specified.
    Method No. 5. The meat shall be ground or chopped into pieces not 
exceeding three-fourths of an inch in diameter. A dry-curing mixture 
containing not less than 3\1/3\ pounds of salt to each hundredweight of 
the unstuffed sausage shall be thoroughly mixed with the ground or 
chopped meat. After being stuffed, the sausage shall be held for not 
less than 65 days at a temperature not lower than 45 [deg]F. The 
coverings for sausage prepared according to this method may be coated at 
any stage of the preparation before or during the holding period with 
paraffin or other substance approved by the Administrator.
    Method No. 6. (A) Basic requirements. The meat shall be ground or 
chopped into pieces not exceeding three-fourths of an inch in diameter. 
A dry-curing mixture containing not less than 3.33 pounds of salt to 
each hundredweight of the unstuffed sausage, excluding the weight of dry 
ingredients, shall be thoroughly mixed with the ground or chopped meat. 
After the curing mixture has been added, the sausage shall be held for 
two time periods, a holding period and a drying period. The holding 
period will be for a minimum of 48 hours at a room temperature not lower 
than 35 [deg]F. This holding period requirement may be fulfilled totally 
or in part before the drying period and then the remainder, if any, 
after the drying period or as an extension of the drying period. During 
the drying period, the sausage shall be held in a drying room at a 
temperature not lower than 50 (10.0 [deg]F. (10.0 [deg]C) for a period 
of time determined by Tables

[[Page 250]]

3A, 3B, and 4. The length of the drying period, established in 
(c)(3)(i)(A), may be modified as provided in paragraphs (c)(3)(i)(B) and 
(c)(3)(i)(C) of this section.

           Table 3A--Sausage Drying Room Times by Method No. 6
------------------------------------------------------------------------
                                                                 Days in
           Diameter of casing at time of stuffing\1\              drying
                                                                 room\2\
------------------------------------------------------------------------
Up to:
    1 inches...................................................       14
    1\1/2\ inches..............................................       15
    2 inches...................................................       16
    2\1/2\ inches..............................................       18
    3 inches...................................................       20
    3\1/2\ inches..............................................       23
    4 inches...................................................       25
    4\1/2\ inches..............................................       30
    5 inches...................................................       35
    5\1/2\ inches..............................................       43
    6 inches...................................................       50
------------------------------------------------------------------------
\1\ The drying room times for flattened or oval sausages shall use a
  diameter derived by measuring the circumference and dividing by 3.14
  (pi).
\2\ Drying room time may be modified as set forth in Tables 3B and 4.

    (B) Reduction in Drying Room Time. During the holding period, the 
sausage may be smoked or fermented. If the temperature is increased to 
70 [deg]F. (21.1 [deg]C) or higher, while the sausage is being held 
after adding curing materials but before the drying period, the 
subsequent drying room times prescribed for this method may be reduced 
according to the schedule in Table 3B. No interpolation of values is 
permissible.

              Table 3B--Percentage Reduction in Drying Room Time (Table 3A) Permitted by Holding Times and Temperatures Prior to Drying \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Minimum Temperature \2\
                                                     ---------------------------------------------------------------------------------------------------
                                                         70        75        80        85        90        95        100       105       110       120
                    Minimum Time                       [deg]F    [deg]F    [deg]F    [deg]F    [deg]F    [deg]F    [deg]F    [deg]F    [deg]F    [deg]F
                                                     ---------------------------------------------------------------------------------------------------
                                                        21.1      23.9      26.7      29.5      32.2      35.0      37.9      40.6      43.3      48.9
                                                       [deg]C    [deg]C    [deg]C    [deg]C    [deg]C    [deg]C    [deg]C    [deg]C    [deg]C    [deg]C
--------------------------------------------------------------------------------------------------------------------------------------------------------
24 hours............................................         4         5         8        10        15        23        37        57        90   \3\ 100
48 hours............................................         9        12        18        25        35        49        88   \3\ 100   \3\ 100       100
72 hours............................................        14        19        28        39        55        74   \3\ 100       100       100       100
96 hours............................................        19        26        38        53        75        98       100       100       100       100
120 hours...........................................        24        33        48        67        95   \3\ 100       100       100       100       100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ In computing the days to be deducted, the number with any fraction shall be rounded to the next lower whole number and shall be deducted from the
  required total drying time. Example: Sausage stuffed in 3 diameter casing requires 20 days in the drying room (from Drying Room Times,
  Table 3A). If allowed to ferment, after addition of curing materials, at 80 [deg]F. for 48 hours, the 20 day drying time may be reduced 18% (from
  Table 3B). Eighteen percent of 20 day equals 3.6 days. Twenty days minus 3 days equals 17 days. The total drying time required in the drying room,
  therefore, will be 17 days.
\2\ Either room temperature or internal product temperature shall be used for sausages that will be subsequently dried to a moisture-protein ratio of
  2.3:1 or less. Internal product temperature shall be used for all other sausages.
\3\ Trichinae will be destroyed during fermentation or smoking at the temperature and length of time indicated. Therefore, no drying room period is
  required for products so treated.

    (C) Reduced Salt Content--Drying Room Times. Salt content of less 
than 3.33 pounds for each hundredweight of sausage formulation, 
excluding dry ingredients, (such as salts, sugars, and spices), may be 
permitted provided the drying time is increased according to the 
schedule contained in Table 4.

             Trichina Treatment of Sausage by Method No. 6;

            Table 4--Reduced Salt Content--Drying Room Times
 [Required percentage increase in drying room time (table 3A) for added
       salt of less than 3.33 pounds per hundredweight of sausage]
------------------------------------------------------------------------
                                                                Increase
                                                               in drying
         Minimum pounds of salt added to sausage \1\           room time
                                                                  \2\
------------------------------------------------------------------------
3.3..........................................................          1
3.2..........................................................          4
3.1..........................................................          7
3.0..........................................................         10
2.9..........................................................         13
2.8..........................................................         16
2.7..........................................................         19
2.6..........................................................         22
2.5..........................................................         25
2.4..........................................................         28
2.3..........................................................         31
2.2..........................................................         34
2.1..........................................................         37

[[Page 251]]

 
2.0..........................................................         40
------------------------------------------------------------------------
\1\ Calculate the salt content for column 1 as follows: Multiply the
  pounds of salt in the sausage formulation by 100. Then divide this
  number by the total weight of sausage formulation minus the weight of
  dry ingredients and round down to the next lowest 0.1%. Percents may
  be substituted for pounds.
Example: 120 lbs. pork, 3.56 lbs. salt, 2 lbs. spices, 0.5 lbs. wine, 1
  lb. water and starter culture, 0.8 lbs. sugar, .012 lbs. sodium
  nitrite total weight is 127.872 lbs.
 
(3.56x100)/(127.872-3.56-2-.8-.012)=356/121.5=2.93
 
Therefore, the sausage drying time must be increased by 13 percent.
\2\ In computing the days to be added to the required total drying time,
  fractions shall be rounded to the next higher whole number and added
  to the required total drying time. Example: Sausage stuffed in 3\1/2\
  inch diameter casing requires 23 days in the drying room (from Drying
  Room Times). If the quantity of salt added per hundredweight of
  sausage is 2 pounds instead of 3.33 pounds, the drying room time must
  be increased by 40 percent (from Reduced Salt Content-Drying Room
  Times), or 9.2 days. The 9.2 is rounded up to 10 days and is added to
  the 23 days to equal 33 days. The total drying time required in the
  drying room, therefore, will be 33 days.

    Method No. 7, Dry Sausages. (A) General Requirements. The 
establishment shall use meat particles reduced in size to no more than 
1/4 inch in diameter. The establishment shall add a curing mixture 
containing no less than 2.7 pounds of salt per hundred pounds of meat 
and mix it uniformly throughout the product. The establishment shall 
hold, heat, and dry the product according to paragraph (B) or (C) below.
    (B) Holding, Heating, and Drying Treatment, Large Sausages. Except 
as permitted in (C) below, the establishment shall subject sausages in 
casings not exceeding 105 mm in diameter, at the time of stuffing, to 
all of the following minimum chamber temperatures and time periods.

 Treatment Schedule for Sausages 105 Millimeters (4\1/8\ Inches) or Less
                               in Diameter
------------------------------------------------------------------------
           Minimum chamber temperature
-------------------------------------------------  Minimum time (hours)
        ([deg]F)                 ([deg]C)
------------------------------------------------------------------------
               50                       10                       12
               90                     32.2                        1
              100                     37.8                        1
              110                     43.3                        1
              120                     48.9                        1
              125                     51.7                        7
------------------------------------------------------------------------

Following the preceding treatment, the establishment shall dry the 
sausages at a temperature not lower than 50 [deg]F (10 [deg]C) for not 
less than 7 days.
    (C) Heating and Drying Treatment, Small Sausages. Alternatively, the 
establishment may subject sausages in casings not exceeding 55 mm in 
diameter, at the time of stuffing, to all of the following minimum 
chamber temperatures and time periods.

 Treatment Schedule for Sausages 55 Millimeters (2\1/8\ Inches) or Less
                               in Diameter
------------------------------------------------------------------------
           Minimum chamber temperature
-------------------------------------------------  Minimum time (hours)
        ([deg]F)                 ([deg]C)
------------------------------------------------------------------------
               50                       10                       12
              100                     37.8                        1
              125                     51.7                        6
------------------------------------------------------------------------

Following the preceding heat treatment, the establishment shall dry the 
sausages at a temperature not lower than 50 [deg]F (10 [deg]C) for not 
less than 4 days.

    (ii) Capocollo (capicola, capacola). Boneless pork butts for 
capocollo shall be cured in a dry-curing mixture containing not less 
than 4\1/2\ pounds of salt per hundredweight of meat for a period of not 
less than 25 days at a temperature not lower than 36 [deg]F. If the 
curing materials are applied to the butts by the process known as 
churning, a small quantity of pickle may be added. During the curing 
period the butts may be overhauled according to any of the usual 
processes of overhauling, including the addition of pickle or dry salt 
if desired. The butts shall not be subjected during or after curing to 
any treatment designed to remove salt from the meat, except that 
superficial washing may be allowed. After being stuffed, the product 
shall be smoked for a period of not less than 30 hours at a temperature 
not lower than 80 [deg]F., and shall finally be held in a drying room 
not less than 20 days at a temperature not lower than 45 [deg]F.
    (iii) Coppa. Boneless pork butts for coppa shall be cured in a dry-
curing mixture containing not less than 4\1/2\ pounds of salt per 
hundredweight of meat for a period of not less than 18 days at a 
temperature not lower than 36 [deg]F. If the curing mixture is applied 
to the butts by the process known as churning, a small quantity of 
pickle may be added. During the curing period the butts may be 
overhauled according to any of the usual processes of overhauling, 
including the addition of pickle or dry salt if desired. The butts shall 
not be subjected during or after curing to any treatment designed to 
remove salt from the meat, except that superficial washing may be 
allowed. After

[[Page 252]]

being stuffed, the product shall be held in a drying room not less than 
35 days at a temperature not lower than 45 [deg]F.
    (iv) Hams and pork shoulder picnics. In the curing of hams and pork 
shoulder picnics, one of the methods below shall be used. For 
calculating days per pound, the establishment shall use the weight of 
the heaviest ham or picnic in the lot.

    Method No. 1. The hams and pork shoulder picnics shall be cured by a 
dry-salt curing process not less than 40 days at a temperature no lower 
than 36 [deg]F. The products shall be laid down in salt, not less than 4 
pounds to each hundredweight of product, the salt being applied in a 
thorough manner to the lean meat of each item. When placed in cure, the 
products may be pumped with pickle if desired. At least once during the 
curing process, the products shall be overhauled (turned over for the 
application of additional cure) and additional salt applied, if 
necessary, so that the lean meat of each item is thoroughly covered. 
After removal from cure, the products may be soaked in water at a 
temperature not higher than 70 [deg]F for not more than 15 hours, during 
which time the water may be changed once, but they shall not be 
subjected to any other treatment designed to remove salt from the meat 
except that superficial washing may be allowed. The products shall 
finally be dried or smoked at a time and temperature not less than a 
combination prescribed in Table 5 of Method No. 3.
    Method No. 2. [Reserved]
    Method No. 3. (A) Curing. (Other than bag curing): Establishments 
shall cure hams and shoulders by using a cure mixture containing not 
less than 70 percent salt by weight to cover all exposed muscle tissue 
and to pack the hock region. Total curing time consists of a mandatory 
cure contact time and an optional equalization time.
    (B) Cure Contact Time. This is the cure contact period, during which 
the establishment shall keep exposed muscle tissue coated with the cure 
mixture at least 28 days but for no less than 1.5 days per pound of ham 
or shoulder. Overhaul is optional so long as the exposed muscle tissue 
remains coated with curing mixture.
    (C) Equalization. The establishment may provide an equalization 
period after the minimum cure contact period in (B) above to permit the 
absorbed salt to permeate the product's inner tissues. Equalization is 
the time after the excess cure has been removed from the product at the 
end of the cure contact period until the product is placed in the drying 
room and the drying period begins. The total curing time (equalization 
plus cure contact) shall be at least 40 days and in no case less than 2 
days per pound of an uncured ham or shoulder.
    (D) Removing Excess Cure. After the required cure contact period, 
the establishment may remove excess cure mixture from the product's 
surface mechanically or by rinsing up to 1 minute with water, but not by 
soaking.
    (E) Bag Curing. Bag curing is a traditional ham curing technique in 
which the manufacturer wraps the ham and all of the cure mixture 
together in kraft paper then hangs them individually. The paper keeps 
the extra cure mixture in close contact with the product making 
reapplication of salt unnecessary, and it protects the product from 
mites and insects. Establishments may employ the bag curing method as an 
alternative to (A) through (D) above. An establishment which elects to 
use the bag curing method shall apply a cure mixture containing at least 
6 pounds of salt per 100 pounds of uncured product. The establishment 
shall rub the curing mixture into the exposed muscle tissue, pack the 
hock region with the curing mixture, and use uncoated wrapping paper to 
wrap the product together with any remaining curing mixture. The bag 
cured product shall remain wrapped throughout the curing period and may 
or may not remain wrapped during the drying period. In any case, the 
curing period shall be at least 40 days but not less than 2 days per 
pound of an uncured ham or shoulder. After curing, the cured product 
shall be exposed to a drying time and temperature prescribed in Table 5.
    (F) Curing Temperature. During the curing period the establishment 
shall use one of the following procedures:
    (1) The establishment shall control the room temperature at not less 
than 35 [deg]F (1.7 [deg]C) nor greater than 45 [deg]F (7.2 [deg]C) for 
the first 1.5 days per pound of an uncured ham or shoulder, and not less 
than 35 [deg]F (1.7 [deg]C) nor greater than 60 [deg]F (15.6 [deg]C) for 
the remainder of the curing period.
    (2) The establishment shall monitor and record daily product 
temperature. The room temperature need not be controlled but days on 
which the product temperature drops below 35 [deg]F (1.7 [deg]C) shall 
not be counted as curing time. If the product temperature exceeds 45 
[deg]F (7.2 [deg]C) within the first period of 1.5 days per pound of an 
uncured ham or shoulder or if it exceeds 60 [deg]F (15.6 [deg]C) for the 
remainder of the curing period, the establishment shall cool the product 
back to the 45 [deg]F (7.2 [deg]C) maximum during the first period or 55 
[deg]F (12.8 [deg]C) maximum during the remainder of the period.
    (3) The establishment shall begin curing product only between the 
dates of December 1 and February 13. The room temperature need not be 
controlled, but the establishment shall monitor and record daily room 
temperatures, and days in which the room

[[Page 253]]

temperature drops below 35 [deg]F (1.7 [deg]C) shall not be counted as 
curing time.
    (G) Drying. After the curing period, establishments shall use one of 
three procedures for drying:
    (1) The establishment shall subject the product to a controlled room 
temperature for a minimum time and minimum temperature combination 
prescribed in Table 5 or for a set of such combinations in which the 
total of the fractional periods (in column 4 of Table 5) exceeds 1.5.
    (2) Establishments using uncontrolled room temperatures shall 
monitor and record the internal product temperature. The drying period 
shall be complete when, from the days which can be counted as curing 
time, one of the time/temperature combinations of Table 5 is satisfied 
or when the total of the fractional values for the combinations exceeds 
1.5.
    (3) Establishments using uncontrolled room temperatures shall dry 
the product for a minimum of 160 days including the entire months of 
June, July, and August. This procedure is obviously dependent on local 
climatic conditions and no problem exists with respect to current 
producers who use this procedure. Future applicants shall demonstrate 
that their local monthly average temperatures and the local monthly 
minimum temperatures are equal to or warmer than the normal average 
temperatures and normal minimum temperatures compiled by the National 
Oceanic and Atmospheric Administration for Boone, North Carolina, 
station 31-0977, 1951 through 1980.

                              Monthly Temperatures ([deg]F) for Boone NC, 1951-1980
----------------------------------------------------------------------------------------------------------------
                          Jan.                             Feb.   Mar.   Apr.   May    June   July   Aug.   Sep.
----------------------------------------------------------------------------------------------------------------
                                           Normal average temperatures
----------------------------------------------------------------------------------------------------------------
                          32.2                             34.1   41.3   51.2   59.1   65.1   68.3   67.5   61.6
---------------------------------------------------------
                                           Normal minimum temperatures
----------------------------------------------------------------------------------------------------------------
                          22.8                             24.2   30.8   39.6   48.1   54.7   58.5   57.6   51.6
----------------------------------------------------------------------------------------------------------------

  Drying Times and Temperatures for Trichina Inactivation in Hams and 
                                Shoulders

         Table 5--Minimum Drying Days at a Minimum Temperature*
------------------------------------------------------------------------
         Minimum Drying Temperature                           Fractional
--------------------------------------------  Minimum days    period for
                                  Degrees       at drying     one day of
      Degrees fahrenheit         centigrade    temperature      drying
------------------------------------------------------------------------
130...........................         54.4             1.5          .67
125...........................         51.7               2          .50
120...........................         48.9               3          .33
115...........................         46.1               4          .25
110...........................         43.3               5          .20
105...........................         40.6               6          .17
100...........................         37.8               7          .14
95............................         35.0               9          .11
90............................         32.2              11         .091
85............................         29.4              18         .056
80............................         26.7              25         .040
75............................         23.9              35         .029
------------------------------------------------------------------------
* Interpolation of these times or temperatures is not acceptable;
  establishments wishing to use temperatures or times not in this Table
  shall first validate their efficacy as provided by 318.10(c)(4) of
  this section.

    Method No. 4. (A) Cure: Establishments shall cure hams and shoulders 
by using a cure mixture containing not less than 71.5 percent salt by 
weight to cover all exposed muscle tissue and to pack the hock region. 
Establishments may substitute potassium chloride (KCl) for up to half of 
the required salt on an equal weight basis.
    (B) Curing. Establishments shall apply the cure at a rate not less 
than 5.72 pounds of salt and KCl per hundred pounds of fresh meat. The 
cure shall be applied in either three or four approximately equal 
amounts (two or three overhauls) at separate times during the first 14 
days of curing.
    (C) Cure Contact Time. Establishments shall keep the product in 
contact with the cure mixture for no less than 2 days per pound of an 
uncured ham or shoulder but for at least 30 days. Establishments shall 
maintain the curing temperature at no less than 35 [deg]F (1.7 [deg]C) 
during the cure contact time.
    (D) Equalization. After the cure contact period, establishments 
shall provide an added equalization period of no less than 1 day per 
pound of an uncured ham or shoulder but at least 14 days. Equalization 
is the time after the excess cure has been removed from the product, the 
end of the cure contact period, and before the drying period begins. 
Establishments may substitute additional cure contact days for an equal 
number of equalization days.
    (E) Removing Excess Cure. After the required cure contact period, 
the establishment may remove excess cure mixture from the product's 
surface mechanically or by rinsing up to 1 minute with water, but not by 
soaking.
    (F) Drying. After the curing period, establishments shall use one of 
the controlled temperature methods for drying listed in Method No. 3 of 
this subparagraph.

[[Page 254]]

    Method No. 5 (A) Curing. The establishment shall cure the ham to a 
minimum brine concentration of 6 percent by the end of the drying 
period. Brine concentration is calculated as 100 times the salt 
concentration divided by the sum of the salt and water concentrations.

Percent brine = 100 x [salt] / ([salt] + [water])

    The Agency will accept the brine concentration in the biceps femoris 
as a reasonable estimate of the minimum brine concentration in the ham.
    (B) Drying and Total Process Times. The establishment shall dry the 
cured ham at a minimum temperature of 55 [deg]F (13 [deg]C) for at least 
150 days. The total time of drying plus curing shall be at least 206 
days.
    (C) Ensuring an Acceptable Internal Brine Concentration. (1) To 
establish compliance, the establishment shall take product samples from 
the first 12 lots of production as follows: From each lot,
    (i) One sample shall be taken from each of 5 or more hams;
    (ii) Each sample shall be taken from the biceps femoris. As an 
alternative to the use of the biceps femoris, the Agency shall consider 
other method(s) of sampling the dry-cured hams to determine the minimum 
internal brine concentration, as long as the establishment proposes it 
and submits data and other information to establish its sufficiency to 
the Director of the Processed Products Inspection Division;
    (iii) Each sample shall weigh no less than 100 grams;
    (iv) The samples shall be combined as one composite sample and 
sealed in a water vapor proof container;
    (v) The composite sample shall be submitted to a laboratory 
accredited under the provisions of Sec. 318.21 to be analyzed for salt 
and water content using methods from the ``Official Methods of Analysis 
of the Association of Official Analytical Chemists (AOAC),'' 15th 
Edition, 1990, Section 983.18 (page 931) and Section 971.19 (page 933) 
which are incorporated by reference. This incorporation by reference was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the 
Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson 
Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the 
Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250 or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. If 
the time between sampling and submittal of the composite sample to the 
accredited laboratory will exceed 8 hours, then the establishment shall 
freeze the composite sample immediately after the samples are combined;
    (vi) Once the laboratory results for the composite sample are 
received, the manufacturer shall calculate the internal brine 
concentration by multiplying the salt concentration by 100 and then 
dividing that figure by the sum of the salt and water concentrations;
    (vii) Compliance is established when the samples from the first 12 
lots of production have a minimum internal brine concentration of 6 
percent. Lots being tested to establish compliance shall be held until 
the internal brine concentration has been determined and found to be at 
least 6 percent. If the minimum internal brine concentration is less 
than 6 percent, the lot being tested shall be held until the 
establishment brings the lot into compliance by further processing.
    (2) To maintain compliance, the establishment shall take samples, 
have the samples analyzed, and perform the brine calculations as set 
forth above from one lot every 13 weeks. Lots being tested to maintain 
compliance shall not be held. If the minimum internal brine 
concentration is less than 6 percent in a lot being tested to maintain 
compliance, the establishment shall develop and propose steps acceptable 
to FSIS to ensure that the process is corrected.
    (3) Accredited laboratory results and the brine calculations shall 
be placed on file at the establishment and available to Program 
employees for review.
    Method No. 6 (A) Curing. The establishment shall cure the ham to a 
minimum brine concentration of 6 percent by the end of the drying 
period. Brine concentration is calculated as 100 times the salt 
concentration divided by the sum of the salt and water concentrations.

Percent brine = 100 x [salt] / ([salt] + [water])

    The Agency will accept the brine concentration in the biceps femoris 
as a reasonable estimate of the minimum brine concentration.
    (B) Drying and Total Process Times. The establishment shall dry the 
cured ham at a minimum temperature of 110 [deg]F (43 [deg]C) for at 
least 4 days. The total time of drying plus curing shall be at least 34 
days.
    (c) Ensuring an Acceptable Internal Brine Concentration. (1) To 
establish compliance the establishment shall take product samples from 
the first 12 lots of production as follows: From each lot,
    (i) One sample shall be taken from each of 5 or more hams;
    (ii) Each sample shall be taken from the biceps femoris. As an 
alternative to the use of the biceps femoris, the Agency will consider 
other methods of sampling the dry-

[[Page 255]]

cured hams to determine internal brine concentration, as long as the 
establishment proposes it and submits data and other information to 
establish its sufficiency to the Director of the Processed Products 
Inspection Division;
    (iii) Each sample shall weigh no less than 100 grams;
    (iv) The samples shall be combined as one composite sample and 
sealed in a water vapor proof container;
    (v) The composite sample shall be submitted to a laboratory 
accredited under the provisions of Sec. 318.21 to be analyzed for salt 
and water content using methods from the ``Official Methods of Analysis 
of the Association of Official Analytical Chemists (AOAC),'' 15th 
Edition, 1990, section 983.18 (page 931) and section 971.19 (page 933) 
which are incorporated by reference. This incorporation by reference was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the 
Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson 
Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the 
Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250 or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. If 
the time between sampling and submittal of the composite sample to the 
accredited laboratory will exceed 8 hours, then the establishment shall 
freeze the composite sample immediately after the samples are combined;
    (vi) Compliance is established when the samples from the first 12 
lots of production have a minimum internal brine concentration of 6 
percent. Lots being tested to establish compliance shall be held until 
the internal brine concentration has been determined and found to be at 
least 6 percent. If the minimum internal brine concentration is less 
than 6 percent, the lot being tested shall be held until the 
establishment brings the lot into compliance by further processing.
    (2) To maintain compliance, the establishment shall take samples, 
have the samples analyzed, and perform the brine calculations as set 
forth above from one lot every 13 weeks. Lots being tested to maintain 
compliance shall not be held. If the minimum internal brine 
concentration is less than 6 percent in a lot being tested to maintain 
compliance, the establishment shall develop and propose steps acceptable 
to FSIS to ensure that the process is corrected.
    (3) Accredited laboratory results and the brine calculations shall 
be placed on file in the establishment and available to Program 
employees for review.

    (v) Boneless pork loins and loin ends. In lieu of heating or 
refrigerating to destroy possible live trichinae in boneless loins, the 
loins may be cured for a period of not less than 25 days at a 
temperature not lower than 36 [deg]F. by the use of one of the following 
methods:

    Method No. 1. Application of a dry-salt curing mixture containing 
not less than 5 pounds of salt to each hundredweight of meats.
    Method No. 2. Application of a pickle solution of not less than 
80[deg] strength (salom eter) on the basis of not less than 60 pounds of 
pickle to each hundredweight of meat.
    Method No. 3. Application of a pickle solution added to the dry-salt 
cure prescribed as Method No. 1 in this subdivision (v) provided the 
pickle solution is not less than 80[deg] strength (salometer).
    After removal from cure, the loins may be soaked in water for not 
more than 1 hour at a temperature not higher than 70 [deg]F. or washed 
under a spray but shall not be subjected, during or after the curing 
process, to any other treatment designed to remove salt.
    Following curing, the loins shall be smoked for not less than 12 
hours. The minimum temperature of the smokehouse during this period at 
no time shall be lower than 100 [deg]F., and for 4 consecutive hours of 
this period the smokehouse shall be maintained at a temperature not 
lower than 125 [deg]F.
    Finally, the product shall be held in a drying room for a period of 
not less than 12 days at a temperature not lower than 45 [deg]F.

    (4) The Administrator shall consider additional processing methods 
upon petition by manufacturers, and shall approve any such method upon 
his/her determination that it can be properly monitored by an inspector 
and that the safety of such methods is adequately documented by data 
which has been developed by following an experimental protocol 
previously reviewed and accepted by the Department.
    (d) General instructions: When necessary to comply with the 
requirements of this section, the smokehouses, drying rooms, and other 
compartments used in the treatment of pork to destroy possible live 
trichinae shall be suitably equipped, by the operator of the official 
establishment, with

[[Page 256]]

accurate automatic recording thermometers. Circuit supervisors are 
authorized to approve for use in sausage smokehouses, drying rooms, and 
other compartments, such automatic recording thermometers as are found 
to give satisfactory service and to disapprove and require 
discontinuance of use, for purposes of the regulations in this 
subchapter, any thermometers (including any automatic recording 
thermometers) of the establishment that are found to be inaccurate or 
unreliable.
    (e) The requirements for using the pooled sample digestion technique 
to analyze pork for the presence of trichina cysts are:
    (1) The establishment shall submit for the approval of the Regional 
Director its proposed procedure for identifying and pooling carcasses, 
collecting and pooling samples, testing samples (including the name and 
address of the laboratory), communicating test results, retesting 
individual carcasses, and maintaining positive identification and clear 
separation of pork found to be trichina-free from untested pork or 
trichina-positive pork.
    (2) The establishment shall use the services of a laboratory 
approved by the Administrator for all required testing. Such approval 
shall be based on adequacy of facilities, reagents, and equipment, and 
on demonstration of continuing competency and reliability in performing 
the pooled sample digestion technique for trichinae.
    (3) The establishment shall sample no less than 5 grams of diaphragm 
muscle or tongue tissue from each carcass or no less than 10 grams of 
other muscle tissue. Samples may be pooled but a pool shall not consist 
of more than 100 grams of sample. Sampling and sample preparation are 
subject to inspection supervision.
    (4) Pork or products made from tested pork shall not be released as 
trichina free from the official establishment without treatment until 
the inspector in charge receives a laboratory report that the tested 
pork is free of trichina cysts.
    (f) Approval of other tests for trichinosis in pork. The 
Administrator shall consider any additional analytical method for 
trichinosis upon petition by a manufacturer, and may approve that method 
upon the determination that it will detect at least 98 percent of swine 
bearing cysts present at a tissue density equal to or less than one cyst 
per gram of muscle from the diaphragm pillars at a 95 percent confidence 
level. Any such petitions shall be supported by any data and other 
information that the Administrator finds necessary. Notice of any 
approval shall be given in the Federal Register, and the approved method 
will be incorporated into this section.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 31517; Nov. 15, 1973; 39 
FR 40580, Nov. 19, 1974; 50 FR 5229, Feb. 7, l985; 50 FR 48075, Nov. 21, 
1985; 52 FR 12517, Apr. 17, 1987; 57 FR 27874, June 22, 1992; 57 FR 
33633, July 30, 1992; 57 FR 56440, Nov. 30, 1992]



Sec. 318.11  [Reserved]



Sec. 318.12  Manufacture of dog food or similar uninspected article at 
official establishments.

    (a) When dog food, or similar uninspected article is manufactured in 
an edible product department, there shall be sufficient space allotted 
and adequate equipment provided so that the manufacture of the 
uninspected article in no way interferes with the handling or 
preparation of edible products. Where necessary to avoid adulteration of 
edible products, separate equipment shall be provided for the 
uninspected article. To assure the maintenance of sanitary conditions in 
the edible product departments, the operations incident to the 
manufacture of the uninspected article will be subject to the same 
sanitary requirements that apply to all operations in edible product 
departments. The manufacture of the uninspected article shall be limited 
to those hours during which the establishment operates under 
inspectional supervision; and there shall be no handling, other than 
receiving at the official establishment, of any of the product 
ingredient of the uninspected article, other than during the regular 
hours of inspection. The materials used in the manufacture of the 
uninspected article shall not be used so as to interfere with the 
inspection of edible product or the maintenance of sanitary conditions 
in the department or render any edible product adulterated. The meat, 
meat byproducts, and meat food

[[Page 257]]

product ingredients of the uninspected article may be admitted into any 
edible products department of an official establishment only if they are 
U.S. Inspected and Passed. Products within Sec. 314.11 of this 
subchapter or parts of carcasses of kinds not permitted under the 
regulations in this subchapter to be prepared for human food (e.g., 
lungs or intestines), which are produced at any official establishment, 
may be brought into the inedible products department of any official 
establishment for use in uninspected articles under this section. The 
uninspected article may be stored in, and distributed from, edible 
product departments: Provided, That adequate facilities are furnished, 
there is no interference with the maintenance of sanitary conditions, 
and such article is properly identified.
    (b) When dog food or similar uninspected article is manufactured in 
a part of an official establishment other than an edible product 
department, the area in which the article is manufactured shall be 
separated from edible product departments in the manner required for 
separation between edible product departments and inedible product 
departments. Sufficient space must be allotted and adequate equipment 
provided so that the manufacture of the uninspected article does not 
interfere with the proper functioning of the other operations at the 
establishment. Except as provided in Sec. 314.11 of this subchapter, 
nothing in this paragraph shall be construed as permitting any deviation 
from the requirement that dead animals, condemned products, and similar 
materials of whatever origin, must be placed in the inedible product 
rendering equipment, and without undue delay. The manufacture of the 
uninspected article must be such as not to interfere with the 
maintenance of general sanitary conditions on the premises, and it shall 
be subject to inspectional supervision similar to that exercised over 
other inedible product departments. There shall be no movement of any 
product from an inedible product department to any edible product 
department. Trucks, barrels, and other equipment shall be cleaned before 
being returned to edible product departments from inedible product 
departments. Unoffensive material prepared outside edible product 
departments may be stored in, and distributed from, edible product 
departments only if packaged in clean, properly identified, sealed 
containers.
    (c) Animal food shall be distinguished from articles of human food, 
so as to avoid distribution of such animal food as human food. To 
accomplish this, such animal food shall be labeled or otherwise 
identified in accordance with Sec. 325.11(d) of this subchapter.

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 53 
FR 24679, June 30, 1988]



Sec. 318.13  Mixtures containing product but not amendable to the Act.

    Mixtures containing product but not classed as a meat food product 
under the Act shall not bear the inspection legend or any abbreviation 
or representation thereof unless manufactured under the food inspection 
service provided for in part 350 of subchapter B of this chapter. When 
such mixtures are manufactured in any part of an official establishment, 
the sanitation of that part of the establishment shall be supervised by 
Program employees, and the manufacture of such mixtures shall not cause 
any deviation from the requirement of Sec. 318.1.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973]



Sec. 318.14  Adulteration of product by polluted water; procedure for 
handling.

    (a) In the event there is polluted water (including but not limited 
to flood water) in an official establishment, all products and 
ingredients for use in the preparation of such products that have been 
rendered adulterated by the water shall be condemned.
    (b) After the polluted water has receded from an official 
establishment, all walls, ceilings, posts, and floors of the rooms and 
compartments involved, including the equipment therein, shall, under the 
supervision of an inspector, be cleaned thoroughly by the official 
establishment personnel. An adequate supply of hot water under pressure 
is essential to make such cleaning effective. After cleaning, a solution 
of sodium hypochlorite containing approximately one-half of 1 percent 
available chlorine (5,000 p/m) or other equivalent

[[Page 258]]

disinfectant approved by the Administrator \1\ shall be applied to the 
surface of the rooms and equipment and rinsed with potable water before 
use.
    (c) Hermetically sealed containers of product which have been 
contaminated by polluted water shall be examined promptly by the 
official establishment under supervision of an inspector and rehandled 
as follows:
    (1) Separate and condemn all product in damaged or extensively 
rusted containers.
    (2) Remove paper labels and wash the remaining containers in warm 
soapy water, using a brush where necessary to remove rust or other 
foreign material. Disinfect these containers by either of the following 
methods:
    (i) Immerse in a solution of sodium hypochlorite containing not less 
than 100 p/m of available chlorine or other equivalent disinfectant 
approved by the Administrator, \1\ rinse in potable water, and dry 
thoroughly; or
---------------------------------------------------------------------------

    \1\ A list of approved disinfectants is available upon request to 
Scientific Services, Meat and Poultry Inspection Program, Food Safety 
and Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250.
---------------------------------------------------------------------------

    (ii) Immerse in 212 [deg]F. water, bring temperature of the water 
back to 212 [deg]F. and maintain the temperature at 212 [deg]F. for 5 
minutes, then remove containers from water and cool them to 95 [deg]F. 
and dry thoroughly.
    (3) After handling as described in paragraph (c)(2) of this section, 
the containers may be relacquered, if necessary, and then relabeled with 
approved labels applicable to the product therein.
    (4) The identity of the canned product shall be maintained 
throughout all stages of the rehandling operations to insure correct 
labeling of the containers.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 34455, Dec. 14, 1973]



Sec. 318.15  Tagging chemicals, preservatives, cereals, spices, etc., 
``U.S. retained.''

    When any chemical, preservative, cereal, spice, or other substance 
is intended for use in an official establishment, it shall be examined 
by a Program employee and if found to be unfit or otherwise unacceptable 
for the use intended, or if final decision regarding acceptance is 
deferred pending laboratory or other examination, the employee shall 
attach a ``U.S. retained'' tag to the substance or container thereof. 
The substance so tagged shall be kept separate from other substances as 
the circuit supervisor may require and shall not be used until the tag 
is removed, and such removal shall be made only by a Program employee 
after a finding that the substance can be accepted, or, in the case of 
an unacceptable substance, when it is removed from the establishment.



Sec. 318.16  Pesticide chemicals and other residues in products.

    (a) Nonmeat ingredients. Residues of pesticide chemicals, food 
additives and color additives or other substances in or on ingredients 
(other than meat, meat byproducts, and meat food products) used in the 
formulation of products shall not exceed the levels permitted under the 
Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must 
otherwise be in compliance with the requirements under that Act.
    (b) Products, and meat, meat byproduct, or other meat food product 
ingredients. Products, and products used as ingredients of products, 
shall not bear or contain any pesticide chemical, food additives, or 
color additive residue in excess of the level permitted under the 
Federal Food, Drug, and Cosmetic Act and the regulations in this 
subchapter, or any other substance that is prohibited by such 
regulations or that otherwise makes the products adulterated.
    (c) Standards and procedures. Instructions specifying the standards 
and procedures for determining when ingredients of finished products are 
in compliance with this section shall be issued to the inspectors by the 
Administrator. Copies of such instructions will be made available to 
interested persons upon request made to the Administrator.



Sec. 318.17  Requirements for the production of cooked beef, roast 
beef, and cooked corned beef products.

    (a) Cooked beef, roast beef, and cooked corned beef products must be

[[Page 259]]

produced using processes ensuring that the products meet the following 
performance standards:
    (1) Lethality. A 6.5-log10 reduction of Salmonella or an 
alternative lethality that achieves an equivalent probability that no 
viable Salmonella organisms remain in the finished product, as well as 
the reduction of other pathogens and their toxins or toxic metabolites 
necessary to prevent adulteration, must be demonstrated to be achieved 
throughout the product. The lethality process must include a cooking 
step. Controlled intermediate step(s) applied to raw product may form 
part of the basis for the equivalency.
    (2) Stabilization. There can be no multiplication of toxigenic 
microorganisms such as Clostridium botulinum, and no more than 1-
log10 multiplication of Clostridium perfringens within the 
product.
    (b) For each product produced using a process other than one 
conducted in accordance with the Hazard Analysis and Critical Control 
Point (HACCP) system requirements in part 417 of this chapter, an 
establishment must develop and have on file and available to FSIS, a 
process schedule, as defined in Sec. 301.2 of this chapter. Each 
process schedule must be approved in writing by a process authority for 
safety and efficacy in meeting the performance standards established for 
the product in question. A process authority must have access to the 
establishment in order to evaluate and approve the safety and efficacy 
of each process schedule.
    (c) Under the auspices of a processing authority, an establishment 
must validate new or altered process schedules by scientifically 
supportable means, such as information gleaned from the literature or by 
challenge studies conducted outside the plant.

[64 FR 744, Jan. 6, 1999]



Sec. 318.18  Handling of certain material for mechanical processing.

    Material to be processed into ``Mechanically Separated (Species)'' 
shall be so processed within 1 hour from the time it is cut or separated 
from carcasses or parts of carcasses, except that such product may be 
held for no more than 72 hours at 40 [deg]F. (4 [deg]C.) or less, or 
held indefinitely at 0 [deg]F. (-18 [deg]C.) or less. ``Mechanically 
Separated (Species)'' shall, directly after being processed, be used as 
an ingredient in a meat food product except that it may be held prior to 
such use for no more than 72 hours at 40 [deg]F. (4 [deg]C.) or less or 
indefinitely at 0 [deg]F. (-18 [deg]C.) or less.

[43 FR 26423, June 20, 1978, as amended at 47 FR 28256, June 29, 1982]



Sec. 318.19  Compliance procedure for cured pork products.

    (a) Definitions. For the purposes of this section:
    (1) A product is that cured pork article which is contained within 
one Group as defined in paragraph (a)(2) of this section and which 
purports to meet the criteria for a single product designated under the 
heading ``Product Name and Qualifying Statements'' in the chart in Sec. 
319.104 or the chart in Sec. 319.105.
    (2) A Product Group or a Group means one of the following:

    Group I, consisting of cured pork products which have been cooked 
while imperviously encased. Any product which fits into the Group will 
be placed in this Group regardless of any other considerations.
    Group II, consisting of cured pork products which have been water 
cooked. Any product which does not fit into Group I but does fit into 
Group II will be placed into Group II regardless of any other 
considerations.
    Group III, consisting of boneless smokehouse heated cured pork 
products. Any boneless product that does not fit into Group I or Group 
II shall be placed in Group III.
    Group IV, consisting of bone-in or semi-boneless smokehouse heated 
cured pork products. Any product that is not completely boneless or 
still contains all the bone which is traditional for bone-in product, 
and does not fit into Group I, Group II, or Group III shall be placed in 
this Group.

    (3) A lot is that product from one production shift.
    (4) A production rate is frequency of production, expressed in days 
per week.
    (5) Protein fat free percentage, protein fat free content, PFF 
percentage, PFF content or PFF of a product means the meat protein 
(indigenous to the raw, unprocessed pork cut) content expressed as a 
percent of the non-fat portion of the finished product.
    (b) Normal Compliance Procedures. The Department shall collect 
samples of cured pork products and analyze them

[[Page 260]]

for their PFF content. Analyses shall be conducted in accordance with 
the ``Official Methods of Analysis of the Association of Official 
Analytical Chemists Sec. Sec. 950.46, and 928.08 (Chapter 39).\1\ The 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 15th edition, 1990, is incorporated by reference with the 
approval of the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Each analytical result shall be 
recorded and evaluated to determine whether future sampling of product 
Groups within an official establishment shall be periodic or daily under 
the provisions of paragraph (b)(1) of this section, and if the affected 
lot and subsequent production of like product shall be U.S. retained, or 
administratively detained, as appropriate, as provided in paragraph 
(b)(2) of this section.\2\
---------------------------------------------------------------------------

    \1\ A copy of the ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 15th edition, 1990, is on file with 
the Director, Office of the Federal Register, and may be purchased from 
the Association of Official Analytical Chemists, Inc., 2200 Wilson 
Boulevard, Suite 400, Arlington, Virginia 22201.
    \2\ Rules for Rounding:
    1. Laboratory results for percent meat protein and fat will be 
reported to the second decimal place (hundredths).
    2. PFF and Sample Values for charting purposes will be calculated 
from the reported laboratory results to the second decimal place. 
Rounding of calculations to reach two decimal places will be done by the 
following rule:
    All values of five-thousandths (0.005) or more will be rounded up to 
the next highest hundredth. All values of less than five-thousandths 
(0.005) will be dropped.
    3. For compliance with the Absolute Minimum PFF requirements, the 
PFF will be rounded to the first decimal place (tenths). Rounding of 
calculations to reach one decimal place will be done by the following 
rule:
    All PFF values of five-hundredths (0.05) or more will be rounded up 
to the next highest tenth. All PFF values of less than five-hundredths 
(0.05) will be dropped.
    4. For product disposition (pass-fail of a minimum PFF standard for 
retained product) the average PFF calculation will be rounded to the 
first decimal place. Individual PFF Values will be calculated to the 
nearest hundredth as in (2) above. The average, however, will be rounded 
to the nearest tenth as in (3) above.
---------------------------------------------------------------------------

    (1) Criteria to determine sampling frequency of Product Groups. For 
each official plant preparing cured pork products, Product Groups shall 
be sampled periodically or daily. Analytical results shall be evaluated 
and the sampling frequency determined as follows:
    (i) Determine the difference between the individual PFF analysis and 
the applicable minimum PFF percentage requirement of Sec. 319.104 or 
Sec. 319.105. The resulting figure shall be negative when the 
individual sample result is less than the applicable minimum PFF 
percentage requirement and shall be positive when the individual sample 
result is greater than the applicable minimum PFF percentage 
requirement.
    (ii) Divide the resulting number by the standard deviation assigned 
to the Product Group represented by the sample to find the Standardized 
Difference. The standard deviation assigned to Groups I and II is 0.75 
and to Groups III and IV is 0.91.
    (iii) Add 0.25 to the Standardized Difference to find the Adjusted 
Standardized Difference.
    (iv) Use the lesser of 1.90 and the Adjusted Standardized Difference 
as the Sample Value.
    (v) Cumulatively total Sample Values to determine the Group Value. 
The first Sample Value in a Group shall be the Group Value, and each 
succeeding Group Value shall be determined by adding the most recent 
Sample Value to the existing Group Value; provided, however, that in no 
event shall the Group Value exceed 1.00. When calculation of a Group 
Value results in a figure greater than 1.00, the Group Value shall be 
1.00 and all previous Sample Values shall be ignored in determining 
future Group Values.
    (vi) The frequency of sampling of a Group shall be periodic when the 
Group Value is greater than -1.40 (e.g., -1.39, -1.14, 0, 0.50, etc.) 
and shall be daily when the Group Value is -1.40 or less (e.g., -1.40, -
1.45, -1.50, etc.); provided, however, that once daily sampling has been 
initiated, it shall continue until the Group Value is 0.00 or greater, 
and each of the last seven Sample Values is -1.65 or greater (e.g., -
1.63, -1.50, etc.), and there is no other product within the affected 
Group being U.S. retained as produced,

[[Page 261]]

under provisions of paragraph (b)(2) or (c).
    (2) Criteria for U.S. retention or administrative detention of cured 
pork products for further analysis. Cured prok products shall be U.S. 
retained, or administratively detained, as appropriate, when prescribed 
by paragraphs (b)(2) (i) or (ii) of this section as follows:
    (i) Absolute Minimum PFF Requirement. In the event that an analysis 
of an individual sample indicates a PFF content below the applicable 
minimum requirement of Sec. 319.104 or Sec. 319.105 by 2.3 or more 
percentage points for a Group I or II product, or 2.7 or more percentage 
points for a Group III or IV product, the lot from which the sample was 
collected shall be U.S. retained if in an official establishment and 
shall be subject to administrative detention if not in an official 
establishment unless returned to an official establishment and there 
U.S. retained. Any subsequently produced lots of like product and any 
lots of like product for which production dates cannot be established 
shall be U.S. retained or subject to administrative detention. Such 
administratively detained product shall be handled in accordance with 
part 329 of this subchapter, or shall be returned to an official 
establishment and subjected to the provisions of paragraph (c)(1) (i) or 
(ii) of this section, or shall be relabeled in compliance with the 
applicable standard, under the supervision of a program employee, at the 
expense of the product owner. Disposition of such U.S. retained product 
shall be in accordance with paragraph (c) of this section.
    (ii) Product Value requirement. The Department shall maintain, for 
each product prepared in an official establishment, a Product Value. 
Except as provided in paragraph (c)(2) of this section, calculation of 
the Product Value and its use to determine if a product shall be U.S. 
retained shall be as follows:
    (A) Determine the difference between the individual PFF analysis and 
applicable minimum PFF percentage requirement of Sec. 319.104 and Sec. 
319.105. The resulting figure shall be negative when the individual 
sample result is less than the applicable minimum PFF percentage 
requirement and shall be positive when the individual sample result is 
greater than the applicable minimum PFF percentage requirement.
    (B) Divide the difference determined in paragraph (b)(2)(ii)(A) of 
this section by the standard deviation assigned to the product's Group 
in paragraph (b)(1)(ii) of this section to find the standardized 
difference.
    (C) Use the lesser of 1.65 and the standardized difference as the 
Sample Value.
    (D) Cumulatively total Sample Values to determine the Product Value. 
The first Sample Value of a product shall be the Product Value, and each 
succeeding Product Value shall be determined by adding the most recent 
Sample Value to the existing Product Value; provided, however, that in 
no event shall the Product Value exceed 1.15. When calculation of a 
Product Value results in a figure greater than 1.15, the Product Value 
shall be 1.15, and all previous Sample Values shall be ignored in 
determining future Product Values.
    (E) Provided daily group sampling is in effect pursuant to the 
provisions of paragraph (b)(1) of this section, and provided further the 
Product Value is -1.65 or less (e.g., -1.66), the affected lot (if 
within the official establishment) and all subsequent lots of like 
product prepared by and still within the official establishment shall be 
U.S. retained and further evaluated under paragraph (c) of this section. 
Except for release of individual lot pursuant to paragraph (c)(1), 
subsequently produced lots of like product shall continue to be U.S. 
retained until discontinued pursuant to paragraph (c)(2) of this 
section.
    (c) Compliance procedure during product retention. When a product 
lot is U.S. retained under the provisions of paragraph (b)(2) of this 
section, the Department shall collect three randomly selected samples 
from each such lot and analyze them individually for PFF content. The 
PFF content of the three samples shall be evaluated to determine 
disposition of the lot as provided in paragraph (c)(1) of this section 
and the action to be taken on subsequently

[[Page 262]]

produced lots of like product as provided in paragraph (c)(2) of this 
section.\3\
---------------------------------------------------------------------------

    \3\ If the processor does not wish to have the product evaluated in 
this manner, alternate sampling plans may be used provided such plans 
have been formulated by the processor and approved by the Administrator 
prior to evaluation by the three-sample criteria, and provided the 
analyses specified in such plans are performed at the expense of the 
processor.
---------------------------------------------------------------------------

    (1) A product lot which is U.S. retained under the provisions of 
paragraph (b)(2) of this section may be released for entry into commerce 
provided one of the following conditions is met:
    (i) The average PFF content of the three samples randomly selected 
from the lot is equal to or greater than the applicable minimum PFF 
percentage required by Sec. 319.104 or Sec. 319.105. Further 
processing to remove moisture for the purpose of meeting this provision 
is permissible. In lieu of further analysis to determine the effects of 
such processing, each 0.37 percent weight reduction due to moisture loss 
resulting from the processing may be considered the equivalent of a 0.1 
percent PFF gain.
    (ii) The lot of the product is relabeled to conform to the 
provisions of Sec. 319.104 or Sec. 319.105, under the supervision of a 
program employee.
    (iii) The lot is one that has been prepared subsequent to 
preparation of the lot which, under the provisions of paragraph (c)(2) 
of this section, resulted in discontinuance of U.S. retention of new 
lots of like product. Such lot may be released for entry into commerce 
prior to receipt of analytical results for which sampling has been 
conducted. Upon receipt of such results, they shall be subjected to the 
provisions of paragraphs (b)(2)(i) and (c)(2) of this section.
    (2) The PFF content of three randomly selected samples from each 
U.S. retained lot shall be used to maintain the Product Value described 
in paragraph (c)(2)(ii). The manner and effect of such maintenance shall 
be as follows: (i) Find the average PFF content of the three samples.
    (ii) Determine the difference between that average and the 
applicable minimum PFF percentage requirement of Sec. 319.104 or Sec. 
319.105. The resulting figure shall be negative when the average of the 
sample results is less than the applicable minimum PFF percentage 
requirement and shall be positive when the average of the sample results 
is greater than the applicable minimum PFF requirements.
    (iii) Divide the resulting figure by the standard deviation assigned 
to the product's Group in paragraph (b)(1)(ii) of this section, to find 
the standardized difference.
    (iv) Use the lesser of 1.30 and the standardized difference as the 
Sample Value.
    (v) Add the first Sample Value thus calculated to the latest Product 
Value calculated under the provisions of paragraph (c)(2)(ii) of this 
section to find the new Product Value. To find each succeeding Product 
Value, add the most recent Sample Value to the existing Product Value; 
provided, however, that in no event shall the Product Value exceed 1.15. 
When the addition of a Sample Value to an existing Product Value results 
in a figure greater than 1.15, the Product Value shall be 1.15 and all 
previous Sample Values shall be ignored in determining future Product 
Values.
    (vi) New lots of like product shall continue to be retained pending 
disposition in accordance with paragraph (c)(1) of this section until, 
after 5 days of production, the Product Value is 0.00 or greater, and 
the PFF content of no individual sample from a U.S. retained lot is less 
than the Absolute Minimum PFF requirement specified in paragraph 
(b)(2)(i) of this section. Should an individual sample fail to meet its 
Absolute Minimum PFF requirement, the 5-day count shall begin anew.
    (vii) When U.S. retention of new lots is discontinued under the 
above provisions, maintenance of the Product Value shall revert to the 
provisions of paragraph (b)(2)(ii) of this section.
    (3) For purposes of this section, the plant owner or operator shall 
have the option of temporarily removing a product from its Product 
Group, provided product lots are being U.S. retained, as produced, and 
provided further that the average production rate of the product, over 
the 8-week period preceding the

[[Page 263]]

week in which the first U.S. retained lot was prepared, is not greater 
than 20 percent of the production rate of its Group. When a product is 
thus removed from its Group, analytical results of product samples shall 
not cause daily sampling of the Group. When pursuant to paragraph 
(c)(2)(vi) of this section, new lots of the product are no longer being 
U.S. retained, the product shall again be considered with its Group.
    (d) Adulterated and misbranded products. Products not meeting 
specified PFF requirements, determined according to procedures set forth 
in this section, may be deemed adulterated under section 1(m)(8) of the 
Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act 
(21 U.S.C. 601(n)).
    (e) Quality control. Cured pork products bearing on their labeling 
the statement ``X% of Weight is Added Ingredients'' shall be prepared 
only under a quality control system or program in accordance with Sec. 
318.4 of this subchapter. With respect to any other cured pork product, 
official establishments may institute quality control procedures under 
Sec. 318.4 of this subchapter. Cured pork products produced in such 
establishments may be exempt from the requirements of this section, 
provided in plant quality control procedures are shown to attain the 
same or higher degree of compliance as the procedures set forth in this 
section; provided, however, that all cured pork products produced shall 
be subject to the applicable Absolute Minimum PFF content requirement, 
regardless of any quality control procedures in effect.

[49 FR 14877, Apr. 13, 1984; 49 FR 33434, Aug. 23, 1984, as amended at 
59 FR 33642, June 30, 1994; 60 FR 10304, Feb. 24, 1995; 62 FR 45025, 
Aug. 25, 1997]



Sec. 318.20  Use of animal drugs.

    Animal drug residues are permitted in meat and meat food products if 
such residues are from drugs which have been approved by the Food and 
Drug Administration and any such drug residues are within tolerance 
levels approved by the Food and Drug Administration, unless otherwise 
determined by the Administrator and listed herein.

[50 FR 32165, Aug. 9, 1985]



Sec. 318.21  Accreditation of chemistry laboratories.

    (a) Definitions--Accredited laboratory-- A non-Federal analytical 
laboratory that has met the requirements for accreditation specified in 
this section and hence, at an establishment's discretion, may be used in 
lieu of an FSIS laboratory for analyzing official regulatory samples. 
Payment for the analysis of official samples is to be made by the 
establishment using the accredited laboratory.
    Accreditation--Determination by FSIS that a laboratory is qualified 
to analyze official samples of product subject to regulations in this 
subchapter and part 381 of this chapter for the presence and amount of 
all four food chemistry analytes (protein, moisture, fat, and salt); or 
a determination by FSIS that a laboratory is qualified to analyze 
official samples of product subject to regulations in this subchapter 
and part 381 of this chapter for the presence and amount of one of 
several classes of chemical residue, in accordance with the requirements 
of the Accredited Laboratory Program. Accreditations are granted 
separately for the food chemistry analysis of official samples and for 
the analysis of such samples for any one of the several classes of 
chemical residue. A laboratory may hold more than one accreditation.
    AOAC methods--Methods of chemical analysis, Chapter 39, Association 
of Official Analytical Chemists (AOAC), published in the ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists,'' 15th edition, 1990.\1\ The ``Official Methods of Analysis of 
the Association of Official Analytical Chemists,'' 15th edition, 1990, 
is incorporated by reference with the approval of the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
---------------------------------------------------------------------------

    \1\ A copy of the ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 15th edition, 1990, is on file with 
the Director, Office of the Federal Register, and may be purchased from 
the Association of Official Analytical Chemists, Inc., 2200 Wilson 
Boulevard, Suite 400, Arlington, Virginia 22201.
---------------------------------------------------------------------------

    Chemical residue misidentification-- see ``correct chemical residue 
identification'' definition.

[[Page 264]]

    Coefficient of variation (CV)-- The standard deviation of a 
distribution of analytical values multiplied by 100, and divided by the 
mean of those values.
    Comparison Mean--The average, for a sample, of all accredited and 
FSIS laboratories' average results, each of which has a large deviation 
measure of zero, except when only two laboratories perform the analysis, 
as in the case of split sample analysis by both an accredited laboratory 
and an FSIS laboratory. In the latter case, the comparison mean is the 
average of the two laboratories' results. For food chemistry, a result 
for a laboratory is the obtained analytical value; for chemical 
residues, a result is the logarithmic transformation of the obtained 
analytical value.
    Correct chemical residue identification--Correct identification by a 
laboratory of a chemical residue whose concentration, in a sample, is 
equal to or greater than the minimum reporting level for that residue, 
as determined by the median of all positive analytical values obtained 
by laboratories analyzing the sample. Failure of a laboratory to report 
the presence such a chemical residue is considered a mis ident i fi 
cation. In addition, reporting the presence of a residue at a level 
equal to or above the minimum reporting level that is not reported by 90 
percent or more of all other laboratories analyzing the sample, is 
considered a misidentification.
    CUSUM--A class of statistical procedures for assessing whether or 
not a process is ``in control''. Each CUSUM value is constructed by 
accumulating incremental values obtained from observed results of the 
process, and then determined to either exceed or fall within acceptable 
limits for that process. The initial CUSUM values for each laboratory 
whose application for accreditation is accepted are set at zero. The 
four CUSUM procedures are:
    (1) Positive systemic laboratory difference CUSUM (CUSUM-P)--
monitors how consistently an accredited laboratory gets numerically 
greater results than the comparison mean;
    (2) Negative systematic laboratory difference CUSUM (CUSUM-N)--
monitors how consistently an accredited laboratory gets numerically 
smaller results than the comparison mean;
    (3) Variability CUSUM (CUSUM-V)--monitors the average ``total 
discrepancy'' (i.e., the combination of the random fluctuations and 
systematic differences) between an accredited laboratory's results and 
the comparison mean;
    (4) Individual large discrepancy CUSUM (CUSUM-D)--monitors the 
magnitude and frequency of large differences between the results of an 
accredited laboratory and the comparison mean.
    Individual large deviation--An analytical result from a non-Federal 
laboratory that differs from the sample comparison mean by more than 
would be expected assuming normal laboratory variability.
    Initial accreditation check sample--A sample prepared and sent by an 
FSIS laboratory to a non-Federal laboratory to ascertain if the non-
Federal laboratory's analytical capability meets the standards for 
granting accreditation.
    Interlaboratory accreditation maintenance check sample--A sample 
prepared and sent by FSIS to a non-Federal laboratory to assist in 
determining if acceptable levels of analytical capability are being 
maintained by the accredited laboratory.
    Large deviation measure--A measure that quantifies an unacceptably 
large difference between a non-Federal laboratory's analytical result 
and the sample comparison mean.
    Minimum proficiency level--The minimum concentration of a residue at 
which an analytical result will be used to assess a laboratory's 
quantification capability. This concentration is an estimate of the 
smallest concentration for which the average coefficient of variation 
(CV) for reproducibility (i.e., combined within and between laboratory 
variability) does not exceed 20 percent. (See Table 2)
    Minimum reporting level--The number such that if any obtained 
analytical value equals or exceeds this number, then the residue is 
reported together with the obtained analytical value.
    Official Sample--A sample selected by a Program employee in 
accordance with FSIS procedures for regulatory use.

[[Page 265]]

    Probation-- The period commencing with official notification to an 
accredited laboratory that its check or split sample results no longer 
satisfy the performance requirements specified in this rule, and ending 
with official notification that accreditation is either fully restored, 
suspended, or revoked.
    QA (quality assurance) recovery--The ratio of a laboratory's 
unadjusted analytical value of a check sample residue to the residue 
level fortified by the FSIS laboratory that prepared the sample, 
multiplied by 100. (See Table 2.)
    QC (quality control) recovery--The ratio of a laboratory's 
unadjusted analytical value of a quality control standard to the 
fortification level of the standard, multiplied by 100. (See Table 2.)
    Refusal of Accreditation--An action taken when a laboratory which is 
applying for accreditation is denied the accreditation.
    Responsibly connected--Any individual who or entity which is a 
partner, officer, director, manager, or owner of 10 per centum or more 
of the voting stock of the applicant or recipient of accreditation or an 
employee in a managerial or executive capacity or any employee who 
conducts or supervises the chemical analysis of FSIS official samples.
    Revocation of Accreditation--An action taken against a laboratory 
which removes its right to analyze official samples.
    Split sample-- An official sample divided into duplicate portions, 
one portion to be analyzed by an accredited laboratory (for official 
regulatory purposes) and the other portion by an FSIS laboratory (for 
comparison purposes).
    Standardizing Constant--The number which is the result of a 
mathematical adjustment to the ``standardized value.'' Specifically, the 
number equals the square root of the expected variance of the difference 
between the accredited or applying laboratory's result and the 
comparison mean on a sample, taking into consideration the standardizing 
value, the correlation and number of repeated results by a laboratory on 
a sample, and the number of laboratories that analyzed the sample.
    Standardized Difference--The quotient of the difference between a 
laboratory's result on a sample and the comparison mean of the sample 
divided by the standardizing constant.
    Standardizing Value--A number representing the performance standard 
deviation of an individual result (see Tables 1 and 2 and footnotes to 
the Tables for determining exact procedures for calculation).
    Suspension of Accreditation--Action taken against a laboratory which 
temporarily removes its right to analyze official samples. Suspension of 
accreditation ends when accreditation is either fully restored or 
revoked.
    Systematic laboratory difference--A comparison of one laboratory's 
results with the comparison means on samples that shows, on average, a 
consistent relationship. A laboratory that is reporting, on average, 
numerically greater results than the comparison mean has a positive 
systematic laboratory difference and, conversely, numerically smaller 
results indicate a negative systematic laboratory difference.
    Variability-- Random fluctuations in a laboratory's processes that 
cause its analytical results to deviate from a true value.
    Variance--The expected average of the squared differences of sample 
results from an expected sample mean.

                                Table 1--Standardizing Values for Food Chemistry
                                         [By product class and analyte]
----------------------------------------------------------------------------------------------------------------
                                                                               Protein
                          Product/Class                             Moisture     \1\        Fat \2\     Salt \3\
----------------------------------------------------------------------------------------------------------------
Cured Pork/Canned Ham............................................       0.50      0.060   0.26 (0.30)      0.127
Ground Beef......................................................       0.71      0.060        (0.35)      0.127
Other............................................................       0.57      0.060   0.26 (0.30)      0.127
----------------------------------------------------------------------------------------------------------------
\1\ To obtain the standardizing value for a sample the appropriate entry in this column is multiplied by X0.65
  where X is the comparison mean of the sample.
\2\ To obtain the standardizing value for a sample, the appropriate entry in this column is multiplied by X0.25,
  where X is the comparison mean of the sample. The appropriate entry is equal to the value in parentheses when
  X is equal to or greater than 12.5 percent, otherwise it is equal to 0.26.
\3\ To obtain the standardizing value for a sample, when the comparison mean of the sample, X, is less than 1.0
  percent, the standardizing value equals 0.127, otherwise the appropriate entry is multiplied by X0.25. When X
  is equal to or greater than 4.0 percent for dry salami and pepperoni products, the standardizing value equals
  0.22.


[[Page 266]]


   Table 2--Minimum Proficiency Levels, Percent Expected Recoveries (QC and QA), and Standardizing Values for
                                                Chemical Residues
----------------------------------------------------------------------------------------------------------------
                                                                             Percent expected
                   Class of residues                          Minimum        recovery (QC and    Standardizing
                                                         proficiency level         QA)             value \3\
----------------------------------------------------------------------------------------------------------------
Chlorinated Hydrocarbons:\1\
    Aldrin.............................................           0.10 ppm             80-110               0.20
    Benzene Hexachloride...............................           0.10 ppm             80-110               0.20
    Chlordane..........................................           0.30 ppm             80-110               0.20
    Dieldrin...........................................           0.10 ppm             80-110               0.20
    DDT................................................           0.15 ppm             80-110               0.20
    DDE................................................           0.10 ppm             80-110               0.20
    TDE................................................           0.15 ppm             80-110               0.20
    Endrin.............................................           0.10 ppm             80-110               0.20
    Heptachlor.........................................           0.10 ppm             80-110               0.20
    Heptachlor Epoxide.................................           0.10 ppm             80-110               0.20
    Lindane............................................           0.10 ppm             80-110               0.20
    Methoxychlor.......................................           0.50 ppm             80-110               0.20
    Toxaphene..........................................           1.00 ppm             80-110               0.20
    Hexachlorobenzene..................................           0.10 ppm             80-110               0.20
    Mirex..............................................           0.10 ppm             80-110               0.20
    Nonachlor..........................................           0.15 ppm             80-110               0.20
Polychlorinated Biphenyls:                                        0.50 ppm             80-110               0.20
    Arsenic \2\........................................           0.20 ppm             90-105               0.25
    Sulfonamides \2\...................................           0.08 ppm             70-120               0.25
    Volatile Nitrosamine \2\...........................              5 ppm             70-110               0.25
----------------------------------------------------------------------------------------------------------------
\1\ Laboratory statistics are computed over all results (excluding PCB results), and for specific chemical
  residues.
\2\ Laboratory statistics are only computed for specific chemical residues.
\3\ The standardizing value of all initial accreditation and probationary check samples computations is 0.15.

    (b) Laboratories accredited for analysis of protein, moisture, fat, 
and salt content of meat and meat products--(1) Applying for 
accreditation. Application for accreditation shall be made on designated 
forms provided by FSIS, or otherwise in writing, by the owner or manager 
of a non-Federal analytical laboratory and sent to the Accredited 
Laboratory Program, Food Safety and Inspection Service, U.S. Department 
of Agriculture, Washington, DC 20250-3700, and shall specify the kinds 
of accreditation that are wanted by the owner or manager of the 
laboratory. A laboratory whose accreditation has been refused or revoked 
may reapply for accreditation after 60 days from the effective date of 
that action, and must provide written documentation specifying what 
corrections were made.
    (i) At the time that an Application for Accreditation is filed with 
the Accredited Laboratory Program, FSIS, and annually thereafter upon 
receipt of the bill issued by FSIS on the anniversary date of each 
accreditation, the management of a laboratory shall reimburse the 
program at the rate specified in 9 CFR 391.5 for the cost of each 
accreditation that is sought for the laboratory or that the laboratory 
holds.
    (ii) Simultaneously with the initial application for accreditation, 
the management of a laboratory shall forward a check, bank draft, or 
money order in the amount specified in 9 CFR 391.5 made payable to the 
U.S. Department of Agriculture along with the completed application for 
the accreditation(s) sought by the laboratory. Accreditation will not be 
granted or continued, without further procedure, for failure to pay the 
accreditation fee(s). The fee(s) paid shall be nonrefundable and shall 
be credited to the account from which the expenses of the laboratory 
accreditation program are paid.
    (iii) Annually on the anniversary date of each accreditation, FSIS 
will issue a bill in the amount specified in 9 CFR 391.5.
    (iv) Bills are payable upon receipt by check, bank draft, or money 
order, made payable to the U.S. Department of Agriculture, and become 
delinquent 30 days from the date of the bill. Accreditation will be 
terminated without further procedure for having a delinquent account. 
The fee(s) paid shall be nonrefundable and shall be credited to the 
account from which the expenses of

[[Page 267]]

the Accredited Laboratory Program are paid.
    (v) The accreditation of a laboratory that was accredited by FSIS on 
or before December 13, 1993 and was not on probation and whose 
accreditation on that date was not in suspension or revocation shall be 
continued, provided that such laboratory reapply for accreditation in 
accordance with the provisions of this paragraph (b)(1) by January 12, 
1994 (30 days after the effective date of this section), and that the 
reapplication be accepted by the Agency. The CUSUM values for such 
laboratory will be reset at zero upon acceptance of its reapplication. 
The accreditation of a laboratory that is on probation shall be 
continued, provided that the laboratory reapply for accreditation by 
February 11, 1994 (60 days after the effective date of this section), 
that the reapplication be accepted by the Agency, and that the 
laboratory satisfy the terms of the probation.
    (2) Criteria for obtaining accreditation. Non-Federal analytical 
laboratories may be accredited for the analyses of moisture, protein, 
fat, and salt content of meat and meat food products. Accreditation will 
be given only if the applying laboratory successfully satisfies the 
requirements presented below, for all four analytes. This accreditation 
authorizes official FSIS acceptance of the analytical test results 
provided by these laboratories on official samples. To obtain FSIS 
accreditation for moisture, protein, fat, and salt analyses, a non-
Federal analytical laboratory must:
    (i) Be supervised by a person holding, as a minimum, a bachelor's 
degree in either chemistry, food science, food technology, or a related 
field and having 1 year's experience in food chemistry, or equivalent 
qualifications, as determined by the Administrator.
    (ii) Demonstrate acceptable levels of systematic laboratory 
difference, variability, and individual large deviations in the analyses 
of moisture, protein, fat, and salt content using AOC methods. An 
applying laboratory will successfully demonstrate these capabilities if 
its moisture, protein, fat, and salt results from a 36 check sample 
accreditation study each satisfy the criteria presented below.\2\ If the 
laboratory's analysis of an analyte (or analytes) from the first set of 
36 check samples does not meet the criteria for obtaining accreditation, 
a second set of 36 check samples will be provided within 30 days 
following the date of receipt by FSIS of a request from the applying 
laboratory. The second set of samples shall be analyzed for only the 
analyte(s) for which unacceptable initial results had been obtained by 
the laboratory. If the results of the second set of samples do not meet 
the accreditation criteria, the laboratory may reapply after a 60-day 
waiting period, commencing from the date of refusal of accreditation by 
FSIS. At that time, a new application, all fees, and all documentation 
of corrective action required for accreditation must be submitted.
---------------------------------------------------------------------------

    \2\ All statistical computations are rounded to the nearest tenth, 
except where otherwise noted.
---------------------------------------------------------------------------

    (A) Systematic laboratory difference: The absolute value of the 
average standardized difference must not exceed 0.73 minus the product 
of 0.17 and the standard deviation of the standardized differences.
    (B) Variability: The estimated standard deviation of the 
standardized differences must not exceed 1.15.
    (C) Individual large deviations: One hundred times the average of 
the large deviation measures of the individual samples must be less than 
5.0.\3\
---------------------------------------------------------------------------

    \3\ A result will have a large deviation measure equal to zero when 
the absolute value of the result's standardized difference, (d), is less 
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------

    (iii) Allow inspection of the laboratory by FSIS officials prior to 
the determination of granting accredited status.
    (iv) Pay the accreditation fee by the date required.
    (3) Criteria for maintaining accreditation. To maintain 
accreditation for moisture, protein, fat, and salt analyses, a non-
Federal analytical laboratory must:
    (i) Report analytical results of the moisture, protein, fat, and 
salt content of official samples, weekly, on designated forms to the 
FSIS Eastern Laboratory, College Station Road, P.O.

[[Page 268]]

Box 6085, Athens, GA 30604, or to the address designated by the 
Assistant Administrator, Office of Public Health and Science.
    (ii) Maintain laboratory quality control records for the most recent 
3 years that samples have been analyzed under this Program.
    (iii) Maintain complete records of the receipt, analysis, and 
disposition of official samples for the most recent 3 years that samples 
have been analyzed under this Program.
    (iv) Maintain a standards book, which is a permanently bound book 
with sequentially numbered pages, containing all readings and 
calculations for standardization of solutions, determination of 
recoveries, and calibration of instruments. All entries are to be dated 
and signed by the analyst immediately upon completion of the entry and 
by his/her supervisor within 2 working days. The standards book is to be 
retained for a period of 3 years after the last entry is made.
    (v) Analyze interlaboratory accreditation maintenance check samples 
and return the results to FSIS within 3 weeks of sample receipt. This 
must be done whenever requested by FSIS and at no cost to FSIS.
    (vi) Inform the Accredited Laboratory Program, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250-3700, by certified or registered mail, within 30 days, when there 
is any change in the laboratory's ownership, officers, directors, 
supervisory personnel, or other responsibly connected individual or 
entity.
    (vii) Permit any duly authorized representative of the Secretary to 
perform both announced and unannounced on-site laboratory reviews of 
facilities and records during normal business hours, and to copy any 
records pertaining to the laboratory's participation in the Accredited 
Laboratory Program.
    (viii) Use official AOAC methods \4\ on official and check samples. 
The ``Official Methods of Analysis of the Association of Official 
Analytical Chemists,'' 15th edition, 1990, is incorporated by reference 
with the approval of the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51.
---------------------------------------------------------------------------

    \4\ A copy of the ``Official Methods of Analysis of the Association 
of Analytical Chemists,'' 15th edition, 1990, is on file with the 
Director, Office of the Federal Register, and may be purchased from the 
Association of Official Analytical Chemists, Inc., 2200 Wilson 
Boulevard, Suite 400, Arlington, Virginia 22201.
---------------------------------------------------------------------------

    (ix) Demonstrate that acceptable limits of systematic laboratory 
difference, variability, and individual large deviations are being 
maintained in the analyses of moisture, protein, fat, and salt content. 
An accredited laboratory will successfully demonstrate the maintenance 
of these capabilities if its moisture, protein, fat, and salt results 
from interlaboratory accreditation maintenance check samples and/or 
split samples satisfy the criteria presented below.\5\
---------------------------------------------------------------------------

    \5\ All statistical computations are rounded to the nearest tenth, 
except where otherwise noted.
---------------------------------------------------------------------------

    (A) Systematic laboratory difference:
    (1) Positive systematic laboratory difference: The standardized 
difference between the accredited laboratory's result and that of the 
FSIS laboratory for each split or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as CUSUM-P. This value is computed and evaluated as follows:
    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 1.6,
-2.0, if the standardized difference is less than -1.6,

 or

the standardized difference minus 0.4, if the standardized difference 
lies between -1.6 and 2.4, inclusive.

    (ii) Compute the new CUSUM-P value. The new CUSUM-P value is 
obtained by adding algebraically, the CUSUM increment to the last 
previously computed CUSUM-P value. If this computation yields a value 
smaller than 0, the new COSUM-P value is set equal to 0. [COSUM-P values 
are initialized at zero; that is, the COSUM-P value associated with the 
first sample is set equal to the CUSUM increment for that sample.]

[[Page 269]]

    (iii) Evaluate the new COSUM-P value. The new COSUM-P value must not 
exceed 5.2.
    (2) Negative systematic laboratory difference: The standardized 
difference between the accredited laboratory's result and that of the 
FSIS laboratory for each split or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-N. This value is computed and evaluated as follows:
    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 1.6,
-2.0, if the standardized difference is less than -2.4,

 or

the standardized difference plus 0.4, if the standardized difference 
lies between -2.4 and 1.6, inclusive.

    (ii) Compute the new COSUM-N value. The new COSUM-N value is 
obtained by subtracting, algebraically, the CUSUM increment to the last 
previously computed COSUM-N value. If this computation yields a value 
smaller than 0, the new COSUM-N value is set equal to 0. [COSUM-N values 
are initialized at zero; that is, the COSUM-N value associated with the 
first sample is set equal to the CUSUM increment for that sample.]
    (iii) Evaluate the new COSUM-N value. The new COSUM-N value must not 
exceed 5.2.
    (B) Variability: The absolute value of the standardized difference 
between the accredited laboratory's result and that of the FSIS 
laboratory for each split sample or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-V. This value is computed and evaluated as follows:
    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the larger of -0.4 and the absolute value of 
the standardized difference minus 0.9. If this computation yields a 
value larger than 1.6, the increment is set equal to 1.6.
    (2) Compute the new COSUM-V value. The new COSUM-V value is obtained 
by adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-V value. If this computation yields a value less than 0, 
the new COSUM-V value is set equal to 0. [COSUM-V values are initialized 
at zero; that is, the COSUM-V value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-V value. The new COSUM-V value must not 
exceed 4.3.
    (C) Large deviations: The large deviation measure of the accredited 
laboratory's result for each split sample or interlaboratory 
accreditation maintenance check sample is used to determine a CUSUM 
value, designated as COSUM-D.\6\ This value is computed and evaluated as 
follows:
---------------------------------------------------------------------------

    \6\ See footnote 3.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the value of the large deviation measure minus 
0.025.
    (2) Compute the new COSUM-D value. The new COSUM-D value is obtained 
by adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-D value. If this computation yields a value less that 0, 
the new COSUM-D value is set equal to 0. [COSUM-D values are initialized 
at zero; that is, the COSUM-D value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-D value. The new COSUM-D value must not 
exceed 1.0.
    (x) Meet the following requirements if placed on probation pursuant 
to paragraph (e) of this section:
    (A) Send all official samples that have not been analyzed as of the 
date of written notification of probation to a specified FSIS laboratory 
by certified mail or private carrier or, as an alternative, to an 
accredited laboratory approved for food chemistry. Mailing expenses will 
be paid by FSIS.
    (B) Analyze a set of check samples similar to those used for initial 
accreditation, and submit the analytical results to FSIS within 3 weeks 
of receipt of the samples.
    (C) Satisfy criteria for check samples specified in paragraphs 
(b)(2)(ii) (A), (B), and (C) of this section.

[[Page 270]]

    (xi) Expeditiously report analytical results of official samples to 
the FSIS Eastern Laboratory, College Station Road, P.O. Box 6085, 
Athens, GA 30604, or to the address designated by the Assistant 
Administrator, Office of Public Health and Science. The Federal 
inspector at any establishment may assign the analysis of official 
samples to an FSIS laboratory if, in the inspector's judgment, there are 
delays in receiving test results on official samples from an accredited 
laboratory.
    (xii) Pay the required accreditation fee when it is due.
    (c) Laboratories accredited for analysis of a class of chemical 
residues in meat and meat food products--(1) Applying for accreditation. 
Application for accreditation shall be made on designated forms provided 
by FSIS, or otherwise in writing, by the owner or manager of the non-
Federal analytical laboratory and sent to the Accredited Laboratory 
Program, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250-3700, and shall specify the kinds of 
accreditation that are wanted by the owner or manager of the laboratory. 
A laboratory whose accreditation has been refused or revoked may reapply 
for accreditation after 60 days from the effective date of that action, 
and must provide written documentation specifying what corrections were 
made.
    (i) At the time that an Application for Accreditation is filed with 
the Accredited Laboratory Program, FSIS, and annually thereafter upon 
receipt of the bill issued by FSIS on the anniversary date of each 
accreditation, the management of a laboratory shall reimburse the 
program at the rate specified in 9 CFR 391.5 for the cost of each 
accreditation that is sought for the laboratory or that the laboratory 
holds.
    (ii) Simultaneously with the initial application for accreditation, 
the management of a laboratory shall forward a check, bank draft, or 
money order in the amount specified in 9 CFR 391.5 made payable to the 
U.S. Department of Agriculture along with the completed application for 
the accreditation(s) sought for the laboratory. Accreditation will not 
be granted or continued, without further procedure, for failure to pay 
the accreditation fee(s). The fee(s) paid shall be nonrefundable and 
shall be credited to the account from which the expenses of the 
laboratory accreditation program are paid.
    (iii) Annually on the anniversary date of each accreditation, FSIS 
will issue a bill in the amount specified in 9 CFR 391.5.
    (iv) Bills are payable upon receipt by check, bank draft, or money 
order, made payable to the U.S. Department of Agriculture, and become 
delinquent 30 days from the date of the bill. Accreditation will be 
terminated without further procedure for having a delinquent account. 
The fee(s) paid shall be nonrefundable and shall be credited to the 
account from which the expenses of the Accredited Laboratory Program are 
paid.
    (v) The accreditation of a laboratory that was accredited by FSIS on 
or before December 13, 1993 and was not on probation and whose 
accreditation on that date was not in suspension or revocation shall be 
continued, provided that such laboratory reapply for accreditation in 
accordance with the provisions of this paragraph (c)(1), by January 12, 
1994 (30 days of the effective date of this section), and that the 
reapplication be accepted by the Agency. The CUSUM values for such 
laboratory will be reset at zero upon acceptance of its reapplication. 
The accreditation of a laboratory that is on probation shall be 
continued, provided that such laboratory reapply for accreditation by 
February 11, 1994 (60 days of the effective date of this section), that 
the reapplication be accepted by the Agency, and that the laboratory 
satisfy the terms of the probation.
    (2) Criteria for obtaining accreditation. Non-Federal analytical 
laboratories may be accredited for the analysis of a class of chemical 
residues in meat and meat food products. Accreditation will be given 
only if the applying laboratory successfully satisfies the requirements 
presented below. This accreditation authorizes official FSIS acceptance 
of the analytical test results provided by these laboratories on 
official samples. To obtain FSIS accreditation for the analysis of a 
class of chemical residues, a non-Federal analytical laboratory must:

[[Page 271]]

    (i) Be supervised by a person holding, as a minimum, a bachelor's 
degree in either chemistry, food science, food technology, or a related 
field. Further, either the supervisor or the analyst assigned to analyze 
the sample must have 3 years' experience determining analytes at or 
below part per million levels, or equivalent qualifications, as 
determined by the Administrator.
    (ii) Demonstrate acceptable limits of systematic laboratory 
difference, variability, individual large deviations, recoveries, and 
proper identification in the analysis of the class of chemical residues 
for which application was made, using FSIS approved procedures. An 
applying laboratory will successfully demonstrate these capabilities if 
its analytical results for each specific chemical residue provided in a 
check sample accreditation study containing a minimum of 14 samples 
satisfy the criteria presented in this paragraph (c)(2)(ii).\7\ In 
addition, if the laboratory is requesting accreditation for the analysis 
of chlorinated hydrocarbons, all analytical results for the residue 
class must collectively satisfy the criteria. [Conformance to criteria 
(c)(2)(ii) (A), (B), (C), (D), (E), and (F) will only be determined when 
six or more analytical results with associated comparison means at or 
above the logarithm of the minimum proficiency level are available.] If 
the results of the first set of check samples do not meet these criteria 
for obtaining accreditation, a second set of at least 14 samples will be 
provided within 30 days following the date of receipt by FSIS of a 
request from the applying laboratory. If the results of the second set 
of samples do not meet accreditation criteria, the laboratory may 
reapply after a 60-day waiting period, commencing from the date of 
refusal of accreditation by FSIS. At that time, a new application, all 
fees, and all documentation of corrective action required for 
accreditation must be submitted.
---------------------------------------------------------------------------

    \7\ All statistical computations are rounded to the nearest tenth, 
except where otherwise noted.
---------------------------------------------------------------------------

    (A) Systematic laboratory difference: The absolute value of the 
average standardized difference must not exceed 1.67 (2.00 if there are 
less than 12 analytical results) minus the product of 0.29 and the 
standard deviation of the standardized differences.
    (B) Variability: The standard deviation of the standardized 
differences must not exceed a computed limit. This limit is a function 
of the number of analytical results used in the computation of the 
standard deviation, and of the amount of variability associated with the 
results from the participating FSIS laboratories.
    (C) Individual large deviations: One hundred times the average of 
the large deviation measures of the individual analytical results must 
be less than 5.0.\8\
---------------------------------------------------------------------------

    \8\ A result will have a large deviation measure equal to zero when 
the absolute value of the result's standardized difference, (d), is less 
than 2.5 and otherwise a measure equal 1-(2.5/d)\4\.
---------------------------------------------------------------------------

    (D) QA recovery: The average of the QA recoveries of the individual 
analytical results must lie within the range given in Table 2 under the 
column entitled ``Percent Expected Recovery.''
    (E) QC recovery: All QC recoveries must lie within the range given 
in Table 2 under ``Percent Expected Recovery.'' Supporting documentation 
must be made available to FSIS upon request.
    (F) Correct identification: There must be correct identification of 
all chemical residues in all samples.
    (iii) Allow inspection of the laboratory by FSIS officials prior to 
the determination of granting accredited status.
    (iv) Pay the accreditation fee by the date required.
    (3) Criteria for maintaining accreditation. To maintain 
accreditation for analysis of a class of chemical residues, a non-
Federal analytical laboratory must:
    (i) [Reserved]
    (ii) Maintain laboratory quality control records for the most recent 
3 years that samples have been analyzed under this Program.
    (iii) Maintain complete records of the receipt, analysis, and 
disposition of official samples for the most recent 3 years that samples 
have been analyzed under the Program.
    (iv) Maintain a standards book, which is a permanently bound book

[[Page 272]]

with sequentially numbered pages, containing all readings and 
calculations for standardization of solutions, determination of 
recoveries, and calibration of instruments. All entries are to be dated 
and signed by the analyst immediately upon completion of the entry and 
by his/her supervisor within 2 working days. The standards book is to be 
retained for a period of 3 years after the last entry is made.
    (v) Analyze interlaboratory accreditation maintenance check samples 
and return the results to FSIS within 3 weeks of sample receipt. This 
must be done whenever requested by FSIS and at no cost to FSIS.
    (vi) Inform the Accredited Laboratory Program, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250-3700, by certified or registered mail, within 30 days of any 
change in the laboratory's ownership, officers, directors, supervisory 
personnel, or any other responsibly connected individual or entity.
    (vii) Permit any duly authorized representative of the Secretary to 
perform both announced and unannounced on-site laboratory reviews of 
facilities and records during normal business hours, and to copy any 
records pertaining to the laboratory's participation in the Accredited 
Laboratory Program.
    (viii) Use analytical procedures designated and approved by FSIS.
    (ix) Demonstrate that acceptable limits of systematic laboratory 
difference, variability, and individual large deviations are being 
maintained in the analysis of samples, in the chemical residue class for 
which accreditation was granted. A laboratory will successfully 
demonstrate the maintenance of these capabilities if its analytical 
results for each specific chemical residue found in interlaboratory 
accreditation maintenance check samples and/or split samples satisfy the 
criteria presented in this paragraph (c)(3)(ix).\9,10\ In addition, if 
the laboratory is accredited for the analysis of chlorinated 
hydrocarbons, all analytical results for the residue class must 
collectively satisfy the criteria.
---------------------------------------------------------------------------

    \9\ All statistical computations are rounded to the nearest tenth, 
except where otherwise noted.
    \10\ An analytical result will only be used in the statistical 
evaluation of the laboratory if the associated comparison mean is equal 
to or greater than the logarithm of the minimum proficiency level for 
the residue.
---------------------------------------------------------------------------

    (A) Systematic laboratory difference:
    (1) Positive systematic laboratory difference: The standardized 
difference between the accredited laboratory's result and that of the 
FSIS laboratory for each split and/or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-P.\11\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \11\ When determining compliance with this criterion for all 
chlorinated hydrocarbon results in a sample collectively, the following 
statistical procedure must be followed to account for the correlation of 
analytical results within a sample: the average of the standardized 
differences of the analytical results within the sample, divided by a 
constant, is used in place of a single standardized difference to 
determine the COSUM-P (or COSUM-N) value for the sample. The constant is 
a function of the number of analytical results used to compute the 
average standardized difference.
---------------------------------------------------------------------------

    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 2.5,
-2.0, if the standardized difference is less than -1.5,

 or

the standardized difference minus 0.5, if the standardized difference 
lies between -1.5 and 2.5, inclusive.

    (ii) Compute the new COSUM-P value. The new COSUM-P value is 
obtained by adding, algebraically, the CUSUM increment to the last 
previously computed COSUM-P value. If this computation yields a value 
smaller than 0, the new COSUM-P value is set equal to 0. [COSUM-P values 
are initialized at zero; that is, the COSUM-P value associated with the 
first sample is set equal to the CUSUM increment for that sample.]
    (iii) Evaluate the new COSUM-P value. The new COSUM-P value must not 
exceed 4.8.
    (2) Negative systematic laboratory difference: The standardized 
difference between the accredited laboratory's result and that of the 
FSIS laboratory

[[Page 273]]

for each split and/or interlaboratory accreditation maintenance check 
sample is used to determine a CUSUM value, designated as COSUM-N.\12\ 
This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \12\ See footnote 11.
---------------------------------------------------------------------------

    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 1.5,
-2.0, if the standardized difference is less than -2.5,

 or

the standardized difference plus 0.5, if the standardized difference 
lies between -2.5 and 1.5, inclusive.

    (ii) Compute the new COSUM-N value. The new COSUM-N value is 
obtained by subtracting, algebraically, the CUSUM increment to the last 
previously computed COSUM-N value. If this computation yields a value 
smaller than 0, the new COSUM-N value is set equal to 0. [COSUM-N values 
are initialized at zero; that is, the COSUM-N value associated with the 
first sample is set equal to the CUSUM increment for that sample.]
    (iii) Evaluate the new COSUM-N value. The new COSUM-N value must not 
exceed 4.8.
    (B) Variability: The absolute value of the standardized difference 
between the accredited laboratory's result and that of the FSIS 
laboratory for each split and/or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-V.\13\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \13\ When determining compliance with this criterion for all 
chlorinated hydrocarbon results in a sample collectively, the following 
statistical procedure must be followed to account for the correlation of 
analytical results within a sample: the square root of the sum of the 
within sample variance and the average standardized difference of the 
sample, divided by a constant, is used in place of the absolute value of 
the standardized difference to determine the COSUM-V value for the 
sample. The constant is a function of the number of analytical results 
used to compute the average standardized difference.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the larger of -0.4 and the absolute value of 
the standardized difference minus 0.9. If this computation yields a 
value larger than 1.6, the increment is set equal to 1.6.
    (2) Compute the new COSUM-V value. The new COSUM-V value is obtained 
by adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-V value. If this computation yields a value less than 0, 
the new COSUM-V value is set equal to 0. [COSUM-V values are initialized 
at zero; that is, the COSUM-V value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-V value. The new COSUM-V value must not 
exceed 4.3.
    (C) Large Deviations: The large deviation measure of the accredited 
laboratory's result for each split and/or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-D.\14\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \14\ A result will have a large deviation measure equal to zero when 
the absolute value of the result's standardized difference, (d), is less 
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the large deviation measure minus 0.025.
    (2) Compute the new COSUM-D value. The new COSUM-D is obtained by 
adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-D value. If this computation yields a value less than 0, 
the new COSUM-D value is set equal to 0. [COSUM-D values are initialized 
at zero; that is, the COSUM-D value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-D value. The new COSUM-D value must not 
exceed 1.0.
    (x) Meet the following requirements if placed on probation pursuant 
to paragraph (e) of this section:
    (A) Send all official samples that have not been analyzed as of the 
date of written notification of probation to a specified FSIS laboratory 
by certified

[[Page 274]]

mail or private carrier or, as an alternative, to an accredited 
laboratory accredited for this specific chemical residue. Mailing 
expense will be paid by FSIS.
    (B) Analyze a set of check samples similar to those used for initial 
accreditation, and submit analytical results to FSIS within 3 weeks of 
receipt of the samples.
    (C) Satisfy criteria for check samples as specified in paragraphs 
(c)(2)(ii) (A), (B), (C), (D), (E), and (F) of this section.
    (xi) Expeditiously report analytical results of official samples to 
the Eastern Laboratory, College Station Road, P.O. Box 6085, Athens, GA 
30604, or to the address designated by the Assistant Administrator, 
Office of Public Health and Science. The Federal inspector at any 
establishment may assign the analysis of official samples to an FSIS 
laboratory if, in the judgment of the inspector, there are delays in 
receiving test results on official samples from an accredited 
laboratory.
    (xii) Every QC recovery associated with reporting of official 
samples must be within the appropriate range given in Table 2 under 
``Percent Expected Recovery.'' Supporting documentation must be made 
available to FSIS upon request.
    (xiii) Demonstrate that acceptable levels of systematic laboratory 
difference, variability, individual large deviations, recoveries, and 
proper identification are being maintained in the analysis of 
interlaboratory accreditation maintenance check samples, in the chemical 
residue class for which accreditation was granted. A laboratory will 
successfully demonstrate the maintenance of these capabilities if its 
analytical results for each specific chemical residue found in 
interlaboratory accreditation maintenance check samples satisfy the 
criteria presented below. In addition, if the laboratory is accredited 
for the analysis of chlorinated hydrocarbons, all analytical results for 
the residue class must collectively satisfy the criteria.
    (A) Systematic laboratory difference--(1) Positive systematic 
laboratory difference: The standardized difference between the 
accredited laboratory's result and the comparison mean for each 
interlaboratory accreditation maintenance check sample is used to 
determine a CUSUM value, designated as COSUM-P.\15\ This value is 
computed and evaluated as follows:
---------------------------------------------------------------------------

    \15\ See footnote 11.
---------------------------------------------------------------------------

    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 2.5,
-2.0, if the standardized difference is less than -1.5,

 or

the standardized difference minus 0.5, if the standardized difference 
lies between -1.5 and 2.5, inclusive.

    (ii) Compute the new COSUM-P value. The new COSUM-P value is 
obtained by adding, algebraically, the CUSUM increment to the last 
previously computed COSUM-P value. If this computation yields a value 
smaller than 0, the new COSUM-P value is set equal to 0. [COSUM-P values 
are initialized at zero; that is, the COSUM-P value associated with the 
first sample is set equal to the CUSUM increment for that sample.]
    (iii) Evaluate the new COSUM-P value. The new COSUM-P value must not 
exceed 4.8.
    (2) Negative systematic laboratory difference: The standardized 
difference between the accredited laboratory's result and the comparison 
mean for each interlaboratory accreditation maintenance check sample is 
used to determine a CUSUM value, designated as COSUM-N.\16\ This value 
is computed and evaluated as follows:
---------------------------------------------------------------------------

    \16\ See footnote 11.
---------------------------------------------------------------------------

    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 1.5,
-2.0, if the standardized difference is less than -2.5,

 or

the standardized difference plus 0.5, if the standardized difference 
lies between -2.5 and 1.5, inclusive.

    (ii) Compute the new COSUM-N value. The new COSUM-N value is 
obtained by subtracting, algebraically, the CUSUM increment to the last 
previously computed COSUM-N value. If

[[Page 275]]

this computation yields a value smaller than 0, the new COSUM-N value is 
set equal to 0. [COSUM-N values are initialized at zero; that is, the 
COSUM-N value associated with the first sample is set equal to the CUSUM 
increment for that sample.]
    (iii) Evaluate the new COSUM-N value. The new COSUM-N value must not 
exceed 4.8.
    (B) Variability: The absolute value of the standardized difference 
between the accredited laboratory's result and the comparison mean for 
each interlaboratory accreditation maintenance check sample is used to 
determine a CUSUM value, designated as COSUM-V.\17\ This value is 
computed and evaluated as follows:
---------------------------------------------------------------------------

    \17\ See footnote 13.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the larger of -0.4 or the absolute value of 
the standardized difference minus 0.9. If this computation yields a 
value larger than 1.6, the increment is set equal to 1.6.
    (2) Compute the new COSUM-V value. The new COSUM-V value is obtained 
by adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-V value. If this computation yields a value less than 0, 
the new COSUM-V value is set equal to 0. [COSUM-V values are initialized 
at zero; that is, the COSUM-V value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-V value. The new COSUM-V value must not 
exceed 4.3.
    (C) Large deviations: The large deviation measure of the accredited 
laboratory's result for each interlaboratory accreditation maintenance 
check sample is used to determine a CUSUM value, designated as COSUM-
D.\18\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \18\ A result will have a large deviation measure equal to zero when 
the absolute value of the result's standardized difference, (d), is less 
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the value of the large deviation measure minus 
0.025.
    (2) Compute the new COSUM-D value. The new COSUM-D is obtained by 
adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-D value. If this computation yields a value less than 0, 
the new COSUM-D value is set equal to 0. [COSUM-D values are initialized 
at zero; that is, the COSUM-D value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-D value. The new COSUM-D value must not 
exceed 1.0.
    (D) Each QC Recovery is within the range given in Table 2 under 
``Percent Expected Recovery''. Supporting documentation must be made 
available to FSIS upon request.
    (E) Not more than 1 residue misidentification in any 2 consecutive 
check samples.
    (F) Not more than 2 residue misidentifications in any 8 consecutive 
check samples.
    (xiv) Pay the accreditation fee when it is due.
    (d) Refusal of accreditation. Upon a determination by the 
Administrator, a laboratory shall be refused accreditation for the 
following reasons:
    (1) A laboratory shall be refused accreditation for moisture, 
protein, fat, and salt analysis for failure to meet the requirements of 
paragraph (b)(1) or (b)(2) of this section.
    (2) A laboratory shall be refused accreditation for chemical residue 
analysis for failure to meet the requirements of paragraph (c)(1) or 
(c)(2) of this section.
    (3) A laboratory shall be refused subsequent accreditation for 
failure to return to an FSIS laboratory, by certified mail or private 
carrier, all official samples which have not been analyzed as of the 
notification of a loss of accreditation.
    (4) A laboratory shall be refused accreditation if the applicant or 
any individual or entity responsibly connected with the applicant has 
been convicted of or is under indictment or if charges on an information 
have been brought against the applicant or responsibly connected 
individual or entity in any Federal or State court concerning the 
following violations of law:

[[Page 276]]

    (i) Any felony.
    (ii) Any misdemeanor based upon acquiring, handling, or distributing 
of unwholesome, misbranded, or deceptively packaged food or upon fraud 
in connection with transactions in food.
    (iii) Any misdemeanor based upon a false statement to any 
governmental agency.
    (iv) Any misdemeanor based upon the offering, giving or receiving of 
a bribe or unlawful gratuity.
    (e) Probation of accreditation. Upon a determination by the 
Administrator, a laboratory shall be placed on probation for the 
following reasons:
    (1) If the laboratory fails to complete more than one 
interlaboratory accreditation maintenance check sample analysis within 
12 consecutive months as required by paragraphs (b)(3)(v) and (c)(3)(v) 
of this section.
    (2) If the laboratory fails to meet any of the criteria set forth in 
paragraphs (b)(3)(v) and ((b)(3)(ix) and (c)(3)(v) and (c)(3)(ix) of 
this section.
    (f) Suspension of accreditation. The accreditation of a laboratory 
shall be suspended if the laboratory or any individual or entity 
responsibly connected with the laboratory is indicted or if charges on 
an information have been brought against the laboratory or responsibly 
connected individual or entity in any Federal or State court concerning 
any of the following violations of law:
    (1) Any felony.
    (2) Any misdemeanor based upon acquiring, handling or distributing 
of unwholesome, misbranded, or deceptively packaged food or upon fraud 
in connection with transactions in food.
    (3) Any misdemeanor based upon a false statement to any governmental 
agency.
    (4) Any misdemeanor based upon the offering, giving or receiving of 
a bribe or unlawful gratuity.
    (g) Revocation of accreditation. The accreditation of a laboratory 
shall be revoked for the following reasons:
    (1) An accredited laboratory which is accredited to perform analysis 
under paragraph (b) of this section shall have its accreditation revoked 
for failure to meet any of the requirements of paragraph (b)(3) of this 
section except for the following circumstances. If the accredited 
laboratory fails to meet the criteria for reporting the analytical 
results on interlaboratory accreditation maintenance check samples as 
set forth in paragraph (b)(3)(v) of this section or if, at any time, the 
CUSUM results from the analysis of such interlaboratory accreditation 
maintenance check samples and/or split samples have not satisfied the 
criteria specified in paragraph (b)(3)(ix) of this section and there 
have been, during the previous 12 months, no other occasions on which 
such CUSUM results have not satisfied such criteria, the laboratory 
shall be placed on probation; but if there have been such other 
occasions during those 12 months, the laboratory's accreditation will be 
revoked.
    (2) An accredited laboratory which is accredited to perform analysis 
for a class of chemical residues under paragraph (c) of this section 
shall have the accreditation to perform this analysis revoked if it 
fails to meet any of the requirements in paragraph (c)(3) of this 
section except for the following circumstances. If the accredited 
laboratory fails to meet any of the criteria set forth in paragraphs 
(c)(3)(v), (c)(3)(ix), and (c)(3)(xiii) of this section and it has not 
so failed during the 12 months preceding its failure to meet the 
criteria, it shall be placed on probation, but if it has so failed at 
any time during those 12 months, its accreditation will be revoked.
    (3) An accredited laboratory shall have its accreditation revoked if 
the Administrator determines that the laboratory or any responsibly 
connected individual or any agent or employee has:
    (i) Altered any official sample or analytical finding, or,
    (ii) Substituted any analytical result from any other laboratory for 
its own.
    (4) An accredited laboratory shall have its accreditation revoked if 
the laboratory or any individual or entity responsibly connected with 
the laboratory is convicted in a Federal or State court of any of the 
following violations of law:
    (i) Any felony.
    (ii) Any misdemeanor based upon acquiring, handling, or distributing 
of

[[Page 277]]

unwholesome, misbranded, or deceptively packaged food or upon fraud in 
connection with transactions in food.
    (iii) Any misdemeanor based upon a false statement to any 
governmental agency.
    (iv) Any misdemeanor based upon the offering, giving or receiving of 
a bribe or unlawful gratuity.
    (h) Notification and hearings. Accreditation of any laboratory shall 
be refused, suspended, or revoked under the conditions previously 
described herein. The owner or operator of the laboratory shall be sent 
written notice of the refusal, suspension, or revocation of 
accreditation by the Administrator. In such cases, the laboratory owner 
or operator will be provided an opportunity to present, within 30 days 
of the date of the notification, a statement challenging the merits or 
validity of such action and to request an oral hearing with respect to 
the denial, suspension, or revocation decision. An oral hearing shall be 
granted if there is any dispute of material fact joined in such 
responsive statement. The proceeding shall thereafter be conducted in 
accordance with the applicable rules of practice which shall be adopted 
for the proceeding. Any such refusal, suspension, or revocation shall be 
effective upon the receipt by the laboratory of the notification and 
shall continue in effect until final determination of the matter by the 
Administrator.

(Reporting and recordkeeping requirements approved by the Office of 
Management and Budget under control number 0583-0015)

[52 FR 2185, Jan. 20, 1987, as amended at 58 FR 65260, 65262-65264, Dec. 
13, 1993; 59 FR 33642, June 30, 1994; 59 FR 66448, Dec. 27, 1994; 60 FR 
10305, Feb. 24, 1995; 69 FR 254, Jan. 5, 2004]



Sec. 318.22  Determination of added water in cooked sausages.

    (a) For purposes of this section, the following definitions apply.
    (1) Cooked sausage. Cooked sausage is any product described in Sec. 
319.140 and Sec. Sec. 319.180-319.182 of this chapter.
    (2) Group 1 Protein-Contributing Ingredients. Ingredients of 
livestock or poultry origin from muscle tissue which is skeletal or 
which is found in the edible organs, with or without the accompanying 
and overlying fat, and the portions of bone, skin, sinew, nerve, and 
blood vessels which normally accompany the muscle tissue and which are 
not separated from it in the process of dressing; meat byproducts; 
mechanically separated (species); and poultry products; except those 
ingredients processed by hydrolysis, extraction, concentrating or 
drying.
    (3) Group 2 Protein-Contributing Ingredients. Ingredients from Gorup 
1 protein-contributing ingredients processed by hydrolysis, extraction, 
concentrating, or drying, or any other ingredient which contributes 
protein.
    (b) The amount of added water in cooked sausage is calculated by:
    (1) Determining by laboratory analysis the total percentage of water 
contained in the cooked sausage; and
    (2) Determining by laboratory analysis the total percentage of 
protein contained in the cooked sausage; and
    (3) Calculating the percentage of protein in the cooked sausage 
contributed by the Group 2 protein-contributing ingredients; and
    (4) Subtracting one pecent from the total percentage of protein 
calculated in (b)(3)); and
    (5) Subtracting the remaining percentage of protein calculated in 
(b)(3) from the total protein content determined in (b)(2); and
    (6) Calculating the percentage of indigenous water in the cooked 
sausage by multiplying the percentage of protein determined in (b)(5) by 
4, (This amount is the percentage of water attributable to Group 1 
protein-contributing ingredients and one percent of Group 2 protein-
contributing ingredients in a cooked sausage.); and
    (7) Subtracting the percentage of water calculated in (b)(6) from 
the total percentage of water determined in (b)(1). (This amount is the 
percentage of added water in a cooked sausage.) \1\
---------------------------------------------------------------------------

    \1\ The equation for the narrative description of the calculation 
for added water is as follows: AW=TW-(TP-(P-1.0))4, Where AW=Added 
Water, TW-Total Water Determined by Laboratory Analysis, TP=Total 
Protein Determined by Laboratory Analysis, P=Protein Contributed by 
Group 2 Protein-Contributing Ingredients, 1.0=Percent Allowance for 
Group 2 Protein-Contributing Ingredients, 4=Moisture-Protein Ratio for 
Cooked Sausage.

[55 FR 7299, Mar. 1, 1990]

[[Page 278]]



Sec. 318.23  Heat-processing and stabilization requirements for uncured 
meat patties.

    (a) Definitions. For purposes of this section, the following 
definitions shall apply:
    (1) Patty. A shaped and formed, comminuted, flattened cake of meat 
food product.
    (2) Comminuted. A processing term describing the reduction in size 
of pieces of meat, including chopping, flaking, grinding, or mincing, 
but not including chunking or sectioning.
    (3) Partially-cooked patties. Meat patties that have been heat 
processed for less time or using lower internal temperatures than are 
prescribed by paragraph (b)(1) of this section.
    (4) Char-marked patties. Meat patties that have been marked by a 
heat source and that have been heat processed for less time or using 
lower internal temperatures than are prescribed by paragraph (b)(1) of 
this section.
    (b) Heat-processing procedures for fully-cooked patties. (1) 
Official establishments which manufacture fully-cooked patties shall use 
one of the following heat-processing procedures:

Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked
                                 Patties
------------------------------------------------------------------------
Minimum internal temperature at the center of each  Minimum holding time
                 patty  (Degrees)                      after required
--------------------------------------------------- internal temperature
                                                     is reached  (Time)
                                                   ---------------------
           Fahrenheit              Or centigrade                   Or
                                                     Minutes    seconds
------------------------------------------------------------------------
151............................  66.1.............        .68         41
152............................  66.7.............        .54         32
153............................  67.2.............        .43         26
154............................  67.8.............        .34         20
155............................  68.3.............        .27         16
156............................  68.9.............        .22         13
157 (and up)...................  69.4 (and up)....        .17         10
------------------------------------------------------------------------

    (2) The official establishment shall measure the holding time and 
temperature of at least one fully-cooked patty from each production line 
each hour of production to assure control of the heat process. The 
temperature measuring device shall be accurate within 1 degree F.
    (3) Requirements for handling heating deviations. (i) If for any 
reason a heating deviation has occurred, the official establishment 
shall investigate and identify the cause; take steps to assure that the 
deviation will not recur; and place on file in the official 
establishment, available to any duly authorized FSIS program employee, a 
report of the investigation, the cause of the deviation, and the steps 
taken to prevent recurrence.
    (ii) In addition, in the case of a heating deviation, the official 
establishment may reprocess the affected product, using one of the 
methods in paragraph (b)(1) in this section; use the affected product as 
an ingredient in another product processed to one of the temperature and 
time combinations in paragraph (b)(1) in this section, provided this 
does not violate the final product's standard of composition, upset the 
order of predominance of ingredients, or perceptibly affect the normal 
product characteristics; or relabel the affected product as a partially-
cooked patty product, if it meets the stabilization requirements in 
paragraph (c) of this section.
    (c) Stabilization. (1) Fully cooked, partially cooked, and char-
marked meat patties must be produced using processes ensuring no 
multiplication of toxigenic microorganisms such as Clostridium 
botulinum, and no more than a 1 log10 multiplication of 
Clostridium perfringens, within the product.
    (2) For each meat patty product produced using a stabilization 
process other than one conducted in accordance with the Hazard Analysis 
and Critical Control Point (HACCP) system requirements in part 417 of 
this chapter, an establishment must develop and have on file, available 
to FSIS, a process schedule, as defined in Sec. 301.2 of this chapter. 
Each process schedule must be approved in writing by a process authority 
for safety and efficacy in meeting the performance standards established 
for the product in question. A process authority must have access to an 
establishment in order to evaluate and approve the safety and efficacy 
of each process schedule.

[[Page 279]]

    (3) Under the auspices of a processing authority, an establishment 
must validate new or altered process schedules by scientifically 
supportable means, such as information gleaned from the literature or by 
challenge studies conducted outside the plant.
    (4) Partially cooked patties must bear the labeling statement 
``Partially cooked: For Safety Cook Until Well Done (Internal Meat 
Temperature 160 degrees F.).'' The labeling statement must be adjacent 
to the product name, and prominently placed with such conspicuousness 
(as compared with other words, statements, designs or devices in the 
labeling) as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use.
    (5) Char-marked patties must bear the labeling statement ``Uncooked, 
Char-marked: For Safety, Cook Until Well Done (Internal Meat Temperature 
160 degrees F.).'' The labeling statement shall be adjacent to the 
product name, at least one-half the size of the largest letter in the 
product name, and prominently placed with such conspicuousness (as 
compared with other words, statements, designs or devices in the 
labeling) as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use.

[64 FR 744, Jan. 6, 1999]



Sec. 318.24  Product prepared using advanced meat/bone separation 
machinery; process control.

    (a) General. Meat, as defined in Sec. 301.2 of this subchapter, may 
be derived by mechanically separating skeletal muscle tissue from the 
bones of livestock, other than skulls or vertebral column bones of 
cattle 30 months of age and older as provided in Sec. 310.22 of this 
subchapter, using advances in mechanical meat/bone separation machinery 
(i.e., AMR systems) that, in accordance with this section, recover 
meat--
    (1) Without significant incorporation of bone solids or bone marrow 
as measured by the presence of calcium and iron in excess of the 
requirements in this section, and
    (2) Without the presence of any brain, trigeminal ganglia, spinal 
cord, or dorsal root ganglia (DRG).
    (b) Process control. As a prerequisite to labeling or using product 
as meat derived by the mechanical separation of skeletal muscle tissue 
from livestock bones, the operator of an establishment must develop, 
implement, and maintain procedures that ensure that the establishment's 
production process is in control.
    (1) The production process is not in control if the skulls entering 
the AMR system contain any brain or trigeminal ganglia tissue, if the 
vertebral column bones entering the AMR system contain any spinal cord, 
if the recovered product fails otherwise under any provision of 
paragraph (c)(1), if the product is not properly labeled under the 
provisions of paragraph (c)(2), or if the spent bone materials are not 
properly handled under the provisions of paragraph (c)(3) of this 
section.
    (2) The establishment must document its production process controls 
in writing. The program must be designed to ensure the on-going 
effectiveness of the process controls. If the establishment processes 
cattle, the program must be in its HACCP plan, its Sanitation SOP, or 
other prerequisite program. The program shall describe the on-going 
verification activities that will be performed, including the 
observation of the bones entering the AMR system for brain, trigeminal 
ganglia, and spinal cord; the testing of the product exiting the AMR 
system for bone solids, bone marrow, spinal cord, and DRG as prescribed 
in paragraph (c)(1) of this section; the use of the product and spent 
bone materials exiting the AMR system; and the frequency with which 
these activities will be performed.
    (3) The establishment shall maintain records on a daily basis 
sufficient to document the implementation and verification of its 
production process.
    (4) The establishment shall make available to inspection program 
personnel the documentation described in paragraphs (b)(2) and (b)(3) of 
this section and any other data generated using these procedures.
    (c) Noncomplying product. (1) Notwithstanding any other provision of 
this section, product that is recovered using advanced meat/bone 
separation machinery is not meat under any one or more of the following 
circumstances:

[[Page 280]]

    (i) Bone solids. The product's calcium content, measured by 
individual samples and rounded to the nearest 10th, is more than 130.0 
mg per 100 g.
    (ii) Bone marrow. The product's added iron content, measured by 
duplicate analyses on individual samples and rounded to the nearest 
10th, is more than 3.5 mg per 100 g.\1\
---------------------------------------------------------------------------

    \1\ The excessive iron (ExcFe) measurement for an analyzed sample is 
equal to the obtained iron (Fe) result expressed in mg/100 g measured 
and rounded to the nearest 100th or more for that sample, minus the 
product of three factors: (1) The iron to protein ratio (IPR) factor 
associated with corresponding hand-deboned product; (2) the obtained 
protein (P) result (%) for that sample; and (3) a constant factor of 
1.10. In formula, this can be written as: ExcFe = mFe - IPR x Protein x 
1.10, where ExcFe represents the excess iron, expressed in units of mg/
100 g; mFe represents the measured level of iron (Fe, mg/100 g), IPR is 
the iron to protein ratio for the appropriate hand-deboned product, and 
``Protein'' is the measured level of protein rounded to the nearest 
100th and expressed as a percentage of the total weight of the sample. 
In lieu of data demonstrating otherwise, the values of IPR to be used in 
the above formula are as follows: For beef products the value of IPR is 
equal to 0.104, except for any combination of bones that include any 
beef neckbone product, for which the value of 0.138 is to be used; for 
pork product, the IPR value is 0.052. Other IPR values can be used 
provided that the operator of an establishment has verified and 
documented the ratio of iron content to protein content in the skeletal 
muscle tissue attached to bones prior to their entering the AMR system, 
based on analyses of hand-deboned samples, and the documented value is 
to be substituted for the IPR value (as applicable) in the above formula 
with respect to product that the establishment mechanically separates 
from those bones.
---------------------------------------------------------------------------

    (iii) Brain or trigeminal ganglia. Skulls that enter the AMR system 
have tissues of brain or trigeminal ganglia.
    (iv) Spinal cord. Vertebral column bones that enter the AMR system 
have tissues of spinal cord, or the product that exits the AMR system 
contains spinal cord.
    (v) DRG. The product that exits the AMR system contains DRG.
    (2) If product that may not be labeled or used as ``meat'' under 
this section meets the requirements of Sec. 319.5 of this subchapter, 
it may bear the name ``Mechanically Separated (Species)'' except as 
follows:
    (i) If skulls or vertebral column bones of cattle younger than 30 
months of age that enter the AMR system have tissues of brain, 
trigeminal ganglia, or spinal cord, the product that exits the AMR 
system shall not be used as an ingredient of a meat food product.
    (ii) If product that exits the AMR system contains spinal cord or 
DRG from bones of cattle younger than 30 months of age, it shall not be 
used as an ingredient of a meat food product.
    (iii) If product derived from any bones of cattle of any age does 
not comply with (c)(1)(i) or (ii), it may bear a common or usual name 
that is not false or misleading, except that the product may not bear 
the name ``Mechanically Separated (Beef).''
    (3) Spent skulls or vertebral column bone materials from cattle 
younger than 30 months of age that exit the AMR system shall not be used 
as an ingredient of a meat food product.

[69 FR 1884, Jan. 12, 2004]

Subparts B-F [Reserved]



                  Subpart G_Canning and Canned Products

    Source: 51 FR 45619, Dec. 19, 1986, unless otherwise noted.



Sec. 318.300  Definitions.

    (a) Abnormal container. A container with any sign of swelling or 
product leakage or any evidence that the contents of the unopened 
container may be spoiled.
    (b) Acidified low acid product. A canned product which has been 
formulated or treated so that every component of the finished product 
has a pH of 4.6 or lower within 24 hours after the completion of the 
thermal process unless data are available from the establishment's 
processing authority demonstrating that a longer time period is safe.
    (c) Bleeders. Small orifices on a retort through which steam, other 
gasses, and condensate are emitted from the retort throughout the entire 
thermal process.
    (d) Canned product. A meat food product with a water activity above 
0.85

[[Page 281]]

which receives a thermal process either before or after being packed in 
a hermetically sealed container. Unless otherwise specified, the term 
``product'' as used in this subpart G shall mean ``canned product.''
    (e) Closure technician. The individual(s) identified by the 
establishment as being trained to perform specific container integrity 
examinations as required by this subpart and designated by the 
establishment to perform such examinations.
    (f) Code lot. All production of a particular product in a specific 
size container marked with a specific container code.
    (g) Come-up time. The elapsed time, including venting time (if 
applicable), between the introduction of the heating medium into a 
closed retort and the start of process timing.
    (h) Critical factor. Any characteristic, condition or aspect of a 
product, container, or procedure that affects the adequacy of the 
process schedule. Critical factors are established by processing 
authorities.
    (i) Headspace. That portion of a container not occupied by the 
product.
    (1) Gross headspace. The vertical distance between the level of the 
product (generally the liquid surface) in an upright rigid container and 
the top edge of the container (i.e., the flange of an unsealed can, the 
top of the double seam on a sealed can, or the top edge of an unsealed 
jar).
    (2) Net headspace. The vertical distance between the level of the 
product (generally the liquid surface) in an upright rigid container and 
the inside surface of the lid.
    (j) Hermetically sealed containers. Air-tight containers which are 
designed and intended to protect the contents against the entry of 
microorganisms during and after thermal processing.
    (1) Rigid container. A container, the shape or contour of which, 
when filled and sealed, is neither affected by the enclosed product nor 
deformed by external mechanical pressure of up to 10 pounds per square 
inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger pressure).
    (2) Semirigid container. A container, the shape or contour of which, 
when filled and sealed, is not significantly affected by the enclosed 
product under normal atmospheric temperature and pressure, but can be 
deformed by external mechanical pressure of less than 10 pounds per 
square inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger pressure).
    (3) Flexible container. A container, the shape or contour of which, 
when filled and sealed, is significantly affected by the enclosed 
product.
    (k) Incubation tests. Tests in which the thermally processed product 
is kept at a specific temperature for a specified period of time in 
order to determine if outgrowth of microorganisms occurs.
    (l) Initial temperature. The temperature, determined at the 
initiation of a thermal process cycle, of the contents of the coldest 
container to be processed.
    (m) Low acid product. A canned product in which any component has a 
pH value above 4.6.
    (n) Process schedule. The thermal process and any specified critical 
factors for a given canned product required to achieve shelf stability.
    (o) Process temperature. The minimum temperature(s) of the heating 
medium to be maintained as specified in the process schedule.
    (p) Process time. The intended time(s) a container is to be exposed 
to the heating medium while the heating medium is at or above the 
process temperature(s).
    (q) Processing authority. The person(s) or organization(s) having 
expert knowledge of thermal processing requirements for foods in 
hermetically sealed containers, having access to facilities for making 
such determinations, and designated by the establishment to perform 
certain functions as indicated in this subpart.
    (r) Program employee. Any inspector or other individual employed by 
the Department or any cooperating agency who is authorized by the 
Secretary to do any work or perform any duty in connection with the 
Program (see Sec. 301.2(f)).
    (s) Retort. A pressure vessel designed for thermal processing of 
product packed in hermetically sealed containers.

[[Page 282]]

    (t) Seals. Those parts of a semirigid container and lid or of a 
flexible container that are fused together in order to hermetically 
close the container.
    (u) Shelf stability. The condition achieved by application of heat, 
sufficient, alone or in combination with other ingredients and/or 
treatments, to render the product free of microorganisms capable of 
growing in the product at nonrefrigerated conditions (over 50 [deg]F or 
10 [deg]C) at which the product is intended to be held during 
distribution and storage. Shelf stability and shelf stable are 
synonymous with commercial sterility and commercially sterile, 
respectively.
    (v) Thermal process. The heat treatment necessary to achieve shelf 
stability as determined by the establishment's processing authority. It 
is quantified in terms of:
    (1) Time(s) and temperature(s); or
    (2) Minimum product temperature.
    (w) Venting. The removal of air from a retort before the start of 
process timing.
    (x) Water activity. The ratio of the water vapor pressure of the 
product to the vapor pressure of pure water at the same temperature.



Sec. 318.301  Containers and closures.

    (a) Examination and cleaning of empty containers. (1) Empty 
containers, closures, and flexible pouch roll stock shall be evaluated 
by the establishment to ensure that they are clean and free of 
structural defects and damage that may affect product or container 
integrity. Such an examination should be based upon a statistical 
sampling plan.
    (2) All empty containers, closures, and flexible pouch roll stock 
shall be stored, handled, and conveyed in such a manner that will 
prevent soiling and damage that could affect the hermetic condition of 
the sealed container.
    (3) Just before filling, rigid containers shall be cleaned to 
prevent incorporation of foreign matter into the finished product. 
Closures, semirigid containers, preformed flexible pouches, and flexible 
pouch roll stock contained in original wrappings do not need to be 
cleaned before use.
    (b) Closure examinations for rigid containers (cans)--(1) Visual 
examinations. A closure technician shall visually examine the double 
seams formed by each closing machine head. When seam defects (e.g., 
cutovers, sharpness, knocked down flanges, false seams, droops) are 
observed, necessary corrective actions, such as adjusting or repairing 
the closing machine, shall be taken. In addition to the double seams, 
the entire container shall be examined for product leakage or obvious 
defects. A visual examination shall be performed on at least one 
container from each closing machine head, and the observations, along 
with any corrective actions, shall be recorded. Visual examinations 
shall be conducted with sufficient frequency to ensure proper closure 
and should be conducted at least every 30 minutes of continuous closing 
machine operation. Additional visual examinations shall be made by the 
closure technician at the beginning of production, immediately following 
every jam in the closing machine and after closing machine adjustment 
(including adjustment for changes in container size).
    (2) Teardown examinations. Teardown examinations of double seams 
formed by each closing machine head shall be performed by a closure 
technician at a frequency sufficient to ensure proper closure. These 
examinations should be made at intervals of not more than 4 hours of 
continuous closing machine operation. At least one container from each 
closing head shall be examined on the packer's end during each regular 
examination period. Examination results along with any necessary 
corrective actions, such as adjusting or repairing the closing machine, 
shall be promptly recorded by the closure technician. The establishment 
shall have container specification guidelines for double seam integrity 
on file and available for review by Program employees. A teardown 
examination of the can maker's end shall be performed on at least one 
container selected from each closing machine during each examination 
period except when teardown examinations are made on incoming empty 
containers or when, in the case of self-manufactured containers, the 
containers are made in the vicinity of the establishment and the 
container plant records are made available to

[[Page 283]]

Program employees. Additional teardown examinations on the packer's end 
should be made at the beginning of production, immediately following 
every jam in a closing machine and after closing machine adjustment 
(including adjustment for a change in container size). The following 
procedures shall be used in teardown examinations of double seams:
    (i) One of the following two methods shall be employed for 
dimensional measurements of the double seam.
    (a) Micrometer measurement. For cylindrical containers, measure the 
following dimensions (Figure 1) at three points approximately 120 
degrees apart on the double seam excluding and at least one-half inch 
from the side seam juncture:
    (1) Double seam length--W;
    (2) Double seam thickness--S;
    (3) Body hook length--BH; and
    (4) Cover hook length--CH.

Maximum and minimum values for each dimensional measurement shall be 
recorded by the closure technician.

[[Page 284]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.016

    (b) Seamscope or seam projector. Required measurements of the seam 
include thickness, body hook, and overlap. Seam thickness shall be 
obtained by micrometer. For cylindrical containers, at least two 
locations, excluding the side seam juncture, shall be used to obtain the 
required measurements.
    (ii) Seam tightness. Regardless of the dimensional measurement 
method used to measure seam dimensions, at a minimum, the seam(s) 
examined shall be stripped to assess the degree of wrinkling.
    (iii) Side seam juncture rating. Regardless of the dimensional 
measurement method used to measure seam dimensions, the cover hook shall 
be stripped to examine the cover hook droop at the juncture for 
containers having side seams.
    (iv) Examination of noncylindrical containers. Examination of 
noncylindrical

[[Page 285]]

containers (e.g., square, rectangular, ``D''-shaped, and irregularly-
shaped) shall be conducted as described in paragraphs (b)(2) (i), (ii), 
and (iii) of this section except that the required dimensional 
measurements shall be made on the double seam at the points listed in 
the establishment's container specification guidelines.
    (c) Closure examinations for glass containers--(1) Visual 
examinations. A closure technician shall visually assess the adequacy of 
the closures formed by each closing machine. When closure defects, such 
as loose or cocked caps, fractured or cracked containers and low vacuum 
jars, are observed, necessary corrective actions, such as adjusting or 
repairing the closing machine shall be taken and recorded. In addition 
to the closures, the entire container shall be examined for defects. 
Visual examinations shall be made with sufficient frequency to ensure 
proper closure and should be conducted at least every 30 minutes of 
continuous closing machine operation. Additional visual examinations 
shall be made by the closure technician and the observations recorded at 
the beginning of production, immediately following every jam in the 
closing machine, and after closing machine adjustment (including 
adjustment for a change in container size).
    (2) Closure examinations and tests. Depending upon the container and 
closure, tests shall be performed by a closure technician at a frequency 
sufficient to ensure proper closure. These examinations should be made 
either before or after thermal processing and at intervals of not more 
than 4 hours of continuous closing machine operation. At least one 
container from each closing machine shall be examined during each 
regular examination period. Examination results along with any necessary 
corrective actions, such as adjusting or repairing the closing machine, 
shall be promptly recorded by the closure technician. The establishment 
shall have specification guidelines for closure integrity on file and 
available for review by Program employees. Additional closure 
examinations should be made at the beginning of production, immediately 
following every jam in the closing machine, and after closing machine 
adjustment (including adjustment for a change in container size).
    (d) Closure examinations for semirigid and flexible containers--(1) 
Heat seals--(i) Visual examinations. A closure technician shall visually 
examine the seals formed by each sealing machine. When sealing defects 
are observed, necessary corrective actions, such as adjusting or 
repairing the sealing machine, shall be taken and recorded. In addition 
to examining the heat seals, the entire container shall be examined for 
product leakage or obvious defects. Visual examinations shall be 
performed before and after the thermal processing operation and with 
sufficient frequency to ensure proper closure. These examinations should 
be conducted at least in accordance with a statistical sampling plan. 
All defects noted and corrective actions taken shall be promptly 
recorded.
    (ii) Physical tests. Tests determined by the establishment as 
necessary to assess container integrity shall be conducted by the 
closure technician at a frequency sufficient to ensure proper closure. 
These tests shall be performed after the thermal processing operation 
and should be made at least every 2 hours of continuous production. The 
establishment's acceptance guidelines for each test procedure shall be 
on file and available for review by Program employees. Test results 
along with any necessary corrective actions, such as adjusting or 
repairing the sealing machine, shall be recorded.
    (2) Double seams on semirigid or flexible containers shall be 
examined and the results recorded as provided in paragraph (b) of this 
section. Any additional measurements specified by the container 
manufacturer shall also be made and recorded.
    (e) Container coding. Each container shall be marked with a 
permanent, legible, identifying code mark. The mark shall, at a minimum, 
identify in code the product (unless the product name lithographed or 
printed elsewhere on the container) and the day and year the product was 
packed.
    (f) Handling of containers after closure. (1) Containers and 
closures shall be protected from damage which may cause defects that are 
likely to affect

[[Page 286]]

the hermetic condition of the containers. The accumulation of stationary 
containers on moving conveyors should be minimized to avoid damage to 
the containers.
    (2) The maximum time lapse between closing and initiation of thermal 
processing shall be 2 hours. However, the Administrator may specify a 
shorter period of time when considered necessary to ensure product 
safety and stability. A longer period of time between closing and the 
initiation of thermal processing may be permitted by the Administrator.

(Approved by the Office of Management and Budget under control number 
0583-0015)



Sec. 318.302  Thermal processing.

    (a) Process schedules. Prior to the processing of canned product for 
distribution in commerce, an establishment shall have a process schedule 
(as defined in Sec. 318.300(n) of this subpart) for each canned meat 
product to be packed by the establishment.
    (b) Source of process schedules. (1) Process schedules used by an 
establishment shall be developed or determined by a processing 
authority.
    (2) Any change in product formulation, ingredients, or treatments 
that are not already incorporated in a process schedule and that may 
adversely affect either the product heat penetration profile or 
sterilization value requirements shall be evaluated by the 
establishment's processing authority. If it is determined that any such 
change adversely affects the adequacy of the process schedule, the 
processing authority shall amend the process schedule accordingly.
    (3) Complete records concerning all aspects of the development or 
determination of a process schedule, including any associated incubation 
tests, shall be made available by the establishment to the Program 
employee upon request.
    (c) Submittal of process information. (1) Prior to the processing of 
canned product for distribution in commerce, the establishment shall 
provide the inspector at the establishment with a list of the process 
schedules (including alternate schedules) along with any additional 
applicable information, such as the retort come-up operating procedures 
and critical factors.
    (2) Letters or other written communications from a processing 
authority recommending all process schedules shall be maintained on file 
by the establishment. Upon request by Program employees, the 
establishment shall make available such letters or written 
communications (or copies thereof). If critical factors are identified 
in the process schedule, the establishment shall provide the inspector 
with a copy of the procedures for measuring, controlling, and recording 
these factors, along with the frequency of such measurements, to ensure 
that the critical factors remain within the limits used to establish the 
process schedule. Once submitted, the process schedules and associated 
critical factors and the procedures for measuring (including the 
frequency), controlling, and recording of critical factors shall not be 
changed without the prior written submittal of the revised procedures 
(including supporting documentation) to the inspector at the 
establishment.

(Approved by the Office of Management and Budget under control number 
0583-0015)



Sec. 318.303  Critical factors and the application of the process 
schedule.

    Critical factors specified in the process schedule shall be 
measured, controlled and recorded by the establishment to ensure that 
these factors remain within the limits used to establish the process 
schedule. Examples of factors that are often critical to process 
schedule adequacy may include:
    (a) General. (1) Maximum fill-in weight or drained weight;
    (2) Arrangement of pieces in the container;
    (3) Container orientation during thermal processing;
    (4) Product formulation;
    (5) Particle size;
    (6) Maximum thickness for flexible, and to some extent semirigid 
containers during thermal processing;
    (7) Maximum pH;
    (8) Percent salt;
    (9) Ingoing (or formulated) nitrite level (ppm);
    (10) Maximum water activity; and
    (11) Product consistency or viscosity.

[[Page 287]]

    (b) Continuous rotary and batch agitating retorts. (1) Minimum 
headspace; and
    (2) Retort reel speed.
    (c) Hydrostatic retorts. (1) Chain or conveyor speed.
    (d) Steam/air retorts. (1) Steam/air ratio; and
    (2) Heating medium flow rate.



Sec. 318.304  Operations in the thermal processing area.

    (a) Posting of processes. Process schedules (or operating process 
schedules) for daily production, including minimum initial temperatures 
and operating procedures for thermal processing equipment, shall be 
posted in a conspicuous place near the thermal processing equipment. 
Alternatively, such information shall be available to the thermal 
processing system operator and the inspector.
    (b) Process indicators and retort traffic control. A system for 
product traffic control shall be established to prevent product from 
bypassing the thermal processing operation. Each basket, crate or 
similar vehicle containing unprocessed product, or at least one visible 
container in each vehicle, shall be plainly and conspicuously marked 
with a heat sensitive indicator that will visually indicate whether such 
unit has been thermally processed. Exposed heat sensitive indicators 
attached to container vehicles shall be removed before such vehicles are 
refilled with unprocessed product. Container loading systems for 
crateless retorts shall be designed to prevent unprocessed product from 
bypassing the thermal processing operation.
    (c) Initial temperature. The initial temperature of the contents of 
the coldest container to be processed shall be determined and recorded 
by the establishment at the time the processing cycle begins to assure 
that the temperature of the contents of every container to be processed 
is not lower than the minimum initial temperature specified in the 
process schedule. Thermal processing systems which subject the filled 
and sealed containers to water at any time before process timing begins 
shall be operated to assure that such water will not lower the 
temperature of the product below the minimum initial temperature 
specified in the process schedule.
    (d) Timing devices. Devices used to time applicable thermal 
processing operation functions or events, such as process schedule time, 
come-up time and retort venting, shall be accurate to assure that all 
such functions or events are achieved. Pocket watches and wrist watches 
are not considered acceptable timing devices. Analog and digital clocks 
are considered acceptable. If such clocks do not display seconds, all 
required timed functions or events shall have at least a 1-minute safety 
factor over the specified thermal processing operation times. 
Temperature/time recording devices shall correspond within 15 minutes to 
the time of the day recorded on written records required by Sec. 
318.306.
    (e) Measurement of pH. Unless other methods are approved by the 
Administrator, potentiometric methods using electronic instruments (pH 
meters) shall be used for making pH determinations when a maximum pH 
value is specified as a critical factor in a process schedule.

(Approved by Office of Management and Budget under control number 0583-
0015)



Sec. 318.305  Equipment and procedures for heat processing systems.

    (a) Instruments and controls common to different thermal processing 
systems--(1) Indicating temperature devices. Each retort shall be 
equipped with at least one indicating temperature device that measures 
the actual temperature within the retort. The indicating temperature 
device, not the temperature/time recording device, shall be used as the 
reference instrument for indicating the process temperature.
    (i) Mercury-in-glass thermometers. A mercury-in-glass thermometer 
shall have divisions that are readable to 1F [deg](or 0.5C[deg]) and 
whose scale contains not more than 17F[deg]/inch (or 4.0C[deg]/cm) of 
graduated scale. Each mercury-in-glass thermometer shall be tested for 
accuracy against a known accurate standard upon installation and at 
least once a year to ensure its accuracy. Records that specify the date, 
standard used, test method, and the person or testing authority 
performing the test shall be

[[Page 288]]

maintained on file by the establishment and made available to Program 
employees. A mercury-in-glass thermometer that has a divided mercury 
column or that cannot be adjusted to the standard shall be repaired and 
tested for accuracy before further use, or replaced.
    (ii) Other devices. Temperature-indicating devices, such as 
resistance temperature detectors, used in lieu of mercury-in-glass 
thermometers, shall meet known, accurate standards for such devices when 
tested for accuracy. The records of such testing shall be available to 
FSIS program employees.
    (2) Temperature/time recording devices. Each thermal processing 
system shall be equipped with at least one temperature/time recording 
device to provide a permanent record of temperatures within the thermal 
processing system. This recording device may be combined with the steam 
controller and may be a recording/controlling instrument. When compared 
to the known accurate indicating temperature device, the recording 
accuracy shall be equal to or better than 1F [deg](or 0.5C[deg]) at the 
process temperature. The temperature recording chart should be adjusted 
to agree with, but shall never be higher than, the known accurate 
indicating temperature device. A means of preventing unauthorized 
changes in the adjustment shall be provided. For example, a lock or a 
notice from management posted at or near the recording device warning 
that only authorized persons are permitted to make adjustments, are 
satisfactory means for preventing unauthorized changes. Air-operated 
temperature controllers shall have adequate filter systems to ensure a 
supply of clean, dry air. The recorder timing mechanism shall be 
accurate.
    (i) Chart-type devices. Devices using charts shall be used only with 
the correct chart. Each chart shall have a working scale of not more 
than 55F[deg]/inch (or 12C[deg]/cm) within a range of 20F [deg](or 
11C[deg]) of the process temperature. Chart graduations shall not exceed 
2F degrees (or 1C degree) within a range of 10F degrees (or 5C degrees) 
of the process temperature. Multipoint plotting chart-type devices shall 
print temperature readings at intervals that will assure that the 
parameters of the process time and process temperature have been met. 
The frequency of recording should not exceed 1-minute intervals.
    (ii) Other devices. Temperature/time recording devices or procedures 
used in lieu of chart-type devices must meet known accurate standards 
for such devices or procedures when tested for accuracy. Such a device 
must be accurate enough for ensuring that process time and temperature 
parameters have been met.
    (3) Steam controllers. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording/controlling instrument when combined with a temperature/
time recording device.
    (4) Air valves. All air lines connected to retorts designed for 
pressure processing in steam shall be equipped with a globe valve or 
other equivalent-type valve or piping arrangement that will prevent 
leakage of air into the retort during the process cycle.
    (5) Water valves. All retort water lines that are intended to be 
closed during a process cycle shall be equipped with a globe valve or 
other equivalent-type valve or piping arrangement that will prevent 
leakage of water into the retort during the process cycle.
    (b) Pressure processing in steam--(1) Batch still retorts. (i) The 
basic requirements and recommendations for indicating temperature 
devices and temperature/time recording devices are described in 
paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths 
or probes of indicating temperature devices and probes of temperature/
time recording devices shall be installed either within the retort shell 
or in external wells attached to the retort. External wells shall be 
connected to the retort through at least a \3/4\ inch (1.9 cm) diameter 
opening and equipped with a \1/16\ inch (1.6 mm) or larger bleeder 
opening so located as to provide a constant flow of steam past the 
length of the bulb or probe. The bleeder for external wells shall emit 
steam continuously during the entire thermal processing period.
    (ii) Steam controllers are required as described under paragraph 
(a)(3) of this section.

[[Page 289]]

    (iii) Steam inlet. The steam inlet to each retort shall be large 
enough to provide steam for proper operation of the retort, and shall 
enter at a point to facilitate air removal during venting.
    (iv) Crate supports. Vertical still retorts with bottom steam entry 
shall employ bottom retort crate supports. Baffle plates shall not be 
used in the bottom of retorts.
    (v) Steam spreader. Perforated steam spreaders, if used, shall be 
maintained to ensure they are not blocked or otherwise inoperative. 
Horizontal still retorts shall be equipped with perforated steam 
spreaders that extend the full length of the retort unless the adequacy 
of another arrangement is documented by heat distribution data or other 
documentation from a processing authority. Such information shall be 
maintained on file by the establishment and made available to Program 
employees for review.
    (vi) Bleeders and condensate removal. Bleeders, except those for 
external wells of temperature devices, shall have \1/8\ inch (or 3 mm) 
or larger openings and shall be wide open during the entire process, 
including the come-up time. For horizontal still retorts, bleeders shall 
be located within approximately 1 foot (or 30 cm) of the outermost 
locations of containers at each end along the top of the retort. 
Additional bleeders shall be located not more than 8 feet (2.4 m) apart 
along the top. Bleeders may be installed at positions other than those 
specified above, as long as the establishment has heat distribution data 
or other documentation from the manufacturer or from a processing 
authority demonstrating that the bleeders accomplish removal of air and 
circulate the steam within the retort. This information shall be 
maintained on file by the establishment and made available to Program 
employees for review. All bleeders shall be arranged in a way that 
enables the retort operator to observe that they are functioning 
properly. Vertical retorts shall have at least one bleeder opening 
located in the portion of the retort opposite the steam inlet. All 
bleeders shall be arranged so that the retort operator can observe that 
they are functioning properly. In retorts having a steam inlet above the 
level of the lowest container, a bleeder shall be installed in the 
bottom of the retort to remove condensate. The condensate bleeder shall 
be so arranged that the retort operator can observe that it is 
functioning properly. The condensate bleeder shall be checked with 
sufficient frequency to ensure adequate removal of condensate. Visual 
checks should be performed at intervals of not more than 15 minutes and 
the results recorded. Intermittent condensate removal systems shall be 
equipped with an automatic alarm system that will serve as a continuous 
monitor of condensate bleeder functioning. The automatic alarm system 
shall be tested at the beginning of each shift for proper functioning 
and the results recorded. If the alarm system is not functioning 
properly, it must be repaired before the retort is used.
    (vii) Stacking equipment--(a) Equipment for holding or stacking 
containers in retorts. Crates, trays, gondolas, carts, and other 
vehicles for holding or stacking product containers in the retort shall 
be so constructed to ensure steam circulation during the venting, come-
up, and process times. The bottom of each vehicle shall have 
perforations at least 1 inch (2.5 cm) in diameter on 2 inch (or 5 cm) 
centers or the equivalent unless the adequacy of another arrangement is 
documented by heat distribution data or other documentation from a 
processing authority and such information is maintained on file by the 
establishment and made available to Program employees for review.
    (b) Divider plates. Whenever one or more divider plates are used 
between any two layers of containers or placed on the bottom of a retort 
vehicle, the establishment shall have on file documentation that the 
venting procedure allows the air to be removed from the retort before 
timing of the thermal process is started. Such documentation shall be in 
the form of heat distribution data or documentation from a processing 
authority. This information shall be made available to Program employees 
for review.
    (viii) Bleeder and vent mufflers. If mufflers are used on bleeders 
or vent systems, the establishment shall have on file documentation that 
the mufflers

[[Page 290]]

do not impede the removal of air from the retort. Such documentation 
shall consist of either heat distribution data or documentation from the 
muffler manufacturer or from a processing authority. This information 
shall be made available to Program employees for review.
    (ix) Vents--(a) Vents shall be located in that portion of the retort 
opposite the steam inlet and shall be designed, installed, and operated 
in such a way that air is removed from the retort before timing of the 
thermal process is started. Vents shall be controlled by a gate, plug 
cock, or other full-flow valve which shall be fully opened to permit 
rapid removal of air from retorts during the venting period.
    (b) Vents shall not be connected to a closed drain system without an 
atmospheric break in the line. Where a retort manifold connects several 
pipes from a single retort, the manifold shall be controlled by a gate, 
plug cock, or other full-flow valve and the manifold shall be of a size 
such that the cross-sectional area of the manifold is larger than the 
total cross-sectional area of all connecting vents. The discharge shall 
not be connected to a closed drain without an atmospheric break in the 
line. A manifold header connecting vents or manifolds from several still 
retorts shall lead to the atmosphere. The manifold header shall not be 
controlled by a valve and shall be of a size such that the cross-
sectional area is at least equal to the total cross-sectional area of 
all connecting retort manifold pipes from the maximum number of retorts 
to be vented simultaneously.
    (c) Some typical installations and operating procedures are 
described below. Other retort installations, vent piping arrangements, 
operating procedures or auxiliary equipment such as divider plates may 
be used provided there is documentation that the air is removed from the 
retort before the process is started. Such documentation shall be in the 
form of heat distribution data or other documentation from the equipment 
manufacturer or processing authority. This information shall be 
maintained on file by the establishment and made available to Program 
employees for review.
    (d) For crateless retort installations, the establishment shall have 
heat distribution data or other documentation from the equipment 
manufacturer or from a processing authority that demonstrates that the 
venting procedure used accomplishes the removal of air and condensate. 
This information shall be maintained on file by the establishment and 
made available to Program employees for review.
    (e) Examples of typical installations and operating procedures that 
comply with the requirements of this section are as follows:
    (1) Venting horizontal retorts.
    (i) Venting through multiple 1 inch (2.5 cm) vents discharging 
directly to the atmosphere.
[GRAPHIC] [TIFF OMITTED] TC11SE91.017

    Specifications (Figure 1): One, 1-inch (2.5 cm) vent for every 5 
feet (1.5 m) of retort length, equipped with a gate, plug cock, or other 
full-flow valve and discharging to atmosphere. The end vents shall not 
be more than 2\1/2\ feet (or 75 cm) from ends of retort. Venting method 
(Figure 1): Vent valves shall be wide open for at least 5 minutes and to 
at least 225 [deg]F (or 107 [deg]C), or at least 7 minutes and to at 
least 220 [deg]F (or 104.5 [deg]C).

    (ii) Venting through multiple 1 inch (2.5 cm) vents discharging 
through a manifold to the atmosphere.
[GRAPHIC] [TIFF OMITTED] TC11SE91.018

    Specifications (Figure 2): One, 1-inch (2.5 cm) vent for every 5 
feet (1.5 m) of retort length; vents not over 2\1/2\ feet (or 75 cm) 
from ends of retort; size of manifold for retorts less than 15 feet (4.6 
m) in length, 2\1/2\ inches (6.4

[[Page 291]]

cm), and for retorts 15 feet (4.6 m) and over in length, 3 inches (7.6 
cm).
    Venting method (Figure 2): The manifold vent gate, plug cock, or 
other full-flow valve shall be wide open for at least 6 minutes and to 
at least 225 [deg]F (or 107 [deg]C) or for at least 8 minutes and to at 
least 220 [deg]F (or 104.5 [deg]C).

    (iii) Venting through water spreaders.
    [GRAPHIC] [TIFF OMITTED] TC11SE91.019
    
    Specifications (Figure 3): Size of vent and vent valve. For retorts 
less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 
feet (4.6 m) and over in length, 2\1/2\ inches (6.4 cm).
    Size of water spreader (Figure 3): For retorts less than 15 feet 
(4.6 m) in length, 1\1/2\ inches (3.8 cm); for retorts 15 feet (4.6 m) 
and over in length, 2 inches (or 5 cm). The number of holes shall be 
such that their total cross-sectional area is equal to the cross-
sectional area of the vent pipe inlet.
    Venting method (Figure 3): The gate, plug cock, or other full-flow 
valve on the water spreader vent shall be wide open for at least 5 
minutes and to at least 225 [deg]F (or 107 [deg]C), or for at least 7 
minutes and to at least 220 [deg]F (or 104.5 [deg]C).

    (iv) Venting through a single 2\1/2\ inch (6.4 cm) top vent for 
retorts not exceeding 15 feet (4.6 m) in length.
[GRAPHIC] [TIFF OMITTED] TC11SE91.020

    Specifications (Figure 4): A 2\1/2\ inch (6.4 cm) vent equipped with 
a 2\1/2\ inch (6.4 cm) gate, plug cock, or other full-flow valve and 
located within 2 feet (61 cm) of the center of the retort.
    Venting method (Figure 4): The vent valve shall be wide open for at 
least 4 minutes and to at least 220 [deg]F (or 104.5 [deg]C).

    (2) Venting vertical retorts.
    (i) Venting through a 1\1/2\ inch (3.8 cm) overflow.
    [GRAPHIC] [TIFF OMITTED] TC11SE91.021
    
                                Figure 5
    Specifications (Figure 5): A 1\1/2\ inch (3.8 cm) overflow pipe 
equipped with a 1\1/2\ inch (3.8 cm) gate, plug cock, or other full-flow 
valve and with not more than 6 feet (1.8 m) of 1\1/2\ inch (3.8 cm) pipe 
beyond the valve before a break to the atmosphere or to a manifold 
header.
    Venting method (Figure 5): The vent valve shall be wide open for at 
least 4 minutes and to at least 218 [deg]F (or 103.5 [deg]C), or for at 
least 5 minutes and to at least 215 [deg]F (or 101.5 [deg]C).

    (ii) Venting through a single 1 inch (2.5 cm) side or top vent.

[[Page 292]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.022

    Specifications (Figure 6 or 7): A 1 inch (2.5 cm) vent in lid or top 
side, equipped with a gate, plug cock, or other full-flow valve and 
discharging directly into the atmosphere or to a manifold header.
    Venting method (Figure 6 or 7): The vent valve shall be wide open 
for at least 5 minutes and to at least 230 [deg]F (110 [deg]C), or for 
at least 7 minutes and to at least 220 [deg]F (or 104.5 [deg]C).

    (2) Batch agitating retorts. (i) The basic requirements for 
indicating temperature devices and temperature/time recording devices 
are described in paragraphs (a) (1) and (2) of this section. 
Additionally, bulb sheaths or probes of indicating temperature devices 
and probes of temperature/time recording devices shall be installed 
either within the retort shell or in external wells attached to the 
retort. External wells shall be connected to the retort through at least 
a \3/4\ inch (1.9 cm) diameter opening and equipped with a \1/16\ (1.6 
mm) or larger bleeder opening so located as to provide a constant flow 
of steam past the length of the bulbs or probes. The bleeder for 
external wells shall emit steam continuously during the entire thermal 
processing period.
    (ii) Steam controllers are required as described in paragraph (a)(3) 
of this section.
    (iii) Steam inlet. The steam inlet to each retort shall be large 
enough to provide steam for proper operation of the retort and shall 
enter at a point(s) to facilitate air removal during venting.
    (iv) Bleeders. Bleeders, except those for external wells of 
temperature devices, shall be \1/8\ inch (or 3 mm) or larger and shall 
be wide open during the entire process including the come-up time. 
Bleeders shall be located within approximately 1 foot (or 30 cm) of the 
outermost location of containers, at each end along the top of the 
retort. Additional bleeders shall be located not more than 8 feet (2.4 
m) apart along the top. Bleeders may be installed at positions other 
than those specified above, as long as the establishment has heat 
distribution data or other documentation from the manufacturer or from a 
processing authority that the bleeders accomplish removal of air and 
circulate the steam within the retort. This information shall be 
maintained on file by the establishment and made

[[Page 293]]

available to Program employees for review. All bleeders shall be 
arranged in a way that enables the retort operator to observe that they 
are functioning properly.
    (v) Venting and condensate removal. The air in the retort shall be 
removed before processing is started. Heat distribution data or other 
documentation from the manufacturer or from the processing authority who 
developed the venting procedure shall be kept on file by the 
establishment and made available to Program employees for review. At the 
time the steam is turned on, the drain shall be opened to remove steam 
condensate from the retort. A bleeder shall be installed in the bottom 
of the retort to remove condensate during retort operation. The 
condensate bleeder shall be so arranged that the retort operator can 
observe that it is functioning properly. The condensate bleeder shall be 
checked with sufficient frequency to ensure adequate removal of 
condensate. Visual checks should be performed at intervals of not more 
than 15 minutes and the results recorded. Intermittent condensate 
removal systems shall be equipped with an automatic alarm system that 
will serve as a continuous monitor of condensate bleeder functioning. 
The automatic alarm system shall be tested at the beginning of each 
shift for proper functioning and the results recorded. If the alarm 
system is not functioning properly, it must be repaired before the 
retort is used.
    (vi) Retort or reel speed timing. The retort or reel speed shall be 
checked before process timing begins and, if needed, adjusted as 
specified in the process schedule. In addition, the rotational speed 
shall be determined and recorded at least once during process timing of 
each retort load processed. Alternatively, a recording tachometer can be 
used to provide a continuous record of the speed. The accuracy of the 
recording tachometer shall be determined and recorded at least once per 
shift by checking the retort or reel speed using an accurate stopwatch. 
A means of preventing unauthorized speed changes on retorts shall be 
provided. For example, a lock or a notice from management posted at or 
near the speed adjustment device warning that only authorized persons 
are permitted to make adjustments are satisfactory means of preventing 
unauthorized changes.
    (vii) Bleeder and vent mufflers. If mufflers are used on bleeders or 
vent systems, the establishment shall have documentation that the 
mufflers do not impede the removal of air from the retort. Such 
documentation shall consist of either heat distribution data or 
documentation from the muffler manufacturer or from a processing 
authority. This information shall be maintained on file by the 
establishment and made available to Program employees for review.
    (3) Continuous rotary retorts. (i) The basic requirements for 
indicating temperature devices and temperature/time recording devices 
are described in paragraphs (a) (1) and (2) of this section. 
Additionally, bulb sheaths or probes of indicating temperature devices 
and probes of temperature/time recording devices shall be installed 
either within the retort shell or in external wells attached to the 
retort. External wells shall be connected to the retort through at least 
a \3/4\ inch (1.9 cm) diameter opening and equipped with a \1/16\ inch 
(1.6 mm) or larger bleeder opening so located as to provide a constant 
flow of steam past the length of the bulbs or probes. The bleeder for 
external wells shall emit steam continuously during the entire thermal 
processing period.
    (ii) Steam controllers are required as described in paragraph (a)(3) 
of this section.
    (iii) Steam inlet. The steam inlet to each retort shall be large 
enough to provide steam for proper operation of the retort, and shall 
enter at a point(s) to facilitate air removal during venting.
    (iv) Bleeders. Bleeders, except those for external wells of 
temperature devices, shall be \1/8\ inch (3.2 mm) or larger and shall be 
wide open during the entire process, including the come-up time. 
B!eeders shall be located within approximately 1 foot (or 30 cm) of the 
outermost location of containers at each end along the top of the 
retort. Additional bleeders shall be located not more than 8 feet (2.4 
m) apart along the top of the retort. Bleeders may be installed at 
positions other than those

[[Page 294]]

specified above, as long as the establishment has heat distribution data 
or other documentation from the manufacturer or a processing authority 
that the bleeders accomplish removal of air and circulate the steam 
within the retort. This information shall be maintained on file by the 
establishment and made available to Program employees for review. All 
bleeders shall be arranged so that the retort operator can observe that 
they are functioning properly.
    (v) Venting and condensate removal. The air in the retort shall be 
removed before processing is started. Heat distribution data or other 
documentation from the manufacturer or from the processing authority who 
deve!oped the venting procedure shall be kept on file by the 
establishment and made available to Program employees for review. At the 
time the steam is turned on, the drain shall be opened to remove steam 
condensate from the retort. A bleeder shall be installed in the bottom 
of the shell to remove condensate during the retort operation. The 
condensate bleeder shall be so arranged that the retort operator can 
observe that it is functioning properly. The condensate bleeder shall be 
checked with sufficient frequency to ensure adequate removal of 
condensate. Visual checks should be performed at intervals of not more 
than 15 minutes and the results recorded. Intermittent condensate 
removal systems shall be equipped with an automatic alarm system that 
will serve as a continuous monitor of condensate bleeder functioning. 
The automatic alarm system shall be tested at the beginning of each 
shift for proper functioning and the results recorded. If the alarm 
system is not functioning properly, it must be repaired before the 
retort is used.
    (vi) Retort speed timing. The rotational speed of the retort shall 
be specified in the process schedule. The speed shall be adjusted as 
specified, and recorded by the establishment when the retort is started, 
and checked and recorded at intervals not to exceed 4 hours to ensure 
that the correct retort speed is maintained. Alternatively, a recording 
tachometer may be used to provide a continuous record of the speed. If a 
recording tachometer is used, the speed shall be manually checked 
against an accurate stopwatch at least once per shift and the results 
recorded. A means of preventing unauthorized speed changes on retorts 
shall be provided. For example, a lock or a notice from management 
posted at or near the speed adjustment device warning that only 
authorized persons are permitted to make adjustments are satisfactory 
means of preventing unauthorized changes.
    (vii) Bleeders and vent mufflers. If mufflers are used on bleeders 
or vent systems, the establishment shall have documentation that the 
mufflers do not impede the removal of air from the retort. Such 
documentation shall consist of either heat distribution data or other 
documentation from the muffler manufacturer or from a processing 
authority. This information shall be maintained on file by the 
establishment and made available to Program employees for review.
    (4) Hydrostatic retorts. (i) The basic requirements for indicating 
temperature devices and temperature/time recording devices are described 
in paragraphs (a) (1) and (2) of this section. Additionally, indicating 
temperature devices shall be located in the steam dome near the steam/
water interface. Where the process schedule specifies maintenance of 
particular water temperatures in the hydrostatic water legs, at least 
one indicating temperature device shall be located in each hydrostatic 
water leg so that it can accurately measure water temperature and be 
easily read. The temperature/time recorder probe shall be installed 
either within the steam dome or in a well attached to the dome. Each 
probe shall have a \1/16\ inch (1.6 mm) or larger bleeder opening which 
emits steam continuously during the processing period. Additional 
temperature/time recorder probes shall be installed in the hydrostatic 
water legs if the process schedule specifies maintenance of particular 
temperatures in these water legs.
    (ii) Steam controllers are required as described in paragraph (a)(3) 
of this section.
    (iii) Steam inlet. The steam inlets shall be large enough to provide 
steam for proper operation of the retort.

[[Page 295]]

    (iv) Bleeders. Bleeder openings \1/4\ inch (or 6 mm) or larger shall 
be located in the steam chamber(s) opposite the point of steam entry. 
Bleeders shall be wide open and shall emit steam continuously during the 
entire process, including the come-up time. All bleeders shall be 
arranged in such a way that the operator can observe that they are 
functioning properly.
    (v) Venting. Before the start of processing operations, the retort 
steam chamber(s) shall be vented to ensure removal of air. Heat 
distribution data or other documentation from the manufacturer or from a 
processing authority demonstrating that the air is removed from the 
retort prior to processing shall be kept on file at the establishment 
and made available to Program employees for review.
    (vi) Conveyor speed. The conveyor speed shall be calculated to 
obtain the required process time and recorded by the establishment when 
the retort is started. The speed shall be checked and recorded at 
intervals not to exceed 4 hours to ensure that the correct conveyor 
speed is maintained. A recording device may be used to provide a 
continuous record of the conveyor speed. When a recording device is 
used, the speed shall be manually checked against an accurate stopwatch 
at least once per shift by the establishment. A means of preventing 
unauthorized speed changes of the conveyor shall be provided. For 
example, a lock or a notice from management posted at or near the speed 
adjustment device warning that only authorized persons are permitted to 
make adjustments are satisfactory means of preventing unauthorized 
changes.
    (vii) Bleeders and vent mufflers. If mufflers are used on bleeders 
or vent systems, the establishment shall have documentation that the 
muffler do not impede the removal of air from the retort. Such 
documentation shall consist of either heat distribution data or other 
documentation from the muffler manufacturer or from a processing 
authority. This information shall be maintained on file by the 
establishment and made available to Program employees for review.
    (c) Pressure processing in water--(1) Batch still retorts. (i) The 
basic requirements for indicating temperature devices and temperature/
time recording devices are described in paragraphs (a)(1) and (2) of 
this section. Additionally, bulbs or probes of indicating temperature 
devices shall be located in such a position that they are beneath the 
surface of the water throughout the process. On horizontal retorts, the 
indicating temperature device bulb or probe shall be inserted directly 
into the retort shell. In both vertical and horizontal retorts, the 
indicating temperature device bulb or probe shall extend directly into 
the water a minimum of 2 inches (or 5 cm) without a separable well or 
sleeve. In vertical retorts equipped with a recorder/controller, the 
controller probe shall be located at the bottom of the retort below the 
lowest crate rest in such a position that the steam does not strike it 
directly. In horizontal retorts so equipped, the controller probe shall 
be located between the water surface and the horizontal plane passing 
through the center of the retort so that there is no opportunity for 
direct steam impingement on the controller probe. Air-operated 
temperature controllers shall have filter systems to ensure a supply of 
clean, dry air.
    (ii) Pressure recording device. Each retort shall be equipped with a 
pressure recording device which may be combined with a pressure 
controller.
    (iii) Steam controllers are required as described in paragraph 
(a)(3) of this section.
    (iv) Heat distribution. Heat distribution data or other 
documentation from the equipment manufacturer or a processing authority 
demonstrating uniform heat distribution within the retort shall be kept 
on file at the establishment and made available to Program employees for 
review.
    (v) Crate supports. A bottom crate support shall be used in vertical 
retorts. Baffle plates shall not be used in the bottom of the retort.
    (vi) Stacking equipment. For filled flexible containers and, where 
applicable, semirigid containers, stacking equipment shall be designed 
to ensure that the thickness of the filled containers does not exceed 
that specified in the process schedule and that the containers do not 
become displaced and

[[Page 296]]

overlap or rest on one another during the thermal process.
    (vii) Drain valve. A nonclogging, water-tight drain valve shall be 
used. Screens shall be installed over all drain openings.
    (viii) Water level. There shall be a means of determining the water 
level in the retort during operation (i.e., by using a gauge, electronic 
sensor, or sight glass indicator). For retorts requiring complete 
immersion of containers, water shall cover the top layer of containers 
during the entire come-up time and thermal processing periods and should 
cover the top layer of containers during cooling. For retorts using 
cascading water or water sprays, the water level shall be maintained 
within the range specified by the retort manufacturer or processing 
authority during the entire come-up, thermal processing, and cooling 
periods. A means to ensure that water circulation continues as specified 
throughout the come-up, thermal processing, and cooling periods shall be 
provided. The retort operator shall check and record the water level at 
intervals to ensure it meets the specified processing parameters.
    (ix) Air supply and controls. In both horizontal and vertical still 
retorts, a means shall be provided for introducing compressed air or 
steam at the pressure required to maintain container integrity. 
Compressed air and steam entry shall be controlled by an automatic 
pressure control unit. A nonreturn valve shall be provided in the air 
supply line to prevent water from entering the system. Overriding air or 
steam pressure shall be maintained continuously during the come-up, 
thermal processing, and cooling periods. If air is used to promote 
circulation, it shall be introduced into the steam line at a point 
between the retort and the steam control valve at the bottom of the 
retort. The adequacy of the air circulation for maintaining uniform heat 
distribution within the retort shall be documented by heat distribution 
data or other documentation from a processing authority, and such data 
shall be maintained on file by the establishment and made available to 
Program employees for review.
    (x) Water recirculation. When a water recirculation system is used 
for heat distribution, the water shall be drawn from the bottom of the 
retort through a suction manifold and discharged through a spreader that 
extends the length or circumference of the top of the retort. The holes 
in the water spreader shall be uniformly distributed. The suction 
outlets shall be protected with screens to keep debris from entering the 
recirculation system. The pump shall be equipped with a pilot light or a 
similar device to warn the operator when it is not running, and with a 
bleeder to remove air when starting operations. Alternatively, a flow-
meter alarm system can be used to ensure proper water circulation. The 
adequacy of water circulation for maintaining uniform heat distribution 
within the retort shall be documented by heat distribution or other 
documentation from a processing authority and such data shall be 
maintained on file by the establishment and made available to Program 
employees for review. Alternative methods for recirculation of water in 
the retort may be used, provided there is documentation in the form of 
heat distribution data or other documentation from a processing 
authority maintained on file by the establishment and made available to 
Program employees for review.
    (xi) Cooling water entry. In retorts for processing product packed 
in glass jars, the incoming cooling water should not directly strike the 
jars, in order to minimize glass breakage by thermal shock.
    (2) Batch agitating retorts. (i) The basic requirements and 
recommendations for indicating temperature devices and temperature/time 
recording devices are described in paragraphs (a) (1) and (2) of this 
section. Additionally, the indicating temperature device bulb or probe 
shall extend directly into the water without a separable well or sleeve. 
The recorder/controller probe shall be located between the water surface 
and the horizontal plane passing through the center of the retort so 
that there is no opportunity for steam to directly strike the controller 
bulb or probe.
    (ii) Pressure recording device. Each retort shall be equipped with a 
pressure

[[Page 297]]

recording device which may be combined with a pressure controller.
    (iii) Steam controllers are required as described in paragraph 
(a)(3) of this section.
    (iv) Heat distribution. Heat distribution data or other 
documentation from the equipment manufacturer or a processing authority 
shall be kept on file by the establishment and made available to Program 
employees for review.
    (v) Stacking equipment. All devices used for holding product 
containers (e.g., crates, trays, divider plates) shall be so constructed 
to allow the water to circulate around the containers during the come-up 
and thermal process periods.
    (vi) Drain valve. A nonclogging, water-tight drain valve shall be 
used. Screens shall be installed over all drain openings.
    (vii) Water level. There shall be a means of determining the water 
level in the retort during operation (i.e., by using a gauge, electronic 
sensor, or sight glass indicator). Water shall completely cover all 
containers during the entire come-up, thermal processing, and cooling 
periods. A means to ensure that water circulation continues as specified 
throughout the come-up, thermal processing, and cooling periods shall be 
provided. The retort operator shall check and record the adequacy of the 
water level with sufficient frequency to ensure it meets the specified 
processing parameters.
    (viii) Air supply and controls. Retorts shall be provided with a 
means for introducing compressed air or steam at the pressure required 
to maintain container integrity. Compressed air and steam entry shall be 
controlled by an automatic pressure control unit. A nonreturn valve 
shall be provided in the air supply line to prevent water from entering 
the system. Overriding air or steam pressure shall be maintained 
continuously during the come-up, thermal processing, and cooling 
periods. If air is used to promote circulation, it shall be introduced 
into the steam line at a point between the retort and the steam control 
valve at the bottom of the retort. The adequacy of the air circulation 
for maintaining uniform heat distribution within the retort shall be 
documented by heat distribution data or other documentation from a 
processing authority, and such data shall be maintained on file by the 
establishment and made available to Program employees for review.
    (ix) Retort or reel speed timing. The retort or reel speed timing 
shall be checked before process timing begins and, if needed, adjusted 
as specified in the process schedule. In addition, the rotational speed 
shall be determined and recorded at least once during process timing of 
each retort load processed. Alternatively, a recording tachometer can be 
used to provide a continuous record of the speed. The accuracy of the 
recording tachometer shall be determined and recorded at least once per 
shift by the establishment by checking the retort or reel speed using an 
accurate stopwatch. A means of preventing unauthorized speed changes on 
retorts shall be provided. For example, a lock or a notice from 
management posted at or near the speed adjustment device warning that 
only authorized persons are permitted to make adjustments are 
satisfactory means of preventing unauthorized changes.
    (x) Water recirculation. If a water recirculation system is used for 
heat distribution, it shall be installed in such a manner that water 
will be drawn from the bottom of the retort through a suction manifold 
and discharged through a spreader which extends the length of the top of 
the retort. The holes in the water spreader shall be uniformly 
distributed. The suction outlets shall be protected with screens to keep 
debris from entering the recirculation system. The pump shall be 
equipped with a pilot light or a similar device to warn the operator 
when it is not running and with a bleeder to remove air when starting 
operations. Alternatively, a flow-meter alarm system can be used to 
ensure proper water circulation. The adequacy of water circulation for 
maintaining uniform heat distribution within the retort shall be 
documented by heat distribution data or other documentation from a 
processing authority, and such data shall be maintained on file by the 
establishment and made available to Program employees for review. 
Alternative methods for recirculation of water in the retort may be used 
provided there is documentation

[[Page 298]]

in the form of heat distribution data or other documentation from a 
processing authority maintained on file by the establishment and made 
available to Program employees for review.
    (xi) Cooling water entry. In retorts for processing product packed 
in glass jars, the incoming cooling water should not directly strike the 
jars, in order to minimize glass breakage by thermal shock.
    (d) Pressure processing with steam/air mixtures in batch retorts. 
(1) The basic requirements for indicating temperature devices and 
temperature/time recording devices are described in paragraphs (a) (1) 
and (2) of this section. Additionally, bulb sheaths or probes for 
indicating temperature devices and temperature/time recording devices or 
controller probes shall be inserted directly into the retort shell in 
such a position that steam does not strike them directly.
    (2) Steam controllers are required as described in paragraph (a)(3) 
of this section.
    (3) Recording pressure controller. A recording pressure controller 
shall be used to control the air inlet and the steam/air mixture outlet.
    (4) Circulation of steam/air mixtures. A means shall be provided for 
the circulation of the steam/air mixture to prevent formation of low-
temperature pockets. The efficiency of the circulation system shall be 
documented by heat distribution data or other documentation from a 
processing authority, and such data shall be maintained on file by the 
establishment and made available to Program employees for review. The 
circulation system shall be checked to ensure its proper functioning and 
shall be equipped with a pilot light or a similar device to warn the 
operator when it is not functioning. Because of the variety of existing 
designs, reference shall be made to the equipment manufacturer for 
details of installation, operation, and control.
    (e) Atmospheric cookers--(1) Temperature/time recording device. Each 
atmospheric cooker (e.g., hot water bath) shall be equipped with at 
least one temperature/time recording device in accordance with the basic 
requirements described in paragraph (a)(2) of this section.
    (2) Heat distribution. Each atmospheric cooker shall be equipped and 
operated to ensure uniform heat distribution throughout the processing 
system during the thermal process. Heat distribution data or other 
documentation from the manufacturer or a processing authority 
demonstrating uniform heat distribution within the cooker shall be kept 
on file by the establishment and made available to Program employees for 
review.
    (f) Other systems. All other systems not specifically delineated in 
this section and used for the thermal processing of canned product shall 
be adequate to produce shelf-stable products consistently and uniformly.
    (g) Equipment maintenance. (1) Upon installation, all 
instrumentation and controls shall be checked by the establishment for 
proper functioning and accuracy and, thereafter, at any time their 
functioning or accuracy is suspect.
    (2) At least once a year each thermal processing system shall be 
examined by an individual not directly involved in daily operations to 
ensure the proper functioning of the system as well as all auxiliary 
equipment and instrumentation. In addition, each thermal processing 
system should be examined before the resumption of operation following 
an extended shutdown.
    (3) Air and water valves that are intended to be closed during 
thermal processing shall be checked by the establishment for leaks. 
Defective valves shall be repaired or replaced as needed.
    (4) Vent and bleeder mufflers shall be checked and maintained or 
replaced by the establishment to prevent any reduction in vent or 
bleeder efficiency.
    (5) When water spreaders are used for venting, a maintenance 
schedule shall be developed and implemented to assure that the holes are 
maintained at their original size.
    (6) Records shall be kept on all maintenance items that could affect 
the adequacy of the thermal process. Records shall include the date and 
type of maintenance performed and the person conducting the maintenance.
    (h) Container cooling and cooling water. (1) Potable water shall be 
used

[[Page 299]]

for cooling except as provided for in paragraphs (h) (2) and (3) of this 
section.
    (2) Cooling canal water shall be chlorinated or treated with a 
chemical approved by the Administrator as having a bactericidal effect 
equivalent to chlorination. There shall be a measurable residual of the 
sanitizer in the water at the discharge point of the canal. Cooling 
canals shall be cleaned and replenished with potable water to prevent 
the buildup of organic matter and other materials.
    (3) Container cooling waters that are recycled or reused shall be 
handled in systems that are so designed, operated, and maintained so 
there is no buildup of microorganisms, organic matter, and other 
materials in the systems and in the waters. System equipment, such as 
pipelines, holding tanks and cooling towers, shall be constructed and 
installed so that they can be cleaned and inspected. In addition, the 
establishment shall maintain, and make available to Program employees 
for review, information on at least the following:
    (i) System design and construction;
    (ii) System operation including the rates of renewal with fresh, 
potable water and the means for treating the water so that there is a 
measurable residual of an acceptable sanitizer, per paragraph (h)(2) of 
this section, in the water at the point where the water exits the 
container cooling vessel;
    (iii) System maintenance including procedures for the periodic 
cleaning and sanitizing of the entire system; and
    (iv) Water quality standards, such as microbiological, chemical and 
physical, monitoring procedures including the frequency and site(s) of 
sampling, and the corrective actions taken when water quality standards 
are not met.
    (i) Post-process handling of containers Containers shall be handled 
in a manner that will prevent damage to the hermetic seal area. All worn 
and frayed belting, can retarders, cushions, and the like shall be 
replaced with nonporous materials. To minimize container abrasions, 
particularly in the seal area, containers should not remain stationary 
on moving conveyors. All post-process container handling equipment 
should be kept clean so there is no buildup of microorganisms on 
surfaces in contact with the containers.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[51 FR 45619, Dec. 19, 1986, as amended at 65 FR 34389, May 30, 2000]



Sec. 318.306  Processing and production records.

    At least the following processing and production information shall 
be recorded by the establishment: date of production; product name and 
style; container code; container size and type; and the process 
schedule, including the minimum initial temperature. Measurements made 
to satisfy the requirements of Sec. 318.303 regarding the control of 
critical factors shall be recorded. In addition, where applicable, the 
following information and data shall also be recorded:
    (a) Processing in steam--(1) Batch still retorts. For each retort 
batch, record the retort number or other designation, the approximate 
number of containers or the number of retort crates per retort load, 
product initial temperature, time steam on, the time and temperature 
vent closed, the start of process timing, time steam off, and the actual 
processing time. The indicating temperature device and the temperature 
recorder shall be read at the same time at least once during process 
timing and the observed temperatures recorded.
    (2) Batch agitating retorts. In addition to recording the 
information required for batch, still steam retorts in paragraph (a)(1) 
of this section, record the functioning of the condensate bleeder(s) and 
the retort or reel speed.
    (3) Continuous rotary retorts. Record the retort system number, the 
approximate total number of containers retorted, product initial 
temperature, time steam on, the time and temperature vent closed, time 
process temperature reached, the time the first can enters and the time 
the last can exits the retort. The retort or reel speed shall be 
determined and recorded at intervals not to exceed 4 hours. Readings of 
the indicating temperature device(s) and temperature recorder(s) shall 
be made and recorded at the time the first container enters the retort 
and thereafter with sufficient frequency to ensure

[[Page 300]]

compliance with the process schedule. These observations should be made 
and recorded at intervals not exceeding 30 minutes of continuous retort 
operation. Functioning of the condensate bleeder(s) shall be observed 
and recorded at the time the first container enters the retort and 
thereafter as specified in Sec. 318.305(b)(3)(v).
    (4) Hydrostatic retorts. Record the retort system number, the 
approximate total number of containers retorted, product initial 
temperature, time steam on, the time and temperature vent(s) closed, 
time process temperature reached, time first containers enter the 
retort, time last containers exit the retort, and, if specified in the 
process schedule, measurements of temperatures in the hydrostatic water 
legs. Readings of the temperature indicating device, which is located in 
the steam/water interface, and the temperature recording device shall be 
observed and the temperatures recorded at the time the first containers 
enter the steam dome. Thereafter, these instruments shall be read and 
the temperatures recorded with sufficient frequency to ensure compliance 
with the temperature specified in the process schedule and should be 
made at least every hour of continuous retort operation. Container 
conveyor speed, and for agitating hydrostatic retorts, the rotative 
chain speed, shall be determined and recorded at intervals of sufficient 
frequency to ensure compliance with the process schedule and should be 
performed at least every 4 hours.
    (b) Processing in water--(1) Batch still retorts. For each retort 
batch, record the retort number or other designation, the approximate 
number of containers or number of retort crates per retort load, product 
initial temperature, time steam on, the start of process timing, water 
level, water recirculation rate (if critical), overriding pressure 
maintained, time steam off, and actual processing time. The indicating 
temperature device and the temperature recorder shall be read at the 
same time at least once during process timing and the observed 
temperatures recorded.
    (2) Batch agitating retorts. In addition to recording the 
information required in paragraph (b)(1) of this section, record the 
retort or reel speed.
    (c) Processing in steam/air mixtures. For each retort batch, record 
the retort number or other designation, the approximate number of 
containers or number of retort crates per retort load, product initial 
temperature, time steam on, venting procedure, if applicable, the start 
of process timing, maintenance of circulation of the steam/air mixture, 
air flow rate or forced recirculation flow rate (if critical), 
overriding pressure maintained, time steam off, and actual processing 
time. The indicating temperature device and the temperature recorder 
shall be read at the same time at least once during process timing and 
the observed temperatures recorded.
    (d) Atmospheric cookers--(1) Batch-type systems. For each cooker 
batch, record the cooker number or other designation and the approximate 
number of containers. In addition, record all critical factors of the 
process schedule such as cooker temperature, initial temperature, the 
time the thermal process cycle begins and ends, hold time, and the final 
internal product temperature.
    (2) Continuous-type systems. Record the cooker number or other 
designation, the time the first containers enter and the last containers 
exit a cooker, and the approximate total number of containers processed. 
In addition, record all critical factors of the process schedule such as 
the initial temperature, cooker speed, and final internal product 
temperature.

(Approved by the Office of Management and Budget under control number 
0583-0015)



Sec. 318.307  Record review and maintenance.

    (a) Process records. Charts from temperature/time recording devices 
shall be identified by production date, container code, processing 
vessel number or other designation, and other data as necessary to 
enable correlation with the records required in Sec. 318.306. Each 
entry on a record shall be made at the time the specific event occurs, 
and the recording individual shall sign or initial each record form. No 
later than 1 working day after the actual process, the establishment 
shall review all

[[Page 301]]

processing and production records to ensure completeness and to 
determine if all product received the process schedule. All records, 
including the temperature/time recorder charts and critical factor 
control records, shall be signed or initialed and dated by the person 
conducting the review. All processing and production records required in 
this subpart shall be made available to Program employees for review.
    (b) Automated process monitoring and recordkeeping. Automated 
process monitoring and recordkeeping systems shall be designed and 
operated in a manner that will ensure compliance with the applicable 
requirements of Sec. 318.306.
    (c) Container closure records. Written records of all container 
closure examinations shall specify the container code, the date and time 
of container closure examination, the measurement(s) obtained, and any 
corrective actions taken. Records shall be signed or initialed by the 
container closure technician and shall be reviewed and signed by the 
establishment within 1 working day after the actual production to ensure 
that the records are complete and that the closing operations have been 
properly controlled. All container closure examination records required 
in this subpart shall be made available to Program employees for review.
    (d) Distribution of product. Records shall be maintained by the 
establishment identifying initial distribution of the finished product 
to facilitate, if necessary, the segregation of specific production lots 
that may have been contaminated or are otherwise unsound for their 
intended use.
    (e) Retention of records. Copies of all processing and production 
records required in Sec. 318.306 shall be retained for no less than 1 
year at the establishment, and for an additional 2 years at the 
establishment or other location from which the records can be made 
available to Program employees within 3 working days.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[51 FR 45619, Dec. 19, 1986, as amended at 65 FR 34389, May 30, 2000]



Sec. 318.308  Deviations in processing.

    (a) Whenever the actual process is less than the process schedule or 
when any critical factor does not comply with the requirements for that 
factor as specified in the process schedule, it shall be considered a 
deviation in processing.
    (b) Deviations in processing (or process deviations) must be handled 
according to:
    (1)(i) A HACCP plan for canned product that addresses hazards 
associated with microbial contamination, or,
    (ii) Alternative documented procedures that will ensure that only 
safe and stable product is shipped in commerce; or
    (iii) Paragraph (d) of this section.
    (c) [Reserved]
    (d) Procedures for handling process deviations where the HACCP plan 
for thermally processed/commercially sterile product does not address 
food safety hazards associated with microbial contamination, where there 
is no approved total quality control system, or where the establishment 
has no alternative documented procedures for handling process 
deviations.
    (1) Deviations identified in-process. If a deviation is noted at any 
time before the completion of the intended process schedule, the 
establishment shall:
    (i) Immediately reprocess the product using the full process 
schedule; or
    (ii) Use an appropriate alternate process schedule provided such a 
process schedule has been established in accordance with Sec. 318.302 
(a) and (b) and is filed with the inspector in accordance with Sec. 
318.302(c); or
    (iii) Hold the product involved and have the deviation evaluated by 
a processing authority to assess the safety and stability of the 
product. Upon completion of the evaluation, the establishment shall 
provide the inspector the following:
    (a) A complete description of the deviation along with all necessary 
supporting documentation;
    (b) A copy of the evaluation report; and
    (c) A description of any product disposition actions, either taken 
or proposed.
    (iv) Product handled in accordance with paragraph (d)(1)(iii) of 
this section

[[Page 302]]

shall not be shipped from the establishment until the Program has 
reviewed all of the information submitted and approved the product 
disposition actions.
    (v) If an alternate process schedule is used that is not on file 
with the inspector or if an alternate process schedule is immediately 
calculated and used, the product shall be set aside for further 
evaluation in accordance with paragraphs (d)(1)(iii) and (iv) of this 
section.
    (vi) When a deviation occurs in a continuous rotary retort, the 
product shall be handled in accordance with paragraphs (d)(1)(iii) and 
(iv) of this section or in accordance with the following procedures:
    (a) Emergency stops.
    (1) When retort jams or breakdowns occur during the processing 
operations, all containers shall be given an emergency still process 
(developed per Sec. 318.302(b)) before the retort is cooled or the 
retort shall be cooled promptly and all containers removed and either 
reprocessed, repacked and reprocessed, or destroyed. Regardless of the 
procedure used, containers in the retort intake valve and in transfer 
valves between retort shells at the time of a jam or breakdown shall be 
removed and either reprocessed, repacked and reprocessed and or 
destroyed. Product to be destroyed shall be handled as ``U.S. Inspected 
and Condemned'', as defined in Sec. 301.2(ttt) of this subchapter, and 
disposed of in accordance with part 314 of this subchapter.
    (2) The time the retort reel stopped and the time the retort is used 
for an emergency still retort process shall be noted on the temperature/
time recording device and entered on the other production records 
required in Sec. 318.306.
    (b) Temperature drops. When the retort temperature drops below the 
temperature specified in the process schedule, the reel shall be stopped 
and the following actions shall be taken:
    (1) For temperature drops of less than 10 [deg]F (or 5.5 [deg]C) 
either, (i) all containers in the retort shall be given an emergency 
still process (developed per Sec. 318.302(b)) before the reel is 
restarted; (ii) container entry to the retort shall be prevented and an 
emergency agitating process (developed per Sec. 318.302(b)) shall be 
used before container entry to the retort is restarted; or (iii) 
container entry to the retort shall be prevented and the reel restarted 
to empty the retort. The discharged containers shall be reprocessed, 
repacked and reprocessed, or destroyed. Product to be destroyed shall be 
handled as ``U.S. Inspected and Condemned'', as defined in Sec. 
318.2(ee) of this subchapter, and disposed of in accordance with part 
314 of this subchapter.
    (2) For temperature drops of 10 [deg]F (or 5.5 [deg]C) or more, all 
containers in the retort shall be given an emergency still process 
(developed per Sec. 318.302(b)). The time the reel was stopped and the 
time the retort was used for a still retort process shall be marked on 
the temperature/time recording device by the establishment and entered 
on the other production records required in Sec. 318.306. 
Alternatively, container entry to the retort shall be prevented and the 
reel restarted to empty the retort. The discharged containers shall be 
either reprocessed, repacked and reprocessed, or destroyed. Product to 
be destroyed shall be handled as ``U.S. Inspected and Condemned'', as 
defined in Sec. 301.2(ee) of this subchapter, and disposed of in 
accordance with part 314 of this subchapter.
    (2) Deviations identified through record review. Whenever a 
deviation is noted during review of the processing and production 
records required by Sec. 318.307 (a) and (b), the establishment shall 
hold the product involved and the deviation shall be handled in 
accordance with paragraphs (d)(1) (iii) and (iv) of this section.
    (e) Process deviation file. The establishment shall maintain full 
records regarding the handling of each deviation. Such records shall 
include, at a minimum, the appropriate processing and production 
records, a full description of the corrective actions taken, the 
evaluation procedures and results, and the disposition of the affected 
product. Such records shall be maintained in a separate file or in a log 
that contains the appropriate information. The file or log shall be 
retained in accordance with Sec. 318.307(e) and shall be made

[[Page 303]]

available to Program employees upon request.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[51 FR 45619, Dec. 19, 1986, as amended at 53 FR 49848, Dec. 12, 1988; 
62 FR 45025, Aug. 25, 1997; 65 FR 34389, May 30, 2000; 65 FR 53532, 
Sept. 5, 2000]



Sec. 318.309  Finished product inspection.

    (a) Finished product inspections must be handled according to:
    (1) A HACCP plan for canned product that addresses hazards 
associated with microbiological contamination;
    (2) An FSIS-approved total quality control system;
    (3) Alternative documented procedures that will ensure that only 
safe and stable product is shipped in commerce; or
    (4) Paragraph (d) of this section.
    (b)-(c) [Reserved]
    (d) Procedures for handling finished product inspections where the 
HACCP plan for thermally processed/commercially sterile product does not 
address food safety hazards associated with microbial contamination, 
where there is no approved total quality control system, or where the 
establishment has no alternative documented procedures for handling 
process deviations.
    (1) Incubation of shelf stable canned product--(i) Incubator. The 
establishment shall provide incubation facilities which include an 
accurate temperature/time recording device, an indicating temperature 
device, a means for the circulation of the air inside the incubator to 
prevent temperature variations, and a means to prevent unauthorized 
entry into the facility. The Program is responsible for the security of 
the incubator.
    (ii) Incubation temperature. The incubation temperature shall be 
maintained at 955 [deg]F (352.8 [deg]C). If the incubation temperature falls below 
90 [deg]F (or 32 [deg]C) or exceeds 100 [deg]F (or 38 [deg]C) but does 
not reach 103 [deg]F (or 39.5 [deg]C), the incubation temperature shall 
be adjusted within the required range and the incubation time extended 
for the time the sample containers were held at the deviant temperature. 
If the incubation temperature is at or above 103 [deg]F (or 39.5 [deg]C) 
for more than 2 hours, the incubation test(s) shall be terminated, the 
temperature lowered to within the required range, and new sample 
containers incubated for the required time.
    (iii) Product requiring incubation. Shelf stable product requiring 
incubation includes:
    (a) Low acid products as defined in Sec. 318.300(m); and
    (b) Acidified low acid products as defined in Sec. 318.300(b).
    (iv) Incubation samples. (a) From each load of product processed in 
a batch-type thermal processing system (still or agitation), the 
establishment shall select at least one container for incubation.
    (b) For continuous rotary retorts, hydrostatic retorts, or other 
continuous-type thermal processing systems, the establishment shall 
select at least one container per 1,000 for incubation.
    (c) Only normal-appearing containers shall be selected for 
incubation.
    (v) Incubation time. Canned product requiring incubation shall be 
incubated for not less than 10 days (240 hours) under the conditions 
specified in paragraph (d)(1)(ii) of this section.
    (vi) Incubation checks and record maintenance. Designated 
establishment employees shall visually check all containers under 
incubation each working day and the inspector shall be notified when 
abnormal containers are detected. All abnormal containers should be 
allowed to cool before a final decision on their condition is made. For 
each incubation test the establishment shall record at least the product 
name, container size, container code, number of containers incubated, in 
and out dates, and incubation results. The establishment shall retain 
such records, along with copies of the temperature/time recording 
charts, in accordance with Sec. 318.307(e).
    (vii) Abnormal containers. The finding of abnormal containers (as 
defined in Sec. 318.300(a)) among incubation samples is cause to 
officially retain at least the code lot involved.
    (viii) Shipping. No product shall be shipped from the establishment 
before the end of the required incubation period except as provided in 
this paragraph or paragraph (b) or (c) of this section. An establishment 
wishing to ship product prior to the completion of

[[Page 304]]

the required incubation period shall submit a written proposal to the 
area supervisor. Such a proposal shall include provisions that will 
assure that shipped product will not reach the retail level of 
distribution before sample incubation is completed and that product can 
be returned promptly to the establishment should such action be deemed 
necessary by the incubation test results. Upon receipt of written 
approval from the area supervisor, product may be routinely shipped 
provided the establishment continues to comply with all requirements of 
this subpart.
    (2) Container condition--(i) Normal containers. Only normal-
appearing containers shall be shipped from an establishment as 
determined by an appropriate sampling plan or other means acceptable to 
Program employees.
    (ii) Abnormal containers. When abnormal containers are detected by 
any means other than incubation, the establishment shall inform the 
inspector, and the affected code lot(s) shall not be shipped until the 
Program has determined that the product is safe and stable. Such a 
determination will take into account the cause and level of abnormals in 
the affected lot(s) as well as any product disposition actions either 
taken or proposed by the establishment.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[51 FR 45619, Dec. 19, 1986, as amended at 57 FR 37872, Aug. 21, 1992; 
57 FR 55443, Nov. 25, 1992; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, May 
30, 2000; 65 FR 53532, Sept. 5, 2000]



Sec. 318.310  Personnel and training.

    All operators of thermal processing systems specified in Sec. 
318.305 and container closure technicians shall be under the direct 
supervision of a person who has successfully completed a school of 
instruction that is generally recognized as adequate for properly 
training supervisors of canning operations.

[51 FR 45619, Dec. 19, 1986]



Sec. 318.311  Recall procedure.

    Establishments shall prepare and maintain a current procedure for 
the recall of all canned product covered by this subpart. Upon request, 
the recall procedure shall be made available to Program employees for 
review.

(Approved by the Office of Management and Budget under control number 
0583-0015)



PART 319_DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION--Table 
of Contents




                            Subpart A_General

Sec.
319.1 Labeling and preparation of standardized products.
319.2 Products and nitrates and nitrites.
319.5 Mechanically Separated (Species).
319.6 Limitations with respect to use of Mechanically Separated 
          (Species).
319.10 Requirements for substitute standardized meat food products named 
          by use of an expressed nutrient content claim and a 
          standardized term.

                       Subpart B_Raw Meat Products

319.15 Miscellaneous beef products.
319.29 Miscellaneous pork products.

                         Subpart C_Cooked Meats

319.80 Barbecued meats.
319.81 Roast beef parboiled and steam roasted.

               Subpart D_Cured Meats, Unsmoked and Smoked

319.100 Corned beef.
319.101 Corned beef brisket.
319.102 Corned beef round and other corned beef cuts.
319.103 Cured beef tongue.
319.104 Cured pork products.
319.105 ``Ham patties,'' ``Chopped ham,'' ``Pressed ham,'' ``Spiced 
          ham,'' and similar products.
319.106 ``Country Ham,'' ``Country Style Ham,'' ``Dry Cured Ham,'' 
          ``Country Pork Shoulder,'' ``Country Style Pork Shoulder,'' 
          and ``Dry Cured Pork Shoulder.''
319.107 Bacon.

               Subpart E_Sausage Generally: Fresh Sausage

319.140 Sausage.
319.141 Fresh pork sausage.
319.142 Fresh beef sausage.
319.143 Breakfast sausage.
319.144 Whole hog sausage.
319.145 Italian sausage products.

                   Subpart F_Uncooked, Smoked Sausage

319.160 Smoked pork sausage.

[[Page 305]]

                        Subpart G_Cooked Sausage

319.180 Frankfurter, frank, furter, hotdog, weiner, vienna, bologna, 
          garlic bologna, knockwurst, and similar products.
319.181 Cheesefurters and similar products.
319.182 Braunschweiger and liver sausage or liverwurst.

Subpart H [Reserved]

Subpart I--Semi-Dry Fermented Sausage [Reserved]

Subpart J--Dry Fermented Sausage [Reserved]

          Subpart K_Luncheon Meat, Loaves and Jellied Products

319.260 Luncheon meat.
319.261 Meat loaf.

       Subpart L_Meat Specialties, Puddings and Nonspecific Loaves

319.280 Scrapple.
319.281 Bockwurst.

       Subpart M_Canned, Frozen, or Dehydrated Meat Food Products

319.300 Chili con carne.
319.301 Chili con carne with beans.
319.302 Hash.
319.303 Corned beef hash.
319.304 Meat stews.
319.305 Tamales.
319.306 Spaghetti with meatballs and sauce, spaghetti with meat and 
          sauce, and similar products.
319.307 Spaghetti sauce with meat.
319.308 Tripe with milk.
319.309 Beans with frankfurters in sauce, sauerkraut with wieners and 
          juice, and similar products.
319.310 Lima beans with ham in sauce, beans with ham in sauce, beans 
          with bacon in sauce, and similar products.
319.311 Chow mein vegetables with meat, and chop suey vegetables with 
          meat.
319.312 Pork with barbecue sauce and beef with barbecue sauce.
319.313 Beef with gravy and gravy with beef.

        Subpart N_Meat Food Entree Products, Pies, and Turnovers

319.500 Meat pies.

    Subpart O_Meat Snacks, Hors d'Oeuvres, Pizza, and Specialty Items

319.600 [Reserved]

                    Subpart P_Fats, Oils, Shortenings

319.700 Margarine or oleomargarine.
319.701 Mixed fat shortening.
319.702 Lard, leaf lard.
319.703 Rendered animal fat or mixture thereof.

       Subpart Q_Meat Soups, Soup Mixes, Broths, Stocks, Extracts

319.720 Meat extract.
319.721 Fluid extract of meat.

                 Subpart R_Meat Salads and Meat Spreads

319.760 Deviled ham, deviled tongue, and similar products.
319.761 Potted meat food product and deviled meat food product.
319.762 Ham spread, tongue spread, and similar products.

Subpart S--Meat Baby Foods [Reserved]

Subpart T--Dietetic Meat Foods [Reserved]

                         Subpart U_Miscellaneous

319.880 Breaded products.
319.881 Liver meat food products.

    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.18, 
2.53.

    Source: 35 FR 15597, Oct. 3, 1970, unless otherwise noted.



                            Subpart A_General



Sec. 319.1  Labeling and preparation of standardized products.

    (a) Labels for products for which standards of identity or 
composition are prescribed in this part shall show the appropriate 
product name, an ingredient statement, and other label information in 
accordance with the special provisions, if any, in this part, and 
otherwise in accordance with the general labeling provisions in part 317 
of this subchapter, and such products shall be prepared in accordance 
with the special provisions, if any, in this part and otherwise in 
accordance with the general provisions in this subchapter. Any product 
for which there is a common or usual name must consist of ingredients 
and be prepared by the use of procedures common or usual to such 
products insofar as specific ingredients or procedures are not 
prescribed or prohibited by the provisions of this subchapter.

[[Page 306]]

    (b) Any binder or antimicrobial agent that has been found to be safe 
and suitable by the Food and Drug Administration and the Food Safety and 
Inspection Service may be used in the production of meat products with 
standards of identity in this part, where the product standards and 
applicable Federal regulations already permit the use of these types of 
ingredients.

[35 FR 15597, Oct. 3, 1970, as amended at 68 FR 22578, Apr. 29, 2003]



Sec. 319.2  Products and nitrates and nitrites.

    Any product, such as frankfurters and corned beef, for which there 
is a standard in this part and to which nitrate or nitrite is permitted 
or required to be added, may be prepared without nitrate or nitrite and 
labeled with such standard name when immediately preceded with the term 
``Uncured'' in the same size and style of lettering as the rest of such 
standard name: Provided, That the product is found by the Administrator 
to be similar in size, flavor, consistency, and general appearance to 
such product as commonly prepared with nitrate and nitrite: And provided 
further, That labeling for such product complies with the provisions of 
Sec. 317.17(c) of this subchapter.

[44 FR 48961, Aug. 21, 1979]



Sec. 319.5  Mechanically Separated (Species).

    (a) Mechanically Separated (Species) is any finely comminuted 
product resulting from the mechanical separation and removal of most of 
the bone from attached skeletal muscle of livestock carcasses and parts 
of carcasses and meeting the other provisions of this paragraph. 
Examples of such product are ``Mechanically Separated Beef'', 
``Mechanically Separated Veal'', ``Mechanically Separated Pork'', and 
``Mechanically Separated Lamb''. At least 98 percent of the bone 
particles present in such product shall have a maximum size no greater 
than 0.5 millimeter in their greatest dimension and there shall be no 
bone particles larger than 0.85 millimeter in their greatest dimension. 
The product resulting from the separating process shall not have a 
calcium content exceeding 0.75 percent, as a measure of a bone solids 
content of not more than 3 percent, and shall have a minimum PER of 2.5 
(except as modified in paragraph (e)(1) of this section). Such product 
also shall have a protein content of not less than 14 percent and a fat 
content of not more than 30 percent, or it shall be deemed to be product 
for processing. Such product failing to meet the bone particle size, 
calcium, or PER requirements of this paragraph shall only be used in 
producing animal fats. Where such product meets the bone particle size, 
calcium, and PER requirements of this paragraph, it may also be used in 
the formulation of meat food products in accordance with Sec. 319.6.
    (b) Mechanically Separated (Beef) is inedible and prohibited for use 
as human food.
    (c)-(d) [Reserved]
    (e)(1) An essential amino acid content of at least 33 percent of the 
total amino acids presents in ``Mechanically Separated (Species)'' shall 
be accepted as evidence of compliance with the protein quality 
requirement set forth in paragraph (a) of this section. For purposes of 
this paragraph, essential amino acid content includes isoleucine, 
leucine, lysine, methionine, phenylalanine, threonine, and valine 
content, and the total amino acids present include isoleucine, leucine, 
lysine, methionine, phenylalanine, threonine, valine, tyrosine, 
arginine, histidine, alanine, aspartic acid, glutamic acid, glycine, 
proline, serine, and hydroxyproline content.
    (2) Analytical methods used by establishments in verifying the fat, 
protein, and calcium content of product consisting of or containing 
Mechanically Separated (Species) shall be among those listed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists (AOAC),'' 16th edition, 1995, Sec. Sec. 960.39, 976.21, 928.08 
(Chapter 39), and 940.33 (Chapter 45), which is incorporated by 
reference, or, if no AOAC method is available, in the ``Chemistry 
Laboratory Guidebook,'' U.S. Department of Agriculture, Washington, 
D.C., March 1986 edition, sections 6.011-6.013, Revised June 1987 (pages 
6-35 through 6-65), or by appropriate methods validated by scientific

[[Page 307]]

bodies in collaborative trials. The ``Official Methods of Analysis of 
the Association of Official Analytical Chemists,'' Chapter 39 and 
Chapter 45, subsection 45.2.06 (AOAC Official Method 940.33), 16th 
edition, 1995, are incorporated by reference with the approval of the 
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 
1 CFR Part 51.

[47 FR 28256, June 29, 1982, as amended at 54 FR 40631, Oct. 3, 1989; 59 
FR 33642, June 30, 1994; 62 FR 45026, Aug. 25, 1997; 65 FR 34389, May 
30, 2000; 69 FR 1874, Jan. 12, 2004]



Sec. 319.6  Limitations with respect to use of Mechanically Separated 
(Species).

    (a) Meat food products required to be prepared from one species 
shall not contain Mechanically Separated (Species) of any other species.
    (b) Mechanically Separated (Species) described in Sec. 319.5 that 
has a protein content of not less than 14 percent and a fat content of 
not more than 30 percent may constitute up to 20 percent of the 
livestock and poultry product portion of any meat food product except 
those listed in paragraph (d) of this section.
    (c) Mechanically Separated (Species) for processing described in 
Sec. 319.5 may constitute up to 20 percent of the livestock and poultry 
product portion of any meat food product that is subject to a definition 
and standard of identity or composition in part 319 which establishes a 
maximum limit on the fat content of such meat food product except those 
listed in paragraph (d) of this section.
    (d) Mechanically Separated (Species) and Mechanically Separated 
(Species) for processing described in Sec. 319.5 shall not be used in 
baby, junior, or toddler foods, ground beef, hamburger, fabricated 
steaks (Sec. 319.15 (a), (b), and (d)), barbecued meats (Sec. 319.80), 
roast beef-parboiled and steam roasted (Sec. 319.81), corned (cured) 
beef cuts (Sec. Sec. 319.100--319.103), certain cured pork products 
(Sec. Sec. 319.104 (a)-(e) and 319.106), tripe with milk (Sec. 
319.308), lima beans with ham and similar products (Sec. 319.310), beef 
with gravy and gravy with beef (Sec. 319.313), and meat pies (Sec. 
319.500).

[47 FR 28257, June 29, 1982]



Sec. 319.10  Requirements for substitute standardized meat food products 
named by use of an expressed nutrient content claim and a standardized term.

    (a) Description. The meat food products prescribed by this general 
definition and standard of identity are those products that substitute, 
in accordance with Sec. 317.313(d), for a standardized product defined 
in this part and use the name of that standardized product in their 
statements of identity, but that do not comply with the established 
standard because of a compositional deviation that results from 
reduction of a constituent that is described by an expressed nutrient 
content claim that has been defined by regulation in part 317, subpart 
B, of this subchapter. The expressed nutrient content claim shall comply 
with the requirements of Sec. 317.313 of this subchapter and with the 
requirements of part 317, subpart B, of this subchapter which define the 
particular nutrient content claim that is used. The meat food product 
shall comply with the relevant standard in this part in all other 
respects, except as provided in paragraphs (b) and (c) of this section.
    (b) Performance characteristics. The performance characteristics, 
such as physical properties, functional properties, and shelf-life, of 
the meat food product shall be similar to those of the standardized meat 
food product produced under this part. If there is a significant 
difference in a performance characteristic that materially limits the 
use of the product compared to the use of the standardized product 
defined in this part, the label shall include a statement in accordance 
with Sec. 317.313(d)(1) and (2) of this subchapter that informs the 
consumer of such differences (e.g., if appropriate, ``not recommended 
for frozen storage'' or ``not suitable for roller grilling''). 
Deviations from the ingredient provisions of the standard must be the 
minimum necessary to qualify for the nutrient content claim, while 
maintaining similar performance characteristics.
    (c) Ingredients used in substitute products. (1) Ingredients used in 
the product shall be those ingredients provided for in the standard as 
defined in this part,

[[Page 308]]

except that safe and suitable ingredients permitted for use in meat food 
products as provided in a regulation permitting that use in this 
subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter 
I, Subchapter A or Subchapter B, may be used at the minimum level 
necessary to improve texture and prevent syneresis, so that the 
substitute product is not inferior in performance characteristics from 
the standardized product defined in this part for which it is a 
substitute.
    (2) An ingredient that is specifically required by the standard 
prescribed in this part shall not be replaced or exchanged with a 
similar ingredient from another source, for example, turnip chunks shall 
not replace potatoes in corned beef hash.
    (3) An ingredient that is specifically prohibited from use in any 
meat food product by this part shall not be added to the substitute meat 
food product under this section.
    (4) Unless otherwise specified in this part, a substitute meat food 
product must meet all other requirements of the applicable standards of 
identity or composition.
    (5) Water and fat-replacers (e.g., binders), in combination, may be 
added to replace fat in accordance with paragraph (c) of this section.
    (6) Textured vegetable protein may be used by itself or in 
combination with other binders and water as a fat replacer in accordance 
with paragraph (c) of this section.
    (d) Nomenclature. The name of a substitute meat food product that 
complies with all parts of this section is the appropriate expressed 
nutrient content claim and the applicable standardized term.
    (e) Label declaration. (1) Each of the ingredients used in the 
substitute meat food product shall be declared on the label as required 
by this section and part 317 of this subchapter.
    (2) Ingredients not provided for, and ingredients used in excess of 
those levels provided for, by the standard as defined in this part, 
shall be identified as such with an asterisk in the ingredients 
statement. The statement ``*Ingredients not in regular --------'' (the 
blank shall be filled in with the name of the traditional standardized 
product) or ``**Ingredients in excess of amounts permitted in regular --
------'' (the blank shall be filled in with the name of the traditional 
standardized product), or both, as appropriate, shall immediately follow 
the ingredients statement in the same type and size.

    Effective Date Note: At 70 FR 33818, June 10, 2005, Sec. 319.10 was 
added, effective Jan. 1, 2008.



                       Subpart B_Raw Meat Products



Sec. 319.15  Miscellaneous beef products.

    (a) Chopped beef, ground beef. ``Chopped Beef'' or ``Ground Beef'' 
shall consist of chopped fresh and/or frozen beef with or without 
seasoning and without the addition of beef fat as such, shall not 
contain more than 30 percent fat, and shall not contain added water, 
phosphates, binders, or extenders. When beef cheek meat (trimmed beef 
cheeks) is used in the preparation of chopped or ground beef, the amount 
of such cheek meat shall be limited to 25 percent; and if in excess of 
natural proportions, its presence shall be declared on the label, in the 
ingredient statement required by Sec. 317.2 of this subchapter, if any, 
and otherwise contiguous to the name of the product.
    (b) Hamburger. ``Hamburger'' shall consist of chopped fresh and/or 
frozen beef with or without the addition of beef fat as such and/or 
seasoning, shall not contain more than 30 percent fat, and shall not 
contain added water, phosphates, binders, or extenders. Beef cheek meat 
(trimmed beef cheeks) may be used in the preparation of hamburger only 
in accordance with the conditions prescribed in paragraph (a) of this 
section.
    (c) Beef patties. ``Beef Patties'' shall consist of chopped fresh 
and/or frozen beef with or without the addition of beef fat as such and/
or seasonings. Binders or extenders, Mechanically Separated (Species) 
used in accordance with Sec. 319.6, and/or partially defatted beef 
fatty tissue may be used without added water or with added water only in 
amounts such that the product characteristics are essentially that of a 
meat pattie.
    (d) Fabricated steak. Fabricated beef steaks, veal steaks, beef and 
veal

[[Page 309]]

steaks, or veal and beef steaks, and similar products, such as those 
labeled ``Beef Steak, Chopped, Shaped, Frozen,'' ``Minute Steak, Formed, 
Wafer Sliced, Frozen,'' ``Veal Steaks, Beef Added, Chopped--Molded--
Cubed--Frozen, Hydrolyzed Plant Protein, and Flavoring'' shall be 
prepared by comminuting and forming the product from fresh and/or frozen 
meat, with or without added fat, of the species indicated on the label. 
Such products shall not contain more than 30 percent fat and shall not 
contain added water or extenders. Transglutaminase enzyme at levels of 
up to 65 ppm may be used as a binder. Beef cheek meat (trimmed beef 
cheeks) may be used in the preparation of fabricated beef steaks only in 
accordance with the conditions prescribed in paragraph (a) of this 
section.
    (e) Partially defatted beef fatty tissue. ``Partially Defatted Beef 
Fatty Tissue'' is a beef byproduct derived from the low temperature 
rendering (not exceeding 120 [deg]F.) of fresh beef fatty tissue. Such 
product shall have a pinkish color and a fresh odor and appearance.

[35 FR 15597, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973; 43 
FR 26424, June 20, 1978; 47 FR 10784, Mar. 12, 1982; 47 FR 28257, June 
29, 1982; 66 FR 54916, Oct. 31, 2001]



Sec. 319.29  Miscellaneous pork products.

    (a) Partially defatted pork fatty tissue. ``Partially Defatted Pork 
Fatty Tissue'' is a pork byproduct derived from the low temperature 
rendering (not exceeding 120 [deg]F.) of fresh pork fatty tissue, 
exclusive of skin. Such product shall have a pinkish color and a fresh 
odor and appearance.



                         Subpart C_Cooked Meats



Sec. 319.80  Barbecued meats.

    Barbecued meats, such as product labeled ``Beef Barbecue'' or 
``Barbecued Pork,'' shall be cooked by the direct action of dry heat 
resulting from the burning of hard wood or the hot coals therefrom for a 
sufficient period to assume the usual characteristics of a barbecued 
article, which include the formation of a brown crust on the surface and 
the rendering of surface fat. The product may be basted with a sauce 
during the cooking process. The weight of barbecued meat shall not 
exceed 70 percent of the weight of the fresh uncooked meat.



Sec. 319.81  Roast beef parboiled and steam roasted.

    ``Roast Beef Parboiled and Steam Roasted'' shall be prepared so that 
the weight of the finished product, excluding salt and flavoring 
material, shall not exceed 70 percent of the fresh beef weight. 
Transglutaminase enzyme at levels of up to 65 ppm may be used as a 
binder in such product. Beef cheek meat and beef head meat from which 
the overlying glandular and connective tissues have been removed, and 
beef heart meat, exclusive of the heart cap may be used individually or 
collectively to the extent of 5 percent of the meat ingredients in the 
preparation of canned product labeled ``Roast Beef Parboiled and Steam 
Roasted.'' When beef cheek meat, beef head meat, or beef heart meat is 
used in the preparation of this product, its presence shall be reflected 
in the statement of ingredients required by part 317 of this subchapter.

[35 FR 15597, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973; 66 
FR 54916, Oct. 31, 2001]



               Subpart D_Cured Meats, Unsmoked and Smoked



Sec. 319.100  Corned beef.

    ``Corned Beef'' shall be prepared from beef briskets, navels, clods, 
middle ribs, rounds, rumps, or similar cuts using one or a combination 
of the curing ingredients specified in a regulation permitting that use 
in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR 
Chapter I, Subchapter A or Subchapter B. Canned product labeled ``Corned 
Beef'' shall be prepared so that the weight of the finished product, 
excluding cure, salt, and flavoring material, shall not exceed 70 
percent of the fresh beef weight. Corned beef other than canned shall be 
cured in pieces weighing not less than 1 pound, and if cooked, its 
weight shall not exceed the weight of the fresh uncured beef. Beef cheek 
meat, beef head meat and beef heart meat may be used to the extent of 5 
percent of the meat ingredient in preparation of this product when 
trimmed as specified in

[[Page 310]]

Sec. 319.81. When beef cheek meat, beef head meat, or beef heart meat 
is used in preparation of this product, its presence shall be reflected 
in the statement of ingredients required by part 317 of this subchapter. 
The application of curing solution to beef cuts, other than briskets, 
which are intended for bulk corned beef shall not result in an increase 
in the weight of the finished cured product of more than 10 percent over 
the weight of the fresh uncured meat.

[35 FR 15597, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 38 
FR 29215, Oct. 23, 1973; 64 FR 72174, Dec. 23, 1999]



Sec. 319.101  Corned beef brisket.

    In preparing ``Corned Beef Brisket,'' the application of curing 
solution to the beef brisket shall not result in an increase in the 
weight of the finished cured product of more than 20 percent over the 
weight of the fresh uncured brisket. If the product is cooked, the 
weight of the finished product shall not exceed the weight of the fresh 
uncured brisket.



Sec. 319.102  Corned beef round and other corned beef cuts.

    In preparing ``Corned Beef Round'' and other corned beef cuts, 
except ``Corned Beef Briskets,'' the curing solution shall be applied to 
pieces of beef weighing not less than one pound and such application 
shall not result in an increased weight of the cured beef product of 
more than 10 percent over the weight of the fresh uncured beef cut. If 
the product is cooked, the weight of the finished product shall not 
exceed the weight of the fresh uncured beef cut.



Sec. 319.103  Cured beef tongue.

    In preparing ``Cured Beef Tongue,'' the application of curing 
solution to the fresh beef tongue shall not result in an increase in the 
weight of the cured beef tongue of more than 10 percent over the weight 
of the fresh uncured beef tongue.



Sec. 319.104  Cured pork products.

    (a) Cured pork products, including hams, shoulders, picnics, butts 
and loins, shall comply with the minimum meat Protein Fat Free (PFF) 
percentage requirements set forth in the following chart:

------------------------------------------------------------------------
                                     Minimum meat
    Type of cured pork product           PFF          Product name and
                                    percentage\1\  qualifying statements
------------------------------------------------------------------------
Cooked ham, loin\2\...............         20.5    (Common and usual).
                                           18.5    (Common and usual)
                                                    with natural juices.
                                           17.0    (Common and usual)
                                                    water added.
                                          <17.0    (Common and usual)
                                                    and water product--
                                                    X% of weight is
                                                    added
                                                    ingredients.\3\
Cooked shoulder, butt, picnic\2\..         20.0    (Common and usual).
                                           18.0    (Common and usual)
                                                    with natural juices.
                                           16.5    (Common and usual)
                                                    water added.
                                          <16.5    (Common and usual)
                                                    and water product--
                                                    X% of weight is
                                                    added
                                                    ingredients.\3\
Uncooked cured ham, loin..........         18.0    Uncooked (common and
                                                    usual).
                                          <18.0    Uncooked (common and
                                                    usual) and water
                                                    product--X% of
                                                    weight is added
                                                    ingredients.\3\
Uncooked cured shoulder, butt,             17.5    Uncooked (common and
 picnic.                                            usual).
                                          <17.5    Uncooked (common and
                                                    usual) and water
                                                    product--X% of
                                                    weight is added
                                                    ingredients.\3\
------------------------------------------------------------------------
\1\ The minimum meat PFF percentage shall be the minimum meat protein
  which is indigenous to the raw unprocessed pork expressed as a percent
  of the non-fat portion of the finished product; and compliance shall
  be determined under Sec. 318.19 of this subchapter for domestic
  cured pork product and Sec. 327.23 of this subchapter for imported
  cured pork product.
\2\ The term ``cooked'' is not appropriate for use on labels of cured
  pork products heated only for the purpose of destruction of possible
  live trichinae.
\3\ Processors may immediately follow this qualifying statement with a
  list of the ingredients in descending order of predominance rather
  than having the traditional ingredients statement. In any case, the
  maximum percent of added substances in the finished product on a total
  weight percentage basis would be inserted as the X value; e.g., Ham
  and Water Product--20% of Weight is Added Ingredients.

    (b) Cured pork products for which there is a qualifying statement 
required in paragraph (a) of this section shall bear that statement as 
part of the product name in lettering not less than \3/8\ inch in 
height, or in lettering not less than one-third the size of the largest 
letter in the product name if it is in the same color and style of print 
and on the same color background as the product name. However, the 
Administrator may approve smaller lettering for labeling of packages of 
1 pound or less, provided such lettering is at least

[[Page 311]]

one-third the size and of the same color and style as the product name.
    (c) Cured pork product prepared pursuant to this section shall be 
subject to the compliance procedures in Sec. 318.19 of this subchapter.
    (d) The binders provided for use in cured pork products in a 
regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or in 
21 CFR Chapter I, Subchapter A or Subchapter B, may be used singly in 
those cured pork products labeled as ``Ham Water Added,'' ``Ham and 
Water Product-X% of Weight is Added Ingredients,'' and ``Ham with 
Natural Juices.'' In addition to the binders referred to in the 
preceding sentence, the following substances are permitted for use as 
binders and may be used singly in those cured pork products labeled as 
``Ham Water Added,'' ``Ham and Water Product-X% of Weight is Added 
Ingredients,'' and ``Ham with Natural Juices'': pork collagen at up to 
3.5% of the product formulation. Unless their use is provided for in a 
regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or in 
21 CFR Chapter I, Subchapter A or Subchapter B, or in this paragraph, 
these binders are not permitted to be used in combination with another 
such binder listed for use in cured pork products. When any such 
substance is added to these products, the substance shall be declared in 
the ingredients statement by its common or usual name in order of 
predominance.

[49 FR 14879, Apr. 13, 1984, as amended at 50 FR 9792, Mar. 12, 1985; 53 
FR 5151, Feb. 22, 1988; 57 FR 42888, Sept. 17, 1992; 62 FR 45026, Aug. 
25, 1997; 63 FR 148, Jan. 5, 1998; 64 FR 27904, May 24, 1999; 65 FR 
34389, May 30, 2000; 66 FR 54916, Oct. 31, 2001]



Sec. 319.105  ``Ham patties,'' ``Chopped ham,'' ``Pressed ham,'' ``Spiced 
ham,'' and similar products.

    (a) Finely divided (chopped, ground, flaked, chipped) cured ham 
products such as ``Ham patties,'' ``Chopped ham,'' ``Pressed ham,'' and 
``Spiced ham'' shall comply with minimum meat Protein Fat Free (PFF) 
percentage requirements set forth in the following chart:

------------------------------------------------------------------------
                                      Minimum
                                      meat PFF       Product name and
    Type of cured pork product       percentage   qualifying statements
                                        \1\
------------------------------------------------------------------------
``Ham Patties,'' ``Chopped Ham,''          19.5      (Common and usual).
 ``Pressed Ham,'' and ``Spiced
 Ham''............................
``Ham Patties,'' ``Chopped Ham,''          17.5  (Common and usual) with
 ``Pressed Ham,'' and ``Spiced                           natural juices.
 Ham''............................
``Ham Patties,'' ``Chopped Ham,''          16.0       (Common and usual)
 ``Pressed Ham,'' and ``Spiced                              water added.
 Ham''............................
``Ham Patties,'' ``Chopped Ham,''         <16.0   (Common and usual) and
 ``Pressed Ham,'' and ``Spiced                    water product--(x)% of
 Ham''............................                       weight is added
                                                        ingredients. \2\
------------------------------------------------------------------------
\1\ The minimum meat PFF percentage shall be the minimum meat protein
  which is indigenous to the raw, unproc essed pork expressed as a
  percent of the nonfat portion of the finished product; and compliance
  shall be determined under section 318.19 of this subchapter.
\2\ Processors may immediately follow this qualifying statement with a
  list of the ingredients in descending order of predominance rather
  than having the traditional ingredients statement. In any case, the
  maximum percent of added substances in the finished product on a total
  weight percentage basis would be inserted as the X value; e.g., Ham
  and Water Product--20% of Weight is Added Ingredients.

    (b) Cured pork products prepared under this section except ``Ham 
patties'' may contain finely chopped ham shank meat to the extent of 25 
percent over that normally present in boneless ham. Mechanically 
Separated (Species) Product may be used in accordance with Sec. 319.6.
    (c) Cured pork product prepared pursuant to this section shall be 
subject to the compliance procedures in Sec. 318.19 of this subchapter, 
and those cured pork products prepared under this section for which 
there is a qualifying statement required shall comply with the 
requirements of Sec. 319.104(b) of this subchapter.
    (d) In addition to the other requirements of this section, ``Ham 
Patties'' may not contain more than 35 percent fat, by analysis.

[49 FR 14880, Apr. 13, 1984, as amended at 53 FR 5151, Feb. 22, 1988; 62 
FR 45026, Aug. 25, 1997; 65 FR 34389, May 30, 2000]

[[Page 312]]



Sec. 319.106  ``Country Ham,'' ``Country Style Ham,'' ``Dry Cured Ham,'' 
``Country Pork Shoulder,'' ``Country Style Pork Shoulder,'' and ``Dry 
Cured Pork Shoulder.''

    (a) ``Country Ham,'' ``Country Style Ham,'' or ``Dry Cured Ham,'' 
and ``Country Pork Shoulder,'' ``Country Style Pork Shoulder,'' or ``Dry 
Cured Pork Shoulder.'' are the uncooked, cured, dried, smoked or 
unsmoked meat food products made respectively from a single piece of 
meat conforming to the definition of ``ham,'' as specified in Sec. 
317.8(b)(13) of this subchapter, or from a single piece of meat from a 
pork shoulder. They are prepared in accordance with paragraph (c) of 
this section by the dry application of salt (NaCl), or by the dry 
application of salt (NaCl) and one or more of the optional ingredients 
as specified in paragraph (d) of this section. They may not be injected 
with curing solutions nor placed in curing solutions.
    (b) The product must be treated for the destruction of possible live 
trichinae in accordance with such methods as may be approved by the 
Administrator upon request in specific instances and none of the 
provisions of this standard can be interpreted as discharging trichinae 
treatment requirements.
    (c)(1) The entire exterior of the ham or pork shoulder shall be 
coated by the dry application of salt or by the dry application of salt 
combined with other ingredients as permitted in paragraph (d) of this 
section.
    (2) Additional salt, or salt mixed with other permitted ingredients, 
may be reapplied to the product as necessary to insure complete 
penetration.
    (3) When sodium or potassium nitrate, or sodium or potassium 
nitrite, or a combination thereof, is used, the application of salt 
shall be in sufficient quantity to insure that the finished product has 
an internal salt content of at least 4 percent.
    (4) When no sodium nitrate, potassium nitrate, sodium nitrite, 
potassium nitrite or a combination thereof is used, the application of 
salt shall be in sufficient quantity to insure that the finished product 
has a brine concentration of not less than 10 percent or a water 
activity of not more than 0.92.
    (5) For hams or pork shoulders labeled ``country'' or ``country 
style,'' the combined period for curing and salt equalization shall not 
be less than 45 days for hams, and shall not be less than 25 days for 
pork shoulders; the total time for curing salt equalization, and drying 
shall not be less than 70 days for hams, and shall not be less than 50 
days for pork shoulders. During the drying and smoking period, the 
internal temperature of the product must not exceed 95 [deg]F., provided 
that such temperature requirement shall not apply to product dried or 
smoked under natural climatic conditions.
    (6) For hams or pork shoulders labeled ``dry cured,'' the combined 
period for curing and salt equalization shall not be less than 45 days 
for hams, and shall not be less than 25 days for pork shoulders; and the 
total time for curing, salt equalization, and drying shall not be less 
than 55 days for hams and shall not be less than 40 days for pork 
shoulders.
    (7) The weight of the finished hams and pork shoulders covered in 
this section shall be at least 18 percent less than the fresh uncured 
weight of the article.
    (d) The optional ingredients for products covered in this section 
are:
    (1) Nutritive sweeteners, spices, seasonings and flavorings.
    (2) Sodium or potassium nitrate and sodium or potassium nitrite if 
used as prescribed in this section and in accordance with a regulation 
permitting that use in this subchapter or 9 CFR Chapter III, Subchapter 
E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.

[42 FR 3299, Jan. 18, 1977, as amended at 64 FR 72174, Dec. 23, 1999]

    Effective Date Note: At 46 FR 1257, Jan. 6, 1981, the Safety and 
Quality Service, Department of Agriculture, announced that ``the 
temperature and time period provisions of 9 CFR 319.106, paragraphs 
(c)(5) and (c)(6), have not been in effect since November 17, 1980, and 
will not be enforced pending future Agency action in the matter. 
However, ham and pork shoulders must continue to be prepared in 
compliance with all other provisions of 9 CFR 319.106 in order to be 
labeled `country ham,' `country style ham,' or `dry cured ham,' and 
`country pork shoulder,'

[[Page 313]]

`country style pork shoulder,' or `dry cured pork shoulder.'''



Sec. 319.107  Bacon.

    The weight of cured pork bellies ready for slicing and labeling as 
``Bacon'' shall not exceed the weight of the fresh uncured pork bellies.

[49 FR 14880, Apr. 13, 1984]



               Subpart E_Sausage Generally: Fresh Sausage



Sec. 319.140  Sausage.

    Except as otherwise provided in this section, or under the Poultry 
Products Inspection Act with respect to products consisting partly of 
poultry, sausage is the coarse or finely comminuted meat food product 
prepared from one or more kinds of meat or meat and meat byproducts, 
containing various amounts of water as provided for elsewhere in this 
part, and usually seasoned with condimented proportions of condimental 
substances, and frequently cured. Certain sausage as provided for 
elsewhere in this part may contain binders and extenders as provided in 
a regulation permitting that use in this subchapter or in 9 CFR Chapter 
III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. 
In addition to the binders and extenders referred to in the preceding 
sentence, the following two substances may also be used as binders in 
those sausages in which the use of such class of substances is 
permitted: pork collagen at up to 3.5% of the product formulation and 
transglutaminase enzyme at up to 65 ppm of the product formulation. 
Sausage may not contain phosphates except that phosphates listed in a 
regulation permitting that use in this subchapter or in 9 CFR Chapter 
III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B 
may be used in cooked sausage. To facilitate chopping or mixing or to 
dissolve the usual curing ingredients, water or ice may be used in the 
preparation of sausage which is not cooked in an amount not to exceed 3 
percent of the total ingredients in the formula. Cooked sausages such as 
Polish sausage, cotto salami, braunschweiger, liver sausage, and similar 
cooked sausage products may contain no more than 10 percent of added 
water in the finished product. Sausage may contain Mechanically 
Separated (Species) used in accordance with Sec. 319.6.

[55 FR 34683, Aug. 24, 1990, as amended at 64 FR 72175, Dec. 23, 1999; 
66 FR 54916, Oct. 31, 2001]



Sec. 319.141  Fresh pork sausage.

    ``Fresh Pork Sausage'' is sausage prepared with fresh pork or frozen 
pork or both, but not including pork byproducts, and may contain 
Mechanically Separated (Species) in accordance with Sec. 319.6, and may 
be seasoned with condimental substances as permitted under part 318 of 
this subchapter. The finished product shall not contain more than 50 
percent fat. To facilitate chopping or mixing, water or ice may be used 
in an amount not to exceed 3 percent of the total ingredients used.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26424, June 20, 1978; 47 
FR 28257, 28258, June 29, 1982]



Sec. 319.142  Fresh beef sausage.

    ``Fresh Beef Sausage'' is sausage prepared with fresh beef or frozen 
beef, or both, but not including beef byproducts, and may contain 
Mechanically Separated (Species) used in accordance with Sec. 319.6, 
and may be seasoned with condimental substances as permitted under part 
318 of this subchapter. The finished product shall not contain more than 
30 percent fat. To facilitate chopping or mixing, water or ice may be 
used in an amount not to exceed 3 percent of the total ingredients used.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26424, June 20, 1978; 47 
FR 28257, June 29, 1982]



Sec. 319.143  Breakfast sausage.

    ``Breakfast sausage'' is sausage prepared with fresh and/or frozen 
meat; or fresh and/or frozen meat and meat byproducts, and may contain 
Mechanically Separated (Species) in accordance with Sec. 319.6, and may 
be seasoned with condimental substances as permitted in part 318 of this 
subchapter. The finished product shall not contain more than 50 percent 
fat. To facilitate chopping or mixing, water or ice may be used in an 
amount not to exceed 3 percent of the total ingredients used.

[[Page 314]]

Binders or extenders may be added as provided in Sec. 319.140 of this 
part.

[55 FR 34683, Aug. 24, 1990, as amended at 66 FR 54916, Oct. 31, 2001]



Sec. 319.144  Whole hog sausage.

    ``Whole Hog Sausage'' is sausage prepared with fresh and/or frozen 
meat from swine in such proportions as are normal to a single animal, 
and may include any Mechanically Separated (Species) produced from the 
animal and used in accordance with Sec. 319.6, and may be seasoned with 
condimental substances as permitted under part 318 of this subchapter. 
The finished product shall not contain more than 50 percent fat. To 
facilitate chopping or mixing, water or ice may be used in an amount not 
to exceed 3 percent of the total ingredients used.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26424, June 20, 1978; 47 
FR 28257, 28258, June 29, 1982]



Sec. 319.145  Italian sausage products.

    (a) Italian sausage products are cured or uncured sausages 
containing at least 85 percent meat, or combination of meat and fat, 
with the total fat content constituting not more than 35 percent of the 
finished product. Such products shall be prepared in accordance with the 
provisions of paragraph (a) (1), (2) or (3) of this section, and shall 
contain salt, pepper, and either fennel or anise, or a combination of 
fennel and anise. Such products may contain any or all of the optional 
ingredients listed in paragraph (b) of this section.
    (1) ``Italian Sausage'' shall be prepared with fresh or frozen pork, 
or pork and pork fat, and may contain Mechanically Separated (Species) 
in accordance with Sec. 319.6.
    (2) ``Italian Sausage with Beef,'' ``Italian Sausage with Veal,'' or 
``Italian Sausage with Beef and Veal,'' shall be prepared so that fresh 
or frozen pork constitutes the major portion of the meat content 
requirement of this paragraph. Mechanically Separated (Species) may be 
used in accordance with Sec. 319.6. When pork muscle tissue is combined 
with beef or veal, or both, in the preparation of bulk-packed products, 
or patties, it shall be treated for the destruction of possible live 
trichinae in accordance with Sec. 318.10 of this subchapter.
    (3) ``Italian Beef Sausage'' or ``Kosher Italian Beef Sausage'' 
shall be prepared with fresh or frozen beef or beef and beef fat. 
``Italian Veal Sausage'' or ``Kosher Italian Veal Sausage'' shall be 
prepared with fresh or frozen veal or veal and veal fat. Mechanically 
Separated (Species) may be used in accordance with Sec. 319.6.
    (4) Italian sausage products made in conformance with the provisions 
of paragraphs (a) (1), (2), and (3) of this section, and with paragraphs 
(b) and (c) of this section, may contain sodium nitrite or potassium 
nitrite in amounts not to exceed those allowed in a regulation 
permitting that use in this subchapter or in 9 CFR Chapter III, 
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, 
provided that such products are labeled with the word ``cured'' in the 
product name, such as ``Cured Italian Sausage.'' The word ``cured'' 
shall be displayed on the product label in the same size and style of 
lettering as other words in the product name.
    (b) Optional ingredients permitted in Italian sausage products 
include:
    (1) Spices (including paprika) and flavorings.
    (2) Water or ice to facilitate chopping or mixing, but not to exceed 
3 percent of the total weight of all ingredients including the water.
    (3) Red or green peppers, or both.
    (4) Dehydrated or fresh onions, garlic, and parsley.
    (5) Sugar, dextrose, corn syrup, corn syrup solids, and glucose 
syrup.
    (6) Monosodium glutamate and antioxidants in accordance with the 
chart of substances a regulation permitting that use in this subchapter 
or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, 
Subchapter A or Subchapter B.
    (c) If Italian sausage products are cooked or smoked, determination 
of compliance with the provisions of paragraphs (a) and (b) of this 
section shall be based on the uncooked or unsmoked product. The product 
before cooking or smoking shall contain no more than 3 percent water as 
specified in paragraph (b)(2) of this section. Product which is cooked 
shall be labeled with the word

[[Page 315]]

``cooked'' in the product name, such as ``Cooked Italian Sausage'' or 
``Cooked Cured Italian Sausage.'' Product which is smoked shall be 
labeled with the word ``smoked'' in the product name, such as ``Smoked 
Italian Sausage'' or ``Smoked Cured Italian Sausage.'' The words 
``cooked'' and ``smoked'' shall be displayed on the product label in the 
same size and style of lettering as other words in the product name.

[41 FR 2630, Jan. 19, 1976, as amended at 43 FR 26424, June 20, 1978; 47 
FR 28257, 28258, June 29, 1982; 49 FR 46533, Nov. 27, 1984; 64 FR 72175, 
Dec. 23, 1999]



                   Subpart F_Uncooked, Smoked Sausage



Sec. 319.160  Smoked pork sausage.

    ``Smoked Pork Sausage'' is pork sausage that is smoked with hardwood 
or other approved nonresinous materials. It may be seasoned with 
condimental substances as permitted in part 318 of this subchapter. The 
finished product shall not contain more than 50 percent fat. To 
facilitate chopping or mixing, water, or ice may be used in an amount 
not to exceed 3 percent of the total ingredients used.

[35 FR 15597, Oct. 3, 1970, as amended at 47 FR 28258, June 29, 1982]



                        Subpart G_Cooked Sausage



Sec. 319.180  Frankfurter, frank, furter, hotdog, weiner, vienna, 
bologna, garlic bologna, knockwurst, and similar products.

    (a) Frankfurter, frank, furter, hot-dog, wiener, vienna, bologna, 
garlic bologna, knockwurst and similar cooked sausages are comminuted, 
semisolid sausages prepared from one or more kinds of raw skeletal 
muscle meat or raw skeletal muscle meat and raw or cooked poultry meat, 
and seasoned and cured, using one or more of the curing agents in 
accordance with a regulation permitting that use in this subchapter or 
in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A 
or Subchapter B. They may or may not be smoked. The finished products 
shall not contain more than 30 percent fat. Water or ice, or both, may 
be used to facilitate chopping or mixing or to dissolve the curing 
ingredients but the sausage shall contain no more than 40 percent of a 
combination of fat and added water. These sausage products may contain 
only phosphates approved under part 318 of this chapter. Such products 
may contain raw or cooked poultry meat and/or Mechanically Separated 
(Kind of Poultry) without skin and without kidneys and sex glands used 
in accordance with Sec. 381.174, not in excess of 15 percent of the 
total ingredients, excluding water, in the sausage, and Mechanically 
Separated (Species) used in accordance with Sec. 319.6. Such poultry 
meat ingredients shall be designated in the ingredient statement on the 
label of such sausage in accordance with the provisions of Sec. 381.118 
of this chapter.
    (b) Frankfurter, frank, furter, hot-dog, wiener, vienna, bologna, 
garlic bologna, knockwurst and similar cooked sausages that are labeled 
with the phrase ``with byproducts'' or ``with variety meats'' in the 
product name are comminuted, semisolid sausages consisting of not less 
than 15 percent of one or more kinds of raw skeletal muscle meat with 
raw meat byproducts, or not less than 15 percent of one or more kinds of 
raw skeletal muscle meat with raw meat byproducts and raw or cooked 
poultry products; and seasoned and cured, using one or more of the 
curing ingredients in accordance with a regulation permitting that use 
in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR 
Chapter I, Subchapter A or Subchapter B. They may or may not be smoked. 
Partially defatted pork fatty tissue or partially defatted beef fatty 
tissue, or a combination of both, may be used in an amount not exceeding 
15 percent of the meat and meat byproducts or meat, meat byproducts, and 
poultry products ingredients. The finished products shall not contain 
more than 30 percent fat. Water or ice, or both, may be used to 
facilitate chopping or mixing to dissolve the curing and seasoning 
ingredients, the sausage shall contain no more than 40 percent of a 
combination of fat and added water. These sausage products may contain 
only phosphates approved under part 318 of this chapter. These sausage 
products may contain poultry products and/or Mechanically

[[Page 316]]

Separated (Kind of Poultry) used in accordance with Sec. 381.174, 
individually or in combination, not in excess of 15 percent of the total 
ingredients, excluding water, in the sausage, and may contain 
Mechanically Separated (Species) used in accordance with Sec. 319.6. 
Such poultry products shall not contain kidneys or sex glands. The 
amount of poultry skin present in the sausage must not exceed the 
natural proportion of skin present on the whole carcass of the kind of 
poultry used in the sausage, as specified in Sec. 381.117(d) of this 
chapter. The poultry products used in the sausage shall be designated in 
the ingredient statement on the label of such sausage in accordance with 
the provisions of Sec. 381.118 of this chapter. Meat byproducts used in 
the sausage shall be designated individually in the ingredient statement 
on the label for such sausage in accordance with Sec. 317.2 of this 
chapter.
    (c) A cooked sausage as defined in paragraph (a) of this section 
shall be labeled by its generic name, e.g., frankfurter, frank, furter, 
hotdog, wiener, vienna, bologna, garlic bologna, or knockwurst. When 
such sausage products are prepared with meat from a single species of 
cattle, sheep, swine, or goats they shall be labeled with the term 
designating the particular species in conjunction with the generic name, 
e.g., ``Beef Frankfurter,'' and when such sausage products are prepared 
in part with Mechanically Separated (Species) in accordance with Sec. 
319.6, they shall be labeled in accordance with Sec. 317.2(j)(13) of 
this subchapter.
    (d) A cooked sausage as defined in paragraph (b) of this section 
shall be labeled by its generic name, e.g., frankfurter, frank, furter, 
hotdog, wiener, vienna, bologna, garlic bologna, or knockwurst, in 
conjunction with the phrase ``with byproducts'' or ``with variety 
meats'' with such supplemental phrase shown in a prominent manner 
directly contiguous to the generic name and in the same color on an 
identical background.
    (e) Binders and extenders as provided in Sec. 319.140 of this part 
may be used in cooked sausage that otherwise comply with paragraph (a) 
or (b) of this section. When any such substance is added to these 
products, the substance shall be declared in the ingredients statement 
by its common or usual name in order of predominance.
    (f) Cooked sausages shall not be labeled with terms such as ``All 
Meat'' or ``All (Species),'' or otherwise to indicate they do not 
contain nonmeat ingredients or are prepared only from meat.
    (g) For the purposes of this section: Poultry meat means deboned 
chicken meat or turkey meat, or both, without skin or added fat; poultry 
products mean chicken or turkey, or chicken meat or turkey meat as 
defined in Sec. 381.118 of this chapter, or poultry byproducts as 
defined in Sec. 381.1 of this chapter; and meat byproducts (or variety 
meats), mean pork stomachs or snouts; beef, veal, lamb, or goat tripe; 
beef, veal, lamb, goat, or pork hearts, tongues, fat, lips, weasands, 
and spleens; and partially defatted pork fatty tissue, or partially 
defatted beef fatty tissue.

[38 FR 14742, June 5, 1973; 38 FR 22621, Aug. 23, 1973; 38 FR 24640, 
Sept. 10, 1973, as amended at 43 FR 26424, June 20, 1978; 45 FR 10318, 
Feb. 15, 1980; 47 FR 10784, Mar. 12, 1982; 47 FR 26374, June 18, 1982; 
47 FR 28257, June 29, 1982; 53 FR 8428, Mar. 15, 1988; 55 FR 34683, Aug. 
24, 1990; 56 FR 41448, Aug. 21, 1991; 60 FR 55982, Nov. 3, 1995; 64 FR 
72175, Dec. 23, 1999; 66 FR 54916, Oct. 31, 2001]



Sec. 319.181  Cheesefurters and similar products.

    ``Cheesefurters'' and similar products are products in casings which 
resemble frankfurters except that they contain sufficient cheese to give 
definite characteristics to the finished article. They may contain 
binders and extenders as provided in Sec. 318.7(c)(4) of this 
subchapter. Limits on use as provided in Sec. 318.7 are intended to be 
exclusive of the cheese constituent. When any such substance is added to 
these products, the substance shall be designated in the ingredients 
statement by its common or usual name in order of predominance. These 
products shall contain no more than 40 percent of a combination of fat 
and added water, and no more than 30 percent fat and shall comply with 
the other provisions for cooked sausages that are in this subchapter.

[55 FR 34683, Aug. 24, 1990, as amended at 56 FR 41448, Aug. 21, 1991]

[[Page 317]]



Sec. 319.182  Braunschweiger and liver sausage or liverwurst.

    (a) ``Braunschweiger'' is a cooked sausage made from fresh, cured, 
and/or frozen pork, beef, and/or veal and at least 30 percent pork, 
beef, and/or veal livers computed on the weight of the fresh livers. It 
may also contain pork and/or beef fat. Mechanically Separated (Species) 
may be used in accordance with Sec. 319.6. Binders and extenders may be 
used as permitted in Sec. 319.140. The product may have a smoked taste 
characteristic, which may be imparted by use of smoked meats, smoke 
flavoring or smoking. If prepared from components of a single species, 
the product name may reflect the species, e.g., ``Beef Braunschweiger.'' 
Braunschweiger may also be labeled as any of the following: 
``Braunschweiger--A Liver Sausage,'' ``Braunschweiger--A Liverwurst,'' 
or ``Braunschweiger (Liver Sausage)'' or ``Braunschweiger 
(Liverwurst).''
    (b) ``Liver Sausage'' or ``Liverwurst'' is a cooked sausage made 
from fresh, cured, and/or frozen pork, beef, and/or veal and at least 30 
percent pork, beef, veal, sheep, and/or goat livers computed on the 
weight of the fresh livers. It may also contain pork and/or beef 
byproducts. Mechanically Separated (Species) may be used in accordance 
with Sec. 319.6. Binders and extenders maybe used as permitted in Sec. 
319.140. If prepared from components of a single species, the product 
name may reflect that species, e.g., ``Pork Liver Sausage.''

[47 FR 36108, Aug. 19, 1982]

Subpart H [Reserved]

Subpart I--Semi-Dry Fermented Sausage [Reserved]

Subpart J--Dry Fermented Sausage [Reserved]



          Subpart K_Luncheon Meat, Loaves and Jellied Products



Sec. 319.260  Luncheon meat.

    ``Luncheon Meat'' is a cured, cooked meat food product made from 
comminuted meat. Mechanically Separated (Species) may be used in 
accordance with Sec. 319.6. To facilitate chopping or mixing or to 
dissolve the usual curing ingredients, water or ice may be used in the 
preparation of luncheon meat in an amount not to exceed 3 percent of the 
total ingredients.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, June 29, 1982]



Sec. 319.261  Meat loaf.

    ``Meat Loaf'' is a cooked meat food product in loaf form made from 
comminuted meat. Mechanically Separated (Species) may be used in 
accordance with Sec. 319.6. To facilitate chopping or mixing, water or 
ice may be used in an amount not to exceed 3 percent of the total 
ingredients used.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, June 29, 1982]



       Subpart L_Meat Specialties, Puddings and Nonspecific Loaves



Sec. 319.280  Scrapple.

    ``Scrapple'' shall contain not less than 40 percent meat and/or meat 
byproducts computed on the basis of the fresh weight, exclusive of bone. 
Mechanically Separated (Species) may be used in accordance with Sec. 
319.6. The meal or flour used may be derived from grain and/or soybeans.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, June 29, 1982]



Sec. 319.281  Bockwurst.

    (a) Bockwurst is an uncured, comminuted meat food product which may 
or may not be cooked. It contains meat, milk or water or a combination 
thereof, eggs, vegetables, and any of the optional ingredients listed in 
paragraph (b) of this section; and is prepared in accordance with the 
provisions of paragraphs (a)(1), (2), (3), and (4) of this section.
    (1) Meat shall constitute not less than 70 percent of the total 
weight of the product and shall consist of pork or a mixture of pork and 
veal, pork and beef, or pork, veal, and beef. Such meat shall be fresh 
or fresh frozen meat. Pork may be omitted when the specie or species of 
meat used in the product is identified in the product name (e.g., Veal 
Bockwurst, Beef Bockwurst, or

[[Page 318]]

Beef and Veal Bockwurst). Mechanically Separated (Species) may be used 
in accordance with Sec. 319.6.
    (2) The ``milk'' may be fresh whole milk, dried milk, nonfat dry 
milk, calcium reduced dried skim milk, enzyme (rennet) treated calcium 
reduced dried skim milk and calcium lactate, or any combination thereof.
    (3) ``Eggs'' refer to whole eggs that are fresh, frozen, or dried.
    (4) ``Vegetables'' refer to onions, chives, parsley, and leeks, 
alone or in any combination.
    (b) Bockwurst may contain one or more of the following optional 
ingredients:
    (1) Pork fat.
    (2) Celery, fresh or dehydrated.
    (3) Spices, flavorings.
    (4) Salt.
    (5) Egg whites, fresh, frozen, or dried.
    (6) Corn syrup solids, corn syrup, or glucose syrup with a maximum 
limit of 2 percent individually or collectively, calculated on a dry 
basis. The maximum quantities of such ingredients shall be computed on 
the basis of the total weight of the ingredients.
    (7) Autolyzed yeast extract, hydrolyzed plant protein, milk protein 
hydrolysate, and monosodium glutamate.
    (8) Sugars (sucrose and dextrose).
    (9) Binders and extenders may be added as provided in Sec. 
318.7(c)(4) of this subchapter. When any such substance is added to 
bockwurst, the substance shall be designated in the ingredients 
statement by its common or usual name in order of predominance.
    (c) If bockwurst is cooked or partially cooked, the composition of 
the raw mix from which it is prepared shall be used in determining 
whether it meets the requirements of this section.

[40 FR 18542, Apr. 29, 1975, as amended at 41 FR 18089, Apr. 30, 1976; 
43 FR 26425, June 20, 1978; 45 FR 10318, Feb. 15, 1980; 47 FR 26374, 
June 18, 1982; 47 FR 28257, 28258, June 29, 1982; 55 FR 34683, Aug. 24, 
1990; 56 FR 41448, Aug. 21, 1991]



       Subpart M_Canned, Frozen, or Dehydrated Meat Food Products



Sec. 319.300  Chili con carne.

    ``Chili con carne'' shall contain not less than 40 percent of meat 
computed on the weight of the fresh meat. Mechanically Separated 
(Species) may be used in accordance with Sec. 319.6. Head meat, cheek 
meat, and heart meat exclusive of the heart cap may be used to the 
extent of 25 percent of the meat ingredients under specific declaration 
on the label. The mixture may contain binders and extenders as provided 
in Sec. 318.7(c)(4) of this subchapter.

[55 FR 34684, Aug. 24, 1990]



Sec. 319.301  Chili con carne with beans.

    Chili con carne with beans shall contain not less than 25 percent of 
meat computed on the weight of the fresh meat. Mechanically Separated 
(Species) may be used in accordance with Sec. 319.6. Head meat, cheek 
meat, or heart meat exclusive of the heart cap may be used to the extent 
of 25 percent of the meat ingredients, and its presence shall be 
reflected in the statement of ingredients required by part 317 of this 
subchapter. The mixture may contain binders and extenders as provided in 
Sec. 318.7(c)(4) of this subchapter.

[55 FR 34684, Aug. 24, 1990]



Sec. 319.302  Hash.

    ``Hash'' shall contain not less than 35 percent of meat computed on 
the weight of the cooked and trimmed meat. The weight of the cooked meat 
used in this calculation shall not exceed 70 percent of the weight of 
the uncooked fresh meat. Mechanically Separated (Species) may be used in 
accordance with Sec. 319.6.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, June 29, 1982]



Sec. 319.303  Corned beef hash.

    (a) ``Corned Beef Hash'' is the semi-solid food product in the form 
of a compact mass which is prepared with beef, potatoes, curing agents, 
seasonings, and any of the optional ingredients listed in paragraph (b) 
of this section, in accordance with the provisions of paragraphs (a) 
(1), (2), (3) and (4) of this section and the provisions of paragraph 
(c) of this section.
    (1) Either fresh beef, cured beef, or canned corned beef or a 
mixture of two or more of these ingredients, may be used, and the 
finished product shall contain not less than 35 percent of beef

[[Page 319]]

computed on the weight of the cooked and trimmed beef. The weight of the 
cooked meat used in this calculation shall not exceed 70 percent of the 
weight of the uncooked fresh meat.
    (2) ``Potatoes'' refers to fresh potatoes, dehydrated potatoes, 
cooked dehydrated potatoes, or a mixture of two or more of these 
ingredients.
    (3) The curing agents that may be used are salt, sodium nitrate, 
sodium nitrite, potassium nitrate, or potassium nitrite, or a 
combination of two or more of these ingredients. When sodium nitrate, or 
sodium nitrite, potassium nitrate, or potassium nitrite is used it shall 
be used in amounts not exceeding those specified in a regulation 
permitting that use in this subchapter or in 9 CFR Chapter III, 
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.
    (4) The seasonings that may be used, singly or in combination, are 
salt, sugar (sucrose or dextrose), spice, and flavoring, including 
essential oils, oleoresins, and other spice extractives.
    (b) Corned beef hash may contain one or more of the following 
optional ingredients:
    (1) Beef cheek meat and beef head meat from which the overlying 
glandular and connective tissues have been removed, and beef heart meat, 
exclusive of the heart cap, may be used individually or collectively to 
the extent of 5 percent of the meat ingredients;
    (2) Onions, including fresh onions, dehydrated onions, or onion 
powder;
    (3) Garlic, including fresh garlic, dehydrated garlic, or garlic 
powder;
    (4) Water;
    (5) Beef broth or beef stock;
    (6) Monosodium glutamate;
    (7) Hydrolyzed plant protein;
    (8) Beef fat;
    (9) Mechanically Separated (Species) when derived from carcasses of 
cattle may be used in accordance with Sec. 319.6.
    (c) The finished product shall not contain more than 15 percent fat 
nor more than 72 percent moisture.
    (d)(1) When any ingredient specified in paragraph (b)(1) of this 
section is used, the label shall bear the following applicable 
statement: ``Beef cheek meat constitutes 5 percent of the meat 
ingredient,'' or ``Beef head meat constitutes 5 percent of the meat 
ingredient,'' or ``Beef heart meat constitutes 5 percent of the meat 
ingredient.'' When two or more of the ingredients are used, the words 
``Constitutes 5 percent of meat ingredient'' need only appear once.
    (2) Whenever the words ``corned beef hash'' are featured on the 
label so conspicuously as to identify the contents, the statements 
prescribed in paragraph (d)(1) of this section shall immediately and 
conspicuously precede or follow such name without intervening written, 
printed, or other graphic matter.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, June 29, 1982; 64 FR 72175, Dec. 23, 1999]



Sec. 319.304  Meat stews.

    Meat stews such as ``Beef Stew'' or ``Lamb Stew'' shall contain not 
less than 25 percent of meat of the species named on the label, computed 
on the weight of the fresh meat. Mechanically Separated (Species) may be 
used in accordance with Sec. 319.6.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, June 29, 1982]



Sec. 319.305  Tamales.

    ``Tamales'' shall be prepared with at least 25 percent meat computed 
on the weight of the uncooked fresh meat in relation to all ingredients 
of the tamales. When tamales are packed in sauce or gravy, the name of 
the product shall include a prominent reference to the sauce or gravy; 
for example, ``Tamales With Sauce'' or ``Tamales With Gravy.'' Product 
labeled ``Tamales With Sauce'' or ``Tamales With Gravy'' shall contain 
not less than 20 percent meat, computed on the weight of the uncooked 
fresh meat in relation to the total ingredients making up the tamales 
and sauce or the tamales and gravy. Mechanically Separated (Species) may 
be used in accordance with Sec. 319.6.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, 28258, June 29, 1982]



Sec. 319.306  Spaghetti with meatballs and sauce, spaghetti with meat 
and sauce, and similar products.

    ``Spaghetti with Meatballs and Sauce'' and ``Spaghetti with Meat and

[[Page 320]]

Sauce,'' and similar products shall contain not less than 12 percent of 
meat computed on the weight of the fresh meat. Mechanically Separated 
(Species) may be used in accordance with Sec. 319.6. The presence of 
the sauce or gravy constituent shall be declared prominently on the 
label as part of the name of the product. Meatballs may be prepared with 
farinaceous material and with other binders and extenders as provided in 
Sec. 318.7(c)(4) of this subchapter.

[55 FR 34684, Aug. 24, 1990]



Sec. 319.307  Spaghetti sauce with meat.

    ``Spaghetti Sauce with Meat'' shall contain not less than 6 percent 
of meat computed on the weight of the fresh meat. Mechanically Separated 
(Species) may be used in accordance with Sec. 319.6.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, June 29, 1982]



Sec. 319.308  Tripe with milk.

    ``Tripe with Milk'' shall be prepared so that the finished canned 
article, exclusive of the cooked-out juices and milk, will contain at 
least 65 percent tripe. The product shall be prepared with not less than 
10 percent milk.



Sec. 319.309  Beans with frankfurters in sauce, sauerkraut with wieners 
and juice, and similar products.

    ``Beans with Frankfurters in Sauce,'' ``Sauerkraut with Wieners and 
Juice,'' and similar products shall contain not less than 20 percent 
frankfurters or wieners computed on the weight of the smoked and cooked 
sausage prior to its inclusion with the beans or sauerkraut.



Sec. 319.310  Lima beans with ham in sauce, beans with ham in sauce, 
beans with bacon in sauce, and similar products.

    ``Lima Beans with Ham in Sauce,'' ``Beans with Ham in Sauce,'' 
``Beans with Bacon in Sauce,'' and similar products shall contain not 
less than 12 percent ham or bacon computed on the weight of the smoked 
ham or bacon prior to its inclusion with the beans and sauce.



Sec. 319.311  Chow mein vegetables with meat, and chop suey vegetables 
with meat.

    ``Chow Mein Vegetables with Meat'' and ``Chop Suey Vegetables with 
Meat'' shall contain not less than 12 percent meat computed on the 
weight of the uncooked fresh meat prior to its inclusion with the other 
ingredients. Mechanically Separated (Species) may be used in accordance 
with Sec. 319.6.

[35 FR 15597, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 43 
FR 26425, June 20, 1978; 47 FR 28257, June 29, 1982]



Sec. 319.312  Pork with barbecue sauce and beef with barbecue sauce.

    ``Pork with Barbecue Sauce'' and ``Beef with Barbecue Sauce'' shall 
consist of not less than 50 percent cooked meat of the species specified 
on the label. Mechanically Separated (Pork) may be used in accordance 
with Sec. 319.6.

[69 FR 34916, June 23, 2004]



Sec. 319.313  Beef with gravy and gravy with beef.

    ``Beef with Gravy'' and ``Gravy with Beef'' shall not be made with 
beef which, in the aggregate for each lot contains more than 30 percent 
trimmable fat, that is, fat which can be removed by thorough, 
practicable trimming and sorting.



        Subpart N_Meat Food Entree Products, Pies, and Turnovers



Sec. 319.500  Meat pies.

    Meat pies such as ``Beef Pie,'' ``Veal Pie,'' and ``Pork Pie'' shall 
contain meat of the species specified on the label, in an amount not 
less than 25 percent of all ingredients including crust and shall be 
computed on the basis of the fresh uncooked meat.

[[Page 321]]



    Subpart O_Meat Snacks, Hors d'Oeuvres, Pizza, and Specialty Items



Sec. 319.600  [Reserved]



                    Subpart P_Fats, Oils, Shortenings



Sec. 319.700  Margarine or oleomargarine.\1\
---------------------------------------------------------------------------

    \1\ Insofar as the standard contains provisions relating to 
margarine or oleomargarine which does not contain any meat food 
products, such provisions merely reflect the applicable standard under 
the Federal Food, Drug, and Cosmetic Act.
---------------------------------------------------------------------------

    (a) Margarine or oleomargarine is the food in plastic form or liquid 
emulsion, containing not less than 80 percent fat determined by the 
method prescribed under Sec. 938.06 (Chapter 33) of the ``Indirect 
Methods'' in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists'', 15th edition, 1990.\2\ The ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists,'' 15th edition, 1990, is incorporated by reference with the 
approval of the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. It is produced from one or more of the 
ingredients designated in paragraph (a)(1) of this section, and one or 
more of the ingredients designated in paragraph (a)(2) of this section, 
to which may be added one or more of the optional ingredients designated 
in paragraph (b) of this section. Margarine or oleomargarine contains 
Vitamin A as provided for in paragraph (a)(3) of this section.
---------------------------------------------------------------------------

    \2\ A copy of the ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 15th edition, 1990, is on file with 
the Director, Office of the Federal Register, and may be purchased from 
the Association of Official Analytical Chemists, Inc., 2200 Wilson 
Boulevard, Suite 400, Arlington, Virginia 22201.
---------------------------------------------------------------------------

    (1) Edible fats and oils or mixtures of these, whose origin is 
vegetable or rendered animal fats from cattle, sheep, swine or goats.
    (2)(i) Water; milk; milk products including, but not limited to, the 
liquid, condensed, or dry form of whey, reduced lactose whey, reduced 
minerals whey, or whey protein concentrate, non-lactose-containing whey 
components, casein, or caseinate; or other suitable edible protein, 
including albumin, vegetable proteins, or soy protein isolate; or any 
mixture of two or more of the articles designated in this subparagraph, 
in amounts not greater than reasonably required to accomplish the 
desired effect.
    (ii) The articles designated in this subparagraph shall be 
pasteurized and then may be subjected to the action of harmless 
bacterial starters. One or more of the articles designated in this 
subparagraph is intimately mixed with the edible fat or oil ingredients, 
or both, to form a solidified or liquid emulsion.
    (3) Vitamin A in such quantity that the finished margarine or 
oleomargarine contains not less than 15,000 International Units (IU) of 
ViTamin A per pound or 33,000 IU per kilogram.
    (b)(1) Vitamin D in such quantity that the finished margarine or 
oleomargarine contains not less than 1,500 IU of Vitamin D per pound or 
3,300 IU per kilogram.
    (2) Salt (sodium chloride); or potassium chloride for dietary 
margarine or oleomargarine.
    (3) Nutritive carbohydrate sweeteners.
    (4) Emulsifiers identified in a regulation permitting that use in 
this subchapter or a regulation permitting that use in this subchapter 
or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, 
Subchapter A or Subchapter B, within these maximum amounts in percent by 
weight of the finished food: Mono- and diglycerides of fatty acids 
esterified with any or all of the following acids: acetic, 
acetyltartaric, citric, lactic, tartaric, and their sodium and calcium 
salts, 0.5 percent; such mono- and diglycerides in combination with the 
sodium sulfoacetate derivatives thereof, 0.5 percent; polyglycerol 
esters of fatty acids, 0.5 percent; 1,2-propylene glycol esters of fatty 
acids, 2 percent; lecithin, 0.5 percent.
    (5) Preservatives identified in a regulation permitting that use in 
this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR 
Chapter I, Subchapter A or Subchapter B, within these maximum amounts in 
percent by weight of the finished food: Sorbic

[[Page 322]]

acid, benzoic acid and their sodium, potassium, and calcium salts, 
individually, 0.1 percent, or in combination, 0.2 percent, expressed as 
the acids; calcium disodium EDTA, 0.0075 percent; stearyl citrate, 0.15 
percent; isopropyl citrate mixture, 0.02 percent.
    (6) Antioxidants identified in a regulation permitting that use in 
this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR 
Chapter I, Subchapter A or Subchapter B, within these maximum amounts in 
percent by weight of the finished food: propyl, octyl and dodecyl 
gallates, BHT (butylated hydroxytoluene), BHA (butylated 
hydroxyanisole), ascorbyl palmitate, ascorbyl stearate, all individually 
or in combination, 0.02 percent. Instead of these antioxidants, TBHQ 
(tertiary butylhydroquinone), alone or in combination only with BHT and/
or BHA, with a maximum 0.02 percent by weight of the fat and oil 
content.
    (7) Coloring agents identified in a regulation permitting that use 
in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR 
Parts 73, 74, 81, or 82, in amounts sufficient for purpose.\3\ For the 
purpose of this subparagraph, provitamine A (beta-carotene) shall also 
be deemed to be a coloring agent.
---------------------------------------------------------------------------

    \3\ Colored margarine or oleomargarine is also subject to the 
provisions of section 407 of the Federal Food, Drug, and Cosmetic Act, 
as amended (21 U.S.C. 347), as reflected in Sec. 317.8(h)(24) of this 
subchapter.
---------------------------------------------------------------------------

    (8) Flavoring substances in amounts sufficient for purpose.
    (9) Acidulants identified in a regulation permitting that use in 
this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR 
Chapter I, Subchapter A or Subchapter B, in amounts sufficient for 
purpose: adipic acid; citric and lactic acids and their potassium and 
sodium salts; phosphoric acid; L-tartaric acid and its sodium and 
sodium-potassium salts; and hydrochloric acid.
    (10) Alkalizers identified in a regulation permitting that use in 
this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR 
Chapter I, Subchapter A or Subchapter B, in amounts sufficient for 
purpose: potassium bicarbonate, potassium carbonate, sodium bicarbonate, 
sodium carbonate, and sodium hydroxide.
    (11) For the purposes of this section, the term ``milk'' unqualified 
means milk from cows. If any milk other than cow's milk is used in whole 
or in part, the animal source shall be identified in conjunction with 
the word ``milk'' in the ingredient statement.

[48 FR 52697, Nov. 22, 1983, as amended at 50 FR 3739, Jan. 28, 1985; 54 
FR 40632, Oct. 3, 1989; 59 FR 33642, June 30, 1994; 64 FR 72175, Dec. 
23, 1999]



Sec. 319.701  Mixed fat shortening.

    Shortening prepared with a mixture of meat fats and vegetable oils 
may be identified either as ``Shortening Prepared with Meat Fats and 
Vegetable Oils'' or ``Shortening Prepared with Vegetable Oils and Meat 
Fats'' depending on the predominance of the fat and oils used, or the 
product may be labeled ``Shortening'' when accompanied by an ingredient 
statement with ingredients listed in descending order of predominance.



Sec. 319.702  Lard, leaf lard.

    (a) Lard is the fat rendered from clean and sound edible tissues 
from swine. The tissues may be fresh, frozen, cooked, or prepared by 
other processes approved by the Administrator in specific cases, upon 
his determination that the use of such processes will not result in the 
adulteration or misbranding of the lard. The tissues shall be reasonably 
free from blood, and shall not include stomachs, livers, spleens, 
kidneys, and brains, or settlings and skimmings. ``Leaf Lard'' is lard 
prepared from fresh leaf (abdominal) fat.
    (b) Lard (when properly labeled) may be hardened by the use of lard 
stearin or hydrogenated lard or both and may contain refined lard and 
deodorized lard, but the labels of such lard shall state such facts, as 
applicable.
    (c) Products labeled ``Lard'' or ``Leaf Lard'' must have the 
following identity and quality characteristics to insure good color, 
odor, and taste of finished product:

(1) Color................................  White when solid, Maximum 3.0
                                            red units in a 5\1/4\ inch
                                            cell on the Lovibond scale.
(2) Odor and taste.......................  Characteristic and free from
                                            foreign odors and flavors.

[[Page 323]]

 
(3) Free fatty acid......................  Maximum 0.5 percent (as
                                            oleic) or 1.0 acid value, as
                                            milligrams KOH per gram of
                                            sample.
(4) Peroxide value.......................  Maximum 5.0 (as
                                            milliequivalents of peroxide
                                            per kilogram fat).
(5) Moisture and volatile matter.........  Maximum 0.2 percent.
(6) Insoluble impurities.................  By appearance of liquid, fat
                                            or maximum 0.05 percent.
 

    (d) Product found upon inspection not to have the characteristics 
specified in paragraph (c) of this section but found to be otherwise 
sound and in compliance with paragraph (a) of this section may be 
further processed for the purpose of achieving such characteristics.

[43 FR 25420, June 13, 1978]



Sec. 319.703  Rendered animal fat or mixture thereof.

    ``Rendered Animal Fat,'' or any mixture of fats containing edible 
rendered animal fat, shall contain no added water, except that ``Puff 
Pastry Shortening'' may contain not more than 10 percent of water.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 25420, June 13, 1978]



       Subpart Q_Meat Soups, Soup Mixes, Broths, Stocks, Extracts



Sec. 319.720  Meat extract.

    Meat extract (e.g., ``Beef Extract'') shall contain not more than 25 
percent of moisture.



Sec. 319.721  Fluid extract of meat.

    Fluid extract of meat (e.g., ``Fluid Extract of Beef'') shall 
contain not more than 50 percent of moisture.



                 Subpart R_Meat Salads and Meat Spreads



Sec. 319.760  Deviled ham, deviled tongue, and similar products.

    (a) ``Deviled Ham'' is a semiplastic cured meat food product made 
from finely comminuted ham and containing condiments. Mechanically 
Separated (Species) may be used in accordance with Sec. 319.6. Deviled 
ham may contain added ham fat: Provided, That the total fat content 
shall not exceed 35 percent of the finished product. The moisture 
content of deviled ham shall not exceed that of the fresh unprocessed 
meat.
    (b) The moisture content of ``Deviled Tongue'' and similar products 
shall not exceed that of the fresh, unprocessed meat.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, June 29, 1982]



Sec. 319.761  Potted meat food product and deviled meat food product.

    ``Potted Meat Food Product'' and ``Deviled Meat Food Product'' shall 
not contain cereal, vegetable flour, nonfat dry milk, or similar 
substances. The amount of water added to potted meat food product and 
deviled meat food product shall be limited to that necessary to replace 
moisture lost during processing.



Sec. 319.762  Ham spread, tongue spread, and similar products.

    ``Ham Spread,'' ``Tongue Spread,'' and similar products shall 
contain not less than 50 percent of the meat ingredient named, computed 
on the weight of the fresh meat. Other meat and fat may be used to give 
the desired spreading consistency provided it does not detract from the 
character of the spreads named. Mechanically Separated (Species) may be 
used in accordance with Sec. 319.6.

[35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 
FR 28257, June 29, 1982]

Subpart S--Meat Baby Foods [Reserved]

Subpart T--Dietetic Meat Foods [Reserved]



                         Subpart U_Miscellaneous



Sec. 319.880  Breaded products.

    The amount of batter and breading used as a coating for breaded 
product shall not exceed 30 percent of the weight of the finished 
breaded product.



Sec. 319.881  Liver meat food products.

    Meat food products characterized and labeled as liver products such 
as liver loaf, liver cheese, liver spread, liver mush, liver paste, and 
liver pudding shall contain not less than 30 percent

[[Page 324]]

of pork, beef, sheep, or goat livers computed on the fresh weight of the 
livers.

[36 FR 12004, June 24, 1971]



PART 320_RECORDS, REGISTRATION, AND REPORTS--Table of Contents




Sec.
320.1 Records required to be kept.
320.2 Place of maintenance of records.
320.3 Record retention period.
320.4 Access to and inspection of records, facilities and inventory; 
          copying and sampling.
320.5 Registration.
320.6 Information and reports required from official establishment 
          operators.
320.7 Reports by consignees of allegedly adulterated or misbranded 
          products; sale or transportation as violations.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.7, 2.18, 2.53.

    Source: 35 FR 15603, Oct. 3, 1970, unless otherwise noted.



Sec. 320.1  Records required to be kept.

    (a) Every person (including every firm or corporation) within any of 
the classes specified in paragraph (a) (1), (2), or (3) of this section 
is required by the Act to keep records which will fully and correctly 
disclose all transactions involved in his or its business subject to the 
Act:
    (1) Any person that engages, for commerce, in the business of 
slaughtering any cattle, sheep, swine, goats, horses, mules, or other 
equines, or preparing, freezing, packaging, or labeling any carcasses, 
or parts or products of carcasses, of any such animals, for use as human 
food or animal food;
    (2) Any person that engages in the business of buying or selling (as 
a meat broker, wholesaler, or otherwise), or transporting in commerce, 
or storing in or for commerce, or importing, any carcasses, or parts or 
products of carcasses, of any such animals;
    (3) Any person that engages in business, in or for commerce, as a 
renderer, or engages in the business of buying, selling, or transporting 
in commerce, or importing, any dead, dying, disabled, or diseased 
cattle, sheep, swine, goats, horses, mules, or other equines, or parts 
of the carcasses of any such animals that died otherwise than by 
slaughter.
    (b) The required records are:
    (1) Records, such as bills of sale, invoices, bills of lading, and 
receiving and shipping papers, giving the following information with 
respect to each transaction in which any livestock or carcass, part 
thereof, meat or meat food product is purchased, sold, shipped, 
received, transported, or otherwise handled by said person in connection 
with any business subject to the Act:
    (i) The name or description of the livestock or article;
    (ii) The net weight of the livestock or article;
    (iii) The number of outside containers (if any);
    (iv) The name and address of the buyer of livestock or article sold 
by such person, and the name and address of the seller of livestock or 
articles purchased by such person;
    (v) The name and address of the consignee or receiver (if other than 
the buyer);
    (vi) The method of shipment;
    (vii) The date of shipment; and
    (viii) The name and address of the carrier.
    (ix) In the case of a person belonging to the class specified in 
paragraph (a)(1), and engaged, for commerce, in the business of 
slaughtering any swine for use as human or animal food, the name and 
address (including the city and state, or the township, county, and 
state) of each person from whom the person belonging to the class so 
specified purchased or otherwise obtained each swine, and the telephone 
number, if available, of the person from whom the swine were purchased 
or otherwise obtained, and all serial numbers and other approved means 
of identification appearing on all test swine selected at antemortem 
inspection by FSIS representatives for residue testing.
    (2) Shipper's certificates and permits required to be kept by 
shippers and carriers of articles under part 325 of this subchapter.
    (3) A record of seal numbers required to be kept by consignees of 
inedible products shipped under unofficial seals under Sec. 325.11(b) 
or (e) of this subchapter, and a record of new consignees of inedible 
products diverted under Sec. 325.11(e) of this subchapter.

[[Page 325]]

    (4) [Reserved]
    (5) Guaranties provided by suppliers of packaging materials under 
Sec. 317.20.
    (6) Records of canning as required by subpart G of this subchapter 
A, 9 CFR chapter III.
    (7) Sample results and calculation results as required by processing 
procedures to destroy trichinae in Sec. 318.10(c)(3)(iv) (Methods 5 and 
6).
    (8) Records of nutrition labeling as required by subpart B, part 
317, of this subchapter.
    (9) Records as required in Sec. 318.23(b) and (c).
    (10) Records documenting the development, implementation, and 
maintenance of procedures for the control of the production process 
using advanced meat/bone separation machinery and meat recovery systems 
as required by Sec. 318.24 of this subchapter.
    (11) Records of all labeling, along with the product formulation and 
processing procedures, as prescribed in Sec. 317.4 and Sec. 317.5.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[35 FR 15603, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971; 37 
FR 1229, Jan. 27, 1972; 43 FR 30793, July 18, 1978; 47 FR 746, Jan. 7, 
1982; 47 FR 17274, Apr. 22, 1982; 49 FR 2235, Jan. 19, 1984; 51 FR 
45633, Dec. 19, 1986; 53 FR 40387, Oct. 14, 1988; 57 FR 27877, June 22, 
1992; 58 FR 675, Jan. 6, 1993; 58 FR 41152, Aug. 2, 1993; 59 FR 6897, 
Feb. 14, 1994; 59 FR 62562, Dec. 6, 1994; 60 FR 67456, Dec. 29, 1995; 64 
FR 745, Jan. 6, 1999; 69 FR 1885, Jan. 12, 2004]



Sec. 320.2  Place of maintenance of records.

    Every person engaged in any business described in Sec. 320.1 and 
required by this part to keep records shall maintain such records at the 
place where such business is conducted except that if such person 
conducts such business at multiple locations, he may maintain such 
records at his headquarters' office. When not in actual use, all such 
records shall be kept in a safe place at the prescribed location in 
accordance with good commercial practices.



Sec. 320.3  Record retention period.

    (a) Every record required to be maintained under this part shall be 
retained for a period of 2 years after December 31 of the year in which 
the transaction to which the record relates has occurred and for such 
further period as the Administrator may require for purposes of any 
investigation or litigation under the Act, by written notice to the 
person required to keep such records under this part.
    (b) Records of canning as required in subpart G of this subchapter 
A, 9 CFR chapter III, shall be retained as required in Sec. 318.307(e); 
except that records required by Sec. 318.302 (b) and (c) shall be 
retained as required by those sections.

[35 FR 15603, Oct. 3, 1970, as amended at 51 FR 45633, Dec. 19, 1986]



Sec. 320.4  Access to and inspection of records, facilities and 
inventory; copying and sampling.

    Representatives of the Secretary afforded access to a business 
specified in Sec. 320.1 of this part (see Sec. 300.6(b)(2) of this 
chapter) also must be afforded any necessary facilities (other than 
reproduction equipment) for the examination and copying of records and 
for the examination and sampling of inventory.

[69 FR 254, Jan. 5, 2004]



Sec. 320.5  Registration.

    (a) Except as provided in paragraph (c) of this section, every 
person that engages in business in or for commerce, as a meat broker, 
renderer, or animal food manufacturer, or engages in business in 
commerce as a wholesaler of any carcasses, or parts or products of the 
carcasses, or any livestock, whether intended for human food or other 
purposes, or engages in business as a public warehouseman storing any 
such articles in or for commerce, or engages in the business of buying, 
selling, or transporting in commerce, or importing, any dead, dying, 
disabled, or diseased livestock, or parts of the carcasses of any such 
livestock that died otherwise than by slaughter, shall register with the 
Administrator, giving such information as is required, including his 
name, and the address of each place of business at which, and all trade 
names under which he conducts such business, by filing with the 
Administrator, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250, a form

[[Page 326]]

containing such information within 90 days after the effective date 
hereof or after such later date as he begins to engage in such business 
if not engaged therein upon said effective date. All information 
submitted shall be current and correct. The registration form shall be 
obtained from Evaluation and Enforcement Division, Office of Program 
Evaluation, Enforcement, and Review, Food Safety and Inspection Service, 
U.S. Department of Agriculture, Washington, DC 20250, or by calling the 
District Office.
    (b) Whenever any change is made in the name of, or address of any 
place of business at which, or any trade name under which a registrant 
conducts his business, he shall report such change in writing to the 
Administrator within 15 days after making the change.
    (c) The registration requirements prescribed in this section shall 
not apply to persons conducting any of the businesses specified in this 
section only at an official establishment.

[35 FR 15603, Oct. 3, 1970, as amended at 57 FR 53982, Nov. 16, 1992; 69 
FR 254, Jan. 5, 2004]



Sec. 320.6  Information and reports required from official establishment 
operators.

    (a) The operator of each official establishment shall furnish to 
Program employees accurate information as to all matters needed by them 
for making their daily reports of the amount of products prepared or 
handled in the departments of the establishment to which they are 
assigned and such reports concerning sanitation, mandatory 
microbiological testing, and other aspects of the operations of the 
establishment and the conduct of inspection, as may be required by the 
Administrator in special cases.
    (b) The operator of each official establishment shall report 
quarterly the number of pounds of meat and meat food product produced at 
that establishment. The report shall be made on a form furnished by the 
Administrator and shall be submitted to an inspector at the 
establishment. Each report shall cover a calendar quarter and shall be 
filed within 15 days after the end of each quarter.
    (c) The operator of each official establishment shall also make such 
other reports as the Administrator may from time to time require under 
the Act.

[35 FR 15603, Oct. 3, 1970, as amended at 45 FR 76968, Nov. 21, 1980; 61 
FR 38866, July 25, 1996]



Sec. 320.7  Reports by consignees of allegedly adulterated or misbranded 
products; sale or transportation as violations.

    Whenever the consignee of any product which bears an official 
inspection legend refuses to accept delivery of such product on the 
grounds that it is adulterated or misbranded, the consignee shall notify 
the Inspector in Charge, Meat and Poultry Inspection Program, Food 
Safety and Inspection Service, U.S. Department of Agriculture, of the 
kind, quantity, source, and present location of the product and the 
respects in which it is alleged to be adulterated or misbranded, and it 
will be a violation of the Act for any person to sell or transport, or 
offer for sale or transportation, or receive for transportation, in 
commerce, any such product which is capable of use as human food and is 
adulterated or misbranded at the time of such sale, transportation, 
offer, or receipt: Provided, however, That any such allegedly 
adulterated or misbranded product may be transported to the official 
establishment from which it had been transported, in accordance with 
Sec. 325.10 of this subchapter.



PART 321_COOPERATION WITH STATES AND TERRITORIES--Table of Contents




Sec.
321.1 Assistance to State and Territorial programs.
321.2 Cooperation of States in Federal programs.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



Sec. 321.1  Assistance to State and Territorial programs.

    (a) The Administrator is authorized under paragraph (a) of section 
301 of the Act, when he determines it would effectuate the purposes of 
the Act, to cooperate with any State (including Puerto Rico) or any 
organized Territory in developing and administering the meat inspection 
program of such jurisdiction with a view to assuring

[[Page 327]]

that it imposes and enforces requirements at least equal to those under 
Titles I and IV of the Act, with respect to establishments at which 
products are prepared for use as human food solely for distribution 
within such jurisdiction, and with respect to the products of such 
establishments. Such cooperation is authorized if the jurisdiction has 
enacted a law imposing mandatory ante-mortem and post-mortem inspection, 
reinspection, and sanitation requirements at least equal to the Federal 
requirements with respect to all or certain classes of persons engaged 
in slaughtering livestock or otherwise preparing products solely for 
distribution within such jurisdiction.
    (b) The Administrator is also authorized under paragraph (a) of 
section 301 of the Act to cooperate with any State (including Puerto 
Rico) or any organized Territory in developing and administering 
programs under the laws of such jurisdiction containing authorities at 
least equal to those in Title II of the Act (relating to records; 
registration of specified classes of operators; dead, dying, disabled, 
or diseased livestock; and products not intended for human food), when 
he determines that such cooperation would effectuate the purposes of the 
Act.
    (c) Such cooperation may include advisory assistance, technical and 
laboratory assistance and training, and financial aid. The Federal 
contribution to any State (or Territory) may not exceed 50 percent of 
the estimated total cost of the cooperative State (or Territorial) 
program. A cooperative program under this section is called a State-
Federal program.

[35 FR 15604, Oct. 3, 1970]



Sec. 321.2  Cooperation of States in Federal programs.

    Under the ``Talmadge-Aiken Act'' of September 28, 1962 (7 U.S.C. 
450), the Administrator is authorized to utilize employees and 
facilities of any State in carrying out Federal functions under the 
Federal Meat Inspection Act. A cooperative program for this purpose is 
called a Federal-State program.

[35 FR 15604, Oct. 3, 1970]



PART 322_EXPORTS \1\--Table of Contents



---------------------------------------------------------------------------

    \1\ Attention is directed to the requirements of part 325 of this 
subchapter, governing transportation, and to the requirements of Sec. 
318.8 of this subchapter that products prepared under that section for 
export be destroyed for food purposes before being sold or offered for 
sale for domestic use.
---------------------------------------------------------------------------

Sec.
322.1 Manner of affixing stamps and marking products for export.
322.2 Export certificates; instructions concerning issuance.
322.3 Transferring products for export.
322.4 Clearance of vessels and transportation without certificate 
          prohibited; exceptions.
322.5 Uninspected tallow, stearin, oleo oil, etc., not to be exported 
          unless certified as prescribed.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 15604, Oct. 3, 1970, unless otherwise noted.



Sec. 322.1  Manner of affixing stamps and marking products for export.

    (a) The outside container (including cloth wrappings) of any 
inspected and passed product for export, except ship stores, small 
quantities exclusively for the personal use of the consignee and not for 
sale or distribution, and shipments by and for the U.S. Armed Forces, 
shall be marked with an official export stamp, as shown in Sec. 312.8 
of this subchapter, bearing the number of the export certificate.
    (b) Each tank car of inspected and passed lard or similar edible 
product, and each door of each railroad car or other closed means of 
conveyance, containing inspected and passed loose product shipped 
directly to a foreign country, shall be marked with an official export 
stamp, as shown in Sec. 312.8 of this subchapter, bearing the number of 
the export certificate.

[42 FR 11825, Mar. 1, 1977, as amended at 50 FR 25204, June 18, 1985]



Sec. 322.2  Export certificates; instructions concerning issuance.

    (a) Upon application of the exporter, the inspector in charge is 
authorized to issue official export certificates for shipments of 
inspected and passed

[[Page 328]]

product to any foreign country. Certificates should be issued at the 
time the products leave the official establishment; if not issued at 
that time they may be issued later only after identification and 
reinspection of the products.
    (b) Official export certificates shall be issued with serial numbers 
and in triplicate form. Quadruplicate certificates may be issued for any 
exportation on request of the exporter. Each certificate shall show the 
names of the exporter and the consignee, the destination, the number and 
types of packages, the shipping marks, the kinds of products, and the 
weight of the products in accordance with Sec. 317.2 of this 
subchapter.
    (c) Only one certificate shall be issued for each consignment, 
except that for sufficient reasons new certificates in lieu of the 
original certificates may be issued. A certificate issued in lieu of 
another shall show in the left hand margin the notation ``Issued in lieu 
of * * *'', and the number of the certificate which is superseded. The 
certificate that is superseded when another is issued in lieu thereof, 
shall if available, be surrendered to the inspector in charge and marked 
by him to show in the left hand margin the number of the certificate 
which supersedes it, as follows: ``Superseded by No. ----''.
    (d) The original of the certificate shall be delivered to the 
shipper and may be furnished by him to the consignee for purposes of 
effecting the entry of product into the foreign country of destination.
    (e) The duplicate of the certificate shall be delivered to the 
shipper and shall be delivered by the shipper to the agent of the 
railroad or other carrier which transports the consignment from the 
United States otherwise than by water, or to the chief officer of the 
vessel on which the export shipment is made, or to the vessel's agent 
and shall be used only by such carrier and only for the purpose of 
effecting the transportation of the consignment certified. The chief 
officer of the vessel or the vessel's agent, shipper or shipper's agent 
shall file such duplicate with the Customs officer within four (4) 
business days of the clearance of the vessel at the time of filing the 
complete manifest. In the interim period, the vessel will be cleared by 
Customs on the basis of a statement, under the shipper's or agent's 
letterhead, containing the number of boxes, the number of pounds, the 
product name and the USDA export certificate number that covers the 
shipment of the product. No clearance shall be given to a vessel 
carrying meat products unless either the duplicate of the certificate or 
the prescribed statement referencing the certificate has been presented 
to Customs.
    (f) The triplicate of the certificate shall be retained in the 
circuit file.
    (g) Under no circumstances shall the original or the triplicate of 
such certificate be used for the purpose prescribed by paragraph (e) of 
this section for the duplicate.
    (h) Upon request, official export certificates may be issued by 
inspectors for export consignments of product of official establishments 
not under their supervision, provided the consignments are first 
identified as having been ``U.S. inspected and passed'' and are found to 
be neither adulterated nor misbranded, and marked as required by Sec. 
322.1.

[35 FR 15604, Oct. 3, 1970, as amended at 42 FR 11826, Mar. 1, 1977; 51 
FR 31938, Sept. 8, 1986]



Sec. 322.3  Transferring products for export.

    When inspected and passed products for export are transferred from 
tank cars to other containers on vessels, such transfer shall be done in 
accordance with the provisions of part 350 of subchapter B of this 
chapter.



Sec. 322.4  Clearance of vessels and transportation without certificate 
prohibited; exceptions.

    No clearance shall be given to any vessel having on board any 
product destined to any foreign country, and no person operating any 
vessel, and no railroad or other carrier, shall receive for 
transportation or transport from the United States to any foreign 
country, any products, unless and until an official export certificate 
covering the same has been issued and delivered as provided in this 
part; except in the case of inspected and passed ship stores and not 
more than 50 pounds of inspected

[[Page 329]]

and passed product for the exclusive personal use of the consignee and 
not for sale or distribution, and except for exempted product eligible 
for exportation under the provisions of the Act and the regulations in 
this subchapter and inedible product that is not capable of use as human 
food and is eligible for exportation under other provisions of said 
regulations.

[38 FR 18868, July 16, 1973]



Sec. 322.5  Uninspected tallow, stearin, oleo oil, etc., not to be 
exported unless certified as prescribed.

    No tallow, stearin, oleo oil, or the rendered fat derived from the 
carcasses of livestock, that has not been inspected and passed, and so 
marked in compliance with the regulations in this subchapter shall be 
exported, unless the product has been denatured as required by Sec. 
314.5 or Sec. 325.13 of this subchapter or identified and marked as 
prescribed by Sec. 325.11 of this subchapter.

[35 FR 15604, Oct. 3, 1970, as amended at 47 FR 17274, Apr. 22, 1982]



PART 325_TRANSPORTATION--Table of Contents




Sec.
325.1 Transactions in commerce prohibited without official inspection 
          legend or certificate when required; exceptions; and vehicle 
          sanitation requirements.
325.2 Parcel post and ferries deemed carriers.
325.3 Product transported within the United States as part of export 
          movement.
325.4 [Reserved]
325.5 Unmarked inspected product transported under official seal between 
          official establishments for further processing; certificate.
325.6 Shipment of paunches between official establishments under 
          official seal; certificate.
325.7 Shipment of products requiring special supervision between 
          official establishments under official seal; certificate.
325.8 Transportation and other transactions concerning certain 
          undenatured lungs or lung lobes from official establishments 
          or in commerce; provisions and restrictions.
325.9 [Reserved]
325.10 Handling of products which may have become adulterated or 
          misbranded; authorization and other requirements.
325.11 Inedible articles: denaturing and other means of identification; 
          exceptions.
325.12 [Reserved]
325.13 Denaturing procedures.
325.14 Certificates, retention by carrier.
325.15 Evidence of proper certification required on waybills; transfer 
          bills, etc., for shipment by connecting carrier; forms of 
          statement.
325.16 Official seals; forms, use, and breaking.
325.17 Loading or unloading products in sealed railroad cars, trucks, 
          etc., en route prohibited; exception.
325.18 Diverting of shipments, breaking of seals, and reloading by 
          carrier in emergency; reporting to Regional Director.
325.19 Provisions inapplicable to specimens for laboratory examination, 
          etc., or to naturally inedible articles.
325.20 Transportation and other transactions concerning dead, dying, 
          disabled, or diseased livestock, and parts of carcasses of 
          livestock that died otherwise than by slaughter.
325.21 Means of conveyance in which dead, dying, disabled, or diseased 
          livestock and parts of carcasses thereof shall be transported.

    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 
2.55.

    Source: 35 FR 15605, Oct. 3, 1970, unless otherwise noted.



Sec. 325.1  Transactions in commerce prohibited without official inspection 
legend or certificate when required; exceptions; and vehicle sanitation 
          requirements.

    (a) No person shall sell, transport, offer for sale or 
transportation, or receive for transportation, in commerce, any product 
which is capable of use as human food unless the product and its 
container, if any, bear the official inspection legend as required under 
parts 316 and 317 of this subchapter or such product is exempted from 
the requirement of inspection under part 303 of this subchapter.
    (b)(1) No carrier shall transport or receive for transportation in 
commerce (including transportation in the course of importation) and no 
person shall offer for transportation any carcass, part thereof, meat or 
meat food product until a certificate, if required for such 
transportation by this part, is made and furnished to the carrier in one 
of the forms prescribed in this part.

[[Page 330]]

    (2) Product imported into the United States may be transported and 
offerred or received for transportation if such product is conveyed in 
railroad cars, trucks or other means of conveyance, prior to inspection, 
to an authorized place of inspection, as provided in Sec. 327.6 of this 
part.
    (c) No person, engaged in the business of buying, selling, freezing, 
storing, or transporting, in or for commerce, meat or meat food products 
capable of use as human food, or importing such articles, shall 
transport, offer for transportation, or receive for transportation in 
commerce or in any State designated under Sec. 331.2 of this 
subchapter, any such meat or meat food product which is capable of use 
as human food and is not wrapped, packaged, or otherwise enclosed to 
prevent adulteration by airborne contaminants, unless the railroad car, 
truck, or other means of conveyance in which the product is contained or 
transported is completely enclosed with tight fitting doors or other 
covers for all openings. In all cases, the means of conveyance shall be 
reasonably free of foreign matter (such as dust, dirt, rust, or other 
articles or residues), and free of chemical residues, so that product 
placed therein will not become adulterated. Any cleaning compound, lye, 
soda solution, or other chemical used in cleaning the means of 
conveyance must be thoroughly removed from the means of conveyance prior 
to its use. Such means of conveyance onto which product is loaded, being 
loaded, or intended to be loaded, shall be subject to inspection by an 
inspector at any official establishment. The decision whether or not to 
inspect a means of conveyance in a specific case, and the type and 
extent of such inspection shall be at the Program's discretion and shall 
be adequate to determine if product in such conveyance is, or when moved 
could become, adulterated. Circumstances of transport that can be 
reasonably anticipated shall be considered in making said determination. 
These include, but are not limited to, weather conditions, duration and 
distance of trip, nature of product covering, and effect of restowage at 
stops en route. Any means of conveyance found upon such inspection to be 
in such condition that product placed therein could become adulterated 
shall not be used until such condition which could cause adulteration is 
corrected. Product placed in any means of conveyance that is found by 
the inspector to be in such condition that the product may have become 
adulterated shall be removed from the means of conveyance and handled in 
accordance with Sec. 318.2(d) of this subchapter.

[35 FR 15605, Oct. 3, 1970, as amended at 41 FR 23700, June 11, 1976; 47 
FR 17274, Apr. 22, 1982; 56 FR 65180, Dec. 16, 1991]



Sec. 325.2  Parcel post and ferries deemed carriers.

    (a) For the purposes of this subchapter, the United States parcel 
post shall be deemed a carrier, and the provisions of this subchapter 
relating to transportation by carrier shall apply, so far as they may be 
applicable, to transportation by parcel post.
    (b) For the purposes of this subchapter, the operator of every ferry 
shall be deemed a carrier, and the provisions of this subchapter 
relating to transportation by carrier shall apply to transportation by 
ferry of any products loaded on a truck or other vehicle, or otherwise 
moved by such ferry.



Sec. 325.3  Product transported within the United States as part of 
export movement.

    When any shipment of any product is offered to any carrier for 
transportation within the United States as a part of an export movement, 
the same certificate shall be required as if the shipment were destined 
to a point within the United States.



Sec. 325.4  [Reserved]



Sec. 325.5  Unmarked inspected product transported under official seal 
between official establishments for further processing; certificate.

    (a) Any product which has been inspected and passed may be 
transported from one official establishment to another for further 
processing without each article being marked with the official 
inspection legend, if it is so transported in a railroad car, 
motortruck, or other means of conveyance which is sealed by a Program 
employee with an official seal of the Department prescribed in Sec. 
312.5(a) of this

[[Page 331]]

subchapter. Unless 25 percent or more of the contents of each car or 
other means of conveyance consists of product not marked with the 
inspection legend, transportation will not be permitted under this 
paragraph.
    (b) When articles are offered for transportation under paragraph (a) 
of this section, the initial carrier shall require, and the shipper 
shall make in duplicate and deliver to the carrier, one copy of a 
certificate in the following form: \1\
---------------------------------------------------------------------------

    \1\ For convenience in filing, it is requested that these 
certificates be made on paper 5\1/2\x8 inches in size.

                                   Date ------------------------, 19----
Name of carrier_________________________________________________________
Establishment number of consignor_______________________________________
Point of shipment_______________________________________________________
Establishment number of consignee_______________________________________
Destination_____________________________________________________________
Car number and initials_________________________________________________
License number of other means of conveyance_____________________________

    I hereby certify that the following described product has been U.S. 
inspected and passed by the U.S. Department of Agriculture; and that it 
is not marked ``U.S. inspected and passed,'' but has been placed in the 
means of conveyance specified above under the supervision of an employee 
of the Meat and Poultry Inspection Programs of said Department, and the 
means of conveyance has been sealed by him with official U.S. Government 
seals Nos. ---- and ----.

                    Kind of product Amount and weight

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

                                                  (Signature of shipper)

                                                    (Address of shipper)


When paunches are offered for transportation under this paragraph, the 
initial carrier shall require, and the shipper shall make in duplicate 
and deliver to the carrier, one copy of a certificate in duplicate in 
the form set out in Sec. 325.5(b), appropriately modified. Certificates 
in this form or copies thereof need not be forwarded to any official or 
office of the Department, but the original of the certificate shall be 
retained by the carrier and a copy shall be retained by the shipper in 
accordance with part 320 of this subchapter. If the shipper is also the 
carrier, he shall nevertheless execute and retain the certificate in 
accordance with part 320 of this subchapter.
    (c) The signature of the shipper or his agent shall be written in 
full. This certificate may be stamped upon or incorporated in any form 
ordinarily used in the transportation of product. Certificates in this 
form or copies thereof need not be forwarded to any official or office 
of the Department. The original of the certificate required by this 
section shall be retained by the carrier and a copy shall be retained by 
the shipper in accordance with part 320 of this subchapter. If the 
shipper is also the carrier, he shall nevertheless execute and retain 
the certificate in accordance with part 320 of this subchapter.



Sec. 325.6  Shipment of paunches between official establishments under 
official seal; certificate.

    Cattle and sheep paunches which have been made clean and from which 
the mucous membrane has not been removed may be transported from one 
official establishment to another official establishment for further 
processing, only under an official seal of the Department as prescribed 
in Sec. 312.5(a) of this subchapter.



Sec. 325.7  Shipment of products requiring special supervision between 
official establishments under official seal; certificate.

    (a) Products passed for cooking, pork that has been refrigerated to 
destroy trichinae, and beef that is to be refrigerated to destroy 
cysticerci, may be shipped loose from one official establishment to any 
other official establishment, for further handling in accordance with 
part 318 of this subchapter, in railroad cars, trucks, or other means of 
conveyance sealed with the official seal of the Department as prescribed 
in Sec. 325.16: Provided, That in the case of railroad cars, the 
receiving establishment has railroad facilities for unloading the 
products directly into the establishment.
    (b) When such restricted product is shipped from one official 
establishment to another official establishment in the same railroad car 
or other means of conveyance with other product, such restricted product 
shall be packed in

[[Page 332]]

individual closed containers as hereinafter provided. Containers shall 
be sealed by firmly applying a pressure sensitive tape around each 
container in two directions and stamping the intersection of the tape 
with the marking device described in Sec. 312.2(a) of this subchapter 
for use on burlap, muslin, etc. (2\1/2\-inch rubber brand). Such tape 
must possess the adhesive property to actually remove a portion of the 
container surface when the tape is removed. Alternatively, an inelastic, 
nonmetallic strap which will retain a legible imprint of the marking 
device (2\1/2\-inch rubber brand) may be used. The imprint of the 
marking device shall be placed partially on the strap and partially on 
the container. Such restricted product shall be marked ``U.S. passed for 
cooking'' or ``pork product ---- [deg]F. ----days refrigeration'' or 
``beef passed for refrigeration,'' as the case may be. In addition, a 
``U.S. retained'' tag shall be securely affixed to each container of 
product passed for cooking and of beef passed for refrigeration. The 
means of conveyance shall not be sealed unless at least 25 percent of 
the other product in the vehicle is unmarked. For each consignment there 
shall be promptly issued and forwarded by the inspector to the inspector 
in charge at destination, a report on the form entitled ``Notice of 
Unmarked Meats Shipped in Sealed Cars,'' appropriately modified to show 
the character of the containers, and that the contents are restricted. A 
duplicate copy shall be retained in the program files.
    (c) When products are offered for transportation under this section, 
the initial carrier shall require and the shipper shall make in 
duplicate and deliver to the carrier one copy of a certificate in the 
form set out in Sec. 325.5(b). Certificates in this form or copies 
thereof need not be forwarded to any official or office of the 
Department, but the original of the certificate shall be retained by the 
carrier and a copy shall be retained by the shipper in accordance with 
part 320 of this subchapter. If the shipper is also the carrier, he 
shall nevertheless execute and retain the certificate in accordance with 
part 320 of this subchapter.

[35 FR 15605, Oct. 3, 1970, as amended at 39 FR 20187, June 7, 1974]



Sec. 325.8  Transportation and other transactions concerning certain 
undenatured lungs or lung lobes from official establishments or in 
commerce; provisions and restrictions.

    (a) Lungs or lung lobes, other than those condemned under Sec. 
310.16(b) of this subchapter, that are prepared at any official 
establishment, may be sold, transported, offered for sale or 
transportation, or received for transportation from the establishment, 
in commerce or otherwise, without denaturing as prescribed in Sec. 
314.1 or Sec. 314.3 of this subchapter: Provided:
    (1) The lungs or lung lobes are sold, transported, or offered for 
sale or transportation to, or received for transportation by: An animal 
food manufacturer for use in manufacturing animal food; a zoo, mink 
farm, or other establishment for use as animal food without further 
processing; a warehouse in the United States for storage and subsequent 
movement to such a manufacturer or establishment in the United States, 
or from one warehouse to another for the account of and subsequent 
movement to such a manufacturer or establishment, or for export, for 
nonhuman food purposes.
    (2) The boxes or other containers used for shipping the undenatured 
lungs or lung lobes are closed with nylon filament tape, metallic on 
nonmetallic straps, round wire, or other similar materials that securely 
effect closure of such containers, and the containers are permanently 
identified in at least 2-inch (5 cm) high lettering with the statement 
``(Species) Lungs--Not Intended for Human Food.'' In lieu of securely 
closing the immediate container with any of the above materials, a 1-
inch (2.5 cm) wide bright orange band, imprinted around the length and 
width of the container may be used.
    (3) The name and place of business of the packer or distributor 
shall be shown on the immediate container of the product. In addition, 
the country of origin shall be shown on the immediate container of 
imported lungs or lung lobes.
    (b) Lungs or lung lobes, other than those condemned under a State 
law or regulation at least equal to Sec. 310.16(b) of this subchapter, 
that are prepared at

[[Page 333]]

any State inspected establishment may be sold, transported, offered for 
sale, or transportation or received for transportation from that 
establishment, in commerce, without denaturing as prescribed under 
section 201 of the Act, provided the State law or regulations permit 
such disposition and provided there is compliance with the provisions of 
paragraph (a) of this section.
    (c) Foreign establishments shall be eligible to export lungs or lung 
lobes, other than those condemned for reasons set forth in Sec. 
310.16(b) of this subchapter, to the United States from such foreign 
country under this section, only if such establishments are certified 
and approved for export of products to the United States under part 327 
of this subchapter, and such product complies with the applicable 
regulations for preventing the introduction into the United States of 
diseases (9 CFR 94), in addition to the requirements of paragraph (a) of 
this section.
    (d) All such lungs or lung lobes, if intended for animal food, are 
subject to the Federal Food, Drug, and Cosmetic Act.

[43 FR 43445, Sept. 26, 1978]



Sec. 325.9  [Reserved]



Sec. 325.10  Handling of products which may have become adulterated or 
misbranded; authorization and other requirements.

    (a) When it is claimed that any inspected and passed product, marked 
with an inspection legend, has become adulterated or misbranded after it 
has been transported from an official establishment, such product may be 
transported in commerce to an official establishment after oral 
permission is obtained from the area supervisor of the area in which 
that offical establishment is located. The transportation of the product 
may be to the official establishment from which it had been transported 
or to another official establishment designated by the person desiring 
to handle the product. The transportation shall be authorized only for 
the purpose of officially determining if the product has become 
adulterated or misbranded and making the appropriate disposition. The 
area supervisor shall make a record of the authorization and such other 
information which will effectively identify the shipment and shall 
provide a copy of the record to the inspector at the establishment 
receiving the product. The shipper shall be furnished a copy of the 
authorization record upon request.
    (b) Upon the arrival of the shipment at the official establishment, 
a careful inspection shall be made of the product by a Program 
inspector, and if it is found that the article is not adulterated, the 
same may be received into the establishment; but if the article is found 
to be adulterated, it shall at once be stamped ``U.S. inspected and 
condemned'' and disposed of in accordance with part 314 of this 
subchapter, and if it is found to be misbranded, it shall be handled in 
accordance with Sec. 318.2(d) of this subchapter: Provided, That when a 
product is found to be affected with one of the correctable conditions 
specified in Sec. 318.2(d) of this subchapter, in respect to which 
rehandling is permitted, it may be transported from the official 
establishment to another official establishment for such rehandling as 
is necessary to assure that the product is not adulterated or misbranded 
when finally released. The transportation of such a product from an 
official establishment shall be done in a manner prescribed in each 
specific case by the Administrator.

[35 FR 15605, Oct. 3, 1970, as amended at 47 FR 17274, Apr. 22, 1982]



Sec. 325.11  Inedible articles: denaturing and other means of 
identification; exceptions.

    (a) Except as provided in Sec. 325.8 and Sec. 325.10, no carcass, 
part of a carcass, rendered grease, tallow, or other fat derived from 
the carcasses of livestock, or other meat food product, that has not 
been inspected and passed at an official establishment under the 
provisions of this subchapter and is not exempted from such inspection, 
and no carcass, part of a carcass, fat or other meat food product that 
is adulterated or misbranded, shall be offered for transportation in 
commerce by any person unless it is handled in accordance with paragraph 
(b), (c), (d), or (e) of this section or is denatured or otherwise 
identified as prescribed in Sec. 325.13,

[[Page 334]]

Sec. 314.1, Sec. 314.3, Sec. 314.9, Sec. 314.10, or Sec. 314.11 of 
this subchapter.
    (b) Inedible rendered animal fats from official or other 
establishments in the United States having the physical characteristics 
of a meat food product fit for human food may be transported in commerce 
without denaturing, if the following conditions are met:
    (1) Such inedible rendered fat shall not be bought, sold, 
transported, or offered for sale or offered for transportation in 
commerce, or imported, except by rendering companies, dealers, brokers, 
or others who obtain a numbered permit for such activities from the 
Regional Director.
    (2) Such inedible rendered animal fat may be so distributed only if 
consigned to a domestic manufacturer of technical articles other than 
for human food or to an export terminal for exportation or storage for 
exportation as an inedible article, and provided, in the case of such 
fat consigned to a domestic manufacturer, the product is for use solely 
by the consignee for manufacturing purposes of nonhuman food articles 
and may not be further sold or shipped without first receiving approval 
of the Regional Director: And provided further, That such fat intended 
for export and stored at a terminal point prior to export will be 
subject to review by Program employees to assure that it is exported as 
inedible.
    (3) When transported in commerce, or imported, such inedible 
rendered fat shall be marked conspicuously with the words ``technical 
animal fat not intended for human food'' on the ends of the shipping 
containers, in letters not less than 2 inches high; in the case of 
shipping containers such as drums, tierces, barrels, and half barrels, 
and not less than 4 inches high in the case of tank cars and trucks. All 
shipping containers shall have both ends painted with a durable paint, 
if necessary, to provide a contrasting background for the required 
marking.
    (4) Such inedible rendered fat shall be transported only in sealed 
shipping containers bearing unofficial seals applied by the shipper, 
which shall include the identification number assigned by said Director 
for the permit holder. The number shall appear on the bill of lading or 
other transportation documents for the shipment. The consignees in the 
United States must retain the seals in their records as prescribed in 
part 320 of this subchapter.
    (5) Any diversion or effort to divert inedible rendered fat contrary 
to the provisions of this paragraph (b) or other violation of the 
provisions of this section may result in the revocation of the permit 
for shipment of technical animal fat at the discretion of the 
Administrator.
    (c) Inedible rendered animal fat derived from condemned or other 
inedible materials at official or other establishments in the United 
States may be transported in commerce if mixed with low grade offal or 
other materials which render the fat readily distinguishable from an 
article of human food, and if the outside container bears the word 
``inedible.''
    (d)(1) Except as provided in paragraphs (d)(2), (3), and (4) of this 
section, or in Sec. Sec. 314.10 and 314.11 of this subchapter, no 
animal food prepared, in whole or in part, from materials derived from 
the carcasses of livestock in an official establishment or elsewhere, 
shall be bought, sold, transported, offered for sale or transportation, 
or received for transportation, in commerce, or imported, unless:
    (i) It is properly identified as animal food;
    (ii) It is not represented as being a human food; and
    (iii) It has been denatured as prescribed in Sec. 325.13(a)(2) so 
as to be readily distinguishable from an article of human food.
    (2) Notwithstanding the provisions of paragraph (d)(1) of this 
section, an animal food that consists of less than 5 percent of parts or 
products of the carcasses of livestock and that is not represented by 
labeling or appearance or otherwise as being a human food or as a 
product of the meat food industry need not be denatured in accordance 
with Sec. 325.13(a)(2).
    (3) Notwithstanding the provisions of paragraph (d)(1) of this 
section, animal food packed in hermetically sealed, retort processed, 
conventional retail-size containers, and retail-size packages of semi-
moist animal food need not be denatured in accordance with Sec. 
325.13(a)(2)

[[Page 335]]

if the name of the article clearly conveys the article's intended use 
for animal food and appeared on the label in a conspicuous manner.
    (i) Except as provided in paragraph (ii) of paragraph (d)(3), the 
name of the article must be stated on the label as ``Animal Food,'' 
``Pet Food,'' or ``(name of species) Food'' (e.g., ``Dog Food'' or ``Cat 
Food''). To be considered conspicuous, the name of the article, wherever 
it appears on the label, must be in letters at least twice as high, 
wide, and thick as the letters indicating the presence in the article of 
any ingredients derived from the carcasses of livestock.
    (ii) Notwithstanding the provisons of paragraph (i) of this 
paragraph (d)(3), the article's name may be stated on the label to show 
that it is or contains livestock-source material and that the article is 
for animals; e.g., ``Horsemeat for Pets'' or ``Beef Stew for Dogs'': 
Provided, That the entire name of the article is stated, wherever it 
appears on the label, as an individual, contiguous unit, whether stated 
on a single line or more than one line, and the letters denoting the 
article's intended use for animal food are at least as high, wide, and 
thick as the letters indicating the presence of material derived from 
any livestock carcass. However, when the label bears on its principal 
display panel a vignette which pictures, in clearly recognizable form 
and size, one or more animals of the species for which the article's 
name indicates the article is intended, the letters used to state the 
article's intended use shall be at least one-half as high, wide, and 
thick as the letters used in the article's name or other letters 
indicating the presence of material derived from any livestock carcass, 
but shall not be less than \1/8\ inches high. The letters used to state 
the article's intended use may be separated from the article's name by 
the vignette.
    (iii) Letters used to denote the intended use of the article must 
contrast as markedly with their background as the letters indicating the 
presence in the article of livestock carcass-source material contrast 
with their background.
    (4) The requirements of this part do not apply to livestock or 
poultry feeds manufactured from processed livestock byproducts (such as 
meat meal tankage, meat and bone meal, blood meal, and feed grade animal 
fat), or to processed dry animal food.
    (e) Except for inedible rendered animal fats and lungs or lung 
lobes, inedible products (including condemned products only if condemned 
for causes specified in Sec. 314.11 of this subchapter) which were 
prepared at any official establishment, or at any State inspected 
establishment in any State not listed in Sec. 331.2 of this subchapter, 
and which have the physical characteristics of a product fit for human 
food, may be transported from an official establishment or in commerce, 
without denaturing as required by this subchapter, if the following 
conditions are met:
    (1) The shipper must have obtained a numbered permit for such 
activity from the appropriate Regional Director, as identified in Sec. 
301.2 of this subchapter. Such permit may be obtained upon written 
application to the appropriate Regional Director and his determination 
that the proposed transportation would be authorized under this 
paragraph (e). The application shall state the name and address of the 
applicant, a description of the type of his business operations, and the 
purpose of making such application.
    (2) Such inedible products may be transported under this paragraph 
(e) only if consigned to a manufacturer in the United States of articles 
other than for human food and if the product is for use solely by the 
consignee for manufacturing articles not for human food. Such products 
may not be transported in commerce to any consignee other than the one 
to which they were originally shipped unless prior notice of the 
diversion is given to the appropriate Regional Director and a record 
identifying the new consignee is maintained by the shipper as required 
by Sec. 320.1 of this subchapter.
    (3) When transported from an official establishment or in commerce 
under this paragraph (e), the outside container of such inedible 
products shall be marked conspicuously with the words ``Inedible--Not 
Intended for Human Food'' in letters not less than 2 inches high, in the 
case of containers,

[[Page 336]]

such as cartons, drums, tierces, barrels, and half barrels, and not less 
than 4 inches high in the case of tank cars and trucks used to transport 
such products not in other containers.
    (4) Such inedible products shall be transported from an official 
establishment or in commerce under this paragraph (e) only in railroad 
cars, trucks, or containers which bear unofficial seals applied by the 
shipper, which shall include the identification number assigned to the 
permit holder and an individual seal serial number assigned by the 
shipper; and the product so transported shall be accompanied by an 
invoice or bill of lading specifying the permit holder's identification 
number. The consignee in the United States must retain a record of the 
identification and serial numbers shown on the seals in his records as 
prescribed in part 320 of this subchapter.
    (5) Any diversion, or effort to divert, undenatured, inedible 
product contrary to the provisions of this paragraph (e) or other 
violation of the provisions of this section may result in the revocation 
of the permit for shipment of inedible products under this paragraph 
(e), at the discretion of the Administrator.

[47 FR 17274, Apr. 22, 1982, as amended at 49 FR 47478, Dec. 5, 1984]



Sec. 325.12  [Reserved]



Sec. 325.13  Denaturing procedures.

    (a) Carcasses, parts thereof, meat and meat food products (other 
than rendered animal fats) that have been treated in accordance with the 
provisions of this paragraph shall be considered denatured for the 
purposes of the regulations in this part, except as otherwise provided 
in part 314 of this subchapter for articles condemned at official 
establishments.
    (1) The following agents are prescribed for denaturing carcasses, 
parts thereof, meat or meat food products which are affected with any 
condition that would result in their condemnation and disposal under 
part 314 of this subchapter if they were at an official establishment: 
Crude carbolic acid; cresylic disinfectant; a formula consisting of 1 
part FD&C green No. 3 coloring, 40 parts water, 40 parts liquid 
detergent, and 40 parts oil of citronella, or other proprietary 
substance approved by the Administrator in specific cases. \3\
---------------------------------------------------------------------------

    \3\ Information as to approval of any proprietary denaturing 
substance may be obtained from the Technical Services, Meat and Poultry 
Inspection, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250.
---------------------------------------------------------------------------

    (2) Except as provided in paragraphs (a)(3), (4), and (5) of this 
section, the following agents are prescribed for denaturing other 
carcasses, parts thereof, meat and meat food products, for which 
denaturing is required by this part: FD&C green No. 3 coloring; FD&C 
blue No. 1 coloring; FD&C blue No. 2 coloring; finely powdered charcoal; 
or other proprietary substance approved by the Administrator in specific 
cases. \3\
    (3) Tripe may be denatured by dipping it in a 6 percent solution of 
tannic acid for 1 minute followed by immersion in a water bath, then 
immersing it for 1 minute in a solution of 0.022 percent FD&C yellow No. 
5 coloring;
    (4) Meat may be denatured by dipping it in a solution of 0.0625 
percent tannic acid, followed by immersion in a water bath, then dipping 
it in a solution of 0.0625 percent ferric acid; and
    (5) When meat, meat byproducts, or meat food products are in ground 
form, 4 percent by weight of coarsely ground hard bone, which shall be 
in pieces no smaller than the opening size specified for No. 5 mesh in 
the standards issued by the U.S. Bureau of Standards or 6 percent by 
weight of coarsely ground hard bone, which shall be in pieces no smaller 
than the opening size specified for No. 8 mesh in said Standards, 
uniformly incorporated with the product may be used in lieu of the 
agents prescribed in paragraph (a)(2) of this section.
    (6) Before the denaturing agents are applied to articles in pieces 
more than 4 inches in diameter, the pieces shall be freely slashed or 
sectioned. (If the articles are in pieces not more than 4 inches in 
diameter, slashing or sectioning will not be necessary.) The application 
of any of the denaturing agents listed in paragraph (a)(1) or (2) of 
this section to the outer surface of molds or blocks of boneless meat, 
meat byproducts, or meat food products shall not be adequate. The 
denaturing

[[Page 337]]

agent must be mixed intimately with all of the material to be denatured, 
and must be applied in such quantity and manner that it cannot easily 
and readily be removed by washing or soaking. A sufficient amount of the 
appropriate agent shall be used to give the material a distinctive 
color, odor, or taste so that such material cannot be confused with an 
article of human food.
    (7) Carcasses (other than viscera), parts thereof, cuts of meat, and 
unground pieces of meat darkened by charcoal or other black dyes shall 
be deemed to be denatured pursuant to this section only if they contain 
at least that degree of darkness depicted by diagram 1 of the Meat 
Denaturing Guide (MP Form 91). \1\
---------------------------------------------------------------------------

    \1\ Copies of MP Form 91 may be obtained, without charge, by writing 
to the Administrative Operations Branch, Food Safety and Inspection 
Service, U.S. Department of Agriculture, 123 East Grant Street, 
Minneapolis, Minnesota 55403. Diagrams 2 and 3 of the Meat Denaturing 
Guide are for comparison purposes only. The Meat Denaturing Guide has 
been approved for incorporation by reference by the Director, Office of 
the Federal Register, and is on file at the Federal Register library.
---------------------------------------------------------------------------

    (b) Inedible rendered animal fats shall be denatured by thoroughly 
mixing therein denaturing oil, No. 2 fuel oil, brucine dissolved in a 
mixture of alcohol and pine oil or oil of rosemary, finely powdered 
charcoal, or any proprietary denaturing agent approved for the purpose 
by the Administrator in specific cases. The charcoal shall be used in no 
less quantity than 100 parts per million and shall be of such character 
that it will remain suspended indefinitely in the liquid fat. Sufficient 
of the chosen identifying agents shall be used to give the rendered fat 
so distinctive a color, odor, or taste that it cannot be confused with 
an article of human food.

[35 FR 15605, Oct. 3, 1970, as amended at 41 FR 22930, June 8, 1976; 44 
FR 67626, Nov. 27, 1979]



Sec. 325.14  Certificates, retention by carrier.

    All original certificates delivered to a carrier in accordance with 
this part shall be filed separate and apart from all its other papers 
and records or identified in such a manner as to be readily checked by 
Department employees. Every certificate required to be maintained under 
this part shall be retained for a period of 2 years after December 31 of 
the year in which the transaction has occurred.



Sec. 325.15  Evidence of proper certification required on waybills; 
transfer bills, etc., for shipment by connecting carrier; forms of 
statement.

    (a) All waybills, transfer bills, running slips, conductor's cards, 
or other papers accompanying a shipment, in the course of importation or 
otherwise in commerce, of any product shall have embodied therein, 
stamped thereon, or attached thereto a signed statement which shall be 
evidence to connecting carriers that the proper shipper's certificate, 
as required by Sec. 325.5, Sec. 325.6, or Sec. 325.7, is on file with 
the initial carrier. No connecting carrier shall receive for 
transportation or transport in the course of importation or otherwise in 
commerce any product unless the waybill, transfer bill, running slip, 
conductor's card, or other papers accompanying the same includes the 
signed statement in the following form:

________________________________________________________________________

(Name of transportation company)
U.S. inspected and passed, as evidenced by shipper's certificate on file 
with initial carrier.
(signed)________________________________________________________________
Agent

    (b) Signatures of agents to statements required under this section 
shall be written in full.

[47 FR 17276, Apr. 22, 1982]



Sec. 325.16  Official seals; forms, use, and breaking.

    (a) The official seals required by this part shall be those 
prescribed in Sec. 312.5(a) of this subchapter.
    (b) Except as provided in Sec. 325.18(b), official seal affixed 
under this part shall be affixed or broken only by Program employees, 
and no person other than a Program employee shall affix, detach, break, 
change, or tamper with any such seal in any way whatever. Commission of 
any such acts contrary to this regulation is a criminal offense.

[[Page 338]]



Sec. 325.17  Loading or unloading products in sealed railroad cars, 
trucks, etc., en route prohibited; exception.

    Unloading any product from an officially sealed railroad car, truck, 
or other means of conveyance containing any unmarked product or loading 
any product or any other commodity in the means of conveyance while en 
route from one official establishment to another official establishment 
is not permitted, except that product transported under Sec. 325.5 from 
one official establishment to another for further processing may be 
unloaded and stored in transit at any approved warehouse which is 
operated under the identification service provided under the regulations 
in part 350 of subchapter B of this chapter and which has railroad 
facilities or a receiving dock for unloading the product directly into 
such warehouse: Provided, That the product is stored in rooms which are 
of such size and type as will not result in adulteration or misbranding 
of the product: And provided further, That the product is transported to 
and from such warehouse, and under official seal as provided in Sec. 
325.5 and stored in such rooms at such warehouse.



Sec. 325.18  Diverting of shipments, breaking of seals, and reloading 
by carrier in emergency; reporting to Regional Director.

    (a) Shipments of inspected and passed product that bear the 
inspection legend may be diverted from the original destination without 
a reinspection of the articles, provided the waybills, transfer bills, 
running slips, conductor's card, or other papers accompanying the 
shipments are marked, stamped, or have attached thereto signed 
statements in accordance with Sec. 325.15.
    (b) In case of wreck or similar extraordinary emergency, the 
Department seals on a railroad car or other means of conveyance 
containing any inspected and passed product may be broken by the 
carrier, and if necessary, the articles may be reloaded into another 
means of conveyance, or the shipment may be diverted from the original 
destination, without another shipper's certificate; but in all such 
cases the carrier shall immediately report the facts by telephone or 
telegraph to the Regional Director in the area in which the emergency 
occurs. Such report shall include the following information:
    (1) Nature of the emergency.
    (2) Place where seals were broken.
    (3) Original points of shipment and destination.
    (4) Number and initial of the original car or truck.
    (5) Number and initials of the car or truck into which the articles 
are reloaded.
    (6) New destination of the shipment.
    (7) Kind and amount of articles.

[35 FR 15605, Oct. 3, 1970, as amended at 42 FR 39087, Aug. 2, 1977]



Sec. 325.19  Provisions inapplicable to specimens for laboratory 
examination, etc., or to naturally inedible articles.

    The provisions of this part do not apply:
    (a) To specimens of product sent to or by the Department of 
Agriculture or divisions thereof in Washington, DC, or elsewhere, for 
laboratory examination, exhibition purposes, or other official use;
    (b) To material released for educational, research and other nonfood 
purposes, as prescribed in Sec. 314.9 of this subchapter;
    (c) To glands and organs for use in preparing pharmaceutical, 
organotherapeutic, or technical products and not used for human food, as 
described in Sec. 318.1(g) of this subchapter;
    (d) To material or specimens of product for laboratory examination, 
research, or other nonhuman food purposes, when authorized by the 
Administrator, and under conditions prescribed by him in specific cases; 
and
    (e) To articles that are naturally inedible by humans, such as 
hoofs, horns, and hides in their natural state.



Sec. 325.20  Transportation and other transactions concerning dead, 
dying, disabled, or diseased livestock, and parts of carcasses of 
livestock that died otherwise than by slaughter.

    No person engaged in the business of buying, selling, or 
transporting in commerce, or importing any dead, dying, disabled or 
diseased animals or parts of

[[Page 339]]

the carcasses of any animals that died otherwise than by slaughter 
shall:
    (a) Buy, sell, transport, or offer for sale or transportation, in 
commerce, or import any dead livestock if its hide or skin has been 
removed;
    (b) Sell, transport, offer for sale or transportation, or receive 
for transportation, in commerce, any dead, dying, disabled, or diseased 
livestock, or parts of the carcasses of any livestock that died 
otherwise than by slaughter, unless such livestock and parts are 
consigned and delivered, without avoidable delay, to establishments of 
animal food manufacturers, renderers, or collection stations that are 
registered as required by part 320 of this subchapter, or to official 
establishments that operate under Federal inspection, or to 
establishments that operate under a State or Territorial inspection 
system approved by the Secretary as one that imposes requirements at 
least equal to the Federal requirements for purposes of paragraph 301(c) 
of the Act; \4\
---------------------------------------------------------------------------

    \4\ A list of such registrants, States, and amendments thereof, will 
be published in the Federal Register, and information concerning the 
registration status of particular animal food manufacturers, renderers, 
or collection stations, or the status of particular States or 
Territories may also be obtained from the Director, Administrative 
Management Staff, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250.
---------------------------------------------------------------------------

    (c) Buy in commerce or import any dead, dying, disabled, or diseased 
livestock or parts of the carcasses of any livestock that died otherwise 
than by slaughter, unless he is an animal food manufacturer or renderer 
and is registered as required by part 320 of this subchapter, or is the 
operator of an establishment inspected as required by paragraph (b) of 
this section and such livestock or parts of carcasses are to be 
delivered to establishments eligible to receive them under paragraph (b) 
of this section;
    (d) Unload en route to any establishment eligible to receive them 
under paragraph (b) of this section, any dead, dying, disabled, or 
diseased livestock or parts of the carcasses of any livestock that died 
otherwise than by slaughter, which are transported in commerce or 
imported by any such person: Provided, That any such dead, dying, 
disabled, or diseased livestock, or parts of carcasses may be unloaded 
from a means of conveyance en route where necessary in case of a wreck 
or otherwise extraordinary emergency, and may be reloaded into another 
means of conveyance; but in all such cases, the carrier shall 
immediately report the facts by telegraph or telephone to the Compliance 
Staff, Meat and Poultry Inspection Field Operations, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250.
    (e) Load into any means of conveyance containing any dead, dying, 
disabled, or diseased livestock, or parts of the carcasses of any 
livestock that died otherwise than by slaughter, while in the course of 
importation or other transportation in commerce any livestock or parts 
of carcasses not within the foregoing description or any other products 
or other commodities.

[35 FR 15605, Oct. 3, 1970, as amended at 42 FR 42309, Aug. 23, 1977]



Sec. 325.21  Means of conveyance in which dead, dying, disabled, or 
diseased livestock and parts of carcasses thereof shall be transported.

    All vehicles and other means of conveyance used by persons subject 
to Sec. 325.20 for transporting in commerce or importing, any dead, 
dying, disabled, and diseased livestock or parts of carcasses of 
livestock that died otherwise than by slaughter shall be leak-proof and 
so constructed and equipped as to permit thorough cleaning and 
sanitizing. The means of conveyance so used in conveying such livestock, 
or parts thereof, shall be cleaned and disinfected prior to use in the 
transportation of any product intended for use as human food. The 
cleaning procedure shall include the complete removal from the means of 
conveyance of any fluid, parts, or product of such dead, dying, 
disabled, or diseased livestock and the thorough application of a 
disinfectant to the interior surfaces of the cargo space. Substances 
permitted for such use are:
    (a) ``Liquified phenol'' (U.S.P. strength 87 percent phenol) in the 
proportion of at least 6 fluid ounces to 1 gallon of water.

[[Page 340]]

    (b) ``Cresylic disinfectant'' in the proportion of not less than 4 
fluid ounces to 1 gallon of water; and such other disinfectants as are 
approved by the Administrator in specific cases. The use of ``cresylic 
disinfectant'' is permitted subject to the conditions prescribed in 
Sec. 71.10(b) of this title.



PART 327_IMPORTED PRODUCTS--Table of Contents




Sec.
327.1 Definitions; application of provisions.
327.2 Eligibility of foreign countries for importation of products into 
          the United States.
327.3 No product to be imported without compliance with applicable 
          regulations.
327.4 Imported products; foreign certificates required.
327.5 Importer to make application for inspection of products for entry; 
          information required; ``streamlined'' inspection procedures 
          for Canadian product.
327.6 Products for importation; program inspection, time, and place; 
          application for approval of facilities as official import 
          inspection establishment; refusal or withdrawal of approval; 
          official numbers.
327.7 Products for importation; movement prior to inspection; handling; 
          bond; assistance.
327.8 Import products; equipment and means of conveyance used in 
          handling to be maintained in sanitary condition.
327.9 Burlap wrapping for foreign meat.
327.10 Samples; inspection of consignments; refusal of entry; marking.
327.11 Receipts to importers for import product samples.
327.12 Foreign canned or packaged products bearing trade labels; 
          sampling and inspection.
327.13 Foreign products offered for importation; reporting of findings 
          to customs; handling of articles refused entry.
327.14 Marking of products and labeling of immediate containers thereof 
          for importation.
327.15 Outside containers of foreign products; marking and labeling; 
          application of official inspection legend.
327.16 Small importations for importer's own consumption; requirements.
327.17 Returned U.S. inspected and marked products.
327.18 Products offered for entry and entered to be handled and 
          transported as domestic; exception.
327.19 Specimens for laboratory examination and similar purposes.
327.20 Importation of foreign inedible fats.
327.21 Inspection procedures for chilled fresh and frozen boneless 
          manufacturing meat.
327.22 [Reserved]
327.23 Compliance procedure for cured pork products offered for entry.
327.24 Appeals; how made.
327.25 Disposition procedures for product condemned or ordered destroyed 
          under import inspection.
327.26 Official import inspection marks and devices.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    Source: 35 FR 15610, Oct. 3, 1970, unless otherwise noted.



Sec. 327.1  Definitions; application of provisions.

    (a) When used in this part, the following terms shall be construed 
to mean:
    (1) Import (imported). To bring within the territorial limits of the 
United States whether that arrival is accomplished by land, air, or 
water.
    (2) For product from eligible countries other than Canada:
    (i) Offer(ed) for entry. The point at which the importer presents 
the imported product to the Program for reinspection.
    (ii) Entry (entered). The point at which imported product offered 
for entry receives reinspection and is marked with the offical mark of 
inspection in accordance with Sec. 327.26 of this subchapter.
    (3) For product from Canada:
    (i) Offer(ed) for entry from establishments participating in the 
``streamlined'' inspection procedures. The point at which an official of 
the Canadian meat inspection system contacts the Import Field Office for 
an inspection assignment.
    (ii) Offer(ed) for entry from nonparticipating establishments. The 
point at which the importer presents the imported product to the Program 
for reinspection.
    (iii) Entry (entered) for product not subject to reinspection. When 
the containers or the products themselves if not in containers are 
marked with the Canadian port stamp and upon the filing of Customs Form 
7533 at the port of entry or at the nearest customhouse in accordance 
with 19 CFR part 123.
    (iv) Entry (entered) for product subject to reinspection. When the 
containers or the products themselves if not in containers are marked 
with the

[[Page 341]]

Canadian export stamp and the foreign inspection certificate 
accompanying the product is stamped as ``Inspected and Passed'' by the 
import inspector.
    (b) The provisions of this part shall apply to products derived from 
cattle, sheep, swine, goats, horses, mules, and other equines, if 
capable of use as human food. Compliance with the conditions for 
importation of products under this part does not excuse the need for 
compliance with applicable requirements under other laws, including the 
provisions in parts 94, 95, and 96 of chapter I of this title.

[35 FR 15610, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971; 54 
FR 41048, Oct. 5, 1989]



Sec. 327.2  Eligibility of foreign countries for importation of products 
into the United States.

    (a)(1) Whenever it shall be determined by the Administrator that the 
system of meat inspection maintained by any foreign country, with 
respect to establishments preparing products in such country for export 
to the United States, insures compliance of such establishments and 
their products with requirements equivalent to all the inspection, 
building construction standards, and all other provisions of the Act and 
the regulations in this subchapter which are applied to official 
establishments in the United States, and their products, and that 
reliance can be placed upon certificates required under this part from 
authorities of such foreign country, notice of that fact will be given 
by including the name of such foreign country in paragraph (b) of this 
section. Thereafter, products prepared in such establishments which are 
certified and approved in accordance with paragraph (a)(3) of this 
section, shall be eligible so far as this subchapter is concerned for 
importation into the United States from such foreign country after 
applicable requirements of this subchapter have been met.
    (2) The determination of acceptability of a foreign meat inspection 
system for purposes of this section shall be based on an evaluation of 
the foreign program in accordance with the following requirements and 
procedures:
    (i) The system shall have a program organized and administered by 
the national government of the foreign country. The system as 
implemented must provide standards equivalent to those of the Federal 
system of meat inspection in the United States with respect to:
    (A) Organizational structure and staffing, so as to insure uniform 
enforcement of the requisite laws and regulations in all establishments 
throughout the system at which products are prepared for export to the 
United States;
    (B) Ultimate control and supervision by the national government over 
the official activities of all employees or licensees of the system;
    (C) The assignment of competent, qualified inspectors;
    (D) Authority and responsibility of national inspection officials to 
enforce the requisite laws and regulations governing meat inspection and 
to certify or refuse to certify products intended for export;
    (E) Adequate administrative and technical support;
    (F) The inspection, sanitation, quality, species verification, and 
residue standards applied to products produced in the United States.
    (G) Other requirements of adequate inspection service as required by 
the regulations in this subchapter.
    (ii) The legal authority for the system and the regulations 
thereunder shall impose requirements equivalent to those governing the 
system of meat inspection organized and maintained in the United States 
with respect to:
    (A) Ante-mortem inspection of animals for slaughter and inspection 
of methods of slaughtering and handling in connection with slaughtering 
which shall be performed by veterinarians or by other employees or 
licensees of the system under the direct supervision of the 
veterinarians;
    (B) Post-mortem inspection of carcasses and parts thereof at time of 
slaughter, performed by veterinarians or other employees or licensees of 
the system under the direct supervision of veterinarians;
    (C) Official controls by the national government over establishment 
construction, facilities, and equipment;
    (D) Direct and continuous official supervision of slaughtering and 
preparation of product, by the assignment of

[[Page 342]]

inspectors to establishments certified under paragraph (a)(3) of this 
section, to assure that adulterated or misbranded product is not 
prepared for export to the United States;
    (E) Complete separation of establishments certified under 
subparagraph (3) of this paragraph from establishments not certified and 
the maintenance of a single standard of inspection and sanitation 
throughout all certified establishments;
    (F) Requirements for sanitation at certified establishments and for 
sanitary handling of product;
    (G) Official controls over condemned material until destroyed or 
removed and thereafter excluded from the establishment;
    (H) A Hazard Analysis and Critical Control Point (HACCP) system, as 
set forth in part 417 of this chapter.
    (I) Other matters for which requirements are contained in the Act or 
regulations in this subchapter.
    (iii) Countries desiring to establish eligibility for importation of 
product into the United States may request a determination of 
eligibility by presenting copies of the laws and regulations on which 
the foreign meat inspection system is based and such other information 
as the Administrator may require with respect to matters enumerated in 
paragraphs (a)(2) (i) and (ii) of this section. Determination of 
eligibility is based on a study of the documents and other information 
presented and an initial review of the system in operation by a 
representative of the Department using the criteria listed in paragraphs 
(a)(2) (i) and (ii) of this section. Maintenance of eligibility of a 
country for importation of products into the United States depends on 
the results of periodic reviews of the foreign meat inspection system in 
operation by a representative of the Department, and the timely 
submission of such documents and other information related to the 
conduct of the foreign inspection system, including information required 
by paragraph (e) of section 20 of the Act, as the Administrator may find 
pertinent to and necessary for the determinations required by this 
section of the regulations.
    (iv) The foreign inspection system must maintain a program to assure 
that the requirements referred to in this section, equivalent to those 
of the Federal system of meat inspection in the United States, are being 
met. The program as implemented must provide for the following:
    (A) Periodic supervisory visits by a representative of the foreign 
inspection system not less frequent than one such visit per month to 
each establishment certified in accordance with paragraph (a)(3) of this 
section to assure that requirements referred to in (A) through (H) of 
paragraph (a)(2)(ii) of this section are being met: Provided, That such 
visits are not required with respect to any establishment during a 
period when the establishment is not operating or is not engaged in 
producing products for exportation to the United States;
    (B) Written reports prepared by the representative of the foreign 
inspection system who has conducted a supervisory visit, documenting his 
or her findings with respect to the requirements referred to in (A) 
through (H) of paragraph (a)(2)(ii) of this section, copies of which 
shall be made available to the representative of the Department at the 
time of that representative's review upon request by that representative 
to a responsible foreign meat inspection official: Provided, That such 
reports are not required with respect to any establishment during a 
period when the establishment is not operating or is not engaged in 
producing products for exportation to the United States; and
    (C) Random sampling of internal organs and fat of carcasses at the 
point of slaughter and the testing of such organs and fat, for such 
residues having been identified by the exporting country's meat 
inspection authorities or by this Agency as potential contaminants, in 
accordance with sampling and analytical techniques approved by the 
Administrator: Provided, That such testing is required only on samples 
taken from carcasses from which meat or meat food products intended for 
importation into the United States are produced.
    (3) Only those establishments that are determined and certified to 
the Department by a responsible official of the foreign meat inspection 
system as

[[Page 343]]

fully meeting the requirements of paragraphs (a)(2) (i) and (ii) of this 
section are eligible to have their products imported into the United 
States. Eligibility of certified establishments is subject to review by 
the Department (including observations of the establishments by Program 
representatives at times prearranged with the officials of the foreign 
meat inspection system). Certifications of establishments must be 
renewed annually. Notwithstanding certification by a foreign official, 
the Administrator may, at his discretion, terminate the eligibility of 
any foreign establishment for importation of its products into the 
United States if he has information that such establishment does not 
comply with the requirements listed in paragraphs (a)(2) (i) and (ii) of 
this section or if he cannot obtain current information concerning such 
establishment. The Administrator will provide reasonable notice to the 
foreign government of the proposed termination of eligibility of any 
foreign establishment for importation of its products into the United 
States unless, in his judgment, delay in terminating its eligibility 
could result in the importation of adulterated or misbranded product. 
Certifications of official establishments by the responsible official of 
the foreign meat inspection system shall be in the following form:

             Foreign Official Meat Establishment Certificate

    I hereby certify that the establishment(s) listed below fully comply 
(complies) with requirements of (specify foreign country) equivalent to 
all the inspection, building construction standards, and other 
requirements for the slaughter and preparation of the carcasses, parts 
thereof, meat and meat food products of cattle, sheep, swine, goats, and 
equines applied to official establishments in the United States under 
the Federal Meat Inspection Act and otherwise meet (meets) the 
requirements of Sec. 327.2(a) of the regulations governing meat 
inspection of the U.S. Department of Agriculture.

 
         Control numbers                 Name               Address
 
 
---------------------------------
 
---------------------------------
 

Date____________________________________________________________________
Signature_______________________________________________________________
Official Title__________________________________________________________

    (4) Product of cattle, sheep, swine, and goats from foreign 
countries not listed in paragraph (b) of this section and product of 
equines from countries not listed in paragraph (c) of this section is 
not eligible for importation into the United States, except as provided 
by Sec. 327.16 or Sec. 327.17. The listing of any foreign country 
under this section may be withdrawn whenever it shall be determined by 
the Administrator that the system of meat inspection maintained by such 
foreign country does not assure compliance with requirements equivalent 
to all the inspection, building construction standards, and other 
requirements of the Act and the regulations in this subchapter as 
applied to official establishments in the United States; or that 
reliance cannot be placed upon certificates required under this part 
from authorities of such foreign country; or that, for lack of current 
information concerning the system of meat inspection being maintained by 
such foreign country, such foreign country should be required to 
reestablish its eligibility for listing.
    (b) It has been determined that product of cattle, sheep, swine, and 
goats from the following countries covered by foreign meat inspection 
certificates of the country of origin as required by Sec. 327.4, except 
fresh, chilled, or frozen or other product ineligible for importation 
into the United States from countries in which the contagious and 
communicable disease of rinderpest or of foot-and-mouth disease or of 
African swine fever exists as provided in part 94 of this title, is 
eligible under the regulations in this subchapter for entry into the 
United States after inspection and marking as required by the applicable 
provisions of this part.

Argentina, Australia, Austria, Belgium, Belize, Brazil, Canada, Chile, 
Costa Rica, Czech Republic, Denmark, Dominican Republic, El Salvador, 
England and Wales, Finland, France, Germany (Federal Republic), 
Guatemala, Honduras, Hungary, Iceland, Ireland (Eire), Italy, Japan, 
Mexico, Netherlands, New Zealand, Nicaragua,

[[Page 344]]

Northern Ireland, Norway, Paraguay, Poland, Republic of China, (Taiwan), 
Republic of Croatia, Republic of Slovenia, Romania, San Marino, \1\ 
Scotland, Slovakia, \2\ Spain, Sweden, Switzerland, Uruguay, Venezuela, 
Yugoslavia.
---------------------------------------------------------------------------

    \1\ Equivalent for processing inspection system only.
    \2\ May export to the United States only processed meat food 
products derived from animals slaughtered under Federal inspection in 
the United States, or in a country eligible to export meat and meat 
products to the United States.

    (c) It has been determined that product of equines from the 
following countries, covered by foreign meat inspection certificates of 
the country of origin as required by Sec. 327.4, is eligible under the 
regulations in this subchapter for importation into the United States 
after inspection and marking as required by the applicable provisions of 
---------------------------------------------------------------------------
this part.

Argentina, Canada, New Zealand, Paraguay.

[35 FR 15610, Oct. 3, 1970]

    Editorial Note: For Federal Register citations affecting Sec. 
327.2, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 327.3  No product to be imported without compliance with applicable 
regulations.

    (a) No product offered for importation from any foreign country 
shall be admitted into the United States if it is adulterated or 
misbranded or does not comply with all the requirements of this 
subchapter that would apply to it if it were a domestic product.
    (b) No cooked or partially cooked meat or meat trimmings, either in 
separable pieces or molded into larger forms, shall be permitted entry 
except under the following conditions:
    (1) A complete procedure for preparing and handling the product in 
the foreign country and en route to the United States shall be submitted 
by the exporter or his authorized agent to the Administrator and 
determined by the Administrator to be adequate to assure that the 
product will not be adulterated or misbranded at the time of offer for 
entry.
    (2) A system acceptable to the Administrator (upon his determination 
that the system will provide a reliable indication of the kinds and 
numbers of microorganisms present) for the microbiological testing of 
the finished product shall be installed by the processor, the product is 
subjected to such testing, and the results thereof are furnished to the 
Administrator and are acceptable to him as showing that the product has 
been prepared and handled in a sanitary manner.
    (c) [Reserved]

[35 FR 15610, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973; 54 
FR 41048, Oct. 5, 1989; 56 FR 38335, Aug. 13, 1991; 57 FR 27906, June 
23, 1992]



Sec. 327.4  Imported products; foreign certificates required.

    (a) Except as provided in Sec. 327.16, each consignment containing 
any fresh meat or fresh meat byproducts consigned to the United States 
from a foreign country shall be accompanied by a foreign-meat-inspection 
certificate for fresh meat and meat byproducts in the following form:

                                ORIGINAL

 Official Meat-Inspection Certificate for Fresh Meat and Meat Byproducts

Place ------------ (City) ------------ (Country) Date ------

    I hereby certify that the meat and meat byproducts herein described 
were derived from livestock which received ante-mortem and post-mortem 
veterinary inspections at time of slaughter in plants certified for 
importation of their products into the United States and are not 
adulterated or misbranded as defined by the regulations governing meat 
inspection of the U.S. Department of Agriculture; and that said products 
have been handled in a sanitary manner in this country and are otherwise 
in compliance with requirements equivalent to those in the Federal Meat 
Inspection Act and said regulations.

 
                     Species of
Kind of product  livestock derived   Number of pieces        Weight
                        from          or containers
------------------------------------------------------------------------
 
----------------
 
----------------
 
----------------
------------------------------------------------------------------------

Identification marks on products and containers_________________________

Consignor_______________________________________________________________

[[Page 345]]

Address_________________________________________________________________
Establishment number____________________________________________________
Consignee_______________________________________________________________
Destination_____________________________________________________________
Shipping marks__________________________________________________________
(Signature)_____________________________________________________________
(Name of official authorized by the national foreign government to issue 
inspection certificates for meat and meat byproducts exported to the 
United States)
(Official title)________________________________________________________

    (b) Except as provided in Sec. 327.16, each consignment containing 
any meat food product consigned to the United States from a foreign 
country shall be accompanied by a foreign-meat-inspection certificate 
for meat food products in the following form:

                                ORIGINAL

       Official Meat-Inspection Certificate for Meat Food Products

Place ------------ (City) ------------ (Country) ------------ Date ----
--

    I hereby certify that the meat food products herein described were 
derived from livestock which received ante-mortem and post-mortem 
veterinary inspections at time of slaughter in plants certified for 
importation of their products into the United States, were handled in a 
sanitary manner, and were prepared under the continuous supervision of 
an inspector under control of the national meat inspection system and 
that said meat food products are not adulterated or misbranded as 
defined by the regulations governing meat inspection of the U.S. 
Department of Agriculture, and are otherwise in compliance with 
requirements equivalent to those in the Federal Meat Inspection Act and 
said regulations.
    I further certify that all products herein described that are 
prepared customarily to be eaten without cooking and contain muscle 
tissue of pork were treated for destruction of trichnae as prescribed in 
Sec. 318.10 of the Meat Inspection Regulations of the U.S. Department 
of Agriculture.

 
                     Species of
Kind of product  livestock derived   Number of pieces        Weight
                        from          or containers
------------------------------------------------------------------------
 
----------------
 
----------------
 
----------------
------------------------------------------------------------------------

Identification marks on products and containers_________________________

Consignor_______________________________________________________________
Address_________________________________________________________________
Establishment number____________________________________________________
Consignee_______________________________________________________________
Destination_____________________________________________________________
Shipping marks__________________________________________________________
(Signature)_____________________________________________________________
(Name of official authorized by the national foreign government to issue 
inspection certificates for meat food product exported to the United 
States)
(Official title)________________________________________________________

    (c) Each foreign meat-inspection certificate shall bear the official 
seal of the national government agency responsible for the inspection of 
the product and be signed and issued by an official authorized to sign 
and issue such certificates by the national government of the foreign 
country in which the product is inspected.
    (d) Each foreign meat-inspection certificate shall be in both the 
English language and the language of the foreign country of origin.
    (e) Except for product subject to procedures in Sec. 327.5(d)(l), 
the foreign meat inspection certificate required by this section to 
accompany each consignment containing any product shall be delivered by 
the consignee, or his agent, in the United States to the Program import 
inspector at the place of inspection, and inspection of the product will 
not be commenced prior to such delivery.

[35 FR 15610, Oct. 3, 1970, as amended at 54 FR 274, Jan. 5, 1989; 60 FR 
38668, July 28, 1995]



Sec. 327.5  Importer to make application for inspection of products for 
entry; information required; ``streamlined'' inspection procedures for 
Canadian product.

    (a) Except for importers of Canadian products, each importer shall 
apply for inspection of any product offered for entry by contacting the 
Import Field Office covering the location where import inspection will 
take place. The Import Field Office will provide specific application 
instructions (See Sec. 301.2 (yyy)).
    (b) The application should be made as long as possible in advance of 
the anticipated arrival of each consignment, except in case of 
consignments of products expressly exempted from inspection by 
Sec. Sec. 327.16 and 327.17, and in the case of product imported from 
Canada.
    (c) Except in the case of product imported from Canada, each 
application shall state the approximate date on which the consignment is 
due to arrive

[[Page 346]]

at such port in the United States, the name of the ship or other carrier 
transporting it, the name of the country from which the product was, or 
is to be, shipped, the place where inspection is desired in accordance 
with Sec. 327.6, the quantity and kind of product, and whether it is 
fresh, cured, canned or otherwise prepared. In case of consignments 
arriving in the United States by water, the application shall also state 
the port of first arrival in the United States.
    (d) For participating Canadian establishments, an official of the 
Canadian meat inspection system shall contact the participating Import 
Field Office for an inspection assignment (See Sec. 301.2 (yyy)).
    (1) If the Automated Import Information System (AIIS) does not 
designate the consignment for reinspection, the consignment may be 
transported to its consignee for further distribution.
    (2) If the AIIS designates the consignment for reinspection, the 
representative shall:
    (i) Select samples in accordance with USDA sampling tables.\3\
---------------------------------------------------------------------------

    \3\ A copy of the sampling tables is available, upon request, from 
the Import Inspection Division, International Programs, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250.
---------------------------------------------------------------------------

    (ii) Identify and place samples in the vehicle for easy removal and 
reinspection by an import inspector.
    (3) In the event that any one of the requirements provided in (d)(2) 
of this section is not met, reinspection of the consignment shall be 
conducted by a Program import inspector in accordance with established 
procedures provided in the regulations for other imported products.

[54 FR 274, Jan. 5, 1989, as amended at 54 FR 41048, Oct. 5, 1989]



Sec. 327.6  Products for importation; program inspection, time and 

place; application for approval of facilities as official import 
inspection establishment; refusal or withdrawal of approval; official 
numbers.

    (a)(1) Except as provided in Sec. Sec. 327.5(d)(1), 327.16 and 
327.17, all products offered for entry from any foreign country shall be 
reinspected by a Program inspector before they shall be allowed entry 
into the United States.
    (2) Every lot of product shall routinely be given visual inspection 
by a Program import inspector for appearance and condition, and checked 
for certification and label compliance, except as provided in 
327.5(d)(1).
    (3) The computerized Automated Import Information System (AIIS) 
shall be consulted for reinspection instructions. The AIIS will assign 
reinspection levels and procedures based on established sampling plans 
or established sampling plans and established product and plant history.
    (4) When the inspector deems it necessary, the inspector may sample 
and inspect lots not designated by AIIS.
    (b) All products, required by this part to be inspected, shall be 
inspected only at an official establishment or at an official import 
inspection establishment approved by the Administrator as provided in 
this section. Such approved official import inspection establishments 
will be listed in the Directory of Meat and Poultry Inspection Program 
Establishments, Circuits and Officials, published by the Food Safety and 
Inspection Service. The listing will categorize the kind or kinds of 
product \2\ which may be inspected at each official import inspection 
establishment, based on the adequacy of the facilities for making such 
inspections and handling such products in a sanitary manner.
---------------------------------------------------------------------------

    \1\ [Reserved]
    \2\ For example: Canned product, boneless meat, carcasses and cuts.
---------------------------------------------------------------------------

    (c) Owners or operators of establishments, other than official 
establishments, who want to have import inspections made at their 
establishments, shall apply to the Administrator for approval of their 
establishments for such purpose. Application shall be made on a form 
furnished by the Program, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC, and shall include all 
information called for by that form.
    (d) Approval for Federal import inspection shall be in accordance 
with part 304 of this subchapter.
    (e) Owners or operators of establishments at which import 
inspections of

[[Page 347]]

product are to be made shall furnish adequate sanitary facilities and 
equipment for examination of such product. The requirements of 
Sec. Sec. 304.2(e), 307.1, 307.2 (b), (d), (f), (h), (k), and (l) and 
416.1 through 416.6 of this chapter shall apply as conditions for 
approval of establishments as official import inspection establishments 
to the same extent and in the same manner as they apply with respect to 
official establishments.
    (f) The Administrator is authorized to approve any establishment as 
an official import inspection establishment provided that an application 
has been filed and drawings have been submitted in accordance with the 
requirements of paragraphs (c) and (d) of this section and he determines 
that such establishment meets the requirements under paragraph (e) of 
this section. Any application for inspection under this section may be 
denied or refused in accordance with the rules of practice in part 500 
of this chapter.
    (g) Approval of an official import inspection establishment may be 
withdrawn in accordance with applicable rules of practice if it is 
determined that the sanitary conditions are such that the product is 
rendered adulterated, that such action is authorized by section 21(b) of 
the Federal Water Pollution Control Act, as amended (84 Stat. 91), or 
that the requirements of paragraph (e) of this section were not complied 
with. Approval may also be withdrawn in accordance with section 401 of 
the Act and applicable rules of practice.
    (h) A special official number shall be assigned to each official 
import inspection establishment. Such number shall be used to identify 
all products inspected and passed for entry at the establishment.
    (i) A sampling inspection shall be made, as provided in paragraph 
(a) of this section, of foreign chilled fresh or frozen fresh meat, 
including defrosting if necessary to determine its condition. Inspection 
standards for foreign chilled fresh or frozen fresh meat shall be the 
same as those used for domestic chilled fresh or frozen fresh meat. (See 
Sec. 327.21)
    (j) Imported canned products are required to be sound, healthful, 
properly labeled, wholesome, and otherwise not adulterated at the time 
the products are offered for importation into the United States. 
Provided other requirements of this part are met, the determination of 
the acceptability of the product and the condition of the containers 
shall be based on the results of an examination of a statistical sample 
drawn from the consignment as provided in paragraph (a) of this section. 
If the inspector determines, on the basis of the sample examination, 
that the product does not meet the requirements of the Act and 
regulations thereunder, the consignment shall be refused entry. However, 
a consignment rejected for container defects but otherwise acceptable 
may be reoffered for inspection under the following conditions:
    (1) If the defective containers are not indicative of an unsafe and 
unstable product as determined by the Administrator;
    (2) If the number and kinds of container defects found in the 
original sample do not exceed the limits specified for this purpose in 
FSIS guidelines; and
    (3) If the defective containers in the consignment have been sorted 
out and exported or destroyed under the supervision of an inspector.
    (k) Program inspectors or Customs officers at border or seaboard 
ports shall report the sealing of cars, trucks, or other means of 
conveyance, and the sealing or identification of containers of foreign 
product on Form MP-410 to Program area supervisors at points where such 
product is to be inspected.
    (l) Representative samples of canned product designated by the 
Administrator in instructions to inspectors shall be incubated under 
supervision of such inspectors in accordance with Sec. 318.309 
(d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii) and 
(d)(1)(viii) of this subchapter. The importers or his/her agent shall 
provide the necessary incubation facilities in accordance with Sec. 
318.309(d)(1)(i) of this subchapter.
    (m) Sampling plans and acceptance levels as prescribed in paragraphs 
(j) and (l) of this section may be obtained, upon request, from 
International Programs, Food Safety and Inspection

[[Page 348]]

Service, U.S. Department of Agriculture, Washington, DC 20250.

[35 FR 15610, Oct. 3, 1970, as amended at 37 FR 21927, Oct. 17, 1972; 38 
FR 29215, Oct. 23, 1973; 49 FR 36818, Sept. 20, 1984; 51 FR 37707, Oct. 
24, 1986; 51 FR 45633, Dec. 19, 1986; 54 FR 274, Jan. 5, 1989; 54 FR 
41048, Oct. 5, 1989; 62 FR 45026, Aug. 25, 1997; 64 FR 56416, Oct. 20, 
1999; 64 FR 66545, Nov. 29, 1999; 65 FR 2284, Jan. 14, 2000]



Sec. 327.7  Products for importation; movement prior to inspection; 
handling; bond; assistance.

    (a) No product required by this part to be inspected shall be moved, 
prior to inspection from any port, or, if arriving by water from the 
wharf where first unloaded, to any place other than the place designated 
by, or in accordance with, this part as the place where the same shall 
be inspected.
    (b) No product required by this part to be inspected shall be 
conveyed, prior to inspection, from any port, or, if arriving by water, 
from the wharf where first unloaded, in any manner other than in 
compliance with this part.
    (c) No product required by this part to be inspected shall be 
delivered to the consignee or his agent prior to inspection, unless the 
consignee shall furnish a bond, in form prescribed by the Secretary of 
the Treasury, conditioned that the product shall be returned, if 
demanded, to the collector of the port where the same is offered for 
clearance through the customs.
    (d) The consignee or his agent shall provide such assistance as 
Program inspectors may require for the handling and marking of product 
offered for entry.

[35 FR 15610, Oct. 3, 1970, as amended at 37 FR 21928, Oct. 17, 1972; 51 
FR 37707, Oct. 24, 1986; 56 FR 65180, Dec. 16, 1991]



Sec. 327.8  Import products; equipment and means of conveyance used in 
handling to be maintained in sanitary condition.

    Compartments of steamships, sailing vessels, railroad cars, and 
other means of conveyance transporting any product to the United States, 
and all trucks, chutes, platforms, racks, tables, tools, utensils, and 
all other devices used in moving and handling any product offered for 
importation into the United States, shall be maintained in a sanitary 
condition.



Sec. 327.9  Burlap wrapping for foreign meat.

    Burlap shall not be used as a wrapping for foreign meat unless the 
meat is first wrapped with a good grade of paper or cloth of a kind 
which will prevent contamination with lint or other foreign material.



Sec. 327.10  Samples; inspection of consignments; refusal of entry; 
marking.

    (a) Program inspectors may take, without cost to the United States, 
for laboratory examination, samples of any product which is subject to 
analysis, from each consignment offered for importation, except that 
such samples shall not be taken of any product offered for importation 
under Sec. 327.16.
    (b) Except for product offered for entry from Canada, the outside 
containers of all products offered for entry from any foreign country 
and accompanied with a foreign inspection certificate as required by 
this part, which, upon reinspection by import inspectors are found not 
to be adulterated or misbranded and are otherwise eligible for entry 
into the United States under this part, or the products themselves if 
not in containers, shall be marked with the official inspection legend 
prescribed in Sec. 327.26 of this part. Except for Canadian product, 
all other products so marked, in compliance with this part, shall be 
entered into the United States, insofar as such entry is regulated under 
the Act.
    (c) Product which is inspected and rejected shall be marked ``U.S. 
Refused Entry'' as shown in Sec. 327.26(c). Such marks shall be applied 
to the shipping container or the product itself if not in a container.
    (d) The inspection legend may be placed on containers of product 
before completion of official import inspection if the containers are 
being inspected by an import inspector who reports directly to an Import 
Field Office Supervisor; the product is not required to be held at the 
establishment pending the receipt of laboratory test results; and a 
written procedure for controlled

[[Page 349]]

stamping, submitted by the import establishment and approved by the 
Director, Import Inspection Division, is on file at the import 
inspection facility where the inspection is to be performed.
    (1) The written procedure for controlled pre-stamping should be in 
the form of a letter and shall include the following:
    (i) That stamping under this part will be limited to those lots of 
product which can be inspected on the day that certificates for the 
product are examined;
    (ii) That all product which has been pre-stamped will be stored in 
the facility where the import inspection will occur;
    (iii) That inspection marks applied under this part will be removed 
from any lot of product subsequently refused entry on the day the 
product is rejected; and
    (iv) That the establishment will maintain a daily stamping log 
containing the following information for each lot of product: the date 
of inspection, the country of origin, the foreign establishment number, 
the product name, the number of units, the shipping container marks, and 
the MP-410 number covering the product to be inspected. The daily 
stamping log must be retained by the establishment in accordance with 
the requirements of Sec. 320.3.
    (2) An establishment's controlled pre-stamping privilege may be 
cancelled orally or in writing by the inspector who is supervising its 
enforcement whenever the inspector finds that the establishment has 
failed to comply with the provisions of this part or any conditions 
imposed pursuant thereto. If the cancellation is oral, the decision and 
the reasons therefor shall be confirmed in writing, as promptly as 
circumstances allow. Any person whose controlled pre-stamping privilege 
has been cancelled may appeal the decision to the Administrator, in 
writing, within ten (10) days after receiving written notification of 
the cancellation. The appeal shall state all of the facts and reasons 
upon which the person relies to show that the controlled pre-stamping 
privilege was wrongfully cancelled. The Administrator shall grant or 
deny the appeal, in writing, stating the reasons for such decision, as 
promptly as circumstances allow. If there is a conflict as to any 
material fact, a hearing shall be held to resolve such conflict. Rules 
of practice concerning such a hearing will be adopted by the 
Administrator. The cancellation of the controlled pre-stamping privilege 
will be in effect until there is a final determination of the 
proceeding.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[35 FR 15610, Oct. 3, 1970, as amended at 53 FR 17014, May 13, 1988; 54 
FR 41048, Oct. 5, 1989]



Sec. 327.11  Receipts to importers for import product samples.

    In order that importers may be assured that samples of foreign 
products collected for laboratory examination are to be used exclusively 
for that purpose, official receipts shall be issued and delivered to 
importers, or their agents, by inspectors for all samples of foreign 
products collected. The official receipt shall be prepared in duplicate, 
over the signature of the inspector who collects the samples, and shall 
show the name of the importer, country of origin, quantity and kind of 
product collected, date of collection, and that the sample was collected 
for laboratory examination. The duplicate copy of the receipt shall be 
retained by the inspectors as their office record.

[35 FR 15610, Oct. 3, 1970, as amended at 51 FR 37707, Oct. 24, 1986]



Sec. 327.12  Foreign canned or packaged products bearing trade labels; 
sampling and inspection.

    (a) Samples of foreign canned or packaged products bearing on their 
immediate containers trade labels which have not been approved under 
Sec. 317.3 of this subchapter shall be collected and forwarded to the 
laboratory by the Program inspector for examination, and the products 
shall be held pending receipt of the report of the laboratory findings 
and the results of the examination of trade labels and the marks on 
shipping containers.
    (b) Foreign canned or packaged products bearing trade labels and 
other markings which have been approved under Sec. 317.3 of this 
subchapter shall be

[[Page 350]]

inspected for soundness and checked for net weight. Samples may be 
collected for laboratory examination, but the products may be released 
under customs' bond pending the report of laboratory findings.
    (c) Samples shall be taken from foreign canned products or packaged 
products as required by Sec. 327.6 (a) and (j) of this part.

[35 FR 15610, Oct. 3, 1970, as amended at 49 FR 36818, Sept. 20, 1984]



Sec. 327.13  Foreign products offered for importation; reporting of 
findings to customs; handling of articles refused entry.

    (a)(1) Program inspectors shall report their findings as to any 
product which has been inspected in accordance with this part, to the 
Director of Customs at the original port of entry where the same is 
offered for clearance through Customs inspection.
    (2) When product has been identified as ``U.S. refused entry, '' the 
inspector shall request the Director of Customs to refuse admission to 
such product and to direct that it be exported by the owner or consignee 
within the time specified in this section, unless the owner or 
consignee, within the specified time, causes it to be destroyed by 
disposing of it under the supervision of a Program employee so that the 
product can no longer be used as human food, or by converting it to 
animal food uses, if permitted by the Food and Drug Administration. The 
owner or consignee of the refused entry product shall not transfer legal 
title to such product, except to a foreign consignee for direct and 
immediate exportation, or to an end user, e.g., an animal food 
manufacturer or a renderer, for destruction for human food purposes. 
``Refused entry'' product must be delivered to and used by the 
manufacturer or renderer within the 45-day time limit. Even if such 
title is illegally transferred, the subsequent purchaser will still be 
required to export the product or have it destroyed as specified in the 
notice under paragraph (a)(5) of this section.
    (3) No lot of product which has been refused entry may be subdivided 
during disposition pursuant to paragraph (a)(2) of this section, except 
that removal and destruction of any damaged or otherwise unsound product 
from a lot destined for reexportation is permitted under supervision of 
USDA prior to exportation. Additionally, such refused entry lot may not 
be shipped for export from any port other than that through which the 
product came into the United States, without the expressed consent of 
the Administrator based on full information concerning the product's 
disposition, including the name of the vessel and the date of export. 
For the purposes of this paragraph, the term ``lot'' shall refer to that 
product indentified on MP Form 410 in the original request for 
inspection for importation pursuant to Sec. 327.5.
    (4) Product which has been refused entry solely because of 
misbranding, in lieu of exportation or destruction pursuant to paragraph 
(a)(2) of this section, may be brought into compliance with the 
requirements of this part, under supervision of an authorized 
representative of the Administrator.
    (5) The owner or consignee shall have 45 days after notice is given 
by FSIS to the Director of Customs at the original port of entry to take 
the action required in paragraph (a)(2) of this section for ``refused 
entry'' product. Extension beyond the 45-day period may be granted by 
the Administrator when extreme circumstances warrant it; e.g., a dock 
workers' strike or an unforeseeable vessel delay.
    (6) If the owner or consignee fails to take the required action 
within the time specified under paragraph (a)(5) of this section, the 
Department will take such action as may be necessary to effectuate its 
order to have the product destroyed for human food purposes. The 
Department shall seek court costs and fees, storage, and proper expense 
in the appropriate legal forum.
    (7) No product which has been refused entry and exported to another 
country pursuant to paragraph (a)(2) of this section may be returned to 
the United States under any circumstance. Any such product so returned 
to the United States shall be subject to administrative detention in 
accordance with section 402 of the Act and seizure and condemnation in 
accordance with section 403 of the Act.

[[Page 351]]

    (b) Upon the request of the Director of Customs at the port where a 
product is offered for clearance through the customs, the consignee of 
the product shall, at the consignee's own expense, immediately return to 
the Director any product which has been delivered to consignee under 
Sec. 327.7 and subsequently designated ``U.S. Refused Entry'' or found 
in any respect not to comply with the requirements in this part.
    (c) All charges for storage, cartage, and labor with respect to any 
product which was imported contrary to the Act shall be paid by the 
owner or consignee, and in default of such payment shall constitute a 
lien against such product and any other product thereafter imported by 
or for such owner or consignee.

[35 FR 15610, Oct. 3, 1970, as amended at 48 FR 15889, Apr. 13, 1983; 49 
FR 29568, July 23, 1984; 50 FR 19907, May 13, 1985; 53 FR 17015, May 13, 
1988; 54 FR 50735, Dec. 11, 1989]



Sec. 327.14  Marking of products and labeling of immediate containers 
thereof for importation.

    (a) Product which is offered for importation, and which is 
susceptible of marking, shall, whether or not enclosed in an immediate 
container, bear the name of the country of origin, preceded by the words 
``product of''; the establishment number assigned by the foreign meat 
inspection system and certified to the Program; and such other markings 
as are necessary for compliance with part 316 of this subchapter. When 
such markings are imprints of stamps or brands made with branding ink, 
such ink shall be harmless and shall create permanent imprints. In case 
the name of the country of origin appears as part of an official mark of 
the national foreign government and such name is prominently and legibly 
displayed, the words ``product of'' may be omitted.
    (b) In addition to the marking of products required under paragraph 
(a) of this section, the immediate container of any product offered for 
importation:
    (1) Shall bear a label showing in accordance with Sec. 317.2 of 
this subchapter all information required by that section (except that 
the establishment number assigned by the foreign meat inspection system 
and certified to the Program and the official inspection mark of the 
foreign meat inspection system shall be shown instead of the official 
inspection legend of the United States) and in addition the name of the 
country of origin preceded by the words ``product of,'' immediately 
under the name or descriptive designation of the product as required by 
Sec. 317.2: Provided, That such establishment number may be omitted 
from a label lithographed directly on a can if said number is 
lithographed or embossed elsewhere on the can; and
    (2) Shall, if such immediate container is a sealed metal container, 
have the establishment number assigned by the foreign meat inspection 
authority and certified by the Program embossed or lithographed on the 
sealed metal container, and such establishment number shall not be 
covered or obscured by any label or other means.
    (c) All marks and other labeling for use on or with immediate 
containers, as well as private brands on carcasses or parts of 
carcasses, shall be approved by the Food Safety and Inspection Service 
in accordance with part 317 of this subchapter before products bearing 
such marks, labeling, or brands will be entered into the United States. 
The marks of inspection of foreign systems embossed on metal containers 
or branded on carcasses or parts thereof need not be submitted to the 
Food Safety and Inspection Service for approval, and such marks of 
inspection put on stencils, box dies, labels, and brands may be used on 
such immediate containers as tierces, barrels, drums, boxes, crates, and 
large-size fiberboard containers of foreign products without such marks 
of inspection being submitted for approval, provided the markings made 
by such articles are applicable to the product and are not false or 
misleading.

[35 FR 15610, Oct. 3, 1970, as amended at 51 FR 37707, Oct. 24, 1986; 60 
FR 67456, Dec. 29, 1995]



Sec. 327.15  Outside containers of foreign products; marking and labeling; 
application of official inspection legend.

    (a) The outside container in which any immediate container of 
foreign

[[Page 352]]

product is shipped to the United States shall bear, in English, in a 
prominent and legible manner:
    (1) The name or descriptive designation of the product in accordance 
with Sec. 317.2 of this subchapter;
    (2) The name of the country of origin; and
    (3) The establishment number assigned by the foreign meat inspection 
system and certified to the Program.
    (b) All labeling used with an outside container of foreign product 
must be approved in accordance with part 317 of this subchapter.
    (c) Except for product offered for entry from Canada, all outside 
containers of products which have been inspected and passed in 
accordance with this part shall be marked by a Program import inspector 
or under a Program import inspector's supervision with the official 
import meat inspection mark prescribed in Sec. 327.26.

[35 FR 15610, Oct. 3, 1970, as amended at 51 FR 37707, Oct. 24, 1986; 54 
FR 41048, Oct. 5, 1989]



Sec. 327.16  Small importations for importer's own consumption; 
requirements.

    Any product in a quantity of 50 pounds or less which was purchased 
by the importer outside the United States for his/her own consumption, 
is eligible to be imported into the United States from any country 
without compliance with the provisions in other sections of this part 
but subject to applicable requirements under other laws, including the 
regulations in part 94 of this title. However, Program employees may 
inspect any product imported under this section to determine whether it 
is within the class eligible to be imported under this paragraph.

[54 FR 41048, Oct. 5, 1989]



Sec. 327.17  Returned U.S. inspected and marked products.

    U.S. inspected and passed and so marked products exported to and 
returned from foreign countries will be admitted into the United States 
without compliance with this part upon notification to and approval of 
the Deputy Administrator, International Programs, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250, in specific cases.

[35 FR 15610, Oct. 3, 1970, as amended at 51 FR 37707, Oct. 24, 1986]



Sec. 327.18  Products offered for entry and entered to be handled and 
transported as domestic; exception.

    (a) All products, after entry into the United States, shall be 
deemed and treated as domestic products and shall be subject to the 
applicable provisions of the Act and the regulations in this subchapter 
and the applicable requirements under the Federal Food, Drug and 
Cosmetic Act, except that products imported under Sec. 327.16 are 
required to comply only with the requirements of that Act and Sec. 
327.16 of this subchapter.
    (b) Products entered in accordance with this part may, subject to 
the provisions of part 318 of this subchapter, be taken into official 
establishments and be mixed with or added to any product in such 
establishments which has been inspected and passed therein.
    (c) Imported product which has been inspected, passed, and marked 
under this part may be transported in the course of importation or 
subsequently in commerce only upon compliance with part 325 of this 
subchapter.

[35 FR 15610, Oct. 3, 1970, as amended at 41 FR 18089, Apr. 30, 1976; 54 
FR 41049, Oct. 5, 1989]



Sec. 327.19  Specimens for laboratory examination and similar purposes.

    The provisions in this part do not apply to specimens of products 
for laboratory examination, research, or similar purposes when 
authorized importation by the Administrator under conditions specified 
by him in specific cases, including requirements of denaturing or other 
identification to deter their use for human food. Authorization will not 
be given for the importation of any products contrary to the provisions 
of part 94 of this chapter.



Sec. 327.20  Importation of foreign inedible fats.

    No inedible grease, inedible tallow, or other inedible rendered fat 
shall be imported into the United States unless it has been first 
denatured as prescribed in Sec. 327.25 of this part and the containers 
marked as prescribed by Sec. 316.15 of this subchapter or unless it is

[[Page 353]]

identified and handled as prescribed by Sec. 325.11 (b) or (c) of this 
subchapter.

[54 FR 41049, Oct. 5, 1989]



Sec. 327.21  Inspection procedures for chilled fresh and frozen boneless 
manufacturing meat.

    (a) Definitions; sampling; standards. (1) Frozen boneless 
manufacturing meat is meat, frozen in the fresh state from cattle, 
sheep, swine, goats, horses, mules, or other equines that has all bone 
removed and is cut into pieces or trimmings, frozen into a compact block 
of any shape and suitable for slicing or chopping in the manufacturing 
of meat food products. As used in this section, the term ``frozen'' 
includes ``chilled fresh,'' and ``lot'' means any amount of frozen 
boneless manufacturing meat of one species, similarly packaged, shipped 
from one establishment, and offered for import inspection under one or 
more foreign inspection certificates.
    (2) Imported frozen boneless manufacturing meat shall be sampled as 
required by Sec. 327.6(a) of this part, and the samples defrosted for 
inspection. The Program import inspector, or in the case of Canadian 
product subject to procedures described in Sec. 327.5(d)(1), the 
Canadian representative will select from a lot the appropriate number of 
cartons specified by the table of sampling plans. The total sample for 
inspection will consist of the necessary number of 12-pound units drawn 
from these cartons. The 12-pound units selected will be completely 
defrosted and examined.
    (b) Lots refused entry. Reinspection (including resampling) will be 
provided for any lot of frozen boneless manufacturing meat which was 
refused entry under this section on the basis of the original evaluation 
of the sample thereof, upon appeal from the inspector's initial 
decision.

[35 FR 15610, Oct. 3, 1970, as amended at 49 FR 36819, Sept. 20, 1984; 
51 FR 44901, Dec. 15, 1986; 54 FR 275, Jan. 5, 1989; 57 FR 27906, June 
23, 1992]



Sec. 327.22  [Reserved]



Sec. 327.23  Compliance procedure for cured pork products offered for 
entry.

    (a) Definitions. For the purposes of this section:
    (1) A Product is that cured pork article which is contained within 
one Group as defined in paragraph (a)(2) of this section and which 
purports to meet the criteria for a single product designated under the 
heading ``Product Name and Qualifying Statements'' in the chart in Sec. 
319.104 or Sec. 319.105 of this subchapter.
    (2) A Product Group or a Group means one of the following:
    (i) Group I, consisting of cured pork products which have been 
cooked while imperviously encased. Any product that fits into the Group 
shall be placed in this Group regardless of any other considerations.
    (ii) Group II, consisting of cured pork products which have been 
water cooked. Any product that does not fit into Group I but does fit 
into Group II shall be placed into Group II regardless of any other 
considerations.
    (iii) Group III, consisting of boneless, smokehouse heated cured 
pork products. Any boneless product that does not fit into Group I or II 
shall be placed in Group III.
    (iv) Group IV, consisting of bone-in or semi-boneless smokehouse 
heated cured pork products. Any product that is not completely boneless 
or still contains all the bone which is traditional for bone-in product 
and does not fit into Group I, II, or III shall be placed in this Group.
    (3) Protein Fat-Free Percentage, Protein Fat-Free Content, PFF 
Percentage, PFF Content or PFF of a product means the meat protein 
(indigenous to the raw, unprocessed pork cut) content expressed as a 
percent of the non-fat portion of the finished product.
    (4) A PFF Standardized Difference is the PFF of the sample minus the 
minimum PFF requirement, set forth in Sec. 319.104 and Sec. 319.105 of 
this subchapter, for the product being analyzed, divided by the 
Appropriate Standard Deviation for the product group.
    (5) The Absolute Minimum PFF Requirement is that no laboratory 
result

[[Page 354]]

of an individual sample for PFF content be below the applicable minimum 
requirement of Sec. 319.104 or Sec. 319.105 of this subchapter by 2.3 
or more percentage points for a Group I or II product or 2.7 or more 
percentage points for a Group III or IV product.
    (6) A PFF Standardized Arithmetic Average of the Country's Products 
is the arithmetic average of PFF Standardized Differences from either 36 
or 100 consecutively sampled lots of product entering the United States 
from a given producing country.
    (7) A PFF Standardized Weighted Average of the Country's Products is 
an estimate of the average of the PFF Standardized Differences from 
either 36 or 100 consecutively sampled lots, adjusted for the size of 
the lot, of different types of cured pork product entering the United 
States from a given producing country. A Standardized Weighted Average 
is computed by multiplying the PFF Standardized Difference calculated 
for each lot by the number of pounds of product in each lot, adding 
those results together, and dividing the sum by the total weight of 
product from all the lots making up the average.
    (8) The Appropriate Standard Deviation is based on within lot 
variability. That assigned to Groups I and II = 0.75 percent PFF and 
that assigned to Groups III and IV = 0.91 percent PFF.
    (9) A Lot is all product of one type from one establishment 
presented by an importer as the unit for inspection at the Port of 
Entry.
    (b) Normal monitoring procedures. Except for product imported from 
Canada, the Department shall collect sample(s) of cured pork product on 
a random basis from lots offered for entry at the Port of Entry and, 
after analyzing the sample for fat and indigenous protein content, 
calculate the PFF percentage. The product shall not be held pending 
laboratory results during the monitoring phase. The PFF percentage for 
each sample shall be considered along with the cumulative results of 
prior samples to assess the effectiveness of a country's overall 
compliance program and to determine the course of action for subsequent 
lots of product.
    (1) Factors determining whether a country's inspection system is 
functioning adequately:
    (i) The PFF percentage for each sample must not be below the minimum 
PFF requirement by 2.3 percentage points for cured pork products in 
Groups I and II or 2.7 percentage points for cured pork products in 
Groups III and IV.
    (ii) Both of the PFF Standardized Averages, Arithmetic and Weighted, 
for the last 100 consecutive lots of all cured pork products from the 
country must be equal to or greater than zero. The count for the 100 
consecutive lots starts with the lots arriving from that country after 
April 15, 1985.
    (iii) Both of the PFF Standardized Averages, Arithmetic and 
Weighted, for the last 36 consecutive lots of all cured pork products 
from the country must be above the lowest 5 percent of the Normal 
distribution. This minimum value is minus 0.28 (-0.28) for the 
Arithmetic Average and depends on the production volume for the Weighted 
Average.
    (2) Actions when calculations indicate that processing procedures in 
a country are out-of-compliance:
    (i) If the PFF level of a sample taken during normal monitoring 
procedures is found to be as low as the Absolute Minimum PFF 
Requirement, the country of origin shall be notified; the lot involved 
shall be retained if still available in an official establishment or 
subject to detention or other actions pursuant to the Act; and all 
subsequently presented lots of that cured pork product from the same 
foreign establishment shall be held under retention until the provisions 
of paragraph (c) are satisfied.
    (ii) If either of the PFF Standardized Averages, Arithmetic or 
Weighted, for the last 100 consecutive lots falls below zero or either 
of the PFF Standardized Averages for the last 36 consecutive lots falls 
below the upper 95 percent of the Normal distribution, all available 
cured pork product from the foreign country shall be subject to 
administrative retention and all subsequently presented lots of cured 
pork product from the foreign country shall be held under retention 
until the provisions of paragraph (c) are satisfied. The country of

[[Page 355]]

origin shall be notified, and shall be subject to other actions pursuant 
to the Act.
    (c) Retention. When lots of cured pork product are under retention 
they shall be refused entry and reexported in accordance with Sec. 
327.13 of this subchapter unless they can be released in accordance with 
the provisions of paragraph (c)(1), establishments may be returned to 
normal monitoring procedures in accordance with paragraph (c)(2), and 
countries may be returned to normal monitoring procedures in accordance 
with paragraph (c)(3).
    (1) If a lot is subject to retention procedures under this section, 
the Department shall collect five randomly selected sample units from 
each lot and determine the PFF of each sample unit. The lot may be 
released into commerce if:
    (i) The average PFF percentage of the five randomly selected sample 
units is equal to or greater than the applicable minimum PFF percentage 
required by Sec. 319.104 or Sec. 319.105 of this subchapter, or
    (ii) The product is relabeled under the supervision of a program 
employee so that it conforms to the provisions of Sec. 319.104 or Sec. 
319.105 of this subchapter.
    (2) If product from a foreign establishment is subject to retention 
procedures under this section, the foreign establishment may be returned 
to normal monitoring procedures when:
    (i) Ten consecutively presented lots of that cured pork product from 
that establishment have been sampled as provided in paragraph (c)(1) of 
this section and the average of each set of five sample units 
representing each lot have been found to be equal to or greater than the 
required minimum PFF percentage; and
    (ii) The PFF percentage of each sample unit (50 in all) is above the 
Absolute Minimum PFF Percentage.
    (3) If a country is subject to retention procedures under this 
section, the country shall be returned to normal monitoring procedures 
when:
    (i) Twenty-five consecutively presented lots of cured pork product 
have been sampled as required in paragraph (c)(1) of this section and 
the average of each set of five sample units representing each lot have 
been found to be equal to or greater than the required minimum PFF 
percentage; and
    (ii) The PFF percentage of each sample unit (125 in all) is above 
the Absolute Minimum PFF Percentage; and
    (iii) Both of the PFF Standardized Averages for 36 consecutive lots 
are in the required percentage of the Normal distribution; and
    (iv) Both of the PFF Standardized Averages for 100 consecutive lots 
are zero or higher.
    (4) The sample units collected under retention procedures as 
provided in paragraph (c)(2) of this section will not be included in the 
PFF standardized averages for 36 and 100 consecutive lots.
    (d) Adulterated and Misbranded Products. Products not meeting 
specified PFF requirements, determined according to procedures set forth 
in this section, may be deemed adulterated under section 1(m)(8) of the 
Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act 
(21 U.S.C. 601(n)).
    (e) Activities requiring additional inspectional supervision, such 
as relabeling, shall be at the importer's expense. In addition, if the 
importer wishes, he or she may have samples analyzed at an accredited 
laboratory.

[50 FR 9792, Mar. 12, 1985, as amended at 54 FR 41049, Oct. 5, 1989]



Sec. 327.24  Appeals; how made.

    Any appeal from a decision of any program employee shall be made to 
his/her immediate supervisor having jurisdiction over the subject matter 
of the appeal, except as otherwise provided in the applicable rules of 
practice.

[51 FR 37707, Oct. 24, 1986, as amended at 60 FR 67456, Dec. 29, 1995]



Sec. 327.25  Disposition procedures for product condemned or ordered 
destroyed under import inspection.

    (a) Carcasses, parts thereof, meat and meat food products (other 
than rendered animal fats) that have been treated in accordance with the 
provisions of this section shall be considered denatured for the 
purposes of the regulations in this part, except as otherwise provided 
in part 314 of this subchapter for articles condemned at official 
establishments or at official import inspection establishments.

[[Page 356]]

    (1) The following agents are prescribed for denaturing carcasses, 
parts thereof, meat or meat food products which are affected with any 
condition that would result in their condemnation and disposal under 
part 314 of this subchapter if they were at an official establishment or 
at an official import inspection establishment: Crude carbolic acid; 
cresylic disinfectant; a formula consisting of 1 part FD&C green No. 3 
coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of 
citronella, or other proprietary substance approved by the Administrator 
in specific cases.\1\
---------------------------------------------------------------------------

    \1\ Information as to approval of any proprietary denaturing 
substance may be obtained from the Meat and Poultry Inspection Technical 
Services, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250.
---------------------------------------------------------------------------

    (2) Meat may be denatured by dipping it in a solution of 0.0625 
percent tannic acid, followed by immersion in a water bath, then dipping 
it in a solution of 0.0625 percent ferric acid; and except as provided 
in paragraphs (a) (3) and (5) of this section, the following agents are 
prescribed for denaturing other carcasses, parts thereof, meat and meat 
food products, for which denaturing is required by this part: FD&C green 
No. 3 coloring; FD&C blue No. 1 coloring; FD&C blue No. 2 coloring; 
finely powdered charcoal; or other proprietary substance approved by the 
Administrator in specific cases.\1\ Carcasses (other than viscera), 
parts thereof, cuts of meat, and unground pieces of meat darkened by 
charcoal or other black dyes shall be deemed to be denatured pursuant to 
this section only if they contain at least that degree of darkness 
depicted by diagram 1 of the Meat Denaturing Guide (MP Form 91).\2\
---------------------------------------------------------------------------

    \2\ Copies of MP Form 91 may be obtained, without charge, by writing 
to the Administrative Operations Branch, Food Safety and Inspection 
Service, U.S. Department of Agriculture, 123 East Grant Street, 
Minneapolis, Minnesota 55403. Diagrams 2 and 3 of the Meat Denaturing 
Guide are for comparison purposes only. The Meat Denaturing Guide has 
been approved for incorporation by reference by the Director, Office of 
the Federal Register, and is on file at the Federal Register Library.
---------------------------------------------------------------------------

    (3) Tripe may be denatured by dipping it in a 6 percent solution of 
tannic acid for 1 minute followed by immersion in a water bath, then 
immersing it for 1 minute in a solution of 0.022 percent FD&C yellow No. 
5 coloring.
    (4) When meat, meat byproducts, or meat food products are in ground 
form, 4 percent by weight of coarsely ground hard done, which shall be 
in pieces no smaller than the opening size specified for No. 5 mesh in 
the standards issued by the U.S. Bureau of Standards or 6 percent by 
weight of coarsely ground hard bone, which shall be in pieces no smaller 
than the opening size specified for No. 8 mesh in said Standards, 
uniformly incorporated with the product, may be used in lieu of the 
agents prescribed in paragraph (a)(2) of this section.
    (5) Before the denaturing agents are applied to articles in pieces 
more than 4 inches in diameter, the pieces shall be freely slashed or 
sectioned. (If the articles are in pieces not more than 4 inches in 
diameter, slashing or sectioning will not be necessary.) The application 
of any of the denaturing agents listed in paragraph (a) (1) or (2) of 
this section to the outer surface of molds or blocks or boneless meat, 
meat by-products, or meat food products shall not be adequate. The 
denaturing agent must be mixed intimately with all the material to be 
denatured, and must be applied in such quantity and manner that it 
cannot easily and readily be removed by washing or soaking. A sufficient 
amount of the appropriate agent shall be used to give the material a 
distinctive color, odor, or taste so that such material cannot be 
confused with an article of human food.
    (b) Inedible rendered animal fats shall be denatured by thoroughly 
mixing therein denaturing oil, No. 2 fuel oil, brucine dissolved in a 
mixture of alcohol and pine oil or oil of rosemary, finely powdered 
charcoal, or any proprietary denaturing agent approved for the purpose 
by the Administrator in specific cases. The charcoal shall be used in no 
less quantity than 100 parts per million and shall be of such character 
that it will remain suspended indefinitely in the liquid fat. Sufficient 
of the chosen identifying agents shall be used to give the rendered fat 
so distinctive a color, odor, or taste that it

[[Page 357]]

cannot be confused with an article of human food.

[51 FR 37707, Oct. 24, 1986]



Sec. 327.26  Official import inspection marks and devices.

    (a) When import inspections are performed in official import 
inspection establishments, the official inspection legend to be applied 
to imported meat and meat food products shall be in the appropriate form 
\1\ as herein specified.
---------------------------------------------------------------------------

    \1\ The number ``I-38'' is given as an example only. The 
establishment number of the official import inspecton establishment 
where the imported product is inspected shall be used in lieu thereof.
[GRAPHIC] [TIFF OMITTED] TC11SE91.023

    For application to cattle, sheep, swine, and goat carcasses, primal 
parts, and cuts, not in containers.
[GRAPHIC] [TIFF OMITTED] TC11SE91.024

    For application to outside containers of meat and meat food products 
prepared from cattle, sheep, swine, and goats.
[GRAPHIC] [TIFF OMITTED] TC11SE91.025

    For application to horse carcasses, primal parts, and cuts, not in 
containers.
[GRAPHIC] [TIFF OMITTED] TC11SE91.026

    For application to outside containers of horsemeat food products.
    [GRAPHIC] [TIFF OMITTED] TC11SE91.027
    
    For application to mule and other (nonhorse) equine carcasses, 
primal parts, and cuts, not in containers.

[[Page 358]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.028

    For application to outside containers of equine meat food products.
    (b) Except for product offered for entry from Canada, when import 
inspections are performed in official establishments the official 
inspection legend to be applied to meat and meat food products offered 
for entry shall be the appropriate form as specified in Sec. Sec. 312.2 
and 312.3 of this subchapter.
    (c) When products are refused entry into the United States, the 
official mark to be applied to the products refused entry shall be in 
the following form:
[GRAPHIC] [TIFF OMITTED] TC11SE91.029

    (d) Devices for applying ``United States Refused Entry'' marks shall 
be furnished to Program inspectors by the Department.
    (e) The ordering and manufacture of brands containing official 
inspection legends shall be in accordance with the provisions contained 
in Sec. 317.3(c) of the Federal meat inspection regulations.

[51 FR 37708, Oct. 24, 1986, as amended at 54 FR 41049, Oct. 5, 1989]



PART 329_DETENTION; SEIZURE AND CONDEMNATION; CRIMINAL OFFENSES--Table 
of Contents




Sec.
329.1 Article or livestock subject to administrative detention.
329.2 Method of detention; form of detention tag.
329.3 Notification of detention to the owner of the article or livestock 
          detained, or the owner's agent, and person having custody.
329.4 Notification of governmental authorities having jurisdiction over 
          article or livestock detained; form of written notification.
329.5 Movement of article or livestock detained; removal of official 
          marks.
329.6 Articles or livestock subject to judicial seizure and 
          condemnation.
329.7 Procedure for seizure, condemnation and disposition.
329.8 Authority for condemnation or seizure under other provisions of 
          law.
329.9 Criminal offenses.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 15617, Oct. 3, 1970, unless otherwise noted.



Sec. 329.1  Article or livestock subject to administrative detention.

    Any carcass, part of a carcass, meat or meat food product of 
livestock, or article exempted from the definition of meat food product, 
or any dead, dying, disabled, or diseased livestock is subject to 
detention for a period not to exceed 20 days when found by any 
authorized representative of the Secretary upon any premises where it is 
held for the purposes of, or during or after distribution in, commerce 
or it is otherwise subject to Title I or II of the Act, and there is 
reason to believe that:
    (a) Any such article is adulterated or misbranded and is capable of 
use as human food; or
    (b) Any such article has not been inspected, in violation of the 
provisions of Title I of the Act, any other Federal law, or the laws of 
any State or Territory, or the District of Columbia; or
    (c) Any such article or livestock has been or is intended to be, 
distributed in violation of the provisions of Title I of the Act, any 
other Federal law, or the laws of any State or Territory, or the 
District of Columbia.



Sec. 329.2  Method of detention; form of detention tag.

    An authorized representative of the Secretary shall detain any 
article or livestock to be detained under this

[[Page 359]]

part, by affixing an official ``U.S. Detained'' tag (FSIS Form 8400-2) 
to such article or livestock.

[55 FR 47842, Nov. 16, 1990]



Sec. 329.3  Notification of detention to the owner of the article or 
livestock detained, or the owner's agent, and person having custody.

    (a) When any article or livestock is detained under this part, an 
authorized representative of the Secretary shall:
    (1) Orally notify the immediate custodian of the article or 
livestock detained, and
    (2) Promptly furnish a copy of a completed ``Notice of Detention'' 
(FSIS Form 8080-1) to the immediate custodian of the detained article or 
livestock.
    (b) If the owner of the detained article or livestock, or the 
owner's agent, is not the immediate custodian at the time of detention 
and if the owner, or owner's agent, can be ascertained and notified, an 
authorized representative of the Secretary shall furnish a copy of the 
completed ``Notice of Detention'' to the owner or the owner's agent. 
Such copy shall be served, as soon as possible, by delivering the 
notification to the owner, or the owner's agent, or by certifying and 
mailing the notification to the owner, or the owner's agent, at his or 
her last known residence or principal office or place of business.

[55 FR 47842, Nov. 16, 1990]



Sec. 329.4  Notification of governmental authorities having jurisdiction 
over article or livestock detained; form of written notification.

    Within 48 hours after the detention of any livestock or article 
pursuant to this part, an authorized representative of the Secretary 
shall give oral or written notification of such detention to any Federal 
authorities not connected with the Program, and any State or other 
governmental authorities, having jurisdiction over such livestock or 
article. In the event notification is given orally, it shall be 
confirmed in writing, as promptly as circumstances permit.



Sec. 329.5  Movement of article or livestock detained; removal of 
official marks.

    (a) No article or livestock detained in accordance with the 
provisions in this part shall be moved by any person from the place at 
which it is located when so detained, until released by an authorized 
representative of the Secretary: Provided, That any such article or 
livestock may be moved from the place at which it is located when so 
detained, for refrigeration, freezing, or storage purposes if such 
movement has been approved by an authorized representative of the 
Secretary: And provided further, That the article or livestock so moved 
will be detained by an authorized representative of the Secretary after 
such movement until such time as the detention is terminated.
    (b) Upon terminating the detention of such article or livestock, an 
authorized representative of the Secretary shall:
    (1) Orally notify the immediate custodian of the released article or 
livestock, and
    (2) Furnish copies of a completed ``Notice of Termination of 
Detention'' (FSIS Form 8400-1) to the persons notified when the article 
or livestock was detained. The notice shall be served by either 
delivering the notice to such persons or by certifying and mailing the 
notice to such persons at their last known residences or principal 
offices or places of business.
    (c) All official marks may be required by such representative to be 
removed from such article or livestock before it is released unless it 
appears to the satisfaction of the representative that the article or 
livestock is eligible to retain such marks.

[35 FR 15617, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971; 39 
FR 36000, Oct. 7, 1974; 55 FR 47842, Nov. 16, 1990]



Sec. 329.6  Articles or livestock subject to judicial seizure and 
condemnation.

    Any carcass, part of a carcass, meat or meat food product, or any 
dead, dying, disabled, or diseased livestock, that is being transported 
in commerce or is otherwise subject to Title I or II of the Act, or is 
held for sale in the

[[Page 360]]

United States after such transportation, is subject to seizure and 
condemnation, in a judicial proceeding pursuant to section 403 of the 
Act if such article or livestock:
    (a) Is or has been prepared, sold, transported, or otherwise 
distributed or offered or received for distribution in violation of the 
Act, or
    (b) Is capable of use as human food and is adulterated or 
misbranded, or
    (c) In any other way is in violation of the Act.



Sec. 329.7  Procedure for seizure, condemnation, and disposition.

    Any article or livestock subject to seizure and condemnation under 
this part shall be liable to be proceeded against and seized and 
condemned, and disposed of, at any time, on an appropriate pleading in 
any United States district court, or other proper court specified in 
section 404 of the Act, within the jurisdiction of which the article or 
livestock is found.



Sec. 329.8  Authority for condemnation or seizure under other provisions 
of law.

    The provisions of this part relating to seizure, condemnation and 
disposition of articles or livestock do not derogate from authority for 
condemnation or seizure conferred by other provisions of the Act, or 
other laws.



Sec. 329.9  Criminal offenses.

    The Act contains criminal provisions with respect to numerous 
offenses specified in the Act, including but not limited to bribery of 
Program employees, receipt of gifts by Program employees, and forcible 
assaults on, or other interference with, Program employees while engaged 
in, or on account of, the performance of their official duties under the 
Act.



PART 331_SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; AND 
FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH AND FOR 
SUCH DESIGNATED ESTABLISHMENTS--Table of Contents




Sec.
331.1 Definition of ``State.''
331.2 Designation of States under paragraph 301(c) of the Act.
331.3 States designated under paragraph 301(c) of the Act; application 
          of regulations.
331.4 Control and disposal of non-federally-inspected products in States 
          designated under paragraph 301(c) of the Act.
331.5 Criteria and procedure for designating establishments with 
          operations which would clearly endanger the public health; 
          disposition of products; application of regulations.
331.6 Designation of States under section 205 of the Act; application of 
          sections of the Act and the regulations.

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 35 FR 19667, Dec. 29, 1970, unless otherwise noted.



Sec. 331.1  Definition of ``State''.

    For purposes of this part, the term ``State'' means any State 
(including the Commonwealth of Puerto Rico) or organized Territory.



Sec. 331.2  Designation of States under paragraph 301(c) of the Act.

    Each of the following States has been designated, under paragraph 
301(c) of the Act, as a State in which the provisions of Titles I and IV 
of the Act shall apply to operations and transactions wholly within such 
State. The Federal provisions apply, effective on the dates shown below:

------------------------------------------------------------------------
                                                  Effective date of
                   State                       application of Federal
                                                     provisions
------------------------------------------------------------------------
Alaska....................................  July 31, 1999.
Arkansas..................................  June 1, 1981.
California................................  Apr. 1, 1976.
Colorado..................................  July 1, 1975.
Connecticut...............................  Oct. 1, 1975.
Florida...................................  Dec. 2, 1997.
Guam......................................  Jan. 21, 1972.
Hawaii....................................  Nov. 1, 1995.
Idaho.....................................  July 1, 1981.
Kentucky..................................  Jan. 14, 1972.
Maryland..................................  March 31, 1991
Massachusetts.............................  Jan. 12, 1976.
Michigan..................................  Oct. 3, 1981.

[[Page 361]]

 
Nebraska..................................  Oct. 1, 1971.
Nevada....................................  July 1, 1973.
New Hampshire.............................  Aug. 6, 1978.
New Jersey................................  July 1, 1975.
New York..................................  July 16, 1975.
Northern Mariana Islands..................  Oct. 29, 1979.
Oregon....................................  July 1, 1972.
Pennsylvania..............................  July 17, 1972.
Puerto Rico...............................  June 18, 1971.
Rhode Island..............................  Oct. 1, 1981.
Tennessee.................................  Oct. 1, 1975.
Virgin Islands of the U.S.................  Nov. 27, 1971.
Washington................................  June 1, 1973.
------------------------------------------------------------------------


[35 FR 19667, Dec. 29, 1970]

    Editorial Note: For Federal Register citations affecting Sec. 
331.2, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 331.3  States designated under paragraph 301(c) of the Act; 
application of regulations.

    The provisions of the regulations in this subchapter apply to 
operations and transactions wholly within each State designated in Sec. 
331.2 under paragraph 301(c) of the Act, except as otherwise provided in 
this section. (The provisions of the regulations apply in all respects 
to operations and transactions in or for commerce.)
    (a) Each establishment located in such a designated State shall be 
granted inspection required under Sec. 302.1(a)(2) of this subchapter 
only if it is found, upon a combined evaluation of its premises, 
facilities, and operating procedures, to be capable of producing 
products that are not adulterated or misbranded.
    (b) Section 305.2 of this subchapter will apply to establishments 
required to have inspection under Sec. 302.1(a)(2) of this subchapter, 
except that existing interconnections between official and unofficial 
establishments will be permitted if it is determined in specific cases 
that the interconnections are such that transfer of inedible product 
into the official establishment would be difficult or unusual, and any 
such transfers are strictly prohibited, except as permitted under other 
provisions of this subchapter. It is essential that separation of 
facilities be maintained to the extent necessary to assure that inedible 
product does not enter the official establishment contrary to the 
regulations in this subchapter.
    (c) Sections 416.2(c), (d), (e), (f), and (h) of this chapter shall 
apply to such establishments.
    (d) Section 314.2 of this subchapter shall apply to such 
establishments, except that a separate room or compartment need not be 
provided for inedible products if they can be handled so that they do 
not create insanitary conditions in any room or compartment used for 
edible products or otherwise render any edible products adulterated and 
do not interfere with the conduct of inspection. For example, 
intestines, paunch contents, feet, and hides might be accumulated on the 
kill floor in clean, watertight drums with close fitting covers if there 
is sufficient space to store them out of the way until the close of the 
day's operation.
    (e) Sections 316.7, 317.3, and 317.4 of this subchapter shall apply 
to such establishments, except as provided in this paragraph (e).
    (1) The operator of each such establishment shall, prior to the 
inauguration of inspection, identify all labeling and marking devices in 
use, or proposed for use (upon the date of inauguration of inspection) 
to the circuit supervisor of the circuit in which the establishment is 
located. Temporary approval, pending formal approval under Sec. Sec. 
316.7, 317.3, and 317.4 of this subchapter, will be granted by the 
circuit supervisor for labeling and marking devices that he determines 
are neither false nor misleading, provided the official inspection 
legend bearing the official establishment number is applied to the 
principal display panel of each label, either by a mechanical printing 
device or a self-destructive pressure sensitive sticker, and provided 
the label shows the true product name, an accurate ingredient statement, 
the name and address of the manufacturer, packer, or distributor, and 
any other features required by paragraph 1(n) of the Act.
    (2) The circuit supervisor will forward one copy of each item of 
labeling and a description of each marking device for which he has 
granted temporary approval to the Washington, DC, office of the Labeling 
and Packaging Staff and will retain one copy in

[[Page 362]]

a temporary approval file for the establishment.
    (3) The operator of the official establishment shall promptly 
forward a copy of each item of labeling and a description of each 
marking device for which temporary approval has been granted by the 
circuit supervisor (showing any modifications required by the circuit 
supervisor) to the Labels and Packaging Staff, Meat and Poultry 
Inspection, Food Safety and Inspection Service, USDA, Washington, DC 
20250, accompanied by the formula and details of preparation and 
packaging for each product. Within 90 days after inauguration of 
inspection, all labeling material and marking devices temporarily 
approved by the circuit supervisor must receive approval as required by 
Sec. Sec. 316.7, 317.3, and 317.4, of this subchapter or their use must 
be discontinued.
    (4) The circuit supervisor will also review all shipping containers 
to insure that they do not have any false or misleading labeling and are 
otherwise not misbranded. Modifications of unacceptable information on 
labeling material by the use of self-destructive pressure sensitive tape 
or by blocking out with an ink stamp will be authorized on a temporary 
basis to permit the maximum allowable use of all labeling materials on 
hand. All unaccept able labeling material which is not modified to 
comply with the requirements of this subchapter must be destroyed or 
removed from the official establishment.
    (f) Sections 320.1, 320.2, 320.3, 320.4, 320.5, 325.20, and 325.21 
apply to operations and transactions not in or for commerce in a State 
designated under paragraph 301(c) only if the State is also designated 
under section 205 of the Act and if such provisions are applicable as 
shown in Sec. 331.6.
    (g) Section 321.1(a) of this subchapter will not apply to States 
designated under paragraph 301(c) of the Act.
    (h) Parts 322 and 327 and Sec. 325.3 of this subchapter relating to 
exports and imports do not apply to operations and transactions solely 
in or for intrastate commerce.
    (i) Part 325 of this subchapter will apply to establishments 
required to have inspection under Sec. 302.1(a)(2) of this subchapter 
and to operations and transactions solely in or for intrastate commerce, 
except as provided in paragraphs (h) and (j) of this section.
    (j) Sections 325.4, 325.15, and 325.1(b) of this subchapter will not 
apply to require a certificate, or evidence thereof, for the 
distribution solely within any designated State of products that are 
U.S. inspected and passed and so marked.

[35 FR 19667, Dec. 29, 1970, as amended at 36 FR 12004, June 24, 1971; 
41 FR 18089, Apr. 30, 1976; 62 FR 45026, Aug. 25, 1997; 64 FR 56416, 
Oct. 20, 1999]



Sec. 331.4  Control and disposal of non-federally-inspected products 
in States designated under paragraph 301(c) of the Act.

    Upon the effective date of designation of a State under paragraph 
301(c) of the Act, no products can be prepared within the State unless 
they are prepared under inspection pursuant to the regulations in this 
subchapter or are exempted from the requirement of inspection under 
Sec. 303.1 of this subchapter, and no unexempted products which were 
prepared without any inspection can lawfully be distributed within the 
State. For a period of 90 days from the effective date of such 
designation, products which were prepared and inspected and passed under 
the supervision of a responsible State or local inspection agency can be 
distributed solely within the State, provided they are not adulterated 
or misbranded, except that the official inspection legend is not 
required. Within the 90-day period, products that have been inspected by 
the State or local inspection agency may be further prepared and 
otherwise handled in official establishments required to have inspection 
under Sec. 302.1(a)(2) of this subchapter or at establishments exempted 
from the requirements of such inspection under Sec. 303.1 of this 
subchapter, and may be distributed as provided in this section but 
otherwise shall be handled in accordance with Sec. 305.4 of this 
subchapter. Such products shall not bear any [Federal] official 
inspection legends. After said 90-day period, only federally inspected 
and passed products may be distributed within the designated State, 
except as provided in Sec. 303.1 of this subchapter.

[[Page 363]]



Sec. 331.5  Criteria and procedure for designating establishments with 
operations which would clearly endanger the public health; disposition 
of products; application of regulations.

    (a) An establishment preparing products solely for distribution 
within any State shall be designated as one producing adulterated 
products which would clearly endanger the public health, if:
    (1) Any meat or meat food product prepared at the establishment is 
adulterated in any of the following respects:
    (i) It bears or contains a pesticide chemical, food additive, or 
color additive, that is ``unsafe'' within the meaning of sections 408, 
409, or 706 of the Federal Food, Drug, and Cosmetic Act or was 
intentionally subjected to radiation in a manner not permitted under 
section 409 of said Act; or if it bears or contains any other added 
poisonous or added deleterious substance which may render it injurious 
to health or make it unfit for human food; or
    (ii) It consists in whole or in part of any filthy, putrid, or 
decomposed substance or is for any other reason unsound, unhealthful, or 
unwholesome or otherwise unfit for human food (for example, it was 
prepared from meat or other ingredients exhibiting spoilage 
characteristics; or it is, or was prepared from, a carcass affected with 
a disease transmissible to humans and its condemnation would be required 
under part 309 or 310 of the Federal Meat Inspection regulations (9 CFR 
parts 309, 310) at federally inspected establishments; or it is a ready-
to-eat pork product which has not been treated to destroy trichinae as 
prescribed in Sec. 318.10 of this subchapter for products at federally 
inspected establishments); or
    (iii) It has been prepared, packed or held under insanitary 
conditions whereby it may have become contaminated with filth or may 
have been rendered injurious to health (for example if insects or vermin 
are not effectively controlled at the establishments, or insanitary 
water is used in preparing meat or meat food products for human food); 
or
    (iv) It is, in whole or in part, the product of an animal that died 
otherwise than by slaughter; or
    (v) Its container is composed, in whole or in part, of any poisonous 
or deleterious substance which may render the contents injurious to 
health; and
    (2) Such adulterated articles are intended to be or are distributed 
from the establishment while capable of use as human food.
    (b) When any such establishment is identified by a Program Inspector 
as one producing adulterated product, which would clearly endanger 
public health under the criteria in paragraph (a) of this section, the 
following procedure will be followed:
    (1) The Program Inspector will informally advise the operator of the 
establishment concerning the deficiencies found by him and report his 
findings to the appropriate Regional Director for the Program. When it 
is determined by the Regional Director that any establishment preparing 
products solely for distribution within any State is producing 
adulterated products for distribution within such State which would 
clearly endanger the public health, written notification thereof will be 
issued to the appropriate State officials, including the Governor of the 
State and the appropriate Advisory Committee, for effective action under 
State or local law to prevent such endangering of the public health. 
Such written notification shall clearly specify the deficiencies deemed 
to result in the production of adulterated products and shall specify a 
reasonable time for such action under State or local law.
    (2) If effective action is not taken under State or local law within 
the specified time, written notification shall be issued by the Regional 
Director to the operator of the establishment, specifying the 
deficiencies involved and allowing him ten days to present his views or 
make the necessary corrections, and notifying him that failure to 
correct such deficiencies may result in designation of the establishment 
and operator thereof as subject to the provisions of titles I and IV of 
the Act as though engaged in commerce.

[[Page 364]]

    (3) Thereafter the Program Inspector shall survey the establishment 
and designate it if he determines, in consultation with the Regional 
Director, that it is producing adulterated products, which would clearly 
endanger the public health, and formal notice of such designation will 
be issued to the operator of the establishment by the Regional Director.
    (c) Products on hand at the time of designation of an establishment 
under this section are subject to detention, seizure and condemnation in 
accordance with part 329 of this subchapter: Provided, That products 
that have been federally inspected and so identified and that have not 
been further prepared at any nonfederally inspected establishment may be 
released for distribution if the products appear to be not adulterated 
or misbranded at the time of such release.
    (d) No establishment designated under this section can lawfully 
prepare any products unless it first obtains inspection or qualifies for 
exemption under Sec. 303.1 of this subchapter. All of the provisions of 
the regulations shall apply to establishments designated under this 
section, except that the exceptions provided for in Sec. 331.3 of this 
part shall apply to such establishments.



Sec. 331.6  Designation of States under section 205 of the Act; 
application of sections of the Act and the regulations.

    Each of the following States has been designated, effective on the 
date shown below, under section 205 of the Act, as a State in which the 
provisions of the sections of the Act and regulations specified below 
shall apply to operators engaged, other than in or for commerce, in the 
kinds of business indicated below:

----------------------------------------------------------------------------------------------------------------
                                                                                              Effective date of
 Sections of act and regulations          Classes of operators                 State             designation
----------------------------------------------------------------------------------------------------------------
Act, section 202; Sec. Sec. Persons engaged (not in or for      Alaska..............  July 31, 1999.
 320.1, 320.2, 320.3, and 320.4.    commerce) in (1) the business of   Arkansas............  Mar. 29, 1982.
                                    slaughtering any livestock or      California..........  Apr. 1, 1976.
                                    preparing, freezing, packaging or  Colorado............  July 1, 1975.
                                    labeling any livestock carcasses   Connecticut.........  Oct. 1, 1975.
                                    or parts or products thereof, for  Guam................  Nov. 19, 1976.
                                    use as human food or animal food;  Idaho...............  Mar. 29, 1982.
                                    (2) the business of buying or      Kentucky............  Apr. 18, 1973.
                                    selling (as a meat broker,         Maryland............  Mar. 31, 1991.
                                    wholesaler, or otherwise),         Massachusetts.......  Jan. 12, 1976.
                                    transporting or storing any        Michigan............  Mar. 29, 1982.
                                    livestock carcasses or parts or    Nebraska............  Jan. 31, 1975.
                                    products thereof; or (3) business
                                    as a renderer, or in the business
                                    of buying, selling, or
                                    transporting any dead, dying,
                                    disabled, or diseased livestock
                                    or parts of carcasses of any
                                    livestock that died otherwise
                                    than by slaughter.
                                   ..................................  Nevada..............  Jan. 31, 1975.
                                                                       New Hampshire.......  Oct. 29, 1979.
                                                                       New Jersey..........  July 1, 1975.
                                                                       New York............  July 16, 1975.
                                                                       Northern Mariana      Oct. 29, 1979.
                                                                        Islands.
                                                                       Oregon..............  Jan. 31, 1975.
                                                                       Pennsylvania........  May 2, 1974.
                                                                       Puerto Rico.........  Nov. 19, 1976.
                                                                       Rhode Island........  Mar. 29, 1982.
                                                                       Tennessee...........  Oct. 1, 1975.
                                                                       Virgin Islands......  Nov. 19, 1976.
                                                                       Washington..........  Jan. 31, 1975.
Act, 203; Sec. 320.5...........  Persons engaged (not in or for      Alaska..............  July 31, 1999.
                                    commerce) in business as a meat    Arkansas............  Mar. 29, 1982.
                                    broker; renderer; animal food      California..........  Apr. 1, 1976.
                                    manufacturer; wholesaler or        Colorado............  July 1, 1975.
                                    public warehouseman of livestock   Connecticut.........  Oct. 1, 1973.
                                    carcasses, or parts or products    Guam................  Nov. 19, 1976.
                                    thereof; or buying, selling, or    Idaho...............  Mar. 29, 1982.
                                    transporting any dead, dying,      Kentucky............  Apr. 18, 1976.
                                    disabled, or diseased livestock,   Maryland............  Mar. 31, 1991.
                                    or parts of carcasses of any such  Massachusetts.......  Jan. 12, 1975.
                                    livestock that dies otherwise
                                    than by slaughter.
                                                                       Michigan............  Mar. 29, 1982.
                                                                       Nebraska............  Jan. 31, 1975.
                                                                       Nevada..............  Jan. 31, 1975.
                                                                       New Hampshire.......  Oct. 29, 1979.
                                                                       New Jersey..........  July 1, 1975.

[[Page 365]]

 
                                                                       New York............  July 16, 1973.
                                                                       Northern Mariana      Oct. 29, 1979.
                                                                        Islands.
                                                                       Oregon..............  Jan. 31, 1974.
                                                                       Pennsylvania........  May 2, 1975.
                                                                       Puerto Rico.........  Nov. 19, 1976.
                                                                       Rhode Island........  Mar. 29, 1982.
                                                                       Tennessee...........  Oct. 1, 1975.
                                                                       Virgin Islands......  Nov. 19, 1976.
                                                                       Washington..........  Jan. 31, 1975.
Act, 204; Sec. Sec. 325.20 and  Persons engaged (not in or for      Alaska..............  July 31, 1999.
 325.21.                            commerce) in the business of       Arkansas............  Mar. 29, 1982.
                                    buying, selling or transporting    Connecticut.........  Oct. 1, 1975.
                                    any dead, dying, disabled or       Guam................  Nov. 19, 1976.
                                    diseased animals, or parts of      Idaho...............  Mar. 29, 1982.
                                    carcasses of any animals that      Kentucky............  Apr. 18, 1973.
                                    died otherwise than by slaughter.  Maryland............  Mar. 31, 1991.
                                                                       Massachusetts.......  Jan. 12, 1976.
                                                                       Michigan............  Mar. 29, 1982.
                                                                       Nevada..............  Jan. 31, 1975.
                                                                       New Hampshire.......  Oct. 29, 1979.
                                                                       New Jersey..........  July 1, 1975.
                                                                       New York............  July 16, 1975.
                                                                       Northern Mariana      Oct. 29, 1979.
                                                                        Islands.
                                                                       Oregon..............  Jan. 31, 1975.
                                                                       Pennsylvania........  May 2, 1974.
                                                                       Puerto Rico.........  Nov. 19, 1976.
                                                                       Rhode Island........  Mar. 29, 1982.
                                                                       Virgin Islands......  Nov. 19, 1976.
                                                                       Washington..........  Jan. 31, 1975.
----------------------------------------------------------------------------------------------------------------


[35 FR 19667, Dec. 29, 1970]

    Editorial Note: For Federal Register citations affecting Sec. 
331.6, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



PART 335_RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE FEDERAL 
MEAT INSPECTION ACT--Table of Contents




    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



                      Subpart A_Criminal Violations

    Authority: Sec. 406, Pub. L. 99-641, 100 Stat. 3571; 21 U.S.C. 606 
note.

[42 FR 10960, Feb. 25, 1977. Redesignated at 64 FR 66545, Nov. 29, 1999]



Sec. 335.40  Opportunity for presentation of views before report of 
criminal violations.

    (a) Except as provided in paragraphs (a)(1) through (5) of this 
section, before any violation of the Federal Meat Inspection Act is 
reported to the Department of Justice by the Secretary for criminal 
prosecution the Secretary must give reasonable notice to the suspected 
violator that the Secretary intends to report the violation for 
prosecution and give the suspected violator an opportunity to present 
the violator's views to the Secretary with respect to such proceeding.
    (1) Notice and opportunity need not be provided if the Secretary has 
any reason to believe that providing such notice and opportunity could 
result in the alteration or destruction of evidence, or where disclosure 
could result in injury to persons or property.
    (2) Notice and opportunity need not be provided if the Secretary has 
any reason to believe that providing such notice and opportunity could 
result in flight of a suspected violator to avoid prosecution.
    (3) Notice and opportunity need not be provided if the Secretary has 
any reason to believe that providing such notice and opportunity could 
result in compromising special investigative

[[Page 366]]

techniques, such as undercover or other covert operations.
    (4) Notice and opportunity need not be provided when the impending 
criminal referral involves suspicion of bribery and related offenses, or 
clandestine slaughtering and/or processing operations.
    (5) Notice and opportunity need not be provided when the impending 
referral is part of an investigation involving non-Act violations, and 
the Act and non-Act violations are jointly referred for prosecution.
    (b) A notice of opportunity to present views will be sent by 
registered or certified mail, summarize the violations that constitute 
the basis of the contemplated prosecution, and describe the procedures 
for presentation of views. Any information given by a respondent, orally 
or in writing, shall become part of the Department's official record 
concerning the matter. The Department is under no obligation to disclose 
evidence to the suspected violator.

[52 FR 13828, Apr. 27, 1987]



PART 350_SPECIAL SERVICES RELATING TO MEAT AND OTHER PRODUCTS--Table 
of Contents




Sec.
350.1 Meaning of words.
350.2 Definitions.
350.3 Types and availability of service.
350.4 [Reserved]
350.5 Application for service.
350.6 Denial or withdrawal of service.
350.7 Fees and charges.
350.8 Scope and applicability of rules of practice.

    Authority: 7 U.S.C. 1622, 1624; 7 CFR 2.17, 2.55.

    Source: 23 FR 9982, Dec. 23, 1958, unless otherwise noted. 
Redesignated at 30 FR 4195, Mar. 31, 1965, and further redesignated at 
35 FR 15554, Oct. 3, 1970.



Sec. 350.1  Meaning of words.

    Words used in this part in the singular form shall be deemed to 
import the plural, and vice versa, as the case may demand.



Sec. 350.2  Definitions.

    For the purposes of the regulations in this part, unless the context 
otherwise requires, the following terms shall be construed, 
respectively, to mean:
    (a) Department. The United States Department of Agriculture.
    (b) Service. The Food Safety and Inspection Service of the 
Department.
    (c) Administrator. The Administrator of the Service or any officer 
or employee of the Department to whom authority has heretofore been 
delegated, or to whom authority may hereafter be delegated, to act in 
his stead.
    (d) [Reserved]
    (e) Inspector. Any officer or employee of the Department authorized 
to perform any duties under the regulations in this part.
    (f) Person. Any individual, corporation, company, association, firm, 
partnership, society, or joint stock company, or other organized group 
of any of the foregoing.
    (g) Federally inspected and passed. Inspected and passed under the 
Meat Inspection Act, as amended (21 U.S.C. 71 et seq.) or under the 
provisions in paragraphs 306 (b) and (c) of the Tariff Act of 1930 (19 
U.S.C. 1306 (b) and (c)).
    (h) Official establishment. An establishment operated under Federal 
meat inspection pursuant to the Meat Inspection Act, as amended (21 
U.S.C. 71 et seq.).
    (i) Food article. Any article of human food derived wholly or in 
part from meat, meat byproducts, or meat food products, which is not 
subject to the Federal meat inspection laws, and animal casings, for 
which the mark of Federal meat inspection is requested: Provided, That 
such articles and casings are derived from federally inspected and 
passed carcasses.
    (j) [Reserved]
    (k) Secretary. The Secretary of Agriculture of the United States, or 
any officer or employee of the Department to whom authority has 
heretofore been delegated, or may hereafter be delegated, to act in his 
stead in connection with the function involved.

[23 FR 9982, Dec. 23, 1958, as amended at 25 FR 9642, Oct. 7, 1960; 30 
FR 258, Jan. 9, 1965. Redesignated and amended at 30 FR 4195, Mar. 31, 
1965; 32 FR 6021, Apr. 15, 1967; 32 FR 13115, Sept. 15, 1967. Further 
redesignated at 35 FR 15554, Oct. 3, 1970, and amended at 43 FR 11147, 
Mar. 17, 1978; 54 FR 1329, Jan. 13, 1989]

[[Page 367]]



Sec. 350.3  Types and availability of service.

    Upon application in accordance with Sec. 350.5 the following types 
of service may be furnished under the regulations in this part:
    (a) Identification service. (1) Meat or other product that is 
federally inspected and passed at an official establishment, or upon 
importation, under the meat inspection laws, is officially marked to 
identify it as federally inspected and passed. In order to facilitate 
the division of such meat or other product into smaller portions or its 
combination into larger units and still maintain its identity as product 
which has been federally inspected and passed and so marked, inspectors 
may supervise the handling of the product and mark such portions or 
units with the marks of Federal inspection when they determine that the 
identity has been maintained.
    (2) At the time service is furnished product must be sound, 
wholesome and fit for human food. The service will be available only on 
premises other than those of an official establishment. The sanitation 
of the plant or area where service is furnished must comply with 
applicable provisions of part 416, Sec. Sec. 416.1 through 416.6 of 
this chapter.
    (3) The mark of inspection shall be applied only under the immediate 
supervision of an inspector.
    (4) The service will be available for products moved in tank cars 
and tank trucks from an official establishment or from a location 
operating under this service only if such tank cars or tank trucks bear 
a label before leaving such official establishment or such other 
location, in accordance with 9 CFR Sec. Sec. 316.14 and 317.2.
    (b) Certification service. At the request of a purchaser, supplier, 
exporter, or others, inspectors may make certification regarding 
livestock products for human food purposes (including casings), to be 
exported, as meeting conditions or standards that are not imposed or are 
in addition to those imposed by the regulations in parts 301 through 331 
of this chapter and the laws under which such regulations were issued.
    (c) Food inspection service. An inspection and certification service 
for wholesomeness relating to the manufacture of a food article may be 
furnished upon application. All applicable provisions of this chapter 
shall apply to the preparation, labeling and certification of the food 
article prepared under this food inspection service.
    (d) [Reserved]

[25 FR 9642, Oct. 7, 1960, as amended at 30 FR 258, Jan. 9, 1965. 
Redesignated at 30 FR 4195, Mar. 31, 1965, and amended at 30 FR 8675, 
July 9, 1965. Further redesignated at 35 FR 15554, Oct. 3, 1970, and 
amended at 38 FR 29215, Oct. 23, 1973; 53 FR 28634, July 29, 1988; 54 FR 
1329, Jan. 13, 1989; 64 FR 56416, Oct. 20, 1999; 65 FR 2284, Jan. 14, 
2000]



Sec. 350.4  [Reserved]



Sec. 350.5  Application for service.

    Any person who desires to receive service under the regulations in 
this part for meat or other product eligible therefor under such 
regulations may make application for service to the Administrator, upon 
an application form which will be furnished by the Administrator upon 
request.

(Approved by the Office of Management and Budget under control number 
0583-0036)

[23 FR 9982, Dec. 23, 1958. Redesignated at 30 FR 4195, Mar. 31, 1965, 
and at 35 FR 15554, Oct. 3, 1970, and amended at 47 FR 746, Jan. 7, 
1982]



Sec. 350.6  Denial or withdrawal of service.

    (a) If any person has applied for service for meat or other product 
not eligible therefor under the regulations in this part, or has failed 
to make proper application for service or to pay fees and charges due 
for service furnished or to be furnished to him under the regulations in 
this part, or if the service cannot be furnished to any person applying 
therefor because of lack of available inspectors or other administrative 
reasons, the service may be denied to such person by the Administrator 
until the condition justifying such denial is corrected.
    (b) Service under the regulations in this part may also be denied to 
any person by the Secretary for such period as he may deem proper, if it 
is determined, after opportunity for hearing

[[Page 368]]

before a proper official in the Department, that such person has been 
responsible for any willful misrepresentation to the Department 
concerning any meat or other product for which service has been 
requested under the regulations, in this part, or that such person has 
been responsible for the use without authority, or the imitation, of any 
marks or certificates of Federal meat inspection on or with respect to 
any meat or other product, or has otherwise been responsible for any 
fraudulent or deceptive practice with respect to such service, or that 
such person has interfered with or obstructed any inspector in the 
performance of his duties under the regulations in this part, or 
attempted to do so. When the Administrator determines that the public 
interest so requires, he may deny or withdraw service provided for in 
this part, without a hearing, pending final determination of the matter. 
The applicant or recipient of service involved shall be notified of the 
Administrator's decision to deny or suspend service and the reasons 
therefor, in writing, in the manner prescribed in Sec. 1.147(b) of the 
rules of practice (7 CFR 1.147(b)), or orally. The Administrator's 
decision to deny or suspend the service shall be effective upon such 
oral or written notification, whichever is earlier, to the applicant or 
recipient of service. If such notification is oral, the Administrator 
shall confirm such decision and the reasons therefor, in writing, as 
promptly as circumstances permit, and such written confirmation shall be 
served upon the applicant or recipient of service, in the manner 
prescribed in Sec. 1.147(b) of the rules of practice (7 CFR 1.147(b)). 
In other cases prior to the institution of proceedings for denial of 
service under this paragraph, the facts or conduct which may warrant 
such action shall be called to the attention of the person involved, in 
writing, and he shall be given an opportunity to demonstrate or achieve 
compliance with all applicable requirements.

[23 FR 9982, Dec. 23, 1958; 25 FR 9642, Oct. 7, 1960. Redesignated at 30 
FR 4195, Mar. 31, 1965, and 35 FR 15554, Oct. 3, 1970, and amended at 43 
FR 11147, Mar. 17, 1978]



Sec. 350.7  Fees and charges.

    (a) Fees and charges for service under the regulations in this part 
shall be paid by the applicant for the service in accordance with this 
section, and, if required by the Administrator, the fees and charges 
shall be paid in advance.
    (b) The fees and charges provided for in this section shall be paid 
by check, draft, or money order payable to the Treasurer of the United 
States and shall be remitted promptly to the Administrator upon 
furnishing to the applicant of a statement as to the amount due.
    (c) The fees to be charged and collected for service under the 
regulations in this part shall be at the rates specified in Sec. Sec. 
391.2, 391.3, and 391.4 respectively for base time; for overtime 
including Saturdays, Sundays, and holidays; and for certain laboratory 
services which are not covered under the base time, overtime, and/or 
holiday costs. Such fees shall cover the costs of the service and shall 
be charged for the time required to render such services. Where 
appropriate, this time will include, but will not be limited to, the 
time required for travel of the inspector or inspectors in connection 
therewith during the regularly scheduled administrative workweek.
    (d) Charges may also be made to cover the cost of travel and other 
expenses incurred by the Service in connection with the furnishing of 
the service.

[23 FR 9982, Dec. 23, 1958, as amended at 53 FR 13397, Apr. 22, 1988; 54 
FR 6389, Feb. 10, 1989]



Sec. 350.8  Scope and applicability of rules of practice.

    The rules of practice of the Department of Agriculture in subpart H 
of part I, subtitle A, title 7 of the Code of Federal Regulations, are 
the rules of practice applicable to adjudicatory, administrative 
proceedings under the regulations in this part (9 CFR part 350).

[43 FR 11147, Mar. 17, 1978]

[[Page 369]]



PART 351_CERTIFICATION OF TECHNICAL ANIMAL FATS FOR EXPORT--Table of 
Contents




                               Definitions

Sec.
351.1 Meaning of words.
351.2 Terms defined.

                     Scope of Certification Service

351.3 Kind of service.

       Procedure for Obtaining Service: Administration of Program

351.4 Application for certification service.
351.5 Conditions of eligibility for certification service; review of 
          applications.
351.6 Official number.
351.7 Administration of certification service program.

                                  Fees

351.8 Charges for surveys of plants.
351.9 Charges for examinations.

                        Facilities and Operations

351.10 Facilities.
351.11 Identification and separation of technical animal fats for 
          certification and materials for use therein; removal of 
          wrappers, etc.; cleaning of equipment.
351.12 Circuit supervisor to be informed when plant operates.
351.13 Inspectors to have access to certified plants at all times.
351.14 Processes to be supervised; extent of examinations.
351.15 Reports of violations.

    Transportation and Exportation of Certified Technical Animal Fat

351.16 Certificate required for shipments of technical animal fat.
351.17 Identification required.

                              Prohibitions

351.18 Official identifications; unauthorized use.

                           Remedies; Penalties

351.19 Refusal of certification for specific lots.
351.20 Withdrawal of service from certified plants.

                                 Appeals

351.21 Appeals.

                           Records and Reports

351.22 Certified plants to maintain records and make reports; access to 
          records.

    Authority: 7 U.S.C. 1622, 1624; 7 CFR 2.17 (g) and (i), 2.55.

    Source: 40 FR 58627, Dec. 18, 1975, unless otherwise noted.

                               Definitions



Sec. 351.1  Meaning of words.

    Words used in this part in the singular form shall be deemed to 
import the plural, and vice versa, as the case may demand.



Sec. 351.2  Terms defined.

    When used in this part, unless the context otherwise requires:
    (a) Department means the United States Department of Agriculture.
    (b) Program means the Meat and Poultry Inspection Program of the 
Food Safety and Inspection Service of the Department.
    (c) Administrator means the Administrator of the Food Safety and 
Inspection Service of the Department, or any officer or employee of the 
Department to whom authority has heretofore been delegated or may 
hereafter be delegated to act in his stead.
    (d) Circuit supervisor means an employee of the Program assigned to 
supervise and perform official work in a circuit. Such employee is 
assigned by and reports directly to the Administrator or person 
designated by him.
    (e) Inspector means an employee of the Program or a cooperating 
State.
    (f) Circuit means one or more inspected plants assigned to a circuit 
supervisor.
    (g) Recognized State means any State not designated in Sec. 331.2 
of this chapter.
    (h) Cooperating State means any State cooperating under Sec. 351.7 
in administration of the regulations in this part.
    (i) Inspection means ante-mortem and post-mortem inspection by 
Program inspectors or inspectors of a Meat Inspection Service of a 
recognized State.
    (j) Animals means cattle, sheep, swine, goats, horses, mules and 
other equines.
    (k) Technical animal fat means animal fat eligible for exportation, 
or storage for exportation, in accordance with Sec. 325.11 of this 
chapter.
    (l) Certified technical animal fat means technical animal fat 
certified for export or storage for export under the regulations in this 
part.
    (m) Tallow means technical animal fat with a minimum titre of 40 
[deg]C.

[[Page 370]]

    (n) Certified plant means any plant or storage facility preparing or 
storing certified technical animal fat for export, or for transfer to 
another certified plant or storage facility for ultimate export, and at 
which certification service is provided under the regulations in this 
part.
    (o) Inspected and Passed means inspected and passed under the 
Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or the meat 
inspection laws of a recognized State.

                     Scope of Certification Service



Sec. 351.3  Kind of service.

    (a) Certification, in the form set forth in paragraph (b), is 
available under the regulations in this part for specific lots of 
technical animal fat for export, if the fat was rendered from materials 
derived from carcasses, or parts of carcasses, that had been inspected 
and passed and came from animals that did not die otherwise than by 
slaughter under inspection. The certification will be made by a Program 
employee when he determines, upon the basis of examinations made by him 
or other inspectors, as provided in Sec. 351.14, and information 
obtained by him or them from the exporter or other sources, as provided 
in the regulations in this part, that the technical animal fat is 
eligible for certification under this section and therefore the 
statements to be certified are correct. The service will be available 
upon a voluntary fee basis in accordance with said regulations.
    (b)(1) The form of Certificate for Export of Technical Animal Fats 
is as follows:
[GRAPHIC] [TIFF OMITTED] TC11SE91.030

    (2) Certified technical animal fat may be described on the 
certificate as ``technical animal fat''; or if it is tallow, it may be 
described on the certificate as ``Tallow'' and the description may 
include the statement ``titre not less than 40 [deg]C.''

       Procedure for Obtaining Service: Administration of Program



Sec. 351.4  Application for certification service.

    Application for certification service under the regulations in this 
part may

[[Page 371]]

be made to the Administrator by the operator of any rendering plant or 
storage facility at which technical animal fat is prepared or stored for 
export. In case of a change of ownership or change of location, a new 
application shall be made. Applications shall be made on forms \1\  
available from the Administrator and provide all information called for 
thereon relating to the identity of the applicant and the plant, and the 
nature of the plant operations, and a certification of specified facts 
and an agreement to comply with specified requirements.
---------------------------------------------------------------------------

    \1\ Copy filed as part of the original document.

(Approved by the Office of Management and Budget under control number 
---------------------------------------------------------------------------
0583-0036)

[40 FR 58627, Dec. 18, 1975, as amended at 47 FR 746, Jan. 7, 1982]



Sec. 351.5  Conditions of eligibility for certification service; review 
of applications.

    (a) To be eligible for certification service under the regulations 
in this part, the operator of a rendering plant must demonstrate that:
    (1) He operates a rendering plant which will receive materials 
derived from inspected and passed carcasses, or parts of carcasses, of 
animals that did not die otherwise than by slaughter under inspection, 
(i.e., not ``dead animals''); and such source materials will be rendered 
at the plant into technical animal fat eligible for export, or storage 
for export, in accordance with the regulations in this part;
    (2) The source materials and the rendered technical animal fat 
described in paragraph (a)(1) will be identified and kept separated at 
all times from other products; and
    (3) He will comply with the applicable regulations in this part.
    (b) To be eligible for certification service under the regulations 
in this part, the operator of a storage facility must demonstrate that:
    (1) He operates a storage facility that will receive for storage 
certified technical animal fat shipped directly from a certified 
rendering plant for storage for export and he will keep such shipments 
identified and separated from other products that are not certified, and 
he will receive such fat only if it is accompanied by MP Form 85, as 
required by Sec. 351.17.
    (2) He will comply with the applicable regulations in this part.
    (c) Each applicant for certification service must file with the 
Administrator, with the application for service, a written description 
of the procedures to be used for receiving, identifying, processing, 
storing, and otherwise handling technical animal fat, and materials for 
use in the preparation thereof, at the plant or storage facility 
involved, and for shipping technical animal fat from the plant or 
facility and storing and exporting such technical animal fat, and a 
written description of the shipping, receiving, and inventory records 
maintained for technical animal fat.
    (d) The Administrator will determine, on the basis of all 
information available to him, whether the arrangements at the plant or 
storage facility are such as will assure that certifications of 
technical animal fat will be correct, and, if so, will grant the 
application for certification service. An applicant will be given an 
opportunity to present his views prior to refusal of the service.

(Approved by the Office of Management and Budget under control number 
0583-0036)

[40 FR 58627, Dec. 18, 1975, as amended at 41 FR 12637, Mar. 26, 1976; 
47 FR 746, Jan. 7, 1982]



Sec. 351.6  Official number.

    The Administrator will assign a certified technical animal fat plant 
number to each plant granted service. Such number shall be preceded by 
the letter ``C'' and be used to identify all certified technical animal 
fat prepared or stored by the plant.



Sec. 351.7  Administration of certification service program.

    (a) The regulations in this part shall be administered by the 
circuit supervisor for the jurisdiction in which is located the 
certified plant or plants for which application for certification 
service is made, and such assistants as may be necessary will be 
assigned by the Administrator.
    (b) The Administrator may enter into a cooperative agreement with 
any recognized State for the conduct by State

[[Page 372]]

employees of any surveys, examinations, and other activities involved in 
the administration of the regulations in this part. However, 
certifications under these regulations may be issued only by Program 
employees, as provided in Sec. 351.3.

                                  Fees



Sec. 351.8  Charges for surveys of plants.

    Applicants for the certification service shall pay the Department 
for salary costs at the rates specified in Sec. Sec. 391.2 and 391.3 
respectively for base time, and for overtime, travel, and per diem 
allowances at rates currently allowed by the Federal Travel Regulations, 
and other expenses incidental to the initial survey of the rendering 
plants or storage facilities for which certification service is 
requested.

[54 FR 6389, Feb. 10, 1989]



Sec. 351.9  Charges for examinations.

    (a) The fees to be charged and collected by the Administrator for 
examination shall be at the rates specified in Sec. Sec. 391.2, 391.3, 
and 391.4 respectively for base time; for overtime including Saturdays, 
Sundays, and holidays, as provided for in Sec. 351.14; and for certain 
laboratory services which are not covered under the base time, overtime, 
and/or holiday costs and which are required to determine the eligibility 
of any technical animal fat for certification under the regulations in 
this Part. Such fees shall be charged for the time required to render 
such service, including, but not limited to, the time required for the 
travel of the inspector or inspectors in connection therewith.
    (b) Charges may also be made to cover the actual cost of travel and 
per diem allowance at rates currently allowed by the General Services 
Administration, and other expenses incurred by the Department in 
connection with such examinations and laboratory service.

[40 FR 58627, Dec. 18, 1975, as amended at 53 FR 13397, Apr. 22, 1988; 
54 FR 6389, Feb. 10, 1989]

                        Facilities and Operations



Sec. 351.10  Facilities.

    (a) Facilities for the preparation, identification, and storage of 
the technical animal fat to be certified shall be furnished and 
maintained by the certified plant in accordance with this section.
    (b) The operator of the certified plant shall provide at the plant, 
rooms, compartments, and equipment needed to maintain the identity of 
certified technical animal fats and materials used in their preparation, 
and separation of such articles from other products. Such rooms, 
compartments, and equipment shall be conspicuously marked with the 
phrase ``Certified Technical Animal Fat'' whenever they contain these 
fats.



Sec. 351.11  Identification and separation of technical animal fats 
for certification and materials for use therein; removal of wrappers, 
etc.; cleaning of equipment.

    (a) All technical animal fat to be offered for certification under 
this part and materials to be used in the preparation of such fat, and 
all certified technical animal fat, shall be identified and kept 
separate from other products from the time of receipt at a certified 
plant and throughout processing or handling at such plant. All wrappers 
and packaging shall be removed from the source materials to the fullest 
extent practicable before the materials are rendered at the plant.
    (b) If a plant's operations are within the provisions of Sec. 
351.14(b)(3), all equipment shall be cleaned before it is used for 
receiving, preparation, or storage of certified technical animal fats or 
material to be used in preparation of such fats. Such cleaning shall be 
done in such manner as to prevent contamination of such certified fats 
or source material with materials that are unacceptable under Sec. 
351.3.



Sec. 351.12  Circuit supervisor to be informed when plant operates.

    The operator of each certified plant shall inform the circuit 
supervisor, in advance, when the plant's work schedule will include 
preparing technical

[[Page 373]]

animal fats for certification and identify the approximate days and 
hours when operations will begin and end.



Sec. 351.13  Inspectors to have access to certified plants at all times.

    For the purpose of administering the regulations in this part, 
inspectors shall have access at all times by day or night to every part 
of a certified plant.



Sec. 351.14  Processes to be supervised; extent of examinations.

    (a) All processes used in the preparation of certified technical 
animal fats at any certified plant shall be subject to supervision by an 
inspector. Certified plants shall not prepare any technical animal fat 
for certification under the regulations in this part, except in 
accordance with such regulations.
    (b) Supervision, ranging from full-time coverage of an entire 
process to one or more reviews per month, to determine a plant's 
compliance with the regulations in this part will be maintained. A 
circuit supervisor may increase the frequency of reviews whenever he 
deems necessary to assure the validity of certifications under the 
regulations in this part. Usual coverage of individual rendering plants 
will be as follows:
    (1) Coverage shall be at least once a month if the plant 
consistently handles only raw materials acceptable under Sec. 351.3 for 
the preparation of certified technical animal fat and the plant 
operator, in writing, certifies that he is maintaining this procedure.
    (2) Coverage shall be at least once a week if the plant consistently 
handles some raw materials that are acceptable, and some that are 
unacceptable, under Sec. 351.3, for the preparation of certified 
technical animal fat, uses separate equipment for processing, and uses 
separate rooms, compartments, and equipment for receiving and storing 
the respective types of raw materials and technical animal fats, and the 
plant operator, in writing, certifies that he is maintaining this 
complete physical separation procedure.
    (3) Coverage shall be fulltime during receiving of raw materials and 
their preparation into certified technical animal fat, if the plant 
handles some raw materials that are acceptable, and some that are 
unacceptable, under Sec. 351.3, for the preparation of certified 
technical animal fat, and uses the same rooms, compartments, and 
equipment, with only time separation between receiving, processing, and 
storing the respective types of raw materials and technical animal fats.



Sec. 351.15  Reports of violations.

    Inspectors shall report to the circuit supervisor any apparent 
violations of the regulations in this part or the Federal Meat 
Inspection Act or regulations thereunder (subchapter A of this chapter) 
which occur at certified plants, or elsewhere, within their knowledge. 
The circuit supervisor shall report such actions to the Administrator 
through appropriate channels.

    Transportation and Exportation of Certified Technical Animal Fat



Sec. 351.16  Certificate required for shipments of technical animal fat.

    No certified plant shall export any certified technical animal fat 
unless the shipment is accompanied by a certificate issued under Sec. 
351.3.



Sec. 351.17  Identification required.

    Certified technical animal fats being exported directly from a 
certified plant or transferred between certified plants for storage for 
export are subject to the requirements of Sec. 325.11 of this chapter. 
In addition, such shipments between certified plants shall be 
accompanied by MP Form 85 (Declaration to Accompany Technical Animal 
Fats Between Certified Technical Animal Fat Plants) \2\ prepared by the 
operator of the certified plant from which shipment is made, certifying 
that the product has been obtained by rendering raw materials derived 
from federally or State inspected and passed carcasses, or parts of 
carcasses. Technical animal fat described on MP Form 85 as tallow must 
meet the definition of ``Tallow'' in Sec. 351.2.
---------------------------------------------------------------------------

    \2\ Copy filed as part of the original document.

---------------------------------------------------------------------------

[[Page 374]]

                              Prohibitions



Sec. 351.18  Official identifications; unauthorized use.

    (a) The form of certification set forth in Sec. 351.3 and the term 
``Certified Technical Animal Fat'' are official identifications for 
purposes of the Agricultural Marketing Act of 1946, as amended, and 
shall not be falsely made, issued, altered, forged, or counterfeited, or 
used for purpose of misrepresentation or deception.
    (b) No container which bears or is to bear any designation as 
certified technical animal fat shall be filled in whole or in part, 
except with technical animal fats which have been certified and 
identified in compliance with this part.

                           Remedies; Penalties



Sec. 351.19  Refusal of certification for specific lots.

    If an inspector has reason to believe that a lot of technical animal 
fat is ineligible for certification under Sec. 351.3, or any materials 
to be used in a lot of technical animal fat would make the technical 
animal fat ineligible for such certification, certification of the lot 
shall be withheld pending final determination by the circuit supervisor. 
The operator of the plant shall be afforded an opportunity to 
demonstrate the eligibility of the lot for certification before the 
final determination is made.



Sec. 351.20  Withdrawal of service from certified plants.

    (a) After opportunity for hearing has been accorded the operator of 
a certified plant, the certification service, provided for in this part, 
may be withdrawn from such plant in accordance with the applicable rules 
of practice, if it is determined that:
    (1) The operator, or his employee or agent:
    (i) Has made any willful misrepresentation or engaged in any 
fraudulent or deceptive practice in connection with the service;
    (ii) Has interfered with or obstructed any Program employee or other 
inspector in the performance of his duties, under the regulations in 
this part, by intimidation, threats, or other improper means; or
    (iii) Has violated section 203(h) of the Agricultural Marketing Act 
of 1946, as amended (7 U.S.C. 1622(h)), or any regulation in this part; 
or
    (2) Facilities or procedures at the certified plant do not conform 
to the arrangements approved by the Administrator under Sec. 351.5.
    (b) Pending final determination of the matter, the Administrator may 
summarily suspend the certification service at any certified plant when 
he has reason to believe that there is cause for withdrawal of the 
service under paragraph (a). The operator of the certified plant shall 
be notified of the Administrator's decision to suspend summarily the 
certification service at such plant and the reasons therefor, in 
writing, in the manner prescribed in Sec. 1.147(b) of the rules of 
practice (7 CFR 1.147(b)), or orally. The Administrator's decision to 
suspend summarily the certification service shall be effective upon such 
oral or written notification, whichever is earlier, to the operator of 
the certified plant. If such notification is oral, the Administrator 
shall confirm such decision, and the reasons therefor, in writing, as 
promptly as circumstances permit, and such written confirmation shall be 
served upon the operator of the certified plant, in the manner 
prescribed in Sec. 1.147(b) of the rules of practice (7 CFR 1.147(b)).
    (c) The rules of practice of the Department of Agriculture in 
subpart H of part I, subtitle A, title 7 of the Code of Federal 
Regulations, are the rules of practice applicable to adjudicatory, 
administrative proceedings under the regulations in this part (9 CFR 
part 351).

[40 FR 58627, Dec. 18, 1975, as amended at 43 FR 11148, Mar. 17, 1978]

                                 Appeals



Sec. 351.21  Appeals.

    Any decision by an employee of the Program may be appealed by any 
adversely affected person to the immediate supervisor of such employee. 
Decisions of other inspectors may be appealed to the circuit supervisor.

[[Page 375]]

                           Records and Reports



Sec. 351.22  Certified plants to maintain records and make reports; 
access to records.

    (a) Each day a certified plant prepares, receives, or ships 
certified technical animal fat or receives material for use in such 
product, the operator of the plant shall prepare records identifying the 
kinds and quantities of such materials and technical animal fats 
received, the number of pounds of certified technical animal fat 
prepared or shipped, and an up-to-date inventory of certified technical 
animal fats in storage. The operator of each certified plant shall 
include in the records required by this section all MP Forms 85 which he 
receives with shipments of certified technical animal fat from any other 
certified plant. These records shall be maintained by the operator of 
each certified plant and made available to an inspector, upon request, 
for examination and copying, for a period of 1 year after the date of 
the transaction involved.
    (b) The operator of each certified plant shall provide such relevant 
information as any inspector may request to enable him to determine 
whether any technical animal fats are eligible for certification and 
whether the plant is eligible for certification service under the 
regulations in this part.

(Approved by the Office of Management and Budget under control number 
0583-0036)

[40 FR 58627, Dec. 18, 1975, as amended at 47 FR 746, Jan. 7, 1982]



PART 352_EXOTIC ANIMALS; VOLUNTARY INSPECTION--Table of Contents




Sec.
352.1 Definitions.
352.2 Type of service available.
352.3 Application by official exotic animal establishment for inspection 
          service.
352.4 Application for ante-mortem inspection service in the field.
352.5 Fees and charges.
352.6 Denial or withrawal of inspection service.
352.7 Marking inspected products.
352.8 Time of inspection in the field and in an official exotic animal 
          establishment.
352.9 Report of inspection work.
352.10 Ante-mortem inspection.
352.11 Post-mortem inspection.
352.12 Disposal of diseased or otherwise adulterated carcasses and 
          parts.
352.13 Handling and disposal of condemned or other inedible exotic 
          animal products at official exotic animal establishments.
352.14 Entry into official establishments; reinspection and preparation 
          of products.
352.15 Records, registration and reports.
352.16 Exports.
352.17 Transportation.
352.18 Cooperation of States in Federal programs.

    Authority: 7 U.S.C. 1622, 1624; 7 CFR 2.17 (g) and (i), 2.55.

    Source: 50 FR 41847, Oct. 16, 1985, unless otherwise noted.



Sec. 352.1  Definitions.

    The definitions in Sec. 301.2, not otherwise defined in this part, 
are incorporated into this part. In addition to those definitions, the 
following definitions will be applicable to the regulations in this 
part.
    (a) Act means the applicable provisions of the Agricultural 
Marketing Act of 1946, as amended (60 Stat. 1087, as amended; 7 U.S.C. 
1621 et seq.).
    (b) Acceptable means suitable for the purpose intended and 
acceptable to the Food Safety and Inspection Service.
    (c) Antelope means any animal belonging to the antelope family.
    (d) Applicant means any interested party who requests any inspection 
service.
    (e) Bison means any American bison or catalo or cattalo.
    (f) Buffalo means any animal belonging to the buffalo family.
    (g) Catalo or Cattalo means any hybrid animal with American bison 
appearance resulting from direct crossbreeding of American bison and 
cattle.
    (h) Condition means any condition, including, but not limited to, 
the state of preservation, cleanliness, or soundness of any product or 
the processing, handling, or packaging which may affect such product.
    (i) Condition and wholesomeness means the condition of any product, 
its healthfulness and fitness for human food.
    (j) Deer means any member of the deer family.
    (k) Exotic animal means any reindeer, elk, deer, antelope, water 
buffalo or bison.
    (l) Elk means any American elk.

[[Page 376]]

    (m) Exotic animal inspection service means the personnel who are 
engaged in the administration, application, and direction of exotic 
animal inspection programs and services pursuant to the regulations in 
this part.
    (n) Exotic animal producer means any interested party that engages 
in the raising and/or marketing of an exotic animal for commercial 
purposes.
    (o) Field ante-mortem inspection means the ante-mortem inspection of 
an exotic animal away from the official exotic animal establishment's 
premises.
    (p) Field designated area means any designated area on the 
applicant's premises, approved by the Regional Director, where field 
ante-mortem inspection is to be performed.
    (q) Identify means to apply official identification to products or 
containers.
    (r) Inspection means any inspection by an inspector to determine, in 
accordance with regulations in this part, (1) the condition and 
wholesomeness of an exotic animal, or (2) the condition and 
wholesomeness of edible product of an exotic animal at any state of the 
preparation or packaging in the official plant where inspected and 
certified, or (3) the condition and wholesomeness of any previously 
inspected and certified product of an exotic animal if such product has 
not lost its identity as an inspected and certified product.
    (s) Interested party means any person financially interested in a 
transaction involving any inspection.
    (t) Official exotic animal establishment means any slaughtering, 
cutting, boning, curing, smoking, salting, packing, rendering, or 
similar establishment at which inspection is maintained under the 
regulations in this part.
    (u) Official device means a stamping appliance, branding device, 
stencil printed label, or any other mechanically or manually operated 
tool that is approved by the Administrator for the purpose of applying 
any official mark or other identification to any product or packaging 
material.
    (v) Official identification means any symbol, stamp, label or seal 
indicating that the product has been officially inspected and/or 
indicating the condition of the product approved and authorized by the 
Administrator to be affixed to any product, or affixed to or printed on 
the packaging material of any product.
    (w) Program means the Voluntary Exotic Animal Inspection Program of 
the Food Safety and Inspection Service.
    (x) Reindeer means any reindeer commonly referred to as caribou.
    (y) Transport vehicle means any vehicle used to transport an exotic 
animal.
    (z) Veterinarian means an authorized veterinarian of the Program 
employed by the Department or any cooperating State who is authorized by 
the Secretary to do any work or perform any duty in connection with the 
Program.
    (aa) Water buffalo means any Asiatic water buffalo, commonly 
referred to as carabao; and the water buffalo of India, commonly 
referred to as the Indian buffalo.

[54 FR 1330, Jan. 13, 1989]



Sec. 352.2  Type of service available.

    Upon application, in accordance with Sec. 352.3, Sec. 352.4, and 
Sec. 352.5, the following type of service may be furnished under the 
regulations in this part:
    (a) Voluntary Inspection Service. An inspection and certification 
service for wholesomeness relating to the slaughter and processing of 
exotic animals and the processing of exotic animal products. All 
provisions of this part shall apply to the slaughter of exotic animals, 
and the preparation, labeling, and certification of the exotic animal 
meat and exotic animal products processed under this exotic animal 
inspection service.
    (b) Only exotic animals which have had ante-mortem inspection as 
described under this part and which are processed in official exotic 
animal establishments in accordance with this part may be marked 
inspected and passed.
    (c) Exotic animals, exotic animal meat and meat food products shall 
be handled in an official exotic animal establishment to ensure 
separation and identity of the exotic animal or exotic animal meat and 
meat food products until they are shipped from the official exotic 
animal establishment to prevent commingling with other species.

[54 FR 1330, Jan. 13, 1989]

[[Page 377]]



Sec. 352.3  Application by official exotic animal establishment for 
inspection services.

    (a) Any person desiring to process an exotic animal, exotic animal 
carcasses, exotic animal meat and meat food products in an establishment 
under exotic animal inspection service must receive approval of such 
establishment and facilities as an official exotic animal establishment 
prior to the rendition of such service. An application for inspection 
service to be rendered in an official exotic animal establishment shall 
be approved in accordance with the provisions contained in Sec. Sec. 
304.1 and 304.2 of subchapter A of this chapter.
    (b) Initial survey. When an application has been filed for exotic 
animal inspection service, the Regional Director or designee, shall 
examine the establishment, premises, and facilities.

[54 FR 1331, Jan. 13, 1989]



Sec. 352.4  Application for ante-mortem inspection service in the field.

    Any exotic animal producer desiring field ante-mortem exotic animal 
inspection service must receive approval of the field ante-mortem 
designated area from the Regional Director or designee prior to the 
rendition of such service. An application seeking approval of the 
designated area for ante-mortem inspection shall be obtained from the 
Regional Director, and completed and submitted to the Regional Director.
    (a) An initial application for field ante-mortem exotic animal 
inspection service shall be made by an official exotic animal 
establishment to the Regional Director. Subsequent requests shall be 
made by the official exotic animal establishment on behalf of an exotic 
animal producer to the Regional Director in one of the following 
manners: (1) telephone, (2) telegraph, (3) mail, or (4) in person as 
determined by the Regional Director.
    (b) Upon receipt of the completed application, the Regional Director 
or designee shall examine the field ante-mortem designated area and 
facilities for approval of the designated area.
    (c) All fees involved for the approval of the designated area, 
including but not limited to any travel, per diem costs, and time 
required to perform such approval services, shall be paid directly by 
the applicant to the Regional Director.

[54 FR 1331, Jan. 13, 1989]



Sec. 352.5  Fees and charges.

    (a) Fees and charges for service under the regulations in this part 
shall be paid by the applicant for the service in accordance with this 
section.
    (b) The fees and charges provided for in this section shall be paid 
by check, draft, or money order payable to the ``Treasurer of the United 
States'' and shall be remitted promptly to the Regional Director upon 
furnishing to the applicant a statement as to the amount due.
    (c) The fees to be charged and collected for service under the 
regulations in this part shall be at the rates specified in Sec. Sec. 
391.2, 391.3, and 391.4 respectively for base time; for overtime 
including Saturdays, Sundays, and holidays; and for certain laboratory 
services which are not covered under the base time, overtime, and/or 
holiday costs. Such fees shall cover the costs of the service and shall 
be charged for the time required to render such service, including, but 
not limited to, the time required for the travel of the inspector or 
inspectors in connection therewith during the regularly scheduled 
administrative workweek.
    (d) Charges may also be made to cover other expenses incurred by the 
Service in connection with the furnishing of the service.
    (e) Fees and charges for any inspection pursuant to a cooperative 
agreement with any State shall be paid in accordance with the terms of 
such cooperative agreement.

[50 FR 41847, Oct. 16, 1988, as amended at 53 FR 13398, Apr. 22, 1988; 
54 FR 6390, Feb. 10, 1989]



Sec. 352.6  Denial or withdrawal of inspection service.

    (a) For miscellaneous reasons. An application or a request for 
service may be rejected, or the benefits of the service may be otherwise 
denied to, or withdrawn from, any person, without a hearing by the 
appropriate Regional Director: (1) for administrative reasons

[[Page 378]]

such as the nonavailability of personnel to perform the service; (2) for 
the failure of payment for service; (3) in case the application or 
request relates to exotic animals or exotic animal products which are 
not eligible for service under this part; (4) for failure to maintain 
the designated area or the plant in a state of repair approved by the 
Service; (5) for the use of operating procedures which are not in 
accordance with the regulations of this part; (6) for alterations of 
buildings, facilities, or equipment which cannot be approved under the 
regulations in this part. Notice of such rejection, denial, or 
withdrawal, and the reasons therefore, shall promptly be given to the 
person involved. The applicant or recipient shall be notified of such 
decision to reject an application or request for service or to deny or 
withdraw the benefits of the service, and the reasons therefor, in 
writing in the manner prescribed in Sec. 1.147(b) of the rules of 
practice (7 CFR 1.147(b)), or orally. Such decision shall be effective 
upon such oral or written notification, whichever is earlier, to the 
applicant or recipient. If such notification is oral, the person making 
such decision shall confirm such decision, and the reasons therefor, in 
writing, as promptly as circumstances permit, and such written 
confirmation shall be served upon the applicant or recipient in the 
manner prescribed in Sec. 1.147(b) of the rules of practice (7 CFR 
1.147(b)).
    (b) For disciplinary reasons--Basis for denial or withdrawal. An 
application or request for service may be denied, or the benefits of the 
service may be withdrawn from, any person or entity who, or whose 
officer, employee or agent in the scope of his employment or agency: (1) 
Has willfully made any misrepresentation or has committed any other 
fraudulent or deceptive practice in connection with any application or 
request for service under this part; (2) has given or attempted to give, 
as a loan or for any other purpose, any money, favor or other thing of 
value, to any employee or agent of the Department or a cooperating State 
authorized to perform any function under this part; (3) has interfered 
with or obstructed, or attempted to interfere with or to obstruct, any 
employee or agent of the Department or cooperating State in the 
performance of his or her duties under this part by intimidation, 
threats, assaults, abuse, or any other improper means; (4) has knowingly 
represented that any exotic animal carcass, or exotic animal product, 
has been officially inspected and passed by an authorized inspector 
under this part, when it had not, in fact, been so inspected; (5) has 
been convicted of more than one misdemeanor under any law based upon the 
acquiring, handling, or distributing of adulterated, mislabeled, or 
deceptively packaged good, or fraud in connection with transactions in 
food, or any felony; Provided, an application or a request for service 
made in the name of a person or entity otherwise eligible for service 
under the regulations may be denied, or the benefits of the service may 
be withdrawn, from such a person or entity in case the service is or 
would be performed at a location operated by a person or entity, from 
whom the benefits of the service are currently being denied or have been 
withdrawn under this part; or by a person or entity having an officer, 
director, partner, manager or substantial investor from whom the 
benefits of service under this part are currently being denied or have 
been withdrawn under this part, and who has any authority with respect 
to the location where service is or would be performed; or in case the 
service is or would be performed with respect to any exotic animal or 
exotic animal product in which any person or entity, from whom the 
benefits of service are currently being denied or have been withdrawn 
under this part, has contract or other financial interest.
    (c) Procedure. (1) An application or request for service may be 
denied or benefits of the service may be withdrawn by the Secretary, as 
provided by paragraph (b) of this section, after notice and opportunity 
for hearing before a designated official of the Department. The 
Administrator may suspend service under this paragraph without hearing, 
pending final determination of the matter, when he determines that the 
public health, interest or safety so requires. The applicant or 
recipient shall

[[Page 379]]

be notified of the Administrator's decision to suspend service, and the 
reasons therefor, in writing or orally. The Administrator's decision to 
suspend service under this part shall be effective upon such an oral or 
written notification, whichever is earlier, to the applicant or 
recipient. If such notification is oral, the Administrator shall confirm 
such decision, and the reasons therefor, in writing, as promptly as 
circumstances permit, and such written confirmation shall be served upon 
the applicant or recipient in the manner prescribed in 1.147(b) of 
Departmental rules of practice (7 CFR 1.147(b)).
    (2) The written notification specified in paragraph (c) of this 
section, which shall constitute the complaint in the proceeding, shall 
briefly set forth the reason for the denial or withdrawal of service, 
including allegations of fact which constitute a basis for the action. 
After the complaint is served upon the respondent, as provided in Sec. 
1.147(b) of Departmental rules of practice (7 CFR 1.147(b)), the 
proceeding shall thereafter be conducted in accordance with rules of 
practice which shall be adopted for the proceeding.

[50 FR 41847, Oct. 16, 1985, as amended at 54 FR 1331, Jan. 13, 1989]



Sec. 352.7  Marking inspected products.

    Wording and form of inspection mark. Except as otherwise authorized 
by the Administrator, the inspection mark applied to inspected and 
passed exotic animal carcasses, meat or meat food products under this 
part shall include wording as follows: ``Inspected and Passed by U.S. 
Department of Agriculture.'' This wording shall be contained within a 
triangle in the form and arrangement shown in this section. The 
establishment number of the official establishment shall be included in 
the triangle unless it appears elsewhere on the packaging material. 
Ordering and manufacture of the triangle brand shall be in accordance 
with the provisions in 9 CFR 317.3(c) of the Federal meat inspection 
regulations. The Administrator may approve the use of abbreviations of 
such inspection mark, and such approved abbreviations shall have the 
same force and effect as the inspection mark. The inspection mark or 
approved abbreviation shall be applied, under the supervision of the 
inspector, to the inspected and passed edible product, packaging 
material, immediate container or shipping container. When the inspection 
mark or approved abbreviation is used on packaging material, immediate 
container or shipping container, it shall be printed on such material or 
container or on a label to be affixed to the packaging material or 
container. The name and address of the packer or distributor of such 
product shall be printed on the packaging material or label. The 
inspection marks may be stenciled on the container, and when the 
inspection mark is so stenciled, the name and address of the packer or 
distributor may be applied by the use of a stencil or rubber stamp. The 
name and address of the packer or distributor, if prominently shown 
elsewhere on the packaging material or container, may be omitted from 
insert labels which bear an official identification if the applicable 
establishment number is shown.
    (a) The inspection mark to be applied to inspected and passed 
carcasses and parts of carcasses of an exotic animal, and products as 
therefrom approved by the Administrator, shall be in the form and 
arrangement as indicated in the example below.\1\ The establishment 
number of the official establishment shall be set forth if it does not 
appear on the packaging material or container.
---------------------------------------------------------------------------

    \1\ The number ``38'' is given as an example only. The establishment 
number of the official exotic animal establishment where the product is 
prepared shall be used in lieu thereof.
---------------------------------------------------------------------------

    (1) For application to exotic animal carcasses, primal parts and 
cuts therefrom, exotic animal livers, exotic animal tongues, and exotic 
animal hearts.

[[Page 380]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.031

    (2) For application to exotic animal calf carcasses.
    [GRAPHIC] [TIFF OMITTED] TC11SE91.032
    
    (3) For application to exotic animal tails.
    [GRAPHIC] [TIFF OMITTED] TC11SE91.033
    
    (4) For application to burlap, muslin, cheesecloth, heavy paper, or 
other acceptable material that encloses carcasses or parts of carcasses.
[GRAPHIC] [TIFF OMITTED] TC11SE91.034

    (b) The official inspection mark to be shown on all labels.\1\ (1) 
For inspected and passed products of an exotic animal shall be in the 
following form, except that it need not be of the size illustrated, 
provided that it is a sufficient size and of such color as to be 
conspicuously displayed and readily legible and the same proportions of 
letter size and boldness are maintained as illustrated:
---------------------------------------------------------------------------

    \1\ The number ``38'' is given as an example only. The establishment 
number of the official exotic animal establishment where the product is 
prepared shall be used in lieu thereof.
[GRAPHIC] [TIFF OMITTED] TC11SE91.035

    (2) This official mark shall be applied by mechanical means and 
shall not be applied by a hand stamp.

[[Page 381]]

    (3) The official inspection legend described in paragraph (b)(1) of 
this section shall also be used on shipping containers, bond labels, 
artificial casings, and other articles with the approval of the 
Administrator.
    (c) Any brand, stamp, label or other device approved by the 
Administrator and bearing any official mark prescribed in paragraph (a) 
or (b) of this section shall be an official device for purposes of the 
Act.

[50 FR 41847, Oct. 16, 1985, as amended at 54 FR 1331, Jan. 13, 1989]



Sec. 352.8  Time of inspection in the field and in an official exotic 
animal establishment.

    The official exotic animal establishment on behalf of the applicant 
shall notify the Regional Director or designee, in advance, of the hours 
when such inspection is desired. Inspection personnel shall have access 
at all times to every part of any field ante-mortem inspection area and/
or official exotic animal establishment to which they are assigned.

[54 FR 1332, Jan. 13, 1989]



Sec. 352.9  Report of inspection work.

    Reports of the work of inspection carried on within the field ante-
mortem inspection area of an exotic animal producer's premises and/or 
official exotic animal establishment shall be forwarded to the 
Administrator by the ante-mortem inspector. The applicant for such 
inspection shall furnish to the Administrator such information as may be 
required on forms provided by the Administrator.

[54 FR 1333, Jan. 13, 1989]



Sec. 352.10  Ante-mortem inspection.

    An ante-mortem inspection of an exotic animal shall, where and to 
the extent considered necessary by the Administrator and under such 
instructions as he may issue from time to time, be made on the day of 
slaughter of an exotic animal, in one of the following listed ways or as 
determined by the Administrator. Humane handling of an exotic animal 
during ante-mortem inspection shall be in accordance with the provisions 
contained in 9 CFR 313.2. Immediately after the animal is stunned or 
killed, it shall be shackled, hoisted, stuck and bled.
    (a) To be performed on an exotic animal in the field in a designated 
area of an exotic animal producer's premises.
    (1) Reindeer, elk, deer, antelope, bison and water buffalo are 
eligible for field ante-mortem inspection. The field ante-mortem 
designated area must be approved by the Regional Director or designee 
prior to rendition of the service.
    (2) Any person who desires to receive field ante-mortem inspection 
must provide:
    (i) Notification from an official exotic animal establishment to the 
Regional Director or designee.
    (ii) A field ante-mortem designated area.
    (iii) A stunning/slaughtering area which is in a condition that 
minimizes the possibility of soiling the animal when stunned/slaughtered 
and bled as determined by the inspector.
    (iv) A transport vehicle that is as sanitary as practicable as 
determined by the inspector.
    (3) The ante-mortem inspector shall determine the acceptableness and 
safety of performing field ante-mortem inspection. If, in the opinion of 
the ante-mortem inspector, an unsafe circumstance exists at the time of 
field ante-mortem inspection, the service shall be denied.
    (4) An exotic animal that, in the ante-mortem inspector's opinion, 
does not pass ante-mortem inspection must be withheld from slaughter.
    (5) Stunning to render the animal unconscious shall be in accordance 
with 9 CFR 313.15 or 313.16.
    (6) All stunned/slaughtered and bled exotic animals shall be tagged 
with a ``U.S. Suspect'' tag in an ear by the ante-mortem inspector or 
designee prior to loading on the transport vehicle.
    (7) The transport of intact exotic animal carcasses to an official 
exotic animal establishment for post-mortem inspection shall be as 
expedient as possible, and must be within the same day as field 
slaughter.
    (8) Ante-mortem cards (Form MP 402-2) shall be filled out by the 
ante-mortem inspector. One copy is to be retained by the ante-mortem 
inspector.

[[Page 382]]

The other copy shall accompany the transport vehicle to the official 
exotic animal establishment and shall be delivered to the post-mortem 
veterinarian.
    (9) The ante-mortem inspector shall supervise all phases of field 
ante-mortem inspection.
    (b) To be performed on exotic animals that are inside of the 
transport vehicle at an official exotic animal establishment.
    (1) Reindeer, elk, deer, antelope, bison, and water buffalo are 
eligible for transport vehicle inspection.
    (2) The ante-mortem inspector shall remain outside the transport 
vehicle while performing ante-mortem inspection.
    (3) The person requesting transport vehicle inspection must provide 
a transport vehicle that is as sanitary as practicable and that would 
safely and thoroughly permit the inspection of an exotic animal from 
outside of the transport vehicle as determined by the inspector.
    (4) The ante-mortem inspector shall determine the adequacy and 
safety of performing ante-mortem inspection. If, in the ante-mortem 
inspector's opinion, the transport vehicle is not adequate or safe to 
perform ante-mortem inspection, the service shall be denied.
    (c) To be performed in pens at official exotic animal 
establishments. The inspection shall be conducted in accordance with the 
provisions contained in 9 CFR part 309.

[54 FR 1333, Jan. 13, 1989]



Sec. 352.11  Post-mortem inspection.

    (a) Post-mortem inspection of reindeer, elk, deer, antelope, bison 
and water buffalo shall be conducted in accordance with the provisions 
contained in 9 CFR part 310 or as determined by the Administrator.
    (b) The post-mortem examination of field ante-mortem-inspected 
exotic animals must occur in the shortest length of time practicable and 
on the day that field ante-mortem inspection is performed to minimize 
the changes in the carcass which can affect the post-mortem examination, 
disposition and wholesomeness of the carcass and its parts.
    (c) The post-mortem veterinarian shall inspect and make the 
disposition of all incoming ``U.S. Suspect'' tagged exotic animals.

[54 FR 1333, Jan. 13, 1989]



Sec. 352.12  Disposal of diseased or otherwise adulterated carcasses 
and parts.

    This shall be conducted in accordance with the provisions contained 
in 9 CFR part 311.



Sec. 352.13  Handling and disposal of condemned or other inedible exotic 
animal products at official exotic animal establishments.

    This shall be conducted in accordance with the provisions contained 
in 9 CFR part 314.



Sec. 352.14  Entry into official establishments; reinspection and 
preparation of products.

    This shall be conducted in accordance with the provisions contained 
in 9 CFR 318.1, 318.2, and 318.3.



Sec. 352.15  Records, registration, and reports.

    This shall be conducted or maintained in accordance with the 
provisions contained in 9 CFR 320.1 through 320.7.



Sec. 352.16  Exports.

    This shall be conducted in accordance with the provisions contained 
in 9 CFR 322.1 through 322.5.



Sec. 352.17  Transportation.

    This shall be conducted in accordance with the provisions contained 
in Sec. Sec. 325.1 through 325.21.



Sec. 352.18  Cooperation of States in Federal programs.

    Under the ``Talmadge-Aiken Act'' of September 28, 1962 (7 U.S.C. 
450), the Administrator is authorized to utilize employees and 
facilities of States in carrying out Federal functions.

[[Page 383]]



PART 354_VOLUNTARY INSPECTION OF RABBITS AND EDIBLE PRODUCTS THEREOF
--Table of Contents




                                 General

Sec.
354.1 Definitions.
354.2 Designation of official certificates, memoranda, marks, other 
          identifications, and devices for purposes of the Agricultural 
          Marketing Act.

                             Administration

354.3 Administration.

                            Basis of Service

354.10 Inspection service.
354.12 Eligibility.
354.13 Supervision.
354.14 Authority to waive provisions of Sec. 354.12.

                         Performance of Services

354.20 Licensed or authorized inspectors.
354.21 Suspension of license; revocation.
354.22 Surrender of license.
354.23 Identification.
354.24 Financial interest of inspectors.
354.25 Political activity.
354.26 Schedule of operation of official plants.

                   Application for Inspection Service

354.30 Who may obtain inspection service.
354.31 How application for service may be made; conditions of resident 
          service.
354.32 Filing of application.
354.33 Authority of applicant.
354.34 Application for inspection service in official plants; approval.
354.35 Rejection of application.
354.36 Withdrawal of application.
354.38 Suspension of plant approval.

                               Violations

354.45 Denial of service.
354.46 Misrepresentation; deceptive or fraudulent acts or practices.
354.47 Use of facsimile forms.
354.48 Willful violation of the regulations.
354.49 Interfering with an inspector or employee of Service.
354.51 Miscellaneous.

                      Other Applicable Regulations

354.53 Other applicable regulations.

                    Identifying and Marking Products

354.60 Approval of official identification.
354.62 Inspection mark with respect to product.
354.63 Marking inspected products.
354.64 Form of official identification.
354.65 Form of inspection mark.

                  Supervision of Marking and Packaging

354.70 Evidence of label approval.
354.71 Affixing of official identification.
354.72 Packaging.
354.73 Retention labels.
354.74 Prerequisites to inspection.
354.75 Accessibility of products.
354.76 Time of inspection in an official plant.

                                 Reports

354.90 Report of inspection work.
354.91 Information to be furnished to inspectors.
354.92 Reports of violations.

                            Fees and Charges

354.100 Payment of fees and charges.
354.101 On a fee basis.
354.105 Fees for additional copies of inspection certificates.
354.106 Travel expenses and other charges.
354.107 Continuous inspection performed on a resident basis.
354.109 Fees or charges for inspection service performed under 
          cooperative agreement.
354.110 Disposition of fees for inspection made under cooperative 
          agreement.

             Inspection Procedures; Ante-Mortem Inspections

354.120 Manner of handling products in an official plant.
354.121 Ante-mortem inspection.
354.122 Condemnation on ante-mortem inspection.
354.123 Segregation of suspects on ante-mortem inspection.
354.124 Quarantine of diseased rabbits.

                         Post-Mortem Inspection

354.125 Evisceration.
354.126 Carcasses held for further examination.
354.127 Condemnation and treatment of carcasses.
354.128 Certification of carcasses.

           Disposition of Diseased Rabbit Carcasses and Parts

354.129 General.
354.130 Diseases or conditions evident which require condemnation.
354.131 Decomposition.
354.132 Disposal of condemned carcasses and parts.

                      Reinspection and Ingredients

354.133 Reinspection of edible products; ingredients.

[[Page 384]]

                                 Appeals

354.134 Appeal inspections; how made.

                         Inspection Certificates

354.140 Forms of inspection certificates.
354.141 Issuance and disposition of rabbits inspection certificates.
354.142 Food product inspection certificates; issuance and disposition.
354.143 Export certificates; issuance and disposition.
354.144 Advance information.

       Basis of Acceptability of Other Official Inspection Systems

354.160 General.
354.161 Requirements as to manner of inspection.
354.162 Determining compliance with Sec. 354.161.

                          Sanitary Requirements

                                 general

354.210 Minimum standards for sanitation, facilities, and operating 
          procedures in official plants.

                     Buildings and Plant Facilities

354.220 Buildings.
354.221 Rooms and compartments.
354.222 Floors, walls, ceilings, etc.
354.223 Drainage and plumbing.
354.224 Water supply.
354.225 Lavatory accommodations.
354.226 Lighting and ventilation.

                         Equipment and Utensils

354.230 Equipment and utensils.
354.231 Accessibility.
354.232 Restrictions on use.

Maintenance of Sanitary Conditions and Precautions Against Contamination 
                               of Products

354.240 General.
354.241 Cleaning of rooms and compartments.
354.242 Cleaning of equipment and utensils.
354.243 Operations and procedures.
354.244 Temperatures and cooling and freezing procedures.
354.245 Vermin.
254.246 Exclusion of diseased persons.
354.247 Table showing types of materials.
354.248 Scope and applicability of rules of practice.

    Authority: 7 U.S.C. 1622, 1624; 7 CFR 2.17 (g) and (i), 2.55.

    Source: 41 FR 23702, June 11, 1976, unless otherwise noted.

                                 General



Sec. 354.1  Definitions.

    Unless the context otherwise requires, the following terms shall 
have the following meaning:
    (a) Act means the applicable provisions of the Agricultural 
Marketing Act of 1946 (60 Stat. 1087; 7 U.S.C. 1621 et seq.) or any 
other act of Congress conferring like authority.
    (b) Acceptable means suitable for the purpose intended and 
acceptable to the Service.
    (c) Administrator means the Administrator of the Food Safety and 
Inspection Service of the Department or any other officer or employee of 
the Department to whom there has heretofore been delegated, or to whom 
there may hereafter be delegated the authority to act in his stead.
    (d) Applicant means any interested party who requests any inspection 
service.
    (e) Area supervisor means any employee of the Department in charge 
of rabbit inspection service in a designated geographical area.
    (f) Carcass means any rabbit carcass.
    (g) Circuit supervisor or technical supervisor means the officer in 
charge of the rabbit inspection service in a circuit consisting of a 
group of stations within an area.
    (h) Class means any subdivision of a product based on essential 
physical characteristics that differentiate between major groups of the 
same kind.
    (i) Condition means any condition, including, but not being limited 
to, the state of preservation, cleanliness, or soundness, of any product 
or the processing, handling, or packaging which may affect such product.
    (j) Condition and wholesomeness means the condition of any product, 
its healthfulness and fitness for human food.
    (k) Department means the United States Department of Agriculture.
    (l) Edible product means any product derived from ready-to-cook 
domestic rabbits.
    (m) Giblets means the liver from which the bile sac has been removed 
and the heart from which the pericardial sac has been removed.

[[Page 385]]

    (n) Holiday or legal holiday shall mean the legal public holidays 
specified by the Congress in paragraph (a) of section 6103, Title 5, of 
the United States Code.
    (o) Identify means to apply official identification to products or 
to containers thereof.
    (p) Inspected and certified or certified means, with respect to any 
product, that it has undergone an inspection and was found, at the time 
of such inspection, to be sound, wholesome, and fit for human food.
    (q) Inspection, inspection service, or inspection of products for 
condition and wholesomeness means any inspection by an inspector to 
determine, in accordance with the regulations in this part, (1) the 
condition and wholesomeness of rabbits, or (2) the condition and 
wholesomeness of any edible product at any state of the preparation or 
packaging thereof in the official plant where inspected and certified, 
or (3) the condition and wholesomeness of any previously inspected and 
certified product if such product has not lost its identity as an 
inspected and certified product.
    (r) Inspection certificate means a statement, either written or 
printed, issued by an inspector, pursuant to the regulations in this 
part, relative to the condition and wholesomeness of products.
    (s) Inspector means any person who is licensed by the Secretary to 
investigate and certify, in accordance with the regulations in this 
part, the condition and wholesomeness of products. An inspector is an 
employee of the Department or of a State; he may be a graduate 
veterinarian or a layman.
    (t) Interested party means any person financially interested in a 
transaction involving any inspection.
    (u) National supervisor means (1) the officer in charge of the 
rabbit inspection service of the Food Safety and Inspection Service, and 
(2) other officers or employees of the Department designated by the 
officer in charge of the rabbit inspection service of the Food Safety 
and Inspection Service.
    (v) Official plant means one or more buildings or parts thereof, 
comprising a single plant in which the facilities and methods of 
operation therein have been approved by the Administrator as suitable 
and adequate for operation under inspection service and in which 
inspection is carried on in accordance with the regulations in this 
part.
    (w) Person means any individual, partnership, association, business 
trust, corporation, or any organized group of persons, whether 
incorporated or not.
    (x) Potable water means water that has been approved by the State 
health authority as safe for drinking and suitable for food processing.
    (y) Product means ready-to-cook cooked rabbits, or edible products 
derived therefrom.
    (z) Rabbit means any domesticated rabbit, whether live or dead.
    (aa) Rabbit inspection service means the personnel who are engaged 
in the administration, application, and direction of rabbit inspection 
programs and services pursuant to the regulations in this part.
    (bb) Ready-to-cook domestic rabbit means any rabbit which has been 
slaughtered for human food, from which the head, blood, skin, feet, and 
inedible viscera have been removed, that is ready to cook without need 
of further processing. Ready-to-cook rabbit also means any cut-up or 
disjointed portion of rabbit or any edible part thereof, as described in 
this paragraph.
    (cc) Regulations means the provisions of this entire part as may be 
in effect at the time inspection is performed.
    (dd) Secretary means the Secretary of the Department, or any other 
officer or employee of the Department to whom there has heretofore been 
delegated, or to whom there may hereafter be delegated, the authority to 
act in his stead.
    (ee) Service means the Food Safety and Inspection Service of the 
Department.
    (ff) Station supervisor means any authorized individual who is 
designated to supervise rabbit inspection service in a large official 
plant or in a group of several small plants.



Sec. 354.2  Designation of official certificates, memoranda, marks, 
other identifications, and devices for purposes of the Agricultural 
Marketing Act.

    Subsection 203(h) of the Agricultural Marketing Act of 1946, as 
amended by Pub. L. 272, 84th Congress, provides

[[Page 386]]

criminal penalties for various specified offenses relating to official 
certificates, memoranda, marks or other identifications, and devices for 
making such marks or identifications, issued or authorized under section 
203 of said Act, and certain misrepresentations concerning the 
inspection of agricultural products under said section. For the purposes 
of said subsection and the provisions in this part, the terms listed in 
this section shall have the respective meanings specified:
    (a) Official certificate means any form of certification, either 
written or printed, used under this part to certify with respect to the 
inspection or class or condition of products.
    (b) Official memorandum means any initial record of findings made by 
an authorized person in the process of inspecting or sampling, pursuant 
to this part, any processing or plant operation report made by an 
authorized person in connection with inspecting or sampling under this 
part, and any report made by an authorized person of services performed 
pursuant to this part.
    (c) Official mark means the inspection mark, and any other mark, or 
any variations in such marks, approved by the Administrator and 
authorized to be affixed to any product, or affixed to or printed on the 
packaging material of any product, stating that the product was 
inspected, or indicating the condition of the product, or for the 
purpose of maintaining the identity of products inspected under this 
part, including, but not limited to, that set forth in Sec. 354.65.
    (d) Official identification means any symbol, stamp, label, or seal 
indicating that the product has been officially inspected and/or 
indicating the class or condition of the product approved by the 
Administrator and authorized to be affixed to any product, or affixed to 
or printed on the packaging material of any product.
    (e) Official device means a stamping appliance, branding device, 
stencil, printed label, or any other mechanically or manually operated 
tool that is approved by the Administrator for the purpose of applying 
any official mark or other identification to any product or the 
packaging material thereof.

                             Administration



Sec. 354.3  Administration.

    The Administrator shall perform, for and under the supervision of 
the Secretary, such duties as are prescribed in the regulations in this 
part and as the Secretary may require in the administration of the 
regulations in this part. The Administrator is authorized to waive for 
limited periods any particular provisions of the regulations to permit 
experimentation so that new procedures, equipment, and processing 
techniques may be tested to facilitate definite improvements and, at the 
same time, to assure full compliance with the spirit and intent of the 
regulations. The Food Safety and Inspection Service and its officers and 
employees shall not be liable in damages through acts of commission or 
omission in the administration of this part.

                            Basis of Service



Sec. 354.10  Inspection service.

    Any inspection service in accordance with the regulations in this 
part shall be for condition and wholesomeness.



Sec. 354.12  Eligibility.

    (a) Only rabbits which are processed in official plants in 
accordance with the regulations in this part may be inspected.
    (b) All rabbits that are eviscerated in an official plant where 
inspection service is maintained shall be inspected for condition and 
wholesomeness and no dressed rabbits or uninspected products shall be 
brought into such official plant.



Sec. 354.13  Supervision.

    All inspection service shall be subject to supervision at all times 
by the station supervisor, circuit supervisor, area supervisor, and 
national supervisor. Such service shall be rendered where the facilities 
and conditions are satisfactory for the conduct of the service and the 
requisite inspectors are available.



Sec. 354.14  Authority to waive provisions of Sec. 354.12.

    The Administrator is authorized to waive the provisions of Sec. 
354.12 which

[[Page 387]]

pertain to the entry of uninspected edible products into official plants 
in specific instances where rabbits are to be brought into compliance 
with a law under the provisions of a court order. Such rabbits shall be 
handled in an official plant in accordance with such procedures as the 
Administrator may prescribe to insure proper segregation and identity of 
the rabbits or rabbit products until they are shipped from the official 
plant.

                         Performance of Services



Sec. 354.20  Licensed or authorized inspectors.

    (a) Any person who is a Federal or State employee or the employee of 
a local jurisdiction possessing proper qualifications as determined by 
an examination for competency, and who is to perform inspection service 
under this part may be licensed or otherwise authorized by the Secretary 
as an inspector.
    (b) All licenses issued by the Secretary shall be countersigned by 
the officer in charge of the rabbit inspection service of the Animal and 
Plant Health Inspection Service or any other designated officer of such 
Service.



Sec. 354.21  Suspension of license; revocation.

    Pending final action by the Secretary, any person authorized to 
countersign a license to perform inspection service may, whenever he 
deems such action necessary to assure that any inspection service is 
properly performed, suspend any license to perform inspection service 
issued pursuant to this part, by giving notice of such suspension to the 
respective licensee, accompanied by a statement of the reasons therefor. 
Within 7 days after the receipt of the aforesaid notice and statement of 
reasons, the licensee may file an appeal in writing, with the Secretary, 
supported by any argument or evidence that he may wish to offer as to 
why his license should not be further suspended or revoked. After the 
expiration of the aforesaid 7-day period and consideration of such 
argument and evidence, the Secretary will take such action as he deems 
appropriate with respect to such suspension or revocation. When no 
appeal is filed within the prescribed 7 days, the license to perform 
inspection service is revoked.



Sec. 354.22  Surrender of license.

    Each license which is suspended, or revoked, or has expired shall 
promptly be surrendered by the licensee to his immediate superior. Upon 
termination of the services of a licensed inspector, the licensee shall 
promptly surrender his license to his immediate superior.



Sec. 354.23  Identification.

    Each inspector shall have in his possession at all times, and 
present upon request while on duty, the means of identification 
furnished by the Department to such person.



Sec. 354.24  Financial interest of inspectors.

    No inspector shall render service on any product in which he is 
financially interested.



Sec. 354.25  Political activity.

    All inspectors are forbidden, during the period of their respective 
appointments or licenses, to take an active part in political management 
or in political campaigns. Political activity in city, county, State, or 
national elections, whether primary or regular, or in behalf of any 
party or candidate, or any measure to be voted upon, is prohibited. This 
applies to all appointees, including, but not being limited to, 
temporary and cooperative employees and employees on leave of absence 
with or without pay. Willful violation of Sec. Sec. 354.20 to 354.25 
will constitute grounds for dismissal in the case of appointees and 
revocation of licenses in the case of licensees.



Sec. 354.26  Schedule of operation of official plants.

    Inspection operating schedules for services performed pursuant to 
Sec. 354.107 shall be requested in writing and be approved by the 
Administrator. Normal operating schedules for a full week consist of a 
continuous 8-hour period per day (excluding not to exceed 1 hour for 
lunch), 5 consecutive days per week, within the period of Monday through 
Saturday, for each shift required. Less

[[Page 388]]

than 8-hour schedules may be requested and will be approved if an 
inspector is available. Sundays may not be approved in any tour of duty. 
Clock hours of daily operations need not be specified in the request, 
although as a condition of continued approval, the hours of operation 
shall be reasonably uniform from day to day. Inspectors are to be 
notified by management 1 day in advance of any change in the hours 
inspection service is requested.

                   Application for Inspection Service



Sec. 354.30  Who may obtain inspection service.

    An application for inspection service may be made by any interested 
person, including, but not being limited to, the United States, any 
State, county, municipality, or common carrier, and any authorized agent 
of the foregoing.



Sec. 354.31  How application for service may be made; conditions of 
resident service.

    (a) On a fee basis. An application for any inspection service on a 
fee basis may be made in any office of inspection or with any inspector 
at or nearest the place where the service is desired. Such application 
may be made orally (in person or by telephone), in writing, or by 
telegraph. If the application for inspection service is made orally, the 
office of inspection or the inspector with whom the application is made, 
or the Administrator, may require that the application be confirmed in 
writing.
    (b) On a resident inspection basis. An application for resident 
inspection service must be made in writing on forms approved by the 
Administrator and filed with the Administrator. Such forms may be 
obtained at the national, area, or State inspection office. In making 
application, the applicant agrees to comply with the terms and 
conditions of the regulations (including, but not being limited to, such 
instructions governing inspection of products as may be issued from time 
to time by the Administrator). No member of or delegate to Congress or 
Resident Commissioner shall be admitted to any benefit that may arise 
from such service unless derived through service rendered a corporation 
for its general benefit.



Sec. 354.32  Filing of application.

    An application for inspection service shall be regarded as filed 
only when made pursuant to the regulations in this part.



Sec. 354.33  Authority of applicant.

    Proof of the authority of any person applying for inspection service 
may be required at the discretion of the Administrator.



Sec. 354.34  Application for inspection service in official plants; 
approval.

    Any person desiring to process and pack products in a plant under 
inspection service must receive approval of such plant and facilities as 
an official plant prior to the rendition of such service. An application 
for inspection service to be rendered in an official plant shall be 
approved according to the following procedure:
    (a) Initial survey. When application has been filed for inspection 
service as aforesaid, the area supervisor, or his assistant, shall 
examine the plant, premises, and facilities and shall specify any 
additional facilities required for the service. Appeals with respect to 
any such specification may be made to the national supervisor.
    (b) Drawings and specifications to be furnished in advance of 
construction or alterations.
    (1) Four copies of drawings or blueprints showing the features 
specified herein shall be submitted to the Administrator. The drawings 
or blueprints shall be legible, made with sharp, clear lines, and 
properly drawn to scale, and shall consist of floor plans and a plot 
plan.
    (2) The plot plan shall show such features as the limits of the 
plant's premises, locations in outline of buildings on the premises, one 
point of the compass, and roadways and railroads serving the plant.
    (3) The floor plan shall show all space to be included in the 
official plant. If rooms or compartments shown on the drawings or 
blueprints are not to be included as part of the official plant, this 
shall be clearly indicated thereon.

[[Page 389]]

    (4) The sheets of paper on which drawings or blueprints are made 
shall not exceed a size 34 x 44. The drawings 
other than of the plot plan shall be made to a scale of \1/8\ 
per foot, except that additional plans for some areas showing detail may 
be drawn to a scale of \1/4\ per foot. The plot plan may be 
drawn to a scale of not less than \1/32\ per foot. The 
drawings shall indicate the scale used and shall also indicate the floor 
shown (e.g., basement, first, or second).
    (c) Features required to be shown on floor plan. The following 
features shall be shown on the floor plan:
    (1) The principal pieces of equipment drawn to scale in the proper 
locations.
    (2) The name of the firm and the address of the plant by street and 
street number, or by other means properly identifying the location of 
the plant.
    (3) One point of the compass.
    (4) The doors and openings for passageways, designating those which 
are self-closing or permanently closed.
    (5) All floor drain openings and gutter drains.
    (6) Lavatories in toilet and processing rooms (lavatories which are 
other than hand-operated shall be so designated on the drawings or 
blueprints).
    (7) All steam and hot and cold water outlets for cleanup purposes.
    (8) Ice-making and storage facilities.
    (9) The point at which live rabbits are hung on the conveyor line, 
the point at which the ready-to-cook rabbits are removed, and any 
intermediate transfer points.
    (10) The routes of the edible and inedible products.
    (11) The location of fresh air inlets, exhaust fans, and hoods.
    (d) Specifications. Specifications covering the following items 
shall accompany the drawings:
    (1) Height of ceilings.
    (2) Type of ceilings--open or closed.
    (3) Finish of ceilings; for example--cement plaster, metal, marine 
plywood, cement, asbestos board, etc.
    (4) Finish of walls; for example--cement plaster, glazed tile, glaze 
brick, glass blocks, etc.
    (5) Screens--indicate whether all outside openings are screened or 
provided with other suitable devices against entrance of flies or other 
insects.
    (6) Finish of floors--concrete, brick, mastic material, etc.
    (7) Drainage--indicate the amount of slope of floors to the drains 
in processing rooms, coolers, toilets, and refuse rooms, and give 
description of trapping and venting of drainage lines and of floor drain 
openings. Indicate size of drainage lines and whether house drainage 
lines and toilet soil lines are separate to a point outside of 
buildings.
    (8) Heating--indicate type.
    (9) Water supply--indicate whether public or private water supply, 
or both, and specify in terms of gallons of water available per minute 
for the processing needs of the plant. Also indicate whether or not a 
nonpotable water supply is used for any purpose in the plant and, if so, 
specify such uses.
    (10) Hot water facilities--specify facilities such as boilers, 
storage tanks, mixing valves, etc., and indicate the size and number of 
boilers and storage tanks.
    (11) Specify number of men and number of women who will use each 
toilet room.
    (12) Sewage disposal--indicate whether city sewer, cesspool, 
sedimentation tank, etc.
    (13) Approximate rate of production--indicate hourly rate of 
slaughter and evisceration for rabbits.
    (e) Rooms and compartments which must be included in the official 
plant. The official plant shall include employees' toilet and dressing 
rooms, office space for the inspectors, storerooms for supplies, refuse 
rooms, and rooms, compartments, or passageways where rabbits or any 
ingredients to be used in the preparation of products under inspection 
will be handled or kept. It also may include other rooms or compartments 
located in the buildings comprising the official plant.
    (f) Changes in drawings or blueprints. When changes are proposed in 
areas for which drawings or blueprints have been previously approved, 
one of the following types of revised drawings or blueprints shall be 
submitted for review and consideration.

[[Page 390]]

    (1) A completely revised sheet or sheets showing proposed 
alterations or additions, or
    (2) Approved pasters of the proposed changes which may be affixed to 
the affected areas on the previously approved drawings or blueprints in 
a manner not obscuring essential data. Paster drawings and blueprints 
shall be prepared to the same scale and presented on a background 
similar to that of the originally approved drawing or blueprint.
    (g) Final survey and plant approval. Prior to the inauguration of 
the inspection service, a final survey of the plant and premises shall 
be made by the area supervisor or his assistant to determine if the 
plant is constructed and facilities are installed in accordance with the 
approved drawings and the regulations in this part. The plant may be 
approved by the Administrator only when these requirements have been 
met, except that conditional approval for a specified limited time may 
be granted only under emergency conditions of restricted availability of 
facilities and construction materials, provided practices suitable to 
the Administrator are employed to effect adequate sanitary conditions in 
the plant.

(Approved by the Office of Management and Budget under control number 
0583-0036)

[41 FR 23702, June 11, 1976, as amended at 47 FR 746, Jan. 7, 1982]



Sec. 354.35  Rejection of application.

    Any application for inspection service may be rejected by the 
Administrator:
    (a) Whenever the applicant fails to meet the requirements of the 
regulations prescribing the conditions under which the service is made 
available;
    (b) Whenever the product is owned by or located on the premises of a 
person currently denied the benefits of the Act;
    (c) Where any individual holding office or a responsible position 
with or having a substantial financial interest or share in the 
applicant is currently denied the benefits of the Act or was responsible 
in whole or in part for the current denial of the benefits of the Act to 
any person;
    (d) Where the Administrator determines that the application is an 
attempt on the part of a person currently denied the benefits of the Act 
to obtain inspection service;
    (e) Whenever the applicant, after an initial survey has been made in 
accordance with Sec. 354.34(a), fails to bring the plant, facilities, 
and operating procedures into compliance with the regulations within a 
reasonable period of time; or
    (f) Notwithstanding any prior approval whenever, before inauguration 
of service, the applicant fails to fulfill commitments concerning the 
inauguration of the service. Each such applicant shall be promptly 
notified by registered mail of the reasons for the rejection. A written 
petition for reconsideration of such rejection may be filed by the 
applicant with the Administrator if postmarked or delivered within 10 
days after the receipt of notice of the rejection. Such petition shall 
state specifically the errors alleged to have been made by the 
Administrator in rejecting the application. Within 20 days following the 
receipt of such a petition for reconsideration, the Administrator shall 
approve the application or notify the applicant by registered mail of 
the reasons for the rejection thereof.



Sec. 354.36  Withdrawal of application.

    Any application for inspection service may be withdrawn by the 
applicant at any time before the service is performed upon payment, by 
the applicant, of all expenses incurred by the Service in connection 
with such application.



Sec. 354.38  Suspension of plant approval.

    (a) Any plant approval given pursuant to the regulations in this 
part may be suspended by the Administrator for:
    (1) Failure to maintain plant and equipment in a satisfactory state 
of repair;
    (2) The use of operating procedures which are not in accordance with 
the regulations in this part; or
    (3) Alterations of buildings, facilities, or equipment which cannot 
be approved in accordance with the regulations in this part.
    (b) During such period of suspension, inspection service shall not 
be rendered. However, the other provisions of

[[Page 391]]

the regulations pertaining to providing service on a resident basis will 
remain in effect unless such service is terminated in accordance with 
the provisions of this part. If the plant facilities or methods of 
operation are not brought into compliance within a reasonable period of 
time, to be specified by the Administrator, the service shall be 
terminated. Upon termination of inspection service in an official plant 
pursuant to the regulations in this part, the plant approval shall also 
become terminated, and all labels, seals, tags or packaging material 
bearing official identification shall, under the supervision of a person 
designated by the Service, either be destroyed, or the official 
identification completely obliterated, or sealed in a manner acceptable 
to the Service.

                               Violations



Sec. 354.45  Denial of service.

    (a) The acts or practices set forth in Sec. Sec. 354.46 through 
354.51 or the causing thereof may be deemed sufficient cause, for the 
debarment, by the Secretary, of any person, including any agents, 
officers, subsidiaries, or affiliates of such person, from any or all 
benefits of the Act for a specified period after notice and opportunity 
for hearing has been afforded.
    (b) Whenever the Administrator has reason to believe that any person 
or his employee, agent, or representative has flagrantly or repeatedly 
committed any of the acts or practices specified in Sec. Sec. 354.46 to 
354.51, he may, without hearing, direct that the benefits of the Act be 
denied such person, including any agents, officers, subsidiaries, or 
affiliates of such person, pending investigation and hearing, and shall 
give notice thereof to any such person in the manner prescribed in Sec. 
1.147(b) of the rules of practice (7 CFR 1.147(b)). The Administrator's 
decision to deny the benefits of the Act to any such person, including 
any agents, officers, subsidiaries, or affiliates of such person, shall 
be effective upon service of such notice. A written petition for 
reconsideration of such interim denial may be filed with the 
Administrator by any person so denied the benefits of the Act within 10 
days after notice of the interim denial. Such petition shall state 
specifically the errors alleged to have been made by the Administrator 
in denying the benefits of the Act pending investigation and hearing. 
Within 20 days following the receipt of such petition for 
reconsideration, the Administrator shall reinstate the benefits of the 
Act or notify the petitioner of the reasons for continued interim 
denial.

[41 FR 23702, June 11, 1976, as amended at 43 FR 11148, Mar. 17, 1978]



Sec. 354.46  Misrepresentation; deceptive or fraudulent acts or practices.

    Any willful misrepresentation or any deceptive or fraudulent act or 
practice made or committed by any person in connection with:
    (a) The making or filing of any application for any inspection 
service;
    (b) The making of the product accessible for inspection;
    (c) The making, issuing, or using, or attempting to issue or use any 
inspection certificate, symbol, stamp, label, seal or identification, 
authorized pursuant to the regulations in this part;
    (d) The use of the terms ``U.S. Inspected'' or ``Government 
Inspected'', or any term of similar import in the labeling or 
advertising of any product.



Sec. 354.47  Use of facsimile forms.

    Using or attempting to use a form which simulates, in whole or in 
part, any certificate, symbol, stamp, label, seal or identification 
authorized to be issued or used under the regulations in this part.



Sec. 354.48  Willful violation of the regulations.

    Any willful violation of the regulations in this part or the Act.



Sec. 354.49  Interfering with an inspector or employee of Service.

    Any interference with or obstruction or any attempted interference 
or obstruction of or assault upon any inspector or employee of the 
Service in the performance of his duties. The giving or offering 
directly or indirectly of any money, loan, gift, or anything of value to 
an employee of the Service or the making or offering of any contribution 
to or in any way supplementing the salary, compensation, or expenses

[[Page 392]]

of an employee of the Service, or the offering or entering into a 
private contract or agreement with an employee of the Service for any 
services to be rendered while employed by the Service.



Sec. 354.51  Miscellaneous.

    The existence of any of the conditions set forth in Sec. 354.35 
constituting a basis for the rejection of an application for inspection 
service.

                      Other Applicable Regulations



Sec. 354.53  Other applicable regulations.

    Compliance with the regulations in this part shall not excuse 
failure to comply with any other Federal or any State or municipal 
applicable laws or regulations.

                    Identifying and Marking Products



Sec. 354.60  Approval of official identification.

    (a) Any label or packaging material which bears any official 
identification shall be used only in such manner as the Administrator 
may prescribe. No label or packaging material bearing official 
identification may be used unless finished copies or samples of such 
labels and packaging material have been approved by the Administrator. 
No label bearing official identification shall be printed for use until 
the printer's final proof has been approved by the Administrator, and no 
label, other than labels for shipping containers or containers for 
institutional packs, bearing any official identification shall be used 
until finished copies or samples of such labels have been approved by 
the Administrator. Final approval may be given to printer's final proof 
or photostatic copies of labels for shipping containers or containers 
for institutional packs, and no such labels shall be used until such 
proofs or copies have been approved by the Administrator. A label which 
bears official identification shall not bear any statement that is false 
or misleading, and if labels in the name of the same packer or 
distributor, or bearing the same brand name, are used on the same or 
similar products which are prepared from products which are not 
inspected, the diameter of the inspection mark used on labels for 
inspected products shall be equal to at least one-tenth of the length of 
the label, plus at least one-tenth of the width of the label. If the 
labeling is printed or otherwise applied directly to the container, the 
principal display panel of such container shall, for this purpose, be 
considered as the label.



Sec. 354.62  Inspection mark with respect to product.

    The Administrator is authorized to prescribe and approve the form of 
the inspection mark that may be used.



Sec. 354.63  Marking inspected products.

    (a) Wording and form of inspection mark. Except as otherwise 
authorized, the inspection mark permitted to be used with respect to 
inspected and certified edible products shall include wording as 
follows: ``Inspected for Wholesomeness by U.S. Department of 
Agriculture.'' This wording shall be contained within a circle in the 
form and arrangement shown in Sec. 354.65. The appropriate plant number 
of the official plant shall be included in the circle unless it appears 
elsewhere on the packaging material. The Administrator may approve the 
use of abbreviations of such inspection mark, and such approved 
abbreviations shall have the same force and effect as the inspection 
mark. The inspection mark or approved abbreviation thereof, as the case 
may be, may be applied to the inspected and certified edible product or 
to the packaging material of such product. When the inspection mark, or 
the approved abbreviation thereof, is used on packaging material, it 
shall be printed on such material or on a label to be affixed to the 
packaging material and the name of the packer or distributor of such 
product shall be printed on the packaging material or label, as the case 
may be, except that on shipping containers and containers for 
institutional packs, the inspection marks may be stenciled on the 
container and, when the inspection mark is so stenciled, the name and 
address of the packer or distributor may be applied by the use of a 
stencil or a rubber stamp. Notwithstanding the foregoing, the name and 
address of the packer or

[[Page 393]]

distributor, if appropriately shown elsewhere on the packaging material, 
may be omitted from insert labels which bear an official identification 
if the applicable plant number is shown.
    (b) Wording on labels. Each trade label to be approved for use 
pursuant to Sec. Sec. 354.60 to 354.64 with respect to any inspected 
and certified edible product shall bear the true name of the edible 
product, the name and address of the packer or distributor thereof, and 
in prominent letters and figures of uniform size, the inspection mark, 
as aforesaid, and the label shall also bear, in such manner as may be 
prescribed or approved by the Administrator, the plant number, if any, 
of the official plant in which such product was inspected and certified. 
The class of the rabbits shall be shown on the label. The appropriate 
designation ``young'', ``mature'', or ``old'' may be used as a prefix to 
the word ``rabbit'' in lieu of the class name.
    (c) Labels in foreign languages. Any trade label to be affixed to a 
container of any edible products for foreign commerce may be printed in 
a foreign language. However, the inspection mark shall appear on the 
label in English, but, in addition, may be literally translated into 
such foreign language. Each such trade label which is to be printed in a 
foreign language must be approved pursuant to Sec. Sec. 354.60 to 
354.64.
    (d) Unauthorized use or disposition of approved labels. (1) Labels 
approved for use pursuant to Sec. Sec. 354.60 to 354.64 shall be used 
only for the purpose for which approved and shall not otherwise be 
disposed of from the plant for which approved except with written 
approval of the Administrator. Any unauthorized use or disposition of 
approved labels or labels bearing official identification may result in 
cancellation of the approval and denial of the use of labels bearing 
official identification or denial of the benefits of the Act pursuant to 
the provisions of Sec. 354.60.
    (2) The use of simulations or imitations of any official 
identification by any person is prohibited.
    (e) Rescindment of approved labels. Once a year, or more often if 
requested, each applicant shall submit to the Administrator a list in 
triplicate of approved labels that have become obsolete, accompanied 
with a statement that such approvals are no longer desired. The 
approvals shall be identified by the date of approval and the name of 
product or other designation showing the class of material.



Sec. 354.64  Form of official identification.

    The form prescribed in Sec. 354.65 is subject to the requirements 
of Sec. Sec. 354.60 to 354.64, Identifying and Marking Products.



Sec. 354.65  Form of inspection mark.

    The inspection mark approved for use on inspected and certified 
edible products shall be contained within a circle and include the 
following wording: ``Inspected for Wholesomeness by U.S. Department of 
Agriculture.'' The form and arrangement of such wording shall be as 
indicated in the example below. The plant number of the official plant 
shall be set forth if it does not appear on the packaging material.
[GRAPHIC] [TIFF OMITTED] TC11SE91.056

                  Supervision of Marking and Packaging



Sec. 354.70  Evidence of label approval.

    No inspector shall authorize the use of official identification for 
any inspected product unless he has on file evidence that such official 
identification or packaging material bearing such official 
identification has been approved in accordance with the provisions of 
Sec. Sec. 354.60 to 354.64.

[[Page 394]]



Sec. 354.71  Affixing of official identification.

    (a) No official identification or any abbreviation, copy, or 
representation thereof may be affixed to or placed on or caused to be 
affixed to or placed on any product or container thereof except by an 
inspector or under the supervision of an inspector. All such products 
shall have been inspected and certified. The inspector shall have 
supervision over the use and handling of all material bearing any 
official identification.
    (b) Each container of inspected and certified products to be shipped 
from one official plant to another official plant for further processing 
shall be marked for identification and shall show the following 
information:
    (1) The name of the inspected and certified products in the 
container;
    (2) The name and address of the packer or distributor of such 
products;
    (3) The net weight of the container;
    (4) The inspection mark permitted to be used pursuant to the 
regulations in this part unless the containers are sealed or otherwise 
identified in such manner as may be approved by the Administrator; and
    (5) The plant number of the official plant where the products were 
packed.



Sec. 354.72  Packaging.

    No container which bears or may bear any official identification or 
any abbreviation or copy or representation thereof may be filled in 
whole or in part except with edible products which were inspected and 
certified and are, at the time of such filing, sound, wholesome, and fit 
for human food. All such filling of containers shall be under the 
supervision of an inspector.



Sec. 354.73  Retention labels.

    An inspector may use such labels, devices, and methods as may be 
approved by the Administrator for the identification of:
    (a) Products which are held for further examination, and
    (b) All equipment and utensils which are to be held for proper 
cleaning.



Sec. 354.74  Prerequisites to inspection.

    Inspection of products shall be rendered pursuant to the regulations 
in this part and under such conditions and in accordance with such 
methods as may be prescribed or approved by the Administrator.



Sec. 354.75  Accessibility of products.

    Each product for which inspection service is requested shall be so 
arranged so as to permit adequate determination of its class, quantity, 
and condition as the circumstances may warrant.



Sec. 354.76  Time of inspection in an official plant.

    The inspector who is to perform the inspection in an official plant 
shall be informed, in advance, by the applicant of the hours when such 
inspection is desired. Inspectors shall have access at all times to 
every part of any official plant to which they are assigned.

                                 Reports



Sec. 354.90  Report of inspection work.

    Reports of the work of inspection carried on within official plants 
shall be forwarded to the Administrator by the inspector in such manner 
as may be specified by the Administrator.



Sec. 354.91  Information to be furnished to inspectors.

    When inspection service is performed within an official plant, the 
applicant for such inspection shall furnish to the inspector rendering 
such service such information as may be required for the purposes of 
Sec. Sec. 354.90 to 354.92.

(Approved by the Office of Management and Budget under control number 
0583-0036)

[41 FR 23702, June 11, 1976, as amended at 47 FR 746, Jan. 7, 1982]



Sec. 354.92  Reports of violation.

    Each inspector shall report, in the manner prescribed by the 
Administrator, all violations of and noncompliance with the Act and the 
regulations in this part of which he has knowledge.

                            Fees and Charges



Sec. 354.100  Payment of fees and charges.

    (a) Fees and charges for any inspection shall be paid by the 
applicant for the service in accordance with the applicable provisions 
of Sec. Sec. 354.100 to

[[Page 395]]

354.110, both inclusive. If so required by the inspector, such fees and 
charges shall be paid in advance.
    (b) Fees and charges for any inspection service shall, unless 
otherwise required pursuant to paragraph (c) of this section, be paid by 
check, draft, or money order payable to the Food Safety and Inspection 
Service and remitted promptly to the Service.
    (c) Fees and charges for any inspection pursuant to a cooperative 
agreement with any State or person shall be paid in accordance with the 
terms of such cooperative agreement.



Sec. 354.101  On a fee basis.

    (a) Unless otherwise provided in this part, the fees to be charged 
and collected for any service performed, in accordance with this part, 
on a fee basis shall be based on the applicable rates specified in this 
section.
    (b) The charges for inspection service will be based on the time 
required to perform such services. The hourly rates shall be as 
specified in Sec. Sec. 391.2 and 391.3 respectively for base time and 
for overtime or holiday work.
    (c) Charges for certain laboratory analysis or laboratory 
examination of rabbits under this part related to inspection service 
shall be at the rate specified in Sec. 391.4 for that part which is not 
covered under the base time, overtime, and/or holiday costs.

[41 FR 23702, June 11, 1976, as amended at 53 FR 13398, Apr. 22, 1988; 
54 FR 6390, Feb. 10, 1989]



Sec. 354.105  Fees for additional copies of inspection certificates.

    Additional copies, other than those provided for in Sec. Sec. 
354.141, 354.142, and 354.143, of any inspection certificates may be 
supplied to any interested party upon payment of a fee of $2.00 for each 
set of five or fewer copies.



Sec. 354.106  Travel expenses and other charges.

    Charges are to be made to cover the cost of travel and other 
expenses incurred by the Service in connection with rendering inspection 
service. Such charges shall include the costs of transportation, per 
diem, and any other expenses.



Sec. 354.107  Continuous inspection performed on a resident basis.

    The charges for inspection of rabbits and products thereof shall be 
those provided for in Sec. 354.101(b) and specified by hourly rates in 
Sec. Sec. 391.2 and 391.3 when the inspection service is performed on a 
continuous year-round resident basis and the services of an inspector or 
inspectors are required 4 or more hours per day. When the services of an 
inspector are required on an intermittent basis, the charges shall be 
those provided for in Sec. 354.101(b) and specified by hourly rates in 
Sec. Sec. 391.2 and 391.3 plus the travel expense and other charges 
provided for in Sec. 354.106.

[54 FR 6390, Feb. 10, 1989]



Sec. 354.109  Fees or charges for inspection service performed under 
cooperative agreement.

    Fees or charges to be made to an applicant for any inspection 
service which differ from those listed in Sec. Sec. 354.100 through 
354.107 shall be provided for by a cooperative agreement.



Sec. 354.110  Disposition of fees for inspection made under cooperative 
agreement.

    Fees for inspection under a cooperative agreement with any State or 
person shall be disposed of in accordance with the terms of such 
agreement. Such portion of the fees collected under a cooperative 
agreement as may be due the United States shall be remitted to the 
Service.

             Inspection Procedures; Ante-Mortem Inspections



Sec. 354.120  Manner of handling products in an official plant.

    Unless otherwise specified in the regulations in this part or by the 
Administrator, products which are to be further processed under 
inspection in an official plant shall be prepared and handled in such 
official plant under the supervision of an inspector.



Sec. 354.121  Ante-mortem inspection.

    An ante-mortem inspection of rabbits shall, where and to the extent 
considered necessary by the Administrator and under such instructions as 
he may issue from time to time, be made of

[[Page 396]]

rabbits on the day of slaughter in any official plant processing rabbits 
under inspection pursuant to the regulations in this part.



Sec. 354.122  Condemnation on ante-mortem inspection.

    Rabbits found in a dying condition on premises of an official plant 
shall be immediately destroyed and, together with any rabbits found dead 
on such premises, shall be disposed of in accordance with Sec. 354.132. 
Rabbits plainly showing, on ante-mortem inspection, any disease or 
condition, that under Sec. Sec. 354.129 to 354.131, inclusive, would 
cause condemnation of their carcasses on post-mortem inspection, shall 
be condemned. Rabbits which, on ante-mortem inspection, are condemned 
shall not be dressed, nor shall they be conveyed into any department of 
the plant where rabbit products are prepared or held. Rabbits which have 
been condemned on ante-mortem inspection and have been killed shall, 
under the supervision of an inspector of the Inspection Service, receive 
treatment as provided in Sec. 354.132.



Sec. 354.123  Segregation of suspects on ante-mortem inspection.

    All rabbits which, on ante-mortem inspection, do not plainly show, 
but are suspected of being affected with any disease or condition that 
under Sec. Sec. 354.129 to 354.131, inclusive, may cause condemnation 
in whole or in part on post-mortem inspection, shall be segregated from 
the other rabbits and held for separate slaughter, evisceration, and 
post-mortem inspection. The inspector shall be notified when such 
segregated lots are presented for post-mortem inspection and inspection 
of such rabbits shall be conducted separately. Such procedure for the 
correlation of ante-mortem and post-mortem findings by the inspector, as 
may be prescribed or approved by the Administrator, shall be carried 
out.



Sec. 354.124  Quarantine of diseased rabbits.

    If live rabbits, which are affected by any contagious disease which 
is transmissible to man, are brought into an official establishment, 
such rabbits shall be segregated. The slaughtering of such rabbits shall 
be deferred and they shall be dealt with in one of the following ways:
    (a) If it is determined by a veterinary inspector that further 
handling of the rabbits will not create a health hazard, the lot shall 
be subject to ante-mortem and post-mortem inspection pursuant to the 
regulations in this part.
    (b) If it is determined by a veterinary inspector that further 
handling of the rabbits will not create a health hazard, such rabbits 
may be released for treatment under the control of an appropriate State 
or Federal agency. If the circumstances are such that release for 
treatment is impracticable, a careful rabbit-by-rabbit ante-mortem 
inspection shall be made, and all rabbits found to be, or which are 
suspected of being, affected with the contagious disease transmissible 
to man shall be condemned.

                         Post-Mortem Inspection



Sec. 354.125  Evisceration.

    No viscera or any part thereof shall be removed from any rabbits 
which are to be processed under inspection in any official plant, except 
at the time of evisceration and inspection. Each carcass to be 
eviscerated shall be opened so as to expose the organs and the body 
cavity for proper examination by the inspector and shall be prepared 
immediately after inspection as ready-to-cook rabbit.



Sec. 354.126  Carcasses held for further examination.

    Each carcass, including all parts thereof, in which there is any 
lesion of disease or other condition, which might render such carcass or 
any part thereof unfit for human food, and with respect to which a final 
decision cannot be made on first examination by the inspector, shall be 
held for further examination. The identity of each such carcass, 
including all parts thereof, shall be maintained until a final 
examination has been completed.



Sec. 354.127  Condemnation and treatment of carcasses.

    Each carcass, or any part thereof, which is found to be unsound, un 
wholesome, or otherwise unfit for

[[Page 397]]

human food shall be condemned by the inspector and shall receive such 
treatment, under the supervision of the inspector, as will prevent its 
use for human food and preclude dissemination of disease through 
consumption by animals.



Sec. 354.128  Certification of carcasses.

    Each carcass and all parts and organs thereof which are found by the 
inspector to be sound, wholesome, and fit for human food shall be 
certified as provided in this part.

           Disposition of Diseased Rabbit Carcasses and Parts



Sec. 354.129  General.

    The carcasses or parts of carcasses of all rabbits inspected at an 
official establishment and found at the time of post-mortem inspection, 
or at any subsequent inspection, to be affected with any of the diseases 
or conditions named in other sections in this part, shall be disposed of 
in accordance with the section pertaining to the disease or condition. 
Owing to the fact that it is impracticable to formulate rules for each 
specific disease or condition and to designate at just what stage a 
disease process results in an unwholesome product, the decision as to 
the disposal of all carcasses, parts, or organs not specifically covered 
by the regulations, or by instructions of the Administrator issued 
pursuant thereto, shall be left to the inspector in charge, and if the 
inspector in charge is in doubt concerning the disposition to be made, 
specimens from such carcasses shall be forwarded to the laboratory for 
diagnosis.



Sec. 354.130  Diseases or conditions evident which require condemnation.

    (a) Carcasses of rabbits affected with or showing lesions of any of 
the following named diseases or conditions shall be condemned: 
Tularemia, anthrax, hemorrhagic septicemia, pyemia, septicemia, 
leukemia, acute enteritis, peritonitis, sarcomatosis, metritis, 
necrobacillosis (Smorl's Disease), tuberculosis, emaciation, 
streptobacillary pseudotuberculosis, and advanced stages of snuffles. 
Rabbits from pathological laboratories shall be condemned.
    (b) Any organ or part of a rabbit carcass affected with a tumor 
shall be condemned and when there is evidence that the general condition 
of the rabbit has been affected by the size, position, or nature of the 
tumor, the whole carcass shall be condemned. In cases of malignant 
neoplasms involving any internal organ to a marked extent, or affecting 
the muscles, skeleton, or body lymph glands, even primarily, the whole 
carcass shall be condemned.
    (c) Carcasses of rabbits showing any disease such as generalized 
melanosis, pseudoleukemia, and the like, which systemically affect the 
rabbit, shall be condemned.
    (d) Any organ or part of a carcass which is badly bruised or which 
is affected by an abscess, or a suppurating sore, shall be condemned. 
Parts or carcasses which are contaminated by pus shall be condemned.
    (e) Carcasses of rabbits contaminated by volatile oils, paints, 
poisons, gases, or other substances which affect the wholesomeness of 
the carcass shall be condemned.
    (f) All carcasses of rabbits so infected that consumption of the 
meat or meat food products thereof may give rise to meat poisoning shall 
be condemned. This includes all carcasses showing signs of any of the 
following diseases: Acute inflammation of the lungs, pleura, 
pericardium, peritoneum or meninges; septicemia or pyemia, whether 
traumatic, or without evident cause; gangrenous or severe hemorrhagic 
enteritis or gastritis; polyarthritis and acute nephritis. Immediately 
after the slaughter of any rabbit so infected, the infected premises and 
implements used shall be thoroughly sanitized. The part or parts of any 
carcass coming into contact with the carcass or any part of the carcass 
of any rabbit covered by this section other than those affected with 
acute inflammation of the lungs, pleura, pericardium, peritoneum or 
meninges, shall be condemned.
    (g) Carcasses showing any degree of icterus with a parenchymatous 
degeneration of organs, the result of infection or intoxication, and 
those which, as a result of a pathological condition,

[[Page 398]]

show an intense yellow or greenish-yellow discoloration without evidence 
of infection or intoxication shall be condemned.
    (h) Carcasses of rabbits affected with mange or scab in advanced 
stages, or showing emaciation or extension of the inflammation to the 
flesh, shall be condemned. When the diseased condition is slight, the 
carcass may be passed for food after removal and condemnation of the 
affected parts.
    (i) In the disposal of carcasses and parts of carcasses showing 
evidence of infestation with parasites not transmissible to man, the 
following general rules shall govern: If the lesions are localized in 
such manner and are of such character that the parasites and the lesions 
caused by them may be radically removed, the non-affected portion of the 
carcass, or part of the carcass, may be certified for food after the 
removal and condemnation of the affected portions. Where a part of a 
carcass shows numerous lesions caused by parasites, or the character of 
the infestation is such that complete extirpation of the parasites and 
lesions is difficult and uncertainly accomplished, or if the parasitic 
infestation or invasion renders the organ or part in any way unfit for 
food, the affected organ or part shall be condemned. Where parasites are 
found to be distributed in a carcass in such a manner or to be of such a 
character that their removal and the removal of the lesions caused by 
them are impracticable, no part of the carcass shall be certified for 
food and the entire carcass shall be condemned. Carcasses infested with 
a hydatid cyst or cysts (Echinococcus granulosis), transmissible to dogs 
and from dogs to man, shall in all cases be condemned regardless of the 
degree of infestation.
    (j) Carcasses of rabbits showing such degree of emaciation or anemic 
condition as would render the meat un wholesome, and carcasses which 
show a slimy degeneration of the fat or a serious infiltration of the 
muscles shall be condemned.



Sec. 354.131  Decomposition.

    Carcasses of rabbits deleteriously affected by post-mortem changes 
shall be disposed of as follows:
    (a) Carcasses which have reached a state of putrefaction or stinking 
fermentation shall be condemned.
    (b) [Reserved]
    (c) Carcasses affected by types of post-mortem change which are 
superficial in nature may be certified for food after removal and 
condemnation of affected parts.



Sec. 354.132  Disposal of condemned carcasses and parts.

    All condemned carcasses, or parts of carcasses, shall be disposed of 
by one of the following methods, under the supervision of an inspector 
of the Inspection Service: (Facilities and materials for carrying out 
the requirements in this section shall be furnished by the official 
establishment.)
    (a) Steam treatment (which shall be accomplished by processing the 
condemned product in a pressure tank under at least 40 pounds of steam 
pressure) or thorough cooking in a kettle or vat for a sufficient time 
to effectively destroy the product for human food purposes and preclude 
dissemination of disease through consumption by animals. Tanks and 
equipment used for this purpose or for rendering or preparing inedible 
products shall be in rooms or compartments separate from those used for 
the preparation of edible products. There shall be no direct connection, 
by means of pipes or otherwise, between tanks containing inedible 
products and those containing edible products.
    (b) Incineration or complete destruction by burning.
    (c) Chemical denaturing, which shall be accomplished by the liberal 
application to all carcasses and parts thereof, of:
    (1) Crude carbolic acid,
    (2) Kerosene, fuel oil, or used crank case oil,
    (3) Any phenolic disinfectant conforming to commercial standards CS 
70-41 or CS 71-41 which shall be used in at least 2 percent emulsion or 
solution, or
    (4) Any other substance that the Administrator approves which will 
decharacterize the carcasses or parts to the extent necessary to 
accomplish the purposes of this section.

[[Page 399]]

                      Reinspection and Ingredients



Sec. 354.133  Reinspection of edible products; ingredients.

    (a) Any inspected and certified edible product may be brought into 
an official plant only if the container of such product is marked for 
identification in the manner prescribed in Sec. 354.71(b) and the 
product is reinspected by an inspector at the time it is brought into 
such plant. Upon reinspection, if any such product or portion thereof is 
found to be unsound, unwholesome, or otherwise unfit for human food, 
such product, or portion thereof, shall be condemned and shall receive 
treatment as provided in Sec. 354.127.
    (b) Any product which is prepared under inspection in an official 
plant shall be inspected in such plant as often as the inspector deems 
it necessary in order to ascertain whether such product is sound, 
wholesome, and fit for human food at the time such product leaves such 
plant. Upon any such inspection, if any such product or portion thereof 
is found to be unsound, unwholesome, or otherwise unfit for human food, 
such product or portion thereof shall be condemned and shall receive 
treatment as provided in Sec. 354.127.
    (c) All substances and ingredients used in the manufacture or 
preparation of any edible product shall be clean, sound, wholesome, and 
fit for human food. Liquid and frozen egg products used in the 
preparation of any edible product shall have been prepared under 
continuous inspection of the Department.

                                 Appeals



Sec. 354.134  Appeal inspections; how made.

    Any person receiving inspection service may, if dissatisfied with 
any decision of an inspector relating to any inspection, file an appeal 
from such decision: Provided, That such appeal is filed within 48 hours 
from the time the decision was made. Any such appeal from a decision of 
an inspector shall be made to his immediate superior having jurisdiction 
over the subject matter of the appeal. Review of such appeal findings, 
when requested, shall be made by the immediate superior of the employee 
of the Department making the appeal inspection. The cost of any such 
appeal shall be borne by the applicant if the Administrator determines 
that the appeal is frivolous. The charges for such frivolous appeal 
shall be based on the hourly rates as specified in Sec. 354.101(b).

                         Inspection Certificates



Sec. 354.140  Forms of inspection certificates.

    Each inspection certificate issued pursuant to the regulations in 
this part shall be approved by the Administrator as to form, and:
    (a) Each rabbit inspection certificate shall show the class or 
classes of rabbits, the quantity of product contained in the respective 
lot, and all pertinent information concerning the condition and 
wholesomeness thereof;
    (b) Each food product inspection certificate shall show the names of 
the edible products covered by such certificate, the quantity of each 
such product, such shipping marks as are necessary to identify such 
products, and all pertinent information concerning the condition and 
wholesomeness thereof;
    (c) Each export certificate shall show the respective names of the 
exporter and the consignee, the destination, the shipping marks, the 
numbers of the export stamps attached to the edible products to be 
exported and covered by the certificate, and the names of such products 
and the total net weight thereof.



Sec. 354.141  Issuance and disposition of rabbits inspection certificates.

    (a) Upon the request of an interested party, any inspector is 
authorized to issue a rabbit inspection certificate with respect to any 
lot of rabbits inspected by him. Each certificate shall be signed by the 
inspector who made the inspection covered by the certificate, and if 
more than one inspector participated in the inspection of the lot of 
rabbits, each such inspector shall sign the certificate with respect to 
such lot.
    (b) The original and a copy of each inspection certificate, issued 
pursuant to Sec. Sec. 354.140 to 354.144, and not to exceed

[[Page 400]]

two additional copies thereof if requested by the applicant prior to 
issuance, shall, immediately upon issuance, be delivered or mailed to 
the applicant or person designated by him. One copy shall be filed in 
the office of the area supervisor serving the area in which the 
inspection was performed, and the remaining copies shall be disposed of 
in such manner as the Administrator may approve. Additional copies of 
any such certificate may be furnished to any interested party as 
provided in Sec. 354.105.



Sec. 354.142  Food product inspection certificates; issuance and 
disposition.

    (a) Upon the request of an interested party, any inspector is 
authorized to issue a food product inspection certificate with respect 
to any inspected and certified edible product after suitable examination 
of the product has been made by the inspector.
    (b) The original of each food product inspection certificate, and 
not to exceed two copies thereof, if requested, shall, immediately upon 
issuance, be delivered or mailed to the applicant or person designated 
by him. Another copy shall be filed in the office of the regional 
supervisor serving the area in which such certificate was issued, and 
one copy shall be forwarded to the Administrator. The last named two 
copies shall be retained until otherwise ordered by the Administrator.



Sec. 354.143  Export certificates; issuance and disposition.

    (a) Upon the request of an exporter, any inspector is authorized to 
issue an export certificate with respect to the shipment to any foreign 
country of any inspected and certified edible product after suitable 
examination of the product has been made by the inspector.
    (b) Each export certificate shall be issued in quintuplicate; the 
original shall be delivered to the exporter who requested such 
certificate, and the duplicate copy shall be delivered to the agent of 
the railroad or other carrier transporting such products from the United 
States. The triplicate copy of such export certificate shall be 
forwarded to the Administrator; the quadruplicate copy shall be filed in 
the office of the regional supervisor serving the area in which such 
export certificate was issued, and the memorandum copy shall be retained 
by the inspector for filing. The last named three copies shall be 
retained until otherwise ordered by the Administrator.



Sec. 354.144  Advance information.

    Upon the request of an applicant, all or part of the contents of any 
inspection certificate issued to such applicant may be telephoned or 
telegraphed to him, or to any person designated by him, at his expense.

       Basis of Acceptability of Other Official Inspection Systems



Sec. 354.160  General.

    Any rabbit inspection system may be deemed to be acceptable to the 
Administrator which:
    (a) Is conducted under the authority of laws, ordinances, or similar 
enactments of the State, county, city, or other political subdivision in 
which is located the official plant at which the ready-to-cook rabbits 
are prepared and
    (b) Imposes at least the requirements set forth in Sec. 354.161: 
Provided, That no such inspection shall be deemed acceptable to the 
Administrator with respect to any official plant in which ready-to-cook 
rabbits are prepared if he finds at any time that such requirements are 
not adequately enforced.



Sec. 354.161  Requirements as to manner of inspection.

    (a) The inspection shall be conducted by an inspector who is a 
qualified veterinarian or under the supervision of a qualified 
veterinarian. All such inspectors shall be employed by the State, 
county, city, or other political subdivision in which the official plant 
is located.
    (b) The inspection shall include post-mortem examination of each 
rabbit carcass during the evisceration operation.
    (c) All carcasses which show evidence of disease or any other 
condition which may render them unwholesome or unfit for food shall be 
condemned and shall be destroyed for food purposes under the supervision 
of an inspector. Each carcass and part thereof which has

[[Page 401]]

been inspected and passed or containers of carcasses or parts thereof 
shall bear the identifying inspection symbol of the official inspection 
system and the marking devices or labels shall be in the custody of the 
inspector at all times.



Sec. 354.162  Determining compliance with Sec. 354.161.

    A qualified veterinary supervisor of the rabbit inspection service 
shall investigate the manner of operation of the inspection system to 
determine the adequacy of the post-mortem examination and the compliance 
with the requirements contained in Sec. Sec. 354.160 to 354.162 prior 
to approving the official plant for the inspection of ready-to-cook 
rabbits. This supervisor, as well as any official graders who may be 
stationed in the official plant, shall periodically observe the 
inspection operations in the official plant to determine that the 
requirements of Sec. Sec. 354.160 to 354.162 are being met.

                          Sanitary Requirements

                                 General



Sec. 354.210  Minimum standards for sanitation, facilities, and operating 
procedures in official plants.

    The provisions of Sec. Sec. 354.210 to 354.247 shall apply with 
respect to inspection service in all official plants. The table set 
forth in Sec. 354.247 indicates some of the types of material which may 
be used in the construction of equipment, utensils, and facilities for 
use in the plant.

                     Buildings and Plant Facilities



Sec. 354.220  Buildings.

    The buildings shall be of sound construction and kept in good 
repair, and shall be of such construction as to prevent the entrance or 
harboring of vermin.
    (a) Outside openings. (1) The doors, windows, skylights, and other 
outside openings of the plant, except receiving rooms and live rabbit 
holding rooms, shall be protected by properly fitted screens or other 
suitable devices against the entrance of flies and other insects.
    (2) Outside doors, except in receiving rooms and live rabbit holding 
rooms, shall be self-closing and so hung that not over \1/4\-inch 
clearance remains when closed. Screen doors shall open toward the 
outside of the building.



Sec. 354.221  Rooms and compartments.

    Rooms and compartments used for edible products shall be separate 
and distinct from inedible products departments and from rooms where 
rabbits are slaughtered and skinned. Separate rooms shall be provided 
when required for conducting processing operations in a sanitary manner, 
and all rooms shall be of sufficient size to permit the installation of 
the necessary equipment for processing operations and the conduct of 
such operations in a sanitary manner.
    (a) Rooms for separate operation. The official plant should have 
separate rooms for each of the following operations depending upon the 
various types of operations conducted, but, in no case, shall the 
receiving or holding of live rabbits or killing operations be permitted 
in rooms in which eviscerating operations are performed:
    (1) The receiving and feeding of live rabbits.
    (2) Killing and skinning operations.
    (3) Eviscerating, chilling, and packing operations for ready-to-cook 
rabbits.
    (4) Inedible products departments.
    (5) Refuse room.
    (b) Rooms for holding carcasses for further inspection. Rooms and 
compartments in which carcasses or parts thereof are held for further 
inspection shall be in such number and such location as the needs of the 
inspection in the plant may require. They shall be equipped with locks 
and keys and the keys shall not leave the custody of the inspector in 
charge of the plant. All such rooms and compartments shall be marked 
conspicuously with the word ``retained'' in letters not less than 2 
inches high.
    (c) Coolers and freezers. Coolers and freezers of adequate size and 
capacity shall be provided to reduce the internal temperature of ready-
to-cook rabbits prepared and otherwise handled in the plant to 36 
[deg]F. within 24 hours unless other cooling facilities are available.

[[Page 402]]

    (d) Refuse rooms. Refuse rooms shall be entirely separate from other 
rooms in the plant, and shall have tight fitting doors and be properly 
ventilated.
    (e) Storage and supply rooms. The storage and supply rooms shall be 
in good repair, kept dry, and maintained in a sanitary condition.
    (f) Boiler room. The boiler room shall be a separate room, if 
necessary, to prevent its being a source of dirt and objectionable odors 
entering any room where ready-to-cook rabbits are prepared, processed, 
handled, and stored.
    (g) Inspector's office. Furnished office space, including, but not 
being limited to, light, heat, and janitor service shall be provided 
rent free in the official plant for the exclusive use for official 
purposes of the inspector and the Administration. The room or rooms set 
apart for this purpose must meet with the approval of the regional 
supervisor and be conveniently located, properly ventilated, and 
provided with lockers or cabinets suitable for the protection and 
storage of supplies and with facilities suitable for inspectors to 
change clothing.
    (h) Toilet rooms. Toilet rooms opening directly into rooms where 
rabbit products are exposed shall have self-closing doors and shall be 
ventilated to the outside of the building.



Sec. 354.222  Floors, walls, ceilings, etc.

    (a) Floors. All floors in rooms where exposed products are prepared 
or handled shall be constructed of or finished with materials impervious 
to moisture, so they can be readily and thoroughly cleaned. The floors 
in killing, ice cooling, ice packing, eviscerating, cooking, boning, and 
cannery rooms shall be graded for complete runoff with no standing 
water.
    (b) Walls, posts, partitions, doors. All walls, posts, partitions, 
and doors in rooms where exposed products are prepared or handled shall 
be smooth and constructed of materials impervious to moisture to a 
height of 6 feet above the floor to enable thorough cleaning. All 
surfaces above this height must be smooth and finished with moisture-
resistant material.
    (c) Ceilings. Ceilings must be moisture-resistant in rooms where 
exposed products are prepared or handled, and finished and sealed to 
prevent collection of dirt or dust that might sift through flooring 
above or fall from collecting surfaces on equipment or exposed product.



Sec. 354.223  Drainage and plumbing.

    There shall be an efficient drainage and plumbing system for the 
plant and premises.
    (a) Drains and gutters. All drains and gutters shall be properly 
installed with approved traps and vents. The drainage and plumbing 
system must permit the quick runoff of all water from plant buildings, 
and surface water around the plant and on the premises, and all such 
water shall be disposed of in such a manner as to prevent a nuisance or 
health hazard.
    (b) Sewage and plant wastes. (1) The sewerage system shall have 
adequate slope and capacity to remove readily all waste from the various 
processing operations and to minimize, and if possible to prevent, 
stoppage and surcharging of the system.
    (2) Grease traps which are connected with the sewerage system shall 
be suitably located but not near any edible products department or in 
any area where products are unloaded from or loaded into vehicles. To 
facilitate cleaning, such traps shall have inclined bottoms and be 
provided with suitable covers.
    (3) Toilet soil lines shall be separate from house drainage lines to 
a point outside the buildings unless they are positively trapped to 
prevent backing up. Drainage from toilet bowls and urinals shall not be 
discharged into a grease catch basin.
    (4) All floor drains shall be equipped with traps, constructed so as 
to minimize clogging, and the plumbing shall be so installed as to 
prevent sewerage from backing up and from flooding the floor.
    (5) Floor drainage lines should be of metal and at least 4 inches in 
diameter and open into main drains of at least 6 inches in diameter and 
shall be properly vented to outside air.
    (6) Where refrigerators are equipped with drains, such drains should 
be properly trapped and should discharge

[[Page 403]]

through an air gap into the sewer system. All new installations, and all 
replacements, or refrigerators equipped with drains shall meet these 
requirements.



Sec. 354.224  Water supply.

    The water supply shall be ample, clean, and potable with adequate 
facilities for its distribution in the plant and its protection against 
contamination and pollution.
    (a) Hot water at a temperature not less than 180 [deg]F. shall be 
available for sanitation purposes.
    (b) Hose connections with steam and water mixing valves or hot water 
hose connections shall be provided at convenient locations throughout 
the plant for cleaning purposes.
    (c) The refuse rooms shall be provided with adequate facilities for 
washing refuse cans and other equipment in the rooms; the rooms, cans, 
and equipment shall be cleaned after each day's use.



Sec. 354.225  Lavatory accommodations.

    Modern lavatory accommodations and properly located facilities for 
cleaning utensils and hands shall be provided.
    (a) Adequate lavatory and toilet accommodations, including, but not 
being limited to, running hot water and cold water, soap, and towels, 
shall be provided. Such accommodations shall be in or near toilet and 
locker rooms and also at such other places in the plant as may be 
essential to the cleanliness of all personnel handling products.
    (b) Sufficient metal containers shall be provided for used towels 
and other wastes.
    (c) An adequate number of hand washing facilities serving areas 
where dressed rabbits and edible products are prepared shall be operated 
by other than hand-operated controls, or shall be of a continuous flow 
type which provides an adequate flow of water for washing hands.
    (d) Durable signs shall be posted conspicuously in each toilet room 
and locker room directing employees to wash their hands before returning 
to work.
    (e) Toilet facilities shall be provided according to the following 
formula:

------------------------------------------------------------------------
                                                                 Toilet
                     Persons of same sex                         bowls
                                                                required
------------------------------------------------------------------------
1 to 15, inclusive...........................................          1
16 to 35, inclusive..........................................          2
36 to 55, inclusive..........................................      \1\ 3
56 to 80, inclusive..........................................      \1\ 4
For each additional 30 persons in excess of 80...............      \1\ 1
------------------------------------------------------------------------
\1\ Urinals may be substituted for toilet bowls but only to the extent
  of \1/3\ of the total number of bowls stated.



Sec. 354.226  Lighting and ventilation.

    There shall be ample light, either natural or artificial or both, of 
good quality and well distributed, and sufficient ventilation for all 
rooms and compartments to insure sanitary conditions.
    (a) All rooms in which rabbits are killed, eviscerated, or otherwise 
processed shall have at least 30 foot candles of light intensity on all 
working surfaces except that at the inspection stations such light 
intensity shall be of 50 foot candles. In all other rooms, there shall 
be provided at least 5 foot candles of light intensity when measured at 
distance of 30 inches from the floor.
    (b) All rooms shall be adequately ventilated to eliminate 
objectionable odors and minimize moisture condensation.

                         Equipment and Utensils



Sec. 354.230  Equipment and utensils.

    Equipment and utensils used for the preparation, processing, or 
other handling of any product in the plant shall be suitable for the 
purpose intended and shall be of such material and construction as will 
facilitate their thorough cleaning and insure cleanliness in the 
preparation and handling of products.
    (a) Live rabbit holding pens shall be so constructed as to allow 
satisfactory ante-mortem examination and to permit proper cleaning.
    (b) Metal refuse containers shall be provided, and such containers 
shall be kept covered.
    (c) Insofar as it is practical, equipment and utensils shall be made 
of metal or other impervious material.

[[Page 404]]

Trucks and receptacles used for handling inedible products shall be of 
similar construction and shall be conspicuously and distinctly marked 
and shall not be used for handling any edible products.
    (d) Chilling vats or tanks used for chilling ready-to-cook rabbits 
shall be made of metal or other hard-surfaced impervious material.
    (e) Where grading bins are used for ready-to-cook rabbits, they 
shall be of sufficient number and capacity to handle the grading 
adequately without the use of makeshift bins and all ready-to-cook 
rabbits shall be kept off the floor. Grading bins may be made of metal 
or enameled wood and shall be constructed and maintained in such a 
manner as to allow easy and thorough cleaning. All replacements of such 
bins shall, however, be of metal.
    (f) Except as otherwise provided herein, all equipment and utensils 
used in the killing, skinning, eviscerating, chilling, and packing rooms 
shall be of metal or other impervious material and constructed so as to 
permit proper and complete cleaning.
    (g) Conveyors: (1) Conveyors used in the preparation of ready-to-
cook rabbits shall be of metal or other acceptable material and of such 
construction as to permit thorough and ready cleaning and easy 
identification of viscera with its carcass.
    (2) Overhead conveyors shall be so constructed and maintained that 
they do not allow grease, oil, or dirt to accumulate on the drop chain 
or shackle, which shall be of noncorrosive metal.
    (3) Nonmetallic belt-type conveyors used in moving edible products 
shall be of water-proof composition.
    (h) Inspection, eviscerating, and cutting tables shall be made of 
metal and have coved corners and be so constructed and placed to permit 
thorough cleaning.
    (i) In plants where no conveyors are used, each carcass shall be 
eviscerated in an individual metal tray of seamless construction.
    (j) Water spray washing equipment shall be used for washing 
carcasses inside and out.
    (k) Watertight metal receptacles shall be used for entrails and 
other waste resulting from preparation of ready-to-cook rabbits.
    (l) Watertight trucks and receptacles for holding or handling 
diseased carcasses and diseased parts of carcasses shall be so 
constructed as to be readily and thoroughly cleaned; such trucks and 
receptacles shall be marked in a conspicuous manner with the word 
``condemned'' in letters not less than 2 inches high and, when required 
by the inspector in charge, shall be equipped with facilities for 
locking and sealing.
    (m) Freezing rooms should be adequately equipped to freeze ready-to-
cook rabbits solid in less than 48 hours. Ready-to-cook rabbits should 
be frozen at temperatures of -10 [deg]F. to -40 [deg]F. and should be 
stored at 0 [deg]F. or below, with the temperature maintained as 
constant as possible. Freezing room should be equipped with floor racks 
or pallets and fans to insure air circulation.
    (n) Cooling racks should be made of metal and be readily accessible 
for thorough washing and cleaning. All replacements of cooling racks 
shall be made of metal.
    (o) Trucks and receptacles in which carcasses or parts thereof are 
held for further inspection shall be in such number and such location as 
the needs of the inspection in the plant may require. They shall be 
equipped for locking by means of lock and key and the key shall not 
leave the custody of the inspector in charge of the plant. Such trucks 
and receptacles shall be marked conspicuously with the word ``retained'' 
in letters not less than 2 inches high.



Sec. 354.231  Accessibility.

    All equipment shall be so placed as to be readily accessible for all 
processing and cleaning operations.



Sec. 354.232  Restrictions on use.

    Equipment and utensils used in the official plant shall not be used 
outside the official plant except under such conditions as may be 
prescribed or approved by the national supervisor, and equipment used in 
the preparation of any article (including, but not being limited to, 
animal food) from inedible material shall not be used outside of

[[Page 405]]

the inedible products department except under such conditions as may be 
prescribed or approved by the national supervisor.

Maintenance of Sanitary Conditions and Precautions Against Contamination 
                               of Products



Sec. 354.240  General.

    The premises shall be kept free from refuse, waste materials, and 
all other sources of objectionable odors and conditions.



Sec. 354.241  Cleaning of rooms and compartments.

    Rooms, compartments, or other parts of the official plant shall be 
kept clean and in sanitary condition.
    (a) All blood, offal, rabbits or parts of rabbits too severely 
damaged to be salvaged and all discarded containers and other materials 
shall be completely disposed of daily.
    (b) All windows, doors, and light fixtures in the official plant 
shall be kept clean.
    (c) All docks and rooms shall be kept clean and free from debris and 
unused equipment and utensils.
    (d) Live rabbit receiving docks and receiving rooms shall be of such 
construction as readily to permit their thorough cleaning, and such 
docks and rooms should be kept clean at all times.
    (e) Floors in live rabbit holding rooms shall be cleaned with such 
regularity as may be necessary to maintain them in a sanitary condition.
    (f) The killing and skinning room shall be kept clean and free from 
offensive odors at all times.
    (g) The walls, floors, and all equipment and utensils used in the 
killing and skinning room shall be thoroughly washed and cleaned after 
each day's operation.
    (h) The floor in the killing and skinning rooms shall be cleaned 
frequently during killing and skinning operations and be kept reasonably 
free from accumulated blood, offal, water, and dirt.
    (i) All equipment in the toilet room and locker room, as well as the 
room itself, shall be kept clean, sanitary, and in good repair.
    (j) Cooler and freezer rooms shall be free from objectionable odors 
of any kind and shall be maintained in a sanitary condition (including, 
but not being limited to, the prevention of drippings from refrigerating 
coils onto products).



Sec. 354.242  Cleaning of equipment and utensils.

    Equipment and utensils used for preparing or otherwise handling any 
product shall be kept clean and in a sanitary condition and in good 
repair.
    (a) Pens shall be cleaned regularly and the manure removed from the 
plant daily.
    (b) All equipment and utensils used in the killing and skinning 
rooms shall be thoroughly washed and cleaned after each day's operation. 
The eviscerating, chilling, and packing room and equipment and utensils 
used therein shall be maintained in a clean and sanitary condition.
    (c) Graders' and packers' gloves and grading bins shall be washed 
daily and used only for grading or packing, as the case may be.
    (d) All crates or pens used for transporting live rabbits to the 
plant shall be cleaned regularly.
    (e) Chilling vats or tanks, if practicable, shall be emptied after 
each use. They shall be thoroughly cleaned once daily and, after each 
cleaning operation, they shall be sanitized with such compounds or by 
such methods as may be approved or prescribed by the Administrator.
    (f) When synchronized overhead conveyors and tray conveyors are 
used, the trays shall be completely washed and sanitized after being 
automatically emptied of inedible viscera.
    (g) When a conveyor tray operation is used, each carcass shall be 
eviscerated in an individual metal tray of seamless construction, and 
such trays shall be completely washed and sanitized after each use.
    (h) Tables, shelves, bins, trays, pans, knives, and all other tools 
and equipment used in the preparation of ready-to-cook rabbits shall be 
kept clean and sanitary at all times. Cleaned equipment and utensils 
shall be drained on racks and shall not be nested.

[[Page 406]]

    (i) Drums, cans, tanks, vats, and other receptacles used to hold or 
transport ready-to-cook rabbits shall be kept in a clean and sanitary 
condition.



Sec. 354.243  Operations and procedures.

    Operations and procedures involving the preparation, storing, or 
handling of any product shall be strictly in accord with clean and 
sanitary methods.
    (a) There shall be no handling or storing of materials which create 
an objectionable condition in rooms, compartments, or other places in 
the plant where any product is prepared, stored, or otherwise handled.
    (b) Blood from the killing operation shall be confined to a 
relatively small area and kept from being splashed about the room.
    (c) In the final washing, the carcass shall be passed through a 
system of sprays providing an abundant supply of fresh clean water.
    (d) The floors in the eviscerating room shall be kept clean and 
reasonably dry during eviscerating operations and free of all refuse.
    (e) Conveyors shall be operated at such speeds as will permit a 
sanitary eviscerating operation and will permit adequate inspection for 
condition and wholesomeness.
    (f) Mechanized packaging equipment shall be maintained in good 
sanitary condition.
    (g) All offal resulting from the eviscerating operation shall be 
removed as often as necessary to prevent the development of a nuisance.
    (h) Paper and other material used for lining containers in which 
products are packaged shall be of such kinds as do not tear readily 
during use, but remain intact when moistened by the product. Wooden 
containers to be used for packaging ready-to-cook rabbits shall be fully 
lined except when the individual carcasses to be packaged therein are 
fully wrapped.
    (i) Protective coverings shall be used for the product in the plant 
and as it is distributed from the plant, as will afford adequate 
protection for the product against contamination by any foreign 
substance (including, but not being limited to, dust, dirt, and 
insects), considering the means intended to be employed in transporting 
the product from the plant.
    (j) Refuse may be moved directly to loading docks only for prompt 
removal.
    (k) Cleanliness and hygiene of personnel: (1) All employees coming 
in contact with exposed edible products or edible products handling 
equipment shall wear clean garments and should wear caps or hair nets, 
and shall keep their hands clean at all times while thus engaged.
    (2) Hands of employees handling edible products or edible products 
handling equipment shall be free of infected cuts, boils, and open sores 
at all times while thus engaged.
    (3) Every person, after each use of toilet or change of garments, 
shall wash his hands thoroughly before returning to duties that require 
the handling of edible products or containers therefor or edible 
products handling equipment.
    (4) Neither smoking nor chewing of tobacco shall be permitted in any 
room where exposed edible products are prepared, processed, or otherwise 
handled.



Sec. 354.244  Temperatures and cooling and freezing procedures.

    Temperatures and procedures which are necessary for cooling and 
freezing of rabbits in accordance with sound commercial practice shall 
be maintained in the coolers and freezers, and chilling temperatures and 
procedures shall also be in accordance with sound commercial practice.
    (a) Cooling. Immediately after evisceration and washing of the 
carcass, it shall be placed in a cooling tank containing running cold 
tap water to remove the animal heat from the carcass. Carcasses shall 
not be allowed to remain in the cooling tank for longer than 1 hour.
    (b) Air chilling. Immediately after the initial water chilling, the 
carcasses shall be placed in cooling racks and thereupon placed in a 
refrigerated cooler with moderate air movements and a temperature which 
will reduce the internal temperature of the carcasses to from 36 [deg]F. 
to 40 [deg]F., both inclusive, within 24 hours.
    (c) Freezing. (1) When ready-to-cook rabbits are packaged in bulk or 
shipping containers, the carcasses should

[[Page 407]]

be individually wrapped or packaged in water-vapor resistant cartons or 
the containers should be lined with heavy water-vapor resistant paper so 
as to assure adequate overlapping of the lining to completely surround 
the carcasses and to permit unsealed closure or sealing in such a manner 
that water-vapor loss from the product is considerably retarded or 
prevented. The rabbit carcasses should receive an initial rapid freezing 
under such packaging, temperature, air circulation, and stacking 
conditions which will result in freezing the carcasses solid in less 
than 48 hours.
    (2) Frozen ready-to-cook rabbits shall be held under conditions 
which will maintain the product in a solidly frozen state with 
temperature maintained as constant as possible.
    (d) Refrigeration. Immediately after packaging, all ready-to-cook 
rabbits, other than those which are shipped from the plant in a 
refrigerated carrier, should be moved into the freezer, except that a 
period not exceeding 72 hours will be permitted for transportation and 
temporary holding before placing in the freezer provided such rabbits 
are held at not above 36 [deg]F.



Sec. 354.245  Vermin.

    Every practicable precaution shall be taken to exclude flies, rats, 
mice, and other vermin from the official plant. Dogs, cats, and other 
pets shall be excluded from rooms where edible products are processed, 
handled, or stored.



Sec. 354.246  Exclusion of diseased persons.

    No person affected with any communicable disease (including, but not 
being limited to, tuberculosis) in a transmissible stage shall be 
permitted in any room or compartment where exposed or unpacked edible 
products are prepared, processed, or otherwise handled.



Sec. 354.247  Table showing types of materials.

----------------------------------------------------------------------------------------------------------------
                                                                              Stainless
               Equipment, utensils, and facilities                  Iron      steel and   Aluminum   Galvanized
                                                                             monel metal                iron
----------------------------------------------------------------------------------------------------------------
Holding pens....................................................         A             A         A             A
Overhead conveyors..............................................         A             A         A             A
Conveyor track..................................................         A             A  ........             A
Shackles........................................................  ........             A  ........             A
Shackle chain...................................................         A             A  ........             A
Eviscerating pans...............................................  ........             A         A             A
Inspection table................................................  ........             A         A             A
Inside and outside washer.......................................  ........             A         A             A
Cooling tanks and racks.........................................  ........             A         A             A
Utensils for handling edible products...........................  ........             A         A             A
Framework (of equipment)........................................         A  ............  ........  ............
----------------------------------------------------------------------------------------------------------------
Key: A--Acceptable.



Sec. 354.248  Scope and applicability of rules of practice.

    The rules of practice of the Department of Agriculture in subpart H 
of part I, subtitle A, title 7 of the Code of Federal Regulations, are 
the rules of practice applicable to adjudicatory, administrative 
proceedings under the regulations in this part (9 CFR part 354).

[43 FR 11148, Mar. 17, 1978]



PART 355_CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; 
INSPECTION, CERTIFICATION, AND IDENTIFICATION AS TO CLASS, QUALITY, 
QUANTITY, AND CONDITION--Table of Contents




                               Definitions

Sec.
355.1 Meaning of words.
355.2 Terms defined.

                       Scope of Inspection Service

355.3 Plants eligible for inspection.

[[Page 408]]

      Application for Inspection, Certification, and Identification

355.4 Application.
355.5 Drawings.
355.6 Review of applications.

                       Inauguration of Inspection

355.7 Inauguration of inspection.
355.8 Official number.
355.9 Numbers granted same ownership or control.
355.10 Assignment of inspectors.

                                  Fees

355.11 Charge for survey.
355.12 Charge for service.

                        Sanitation and Facilities

355.13 Sanitation.
355.14 Facilities.
355.15 Inedible material operating and storage rooms; outer premises, 
          docks, driveways, etc.; fly-breeding material; nuisances.
355.16 Control of flies, rats, mice, etc.
355.17 Tagging equipment ``U.S. rejected.''
355.18 Drawings and specifications to be furnished.

                          Inspection Procedure

355.19 Inspector to be informed when plant operates.
355.20 Inspector to have access to plant at all times.
355.21 Products entering inspected plants.
355.22 Designation of place of receipt of returned products.
355.23 Tagging products ``U.S. retained.''
355.24 Processes to be supervised.
355.25 Canning with heat processing and hermetically sealed containers; 
          closures; code marking; heat processing; incubation.
355.26 Samples of certified products, ingredients, etc., to be taken for 
          examination.
355.27 Reports of violations of regulations.

                     Disposal of Condemned Material

355.28 Unfit material to be condemned.

                    Composition of Certified Products

355.29 Composition of certified products for dogs, cats, and other 
          carnivora.

                               Supervision

355.31 Supervision by inspector.

                                Labeling

355.32 Labeling required.
355.33 Plant number to be embossed on metal containers.
355.34 Labels, approval of, by Administrator.
355.35 Label information to be displayed on principal panel.
355.36 Obsolete labels.
355.37 Alteration or limitation of statement of certification.

                                Penalties

355.38 Withdrawal of service.

                                 Appeals

355.39 Appeals from decisions made under this part.

                                 Reports

355.40 Plants to furnish information for reports.

             Mule Meat and Animal Food, Mule Meat By-Product

355.41 Antemortem and postmortem inspection for mules.
355.42 Marking of mule meat and animal food mule meat by-product.
355.43 Scope and applicability of rules of practice.

    Authority: 7 U.S.C. 1622, 1624; 7 CFR 2.17 (g) and (i), 2.55.

    Source: 23 FR 10107, Dec. 23, 1958, unless otherwise noted. 
Redesignated at 30 FR 4195, Mar. 31, 1965.

                               Definitions



Sec. 355.1  Meaning of words.

    Words used in this part in the singular form shall be deemed to 
import the plural, and vice versa, as the case may demand.



Sec. 355.2  Terms defined.

    When used in this part unless otherwise distinctly expressed or 
manifestly incompatible with the intent thereof:
    (a) Person means any individual, partnership, association, business 
trust, corporation, or any organized group of persons, whether 
incorporated or not.
    (b) Program means the Meat and Poultry Inspection Program of the 
Food Safety and Inspection Service of the United States Department of 
Agriculture.
    (c) Circuit supervisor means an inspector of the Program assigned to 
supervise and perform official work at a circuit. Such inspector is 
assigned by and reports directly to the Administrator or other person 
designated by him.
    (d) Inspector means an inspector of the Program.
    (e) Inspected plant means any plant preparing certified products for 
dogs,

[[Page 409]]

cats, or other carnivora at which inspection is maintained under the 
regulations contained in this part.
    (f) Circuit means one or more inspected plants assigned to a circuit 
supervisor.
    (g) Animal protein supplement means a product containing animal 
protein and other elements normal to the component for use in 
compounding a maintenance food for dogs, cats, and other carnivora.
    (h) Products means the products for dogs, cats, and other carnivora 
marked, or to be marked, with the certification provided in this part.
    (i) Meat means the U.S. inspected and passed and so identified 
clean, wholesome muscle tissue of cattle, sheep, swine, or goats which 
is skeletal or which is found in the tongue, in the diaphragm, in the 
heart, or in the esophagus with or without the accompanying and 
overlying fat and the portions of skin, sinews, nerves, and blood 
vessels which normally accompany the muscle tissue and which are not 
separated from it in the process of dressing. It does not include the 
muscle found in the lips, snout, or ears.
    (j) Animal food meat by-product means the part other than meat which 
has been derived from one or more cattle, sheep, swine or goats that 
have been U.S. Inspected and Passed and is fit for use as animal food.
    (k) Horse meat means the U.S. inspected and passed and so identified 
clean, wholesome muscle tissue of horses which is skeletal or which is 
found in the tongue, in the diaphragm, in the heart, or in the 
esophagus, with or without the accompanying and overlying fat and the 
portions of sinews, nerves, and blood vessels which normally accompany 
the muscle tissue and which are not separated from it in the process of 
dressing.
    (l) Animal food horse meat by-product means the part other than meat 
which has been derived from one or more horses that have been U.S. 
Inspected and Passed and is fit for use as animal food.
    (m) Mule meat means the clean, sound, healthful, wholesome muscle 
tissue derived from mules as determined by antemortem and postmortem 
inspection by an inspector in accordance with Sec. 355.41. It includes 
muscle tissue which is found in the tongue, in the diaphragm, in the 
heart or in the esophagus, with or without the accompanying and 
overlying fat and the portions of sinews, nerves, and blood vessels 
which normally accompany the muscle tissue and which are not separated 
from it in the process of dressing.
    (n) Animal food mule meat by-product means the part other than meat 
which has been derived from one or more mules that have been handled in 
accordance with Sec. 355.41 and is fit for use as animal food.
    (o) Bone means the U.S. inspected and passed and so identified 
clean, wholesome bone which has been derived from cattle, sheep, swine, 
goats or horses, or bone derived from mules slaughtered and passed under 
Program inspection in accordance with Sec. 355.41.
    (p) Poultry means any domesticated bird slaughtered in accordance 
with the Poultry Products Inspection Act, Public Law 85-172, 85th 
Congress, S. 1747, dated August 28, 1957 (21 U.S.C. 451 et seq.).
    (q) Poultry product means any edible part of fresh poultry which 
have been slaughtered for human food and from which the blood, feathers, 
feet, head and viscera have been removed in accordance with rules and 
regulations promulgated by the Secretary of Agriculture.
    (r) Administrator. The Administrator of the Food Safety and 
Inspection Service or any officer or employee of the Department to whom 
authority has heretofore been delegated or may hereafter be delegated to 
act in his stead.
    (s) Whale meat means the muscle tissue of whales which is fit for 
use in animal food.
    (t) Fish means the whole or part of any aquatic, water breathing 
vertebrates, commonly designated as fish, which is fit for use in animal 
food.
    (u) Animal food poultry byproduct means any portion of carcasses of 
poultry slaughtered under inspection and passed in accordance with the 
Poultry

[[Page 410]]

Products Inspection Act which is fit for use in animal food.

[23 FR 10107, Dec. 23, 1958, as amended at 25 FR 1356, Feb. 1960; 29 FR 
18418, Dec. 25, 1964. Redesignated and amended at 30 FR 4195, Mar. 31, 
1965; 32 FR 13115, Sept. 15, 1967; 33 FR 6707, May 2, 1968]

                       Scope of Inspection Service



Sec. 355.3  Plants eligible for inspection.

    Upon application, inspection may be granted at a plant where 
products are to be prepared, when the Administrator has determined that 
the application conforms to and the plant meets with the requirements of 
this part.

      Application for Inspection, Certification, and Identification



Sec. 355.4  Application.

    The owner or operator of any plant of the kind specified in Sec. 
355.3 may apply to the Administrator for inspection, certification, and 
identification. In cases of change of ownership or change of location, 
new applications shall be made.

(Approved by the Office of Management and Budget under control number 
0583-0036)

[23 FR 10107, Dec. 23, 1958. Redesignated at 30 FR 4195, Mar. 31, 1965, 
and amended at 47 FR 746, Jan. 7, 1982]



Sec. 355.5  Drawings.

    Triplicate copies of complete drawings with specifications, 
consisting of floor plans showing the locations of such features as the 
principal pieces of equipment, floor drains, principal drainage lines, 
hand-washing basins, and hose connections for cleanup purposes; 
elevations; roof plans when necessary to show size and location of 
skylights and the like; cross and longitudinal sections of the various 
buildings, showing such features as principal pieces of equipment, 
heights of ceilings, conveyor rails, and character of floors, walls, and 
ceilings; and a plot plan showing relationship of various departments 
and structures of the plants, properly drawn to scale, shall accompany 
applications. Where complete approved drawings and specifications are 
available in the files of the Meat and Poultry Inspection Program, Food 
Safety and Inspection Service, U.S. Department of Agriculture, covering 
a plant operating under the supervision of that Program, it will not be 
necessary that drawings and specifications accompany an application made 
under this part for inspection at such plant.

[23 FR 10107, Dec. 23, 1958. Redesignated and amended at 30 FR 4195, 
Mar. 31, 1965; 32 FR 13115, Sept. 15, 1967]



Sec. 355.6  Review of applications.

    The Administrator will determine whether applications shall be 
granted or refused.

                       Inauguration of Inspection



Sec. 355.7  Inauguration of inspection.

    When an application for inspection, certification, and 
identification is granted, the circuit supervisor shall, at or prior to 
the inauguration of inspection, inform the owner or operator of the 
plant of the requirements of the regulations contained in this part. 
Inspection shall not be begun if a plant is not in a sanitary condition. 
The applicant shall adopt and enforce all necessary measures and shall 
comply with all such directions as the circuit supervisor may prescribe 
for carrying out the purposes of this part.



Sec. 355.8  Official number.

    To each plant granted inspection an official number shall be 
assigned. Such number shall be preceded by the letter ``A'' and used to 
identify all certified products prepared in the plant.



Sec. 355.9  Numbers granted same ownership or control.

    Two or more official plants under the same ownership or control may 
be granted the same official number, provided a serial letter is added 
after the number in each case to identify the plant.



Sec. 355.10  Assignment of inspectors.

    The Administrator shall designate a circuit supervisor of the 
inspection at each circuit and assign to him such assistants as may be 
necessary.

[[Page 411]]

                                  Fees



Sec. 355.11  Charge for survey.

    Applicants for the inspection, certification, and identification 
shall reimburse the department for salary, travel cost, per diem 
allowance, and the like, expended incidental to any survey of the 
premises for which the inspection is requested, and in connection with 
any review of plans which may be made.



Sec. 355.12  Charge for service.

    The fees to be charged and collected by the Administrator shall be 
at the rates specified in Sec. Sec. 391.2, 391.3, and 391.4 
respectively for base time; for overtime, including Saturdays, Sundays, 
and holidays; and for certain laboratory services which are not covered 
under the base time, overtime, and/or holiday costs. Such fees shall 
reimburse the Service for the cost of the inspection service furnished.

[54 FR 6390, Feb. 10, 1989]

                        Sanitation and Facilities



Sec. 355.13  Sanitation.

    Sanitary facilities and accommodations shall be furnished by every 
inspected plant. Of these the following are specifically required:
    (a) Dressing rooms, toilet rooms, and urinals shall be sufficient in 
number, ample in size, and conveniently located. They shall be properly 
lighted and ventilated and of sanitary construction. They shall be 
separate from the rooms and compartments in which certified products are 
prepared, stored or handled.
    (b) Modern hand-washing basins, including running hot and cold 
water, soap and towels shall be placed in or near toilet rooms.
    (c) Toilet soil lines shall be separate from house drainage lines to 
a point outside the buildings and drainage from toilet soil lines shall 
not be discharged into a grease catchbasin.
    (d) Properly located facilities shall be provided for cleansing 
utensils and hands of all persons handling or preparing any products to 
be certified.
    (e) Equipment and utensils used for preparing any products to be 
certified shall be of such material and construction as will make them 
susceptible of being readily and thoroughly cleaned.
    (f) Trucks and receptacles used for inedible materials shall be of 
such construction as to permit ready and thorough cleansing, shall bear 
a conspicuous and distinctive mark, and shall be used exclusively for 
handling inedible material.
    (g) Rooms, compartments, places, equipment and utensils used for 
preparing, storing or otherwise handling any certified products, and all 
other parts of the inspected plant, shall be kept clean. There shall be 
no handling or storing of materials which creates an objectionable 
condition in rooms, compartments or places where certified products are 
prepared, stored or otherwise handled.



Sec. 355.14  Facilities.

    Adequate facilities for the preparation and inspection of the 
products to be certified shall be furnished and maintained by the 
inspected plant. Of these the following are specifically required:
    (a) A room or compartment adequately equipped for locking or sealing 
shall be provided for holding products prepared for certification or 
material used in their preparation which are identified as ``U.S. 
retained,'' and such rooms and compartments shall be conspicuously 
marked with the phrase ``U.S. retained'' prominently displayed.
    (b) Adequate facilities, including denaturing materials, for the 
proper disposal of condemned articles including carcasses, parts of 
carcasses and other materials, shall be provided.
    (c) Rooms or compartments adequate in size and properly equipped for 
holding samples of canned products prepared for certification under 
incubation, shall be maintained at the temperature specified in Sec. 
355.25(i).
    (d) Furnished office room, including light, heat, janitor, and 
laundry service shall be provided rent free for the exclusive use of the 
inspector. These facilities shall be set apart for this purpose and 
provided with lockers suitable for the protection and storage of program 
supplies. Laundering of inspectors' outer work clothing shall be 
provided by the management of inspected plants.

[[Page 412]]



Sec. 355.15  Inedible material operating and storage rooms; outer 
premises, docks, driveways, etc.; fly-breeding material; nuisances.

    All operating and storage rooms and departments of inspected plants 
used for inedible material shall be maintained in clean condition, and 
shall be separate and apart from rooms and departments where certified 
products are prepared, handled, or stored. Docks and areas where cars 
and vehicles are loaded, and driveways, approaches and alleyways shall 
be properly paved and drained and the outer premises of every inspected 
plant shall be kept in clean and orderly condition. All catchbasins on 
the premises shall be of such construction and location and shall be 
given such attention as will insure their being kept in acceptable 
condition as regards odors and cleanliness. The accumulation on the 
premises of any material in which flies may breed, or the maintenance of 
any nuisance on the premises shall not be allowed.



Sec. 355.16  Control of flies, rats, mice, etc.

    Flies, rats, mice, and other vermin shall be excluded from inspected 
plants and premises.



Sec. 355.17  Tagging equipment ``U.S. rejected.''

    When necessary, inspectors shall attach a ``U.S. rejected'' tag to 
any equipment or utensil which is unclean or the use of which would be 
in conflict with the provisions of this part. No equipment or utensil so 
tagged shall again be used until made acceptable under this part and 
until removal of the tag. Such tag shall not be removed from the 
equipment or utensil by anyone other than an inspector.



Sec. 355.18  Drawings and specifications to be furnished.

    Triplicate copies of complete drawings and specifications for 
remodeling inspected plants or for new structures at such plants shall 
be submitted to the Administrator and approval obtained for the plans in 
advance of construction.

                          Inspection Procedure



Sec. 355.19  Inspector to be informed when plant operates.

    The management of an inspected plant shall inform the inspector or 
the circuit supervisor when work in each department has been concluded 
for the day, and the day and hour when work will be resumed therein. 
There shall be no preparation of certified products at an inspected 
plant except under the supervision of an inspector.



Sec. 355.20  Inspector to have access to plant at all times.

    For the purpose of examination or inspection necessary to enforce 
any of the provisions of this part, inspectors shall have access at all 
times by day or night, whether the plant is being operated or not, to 
every part of an inspected plant.



Sec. 355.21  Products entering inspected plants.

    All products of a kind certified under this part or materials to be 
used in the preparation of such products when brought into an inspected 
plant shall be identified and inspected at the time of receipt and be 
subject to further inspection in such manner and at such time as may be 
deemed necessary. If, upon inspection, any such article is found to be 
unsound or otherwise unfit, it shall be handled as provided in Sec. 
355.28.



Sec. 355.22  Designation of place of receipt of returned products.

    Certified products returned to an inspected plant shall be received 
at a dock or place specifically designated for the purpose by the plant 
management with the approval of the circuit supervisor. Such returned 
products shall be inspected there by the inspector before further 
entering the plant.



Sec. 355.23  Tagging products ``U.S. retained.''

    A ``U.S. Retained'' tag shall be placed by an inspector at the time 
of inspection on all certified products, materials to be used in the 
preparation of certified products, or containers thereof, whenever such 
certified products, materials, or containers are suspected

[[Page 413]]

of being unsound or otherwise unfit or not in conformity with the 
requirements contained in this part. Such tags so placed shall not be 
removed by anyone other than an inspector.



Sec. 355.24  Processes to be supervised.

    All processes used in the preparation of the certified products 
shall be supervised by an inspector. All steps in the process of 
manufacture shall be conducted carefully and with strict cleanliness. 
Inspected plants shall not prepare products of a kind certified under 
this part unless they conform with the regulations contained in this 
part.



Sec. 355.25  Canning with heat processing and hermetically sealed 
containers; closures; code marking; heat processing; incubation.

    (a) Containers shall be cleaned thoroughly immediately before 
filling, and precaution must be taken to avoid soiling the inner 
surfaces subsequently.
    (b) The inside surfaces of containers of metal, glass, or other 
material shall be washed by spraying in an inverted position with 
running water at a temperature of at least 180 [deg]F. The container 
washing equipment shall be provided with a thermometer to register the 
temperature of the water used for cleaning the containers.
    (c) Perfect closure is required for hermetically sealed containers. 
Heat processing shall follow promptly after closing.
    (d) Careful inspection shall be made of the containers by competent 
plant employees immediately after closing, and containers which are 
defectively filled or defectively closed, or which show inadequate 
vacuum, shall not be further processed until the defect has been 
corrected. The containers shall again be inspected by plant employees 
when they have cooled sufficiently for handling after processing by 
heating. The contents of defective containers shall be condemned unless 
correction of the defect is accomplished within six hours following the 
sealing of the containers or completion of the heat processing, as the 
case may be, except that (1) if the defective condition is discovered 
during an afternoon run the cans of product may be held in coolers at a 
temperature not exceeding 38 [deg]F. under conditions that will promptly 
and effectively chill them until the following day when the defect may 
be corrected; and (2) short vacuum or overstuffed cans of products which 
have not been handled in accordance with the above may be incubated as 
provided in paragraph (i) of this section in the inspected plant under 
Program supervision, after which the cans shall be opened and the sound 
products passed.
    (e) Canned products shall not be passed unless, after cooling to 
atmospheric temperature, they show the external characteristic of sound 
cans; that is, the cans shall not be overfilled, the ends of the cans 
shall be concave, there shall be no bulging of the cans, the sides and 
ends of the cans shall conform to the products, and there shall be no 
slack or loose tin in the cans.
    (f) All canned products shall be plainly and permanently marked on 
the containers by code or otherwise with the identity of the contents 
and date of canning. The code used and its meaning shall be on record in 
the office of the circuit supervisor before use.
    (g) The canned products must be processed at such temperature and 
for such period of time as will assure keeping without refrigeration 
under usual conditions of storage and transportation as evidenced by the 
incubation test.
    (h) Lots of canned products shall be identified during their 
handling preparatory to and during heat processing by tagging the 
baskets or cages in which the cans are being conveyed, with a tag which 
will change color on going through the heat processing or by other 
effective means so as to insure the proper channeling of the products 
for effective heat processing after closing the cans.
    (i) Facilities shall be provided to incubate at least representative 
samples of the fully processed canned products. The incubation shall 
consist of holding the canned products for at least 10 days at about 98 
[deg]F. The extent to which incubation tests shall be required by 
inspectors depends on conditions such as the record of the inspected 
plant in conducting canning operations, the extent to which the plant 
furnishes competent supervision and inspection in

[[Page 414]]

connection with the canning operations, the character of the equipment 
used, and the degree to which such equipment is maintained at maximum 
efficiency. Such factors shall be considered by the circuit supervisor 
in determining the extent of incubation testing at a particular plant. 
In the event of failure by an inspected plant to provide suitable 
facilities for incubation of test samples, the circuit supervisor may 
require holding of the entire lot under such conditions and for such 
period of time as may, in his discretion, be necessary to establish the 
stability of the canned products. The circuit supervisor may permit lots 
of canned certified products to be shipped from the inspected plant 
prior to completion of sample incubation when he has no reason to 
suspect unsoundness in the particular lots, and under circumstances 
which will assure the return of the products to the plant for inspection 
should such action be indicated by the incubation results.



Sec. 355.26  Samples of certified products, ingredients, etc., to be 
taken for examination.

    Samples of certified products, water, chemicals, flavorings or other 
articles in an inspected plant shall be taken without cost to the 
Program for an examination as often as may be deemed necessary for the 
efficient conduct of the inspection. The frequency of sampling shall be 
determined by the needs of the inspection.



Sec. 355.27  Reports of violations of regulations.

    Inspectors shall report to the circuit supervisor violations of or 
failures to conform with these regulations which occur at inspected 
plants, and the circuit supervisor shall report the same to the 
Administrator.

                     Disposal of Condemned Material



Sec. 355.28  Unfit material to be condemned.

    Subject to Sec. 355.41, any certified products, or ingredients 
intended for use therein, which are decomposed or adulterated or 
otherwise unsound or unfit for use shall be condemned and destroyed, 
except that if the adulteration is such as will not preclude their 
legitimate use for some purpose other than the preparation of the 
certified products, they may be released by authorized inspectors for 
such other purpose for disposition under the supervision of the proper 
local, State, or Federal official. The operator of the inspected plant 
shall make such arrangement as may be necessary with the proper 
officials for the disposition of the article.

                    Composition of Certified Products



Sec. 355.29  Composition of certified products for dogs, cats, and 
other carnivora.

    (a) Composition of canned or semi-moist certified maintenance food. 
(1) Only ingredients which are normal to canned or semi-moist food for 
dogs, cats, and other carnivora, which are favorable to adequate 
nutrition, and which are classed by the Administrator as conforming with 
requirements contained in this part shall be used in the preparation of 
certified maintenance food.
    (2) Not less than 30 percent of meat or animal food meat byproduct 
or both, or of horse meat or animal food horse meat byproduct or both, 
or of mule meat or animal food mule meat byproduct or both, or of 
poultry products, shall be used in the preparation of canned or 
semimoist certified maintenance food. Upon specific approval of the 
Administrator, combinations of the above specified ingredients may be 
used. The uncooked weight of the meat or animal food meat byproduct or 
both, or of the horse meat or animal food horse meat byproduct or both, 
or of the mule meat or animal food mule meat byproduct or both, or of 
the poultry products, or of the combinations thereof, shall be used in 
the calculation, and the percentage shall be obtained by relating this 
weight to the total weight of the certified maintenance food.
    (3) Certified maintenance food shall contain not less than 10 
percent of protein.
    (4) Certified maintenance food shall contain a level of minerals and 
vitamins generally recognized to be essential to the nutritional value 
of the food.
    (5) Vegetables and grains and their derivatives, used as ingredients 
of certified maintenance food, shall be of

[[Page 415]]

good quality, shall be free from discoloration, mold, smut, and insect 
infestation, and shall be otherwise fit for use as animal food.
    (6) Inedible material such as tankage, dried blood, bone meal, and 
the like shall not be used as ingredients of certified maintenance food.
    (7) Semi-moist certified maintenance food shall have a soft granular 
consistency, shall be shelf stable, and shall be processed so that the 
moisture content thereof does not exceed 27 percent of the net weight of 
such food.
    (b) Composition of canned or fresh frozen certified supplemental 
animal foods. (1) Certified animal protein supplement shall comply with 
the following requirements:
    (i) Certified animal protein supplement shall contain not less than 
95 percent of meat or animal food meat byproduct or both, or of horse 
meat or animal food horse meat byproduct or both, or of mule meat or 
animal food mule meat byproduct or both, or of poultry products. Upon 
specific approval of the Administrator, combinations of the above 
specified ingredients may be used;
    (ii) Certified animal protein supplement shall have added thereto a 
sufficient amount of fresh ground bone or other acceptable agent to 
satisfy the requirements of the regulations promulgated under the Meat 
Inspection Act (34 Stat. 1260), as amended (21 U.S.C. 71 et seq.), and 
the Horse Meat Act (41 Stat. 241; 21 U.S.C. 96), in order to insure 
decharacterization of the product for human food purposes;
    (iii) Certified animal protein supplement may contain not more than 
3 percent wheat flour or other processing aid acceptable to the 
Administrator, which shall be of good quality, shall be free from insect 
infestation, and shall be otherwise fit for use as animal food;
    (iv) Certified animal protein supplement shall contain not less than 
15 percent protein; and
    (v) Certified animal protein supplement shall contain not less than 
3 percent fat.
    (2) Certified pet food supplement shall comply with the following 
requirements:
    (i) Certified pet food supplement shall contain not less than 50 
percent of meat or animal food meat byproduct or both, or of horse meat 
or animal food horse meat byproduct or both, or of mule meat or animal 
food mule meat byproduct or both, or of poultry products. Upon specific 
approval of the Administrator, combinations of the above specified 
ingredients may be used;
    (ii) Certified pet food supplement shall have added thereto a 
sufficient amount of fresh ground bone or other acceptable agent to 
satisfy the requirements of the regulations promulgated under the Meat 
Inspection Act (34 Stat. 1260), as amended (21 U.S.C. 71 et seq.), and 
the Horse Meat Act (41 Stat. 241; 21 U.S.C. 96), in order to insure 
decharacterization of the product for human food purposes;
    (iii) Certified pet food supplement may contain various cereals, 
flours, vegetables, flavorings, seasonings and other processing aids 
acceptable to the Administrator which shall be of good quality, shall be 
free from discoloration, mold, smut, and insect infestation, and shall 
be otherwise fit for use as animal food;
    (iv) Certified pet food supplement shall contain not less than 11 
percent protein;
    (v) Certified pet food supplement shall contain not less than 3 
percent fat; and
    (vi) Certified pet food supplement may not contain more than 74 
percent moisture.
    (c) Composition of canned certified variety pet food. (1) Certified 
variety pet food shall contain not less than 25 percent of meat or 
animal food meat byproduct or both, or of horse meat or animal food 
horse meat byproduct or both, or of mule meat or animal food mule meat 
byproduct or both, or of poultry products. Upon specific approval of the 
Administrator, combinations of the above specified ingredients may be 
used.
    (2) Certified variety pet food shall contain a variety of vegetables 
and may contain other ingredients which are favorable to adequate 
nutrition.
    (3) Vegetables and grains and their derivatives used as ingredients 
of certified variety pet food shall be of good

[[Page 416]]

quality, shall be free from discoloration, mold, smut, and insect 
infestation, and shall be otherwise fit for use as animal food.
    (4) Certified variety pet food shall contain not less than 8 percent 
protein.
    (5) Certified variety pet food shall contain not less than 2 percent 
fat.
    (6) Certified variety pet food may contain not more than 75 percent 
moisture.
    (d) Certified products for dogs, cats, and other carnivora may 
contain whale meat, fish, and animal food poultry byproducts or 
combinations thereof as optional ingredients in lieu of some but not all 
of the ingredients named in paragraphs (a)(2), (b)(1)(i), and (c)(1) of 
this section, respectively, upon specific approval of the Administrator.

[26 FR 3984, May 9, 1961, as amended at 29 FR 9819, July 22, 1964; 29 FR 
18419, Dec. 25, 1964. Redesignated at 30 FR 4195, Mar. 31, 1965, and 
amended at 30 FR 10284, Aug. 19, 1965; 32 FR 13115, Sept. 15, 1967; 33 
FR 6707, May 2, 1968]

                               Supervision



Sec. 355.31  Supervision by inspector.

    No container which bears or is to bear a label as provided for under 
this part shall be filled in whole or in part except with certified 
products which have been inspected in compliance with this part, which 
are sound, healthful, wholesome, and otherwise fit for dogs, cats, and 
other carnivora, and which are strictly in accordance with the 
statements on the label. No such container shall be filled in whole or 
in part and no such label shall be affixed thereto except under the 
supervision of an inspector.

                                Labeling



Sec. 355.32  Labeling required.

    Each container of inspected and certified product shall have affixed 
thereto a label bearing the following information, prominently 
displayed:
    (a) The name of the product, class of product, ingredient statement, 
and the animal foods inspection legend in the manner provided by 
paragraphs (a) (1), (2), (3), (4), (5), and (6) of this section.
    (1) The name of the canned or semimoist certified food shall include 
words such as ``dog food,'' ``cat food,'' ``dog and cat food,'' or ``fox 
food,'' accompanied with such references to optional ingredients as may 
be required by the Administrator under this part. Product names shall 
not be misleading in regard to class of canned or semi-moist certified 
food for which label is intended.
    (2) Class of product as outlined in paragraphs (a), (b), and (c) of 
Sec. 355.29 shall be declared on either the main display or 20 percent 
panel of the label.
    (3) The word ``ingredients,'' followed by a complete list of 
ingredients of the food in the order of their predominance and by their 
common or usual names, shall appear on the label with the name of the 
food.
    (4) The inspection legend for canned, semi-moist or frozen certified 
animal food shall appear on the label in the form shown herewith, except 
that the plant number need not appear with the legend when such number 
is embossed on the sealed metal container as provided in Sec. 355.33.
[GRAPHIC] [TIFF OMITTED] TC11SE91.036

    (5) When a product is prepared in whole from any of the items 
defined in Sec. 355.2 (i) through (n), its name shall identify the item 
and there shall appear contiguous to the name of the item the name of 
the decharacterizing agent used, followed by the word ``added'' as, for 
example, ``bone added.''
    (6) When wheat flour or other processing aid is added to the 
product, there shall appear on the label, with the name of the 
decharacterizing agent, in predominating order, the name of the 
processing aid, as, for example, ``Wheat flour and bone added'' or 
``Bone and wheat flour added.''
    (b) A statement of the quantity of contents of the container, 
representing in terms of avoirdupois weight the quantity of product in 
the container.

[[Page 417]]

    (c) The name and place of business of the manufacturer, packer, or 
distributor. The name under which inspection is granted to a plant may 
appear without qualification on the label of a product prepared by that 
plant. When the certified product is not prepared by the person whose 
name appears on the label, the name shall be qualified by a phrase which 
reveals the connection such person has with the product as, for example, 
``Prepared for --------------------.''

[23 FR 10107, Dec. 23, 1958, as amended at 25 FR 1357, Feb. 16, 1960; 26 
FR 3984, May 9, 1961; 29 FR 9819, July 22, 1964. Redesignated at 30 FR 
4195, Mar. 31, 1965, and amended at 32 FR 13115, Sept. 15, 1967]



Sec. 355.33  Plant number to be embossed on metal containers.

    The official number assigned to an inspected plant under Sec. 355.8 
shall be embossed on all sealed metal containers of certified products 
filled in such plant, except that such containers which bear labels 
lithographed directly on the container and in which the plant number is 
incorporated need not have the plant number embossed thereon. Labels and 
embossed code identification shall be affixed so as not to obscure the 
embossed plant number.

[23 FR 10107, Dec. 23, 1958. Redesignated and amended at 30 FR 4195, 
Mar. 31, 1965; 32 FR 13115, Sept. 15, 1967; 38 FR 29215, Oct. 23, 1973]



Sec. 355.34  Labels, approval of, by Administrator.

    (a) Except as provided in paragraph (c) of this section, no label 
shall be used on any container of certified products until it has been 
approved by the Administrator. For the convenience of the inspected 
plant, sketches or proofs of proposed labels may be submitted in 
triplicate to the Administrator for approval, and the preparation of the 
finished labels deferred until such approval is obtained. All finished 
labels shall be submitted in quadruplicate to the Administrator for 
approval. In the case of lithographed labels, paper take-offs in lieu of 
sections of the metal containers shall be submitted for approval. Such 
paper take-offs shall not be in the form of a negative but shall be a 
complete reproduction of the label as it will appear on the package, 
including any color scheme involved.
    (b) Inserts, tags, liners, pasters, and like devices containing 
printed or graphic matter for use on, or to be placed within, containers 
and coverings of certified products shall be submitted for approval in 
the same manner as provided for labels in paragraph (a) of this section, 
except that inspectors in charge may permit the use of such devices if 
they contain no reference to the certified products and bear no 
misleading feature.
    (c) Stencils, labels, box dies, and brands may be used on shipping 
containers, including tierces, barrels, drums, boxes, crates, and large-
size fiberboard containers, without approval by the Administrator, 
provided the markings are applicable to the certified products, are not 
false or deceptive, and are used with the approval of the circuit 
supervisor.
    (d) No certified product and no container thereof shall be labeled 
with any false or deceptive term, and no statement, word, picture, 
design, or device which conveys any false impression or gives any false 
indication of the origin, quality, or quantity of the product shall 
appear on any label.



Sec. 355.35  Label information to be displayed on principal panel.

    The label information required by Sec. 355.32 shall be displayed on 
the principal panel or panels of the label except that label information 
other than the name of the product and the ingredient statement may be 
displayed on a panel immediately adjacent to the principal panel or 
panels if such supplemental panel consists of at least 20 percent of the 
label and is reserved exclusively for required labeling information.



Sec. 355.36  Obsolete labels.

    At least once each year, each inspected plant shall submit to the 
Administrator, in quadruplicate, a list of approvals for labels that 
have become obsolete, accompanied by a statement that such approvals are 
no longer desired. The approvals shall be identified by the number, the 
date of approval, and the name of the product.

[[Page 418]]



Sec. 355.37  Alteration or limitation of statement of certification.

    The statement of certification provided for by Sec. 355.32(a)(4) 
shall not be altered, defaced, imitated, or simulated in any respect or 
used for the purpose of misrepresentation or deception.

[25 FR 1357, Feb. 16, 1960. Redesignated at 30 FR 4195, Mar. 31, 1965]

                                Penalties



Sec. 355.38  Withdrawal of service.

    After opportunity for hearing before a proper official of the 
Department has been accorded the operator of an inspected plant, the 
inspection, certification, and identification provided for in this part 
may be withdrawn from such plant if the operator: (a) Persist ently 
fails to comply with any provision of the regulations in this part or of 
instructions or directions issued thereunder; (b) makes any willful 
misrepresentation or engages in any fraudulent or deceptive practice in 
connection with the making of any application for service; (c) violates 
Sec. 355.37; or (d) interferes with or obstructs any program employee 
in the performance of his duties under the regulations in this part by 
intimidation, threats, or other improper means. Pending final 
determination of the matter, the Administrator may suspend such 
inspection, certification, and identification without hearing in cases 
of willfulness or those in which the public health, interest, or safety 
requires such action. The operator of the inspected plant shall be 
notified of the Administrator's decision to suspend such inspection, 
certification or identification service, and the reasons therefor, in 
writing, in the manner prescribed in Sec. 1.147(b) of the rules of 
practice (7 CFR 1.147(b)), or orally. The Administrator's decision to 
suspend such inspection, certification or identification service shall 
be effective upon such oral or written notification, whichever is 
earlier, to the operator of the plant. If such notification is oral, the 
Administrator shall confirm such decision and the reasons therefor, in 
writing, as promptly as circumstances permit, and such written 
confirmation shall be served upon the operator of the inspected plant, 
in the manner prescribed in Sec. 1.147(b) of the rules of practice (7 
CFR 1.147(b)). In other cases, prior to the institution of proceedings 
for any withdrawal or suspension, the facts or conduct which may warrant 
such action shall be called to the attention of the operator in writing 
and he shall be given an opportunity to demonstrate or achieve 
compliance with the requirements of the regulations in this part and 
instructions and directions issued thereunder.

[23 FR 10107, Dec. 23, 1958. Redesignated at 30 FR 4195, Mar. 31, 1965, 
and amended at 43 FR 11148, Mar. 17, 1978]

                                 Appeals



Sec. 355.39  Appeals from decisions made under this part.

    Any appeal from a decision by an employee of the Program shall be 
made to his immediate superior having jurisdiction over the subject 
matter of the appeal.

                                 Reports



Sec. 355.40  Plants to furnish information for reports.

    Each day the operator of every inspected plant shall furnish the 
inspector assigned to that plant with a statement of the number of 
pounds of product certified by the inspector.

(Approved by the Office of Management and Budget under control number 
0583-0036)

[23 FR 10107, Dec. 23, 1958. Redesignated at 30 FR 4195, Mar. 31, 1965, 
and amended at 47 FR 746, Jan. 7, 1982]

             Mule Meat and Animal Food, Mule Meat By-Product



Sec. 355.41  Antemortem and postmortem inspection for mules.

    (a)(1) An antemortem examination and inspection shall be made of all 
mules about to be slaughtered for use in the preparation of products 
under this part, before their slaughter shall be allowed for such use. 
Such inspection shall be made on the day of slaughter.
    (2) Mules found on such inspection to show symptoms of disease shall 
be set apart and slaughtered separately. Those found to be affected with 
strangles, purpura hemorrhagica, azoturia,

[[Page 419]]

infectious equine encephalomyelitis, toxic encephalomyelitis (forage 
poisoning), infectious anemia (swamp fever), dourine, acute influenza, 
generalized osteoporosis, glanders, farcy, or other malignant disorder, 
acute inflammatory lameness or extensive fistula, shall be condemned and 
destroyed. Any mule which is suspected on antemortem inspection of being 
infected with glanders shall be tested with mallein, and any mule which 
on physical examination is suspected of being affected with dourine 
shall be held for further examination or for such test as the 
Administrator may prescribe.
    (b)(1) A careful postmortem examination and inspection shall be made 
of all carcasses and parts thereof of all mules inspected under this 
section, at the time of slaughter. All carcasses and parts of mules 
found to be affected with any disease listed under paragraph (a) of this 
section shall be condemned and destroyed.
    (2) Other carcasses and parts of mules found abnormal or diseased 
upon inspection under this section shall be disposed of in accordance 
with such provisions of the Meat Inspection Regulations (Subchapter A of 
this chapter) as are deemed applicable by the Administrator.



Sec. 355.42  Marking of mule meat and animal food mule meat by-product.

    All mule meat and animal food mule meat by-product inspected under 
this part shall be marked and identified as the Administrator may 
require in any particular case.

[25 FR 1357, Feb. 16, 1960. Redesignated at 30 FR 4195, Mar. 31, 1965, 
and amended at 32 FR 13115, Sept. 15, 1967]



Sec. 355.43  Scope and applicability of rules of practice.

    The rules of practice of the Department of Agriculture in subpart H 
of part I, subtitle A, title 7 of the Code of Federal Regulations, are 
the rules of practice applicable to adjudicatory, admininstrative 
proceedings under the regulations in this part (9 CFR part 355).

[43 FR 11148, Mar. 17, 1978]



PART 362_VOLUNTARY POULTRY INSPECTION REGULATIONS--Table of Contents




Sec.
362.1 Definitions.
362.2 Types and availability of service.
362.3 Application for service.
362.4 Denial or withdrawal of service.
362.5 Fees and charges.

    Authority: 7 U.S.C. 1622; 7 CFR 2.18 (g) and (i) and 2.53.

    Source: 41 FR 23715, June 11, 1976, unless otherwise noted.



Sec. 362.1  Definitions.

    The definitions in Sec. 381.1 are incorporated in this part except 
for the definitions excluded in Sec. 362.2(a). In addition to those 
definitions, the following definitions will be applicable to the 
regulations in this part.
    (a) Act. ``Act'' means the Agricultural Marketing Act of 1946, as 
amended (60 Stat. 1087, as amended; 7 U.S.C. 1621 et seq.).
    (b) Inspector. ``Inspector'' means any officer or employee of the 
Department authorized to perform any duties under the regulations in 
this part.
    (c) Person. ``Person'' means any individual, corporation, company, 
association, firm, partnership, society, or joint stock company, or 
other organized business unit.
    (d) Poultry. ``Poultry'' means any migratory water fowl or game 
bird, whether dead or alive.
    (e) Poultry Product. ``Poultry product'' means any poultry carcass 
or part thereof; or any human food product which is made wholly or in 
part from the carcass of any domesticated bird (as defined in Sec. 
381.1(b) of this chapter) and is excepted from the inspection 
requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et 
seq.).

[66 FR 22905, May 7, 2001]



Sec. 362.2  Types and availability of service.

    Upon application, in accordance with Sec. 362.3, the following 
types of service may be furnished under the regulations in this part:
    (a) Inspection service. An inspection and certification service for 
wholesomeness relating to the slaughter and

[[Page 420]]

processing of poultry and the processing of poultry products. All 
provisions of Part 381 and Sec. Sec. 416.1 through 416.6 of this 
chapter shall apply to the slaughter of poultry, and the preparation, 
labeling, and certification of the poultry and poultry products 
processed under this poultry inspection service except for the following 
provisions: the definitions of ``Act,'' ``animal food manufacturer,'' 
``Inspection Service,'' ``inspector,'' ``Inspector in Charge,'' 
``poultry,'' ``poultry product,'' ``poultry food product,'' ``poultry 
products broker,'' ``renderer,'' and ``U.S. Refused Entry'' in 
Sec. Sec. 381.1 (b), 381.3 (a), 381.6, 381.10, 381.13-381.17, 381.21, 
381.29, 381.39-381.42, 381.175 (a)(2), 381.175 (a)(3), 381.179, 381.185-
381.187, 381.192, and 381.195-381.225.
    (b) Export certification service. At the request of any person 
intending to export any slaughtered poultry or poultry product, 
inspectors may make certification regarding products for human food 
purposes, to be exported, as meeting conditions or standards that are 
not imposed or are in addition to those imposed by the regulations in 
this chapter and the laws under which such regulations were issued.
    (c) Identification Service. (1) Poultry or other product that is 
federally inspected and passed at an official establishment, or upon 
importation, under the Poultry Products Inspection Act, is officially 
marked to identify it as federally inspected and passed. In order to 
facilitate the division of such poultry or other product into smaller 
portions or its combination into larger units and still maintain its 
identify as product which has been federally inspected and passed and so 
marked, inspectors may supervise the handling and weighing of the 
product and mark such portions and units with the official mark of 
inspection when they determine that identify has been maintained.
    (2) At the time service is furnished, product must be sound, 
wholesome, and fit for human food. The service will be available only on 
premises other than those of an official establishment. The sanitation 
of the place or area where service is furnished must comply with 
provisions of Sec. Sec. 416.1 through 416.6 of this chapter.
    (3) The mark of inspection shall be applied only under the immediate 
supervision of an inspector.
    (4) This service does not cover further cutting and processing of 
products. These activities must take place at an official establishment.
    (5) The registration and recordkeeping requirements enumerated in 
Part 381, subpart Q, of this chapter shall apply to persons requesting 
voluntary identification service under this paragraph (c).

[66 FR 22905, May 7, 2001]



Sec. 362.3  Application for service.

    Any person who desires to receive service under the regulations in 
this part for poultry or other product eligible therefor under such 
regulations may make application for service to the Administrator, upon 
an application form which will be furnished by the Administrator upon 
request to the Meat and Poultry Inspection Program, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250. The application must include all the information called for by 
that form. In case of change of name, ownership, management, or 
location, a new application shall be made.

(Approved by the Office of Management and Budget under control number 
0583-0036)

[41 FR 23715, June 11, 1976, as amended at 47 FR 746, Jan. 7, 1982]



Sec. 362.4  Denial or withdrawal of service.

    (a) For disciplinary reasons--(1) Bases for denial or withdrawal. An 
application or request for service may be rejected, or the benefits of 
the service may be otherwise denied to, or withdrawn from, any person 
who, or whose employee or agent in the scope of his employment or 
agency, (i) has willfully made any misrepresentation or has committed 
any other fraudulent or deceptive practice in connection with any 
application or request for service under the regulations in this 
chapter; (ii) has given or attempted to give, as a loan or for any other 
purpose, any money, favor, or other thing of value, to any employee of 
the Department authorized to perform any function under the regulations 
in this chapter; (iii) has

[[Page 421]]

interfered with or obstructed, or attempted to interfere with or to 
obstruct, any employee of the Department in the performance of his 
duties under the regulations in this chapter by intimidation, threats, 
assaults, abuse, or any other improper means; (iv) has knowingly falsely 
made, issued, altered, forged, or counterfeited any official 
certificate, memorandum, mark, or other identification, or device for 
making any such mark or identification authorized or issued under this 
chapter; (v) has knowingly uttered, published, or used as true any such 
falsely made, issued, altered, forged, or counterfeited certificate, 
memorandum, mark, identification, or device; (vi) has knowingly obtained 
or retained possession of any such falsely made, issued, altered, 
forged, or counterfeited certificate, memorandum, mark, identification, 
or device, or of any carcass or poultry or product bearing any such 
falsely made, issued, altered, forged or counterfeited certificate, 
memorandum, mark, or identification; (vii) has knowingly represented 
that any carcass, poultry, or product has been officially inspected and 
passed (by an authorized inspector) under this chapter, when it had not 
in fact been so inspected; (viii) has, within the previous ten years, 
been convicted of any felony or more than one misdemeanor under any law 
based upon the acquiring, handling, or distributing of adulterated, 
mislabeled, or deceptively packaged food, or fraud in connection with 
transactions in food, or any felony indicating a lack of the integrity 
needed for the conduct of operations affecting the public health; (ix) 
has in any manner not specified in this paragraph violated subsection 
203(h) of the Act:
    Provided, That paragraph (a)(1)(vi) of this section shall not be 
deemed to be violated if the person in possession of any item mentioned 
therein notifies the inspector without delay that he has possession of 
such item and, in the case of an official device, surrenders it to the 
inspector, and, in the case of any other item, surrenders it to the 
inspector or destroys it or brings it into compliance with the 
regulations by obliterating or removing the violative features under 
supervision of the inspector; And provided further, That an application 
or a request for service may be rejected, or the benefits of the service 
may be otherwise denied to, or withdrawn from any person who operates an 
establishment for which he has made application for service if, with the 
knowledge of such operator, any other person conducting any operations 
in such establishment has committed any of the offenses specified in 
paragraphs (a)(1) (i) through (ix) of this section after such 
application was made. Moreover, an application or a request for service 
made in the name of a person otherwise eligible for service under the 
regulations may be rejected, or the benefits of the service may be 
otherwise denied to, or withdrawn from, such a person (a) in case the 
service is or would be performed at an establishment operated (1) by a 
corporation, partnership, or other person from whom the benefits of the 
service are currently being withheld under this chapter, or (2) by a 
corporation, partnership, or other person having an officer, director, 
partner, or substantial investor from whom the benefits of service under 
this chapter are currently being withheld and who has any authority with 
respect to the establishment where service is or would be performed, or 
(b) in case the service is or would be performed with respect to any 
poultry or product in which any corporation, partnership, or other 
person within (a)(1) of this section has a contract or other financial 
interest.
    (2) Procedure. An application or request for service may be 
rejected, or benefits of the service may be otherwise denied to or 
withdrawn by the Secretary, as provided by this paragraph, after notice 
and opportunity for hearing before a proper official of the Department. 
The Administrator may reject an application or request for service or 
deny or withdraw service under this paragraph without hearing, pending 
final determination of the matter, when he determines that the public 
interest so requires. The operator or applicant of such plant shall be 
notified of the Administrator's decision to reject the application or 
request for service or to deny or withdraw such service, and the reasons

[[Page 422]]

therefor, in writing, in the manner prescribed in Sec. 1.147(b) of the 
rules of practice (7 CFR 1.147(b)), or orally. The Administrator's 
decision to reject an application or request for service or to deny or 
withdraw the benefits of service under the Act shall be effective upon 
such oral or written notification, whichever is earlier, to the operator 
or applicant of such plant. If such notification is oral, the 
Administrator shall confirm such decision, and the reasons therefor, in 
writing, as promptly as circumstances permit, and such written 
confirmation shall be served upon the operator or applicant of such 
plant in the manner prescribed in Sec. 1.147(b) of the rules of 
practice (7 CFR 1.147(b)).
    (b) For correctable cause--(1) Basis for denial or withdrawal. An 
application or request for service may be rejected, or the benefits of 
the service may be otherwise denied to, or withdrawn from, any person 
whose establishment does not meet the requirements as to premises, 
facilities, and equipment, and the operation thereof, prescribed in the 
regulations to prevent the distribution of adulterated poultry or 
poultry products, or who has not received approval of labeling and 
containers to be used at the establishment as required by the 
regulations.
    (2) Procedure. An application or request for service may be 
rejected, or benefits of the service may be otherwise denied to or 
withdrawn by the Secretary, as provided by this paragraph, after notice 
and opportunity for hearing before a proper official of the Department. 
The Administrator may reject an application or request for service or 
deny or withdraw service under this paragraph without hearing, pending 
final determination of the matter, when he determines that the public 
interest so requires. The operator or applicant of such plant shall be 
notified of the Administrator's decision to reject the application or 
request for service or to deny or withdraw such service, and the reasons 
therefor, in writing, in the manner prescribed in Sec. 1.147(b) of the 
rules of practice (7 CFR 1.147(b)), or orally. The Administrator's 
decision to reject an application or request for service or to deny or 
withdraw the benefits of service under the Act shall be effective upon 
such oral or written notification, whichever is earlier, to the operator 
or applicant of such plant. If such notification is oral, the 
Administrator shall confirm such decision, and the reasons therefor, in 
writing, as promptly as circumstances permit, and such written 
confirmation shall be served upon the operator or applicant of such 
plant in the manner prescribed in Sec. 1.147(b) of the rules of 
practice (7 CFR 1.147(b)).
    (c) For miscellaneous reasons. An application or a request for 
service may be rejected, or the benefits of the service may be otherwise 
denied to, or withdrawn from, any person, without a hearing, by the 
official in charge of the appropriate regional office, with the 
concurrence of the Regional Director (1) for administrative reasons such 
as the nonavailability of personnel to perform the service; (2) for the 
failure to pay for service; (3) in case the application or request 
relates to birds or products which are not eligible for service under 
this part 362; or (4) in case the person is a partnership, corporation, 
or other person from whom the benefits of the service are currently 
being withheld under paragraph (a) of this section. Notice of such 
rejection, denial, or withdrawal, and the reasons therefor, shall 
promptly be given to the person involved. The operator or applicant of 
such plant shall be notified of such decisions to reject an application 
or request for service or to deny or withdraw the benefits of the 
service, and the reasons therefor, in writing, in the manner prescribed 
in Sec. 1.147(b) of the rules of practice (7 CFR 1.147(b)), or orally. 
Such decision shall be effective upon such oral or written notification, 
whichever is earlier, to the operator or applicant of such plant. If 
such notification is oral, the person making such decision shall confirm 
such decision, and the reasons therefor, in writing, as promptly as 
circumstances permit, and such written confirmation shall be served upon 
the operator or applicant of such plant in the manner prescribed in 
Sec. 1.147(b) of the rules of practice (7 CFR 1.147(b)).
    (d) Scope and applicability of rules of practice. The rules of 
practice of the Department of Agriculture in subpart H of part I, 
subtitle A, title 7 of the Code of Federal Regulations, are the

[[Page 423]]

rules of practice applicable to adjudicatory, administrative proceedings 
under the regulations in this part (9 CFR part 362).

[41 FR 23715, June 11, 1976, as amended at 43 FR 11148, Mar. 17, 1978]



Sec. 362.5  Fees and charges.

    (a) Fees and charges for service under the regulations in this part 
shall be paid by the applicant for the service in accordance with this 
section, and, if required by the Administrator, the fees and charges 
shall be paid in advance.
    (b) The fees and charges provided for in this section shall be paid 
by check, draft, or money order payable to the Treasurer of the United 
States and shall be remitted promptly to the Administrator upon 
furnishing to the applicant a statement as to the amount due.
    (c) The fees to be charged and collected for service under the 
regulations in this part shall be at the rates specified in Sec. Sec. 
391.2, 391.3, and 391.4 respectively for base time; for overtime 
including Saturdays, Sundays, and holidays; and for certain laboratory 
services which are not covered under the base time, overtime, and/or 
holiday costs. Such fees shall cover the costs of the services and shall 
be charged for the time required to render such service, including, but 
not limited to, the time required for the travel of the inspector or 
inspectors in connection therewith during the regularly scheduled 
administrative workweek.
    (d) Charges may also be made to cover the cost of travel and other 
expenses incurred by the Service in connection with the furnishing of 
the service.

[41 FR 23715, June 11, 1976, as amended at 53 FR 13398, Apr. 22, 1988; 
54 FR 6390, Feb. 10, 1989]



PART 381_POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents




                          Subpart A_Definitions

Sec.
381.1 Definitions.

     Subpart B_Administration; Application of Inspection and Other 
                              Requirements

381.3 Administration.
381.4 Inspection in accordance with methods prescribed or approved.
381.5 Publications.
381.6 Establishments requiring inspection.
381.7 Coverage of all poultry and poultry products processed in official 
          establishments.

                          Subpart C_Exemptions

381.10 Exemptions for specified operations.
381.11 Exemptions based on religious dietary laws.
381.12 Effect of religious dietary laws exemptions on other persons.
381.13 Suspension or termination of exemptions.
381.14 Inspection concerning purportedly exempted operations.
381.15 Exemption from definition of ``poultry product'' of certain human 
          food products containing poultry.

  Subpart D_Application for Inspection; Grant or Refusal of Inspection

381.16 How application shall be made.
381.17 Filing of application.
381.18 Authority of applicant.
381.20 Survey and grant of inspection.
381.21 Refusal of inspection.
381.22 Conditions for receiving inspection.

 Subpart E_Inauguration of Inspection; Official Establishment Numbers; 
   Separation of Establishments and Other Requirements; Withdrawal of 
                               Inspection

381.25 Official establishment numbers.
381.26 Separation of establishments.
381.27 Inauguration of service; notification concerning regulations; 
          status of uninspected poultry products.
381.28 Report of violations.

   Subpart F_Assignment and Authorities of Program Employees; Appeals

381.30-381.31 [Reserved]
381.32 Access to establishments.
381.33 Identification.
381.34 Financial interest of inspectors.
381.35 Appeal inspections; how made.

   Subpart G_Facilities for Inspection; Overtime and Holiday Service; 
                         Billing Establishments

381.36 Facilities required.
381.37 Schedule of operations.
381.38 Overtime and holiday inspection service.

[[Page 424]]

381.39 Basis of billing for overtime and holiday services.

Subpart H [Reserved]

                     Subpart I_Operating Procedures

381.65 Operations and procedures, generally.
381.66 Temperatures and chilling and freezing procedures.
381.67 Young chicken and squab slaughter inspection rate maximums under 
          traditional inspection procedure.
381.68 Maximum inspection rates--New turkey inspection system.

                    Subpart J_Ante Mortem Inspection

381.70 Ante mortem inspection; when required; extent.
381.71 Condemnation on ante mortem inspection.
381.72 Segregation of suspects on ante mortem inspection.
381.73 Quarantine of diseased poultry.
381.74 Poultry suspected of having biological residues.
381.75 Poultry used for research.

  Subpart K_Post Mortem Inspection; Disposition of Carcasses and Parts

381.76 Post-mortem inspection, when required; extent; traditional, 
          Streamlined Inspection System (SIS), New Line Speed (NELS) 
          Inspection System and the New Turkey Inspection (NTI) System; 
          rate of inspection.
381.77 Carcasses held for further examination.
381.78 Condemnation of carcasses and parts: separation of poultry 
          suspected of containing biological residues.
381.79 Passing of carcasses and parts.
381.80 General; biological residues.
381.81 Tuberculosis.
381.82 Diseases of the leukosis complex.
381.83 Septicemia or toxemia.
381.84 Airsacculitis.
381.85 Special diseases.
381.86 Inflammatory processes.
381.87 Tumors.
381.88 Parasites.
381.89 Bruises.
381.90 Cadavers.
381.91 Contamination.
381.92 Overscald.
381.93 Decomposition.
381.94 Contamination with Microorganisms; process control verification 
          criteria and testing; pathogen reduction standards.

Subpart L_Handling and Disposal of Condemned or Other Inedible Products 
                       at Official Establishments

381.95 Disposal of condemned poultry products.

      Subpart M_Official Marks, Devices and Certif icates; Export 
                 Certificates; Certification Procedures

381.96 Wording and form of the official inspection legend.
381.97 [Reserved]
381.98 Official seal.
381.99 Official retention and rejection tags.
381.100 Official detention tag.
381.101 Official U.S. Condemned mark.
381.102 [Reserved]
381.103 Official poultry condemnation certificates; issuance and form.
381.104 Official export certificates, marks and devices.
381.105 Export certification; marking of containers.
381.106 Form of official export certificate.
381.107 Special procedures as to certification of poultry products for 
          export to certain countries.
381.108 Official poultry inspection certificates; issuance and 
          disposition.
381.109 Form of official poultry inspection certificate.
381.110 Erasures or alterations made on certificates.
381.111 Data to be entered in proper spaces.
381.112 Official mark for maintaining the identity and integrity of 
          samples.

                    Subpart N_Labeling and Containers

381.115 Containers of inspected and passed poultry products required to 
          be labeled.
381.116 Wording on labels of immediate containers.
381.117 Name of product and other labeling.
381.118 Ingredients statement.
381.119 Declaration of artificial flavoring or coloring.
381.120 Antioxidants; chemical preservatives; and other additives.
381.121 Quantity of contents.
381.121a Quantity of contents labeling.
381.121b Definitions and procedures for determining net weight 
          compliance.
381.121c Scale requirements for accurate weights, repairs, adjustments, 
          and replacement after inspection.
381.121d Scales; testing of.
381.121e Handling of failed product.
381.122 Identification of manufacturer, packer or distributor.

[[Page 425]]

381.123 Official inspection mark; official establishment number.
381.124 Dietary food claims.
381.125 Special handling label requirements.
381.126 Date of packing and date of processing; contents of cans.
381.127 Wording on labels of shipping containers.
381.128 Labels in foreign languages.
381.129 False or misleading labeling or containers.
381.130 False or misleading labeling or containers; orders to withhold 
          from use.
381.131 Preparation of labeling or other devices bearing official 
          inspection marks without advance approval prohibited; 
          exceptions.
381.132 Labeling approval.
381.133 Generically approved labeling.
381.134 Requirement of formulas.
381.136 Affixing of official identification.
381.137 Evidence of labeling and devices approval.
381.138 Unauthorized use or disposition of approved labeling or devices.
381.139 Removal of official identifications.
381.140 Relabeling poultry products.
381.141-381.143 [Reserved]
381.144 Packaging materials.

  Subpart O_Entry of Articles Into Official Establishments; Processing 
       Inspection and Other Reinspections; Processing Requirements

381.146 Sampling at official establishments.
381.148 Processing and handling requirements for frozen poultry 
          products.
381.150 Requirements for the production of fully cooked poultry products 
          and partially cooked poultry breakfast strips.
381.151 Adulteration of product by polluted water; procedure for 
          handling.
381.152 Preparation in an official establishment of articles not for 
          human food.
381.153 Accreditation of chemistry laboratories.

     Subpart P_Definitions and Standards of Identity or Composition

381.155 General.
381.156 Poultry meat content standards for certain poultry products.
381.157 Canned boned poultry and baby or geriatric food.
381.158 Poultry dinners (frozen) and pies.
381.159 Poultry rolls.
381.160 (Kind) burgers; (Kind) patties.
381.161 ``(Kind) A La Kiev.''
381.162 ``(Kind) steak or fillet.''
381.163 ``(Kind) baked'' or ``(Kind) roasted.''
381.164 ``(Kind) barbecued.''
381.165 ``(Kind) barbecued prepared with moist heat.''
381.166 Breaded products.
381.167 Other poultry dishes and specialty items.
381.168 Maximum percent of skin in certain poultry products.
381.169 Ready-to-cook poultry products to which solutions are added.
381.170 Standards for kinds and classes, and for cuts of raw poultry.
381.171 Definition and standard for ``Turkey Ham.''
381.172 Requirements for substitute standardized poultry products named 
          by use of an expressed nutrient content claim and a 
          standardized term.
381.173 Mechanically Separated (Kind of Poultry).
381.174 Limitations with respect to use of Mechanically Separated (Kind 
          of Poultry).

              Subpart Q_Records, Registration, and Reports

381.175 Records required to be kept.
381.176 Place of maintenance of records.
381.177 Record retention period.
381.178 Access to and inspection of records, facilities and inventory; 
          copying and sampling.
381.179 Registration.
381.180 Information and reports required from official establishment 
          operators.
381.181 Reports by consignees of allegedly adulterated or misbranded 
          products; sale or transportation as violations.
381.182 Reports of inspection work.

  Subpart R_Cooperation With States and Territories; Certification of 
   State and Territorial Programs as at Least Equal to Federal Program

381.185 Assistance to State and Territorial programs.
381.186 Cooperation of States and other jurisdictions in Federal 
          programs.

  Subpart S_Transportation; Exportation; or Sale of Poultry or Poultry 
                                Products

381.189 Provisions inapplicable to specimens for laboratory examination, 
          etc., or to naturally inedible articles.
381.190 Transactions in slaughtered poultry and other poultry products 
          restricted; vehicle sanitation requirements.
381.191 Distribution of inspected products to small lot buyers.
381.192 Penalties inapplicable to carriers.
381.193 Poultry carcasses, etc., not intended for human food.
381.194 Transportation and other transactions concerning dead, dying, 
          disabled, or diseased poultry, and parts of carcasses of 
          poultry that died otherwise than by slaughter.

[[Page 426]]

                   Subpart T_Imported Poultry Products

381.195 Definitions; requirements for importation into the United 
          States.
381.196 Eligibility of foreign countries for importation of poultry 
          products into the United States.
381.197 Imported products; foreign inspection certificates required.
381.198 Importer to make application for inspection of poultry products 
          offered for entry.
381.199 Inspection of poultry products offered for entry.
381.200 Poultry products offered for entry, retention in customs 
          custody; delivery under bond; movement prior to inspection; 
          handling; facilities and assistance.
381.201 Means of conveyance and equipment used in handling poultry 
          products offered for entry to be maintained in sanitary 
          condition.
381.202 Poultry products offered for entry; reporting of findings to 
          customs; handling of articles refused entry; appeals, how 
          made; denaturing procedures.
381.203 Products offered for entry; charges for storage, cartage, and 
          labor with respect to products which are refused entry.
381.204 Marking of poultry products offered for entry; official import 
          inspection marks and devices.
381.205 Labeling of immediate containers of poultry products offered for 
          entry.
381.206 Labeling of shipping containers of poultry products offered for 
          entry.
381.207 Small importations for consignee's personal use, display, or 
          laboratory analysis.
381.208 Poultry products offered for entry and entered to be handled and 
          transported as domestic; entry into official establishments; 
          transportation.
381.209 Returned United States inspected and marked poultry products: 
          exemption.

    Subpart U_Detention; Seizure and Condemnation; Criminal Offenses

381.210 Poultry and other articles subject to administrative detention.
381.211 Method of detention; form of detention tag.
381.212 Notification of detention to the owner of the poultry or other 
          article, or the owner's agent, and person having custody.
381.213 Notification of governmental authorities having jurisdiction 
          over article detained; form of written notification.
381.214 Movement of poultry or other article detained; removal of 
          official marks.
381.215 Poultry or other articles subject to judicial seizure and 
          condemnation.
381.216 Procedure for judicial seizure, condemnation, and disposition.
381.217 Authority for condemnation or seizure under other provisions of 
          law.
381.218 Criminal offenses.

  Subpart V_Special Provisions for Designated States and Territories; 
 Criteria and Procedure for Designating Establishments With Operations 
 Which Would Clearly Endanger the Public Health; Disposition of Poultry 
                            Products Therein

381.220 Definition of ``State''.
381.221 Designation of States under paragraph 5(c) of the Act.
381.222 States designated under paragraph 5(c) of the Act; application 
          of regulations.
381.223 Control and disposition of nonfed erally inspected poultry 
          products in States designated under paragraph 5(c) of the Act.
381.224 Designation of States under section 11 of the Act; application 
          of sections of the Act and the regulations.
381.225 Criteria and procedure for designat ing establishments with 
          operations which would clearly endanger the public health; 
          disposition of poultry products therein.

                  Subpart X_Canning and Canned Products

381.300 Definitions.
381.301 Containers and closures.
381.302 Thermal processing.
381.303 Critical factors and the application of the process schedule.
381.304 Operations in the thermal processing area.
381.305 Equipment and procedures for heat processing systems.
381.306 Processing and production records.
381.307 Record review and maintenance.
381.308 Deviations in processing.
381.309 Finished product inspection.
381.310 Personnel and training.
381.311 Recall procedure.

                      Subpart Y_Nutrition Labeling

381.400 Nutrition labeling of poultry products.
381.401 [Reserved]
381.402 Location of nutrition information.
381.403-381.407 [Reserved]
381.408 Labeling of poultry products with number of servings.
381.409 Nutrition label content.
381.410-381.411 [Reserved]
381.412 Reference amounts customarily consumed per eating occasion.
381.413 Nutrient content claims; general principles.
381.414-381.442 [Reserved]
381.443 Significant participation for voluntary nutrition labeling.

[[Page 427]]

381.444 Identification of major cuts of poultry products.
381.445 Guidelines for voluntary nutrition labeling of single-
          ingredient, raw products.
381.446-381.453 [Reserved]
381.454 Nutrient content claims for ``good source,'' ``high,'' and 
          ``more''.
381.455 [Reserved]
381.456 Nutrient content claims for ``light'' or ``lite''.
381.457-381.459 [Reserved]
381.460 Nutrient content claims for calorie content.
381.461 Nutrient content claims for the sodium content.
381.462 Nutrient content claims for fat, fatty acids, and cholesterol 
          content.
381.463 Nutrient content claims for ``healthy.''
381.464-381.468 [Reserved]
381.469 Labeling applications for nutrient content claims.
381.470-381.479 [Reserved]
381.480 Label statements relating to usefulness in reducing or 
          maintaining body weight.
381.481-381.499 [Reserved]
381.500 Exemption from nutrition labeling.

    Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7, 2.18, 
2.53.

    Source: 37 FR 9706, May 16, 1972, unless otherwise noted.



                          Subpart A_Definitions



Sec. 381.1  Definitions.

    (a) For the purposes of the regulations in this part, unless 
otherwise required by the context, the singular form shall also import 
the plural and the masculine form shall also import the feminine, and 
vice versa.
    (b) For the purposes of such regulations, unless otherwise required 
by the context, the following terms shall be construed, respectively, to 
mean:
    Acceptable. ``Acceptable'' means suitable for the purpose intended 
and acceptable to the Administrator.
    Act. ``Act'' means the Poultry Products Inspection Act (71 Stat. 
441, as amended by the Wholesome Poultry Products Act, 82 Stat. 791; 21 
U.S.C. 451 et seq.).
    Adulterated. ``Adulterated'' applies to any poultry product under 
one or more of the following circumstances:
    (i) If it bears or contains any poisonous or deleterious substance 
which may render it injurious to health; but in case the substance is 
not an added substance, such article shall not be considered adulterated 
under this clause if the quantity of such substance in or on such 
article does not ordinarily render it injurious to health;
    (ii)(a) If it bears or contains (by reason of administration of any 
substance to the live poultry or otherwise) any added poisonous or added 
deleterious substance (other than one which is a pesticide chemical in 
or on a raw agricultural commodity; a food additive; or a color 
additive) which may, in the judgment of the Administrator, make such 
article unfit for human food;
    (b) If it is, in whole or part, a raw agricultural commodity and 
such commodity bears or contains a pesticide chemical which is unsafe 
within the meaning of section 408 of the Federal Food, Drug, and 
Cosmetic Act;
    (c) If it bears or contains any food additive which is unsafe within 
the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act;
    (d) If it bears or contains any color additive which is unsafe 
within the meaning of section 706 of the Federal Food, Drug, and 
Cosmetic Act:

Provided, That an article which is not otherwise deemed adulterated 
under paragraphs (b)(4)(ii) (b), (c), or (d) of this section shall 
nevertheless be deemed adulterated if use of the pesticide chemical, 
food additive, or color additive in or on such article is prohibited by 
the regulations in this part in official establishments;
    (iii) If it consists in whole or in part of any filthy, putrid, or 
decomposed substance or is for any other reason unsound, unhealthful, 
unwholesome, or otherwise unfit for human food;
    (iv) If it has been prepared, packed, or held under insanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health;
    (v) If it is, in whole or in part, the product of any poultry which 
has died otherwise than by slaughter;
    (vi) If its container is composed, in whole or in part, of any 
poisonous or deleterious substance which may render the contents 
injurious to health;
    (vii) If it has been intentionally subjected to radiation, unless 
the use of the radiation was in conformity with a

[[Page 428]]

regulation or exemption in effect pursuant to section 409 of the Federal 
Food, Drug, and Cosmetic Act; or
    (viii) If any valuable constituent has been in whole or in part 
omitted or abstracted therefrom; or if any substance has been 
substituted, wholly or in part therefor; or if damage or inferiority has 
been concealed in any manner; or if any substance has been added thereto 
or mixed or packed therewith so as to increase its bulk or weight, or 
reduce its quality or strength, or make it appear better or of greater 
value than it is.
    Animal food. Any article intended for use as food for dogs, cats, or 
other animals, derived wholly, or in part, from carcasses or parts or 
products of the carcass of poultry, except that the term animal food as 
used herein does not include (i) processed dry animal food or (ii) 
livestock or poultry feeds manufactured from processed poultry 
byproducts (such as poultry byproduct meal, hydrolyzed poultry feathers, 
and hydrolyzed poultry byproducts aggregate).
    Animal food manufacturer. ``Animal Food Manufacturer'' means any 
person engaged in the business of manufacturing or processing animal 
food.
    Applicant. ``Applicant'' means any person who requests inspection 
service, exemption, or other authorization under the regulations.
    Biological residue. ``Biological Residue'' means any substance, 
including metabolites, remaining in poultry at the time of slaughter or 
in any of its tissues after slaughter, as the result of treatment or 
exposure of the live poultry to a pesticide, organic compound, metallic 
or other inorganic compound, hormone, hormone-like substance, growth 
promoter, antibiotic, anthelmintic, tranquilizer, or other agent that 
leaves a residue.
    Capable of use as human food. The term ``capable of use as human 
food'' applies to any carcass, or part or product of a carcass of any 
poultry, unless it is denatured or otherwise identified as required by 
the regulations, or it is naturally inedible by humans.
    Carcass. This term means all parts, including viscera, of any 
slaughtered poultry.
    Commerce. ``Commerce'' means commerce between any State, any 
territory, or the District of Columbia, and any place outside thereof; 
or within any territory not organized with a legislative body, or the 
District of Columbia.
    Consumer package. ``Consumer package'' means any container in which 
a poultry product is enclosed for the purpose of display and sale to 
household consumers.
    Container. The term ``container'' includes any box, can, tin, cloth, 
plastic, or any other receptacle, wrapper, or cover.
    Edible. This term means that an article is intended for use as human 
food.
    Egg Products Inspection Act. ``Egg Products Inspection Act'' means 
the Act so entitled, approved December 29, 1970 (84 Stat. 1620, 21 
U.S.C. 1031 et seq.).
    Federal Food, Drug, and Cosmetic Act. ``Federal Food, Drug, and 
Cosmetic Act'' means the Act so entitled, approved June 25, 1938 (52 
Stat. 1040), and acts amendatory thereof or supplementary thereto (21 
U.S.C. 301 et seq.).
    Federal Meat Inspection Act. ``Federal Meat Inspection Act'' means 
the Act so entitled, approved March 4, 1907, 34 Stat. 1260, as amended 
by the Wholesome Meat Act, 81 Stat. 584 (21 U.S.C. 601 et seq.).
    Free from protruding pinfeathers. ``Free from protruding 
pinfeathers'' means that the carcass is free from protruding pinfeathers 
which are visible to an inspector during an examination of the carcass 
at normal operating speeds. However, a carcass may be considered as 
being free from protruding pinfeathers if it has a generally clean 
appearance (especially on the breast), and if not more than an 
occasional protruding pinfeather is in evidence during a more careful 
examination of the carcass.
    Giblets. ``Giblets'' means the liver from which the bile sac has 
been removed, the heart from which the pericardial sac has been removed, 
and the gizzard from which the lining and contents have been removed: 
Provided, That each such organ has been properly trimmed and washed.

[[Page 429]]

    Immediate container. ``Immediate container'' includes any consumer 
package; or any other container in which poultry products, not consumer 
packaged, are packed.
    Inedible. This term means any carcass or any part of a carcass that 
is either naturally inedible by humans or is rendered unfit for human 
food by reason of adulteration or denaturing.
    Inspected for wholesomeness. This term means that the poultry 
product so identified has been inspected and was found at the time of 
such inspection to be not adulterated.
    Inspection. ``Inspection'' means any inspection required by the 
regulations to determine whether any poultry or poultry products comply 
with the requirements of the Act and the regulations.
    Label. This term applies to any display of written, printed, or 
graphic matter upon any article or the immediate container (not 
including package liners) of any article.
    Labeling. This term applies to all labels and other written, 
printed, or graphic matter (i) upon any article or any of its containers 
or wrappers, or (ii) accompanying such article.
    Misbranded. This term applies to any poultry product under one or 
more of the following circumstances:
    (i) If its labeling is false or misleading in any particular;
    (ii) If it is offered for sale under the name of another food;
    (iii) If it is an imitation of another food, unless its label bears, 
in type of uniform size and prominence, the word ``imitation'' and 
immediately thereafter, the name of the food imitated;
    (iv) If its container is so made, formed, or filled as to be 
misleading;
    (v) If in a package or other container, unless it bears a label 
showing:
    (a) The name and place of business of the manufacturer, packer, or 
distributor; and
    (b) An accurate statement of the quantity of the contents in terms 
of weight, measure, or numerical count; except as otherwise provided in 
Sec. 381.121(a) with respect to the quantity of contents;
    (vi) If any word, statement, or other information required by or 
under authority of the Act to appear on the label or other labeling is 
not prominently placed thereon with such conspicuousness (as compared 
with other words, statements, designs, or devices, in the labeling) and 
in such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use;
    (vii) If it purports to be or is represented as a food for which a 
definition and standard of identity or composition is prescribed by the 
regulations in subpart P of this part unless:
    (a) It conforms to such definition and standard, and
    (b) Its label bears the name of the food specified in the definition 
and standard, and insofar as may be required by such regulations, the 
common names of optional ingredients (other than spices, flavoring, and 
coloring) present in such food.
    (viii) If it purports to be or is represented as a food for which a 
standard or standards of fill of container have been prescribed by 
regulations of the Secretary, \2\ and falls below the standard of fill 
of container applicable thereto, unless its label bears, in such manner 
and form as such regulations specify, a statement that it falls below 
such standard;
---------------------------------------------------------------------------

    \2\ No such standards are currently in effect. However, Sec. 
381.129 prohibits the use of false or misleading containers.
---------------------------------------------------------------------------

    (ix) If it is not subject to the provisions of paragraph (b)(vii) of 
this section, unless its label bears:
    (a) The common or usual name of the food, if any there be, and
    (b) In case it is fabricated from two or more ingredients, the 
common or usual name of each ingredient, except as otherwise provided in 
Sec. 381.118(c);
    (x) If it purports to be or is represented for special dietary uses, 
unless the label bears such information concerning its vitamin, mineral, 
and other dietary properties as is required by Sec. 381.124;
    (xi) If it bears or contains any artificial flavoring, artificial 
coloring, or chemical preservative, unless it bears a label stating that 
fact; except as otherwise provided in Sec. 381.119, or
    (xii) If it fails to bear, directly thereon or on its containers, 
when required

[[Page 430]]

by Sec. 381.123, the official inspection legend and the official 
establishment number of the establishment where the product was 
processed; and unrestricted by any of the foregoing; such other 
information as the Administrator may require in the regulations to 
assure that it will not have false or misleading labeling and that the 
public will be informed of the manner of handling required to maintain 
the article in a wholesome condition.
    Nonfood compounds. Any substance proposed for use in official 
establishments, the intended use of which will not result, directly or 
indirectly, in the substance becoming a component or otherwise affecting 
the characteristics of poultry or poultry products, excluding labeling 
and packaging materials as covered in subpart N of this part.
    Official certificate. This term means any certificate prescribed in 
subpart M of this part relating to poultry or poultry products.
    Official device. This term means any label or other device 
prescribed in subpart M of this part for use in applying any official 
mark.
    Official establishment. ``Official establishment'' means any 
establishment as determined by the Administrator at which inspection of 
the slaughter of poultry, or the processing of poultry products, is 
maintained pursuant to the regulations.
    Official inspection legend. This term means the official inspection 
mark prescribed in Sec. 381.96 or the official poultry identification 
mark prescribed in Sec. 381.97, showing that an article was inspected 
for wholesomeness and passed in accordance with the Act.
    Official mark. This term means any symbol prescribed in subpart M of 
this part to identify the status of any article or poultry under the 
Act.
    Packaging material. Any cloth, paper, plastic, metal, or other 
material used to form a container, wrapper, label, or cover for poultry 
products.
    Pesticide chemical, food additive, color additive, raw agricultural 
commodity. These terms shall have the same meanings for the purposes of 
the Act and the regulations as under the Federal Food, Drug, and 
Cosmetic Act.
    Poultry. ``Poultry'' means any domesticated bird (chickens, turkeys, 
ducks, geese, guineas, ratites, or squabs, also termed young pigeons 
from one to about thirty days of age), whether live or dead.
    Poultry product. (i) This term means any poultry carcass or part 
thereof; or any product which is made wholly or in part from any poultry 
carcass or part thereof, excepting those exempted from definition as a 
poultry product in Sec. 381.15. Except where the context requires 
otherwise (e.g., in paragraph (b)(42) of this section), this term is 
limited to articles capable of use as human food.
    (ii) Poultry food product. This term means any product capable of 
use as human food which is made in part from any poultry carcass or part 
thereof, excepting those exempted from definition as a poultry product 
in Sec. 381.15.
    Poultry products broker. ``Poultry products broker'' means any 
person engaged in the business of buying or selling poultry products on 
commission, or otherwise negotiating purchases or sales of such articles 
other than for his own account or as an employee of another person.
    Process. Process used as a verb means to conduct any operation or 
combination of operations, whereby poultry is slaughtered, eviscerated, 
canned, salted, stuffed, rendered, boned, cut up, or otherwise 
manufactured or processed. The term ``process'' does not refer to 
freezing of poultry products, except when freezing is incidental to 
operations otherwise classed as ``processing'' under this paragraph.
    Process authority. A person or organization with expert knowledge in 
poultry production process control and relevant regulations.
    Process schedule. A written description of processing procedures, 
consisting of any number of specific, distinct, and ordered operations 
directly under control of the establishment employed in the manufacture 
of a specific product, including the control, monitoring, verification, 
validation, and corrective action activities associated with production.
    Ready-to-cook poultry. ``Ready-to-cook poultry'' means any 
slaughtered poultry free from protruding pinfeathers and vestigial 
feathers (hair or down), from which the head, feet, crop,

[[Page 431]]

oil gland, trachea, esophagus, entrails, and lungs have been removed, 
and from which the mature reproductive organs and kidneys may have been 
removed, and with or without the giblets, and which is suitable for 
cooking without need of further processing. Ready-to-cook poultry also 
means any cut-up or disjointed portion of poultry or other parts of 
poultry, such as reproductive organs, head, or feet that are suitable 
for cooking without need of further processing.
    Regulations. ``Regulations'' means the provisions of this entire 
part.
    Renderer. ``Renderer'' means any person engaged in the business of 
rendering carcasses, or parts or products of the carcasses, of poultry, 
except rendering conducted under inspection or exemption pursuant to the 
regulations.
    Shipping container. ``Shipping container'' means any container used 
or intended for use in packaging the product packed in an immediate 
container.
    Slaughter. ``Slaughter'' means the act of killing poultry for human 
food.
    State. Except as otherwise provided in Sec. 381.220 ``State'' means 
any State of the United States and the Commonwealth of Puerto Rico.
    Supervision. This term means the controls, as prescribed in 
instructions to Inspection Service employees, to be exercised by them 
over particular operations to insure that such operations are conducted 
in compliance with the Act and the regulations in this part.
    Territory. The term ``territory'' means Guam, the Virgin Islands of 
the United States, American Samoa, and any other territory or possession 
of the United States, excluding the Canal Zone.
    United States. This term means the States, the District of Columbia, 
and the territories of the United States.
    U.S. Condemned. This term means that the poultry carcass, or part or 
product of a poultry carcass, so identified was inspected and found to 
be adulterated and is condemned.
    U.S. Detained. This term is applicable to poultry, poultry products, 
and other articles which are held in official custody in accordance with 
section 19 of the Act and Sec. 381.210, pending disposal as provided in 
said section 19.
    U.S. Refused Entry. This term means that the slaughtered poultry or 
other poultry product so identified was presented for inspection for 
entry into the United States and was found not to comply with the 
requirements of the Act.
    U.S. Rejected. This term means that the equipment or facility so 
identified is prohibited from being used in the processing of any 
poultry or poultry product until such equipment or facility is found by 
an inspector to be sanitary and otherwise eligible for use under the 
regulations.
    U.S. Retained. This term means that the poultry or carcass, or part 
or product of a carcass, of poultry so identified is held at an official 
establishment by the inspection service for further determination as to 
its disposal.
    (c) For the purposes of the standard for cooked, smoked sausage 
(Sec. 319.180 of this chapter), the term ``poultry byproduct'' means 
the skin, fat, gizzard, heart, or liver, or any combination thereof, of 
any poultry.

[37 FR 9706; May 16, 1972, as amended at 39 FR 4568, Feb. 5, 1974; 40 FR 
42338, Sept. 12, 1975; 48 FR 6091, Feb. 10, 1983; 49 FR 2236, Jan. 19, 
1984; 49 FR 3643, Jan. 30, 1984; 49 FR 47478, Dec. 5, 1984; 51 FR 37709, 
Oct. 24, 1986; 64 FR 745, Jan. 6, 1999; 64 FR 56416, Oct. 20, 1999; 66 
FR 1770, Jan. 9, 2001; 66 FR 22905, May 7, 2001; 67 FR 13258, Mar. 22, 
2002; 69 FR 255, Jan. 5, 2004]



     Subpart B_Administration; Application of Inspection and Other 
                              Requirements



Sec. 381.3  Administration.

    (a) [Reserved]
    (b) The Administrator may in specific classes of cases waive for 
limited periods any provisions of the regulations in order to permit 
appropriate and necessary action in the event of a public health 
emergency or to permit experimentation so that new procedures, 
equipment, and processing techniques may be tested to facilitate 
definite improvements: Provided, That such waivers of the provisions of 
the regulations are not in conflict with the purposes or provisions of 
the Act.

[[Page 432]]

    (c) Pursuant to section 6 of the Act, the Administrator believes 
that, in establishments processing poultry products at which inspection 
under the Act and regulations is required, the frequency with which and 
the manner in which poultry products made from poultry previously 
slaughtered and eviscerated in official establishments are reinspected 
by Inspection Service employees should be based on considerations 
relevant to effective regulation of poultry products and protection of 
the health and welfare of consumers. In order to test procedures for use 
in making such determinations and, in particular, for determining 
whether and, if so, to what extent the intensity of inspection coverage 
exceeds that which should be deemed necessary pursuant to section 6 of 
the Act, the Administrator is initiating experimentation of a new system 
of inspection for reviewing the performance of establishments and for 
designing the supervision and other conditions and methods of inspection 
coverage. For the period of such experimentation, the Administrator 
shall identify establishments for review, and the frequency and the 
manner of inspection by Inspection Service employees shall be determined 
on the basis of the results of those reviews and be otherwise in 
accordance with this section.
    (d) The determinations referred to in paragraph (c) of this section 
shall be made by the Inspection Service and shall reflect evaluations of 
the performance and the characteristics of such establishments.
    (1) In assessing the performance of an establishment, the following 
factors are appropriate for consideration:
    (i) The history of compliance with applicable regulatory 
requirements by the person operating such establishment or by anyone 
responsibly connected with the business operating such establishment, as 
``responsibly connected'' is defined in section 18(a) of the Act,
    (ii) The competence of the person operating such establishment, as 
indicated by:
    (A) Knowledge of appropriate manufacturing practices and applicable 
regulatory requirements,
    (B) Demonstrated ability to apply such knowledge in a timely and 
consistent manner, and
    (C) Commitment to correcting deficiencies noted by Inspection 
Service employees and otherwise assuring compliance with applicable 
regulatory requirements, and
    (iii) The procedures used in such establishment to control the 
production process, environment, and resulting product in order to 
assure and monitor compliance with the requirements of the Act and the 
rules and regulations promulgated thereunder.
    (2) In assessing the characteristics of an establishment, the 
following factors are appropriate for consideration:
    (i) The complexity of the processing operation(s) conducted at such 
establishment,
    (ii) The frequency with which each such operation is conducted at 
such establishment,
    (iii) The volume of product resulting from each such operation at 
such establishment,
    (iv) Whether and to what extent slaughter and evisceration 
operations also are conducted at such establishment,
    (v) What, if any, food products not regulated under this Act or the 
Federal Meat Inspection Act also are processed at such establishment, 
and
    (vi) The size of such establishment.
    (e)(1) For the period of experimentation described in paragraph (c) 
of this section, the frequency of inspection by Inspection Service 
employees of operations other than slaughter and evisceration may be 
reduced in an establishment in which the procedures referred to therein 
are being tested if and only if the evaluation of the performance of 
such establishment described in paragraph (d)(1) indicates that there 
are:
    (i) No instances, documented in records compiled no earlier than 10 
years before, of substantial and recent noncompliance with applicable 
regulatory requirements (taking into account both the nature and 
frequency of any such noncompliance), and
    (ii) The competence and control procedures needed to assure and 
monitor compliance with applicable regulatory requirements.

[[Page 433]]

    (2)(i) The frequency of Federal inspection and other conditions and 
methods of inspection coverage in any establishment in which the 
frequency of Federal inspection is reduced shall be based on:
    (A) The evaluation of the characteristics of such establishment 
described in paragraph (d)(2) of this section,\1\
---------------------------------------------------------------------------

    \1\ These evaluations will be based upon guidelines developed by 
FSIS and the complexity categorization in FSIS Directive 1030.2 
(Documentation of Processing and Combination Assignments, 4/22/85). The 
guidelines and Directive will be available for public inspection and 
copying in the Policy Office, Room 3168, South Agriculture Building, 
14th Street and Independence Avenue, SW., Washington, DC.
---------------------------------------------------------------------------

    (B) The significance of potential public health consequences of 
noncompliance, and
    (C) The availability of Inspection Service employees.
    (ii) To the extent that frequency of inspection or other conditions 
and methods of inspection coverage are identified as conflicting with 
provisions of the regulations in this part, the Administrator will waive 
such provisions for the period of experimentation, in accordance with 
paragraph (b) of this section.

[37 FR 9706, May 16, 1972, as amended at 52 FR 10033, Mar. 30, 1987; 69 
FR 255, Jan. 5, 2004]



Sec. 381.4  Inspection in accordance with methods prescribed or approved.

    Inspection of poultry products shall be rendered pursuant to the 
regulations and under such conditions and in accordance with such 
methods as may be prescribed or approved by the Administrator.



Sec. 381.5  Publications.

    Publications under the Act and the regulations shall be made in the 
Federal Register and in such other media as the Administrator may 
designate.



Sec. 381.6  Establishments requiring inspection.

    Inspection under the regulations is required at:
    (a) Every establishment, except as provided in Sec. 381.10 (a) and 
(b) or Sec. 381.11, in which any poultry is slaughtered for 
transportation or sale in commerce, or in which any poultry products are 
wholly or in part, processed for transportation or sale in commerce, as 
articles intended for use as human food;
    (b) Every establishment, except as provided in Sec. 381.10 (a) and 
(b), (c), or (d), or Sec. 381.11, within any State or organized 
territory which is designated in Sec. 381.221 pursuant to section 5(c) 
of the Act, at which any poultry is slaughtered or any poultry products 
are processed, for use as human food solely for distribution within such 
jurisdiction; and
    (c) Except as provided in Sec. 381.10 (a) and (b), or (c), or Sec. 
381.11, every establishment designated by the Administrator pursuant to 
section 5(c) of the Act as one producing adulterated poultry products 
which would clearly endanger the public health.



Sec. 381.7  Coverage of all poultry and poultry products processed in 
official establishments.

    All poultry and poultry products processed in an official 
establishment shall be inspected, handled, processed, marked, and 
labeled as required by the regulations.



                          Subpart C_Exemptions



Sec. 381.10  Exemptions for specified operations.

    (a) The requirements of the Act and the regulations for inspection 
of the processing of poultry and poultry products shall not apply to:
    (1) Any retail dealer with respect to poultry products sold in 
commerce directly to consumers in an individual retail store, if the 
only processing operation performed by such retail dealer is the cutting 
up of poultry products on the premises where such sales to consumers are 
made: Provided, That such operation is conducted under such sanitary 
standards, practices, and procedures as result in the preparation of 
poultry products that are not adulterated: And provided further, That 
the poultry products sold in commerce are derived from poultry inspected 
and passed under the Act and such poultry products are not adulterated 
or misbranded at the time of sale (except that the official inspection 
legend shall not

[[Page 434]]

be used). (For the purposes of this subparagraph, a retail dealer is any 
person who sells poultry products directly to consumers as defined in 
paragraph (d)(2)(vi) of this section and whose sales of poultry products 
to household consumers constitute, in terms of dollar value, at least 75 
percent of his total sales of poultry products.)
    (2) The slaughter of poultry, and the processing of poultry 
products, by any person in any territory not organized with a 
legislative body, solely for distribution within such territory: 
Provided, That such poultry is sound and healthy and is slaughtered 
under such sanitary standards, practices, and procedures as result in 
the preparation of poultry products that are not adulterated: And 
provided further, That the poultry products are not adulterated or 
misbranded when so distributed (except that the official inspection 
legend shall not be used).
    (3) The slaughtering by any person of poultry of his own raising, 
and the processing by him and transportation in commerce of the poultry 
products exclusively for use by him and members of his household and his 
nonpaying guests and employees: Provided, That in lieu of complying with 
all the adulteration and misbranding provisions of the Act, such poultry 
is healthy and is slaughtered and processed under such sanitary 
standards, practices, and procedures as result in the preparation of 
poultry products that are sound, clean, and fit for human food, and the 
shipping containers of such poultry products bear the producer's name 
and address and the statement ``Exempted--P.L. 90-492.''
    (4) The custom slaughter by any person of poultry delivered by the 
owner thereof for such slaughter, and the processing by such slaughterer 
and transportation in commerce of the poultry products exclusively for 
use, in the household of such owner, by him and members of his household 
and his nonpaying guests and the employees: Provided, That such custom 
slaughterer does not engage in the business of buying or selling any 
poultry products capable of use as human food: And provided further, 
That in lieu of complying with all the adulteration and misbranding 
provisions of the Act, such poultry is healthy and is slaughtered and 
processed under such sanitary standards, practices, and procedures as 
result in the preparation of poultry products that are sound, clean and 
fit for human food, and the shipping containers of such poultry products 
bear the owner's name and address and the statement ``Exempted--P.L. 90-
492.''
    (5) The slaughtering of sound and healthy poultry and processing of 
poultry products therefrom in any State or territory or the District of 
Columbia by any poultry producer on his own premises with respect to 
poultry raised on his premises, and the distribution by any person 
solely within such jurisdiction of the poultry products derived from 
such operations: Provided, That (i) in lieu of complying with all the 
adulteration provisions of the Act, such poultry is slaughtered and 
otherwise processed and handled under such sanitary standards, 
practices, and procedures as result in the preparation of poultry 
products that are sound, clean, and fit for human food when so 
distributed; (ii) such poultry products when so distributed, bear (in 
lieu of labeling that would otherwise be required) the producer's name 
and address and the statement ``Exempted--P.L. 90-492'' and such poultry 
products are not otherwise misbranded; (iii) such producer and 
distributor do not engage in the current calendar year in the business 
of buying or selling any poultry or poultry products other than as 
specified in this paragraph (a) (5) or (6) of this section; and (iv) 
neither such producer or distributor slaughters or processes the 
products of more poultry than allowed by paragraph (b) of this section.
    (6) The slaughtering of sound and healthy poultry or the processing 
of poultry products of such poultry in any State or territory or the 
District of Columbia by any poultry producer or other person for 
distribution by him solely within such jurisdiction directly to 
household consumers, restaurants, hotels, and boardinghouses, for use in 
their own dining rooms, or in the preparation of meals for sales direct 
to consumers: Provided, That (i) in lieu of complying with all the 
adulteration provisions of the Act, such poultry is

[[Page 435]]

slaughtered and otherwise processed and handled under such sanitary 
standards, practices, and procedures as result in the preparation of 
poultry products that are sound, clean, and fit for human food when 
distributed by such processor; (ii) such poultry products when so 
distributed bear (in lieu of labeling that would otherwise be required) 
the processor's name and address and the statement ``Exempted--P.L. 90-
492'' and such poultry products are not otherwise misbranded; (iii) such 
processor does not engage in the current calendar year in the business 
of buying or selling any poultry or poultry products other than as 
specified in this paragraph (a) (6) or (5) of this section; and (iv) 
such proc essor does not exceed the volume limitation prescribed in 
paragraph (b) of this section.
    (7) The operations and products of small enterprises (including 
poultry producers) not exempted under paragraphs (a) (1) through (6) of 
this section that are engaged in any State or territory or the District 
of Columbia in slaughtering and/or cutting up poultry for distribution 
as carcasses or parts thereof solely for distribution within such 
jurisdiction; Provided, That (i) such poultry is sound and healthy when 
slaughtered and is slaughtered and/or cut up and handled under such 
sanitary standards, practices and procedures as result in the 
preparation of poultry products that are not adulterated when so 
distributed; and (ii) when so distributed, such poultry products are not 
misbranded (except that the official inspection legend shall not be 
used).
    (b) No person qualifies for any exemption specified in paragraph 
(a)(5), (6), or (7) of this section if, in the current calendar year, 
such person:
    (1) Slaughters or processes the products of more than 20,000 
poultry, or
    (2) Slaughters or processes poultry products at a facility used for 
slaughtering or processing poultry products by any other person, except 
when the Administrator grants such exemption after determining, upon 
review of a person's application, that such an exemption will not impair 
effectuating the purposes of the Act.
    (c) The provisions of the Act and the regulations do not apply to 
any poultry producer with respect to poultry, of his own raising on his 
own farm, which he slaughters if:
    (1) Such producer slaughters not more than 1,000 poultry during the 
calendar year for which this exemption is being determined;
    (2) Such poultry producer does not engage in buying or selling 
poultry products other than those produced from poultry raised on his 
own farm; and
    (3) None of such poultry moves in ``commerce'' (as defined in Sec. 
381.1).
    (d)(1) The requirements of the Act and the regulations for 
inspection of the processing of poultry and poultry products do not 
apply to operations of types traditionally and usually conducted at 
retail stores and restaurants, when conducted at any retail store or 
restaurant or similar-retail-type establishment for sale in normal 
retail quantities or service of such articles to consumers at such 
establishments.
    (2) For the purposes of paragraph (d)(1) of this section:
    (i) Operations of types traditionally and usually conducted at 
retail stores and restaurants include any processing of poultry products 
except canning of poultry products and except slaughtering of poultry 
unless such slaughtering is conducted at a retail store with respect to 
live poultry purchased by the consumer at the retail store and processed 
by the retail store operator in accordance with the consumer's 
instructions.
    (ii) A normal retail quantity is any quantity of a poultry product 
purchased by a household consumer from a retail supplier that in the 
aggregate does not exceed 75 pounds. A normal retail quantity sold by a 
retail supplier to other than a household consumer is any quantity that 
in the aggregate does not exceed 150 pounds.
    (iii) A retail store is any place of business where:
    (a) The sales of poultry products are made to consumers only;
    (b) At least 75 percent, in terms of dollar value, of total sales of 
product represents sales to household consumers and the total dollar 
value of sales of product to consumers other than household consumers 
does not exceed the dollar limitation per calendar

[[Page 436]]

year set by the Administrator. This dollar limitation is a figure which 
will automatically be adjusted during the first quarter of each calendar 
year, upward or downward, whenever the Consumer Price Index, published 
by the Bureau of Labor Statistics, Department of Labor, indicates a 
change in the price of this same volume of product which exceeds $500. 
Notice of the adjusted dollar limitation will be published in the 
Federal Register. \1\
---------------------------------------------------------------------------

    \1\ The dollar limitation currently in effect may be obtained by 
contacting Director, Slaughter Inspection Standards and Procedures 
Division, Technical Services, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250 (202) 447-3219.
---------------------------------------------------------------------------

    (c) Only federally or State inspected and passed, or exempted (or, 
as provided in Sec. 381.223, State or local agency inspected and passed 
or exempted) poultry products are handled or used in the preparation of 
any poultry products;
    (d) No sale of poultry products is made in excess of a normal retail 
quantity as defined in paragraph (d)(2)(ii) of this section; and
    (e) The processing of poultry products for sale is limited to 
traditional and usual operations as defined in paragraph (d)(2)(i) of 
this section.
    (iv) Restaurants. (a) A restaurant is any establishment where:
    (1) Poultry products are processed only for sale or service in meals 
or as entrees directly to individual consumers at such establishments;
    (2) Only federally inspected and passed, or exempted (or, as 
provided in Sec. 381.223, State or local agency inspected and passed or 
exempted) poultry products are handled or used in the preparation of any 
poultry products;
    (3) No sale of poultry products is made in excess of a normal retail 
quantity as defined in paragraph (d)(2)(ii) of this section; and
    (4) The processing of poultry products is limited to traditional and 
usual operations as defined in paragraph (d)(2)(i) of this section.
    (b) The definition of a restaurant includes a caterer which delivers 
or serves product in meals, or as entrees, only to individual consumers 
and otherwise meets the requirements of this paragraph.
    (c) For purposes of this paragraph, operations conducted as a 
restaurant central kitchen facility shall be considered as being 
conducted at a restaurant if the restaurant central kitchen prepares 
poultry products that are ready to eat when they leave such facility 
(i.e., no further cooking or other preparation is needed, except that 
they may be reheated prior to serving if chilled during transportation), 
transported directly to a receiving restaurant by its own employees, 
without intervening transfer or storage, maintained in a safe, 
unadulterated condition during transportation, and served in meals or as 
entrees only to customers at restaurants, or through vending machines, 
owned or operated by the same person that owns or operates such 
facility, and which otherwise meets the requirement of this paragraph: 
Provided, That the requirements of Sec. Sec. 381.175 through 381.178 of 
this subchapter apply to such facility. Provided further, That the 
exempted facility may be subject to inspection requirements under the 
Act for as long as the Administrator deems necessary if the 
Administrator determines that the sanitary conditions or practices of 
the facility or the processing procedures or methods at the facility are 
such that any of its poultry products are rendered adulterated. When the 
Administrator has made such determination and subjected a restaurant 
central kitchen facility to such inspection requirements, the operator 
of such facility shall be afforded an opportunity to dispute the 
Administrator's determination in a hearing pursuant to rules of practice 
which will be adopted for this proceeding.
    (v) A similar retail-type establishment is any establishment which 
is a combination retail store and restaurant; any delicatessen which 
meets the requirements for a retail store or restaurant as prescribed in 
paragraph (d)(2) (iii) or (iv) of this section; or other establishment 
as determined by the Administrator in specific cases.
    (vi) A consumer is any household consumer, hotel, or restaurant, or 
similar institution as determined by the Administrator in specific 
cases.

[[Page 437]]

    (3) Whenever any complaint is received by the Administrator from any 
person alleging that any retail establishment or restaurant claiming 
exemption under this paragraph (d) in any designated State or organized 
territory listed in Sec. 381.221 that is also identified in Sec. 
381.224 as a jurisdiction that does not have or is not exercising 
adequate authority with respect to recordkeeping requirements, has been 
operated in violation of the conditions prescribed in this paragraph (d) 
for such exemption, and the Administrator, upon investigation of the 
complaint, has reason to believe that any such violation has occurred, 
he shall so notify the operator of the retail establishment or 
restaurant and afford him reasonable opportunity to present his views 
informally with respect to the matter. Thereafter, if the Administrator 
determines that such a violation has occurred, and that a requirement 
that the operator keep records concerning the operations of the retail 
establishment or restaurant would effectuate the purposes of the Act, 
the Administrator shall order the operator to maintain complete, 
accurate, and legible records of his total monthly purchases and of his 
total monthly sales of poultry and poultry products. Such records shall 
separately show total sales to household consumers and total sales to 
other consumers, and shall be maintained for the period prescribed in 
Sec. 381.177. If the operator maintains copies of bills of lading, 
receiving and shipping invoices, warehouse receipts, or similar 
documents which give the information required herein, additional records 
are not required by this subparagraph.
    (4) The adulteration and misbranding provisions of the Act and the 
regulations other than the requirement of the official inspection 
legend, apply to articles which are exempted from inspection under this 
paragraph (d).
    (e)(1) The requirements of the Act and the regulations in this 
subchapter for inspection of the preparation of products do not apply to 
poultry pizzas containing poultry product ingredients which were 
prepared, inspected, and passed in a cured or cooked form as ready-to-
eat (i.e., no further cooking or other preparation is needed) in 
compliance with the requirements of the Act and these regulations; and 
the poultry pizzas are to be served in public or private nonprofit 
institutions, provided that the poultry pizzas are ready to eat (i.e., 
no further cooking or other preparation is needed, except that they may 
be reheated prior to serving if chilled during transportation), 
transported directly to the receiving institution by employees of the 
preparing firm, receiving institution, or a food service management 
company contracted to conduct food service at the public or private 
nonprofit institution, without intervening transfer or storage.
    (2) The definitions at Chapter 1, 1-102, except 1-102(z) and the 
provisions of Chapters 2 through 8, except sections 2-102 (a) and (b), 
2-302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506, 
2-508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c), 
5-203, and 6-105, Part IV, of the Food and Drug Administration's Food 
Service Sanitation Manual (1976 Recommendations), DHEW Publication No. 
(FDA) 78-2081, which is incorporated by reference, shall apply to the 
facilities and operations of businesses claiming this exemption. (These 
materials are incorporated as they exist on the date of approval. This 
incorporation by reference was approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be purchased from the Superintendent of Documents, U.S. Government 
Printing Office, Washington, DC 20402. It is also available for 
inspection at the FSIS Hearing Clerk, room 3171, South Building, Food 
Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250 or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (3) Facilities and operations of businesses claiming this exemption 
shall also conform to the following requirements:
    (i) Manual cleaning and sanitizing. (A) For manual washing, rinsing 
and sanitizing of utensils and equipment, a sink

[[Page 438]]

with not fewer than three compartments shall be provided and used. Sink 
compartments shall be large enough to permit the accommodation of the 
equipment and utensils, and each compartment of the sink shall be 
supplied with hot and cold potable running water. Fixed equipment and 
utensils and equipment too large to be cleaned in sink compartments 
shall be washed manually or cleaned through pressure spray methods.
    (B) Drain boards or easily movable dish tables of adequate size 
shall be provided for proper handling of soiled utensils prior to 
washing and for cleaned utensils following sanitizing and shall be 
located so as not to interfere with the proper use of the dishwashing 
facilities.
    (C) Equipment and utensils shall be preflushed or prescraped and, 
when necessary, presoaked to remove gross food particles and soil.
    (D) Except for fixed equipment and utensils too large to be cleaned 
in sink compartments, manual washing, rinsing and sanitizing shall be 
conducted in the following sequence:
    (1) Sinks shall be cleaned prior to use.
    (2) Equipment and utensils shall be thoroughly washed in the first 
compartment with a hot detergent solution that is kept clean.
    (3) Equipment and utensils shall be rinsed free of detergent and 
abrasives with clean water in the second compartment.
    (4) Equipment and utensils shall be sanitized in the third 
compartment according to one of the methods prescribed in paragraph 
(e)(3)(i)(E) (1) through (4) of this section.
    (E) The food-contact surfaces of all equipment and utensils shall be 
sanitized by:
    (1) Immersion for at least \1/2\ minute in clean, hot water at a 
temperature of at least 170 [deg]F; or
    (2) Immersion for at least 1 minute in a clean solution containing 
at least 50 parts per million of available chlorine as a hypochlorite 
and at a temperature of at least 75 [deg]F; or
    (3) Immersion for at least 1 minute in a clean solution containing 
at least 12.5 parts per million of available iodine and having a pH not 
higher than 5.0 and at a temperature of at least 75 [deg]F; or
    (4) Immersion in a clean solution containing any other chemical 
sanitizing agent allowed under 21 CFR 178.1010 that will provide the 
equivalent bactericidal effect of a solution containing at least 50 
parts per million of available chlorine as a hypochlorite at a 
temperature of at least 75 [deg]F for 1 minute; or
    (5) Treatment with steam free from materials or additives other than 
those specified in 21 CFR 173.310 in the case of equipment too large to 
sanitize by immersion, but in which steam can be confined; or
    (6) Rinsing, spraying, or swabbing with a chemical sanitizing 
solution of at least twice the strength required for that particular 
sanitizing solution under paragraph (e)(3)(i)(E)(4) of this section in 
the case of equipment too large to sanitize by immersion.
    (F) When hot water is used for sanitizing, the following facilities 
shall be provided and used:
    (1) An integral heating device or fixture installed in, on, or under 
the sanitizing compartment of the sink capable of maintaining the water 
at a temperature of at least 170 [deg]F; and
    (2) A numerically scaled indicating thermometer, accurate to 3 [deg]F, convenient to the sink for frequent checks of 
water temperature; and
    (3) Dish baskets of such size and design to permit complete 
immersion of the tableware, kitchenware, and equipment in the hot water.
    (G) When chemicals are used for sanitization, they shall not have 
concentrations higher than the maximum permitted under 21 CFR 178.1010 
and a test kit or other device that accurately measures the parts per 
million concentration of the solution shall be provided and used.
    (ii) Mechanical cleaning and sanitizing. (A) Cleaning and sanitizing 
may be done by spray-type or immersion dishwashing machines or by any 
other type of machine or device if it is demonstrated that it thoroughly 
cleans and sanitizes equipment and utensils. These machines and devices 
shall be properly installed and maintained in good repair. Machines and 
devices shall

[[Page 439]]

be operated in accordance with manufacturers' instructions, and utensils 
and equipment placed in the machine shall be exposed to all dishwashing 
cycles. Automatic detergent dispensers, wetting agent dispensers, and 
liquid sanitizer injectors, if any, shall be properly installed and 
maintained.
    (B) The pressure of final rinse water supplied to spray-type 
dishwashing machines shall not be less than 15 nor more than 25 pounds 
per square inch measured in the water line immediately adjacent to the 
final rinse control valve. A \1/4\-inch IPS valve shall be provided 
immediately upstream from the final rinse control valve to permit 
checking the flow pressure of the final rinse water.
    (C) Machine or water line mounted numerically scaled indicating 
thermometers, accurate to 3 [deg]F, shall be 
provided to indicate the temperature of the water in each tank of the 
machine and the temperature of the final rinse water as it enters the 
manifold.
    (D) Rinse water tanks shall be protected by baffles, curtains, or 
other effective means to minimize the entry of wash water into the rinse 
water. Conveyors in dishwashing machines shall be accurately timed to 
assure proper exposure times in wash and rinse cycles in accordance with 
manufacturers' specifications attached to the machines.
    (E) Drain boards shall be provided and be of adequate size for the 
proper handling of soiled utensils prior to washing and of cleaned 
utensils following sanitization and shall be so located and constructed 
as not to interfere with the proper use of the dishwashing facilities. 
This does not preclude the use of easily movable dish tables for the 
storage of soiled utensils or the use of easily movable dishtables for 
the storage of clean utensils following sanitization.
    (F) Equipment and utensils shall be flushed or scraped and, when 
necessary, soaked to remove gross food particles and soil prior to being 
washed in a dishwashing machine unless a prewashcycle is a part of the 
dishwashing machine operation. Equipment and utensils shall be placed in 
racks, trays, or baskets, or on conveyors, in a way that food-contact 
surfaces are exposed to the unobstructed application of detergent wash 
and clean rinse waters and that permits free draining.
    (G) Machines (single-tank, stationary-rack, door-type machines and 
spray-type glass washers) using chemicals for sanitization may be used: 
Provided, That,
    (1) The temperature of the wash water shall not be less than 120 
[deg]F.
    (2) The wash water shall be kept clean.
    (3) Chemicals added for sanitization purposes shall be automatically 
dispensed.
    (4) Utensils and equipment shall be exposed to the final chemical 
sanitizing rinse in accordance with manufacturers' specifications for 
time and concentration.
    (5) The chemical sanitizing rinse water temperature shall be not 
less than 75 [deg]F nor less than the temperature specified by the 
machine's manufacturer.
    (6) Chemical sanitizers used shall meet the requirements of 21 CFR 
178.1010.
    (7) A test kit or other device that accurately measures the parts 
per million concentration of the solution shall be available and used.
    (H) Machines using hot water for sanitizing may be used provided 
that wash water and pumped rinse water shall be kept clean and water 
shall be maintained at not less than the following temperatures:
    (1) Single-tank, stationary-rack, dual-temperature machine:

Wash temperature..............................................150 [deg]F
Final rinse temperature.......................................180 [deg]F

    (2) Single-tank, stationary-rack, single-temperature machine:

Wash temperature..............................................165 [deg]F
Final rinse temperature.......................................165 [deg]F

    (3) Single-tank, conveyor machine:

Wash temperature..............................................160 [deg]F
Final rinse temperature.......................................180 [deg]F

    (4) Multitank, conveyor machine:

Wash temperature..............................................150 [deg]F
Pumped rinse temperature......................................160 [deg]F
Final rinse temperature.......................................180 [deg]F

    (5) Single-tank, pot, pan, and utensil washer (either stationary or 
moving-rack):


[[Page 440]]


Wash temperature..............................................140 [deg]F
Final rinse temperature.......................................180 [deg]F

    (I) All dishwashing machines shall be thoroughly cleaned at least 
once a day or more often when necessary to maintain them in a 
satisfactory operating condition.
    (iii) Steam. Steam used in contact with food or food-contact 
surfaces shall be free from any materials or additives other than those 
specified in 21 CFR 173.310.
    (4) For purposes of this paragraph, the term ``private nonprofit 
institution'' means ``a corporation, and any community chest, fund, or 
foundation, organized and operated exclusively for religious, 
charitable, scientific, testing for public safety, literary, or 
educational purposes, or to foster national or international amateur 
sports competition (but only if no part of its activities involve the 
provision of athletic facilities or equipment), or for the prevention of 
cruelty to children or animals, no part of the net earnings of which 
inures to the benefit of any private shareholder or individual, no 
substantial part of the activities of which is carrying on propaganda, 
or otherwise attempting, to influence legislation, and which does not 
participate in, or intervene in (including the publishing or 
distribution of statements), any political campaign on behalf of (or in 
opposition to) any candidate for public office.''
    (5) The Administrator may withdraw or modify the exemption set forth 
in Sec. 381.10(e)(1) for a particular establishment when he or she 
determines that such action is necessary to ensure food safety and 
public health. Before such action is taken, the owner or operator of the 
particular establishment shall be notified, in writing, of the reasons 
for the proposed action and shall be given an opportunity to respond, in 
writing, to the Administrator within 20 days after notification of the 
proposed action. The written notification shall be served on the owner 
or operator of the establishment in the manner prescribed in section 
1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)). 
In those instances where there is conflict of any material fact, the 
owner or operator of the establishment, upon request, shall be afforded 
an opportunity for a hearing with respect to the disputed fact, in 
accordance with rules of practice which shall be adopted for the 
proceeding. However, such withdrawal or modification shall become 
effective pending final determination in the proceeding when the 
Administrator determines that an imminent threat to food safety or 
public health exists, and that such action is, therefore, necessary to 
protect the public health, interest or safety. Such withdrawal or 
modification shall be effective upon oral or written notification, 
whichever is earlier, to the owner or operator of the particular 
establishment as promptly as circumstances permit. In the event of oral 
notification, written confirmation shall be given to the owner or 
operator of the establishment as promptly as circumstances permit. This 
withdrawal or modification shall continue in effect pending the 
completion of the proceeding and any judicial review thereof, unless 
otherwise ordered by the Administrator.
    (6) The adulteration and misbranding provisions of the Act and the 
regulations apply to articles which are exempted from inspection under 
Sec. 381.10(e).

[37 FR 9706, May 16, 1972, as amended at 38 FR 16991, June 28, 1973; 45 
FR 27922, Apr. 25, 1980; 46 FR 46288, Sept. 16, 1981; 48 FR 2959, Jan. 
24, 1983; 51 FR 29909, Aug. 21, 1986; 53 FR 24679, June 30, 1988; 57 FR 
34184, Aug. 3, 1992]



Sec. 381.11  Exemptions based on religious dietary laws.

    (a) Any person who slaughters, processes, or otherwise handles 
poultry or poultry products which have been or are to be processed as 
required by recognized religious dietary laws may apply for exemption 
from specific provisions of the Act or regulations which are in conflict 
with such religious dietary laws. Any person desiring such an exemption 
shall apply in writing to the Meat and Poultry Inspection Program, Food 
Safety and Inspection Service, Department of Agriculture, Washington, DC 
20250, setting forth the specific provisions of the Act and the 
regulations from which exemption is sought and setting forth the 
provisions of the religious dietary laws in support

[[Page 441]]

of the requested exemption. In addition, the applicant for such an 
exemption shall submit a statement from the clerical official having 
jurisdiction over the enforcement of the religious dietary laws with 
respect to the poultry or poultry products involved, which identifies 
the requirements of such laws pertaining to the slaughter of the poultry 
and the processing or other handling of the poultry products involved, 
and certifies that such requirements are in conflict with specific 
provisions of the Act and regulations from which the exemption is 
sought.
    (b) The Administrator, upon a determination that an exemption should 
be granted, will grant such exemption to the extent necessary to avoid 
conflict with the religious requirements while still effectuating the 
purposes of the Act. He may impose such conditions as to sanitary 
standards, practices, and procedures in granting such exemption as he 
deems necessary to effectuate the purposes of the Act. Any person who 
processes poultry or poultry products under exemption from certain 
requirements as provided in this section shall be subject to all of the 
other applicable provisions of the Act and the regulations. Processing 
plants shall meet the sanitary requirements set forth in this part and 
unless exempted from inspection under the provisions of this subpart, 
shall be required to qualify for inspection and operate as official 
establishments. Slaughtered poultry which is prepared under an exemption 
authorizing the sale of noneviscerated poultry in commerce shall be 
individually identified with a label approved by the Administrator which 
identifies the clerical official under whose supervision the poultry was 
slaughtered.



Sec. 381.12  Effect of religious dietary laws exemptions on other persons.

    Whenever a slaughterer or processor is granted an exemption under 
Sec. 381.11 with respect to the slaughtering or processing of any 
poultry or poultry products under this part, under specified conditions, 
the sale, offer for sale, transportation and other handling in commerce 
by any person of such poultry and poultry products in accordance with 
such conditions is hereby authorized, except as restricted by the Act.



Sec. 381.13  Suspension or termination of exemptions.

    (a) The Administrator may, by order, in accordance with the 
applicable rules of practice suspend or terminate any exemption under 
Sec. 381.10(a) with respect to any person whenever he finds that such 
action will aid in effectuating the purposes of the Act. Failure to 
comply with the conditions of the exemption, including, but not limited 
to, failure to process poultry and poultry products under clean and 
sanitary conditions may result in termination of an exemption, in 
addition to any other penalties provided by law.
    (b) Except as provided in Sec. 381.10(c), the Administrator may 
extend the requirements of the Act to any establishment in any State or 
organized territory at which poultry products are processed for 
distribution solely within such jurisdiction if he determines in 
accordance with the provisions of subparagraph 5(c)(1) of the Act that 
the establishment is producing adulterated poultry products which would 
clearly endanger the public health.



Sec. 381.14  Inspection concerning purportedly exempted operations.

    Inspectors of the Inspection Service are authorized to make 
inspections in accordance with law to ascertain whether any of the 
provisions of the Act or the regulations applying to producers, 
retailers, or other persons purporting to be exempted from any 
requirements under this subpart have been violated.



Sec. 381.15  Exemption from definition of ``poultry product'' of 
certain human food products containing poultry.

    The following articles contain poultry ingredients only in a 
relatively small proportion or historically have not been considered by 
consumers as products of the poultry food industry. Therefore said 
articles are exempted from the definition of ``poultry product'' and the 
requirements of the Act and the regulations applicable to poultry 
products, if they comply with the conditions specified in this section.
    (a) Any human food product (in a consumer package) not provided for 
in paragraph (c) of this section, if:

[[Page 442]]

    (1) It contains less than 2 percent cooked poultry meat (deboned 
white or dark poultry meat, or both) and/or ``Mechanically Separated 
(Kind of Poultry)'' as defined in Sec. 381.173;
    (2) It contains less than 10 percent of cooked poultry skins, 
giblets, or fat, separately, and less than 10 percent of cooked poultry 
skins, giblets, fat, and meat (as meat is limited in paragraph (a)(1) of 
this section) or ``Mechanically Separated (Kind of Poultry)'' as defined 
in Sec. 381.173, in any combination;
    (3) The poultry ingredients used in the product were prepared under 
inspection as defined in Sec. 381.1, or were inspected under a foreign 
inspection system approved under Sec. 381.196(b) and imported in 
compliance with the Act and the regulations;
    (4) The immediate container of the product bears a label which shows 
the name of the product in accordance with this section; and
    (5) The product is not represented as a poultry product. The 
aforesaid percentages of ingredients shall be computed on the basis of 
the moist, deboned, cooked poultry in the ready-to-serve product when 
prepared according to the serving directions on the consumer package.
    (b) Any human food product (in an institutional pack), not provided 
for in paragraph (c) of this section, if:
    (1) It is prepared for sale only to institutional users, such as 
hotels, restaurants, and boardinghouses, for use as a soup base or 
flavoring;
    (2) It contains less than 15 percent cooked poultry meat (deboned 
white or dark poultry meat or both) and/or ``Mechanically Separated 
(Kind of Poultry)'' as defined in Sec. 381.173, computed on the basis 
of the moist deboned, cooked poultry meat and/or ``Mechanically 
Separated (Kind of Poultry)'' in such product; and
    (3) It complies with the provisions of paragraphs (a)(3), (4), and 
(5) of this section in all respects.
    (c) Bouillon cubes, poultry broths, gravies, sauces, seasonings, and 
flavorings if:
    (1) They contain poultry meat and/or ``Mechanically Separated (Kind 
of Poultry)'' as defined in Sec. 381.173 or poultry fat only in 
condimental quantities;
    (2) They comply with the provisions of paragraphs (a)(3), (4), and 
(5) of this section in all respects; and
    (3) In the case of poultry broth, it will not be used in the 
processing of any poultry product in any official establishment.
    (d) Fat capsules and sandwiches containing poultry products if they 
comply with the provisions of paragraphs (a)(3), (4), and (5) of this 
section in all respects.
    (e) Products of the types specified in this section except those 
specified in paragraphs (c) and (d) of this section will be deemed to be 
represented as poultry products if the kind name of the poultry 
(chicken, turkey, etc.) is used in the product name of the product 
without appropriate qualification. For example, a consumer-packaged 
noodle soup product containing less than 2 percent chicken meat on a 
ready-to-serve basis may not be labeled ``Chicken Noodle Soup'' but, 
when appropriate, could be labeled as ``Chicken Flavored Noodle Soup.'' 
Products exempted under this section are subject to the requirements of 
the Federal Food, Drug, and Cosmetic Act.

[37 FR 9706, May 16, 1972, as amended at 60 FR 55982, Nov. 3, 1995]



  Subpart D_Application for Inspection; Grant or Refusal of Inspection



Sec. 381.16  How application shall be made.

    The operator of each establishment of the kind required by Sec. 
381.6 to have inspection shall make application to the Administrator for 
inspection service. In cases of change of name, ownership, or location, 
a new application shall be made.



Sec. 381.17  Filing of application.

    Every application for inspection at any establishment shall be made 
by the operator on a form furnished by the Meat and Poultry Inspection 
Program, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250, and shall include all information 
called for by that form, including the name of any subsidiary 
corporation that will prepare any poultry

[[Page 443]]

product or conduct any other operation at the establishment for which 
inspection is requested. The applicant for inspection will be held 
responsible for compliance by all its subsidiaries with the requirements 
of the regulations at such establishments if inspection is granted. 
Processing of poultry products and other operations at the establishment 
for which inspection is granted may be conducted only by the applicant, 
except that such a subsidiary of the grantee, may conduct such 
operations at such establishment.



Sec. 381.18  Authority of applicant.

    Any person applying for inspection service may be required at the 
discretion of the Administrator to demonstrate that the operator of the 
establishment authorized him to do so.



Sec. 381.20  Survey and grant of inspection.

    (a) Before inspection is granted, FSIS shall survey the 
establishment to determine if the construction and facilities of the 
establishment are in accordance with the regulations. FSIS will grant 
inspection, subject to Sec. 381.21, when these requirements are met.
    (b) FSIS shall give notice in writing to each applicant granted 
inspection and shall specify in the notice the establishment, including 
the limits of the establishment's premises, to which the grant pertains.

[62 FR 45026, Aug. 25, 1997]



Sec. 381.21  Refusal of inspection.

    (a) Any application for inspection in accordance with this part may 
be denied or refused in accordance with the rules of practice in part 
500 of this chapter.
    (b)(1) Any applicant for inspection at an establishment where the 
operations thereof may result in any discharge into the navigable waters 
of the United States is required by subsection 21(b) of the Federal 
Water Pollution Control Act, as amended, to provide the Administrator 
with a certification as prescribed in said subsection that there is 
reasonable assurance that such activity will be conducted in a manner 
which will not violate the applicable water quality standards. No grant 
of inspection can be issued after April 3, 1970 (the date of enactment 
of the Water Quality Improvement Act), unless such certification has 
been obtained, or is waived because of failure or refusal of the State, 
interstate agency, or the Administrator of the Environmental Protection 
Agency to act on a request for certification within 1 year after receipt 
of such request. Further, upon receipt of an application for inspection 
and a certification as required by subsection 21(b) of the Federal Water 
Pollution Control Act, the Administrator (as defined in Sec. 381.1) is 
required by paragraph (2) of said subsection to notify the Administrator 
of the Environmental Protection Agency for proceedings in accordance 
with that paragraph. No grant of inspection can be made until the 
requirements of said paragraph (2) have been met.
    (2) However, certification under subsection 21(b) of the Federal 
Water Pollution Control Act is not initially required in connection with 
an application for inspection granted after April 3, 1970, for 
facilities existing or under construction on April 3, 1970, although 
certification for such facilities is required to be obtained within the 
3-year period immediately following April 3, 1970. Failure to obtain 
such certification or to meet the other requirements of subsection 21(b) 
prior to April 3, 1973, will result in the termination of inspection at 
such facilities on that date.
    (3) Further, any application for inspection pending on April 3, 
1970, and granted within 1 year thereafter shall not require 
certification for 1 year following the grant of inspection but such 
grant of inspection shall terminate at the end of 1 year after its 
issuance unless prior thereto such certification has been obtained and 
the other requirements of subsection 21(b) are met.
    (4) In the case of any activity which will affect water quality but 
for which there are no applicable water quality standards, no 
certification is required prior to the grant of inspection but such 
grant will be conditioned upon a requirement of compliance with the 
purpose of the Federal Water Pollution Control Act as provided in 
paragraph 21(b)(9) of said Act.

[37 FR 9706, May 16, 1972, as amended at 64 FR 66545, Nov. 29, 1999]

[[Page 444]]



Sec. 381.22  Conditions for receiving inspection.

    (a) Before being granted Federal inspection, an establishment shall 
have developed written sanitation Standard Operating Procedures, in 
accordance with part 416 of this chapter.
    (b) Before being granted Federal inspection, an establishment shall 
have conducted a hazard analysis and developed and validated a HACCP 
plan, in accordance with Sec. Sec. 417.2 and 417.4 of this chapter. A 
conditional grant of inspection shall be issued for a period not to 
exceed 90 days, during which period the establishment must validate its 
HACCP plan.
    (c) Before producing new product for distribution in commerce, an 
establishment shall have conducted a hazard analysis and developed a 
HACCP plan applicable to that product in accordance with Sec. 417.2 of 
this chapter. During a period not to exceed 90 days after the date the 
new product is produced for distribution in commerce, the establishment 
shall validate its HACCP plan, in accordance with Sec. 417.4 of this 
chapter.

[61 FR 38866, July 25, 1996]



 Subpart E_Inauguration of Inspection; Official Establishment Numbers; 
   Separation of Establishments and Other Requirements; Withdrawal of 
                               Inspection



Sec. 381.25  Official establishment numbers.

    An official establishment number shall be assigned to each 
establishment granted inspection service. Such number shall be used to 
identify all containers of inspected poultry products prepared in the 
establishment. An establishment shall not have more than one 
establishment number.



Sec. 381.26  Separation of establishments.

    Each official establishment shall be separate and distinct from any 
other official establishment and from any unofficial establishment 
except an establishment preparing meat products under the Federal Meat 
Inspection Act or under State meat inspection. Further, doorways, or 
other openings, may be permitted between establishments at the 
discretion of the Administrator and under such conditions as he may 
prescribe.



Sec. 381.27  Inauguration of service; notification concerning 
regulations; status of uninspected poultry products.

    The inspector in charge or his supervisor shall, upon or prior to 
the inauguration of service, inform the operator of the establishment of 
the requirements of the regulations. If the establishment at the time 
service is inaugurated contains any poultry product which has not been 
inspected and marked in compliance with the regulations, its identity 
shall be maintained, and it shall not be represented or dealt with as a 
product which has been inspected. Such products may not be shipped in 
commerce unless such products are eligible for such shipment under an 
exemption from inspection under subpart C and comply with all 
requirements of said subpart.



Sec. 381.28  Report of violations.

    Each inspector, agent, representative, or employee of the Inspection 
Service shall report, in the manner prescribed by the Administrator, all 
violations of the Act and noncompliance with the regulations of which he 
has knowledge.



   Subpart F_Assignment and Authorities of Program Employees; Appeals



Sec. Sec. 381.30-381.31  [Reserved]



Sec. 381.32  Access to establishments.

    [See Sec. 300.6 of this chapter regarding access to establishments 
and other places of business.]

[69 FR 255, Jan. 5, 2004]



Sec. 381.33  Identification.

    Each inspector will be furnished with a numbered official inspection 
badge, which shall remain in his or her possession at all times, and 
which shall be worn in such manner and at such times as the 
Administrator may prescribe.

[59 FR 42156, Aug. 17, 1994, as amended at 69 FR 255, Jan. 5, 2004]

[[Page 445]]



Sec. 381.34  Financial interest of inspectors.

    (a) No inspector shall inspect any poultry or poultry product in 
which he, his spouse, minor child, partner, organization in which he is 
serving as officer, director, trustee, partner, or employee, or any 
person with whom he is negotiating or has any arrangement concerning 
prospective employment, is financially interested.
    (b) All inspectors are subject to statutory restrictions with 
respect to political activities; e.g., 5 U.S.C. 7324 and 1502.
    (c) Violation of the provisions of paragraph (a) of this section or 
the provisions of applicable statutes referenced in paragraph (b) of 
this section will constitute grounds for dismissal in the case of 
appointees and for revocation of licenses in the case of licensees.
    (d) Inspectors are subject to all applicable provisions of law and 
regulations and instructions of the Department and the Food Safety and 
Inspection Service and other authority concerning employee 
responsibilities and conduct. The setting forth of certain prohibitions 
in this part in no way limits the applicability of such general or other 
regulations or instructions.



Sec. 381.35  Appeal inspections; how made.

    Any person receiving inspection service may, if dissatisfied with 
any decision of an inspector relating to any inspection, file an appeal 
from such decision: Provided, That such appeal is filed within 48 hours 
from the time the decision was made. Any such appeal from a decision of 
an inspector shall be made to his immediate superior having jurisdiction 
over the subject matter of the appeal, and such superior shall determine 
whether the inspector's decision was correct. Review of such appeal 
determination, when requested, shall be made by the immediate superior 
of the employee of the Department making the appeal determination. The 
cost of any such appeal shall be borne by the appellant if the 
Administrator determines that the appeal is frivolous. The charges for 
such frivolous appeal shall be at the rate of $9.28 per hour for the 
time required to make the appeal inspection. The poultry or poultry 
products involved in any appeal shall be identified by U.S. retained 
tags and segregated in a manner approved by the inspector pending 
completion of an appeal inspection.

[48 FR 11419, Mar. 18, 1983, as amended at 60 FR 67456, Dec. 29, 1995]



   Subpart G_Facilities for Inspection; Overtime and Holiday Service; 
                         Billing Establishments



Sec. 381.36  Facilities required.

    (a) Inspector's Office. Office space, including, but not being 
limited to furnishings, light, heat, and janitor service, shall be 
provided rent free in the official establishment, for the use of 
Government personnel for official purposes. The room or space set apart 
for this purpose must meet the approval of the Inspection Service and be 
conveniently located, properly ventilated, and provided with lockers or 
file cabinets suitable for the protection and storage of supplies and 
with facilities suitable for inspectors to change clothing. At the 
discretion of the Administrator, small plants requiring the services of 
less than one full-time inspector need not furnish facilities for 
Program employees as prescribed in this section, where adequate 
facilities exist in a nearby convenient location. Each official 
establishment shall provide commercial laundry service for inspectors' 
outer work clothing, or disposable outer work garments designed for one-
time use, or uniform rental service garments which are laundered by the 
rental service.
    (b) Facilities for ante mortem inspection. A suspect pen is required 
for adequate ratite inspection.
    (c) Facilities for the Streamlined Inspection System (SIS). The 
following requirements for lines operating under SIS are in addition to 
the normal requirements to obtain a grant of inspection. The 
requirements for SIS in Sec. 381.76(b) also apply.
    (1) The following provisions shall apply to every inspection 
station:
    (i) The conveyor line shall be level for the entire length of the 
inspection station. The vertical distance from the bottom of the 
shackles to the top of the adjustable platform (paragraph (c)(1)(iv) of 
this section) in its lowest

[[Page 446]]

position shall not be less than 60 inches.
    (ii) Floor space shall consist of 4 feet along the conveyor line for 
the inspector, and 4 feet for the establishment helper. A total of at 
least 8 feet along the conveyor line shall be supplied for one 
inspection station and 16 feet for two-inspection stations.
    (iii) Selectors or ``kickouts'' shall be installed in establishments 
with two inspection stations on a line so each inspector will receive 
birds on 12-inch centers with no intervening birds to impede inspection. 
The selector must move the bird to the edge of the trough for the 
inspector and establishment helper. The selectors must be smooth, 
steady, and consistent in moving the birds parallel and through the 
inspection station. Birds shall be selected and released smoothly to 
avoid swinging when entering the inspection station.
    (iv) Each inspector's station shall have a platform that is slip-
resistant and can be safely accessed by the inspector. The platform 
shall be designed so that it can be easily and rapidly adjusted for a 
minimum of 14 inches vertically while standing on the platform. The 
platform shall be a minimum length of 4 feet and have a minimum width of 
2 feet; the platform shall be designed with a 42-inch high rail on the 
back side and with \1/2\-inch foot bumpers on both sides and front to 
allow safe working conditions. The platform must have a safe lift 
mechanism and be large enough for the inspector to sit on a stool and to 
change stations during breaks or station rotation.
    (v) Conveyor line stop/start switches shall be located within easy 
reach of each inspector.
    (vi) A trough or other facilities shall extend beneath the conveyor 
at all places where processing operations are conducted from the point 
where the carcass is opened to the point where the trimming has been 
performed. The trough must be of sufficient width to preclude trimmings, 
drippage, and debris from accumulating on the floor or platforms. The 
clearance between the suspended carcasses and the trough must be 
sufficient to preclude contamination of carcasses by splash.
    (vii) A minimum of 200-footcandles of shadow-free lighting with a 
minimum color rendering index value of 85 where the birds are inspected 
to facilitate inspection.
    (viii) Online handrinsing facilities with a continuous flow of water 
must be provided for and within easy reach of each inspector and each 
establishment helper. The hand-contact element must be rinsed 
automatically with a sufficient volume of water to remove all fat, 
tissue, debris, and other extraneous material from the hand contact 
element after each use. Both hot and cold running water shall be 
available at each inspection station on the eviscerating line and shall 
be delivered through a suitable mixing device controlled by the 
inspector. Alternatively, water for hand washing shall be delivered to 
such inspection stations at a minimum temperature of 65 degrees F.
    (ix) Hangback racks shall be provided for and positioned within easy 
reach of the establishment helpers.
    (x) Each inspection station shall be provided with receptacles for 
condemned carcasses and parts. Such receptacles shall comply with the 
performance standards in Sec. 416.3(c) of this chapter.
    (2) The following provisions shall apply only to prechill and 
postchill reinspection stations:
    (i) Floor space shall consist of a minimum of 3 feet along each 
conveyor line and after each chiller to allow carcasses to be removed 
for evaluation. The space shall be level and protected from all traffic 
and overhead obstructions.
    (ii) The vertical distance from the bottom of the shackles to the 
floor shall not be less than 48 inches.
    (iii) A table, at least 2 feet wide, 2 feet deep, and 3 feet high 
designed to be readily cleanable and drainable shall be provided for 
reinspecting the sampled birds.
    (iv) A minimum of 200-footcandles of shadow-free lighting with a 
minimum color rendering index of 85 on the table surface shall be 
provided.
    (v) A separate clip board holder shall be provided for holding the 
recording sheets.
    (vi) Handwashing facilities shall be provided for and shall be 
within easy

[[Page 447]]

access of persons working at the stations.
    (vii) Hangback racks designed to hold 10 carcasses shall be provided 
for and positioned within easy reach of the person at the station.
    (d) Facilities for the New Line Speed (NELS) inspection system. The 
following requirements for lines operating under the NELS inspection 
system are in addition to the normal requirements to obtain a grant of 
inspection and to the requirements for NELS in Sec. 381.76 (b) and (c).
    (1) The following provisions shall apply to every inspection 
station:
    (i) The conveyor line shall be level for the entire length of the 
inspection station. The vertical distance from the bottom of the 
shackles to the top of the adjustable platform (paragraph (d)(1)(iv) of 
this section) in its lowest position shall not be less than 60 inches.
    (ii) Floor space shall consist of 6 feet along the conveyor line for 
the establishment employee presenting the birds, 4 feet for the 
inspector, and 4 feet for the establishment helper. A total of at least 
42 feet along the conveyor line shall be supplied for three inspection 
stations.
    (iii) Selectors or ``kickouts'' shall be installed so the three 
inspection stations will receive birds on 18-inch centers with no 
intervening birds to impede inspection. The selector must move the bird 
to the end of the trough for the presenter, inspector, and establishment 
helper. The selectors must be smooth, steady, and consistent in moving 
the birds parallel and through the inspection station. Birds shall be 
selected and released smoothly to avoid splashing the mirror (paragraph 
(d)(1)(vii) of this section) and swinging when entering the inspection 
station. Guide bars shall not extend in front of the inspection station 
mirror to avoid obstructing the inspector's view.
    (iv) Each inspector's station shall have an easily and rapidly 
adjustable platform, with a minimum of 14 inches of vertical adjustment, 
which covers the entire length of the station (4 feet) and has a minimum 
width of 2 feet. The platform shall be designed with a 42-inch high rail 
on the back side and with \1/2\-inch foot bumpers on both sides and 
front to allow safe working conditions.
    (v) Conveyor line stop/start switches shall be located within easy 
reach of each inspector.
    (vi) A trough shall extend beneath the conveyor at all places where 
processing operations are conducted from the point where the carcass is 
opened to the point where the trimming has been performed. The trough 
must be of sufficient width to preclude trimmings, drippage, and debris 
from accumulating on the floor or platforms. The clearance between the 
suspended carcasses and the trough must be sufficient to preclude 
contamination of carcasses by splash.
    (vii) A distortion-free mirror, at least 3 feet wide and 2 feet 
high, shall be mounted at each inspection station so that it can be 
adjusted between 5 and 15 inches behind the shackles, tilt up and down, 
tilt from side to side, and be raised and lowered. The mirror shall be 
positioned in relation to the inspection platform so that the inspector 
can position himself/herself opposite it 8 to 12 inches from the 
downstream edge. The mirror must be maintained abrasion free.
    (viii) A minimum of 200-footcandles of shadow-free lighting with 
minimum color rendering index value of 85 \1\ where the birds are 
inspected to facilitate inspection. A light shall also be positioned 
above and slightly in front of the mirror to facilitate the illumination 
of the bird and mirror surfaces.
---------------------------------------------------------------------------

    \1\ This requirement may be met by deluxe cool white type of 
fluorescent lighting.
---------------------------------------------------------------------------

    (ix) ``One-line'' handrinsing facilities with a continuous flow of 
water shall be provided for and within easy reach of each inspector and 
each establishment presenter and helper.
    (x) Hangback racks shall be provided for and positioned within easy 
reach of the establishment helpers.
    (xi) Each inspection station shall be provided with receptacle for 
condemned carcasses and parts. Such receptacles shall comply with the 
performance standards in Sec. 416.3(c) of this chapter.
    (2) The following provisions shall apply only to the reinspection 
station:

[[Page 448]]

    (i) Floor space shall consist of 6 feet along the conveyor line. The 
space shall be level and protected from all traffic and overhead 
obstructions.
    (ii) The vertical distance from the bottom of the shackles to the 
floor shall not be less than 48 inches.
    (iii) A table, at least 3 feet wide and 2 feet deep, shall be 
provided for reinspecting the sample birds.
    (iv) A minimum of 200-footcandles of shows free lighting with a 
minimum color rendering index of 85 \1\ on the table surface.
    (v) A separate clip board holder shall be provided for holding the 
recording sheets.
    (vi) Handwashing facilities shall be provided for and shall be 
within easy reach of persons working at the station.
    (vii) Hangback racks designed to hold 10 carcasses shall be provided 
for and positioned within easy reach of the person at the station.
    (e) Facilities for the New Turkey Inspection (NTI) System. The 
following requirements for lines operating under the NTI System are in 
addition to the normal requirements to obtain a grant of inspection and 
to the requirements for the NTI System in Sec. 381.76 (b) and (c).
    (1) The following provisions apply to every inspection station:
    (i) The conveyor line must be level for the entire length of the 
inspection station. The vertical distance from the bottom of the 
shackles to the top of the adjustable platform (paragraph (e)(1)(iii) of 
this section) in its lowest position shall not be less than 60 inches.
    (ii) Floor space shall consist of 8 feet along the conveyor line; at 
least 4 feet for the inspector, and at least 4 feet for the 
establishment helper.
    (iii) The inspector's station shall have an easily and rapidly 
adjustable platform with a minimum width of 2 feet which covers the 
entire length of the station (4 feet). The platform must adjust 
vertically a minimum of 14 inches, and must have a 42-inch rail on the 
back side and \1/2\-inch foot bumpers on the sides and the front to 
allow safe working conditions.
    (iv) Conveyor line stop/start switches shall be located within easy 
reach of each inspector.
    (v) A trough or other facilities shall extend beneath the conveyor 
at all places where processing operations are conducted from the point 
where the carcass is opened to the point where the trimming has been 
performed. The trough must be wide enough to prevent trimmings, 
drippage, and debris from accumulation on the floor or platforms. The 
clearance between suspended carcasses and the trough must be sufficient 
to prevent contamination of carcasses by splash.
    (vi) A minimum of 200 foot-candles of shadow-free lighting with a 
minimum color rendering index value of 85 \1\ where the birds are 
inspected to facilitate inspection is required. The minimum lighting 
requirement for inspection stations in Sec. 381.52(b) shall not apply.
---------------------------------------------------------------------------

    \1\ This requirement may be met by deluxe cool white fluorescent 
lighting.
---------------------------------------------------------------------------

    (vii) On-line handrinsing facilities with a continuous flow of water 
shall be provided for and within easy reach of each inspector and each 
establishment helper.
    (viii) Hangback racks shall be provided for and within easy reach of 
the establishment helper.
    (ix) Each inspection station shall be provided with receptacles for 
condemned carcasses and parts. Such receptacles shall comply with the 
performance standards in Sec. 416.3(c) of this chapter.
    (2) The following provisions shall apply only to the reinspection 
station:
    (i) Floor space shall consist of a minimum of 3 feet along the 
conveyor line so carcasses can be removed from each line for evaluation. 
The space shall be level and protected from all traffic and overhead 
obstructions.
    (ii) The vertical distance from the bottom of the shackles to the 
floor must not be less than 48 inches.
    (iii) A table at least 3 feet wide and 2 feet deep designed to be 
readily cleanable and drainable shall be provided for reinspecting the 
sampled birds.
    (iv) A minimum of 200 foot-candles of shadow-free lighting with a 
minimum

[[Page 449]]

color rendering index of 85 \1\ at the table surface is required.
    (v) A clipboard holder shall be provided for holding the recording 
sheets.
    (vi) Handwashing facilities shall be provided for and within easy 
reach of persons working at the station.
    (vii) Hangback racks designed to hold 10 carcasses shall be provided 
for and positioned within easy reach of the person at this station.

[37 FR 9706, May 16, 1972, as amended at 38 FR 9794, Apr. 20, 1973; 47 
FR 23434, May 28, 1982; 49 FR 42554, Oct. 23, 1984; 50 FR 37512, Sept. 
16, 1985; 52 FR 39209, Oct. 21, 1987; 64 FR 56416, Oct. 20, 1999; 66 FR 
22905, May 7, 2001]



Sec. 381.37  Schedule of operations.

    (a) No operations requiring inspection shall be conducted except 
under the supervision of an Inspection Service employee. All 
eviscerating of poultry and further processing shall be done with 
reasonable speed, considering the official establishment's facilities.
    (b) A shift is a regularly scheduled operating period, exclusive of 
mealtime. One lunch period is the only official authorized interruption 
in the inspector's tour of duty once it begins. Lunch periods may be 30 
minutes, 45 minutes, or in any case may not exceed one hour in duration. 
Once established, the lunch period must remain relatively constant as to 
time and duration. Lunch periods for inspectors shall not, except as 
provided herein, occur prior to 4 hours after the beginning of scheduled 
operations nor later than 5 hours after operations begin. In plants 
where a company rest break of not less than 30 minutes is regularly 
observed, approximately midpoint between start of work and the lunch 
period, and the inspector is allowed this time to meet his personal 
needs, the lunch period may be scheduled as long as 5\1/2\ hours after 
the beginning of scheduled operations.
    (c) Official establishments, importers, and exporters shall be 
provided inspection service, without charge, up to 8 hours per shift 
during the basic workweek subject to the provisions of Sec. 381.38: 
Provided, That any additional shifts meet requirements as determined by 
the Administrator or his designee. The basic workweek shall consist of 5 
consecutive 8-hour days within the administrative workweek Sunday 
through Saturday, excluding the lunch period; except that, when 
possible, the Department shall schedule the basic workweek so as to 
consist of 5 consecutive 8-hour days Monday through Friday, excluding 
lunch period. The Department may depart from the basic workweek in those 
cases where maintaining such a schedule would seriously handicap the 
Department in carrying out its functions. These provisions are 
applicable to all official establishments except in certain cases as 
provided in Sec. 381.145(h) of this subchapter.
    (d)(1) Each official establishment shall submit a work schedule to 
the area supervisor for approval. In consideration of whether the 
approval of an establishment work schedule shall be given, the area 
supervisor shall take in account the efficient and effective use of 
inspection personnel. The work schedule must specify the workweek, daily 
clock hours of operation, and lunch periods for all departments of the 
establishment requiring inspection.
    (2) Establishments shall maintain consistent work schedules. Any 
request by an establishment for a change in its work schedule involving 
changes in the workweek or an addition or elimination of shifts shall be 
submitted to the area supervisor at least 2 weeks in advance of the 
proposed change. Frequent requests for change shall not be approved: 
Provided, however, Minor deviations from a daily operating schedule may 
be approved by the inspector in charge if such request is received on 
the day preceding the day of change.
    (3) Requests for inspection service outside an approved work 
schedule shall be made as early in the day as possible for overtime work 
to be performed within that same workday; or made prior to the end of 
the day's operation when such a request will result in overtime service 
at the start of the following day: Provided, That an inspector may be 
recalled to his assignment after the completion of his daily tour of 
duty under the provisions of Sec. 381.39(b).

[40 FR 45800, Oct. 3, 1975, as amended at 40 FR 50719, Oct. 31, 1975; 41 
FR 15401, Apr. 13, 1976; 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept. 
11, 1986]

[[Page 450]]



Sec. 381.38  Overtime and holiday inspection service.

    (a) The management of an official establishment, an importer, or an 
exporter shall reimburse the Program, at the rate specified in Sec. 
391.3, for the cost of the inspection service furnished on any holiday 
specified in paragraph (b) of this section; or for more than 8 hours on 
any day, or more than 40 hours in any administrative workweek Sunday 
through Saturday.
    (b) Holidays for Federal employees shall be New Year's Day, January 
1; Birthday of Martin Luther King, Jr., the third Monday in January; 
Washington's Birthday, the third Monday in February; Memorial Day, the 
last Monday in May; Independence Day, July 4; Labor Day, the first 
Monday in September; Columbus Day, the second Monday in October; 
Veterans' Day, November 11; Thanksgiving Day, the fourth Thursday in 
November; Christmas Day, December 25. When any of the above-listed 
holidays falls outside the basic workweek, the nearest workday within 
that week shall be the holiday.

[40 FR 45801, Oct. 3, 1975, as amended at 43 FR 51754, Nov. 7, 1978; 50 
FR 51513, Dec. 18, 1985; 52 FR 5, Jan. 2, 1987; 53 FR 13398, Apr. 22, 
1988; 54 FR 6390, Feb. 10, 1989]



Sec. 381.39  Basis of billing for overtime and holiday services.

    (a) Each recipient of overtime or holiday inspection service, or 
both, shall be billed as provided for in Sec. 381.38(a) and at the rate 
specified in Sec. 391.3, in increments of quarter hours. For billing 
purposes, 8 or more minutes shall be considered a full quarter hour. 
Billing will be for each quarter hour of service rendered by each 
Inspection Service employee.
    (b) Official establishments, importers, or exporters requesting and 
receiving the services of an Inspection Service employee after he has 
completed his day's assignment and left the premises, or called back to 
duty during any overtime or holiday period, shall be billed for a 
minimum of 2 hours overtime or holiday inspection service at the 
established rate.
    (c) Bills are payable upon receipt and become delinquent 30 days 
from the date of the bill. Overtime or holiday inspection will not be 
performed for anyone having a delinquent account.

[40 FR 45801, Oct. 3, 1975, as amended at 54 FR 6390, Feb. 10, 1989]

Subpart H [Reserved]



                     Subpart I_Operating Procedures



Sec. 381.65  Operations and procedures, generally.

    (a) Operations and procedures involving the processing, other 
handling, or storing of any poultry product must be strictly in accord 
with clean and sanitary practices and must be conducted in a manner that 
will result in sanitary processing, proper inspection, and the 
production of poultry and poultry products that are not adulterated.
    (b) Poultry must be slaughtered in accordance with good commercial 
practices in a manner that will result in thorough bleeding of the 
carcasses and ensure that breathing has stopped prior to scalding. Blood 
from the killing operation must be confined to a relatively small area.
    (c) When thawing frozen ready-to-cook poultry in water, the 
establishment must use methods that prevent adulteration of, or net 
weight gain by, the poultry.
    (d) The water used in washing the poultry must be permitted to drain 
freely from the body cavity.
    (e) Poultry carcasses contaminated with visible fecal material shall 
be prevented from entering the chilling tank.
    (f) Detached ova may be collected for human food and handled only in 
accordance with 9 CFR 590.44 and may leave the establishment only to be 
moved to an official egg product processing plant for processing. Ova 
from condemned carcasses must be condemned and treated as required in 
Sec. 381.95.

[66 FR 1771, Jan. 9, 2001; 66 FR 19714, Apr. 17, 2001]



Sec. 381.66  Temperatures and chilling and freezing procedures.

    (a) General. Temperatures and procedures that are necessary for 
chilling and freezing ready-to-cook poultry, including all edible 
portions thereof, must be in accordance with operating

[[Page 451]]

procedures that ensure the prompt removal of the animal heat, preserve 
the condition and wholesomeness of the poultry, and assure that the 
products are not adulterated.
    (b) General chilling requirements, except for ratites. (1) All 
poultry that is slaughtered and eviscerated in the official 
establishment shall be chilled immediately after processing so that the 
internal temperature is reduced to 40 [deg]F. or less, as provided in 
paragraph (b)(2) of this section unless such poultry is to be frozen or 
cooked immediately at the official establishment. Eviscerated poultry to 
be shipped from the establishment in packaged form shall be maintained 
at 40 [deg]F. or less, except that during further processing and 
packaging operations, the internal temperature may rise to a maximum of 
55 [deg]F.: Provided, That immediately after packaging, the poultry is 
placed under refrigeration at a temperature that will promptly lower the 
internal temperature of the product to 40 [deg]F. or less, or the 
poultry is placed in a freezer. Poultry which is to be held at the plant 
in packaged form in excess of 24 hours shall be held in a room at a 
temperature of 36 [deg]F. or less.
    (2) Major portions of poultry carcasses, as defined in Sec. 
381.170(b)(22), and poultry carcasses shall be chilled to 40 [deg]F. or 
lower within the following specified times:

------------------------------------------------------------------------
                                                                  Time
                      Weight of carcass                         (hours)
------------------------------------------------------------------------
Under 4 pounds...............................................          4
4 to 8 pounds................................................          6
Over 8 pounds................................................          8
------------------------------------------------------------------------

    (c) Ice and water chilling. (1) Only ice produced from potable water 
may be used for ice and water chilling, except that water and ice used 
for chilling may be reused in accordance with Sec. 416.2(g). The ice 
must be handled and stored in a sanitary manner.
    (2)(i) Poultry chilling equipment must be operated in a manner 
consistent with meeting the applicable pathogen reduction performance 
standards for raw poultry products as set forth in Sec. 381.94 and the 
provisions of the establishment's HACCP plan.
    (ii) Major portions of poultry carcasses, as defined in Sec. 
381.170(b)(22), may be chilled in water and ice.
    (3) Previously chilled poultry carcasses and major portions must be 
maintained constantly at 40 [deg]F or below until removed from the vats 
or tanks for immediate packaging. Such products may be removed from the 
vats or tanks prior to being cooled to 40 [deg]F or below, for freezing 
or cooling in the official establishment. Such products must not be 
packed until after they have been chilled to 40 [deg]F or below, except 
when the packaging will be followed immediately by freezing at the 
official establishment.
    (4) Giblets must be chilled to 40 [deg]F or below within 2 hours 
from the time they are removed from the inedible viscera, except that 
when they are cooled with the carcass, the requirements of paragraph 
(b)(2) of this section must apply. Any of the acceptable methods of 
chilling the poultry carcass may be followed in cooling giblets.
    (d) Water absorption and retention. (1) Poultry washing, chilling, 
and draining practices and procedures must be such as will minimize 
water absorption and retention at time of packaging.
    (2) The establishment must provide scales, weights, identification 
devices, and other supplies necessary to conduct water tests.
    (e) Air chilling. In air chilling ready-to-cook poultry, the 
internal temperature of the carcasses shall be reduced to 40 [deg]F. or 
less within 16 hours.
    (f) Freezing. (1) Ready-to-cook poultry which is to be or is labeled 
with descriptive terms such as ``fresh frozen,'' ``quick frozen'' or 
``frozen fresh'' or any other term implying a rapid change from a fresh 
state to a frozen state shall be placed into a freezer within 48 hours 
after initial chilling in accordance with paragraph (b) of this section. 
During this period, if such poultry is not immediately placed into a 
freezer after chilling and packaging, it shall be held at 36 [deg]F. or 
lower.
    (2) Ready-to-cook poultry shall be frozen in a manner so as to bring 
the internal temperature of the birds at the center of the package to 0 
[deg]F. or below within 72 hours from the time of entering the freezer. 
Such procedures shall not apply to raw poultry product described in 
Sec. 381.129(b)(6)(i) of this subchapter.

[[Page 452]]

    (3) Upon written request, and under such conditions as may be 
prescribed by the Administrator, in specific cases, ready-to-cook 
poultry which is to be frozen immediately may be moved from the official 
establishment prior to freezing: Provided, That the plant and freezer 
are so located and such necessary arrangements are made that the 
Inspection Service will have access to the freezing room and adequate 
opportunity to determine compliance with the time and temperature 
requirements specified in paragraph (f)(2) of this section.
    (4) Warm packaged ready-to-cook poultry which is to be chilled by 
immediate entry into a freezer within the official establishment shall 
within 2 hours from time of slaughter be placed in a plate freezer or a 
freezer with a functioning circulating air system where a temperature of 
-10 [deg]F. or lower is maintained.
    (5) Frozen poultry shall be held under conditions which will 
maintain the product in a solidly frozen state with temperature 
maintained as constant as possible under good commercial practice.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4568, 4569, Feb. 5, 1974; 
40 FR 42338, Sept. 12, 1975; 49 FR 9411, Mar. 13, 1984; 60 FR 44412, 
Aug. 25, 1995; 63 FR 48960, Sept. 11, 1998; 66 FR 1771, Jan. 9, 2001; 66 
FR 19714, Apr. 17, 2001; 66 FR 22905, May 7, 2001]



Sec. 381.67  Young chicken and squab slaughter inspection rate maximums 
under traditional inspection procedure.

    The maximum number of birds to be inspected by each inspector per 
minute under the traditional inspection procedure for the different 
young chicken and squab slaughter line configurations are specified in 
the following table. These maximum rates will not be exceeded. The 
inspector in charge will be responsible for reducing production line 
rates where in the inspector's judgment the prescribed inspection 
procedure cannot be adequately performed within the time available, 
either because the birds are not presented by the official establishment 
in such a manner that the carcasses, including both internal and 
external surfaces and all organs, are readily accessible for inspection, 
or because the health conditions of a particular flock dictate a need 
for a more extended inspection procedure. The standards in 381.170(a) of 
this part specify which classes of birds constitute young chickens and 
squabs. Section 381.76(b) specifies when either the traditional 
inspection procedure or the modified traditional inspection procedure 
can or must be used.

     Maximum Production Line Rates--Chickens and Squabs-Traditional
                          Inspection Procedures
------------------------------------------------------------------------
                                                               Birds per
                                                    Number of  inspector
              Line configuration \1\               inspection     per
                                                    stations     minute
------------------------------------------------------------------------
6-1..............................................          1          25
12-1.............................................          2          23
12-2.............................................          2          21
18-1.............................................          3          19
18-2.............................................          3          19
18-3.............................................          3          18
24-1.............................................          4     16\1/2\
24-2.............................................          4          16
24-4.............................................          4     15\1/2\
------------------------------------------------------------------------
\1\ Birds are suspended on the slaughter line at 6-inch intervals. The
  first number indicates the interval in inches between the birds that
  each inspector examines. The second number indicates how many of the
  birds presented, the inspector is to inspect, i.e., ``1'' means
  inspect every bird. ``4'' means inspect every fourth bird, etc.


[47 FR 23435, May 28, 1982, as amended at 66 FR 22905, May 7, 2001]



Sec. 381.68  Maximum inspection rates--New turkey inspection system.

    (a) The maximum inspection rates for one inspector New Turkey 
Inspection (NTI-1) and two inspector New Turkey Inspection (NTI-2) are 
listed in the table below. These line speeds are for lines using 
standard 9-inch shackles on 12-inch centers with birds hung on every 
shackle and opened with J-type or Bar-type opening cuts. Maximum rates 
for those establishments having varying configurations will be 
established by the Administrator but will not exceed those in the table. 
Neither the rates in the table nor those established for establishments 
with varying configurations shall be exceeded under any circumstances.
    (b) There are two categories of turkeys for determining inspection 
rates, ``light turkeys'' and ``heavy turkeys''. Light turkeys are all 
turkeys weighing less than 16 pounds. Heavy turkeys are all turkeys 
weighing 16 pounds or

[[Page 453]]

more. The weights refer to the bird at the point of post-mortem 
inspection, with blood, feathers and feet removed.
    (c) The inspector in charge may reduce inspection line rates when in 
his/her judgment the prescribed inspection procedure cannot be 
adequately performed within the time available because the health 
conditions of a particular flock dictate a need for a more extended 
inspection.

                                                             Maximum Turkey Inspection Rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                       Birds/Minute
                                                                ----------------------------------------------------------------------------------------
                                          Line       Number of                      J-Type                                     Bar-Type
         Inspection system           configuration   inspectors ----------------------------------------------------------------------------------------
                                                                 (<16)  (16)\1\  (<)  (16)\1\)
                                                                      light                 heavy                 light                 heavy
--------------------------------------------------------------------------------------------------------------------------------------------------------
NTI-1..............................     12-1             1             32                     30                   25                    21
NTI-2..............................  \2\ 24-2            2             51                     41                   45                    35
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This weight refers to the bird at the point of post-mortem inspection, without blood, feathers, or feet.
\2\ The turkeys are suspended on the slaughter line at 12-inch intervals, with two inspectors each looking at alternating birds at 24-inch intervals.


[50 FR 37512, Sept. 16, 1985]



                    Subpart J_Ante Mortem Inspection



Sec. 381.70  Ante mortem inspection; when required; extent.

    (a) An ante mortem inspection of poultry shall, where and to the 
extent considered necessary by the Administrator and under such 
instructions as he may issue from time to time, be made of poultry on 
the day of slaughter in any official establishment.
    (b) The examination and inspection of ratites will be on the day of 
slaughter, except:
    (1) When it is necessary for humane reasons to slaughter an injured 
animal at night or on a Sunday or holiday, and the FSIS veterinary 
medical officer cannot be obtained; or
    (2) In low volume establishments, when ante mortem inspection cannot 
be done on the day of slaughter, and the birds to be slaughtered have 
received ante mortem inspection in the last 24 hours, provided the 
establishment has an identification and control system over birds that 
have received ante mortem inspection.

[37 FR 9706, May 16, 1972, as amended at 66 FR 22906, May 7, 2001]



Sec. 381.71  Condemnation on ante mortem inspection.

    (a) Birds plainly showing on ante mortem inspection any disease or 
condition, that under Sec. Sec. 381.80 to 381.93, inclusive, would 
cause condemnation of their carcasses on post mortem inspection, shall 
be condemned. Birds which on ante mortem inspection are condemned shall 
not be dressed, nor shall they be conveyed into any department of the 
official establishment where poultry products are prepared or held. 
Poultry which has been condemned on ante mortem inspection and has been 
killed or died otherwise shall under the supervision of an inspector of 
the Inspection Service, be disposed of as provided in Sec. 381.95.
    (b) Dead-on-arrival ratites and ratites condemned on ante mortem 
inspection will be tagged ``U.S. Condemned'' by an establishment 
employee under FSIS supervision and disposed of by one of the methods 
prescribed in Sec. 381.95.
    (c) All seriously crippled ratites and non-ambulatory ratites, 
commonly termed ``downers,'' shall be identified as ``U.S. Suspects.''
    (d) Ratites exhibiting signs of drug or chemical poisoning shall be 
withheld from slaughter.
    (e) Ratites identified as ``U.S. Suspects'' or ``U.S. Condemned'' 
may be set aside for treatment. The ``U.S. Suspect'' or ``U.S. 
Condemned'' identification device will be removed by an establishment 
employee under FSIS supervision following treatment if the bird is found 
to be free of disease. Such a bird found to have recovered from the 
condition for which it was treated may

[[Page 454]]

be released for slaughter or for purposes other than slaughter, provided 
that in the latter instance permission is first obtained from the local, 
State, or Federal sanitary official having jurisdiction over movement of 
such birds.
    (f) When it is necessary for humane reasons to slaughter an injured 
ratite at night or Sunday or a holiday, and the Agency veterinary 
medical officer cannot be obtained, the carcass and all parts shall be 
kept for inspection, with the head and all viscera except the 
gastrointestinal tract held by the natural attachment. If all parts are 
not so kept for inspection, the carcass shall be condemned. If on 
inspection of a carcass slaughtered in the absence of an inspector, any 
lesion or other evidence is found indicating that the bird was sick or 
diseased, or affected with any other condition requiring condemnation of 
the animal on ante mortem inspection, or if there is lacking evidence of 
the condition that rendered emergency slaughter necessary, the carcass 
shall be condemned. Ratites that are sick, dying, or that have been 
treated with a drug or chemical and presented for slaughter before the 
required withdrawal period, are not covered by emergency slaughter 
provisions.

[37 FR 9706, May 16, 1972, as amended at 66 FR 22906, May 7, 2001; 67 FR 
13258, Mar. 22, 2002]



Sec. 381.72  Segregation of suspects on ante mortem inspection.

    (a) All birds, except ratites, that on ante mortem inspection do not 
plainly show, but are suspected of being affected with, any disease or 
condition that under Sec. Sec. 381.80 to 381.93 of this Part may cause 
condemnation in whole or in part on post mortem inspection, shall be 
segregated from the other poultry and held for separate slaughter, 
evisceration, and post mortem inspection. The inspector shall be 
notified when such segregated lots are presented for post mortem 
inspection, and inspection of such birds shall be conducted separately. 
Such procedure for the correlation of ante mortem and post mortem 
findings by the inspector, as may be prescribed or approved by the 
Administrator, shall be carried out.
    (b) All ratites showing symptoms of disease will be segregated, 
individually tagged as ``U.S. Suspects'' by establishment personnel 
under FSIS supervision with a serially numbered metal or plastic leg 
band or tag bearing the term ``U.S. Suspect,'' and held for further 
examination by an FSIS veterinarian. Depending upon the findings of the 
veterinarian's examination, these birds will either be passed for 
regular slaughter, slaughtered as suspects, withheld from slaughter, or 
condemned on ante mortem. Those ratites affected with conditions that 
would be readily detected on post mortem inspection need not be 
individually tagged on ante mortem inspection with the ``U.S. Suspect'' 
tag provided that such ratites are segregated and otherwise handled as 
``U.S. Suspects.'' All ratites identified as ``U.S. Condemned'' shall be 
tagged by establishment personnel, under FSIS supervision, with a 
serially numbered metal or plastic leg band or tag bearing the term 
``U.S. Condemned.''

[66 FR 22906, May 7, 2001]



Sec. 381.73  Quarantine of diseased poultry.

    If live poultry, which is affected by any contagious disease which 
is transmissible to man, is brought into an official establishment, such 
poultry shall be segregated. The slaughtering of such poultry shall be 
deferred and the poultry shall be dealt with in one of the following 
ways:
    (a) If it is determined by a veterinary inspector that further 
handling of the poultry will not create a health hazard, the lot shall 
be slaughtered separately, subject to ante mortem and post mortem 
inspection pursuant to the regulations.
    (b) If it is determined by a veterinary inspector that further 
handling of the poultry will create a health hazard, such poultry may be 
released for treatment under the control of an appropriate State or 
Federal agency. If the circumstances are such that release for treatment 
is impracticable, a careful bird-by-bird ante mortem inspection shall be 
made, and all birds found to be, or which are suspected of being, 
affected with a contagious disease transmissible to man shall be 
condemned.

[[Page 455]]



Sec. 381.74  Poultry suspected of having biological residues.

    When any poultry at an official establishment is suspected of having 
been treated with or exposed to any substance that may impart a 
biological residue that would make their edible tissues adulterated, 
they shall, at the option of the operator of the establishment, be 
processed at the establishment and the carcasses and all parts thereof 
retained under U.S. Retained tags, pending final disposition in 
accordance with Sec. 381.80, of this part, and other provisions in 
subpart K; or they shall be slaughtered at the establishment and buried 
or incinerated in a manner satisfactory to the inspector. Alternatively, 
such poultry may be returned to the grower, if further holding is likely 
to result in their not being adulterated by reason of any residue. The 
Inspection Service will notify the other Federal and State agencies 
concerned of such action. To aid in determining the amount of residue 
present in the poultry, officials of the Inspection Service may permit 
the slaughter of any such poultry for the purpose of collecting tissues 
for analysis of the residue. Such analysis may include the use of 
inplant screening procedures designed to detect the presence of 
antimicrobial residues in any species of poultry.

[47 FR 41336, Sept. 20, 1982]



Sec. 381.75  Poultry used for research.

    (a) No poultry used in any research investigation involving an 
experimental biological product, drug, or chemical shall be eligible for 
slaughter at an official establishment unless the operator of such 
establishment, the sponsor of the investigation, or the investigator has 
submitted to the Inspection Service, or the Veterinary Biologics unit of 
Veterinary Services, Animal and Plant Health Inspection Service of the 
Department or the Environmental Protection Agency, or the Food and Drug 
Administration of the Department of Health, Education, and Welfare, data 
or a summary evaluation of the data which demonstrates that the use of 
such biological product, drug, or chemical will not result in the 
products of such poultry being adulterated, and the Administrator has 
approved such slaughter.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]



  Subpart K_Post Mortem Inspection; Disposition of Carcasses and Parts



Sec. 381.76  Post-mortem inspection, when required; extent; traditional, 
Streamlined Inspection System (SIS), New Line Speed (NELS) Inspection 
System and the New Turkey Inspection (NTI) System; rate of inspection.

    (a) A post-mortem inspection shall be made on a bird-by-bird basis 
on all poultry eviscerated in an official establishment. No viscera or 
any part thereof shall be removed from any poultry processed in any 
official establishment, except at the time of post-mortem inspection, 
unless their identify with the rest of the carcass is maintained in a 
manner satisfactory to the inspector until such inspection is made. Each 
carcass to be eviscerated shall be opened so as to expose the organs and 
the body cavity for proper examination by the inspector and shall be 
prepared immediately after inspection as ready-to-cook poultry. If a 
carcass is frozen, it shall be thoroughly thawed before being opened for 
examination by the inspector. Each carcass, or all parts comprising such 
carcass, shall be examined by the inspector, except for parts that are 
not needed for inspection purposes and are not intended for human food 
and are condemned.
    (b)(1) There are five systems of post-mortem inspection: Streamlined 
Inspection System (SIS) and the New Line Speed (NELS) Inspection System, 
both of which shall be used only for broilers and cornish game hens; the 
New Turkey Inspection (NTI) System, which shall be used only for 
turkeys; Traditional Inspection; and Ratite Inspection.
    (i) The SIS shall be used only for broilers and cornish game hens 
if:
    (a) The Administrator determines that SIS will increase inspector 
efficiency; or

[[Page 456]]

    (b) The operator requests SIS and the Administrator determines that 
the system will result in no loss of inspection efficiency.
    (ii) The NELS Inspection System shall be used only for broilers and 
cornish game hens if:
    (a) The operator requests the NELS Inspection System, and
    (b) The Administrator determines that the establishment has the 
intent and capability to operate at line speeds greater than 70 birds 
per minute, and meets all the facility requirements in Sec. 381.36(d).
    (iii) The NTI System shall be used only for turkeys if:
    (a) The operator requests it, and
    (b) The Administrator determines that the establishment meets all 
the facility requirements in Sec. 381.36(e).
    (iv) Traditional inspection shall be used for turkeys when the NTI 
System is not used. For other classes of poultry, Traditional Inspection 
shall be used when neither the SIS nor the NELS Inspection System is 
used.
    (2) The requirements of paragraph (a) of this section are applicable 
to all four inspection systems.
    (3) The following requirements are applicable to SIS:
    (i) Definitions. For purposes of this paragraph, the following 
definitions shall apply:
    (a) Cumulative sum (CUSUM). A statistical concept used by the 
establishment and monitored by the inspector whereby compliance is 
determined based on sample results collected over a period of time. For 
purposes of determining compliance with the finished product standards, 
the CUSUM is equal to the sum of prior test results plus the weighted 
result of the current test minus the tolerance, with the condition that 
the resulting CUSUM cannot go below zero.
    (b) Tolerance number. A weighted measure that equates to product 
being produced at a national product quality level. See Table 2.
    (c) Action number. A level reached by the CUSUM where the process is 
out of control and product action is required by the establishment or 
the inspector. See Table 2.
    (d) ``Start number''. A value halfway between zero and the action 
number. The start number is used to determine the starting CUSUM for the 
first subgroup of a shift and to reset the CUSUM value if the CUSUM is 
equal to or greater than the action number. See Table 2.
    (e) Subgroup. A 10-bird sample collected before product enters the 
chiller and after product leaves the chiller.
    (f) Subgroup absolute limit. The tolerance number plus 5. See Table 
2.
    (g) Prechill testing. Testing conducted by the establishment to 
determine the CUSUM on consecutive 10-bird subgroup samples collected 
prior to product entering the chilling system.
    (h) Postchill testing. Testing conducted by the establishment to 
determine the CUSUM on consecutive 10-bird subgroup samples collected as 
the product leaves the chilling system.
    (i) Rework. Reprocessing the product to correct the condition or 
conditions causing the nonconformances listed in Table 1.
    (ii) General. (a) Under SIS, one inspector inspects the outside, 
inside, and viscera of each bird. There may be two inspectors on one 
processing line, each inspecting every other bird. For the establishment 
to run its processing line(s) at maximum speed, optimal conditions must 
be maintained so that inspection may be conducted efficiently. The 
inspector in charge determines the speed at which each processing line 
may be operated to permit inspection. A variety of conditions may affect 
this determination including the health of each flock and the manner in 
which birds are being presented to the inspector for inspection.
    (b) SIS may be performed by one inspector (SIS-1) or two inspectors 
(SIS-2). SIS-1 requires that the establishment provide one inspection 
station for each line and adequate reinspection facilities so carcasses 
can be removed from each line for evaluation. The maximum line speed for 
SIS-1 is 35 birds per minute. SIS-2 requires that the establishment 
provide two inspection stations for each line and adequate reinspection 
facilities so carcasses can be removed from each line for evaluation. 
The maximum line speed for SIS-2 is 70 birds per minute.
    (c) Under all inspection systems, including SIS, inspectors conduct 
post-

[[Page 457]]

mortem inspection and look for a number of conditions, as specified 
elsewhere in this subpart, which may indicate adulteration. Adulterated 
product is condemned and destroyed, except that carcasses and parts 
which may be made unadulterated by reprocessing (reworking) may be so 
reprocessed under the supervision of an inspector and reinspected. Under 
SIS, inspectors also reinspect product by sampling finished birds (both 
before and after chilling) for nonconformances with finished product 
standards (see Table 1). If such nonconformances are present at certain 
statistical levels, it may indicate process difficulties requiring 
corrective action by the establishment. If the establishment does not 
take adequate corrective action, the inspector shall initiate corrective 
actions such as conducting closer post-mortem inspections and requiring 
reprocessing and reinspection of previously processed carcasses and 
parts. Thus, SIS is conducted in two phases--a post-mortem inspection 
phase and a reinspection phase. The following paragraphs describe the 
inspection requirements (not addressed elsewhere in this subpart) under 
each.
    (iii) Post-mortem inspection. (a) Facilities: Each inspection 
station must comply with the facility requirements in Sec. 381.36(c).
    (b) Presentation: Each inspector shall be flanked by an 
establishment employee assigned to be the inspector's helper. The one 
inspector on the SIS-1 line shall be presented every bird. Each 
inspector on the SIS-2 line shall be presented every other bird on the 
line. An establishment employee shall present each bird to the inspector 
properly eviscerated with the back side toward the inspector and the 
viscera uniformly trailing or leading. Each inspector shall inspect the 
inside, viscera, and outside of all birds presented.
    (c) Disposition: The inspector shall determine which birds shall be 
salvaged, reprocessed, condemned, retained for disposition by the 
veterinarian, or allowed to proceed down the line as a passed bird 
subject to trim and reinspection. Carcasses with certain defects not 
requiring condemnation of the entire carcass shall be passed by the 
inspector, but shall be subject to reinspection to ensure the physical 
removal of the defects. The helper, under the supervision of the 
inspector, shall mark such carcasses for trim when the defects are not 
readily observable. Trimming of birds passed subject to reinspection 
shall be performed by:
    (1) The helper, time permitting, and
    (2) One or more plant trimmers positioned after all giblets are 
harvested and prior to reinspection.
    (iv) Reinspection. (a) Facilities: Reinspection stations are 
required at both the prechill and postchill locations. The Agency will 
determine the number of stations needed in those establishments having 
more than one processing line or more than one chiller. One or more 
prechill reinspection stations shall be conveniently located at the end 
of the line or lines prior to chilling. One or more postchill stations 
must be conveniently located at the end of the chiller or chillers. The 
prechill and postchill reinspection stations must meet the following 
provisions:
    (1) Floor space shall consist of 3 feet along each conveyor line. 
The space shall be level and protected from all traffic and overhead 
obstructions.
    (2) A table at least 2 feet wide and 2 feet deep and 3 feet in 
height designed to be readily cleanable and drainable shall be provided 
for reinspecting the sampled birds.
    (3) A minimum of 200 foot-candles of shadow-free lighting with a 
minimum color rendering index of 85 on the table surface.
    (4) A separate clip board holder shall be provided for holding the 
recording sheets.
    (5) Hangback racks designed to hold 10 carcasses shall be provided 
for and positioned within easy reach of the person at the station.
    (b) Disposition: An inspector shall monitor the establishment's 
application of the Finished Product Standards program and shall take 
corrective action including retaining product to prevent adulterated 
product from leaving the establishment when the inspector determines 
that the establishment has failed to apply the program as prescribed in 
paragraph (b)(3)(iv)(c) of this section).

[[Page 458]]

    (c) Finished Product Standards: Finished Product Standards (FPS) are 
criteria applied to processed birds before and after chill to ensure 
that the product being produced is consistently wholesome and 
unadulterated. These criteria consist of nonconformances (listed in 
Table 1), the incidence of which is determined from 10 bird subgroup 
samples, reduced to a CUSUM number, and measured against the standards 
(Table 2). The standards are applied to permit the Agency to estimate 
when the production process is in control and when it is out of control. 
The establishment is responsible for maintaining FPS which, in turn, is 
monitored by the inspector. FPS is applied in two separate parts. The 
first is called prechill testing. It is designed to ensure that the 
slaughter and evisceration procedures are in control. Compliance is 
measured by determining the CUSUM on consecutive 10-bird subgroup 
samples collected prior to product entering the chilling system. The 
second part of the FPS is called postchill testing. It is designed to 
monitor the production through the chill system to ensure that it meets 
the postchill FPS. This test is independent of the prechill test. 
Compliance is measured by determining the CUSUM on consecutive 10-bird 
subgroup samples as they exit the chilling system. When the system is 
operating within compliance, the establishment applies the FPS to 
product samples at the prechill reinspection station. Testing time and 
time between tests are such that birds represented by the test are still 
within the chiller. If an out-of-compliance condition is found, the 
product leaving the chiller is segregated for rework and retested before 
it may proceed into commerce. A second 10 bird subgroup sample of the 
birds is taken after they leave the chiller to ensure that the product 
meets the postchill FPS. Since the product is closer to the end of 
processing, the controls on releasing reworked product are stricter than 
controls under prechill testing, again to ensure that no adulterated 
product enters into commerce.
    (d) Prechill testing. The prechill FPS have been divided into 
processing and trim categories. The processing category is designed to 
monitor the output of the dressing and evisceration procedures. The trim 
category monitors the establishment's ability to remove unwholesome 
lesions and conditions from inspected and passed carcasses. Each 
category is monitored independently of the other category using a 
separate CUSUM for each category.
    (1) Actions to be taken when the process is in control. If the CUSUM 
is less than the action number and the subgroup absolute limit is not 
exceeded, the process is judged to be in control.
    (i) Establishment Actions. The establishment shall:
    (A) Randomly select and record subgroup sampling times for each 
production unit of time before product reaches the prechill reinspection 
station on the production line. In no case shall the time between tests 
exceed 1 hour of production time.
    (B) Conduct a 10-bird subgroup test at a random time on each poultry 
slaughter line. These times are preselected by the establishment and 
available to the inspector prior to the start of the shift/day's 
operations. All 10 samples of the subgroup shall be collected at the 
random time.
    (C) Obtain the weighted value of each nonconformance by multiplying 
the number recorded for each nonconformance by the ``factor'' in Table 
1, sum the total of all the nonconformances, and calculate the CUSUM 
value for that test.
    (ii) Inspector Actions. The inspector shall:
    (A) Select random times for monitoring subgroup tests for each half-
shift on the evisceration line. In establishments that have multiple 
evisceration lines on a production shift, monitor all lines of product 
at the random times.
    (B) Collect the subgroup samples to be monitored at preselected 
times. All 10 samples of the subgroup shall be collected at the random 
time selected in paragraph (b)(3)(iv)(d)(1)(ii)(A) of this section.
    (C) Conduct the 10-bird monitoring subgroup test.
    (2) Actions to be taken when the subgroup absolute limit is 
exceeded. If either an inspector or establishment subgroup

[[Page 459]]

test exceeds the subgroup absolute limit of tolerance plus 5 (T+5), the 
establishment shall determine if any of the immediate past 5 plant 
prechill subgroups for that category (processing or trim) resulted in a 
CUSUM above the start number.
    (i) If all of the past 5 plant prechill subgroups are at or below 
the start number, the establishment shall immediately conduct a retest 
subgroup on that category of prechill to determine sample validity. If 
retest subgroup total equals tolerance or less, the establishment 
resumes random time testing. If the retest subgroup total exceeds 
tolerance, the establishment shall proceed as if CUSUM reaches the 
action number and shall begin process actions as set forth in paragraph 
(b)(3)(iv)(d)(4) of this section. In either case, the prechill retest 
results will be used to calculate CUSUM.
    (ii) If any of the past 5 plant prechill subgroups resulted in a 
CUSUM above the start number, the establishment shall proceed as if 
CUSUM reaches the action number and shall begin process actions as set 
forth in paragraph (b)(3)(iv)(d)(4) of this section.
    (3) Actions to be taken when a trimmable lesion/condition is found. 
If either inspection or plant monitoring finds any trimmable lesion or 
condition as specified in item B(7) of Table 1 during a prechill 
subgroup test, the establishment shall immediately conduct an additional 
prechill subgroup test for the same trimmable lesion/condition category. 
This is a requirement on the subgroup testing for the prechill trim 
nonconformance that is in addition to the CUSUM test described in 
paragraph (b)(3)(iv)(d)(1) of this section.
    (i) If no additional item in the same category is found on retest, 
the establishment shall resume random time sampling.
    (ii) If an additional item in the same category is found on retest, 
the establishment shall proceed as if CUSUM reaches the action number 
and shall initiate corrective action set forth in paragraph 
(b)(3)(iv)(d)(4) of this section for this category only.
    (4) Actions to be taken when the CUSUM reaches the action number. 
Once CUSUM reaches the action number, the process is judged to be not in 
control.
    (i) Establishment Actions. The establishment shall:
    (A) Immediately notify the inspector in charge and the production 
supervisor responsible for the affected evisceration line.
    (B) Suspend random time prechill testing of the affected 
nonconformance category (processing or trim). Suspend random time 
postchill subgroup testing when the processing category is the affected 
nonconformance category.
    (C) Conduct subgroup retests on carcasses leaving the chill system. 
Apply the prechill criteria in Table 1 (A) or (B), depending upon which 
category caused the action, and apply prechill Finished Product 
Standards as listed in Table 2 to determine product compliance. In no 
case shall the time between retests exceed 30 minutes of production 
time. Apply prechill standard criteria at the postchill location after 
notifying the establishment's production supervisor. If any of these 
subgroup retests on product leaving the chill system result in a 
subgroup total exceeding tolerance, identify for rework subsequent 
product at the postchill location. All noncomplying product will be 
brought into compliance prior to release into commerce. Product from the 
chiller will continue accumulating for rework until a subsequent 
subgroup test results in a subgroup total equal to or less than 
tolerance.
    (D) Conduct additional subgroup tests at the prechill reinspection 
station to determine the adequacy of production corrective action. If 
the prechill tests results in a subgroup total exceeding the tolerance, 
notify the production supervisor. The number of additional tests at the 
postchill reinspection station using prechill standards is increased as 
required to include the product in the chiller represented by this 
additional prechill test.
    (E) After two consecutive additional prechill subgroup tests result 
in subgroup totals equal to or less than tolerance:
    --Resume random time prechill subgroup testing as set forth in 
actions to be taken when the process is in control at paragraph 
(b)(3)(iv)(d)(1) of this section.
    --Identify product entering the chill system that will mark the end 
of the

[[Page 460]]

retest action upon arrival at the postchill sampling location. Such 
identification may include tagging or empty space in chillers, depending 
upon the establishment's identification method.
    --Once all product identified as needing retesting has arrived at 
the postchill sampling location, random time postchill FPS testing 
resumes.
    --If two consecutive additional prechill subgroup tests demonstrate 
process control with subgroup totals equal to or less than tolerance, 
but they do not cause CUSUM to fall to the start line or below, reset 
CUSUM at the start number.
    (ii) Inspector Actions. The inspector shall monitor product and 
process actions by making spot-check observations to ensure that all 
program requirements are met.
    (e) Postchill testing. Postchill subgroups shall be collected after 
the product leaves the chiller but before the product is divided into 
separate processes. Each bird sampled shall be observed and its 
conformance measured against the postchill criteria. The subgroup 
nonconformance weights shall be totaled and the CUSUM calculated by 
subtracting the tolerance from the sum of the subgroup total and the 
starting CUSUM.
    (1) Actions to be taken when the process is in control. If the CUSUM 
is less than the action number and the subgroup absolute limit is not 
exceeded, the process is judged to be in control.
    (i) Establishment Actions. The establishment shall conduct a 10-bird 
subgroup test for each chiller system at a randomly selected time of 
production. In no case shall the time between tests exceed 2 hours of 
production time.
    (ii) Inspector Actions. The inspector shall:
    (A) Select random times for postchill monitoring.
    (B) Monitor each chill system twice per shift.
    (C) Conduct subgroup tests at preselected random times.
    (2) Actions to be taken when the subgroup absolute limit is 
exceeded. If either an inspector or establishment subgroup test exceeds 
the subgroup absolute limit of tolerance plus 5(T+5), the establishment 
shall determine if any of the last 5 postchill monitoring subgroups 
resulted in a CUSUM above the start number.
    (i) If all of the past 5 postchill monitoring subgroups resulted in 
a CUSUM at or below the start number, the establishment shall 
immediately retest a subgroup to determine sample validity. If this 
retest subgroup total exceeds tolerance, the establishment shall proceed 
as if CUSUM reaches the action number and shall begin process actions as 
set forth in paragraph (b)(3)(iv)(e)(3) of this section.
    (ii) If any of the past 5 postchill monitoring subgroups resulted in 
a CUSUM above the start number, the establishment shall proceed as if 
CUSUM reaches the action number and shall begin process actions as set 
forth in paragraph (b)(3)(iv)(e)(3) of this section.
    (3) Actions to be taken when the CUSUM reaches the action number. 
Once CUSUM reaches the action number, the process is judged to be not in 
control.
    (i) Establishment Actions. The establishment shall:
    (A) Notify the inspector in charge and the production supervisor 
responsible for product in the chiller.
    (B) Suspend random time postchill subgroup testing.
    (C) Immediately conduct an additional postchill subgroup test. If 
the retest subgroup total exceeds tolerance, the establishment shall 
identify subsequent product for rework. Product will continue 
accumulating for rework until a subsequent subgroup test results in a 
subgroup total equal to or less than tolerance.
    (D) After two consecutive additional postchill subgroup tests 
results in subgroup totals equal to or less than tolerance:
    --Resume random time postchill subgroup testing as set forth in 
actions to be taken when the process is in control at paragraph 
(b)(3)(iv)(e)(1) of this section.
    --If the two consecutive additional postchill subgroup totals equal 
to or less than tolerance do not cause CUSUM to fall to the start number 
or below, reset CUSUM at the start number.

[[Page 461]]

    (ii) Inspector Actions. The inspector shall monitor product and 
process actions to ensure that program requirements are met.
    (v) When the prechill or postchill product has been identified as 
having been produced when the process was not in control, additional 
online subgroup testing by the establishment is required to determine 
its conformance to the standard. If any of the additional plant subgroup 
testing results in a subgroup total exceeding tolerance, offline product 
corrective actions must take place. The responsibilities of the 
establishment and the inspector change depending on the CUSUM.
    All corrective actions such as identifying affected product, 
segregating product, and maintaining control through rework actions are 
the establishment's responsibility. Corrective actions by the inspector 
depends upon the establishment's ability to control rework of affected 
product. If the establishment fails in its responsibilities, the 
inspector will identify, segregate, and retain affected product to 
prevent adulterated product from reaching consumers.
    (a) Offline product. The establishment shall identify the affected 
product so that it may be segregated and accumulated offline for rework. 
The inspector shall spot check the establishment's identification, 
segregation, and control of reworked product to ensure that program 
requirements are met.
    (b) Reworked product. Reworked product must be tested by the 
establishment with a randomly selected subgroup test of the accumulated 
reworked lot. Before product is released, the random subgroup test must 
result in a subgroup total equal to or less than tolerance. If the 
subgroup test of a reworked lot results in a subgroup total exceeding 
tolerance, the lot must be reworked again before another subgroup is 
selected. The following actions are required.
    (1) Establishment Actions. The establishment shall:
    (i) Select the random subgroup from throughout the lot only after 
the total lot has been reworked.
    (ii) Conduct the subgroup test using the same criteria (prechill or 
postchill) that resulted in the rework action.
    (iii) Release the lot if the reworked subgroup test resulted in a 
subgroup total equal to or less than tolerance.
    (iv) Identify and control the lot to be reworked if the reworked 
subgroup total again exceeds tolerance.
    (2) Inspector Actions: The inspector shall spot check the rework 
procedure to ensure that plant monitoring and production meet the 
requirements of the program.
    (vi) After the 10 bird subgroup tests are completed, the prechill 
and postchill processing nonconformances shall be corrected on all bird 
samples prior to returning the samples to the product flow. Samples with 
trim nonconformances shall be returned to the trim station for 
correction prior to their return to the product flow.

                 Table 1--Definitions of Nonconformances
                      A Processing Nonconformances
1 Extraneous material <=\1/16\
    --Include any specks, tiny smears, or stains of material that
     measure \1/16\ or less in the greatest dimension.
    Examples: Ingesta, unattached feathers, grease, bile remnants, and/
     or whole gall bladder or spleen, embryonic yolk, etc.
    --Factor is one.
    --1 to 5=1 defect: 6 to 10=2 defects; 11 or more=3 defects. A
     maximum of three incidents per carcass.
2 Extraneous material \1/16\ to 1
    --The same material as line 1, but measuring \1/16\ to 1 in the longest dimension.
    --Factor is one.
    --A maximum of three incidents per carcass.
3 Extraneous material 1
    --The same material as lines 1 to 2, but measuring greater than one
     inch.
    --Factor is two.
    --A maximum of two incidents per carcass.
4 Oil glands remnant--less than two whole glands
    --Recognizable fragment(s) of one or both oil glands equals one
     incident.
    --Factor is one.
    --Maximum of one incident per carcass.
5 Oil glands--two whole glands
    --Both whole oil glands with no missing fragments equals one
     incident. If the oil glands are cut, but no fragment is removed,
     consider them to be whole. But if even a small fragment is removed,
     use line 4.
    --Factor is two.
    --A maximum of one incident per carcass.

[[Page 462]]

 
6 Lung =\1/4\ whole
    --Any portion less than a whole lung, and equal to or greater than
     \1/4\ at the greatest dimension, equals one incident.
    --Factor is one.
    --A maximum of two incidents per carcass.
7 Lung--whole
    --Each whole lung equals one incident.
    --Factor is two.
    --A maximum of two incidents per carcass.
8 Intestine
    --Any identifiable portion of the terminal portion of the intestinal
     tract with a lumen (closed circle) present, or split piece of
     intestine large enough to be closed to form a lumen.
    --Factor is five.
    --A maximum of one incident per carcass.
9 Cloaca
    --Any identifiable portion of the terminal portion of the intestinal
     tract with mucosal lining.
    --Factor is five.
    --A maximum of one incident per carcass.
10 Bursa of Fabricius
    --A whole rosebud, or identifiable portion with two or more mucosal
     folds.
    --Factor is two.
    --A maximum of one incident per carcass.
11 Esophagus
    --Any portion of the esophagus with identifiable mocosal lining.
    --Factor is two.
    --A maximum of one incident per carcass.
12 Crop--partial--with mucosa
    --Any portion of the crop that includes the mucosal lining.
    --Factor is two.
    --A maximum of one incident per carcass.
13 Crop--whole
    --Any complete crop.
    --Factor is five.
    --A maximum of one incident per carcass.
14 Trachea <=1
    --Identifiable portion of trachea less than or equal to one inch
     long.
    --Factor is one.
    --A maximum of one incident per carcass.
15 Trachea 1
    --Identifiable portion of trachea greater than one inch.
    --Factor is two.
    --A maximum of one incident per carcass.
16 Hair =\1/4\ 26 or more.
    --Hair which is one-fourth inch long or longer measured from the top
     of the follicle to the end of the hair. 26 or more hairs equal one
     incident.
    --Factor is one.
    --A maximum of one incident per carcass.
17 Feather and/or Pinfeathers <=1
    --Attached feathers or protruding pinfeathers less than or equal to
     one inch long. Scored 5 to 10 per carcass as one incident, 11 to 15
     per carcass as two incidents, and 16 or more as three incidents.
    --Factor is one.
    --A maximum of three incidents per carcass.
18 Feathers 1
    --Attached feathers longer than one inch. Scored 1 to 3 per carcass
     as one incident 4 to 6 per carcass as two incidents, and 7 or more
     as three incidents.
    --Factor is one.
    --A maximum of three incidents per carcass.
19 Long Shank--both condyles covered
    --If the complete tibiotarsal joint is covered, it equals one
     incident.
    --Factor is two.
    --A maximum of two incidents per carcass.
                         B Trim nonconformances
1 Breast blister
    --Inflammatory tissue, fluid, or pus between the skin and keel must
     be trimmed if membrane ``slips'' or if firm nodule is greater than
     \1/2\ in diameter (dime size).
    --Factor is two.
    --A maximum of one incident per carcass.
2 Breast blister--partially trimmed
    --All inflammatory tissue, including that which adheres tightly to
     the keel bone, must be removed.
    --Factor is two.
    --A maximum of one incident per carcass.
3 Bruise \1/2\ to 1
    --Blood clumps or clots in the superficial layers of tissue, skin,
     muscle or loose subcutaneous tissue may be slit and the blood
     completely washed out. When the bruise extends into the deeper
     layers of muscle, the affected tissue must be removed. Very small
     bruises less than \1/2\ (dime size) and areas showing
     only slight reddening need not be counted as defects.
    --Factor is one.
    --A maximum of five incidents per carcass.

[[Page 463]]

 
4 Bruise 1
    --Same criteria as in line three, but greater than one inch in
     greatest dimension.
    --Factor is two.
    --A maximum of three incidents per carcass.
5 Bruise black/green \1/4\ to 1
    --Bruises \1/4\ to 1 that have changed from
     red to a black/blue or green color due to age.
    --Factor is two.
    --A maximum of three incidents per carcass.
6 Bruise Black/green 1
    --Same as line 5, but measuring greater that 1 in
     greatest dimension.
    --Factor is five.
    --A maximum of two incidents per carcass.
7 Trimmable lesions/Condition
    --A trimmable tumor or identifiable portion of a tumor on any part
     of the carcass.
    --Trimmable Synovitis/airsacculitis (saddle/frog) lesions that have
     not been removed.
    --Lesion/condition subject to removal following an approved cleanout
     process. Examples: airsacculitis, salpingitis, nephritis, spleen,
     or liver conditions requiring removal of the kidneys.
Note: All establishments shall develop and maintain a permanent marking
 system that identifies carcasses with removable lesions/conditions on
 the inside surfaces. When removable lesions/conditions are identified
 inside the carcass by the inspector, the helper will be notified to
 apply the permanent mark. When removable inside lesions/conditions are
 found on a subgroup sample without the permanent mark, the error is not
 recorded in line 7. The affected carcass(s) will be hungback for IIC
 disposition and corrective action.
    --Factor is five.
    --A maximum of one incident per carcass.
8 Failure to complete task as indicated by marking system.
    Example: Synovitis, airsacculitis, inflammatory process,
     contamination, etc.
    --The helper, under the inspector's direction, will apply a mark to
     the carcass, indicating to the trimmer(s) that specific action must
     be taken on that carcass. When airsac and kidney cleanout, or
     synovitis part removal, or carcass removal from the line is not
     completed, or only partially completed, this occurrence is recorded
     as one defect.
    --Factor is five. It will also be recorded as a line 7 defect for a
     total factor of 10.
    --A maximum of one incident per carcass.
9 Compound fracture
    --Any bone fracture (i.e., leg or wing) that has caused an opening
     through the skin. May be accompanied with a bruise, but not always.
     Do not count the bruise in line 3 or 4 if it is associated with the
     compound fracture.
    --Factor is two.
    --A maximum of three incidents per carcass.
10 Wingtip compound fracture
    --Same criteria as line 9, but only for wingtips.
      Note: Bruises not associated with the fracture should be recorded
       in the appropriate lines.
    --Factor is one.
    --A maximum of two incidents per carcass.
11 Untrimmed short hock
    --When no cartilage of the hock surface is present and no tendons
     are attached to the bone.
    --Factor is two.
    --A maximum of two incidents per carcass.
12 Sores, scabs, inflammatory process, etc. <=\1/2\
    --Any defects such as sores, abscesses, scabs, wounds, dermatitis,
     inflammatory process, that measure less than or equal to \1/2\ in the greatest dimension.
    --Factor is two.
    --A maximum of two incidents per carcass.
13 Sores, scabs, inflammatory process, etc. \1/2\
    --Same as line 12, but greatest dimension is greater than \1/2\, or a cluster of smaller lesions in close proximity \1/2\, this category also includes turkey leg edema.
    --Factor is five.
    --A maximum of one incident per carcass.
14 External mutilation
    --Mutilation to the skin and/or muscle that is caused by the
     slaughter, dressing or eviscerating processes. Skinned elbows
     (bucked wings) do not trim require unless affected wing joint
     capsule is also opened.
    --Factor is one.
    --A maximum of three incidents per carcass.

[[Page 464]]

 
 C Postchill nonconformances--(Designed to monitor those nonconformances
              added to product during the chilling process)
1 Extraneous material <=\1/16\
    --Include specks, grease, or unidentifiable foreign material that
     measure \1/16\ or less in the greatest dimension.
    --Example: Ingesta, grease, or unidentifiable foreign material.
    --Factor is one.
    --3 to 7=1 defect; 8 to 12=2 defects; 13 or more=3 defects. A
     maximum of three incidents per carcass.
2 Extraneous material \1/16\ to 1
    --This includes ingesta, grease, or unidentifiable foreign material
     measureing \1/16\ to 1 longest
     dimension.
    --Factor is one.
    --A maximum of three incidents per carcass.
3 Extraneous material 1
    --The same material as line 2, but measuring greater than one inch.
    --Factor is two.
    --A maximum of two incidents per carcass.
 


                   Table 2--Finished Product Standards
 
                                                                    SIS
 
Prechill Processing Nonconformance
    Tolerance number (T).........................................     25
    Subgroup Absolute Limit (T+5)................................     30
    Action number................................................     22
    Start number.................................................     11
Prechill Trim Nonconformance
    Tolerance number (T).........................................     12
    Subgroup Absolute Limit (T+5)................................     17
    Action number................................................     15
    Start number.................................................      8
Postchill Nonconformance
    Tolerance number (T).........................................      5
    Subgroup Absolute Limit (T+5)................................     10
    Action number................................................     10
    Start number.................................................      5
 

    (4) The following requirements are also applicable to NELS 
inspection:
    (i) Inspection under NELS is conducted in two phases, as post-mortem 
inspection phase and a reinspection phase.
    (a) Post-mortem inspection. The establishment shall provide three 
inspection stations on each eviscerating line in compliance with the 
facility requirements Sec. 381.36(d)(1). The three inspectors shall 
inspect the inside, viscera, and outside of all birds presented. Each 
inspector shall be flanked by two establishment employees--the presenter 
and the helper. The presenter shall ensure that the bird is properly 
eviscerated and presented for inspection and the viscera uniformly 
trailing or leading. The inspector shall determine which birds shall be 
salvaged, reprocessed, condemned, retained for disposition by the 
veterinarian, or allowed to proceed down the line as a passed bird 
subject to reinspection. Poultry carcasses with certain defects not 
requiring condemnation of the entire carcass shall be passed by the 
inspector, but shall be subject to reinspection to ensure the physical 
removal of the specified defects. The helper, under the supervision of 
the inspector, shall mark such carcasses for trim when the defects are 
not readily observable. Trimming or birds passed subject to reinspection 
shall be performed by:
    (1) The helper, time permitting, and
    (2) One or more plant trimmers positioned after giblet harvest and 
prior to reinspection.
    (b) A reinspection station shall be located at the end of each line. 
This station shall comply with the facility requirements in Sec. 
381.36(d)(2). The inspector shall ensure that the establishment has 
performed the indicated trimming of carcasses passed subject to 
reinspection by visually monitoring, checking data, or gathering samples 
at the station or at other critical points on the line.
    (ii)-(iii) [Reserved]
    (iv) The maximum inspection rate for NELS shall be 91 birds per 
minute per eviscerating line.
    (5) The following requirements are also applicable to the NTI 
System:
    (i) Inspection under the NTI System is conducted in two phases, a 
post-mortem inspection phase and a reinspection phase. The NTI-1 
Inspection System requires that the establishment provide one inspection 
station for each line and adequate reinspection facilitiates so 
carcasses can be removed from each line for evaluation. The NTI-2 
Inspection System requires that the establishment provide two inspection 
stations for each line and adequate reinspection facilities so carcasses 
can be removed from each line for evaluation.
    (a) Post-mortem inspection. Each inspection station must comply with 
the facility requirements in Sec. 381.36(e)(1).

[[Page 465]]

Each inspector shall be flanked by and establishment employee assigned 
to be the inspector's helper. The one inspector on an NTI-1 Inspection 
System shall be presented every bird. Each inspector on an NTI-2 
Inspection System line shall be presented every other bird on the line. 
An establishment employee shall present each bird to the inspector 
properly eviscerated with the back side toward the inspector and the 
viscera uniformly trailing or leading. Each inspector shall inspect the 
inside, viscera, and outside of all birds presented. The inspector shall 
determine which bird shall be salvaged, reprocessed, condemned, retained 
for disposition by a veterinarian, or allowed to proceed down the line 
as a passed bird subject to reinspection. Turkey carcasses with certain 
defects not requiring condemnation of the entire carcass shall be passed 
by the inspector, but shall be subject to reinspection to ensure the 
physical removal of the specified defects. The helper, under the 
supervision of the inspector, shall mark such carcasses for trim when 
the defects of birds passed subject to reinspection shall be performed 
by:
    (1) The helper, time permitting, and
    (2) One or more plant trimmers positioned after the giblet harvest 
and prior to reinspection.
    (b) Reinspection. A reinspection station shall be located at the end 
of the lines. This station shall comply with the facility requirements 
in Sec. 381.36(e)(2). The inspector shall ensure that establishments 
have performed the indicated trimming of each carcass passed subject to 
reinspection by visually monitoring, checking data, and/or sampling 
product at the reinspection station and, if necessary, at other points, 
critical to the wholesomeness of product, on the eviscerating line.
    (ii)-(iii) [Reserved]

(Recordkeeping requirements approved by the Office of Management and 
Budget under control number 0583-0008)

[47 FR 23435, May 28, 1982, as amended at 49 FR 42555, Oct. 23, 1984; 50 
FR 37513, Sept. 16, 1985; 50 FR 38097, Sept. 20, 1985; 51 FR 3574, Jan. 
29, 1986; 53 FR 46861, Nov. 21, 1988; 62 FR 5143, Feb. 4, 1997; 65 FR 
34390, May 30, 2000; 66 FR 22906, May 7, 2001]



Sec. 381.77  Carcasses held for further examination.

    Each carcass, including all parts thereof, in which there is any 
lesion of disease, or other condition which might render such carcass or 
any part thereof adulterated and with respect to which a final decision 
cannot be made on first examination by the inspector, shall be held for 
further examination. The identity of each such carcass, including all 
parts thereof, shall be maintained until a final examination has been 
completed.



Sec. 381.78  Condemnation of carcasses and parts: separation of poultry 
suspected of containing biological residues.

    (a) At the time of any inspection under this subpart each carcass, 
or any part thereof, which is found to be adulterated shall be 
condemned, except that any such articles which may be made not 
adulterated by reprocessing, need not be so condemned if so reprocessed 
under the supervision of an inspector and thereafter found to be not 
adulterated.
    (b) When a lot of poultry suspected of containing biological 
residues is inspected in an official establishment, all carcasses and 
any parts of carcasses in such lot which are condemned shall be kept 
separate from all other condemned carcasses or parts.

[37 FR 9706, May 16, 1972, as amended at 48 FR 22899, May 23, 1983; 48 
FR 23807, May 27, 1983]



Sec. 381.79  Passing of carcasses and parts.

    Each carcass and all organs and other parts of carcasses which are 
found to be not adulterated shall be passed for human food.



Sec. 381.80  General; biological residues.

    (a) The carcasses or parts of carcasses of all poultry inspected at 
an official establishment and found at the time of post mortem 
inspection, or at any subsequent inspection, to be affected with any of 
the diseases or conditions named in other sections in this subpart, 
shall be disposed of in accordance with the section pertaining to the 
disease or condition. Owing to the fact that it is impracticable to 
formulate

[[Page 466]]

rules for each specific disease or conditions and to designate at just 
what stage a disease process results in an adulterated article, the 
decision as to the disposal of all carcasses, organs or other parts not 
specifically covered by the regulations, or by instructions of the 
Administrator issued pursuant thereto, shall be left to the inspector in 
charge, and if the inspector in charge is in doubt concerning the 
disposition to be made, specimens from such carcasses shall be forwarded 
to the Inspection Service laboratory for diagnosis.
    (b) All carcasses, organs, or other parts of carcasses of poultry 
shall be condemned if it is determined on the basis of a sound 
statistical sample that they are adulterated because of the presence of 
any biological residues.



Sec. 381.81  Tuberculosis.

    Carcasses of poultry affected with tuberculosis shall be condemned.



Sec. 381.82  Diseases of the leukosis complex.

    Carcasses of poultry affected with any one or more of the several 
forms of the avian leukosis complex shall be condemned.



Sec. 381.83  Septicemia or toxemia.

    Carcasses of poultry showing evidence of any septicemic or toxemic 
disease, or showing evidence of an abnormal physiologic state, shall be 
condemned.



Sec. 381.84  Airsacculitis.

    Carcasses of poultry with evidence of extensive involvement of the 
air sacs with airsacculitis or those showing airsacculitis along with 
systemic changes shall be condemned. Less affected carcasses may be 
passed for food after complete removal and condemnation of all affected 
tissues including the exudate.

[40 FR 14297, Mar. 31, 1975]



Sec. 381.85  Special diseases.

    Carcasses of poultry showing evidence of any disease which is 
characterized by the presence, in the meat or other edible parts of the 
carcass, or organisms or toxins dangerous to the consumer, shall be 
condemned.



Sec. 381.86  Inflammatory processes.

    Any organ or other part of a carcass which is affected by an 
inflammatory process shall be condemned and, if there is evidence of 
general systemic disturbance, the whole carcass shall be condemned.



Sec. 381.87  Tumors.

    Any organ or other part of a carcass which is affected by a tumor 
shall be condemned and when there is evidence of metastasis or that the 
general condition of the bird has been affected by the size, position, 
or nature of the tumor, the whole carcass shall be condemned.



Sec. 381.88  Parasites.

    Organs or other parts of carcasses which are found to be infested 
with parasites, or which show lesions of such infestation shall be 
condemned and, if the whole carcass is affected, the whole carcass shall 
be condemned.



Sec. 381.89  Bruises.

    Any part of a carcass which is badly bruised shall be condemned and, 
if the whole carcass is affected as a result of the bruise, the whole 
carcass shall be condemned. Parts of a carcass which show only slight 
reddening from a bruise may be passed for food.



Sec. 381.90  Cadavers.

    Carcasses of poultry showing evidence of having died from causes 
other than slaughter shall be condemned.



Sec. 381.91  Contamination.

    (a) Carcasses of poultry contaminated by volatile oils, paints, 
poisons, gases, scald vat water in the air sac system, or other 
substances which render the carcasses adulterated shall be condemned. 
Any organ or other part of a carcass which has been accidentally 
multilated in the course of processing shall be condemned, and if the 
whole carcass is affected, the whole carcass shall be condemned.
    (b)(1) Any carcass of poultry accidentally contaminated during 
slaughter with digestive tract contents shall not be condemned if 
promptly reproc essed under the supervision of an inspector

[[Page 467]]

and thereafter found not to be adulterated. Contaminated surfaces that 
are cut shall be removed only by trimming. Contaminated inner surfaces 
that are not cut may be cleaned by trimming alone, or at an approved 
reprocessing station away from the main processing line, by any method 
that will remove the contamination, such as vacuuming, washing, and 
trimming, singly or in combination. All visible specks of contamination 
must be removed, and if the inner surfaces are reprocessed other than 
soley by trimming, all surfaces of the carcass shall be treated with 
chlorinated water containing 20 ppm available chlorine.
    (2) An area will be designated as an approved reprocessing station 
only if the Administrator determines that reprocessing operations can be 
conducted in that area in accordance with all of the requirements of 
this part, and that the reprocessing methods to be utilized are capable 
of removing all visible specks of contamination on the inner surface of 
a carcass. Requests for such approval shall be submitted to the 
inspector in charge and shall describe the proposed area, proposed 
methods of reprocessing, and proposed equipment to be utilized. Whenever 
the Administrator finds that reprocessing operations cannot be conducted 
in such area in accordance with all of the requirements of this part or 
that the reprocessing methods utilized are not capable of removing all 
visible specks of contamination on the inner surface of a carcass, he 
may withdraw approval of such area, effective upon oral or written 
notification, whichever is earlier, to the operator of the 
establishment. In the event of oral notification, a written confirmation 
thereof shall be given to the operator as promptly as circumstances 
permit. The notification shall specify the reasons for such withdrawal 
and shall afford the operator of the establishment an opportunity to 
present his views. In any instance where there is a conflict as to the 
facts, a hearing shall be held to resolve such conflict.

[37 FR 9706, May 16, 1972, as amended at 43 FR 12847, Mar. 28, 1978]



Sec. 381.92  Overscald.

    Carcasses of poultry which have been overscalded, resulting in a 
cooked appearance of the flesh, shall be condemned.



Sec. 381.93  Decomposition.

    Carcasses of poultry deleteriously affected by post mortem changes 
shall be disposed of as follows:
    (a) Carcasses which have reached a state of putrefaction or stinking 
fermentation shall be condemned.
    (b) Any part of a carcass which is green struck shall be condemned 
and, if the carcass is so extensively affected that removal of affected 
parts is impracticable, the whole carcass shall be condemned.
    (c) Carcasses affected by types of post mortem change which are 
superficial in nature may be passed for human food after removal and 
condemnation of the affected parts.



Sec. 381.94  Contamination with Microorganisms; process control 
verification criteria and testing; pathogen reduction standards.

    (a) Criteria for verifying process control; E. coli testing.
    (1) Each official establishment that slaughters poultry shall test 
for Escherichia coli Biotype I (E. coli). Establishments that slaughter 
more than one type of poultry and/or poultry and livestock, shall test 
the type of poultry or livestock slaughtered in the greatest number. The 
establishment shall:
    (i) Collect samples in accordance with the sampling techniques, 
methodology, and frequency requirements in paragraph (a)(2) of this 
section;
    (ii) Obtain analytic results in accordance with paragraph (a)(3) of 
this section; and
    (iii) Maintain records of such analytic results in accordance with 
paragraph (a)(4) of this section.
    (2) Sampling requirements.
    (i) Written procedures. Each establishment shall prepare written 
specimen collection procedures which shall identify employees designated 
to collect samples, and shall address location(s) of sampling, how 
sampling randomness is achieved, and handling of the sample

[[Page 468]]

to ensure sample integrity. The written procedure shall be made 
available to FSIS upon request.
    (ii) Sample collection. A whole bird must be taken from the end of 
the chilling process. If this is impracticable, the whole bird can be 
taken from the end of the slaughter line. Samples must be collected by 
rinsing the whole carcass in an amount of buffer appropriate for that 
type of bird. Samples from turkeys or ratites also may be collected by 
sponging the carcass on the back and thigh.\1\
---------------------------------------------------------------------------

    \1\ A copy of FSIS's ``Guidelines for Escherichia coli Testing for 
Process Control Verification in Poultry Slaughter Establishments,'' and 
``FSIS Turkey Microbiological Procedures for Sponge Sample Collection 
and Methods of Analysis'' are available for inspection in the FSIS 
Docket Room.
---------------------------------------------------------------------------

    (iii) Sampling frequency. Slaughter establishments, except very low 
volume establishments as defined in paragraph (a)(2)(v) of this section, 
must take samples at a frequency proportional to the establishment's 
volume of production at the following rates:
    (A) Chickens: 1 sample per 22,000 carcasses, but a minimum of one 
sample during each week of operation.
    (B) Turkeys, Ducks, Geese, Guineas, Squabs, and Ratites: 1 sample 
per 3,000 carcasses, but at a minimum one sample each week of operation.
    (iv) Sampling frequency alternatives. An establishment operating 
under a validated HACCP plan in accordance with Sec. 417.2(b) of this 
chapter may substitute an alternative frequency for the frequency of 
sampling required under paragraph (a)(2)(iii) of this section if,
    (A) The alternative is an integral part of the establishment's 
verification procedures for its HACCP plan and,
    (B) FSIS does not determine, and notify the establishment in 
writing, that the alternative frequency is inadequate to verify the 
effectiveness of the establishment's processing controls.
    (v) Sampling in very low volume establishments. (A) Very low volume 
establishments annually slaughter no more than 440,000 chickens, 60,000 
turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas, 60,000 squabs, 
6,000 ratites, or a combination of all types of poultry not exceeding 
60,000 turkeys and 440,000 birds total. Very low volume establishments 
that slaughter turkeys, ducks, geese, guineas, squabs, or ratites in the 
largest number must collect at least one sample during each week of 
operation after June 1 of each year, and continue sampling at a minimum 
of once each week the establishment operates until June of the following 
year or until 13 samples have been collected, whichever comes first.
    (B) Upon the establishment's meeting the requirements of paragraph 
(a)(2)(v)(A) of this section, weekly sampling and testing is optional, 
unless changes are made in establishment facilities, equipment, 
personnel or procedures that may affect the adequacy of existing process 
control measures, as determined by the establishment or by FSIS. FSIS 
determinations that changes have been made requiring resumption of 
weekly testing shall be provided to the establishment in writing.
    (3) Analysis of samples. Laboratories may use any quantitative 
method for analysis of E. coli that is approved as an AOAC Official 
Method of the AOAC International (formerly the Association of Official 
Analytical Chemists) \2\ or approved and published by a scientific body 
and based on the results of a collaborative trial conducted in 
accordance with an internationally recognized protocol on collaborative 
trials and compared against the three tube Most Probable Number (MPN) 
method and agreeing with the 95 percent upper and lower confidence limit 
of the appropriate MPN index.
---------------------------------------------------------------------------

    \2\ A copy of the current edition/revision of the ``Official Methods 
of AOAC International,'' 16th edition, 3rd revision, 1997, is on file 
with the Director, Office of the Federal Register, and may be purchased 
from the Association of Official Analytical Chemists International, 
Inc., 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------

    (4) Recording of test results. The establishment shall maintain 
accurate records of all test results, in terms of CFU/ml of rinse fluid. 
Results shall be recorded onto a process control chart or table showing 
at least the most recent 13 test results, by type of poultry 
slaughtered. Records shall be retained at the establishment for a period 
of 12 months and shall be made available to FSIS upon request.

[[Page 469]]

    (5)(i) Criteria for Evaluation of test results. An establishment is 
operating within the criteria when the most recent E. coli test result 
does not exceed the upper limit (M), and the number of samples, if any, 
testing positive at levels above (m) is three or fewer out of the most 
recent 13 samples (n) taken, as follows:

                                   Table 1--Evaluation of E. Coli Test Results
----------------------------------------------------------------------------------------------------------------
                                                                                                  Maximum number
                                                  Lower limit of  Upper limit of     Number of     permitted in
                Types of poultry                  marginal range  marginal range      samples     marginal range
                                                        (m)             (M)         tested (n)          (c)
----------------------------------------------------------------------------------------------------------------
Chickens........................................         \1\ 100       \1\ 1,000              13               3
Turkeys.........................................             *NA             *NA             *NA             *NA
Ducks...........................................             *NA             *NA             *NA             *NA
Geese...........................................             *NA             *NA             *NA             *NA
Guineas.........................................             *NA             *NA             *NA             *NA
Squabs..........................................             *NA             *NA             *NA             *NA
Ratites.........................................             *NA             *NA             *NA             *NA
----------------------------------------------------------------------------------------------------------------
\1\ CFU/ml.
* Values will be added upon completion of data collection programs.

    (ii) For types of poultry appearing in paragraph (a)(5)(1) Table 1 
of this section that do not have m/N criteria, establishments shall 
evaluate E. coli test results using statistical process control 
techniques.
    (6) Failure to meet criteria. Test results that do not meet the 
criteria described in paragraph (a)(5) of this section are an indication 
that the establishment may not be maintaining process controls 
sufficient to prevent fecal contamination. FSIS shall take further 
action as appropriate to ensure that all applicable provisions of the 
law are being met.
    (7) Failure to test and record. Inspection will be suspended in 
accordance with rules of practice that will be adopted for such 
proceeding, upon a finding by FSIS that one or more provisions of 
paragraphs (a) (1)-(4) of this section have not been complied with and 
written notice of same has been provided to the establishment.
    (b) Pathogen reduction performance standards; Salmonella--(1) Raw 
poultry product performance standards for Salmonella. (i) An 
establishment's raw poultry products, when sampled and tested by FSIS 
for Salmonella as set forth in this section, may not test positive for 
Salmonella at a rate exceeding the applicable national pathogen 
reduction performance standard, as provided in Table 2:

                                    Table 2--Salmonella Performance Standards
----------------------------------------------------------------------------------------------------------------
                                                               Performance
                                                                Standard          Number of      Maximum  number
                     Class of product                           (percent       samples tested   of  positives to
                                                              positive for           (n)             achieve
                                                             salmonella) \a\                      standard (c)
----------------------------------------------------------------------------------------------------------------
Broilers..................................................             20.0%                51                12
Ground chicken............................................              44.6                53                26
Ground turkey.............................................              49.9                53                29
Turkeys...................................................              b NA                NA                NA
Squabs....................................................              b NA                NA                NA
Ratites...................................................              b NA                NA                NA
----------------------------------------------------------------------------------------------------------------
a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw
  products based on data developed by FSIS in its nationwide microbiological baseline data collection programs
  and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide
  Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the
  FSIS Docket Room.)
b Not available; baseline targets for turkeys, squabs, or ratites will be added upon completion of the data
  collection programs for that product.

    (2) Enforcement. FSIS will sample and test raw poultry products in 
an individual establishment on an unannounced basis to determine 
prevalence of Salmonella in such products to determine compliance with 
the standard.

[[Page 470]]

The frequency and timing of such testing will be based on the 
establishment's previous test results and other information concerning 
the establishment's performance. In an establishment producing more than 
one class of product subject to the pathogen reduction standard, FSIS 
may sample any or all such classes of products.\3\
---------------------------------------------------------------------------

    \3\ A copy of FSIS's ``Sample Collection Guidelines and Procedure 
for Isolation and Identification of Salmonella from Raw Meat and Poultry 
Products'' is available for inspection in the FSIS Docket Room.
---------------------------------------------------------------------------

    (3) Noncompliance and establishment response. When FSIS determines 
that an establishment has not met the performance standard:
    (i) The establishment shall take immediate action to meet the 
standard.
    (ii) If the establishment fails to meet the standard on the next 
series of compliance tests for that product, the establishment shall 
reassess its HACCP plan for that product.
    (iii) Failure by the establishment to act in accordance with 
paragraph (b)(3)(ii) of this section, or failure to meet the standard on 
the third consecutive series of FSIS-conducted tests for that product, 
constitutes failure to maintain sanitary conditions and failure to 
maintain an adequate HACCP plan, in accordance with part 417 of this 
chapter, for that product, and will cause FSIS to suspend inspection 
services. Such suspension will remain in effect until the establishment 
submits to the FSIS Administrator or his/her designee satisfactory 
written assurances detailing the action taken to correct the HACCP 
system and, as appropriate, other measures taken by the establishment to 
reduce the prevalence of pathogens.

[61 FR 38866, July 25, 1996, as amended at 62 FR 26218, May 13, 1997; 62 
FR 61009, Nov. 14, 1997; 64 FR 66553, Nov. 29, 1999; 67 FR 13258, Mar. 
22, 2002]



Subpart L_Handling and Disposal of Condemned or Other Inedible Products 
                       at Official Establishments



Sec. 381.95  Disposal of condemned poultry products.

    All condemned carcasses, or condemned parts of carcasses, or other 
condemned poultry products, except those condemned for biological 
residues shall be disposed of by one of the following methods, under the 
supervision of an inspector of the Inspection Service. (Facilities and 
materials for carrying out the requirements in this section shall be 
furnished by the official establishment.)
    (a) Steam treatment (which shall be accomplished by processing the 
condemned product in a pressure tank under at least 40 pounds of steam 
pressure) or thorough cooking in a kettle or vat, for a sufficient time 
to effectively destroy the product for human food purposes and preclude 
dissemination of disease through consumption by animals. (Tanks and 
equipment used for this purpose or for rendering or preparing inedible 
products shall be in rooms or compartments separate from those used for 
the preparation of edible products. There shall be no direct connection 
by means of pipes, or otherwise, between tanks containing inedible 
products and those containing edible products.)
    (b) Incineration or complete destruction by burning.
    (c) Chemical denaturing, which shall be accomplished by the liberal 
application to all carcasses and parts thereof, of:
    (1) Crude carbolic acid,
    (2) Kerosene, fuel oil, or used crankcase oil, or
    (3) Any phenolic disinfectant conforming to commercial standards CS 
70-41 or CS 71-41 which shall be used in at least 2 percent emulsion or 
solution.
    (d) Any other substance or method that the Administrator approves in 
specific cases, which will denature the poultry product to the extent 
necessary to accomplish the purposes of this section.
    (e) Carcasses and parts of carcasses condemned for biological 
residue shall

[[Page 471]]

be disposed of in accordance with paragraph (b) of this section or by 
burying under the supervision of an inspector.



      Subpart M_Official Marks, Devices, and Certificates; Export 
                 Certificates; Certification Procedures



Sec. 381.96  Wording and form of the official inspection legend.

    Except as otherwise provided in this subpart, the official 
inspection legend required to be used with respect to inspected and 
passed poultry products shall include wording as follows: ``Inspected 
for wholesomeness by U.S. Department of Agriculture.'' This wording 
shall be contained within a circle. The form and arrangement of such 
wording shall be exactly as indicated in the example in Figure 1, except 
that the appropriate official establishment number shall be shown, and 
if the establishment number appears elsewhere on the labeling material 
in the manner prescribed in Sec. 381.123(b), it may be omitted from the 
inspection mark. The administrator may approve the use of abbreviations 
of such inspection mark; and such approved abbreviations shall have the 
same force and effect as the inspection mark. The official inspection 
legend, or the approved abbreviation thereof, shall be printed on 
consumer packages and other immediate containers of inspected and passed 
poultry products, or on labels to be securely affixed to such containers 
of such products and may be printed or stenciled thereon, but shall not 
be applied by rubber stamping. When applied by a stencil, the legend 
shall not be less than 4 inches in diameter. An official brand must be 
applied to inspected and passed carcasses and parts of ratites that are 
shipped unpacked.
[GRAPHIC] [TIFF OMITTED] TC11SE91.037


[66 FR 22906, May 7, 2001]



Sec. 381.97  [Reserved]



Sec. 381.98  Official seal.

    The official mark for use in sealing means of conveyance used in 
transporting poultry products under any requirement in this part shall 
be the inscription and a serial number as shown below, and any seals 
approved by the Administrator for applying such mark shall be an 
official device.
[GRAPHIC] [TIFF OMITTED] TC11SE91.038



Sec. 381.99  Official retention and rejection tags.

    The official marks for use in post-mortem inspection and 
identification of adulterated products, insanitary equipment and 
facilities are:
    (a) A paper tag (a portion of Form MP-35) bearing the legend ``U.S. 
Retained'' for use on poultry or poultry products under this section.
    (b) A paper tag (another portion of Form C&MS 510) bearing the 
legend ``U.S. Rejected'' for use on equipment, utensils, rooms and 
compartments under this section.

[64 FR 56417, Oct. 20, 1999]

[[Page 472]]



Sec. 381.100  Official detention tag.

    The detention tag prescribed in Sec. 381.211 is an official device.



Sec. 381.101  Official U.S. Condemned mark.

    The term ``U.S. Condemned'' as shown below is an official mark and 
the devices used by the Department for applying such mark are official 
devices.
[GRAPHIC] [TIFF OMITTED] TC11SE91.039



Sec. 381.102  [Reserved]



Sec. 381.103  Official poultry condemnation certificates; issuance 
and form.

    Upon request by the operator of the establishment, the inspector in 
charge shall issue a poultry condemnation certificate (Form MP-514-1), 
showing the total number of poultry in the lot and the numbers condemned 
and the reasons for such condemnations.
    The official poultry condemnation certificate authorized by this 
subpart is a paper certificate (Form MP-514-1), for signature by an 
inspector, bearing the legend

   U.S. Department of Agriculture Animal and Plant Health Inspection 
                                 Service

                    poultry condemnation certificate

and the seal of the United States Department of Agriculture, with a 
certification that the poultry enumerated on the form were inspected and 
condemned for the listed causes in compliance with the regulations of 
the Department. A statement to the effect that certain figures on the 
certificate were derived from information supplied by plant management, 
and a signature line for an authorized plant official is also shown.



Sec. 381.104  Official export certificates, marks and devices.

    The form of certificate described in Sec. 381.106 is an official 
export certificate, and the mark shown below is the official mark used 
on outside containers to identify inspected and passed poultry products 
for export. Devices used by the Department to apply such a mark are 
official devices.
[GRAPHIC] [TIFF OMITTED] TC11SE91.040


[47 FR 29823, July 9, 1982]



Sec. 381.105  Export certification; marking of containers.

    (a) Upon request or application by any person intending to export 
any poultry product, any inspector is authorized to issue an official 
export certificate as prescribed in Sec. 381.107 with respect to the 
shipment to any foreign country of any inspected and passed poultry 
product, after adequate inspection of the product has been made by the 
inspector to determine its identity as inspected and passed and eligible 
for export: Provided, that the product is offered for inspection at an 
official establishment. Each shipping container covered by the export 
certificate, except ship stores, small quantities exclusively for the 
personal use of the consignee and not for sale or distribution, and 
shipments by and for the U.S. Armed Forces, shall be marked with an 
official export stamp as shown in Sec. 381.104 bearing the number of 
the export certificate. Official export certificates will be issued only 
upon condition that the products covered thereby shall be subject to 
reinspection at any place and at any time prior to exportation to 
determine the identity of the products and their eligibility for 
certification, and such certificates shall

[[Page 473]]

become invalid if such reinspection is refused or discloses that the 
products are not eligible for certification. If reinspection discloses 
that any poultry products covered by an export certificate are not 
eligible for such certification, a superseding certificate setting forth 
such findings shall be issued and copies shall be furnished to 
interested persons.
    (b) The original and a duplicate of each official export certificate 
shall be delivered to the person who requested such certificate or his 
agent. Such person may duplicate such numbers of exact copies of the 
original as he requires in connection with the exportation of the 
poultry products. Additional official file copies of the export 
certificates shall be prepared and distributed by the inspector in 
accordance with the instructions of the Administrator.
    (c) Only one certificate shall be issued for each consignment, 
except in case of error in the certificate or loss of the certificate 
originally issued. A request for a new certificate, except in the case 
of a lost certificate, shall be accompanied by the original and all 
copies of the first certificate. The new certificate shall carry the 
following statement: ``This certificate supersedes certificate No. ----
-- Dated ----------. The outside container of the poultry product 
covered by this certificate is stamped with United States Department of 
Agriculture Certificate No. ------.''

[37 FR 9706, May 16, 1972, as amended at 50 FR 25204, June 18, 1985]



Sec. 381.106  Form of official export certificate.

    The official export certificate authorized by this subpart is a 
paper certificate form for signature by an inspector, bearing a 
letterhead and the seal of the U.S. Department of Agriculture, with a 
certification that the slaughtered poultry and other poultry products 
described on the form came from birds that were officially given an 
ante-mortem and post-mortem inspection and passed in accordance with the 
regulations of the Department and that such products are wholesome and 
fit for human consumption. The certificate also bears a serial number, 
such as ``MPA 002805'', and shows the respective names of the exporter 
and consignee, the destination, the shipping marks, the names of such 
products, the total net weight thereof, and such other information as 
the Administrator may prescribe or approve in specific cases.

[47 FR 29823, July 9, 1982]



Sec. 381.107  Special procedures as to certification of poultry products 
for export to certain countries.

    When export certificates are required by any foreign country for 
poultry products exported to such country, the Administrator shall in 
specific cases prescribe or approve the form of export certificate to be 
used and the methods and procedures he deems appropriate with respect to 
the processing of such products, in order to comply with requirements 
specified by the foreign country regarding the export products. 
Inspectors shall satisfy themselves that all such requirements are met 
before issuing such an export certificate. It shall be the 
responsibility of the exporter to provide any unofficial documentation 
needed to meet the foreign requirements, before the export certificate 
will be issued. Such certificates may also cover articles exempted from 
definition as a poultry product under Sec. 381.15 if they have been 
inspected and are certified under the regulations in part 362 of this 
chapter.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 41 FR 
23702, June 11, 1976]



Sec. 381.108  Official poultry inspection certificates; issuance and 
disposition.

    (a) Upon the request of an interested party, any veterinary 
inspector is authorized to issue an official poultry inspection 
certificate with respect to any lot of slaughtered poultry inspected by 
him. At any official establishment each such certificate shall be signed 
by the inspector who made the inspection covered by the certificate, and 
if more than one inspector participated in the inspection of the lot of 
poultry, each such inspector shall sign the certificate with respect to 
such lot. If the inspection of a lot covered by a certificate

[[Page 474]]

was made by a food inspector, such certificate shall also be signed by 
the inspector in charge when such inspection was made. Any inspector is 
authorized to issue a poultry inspection certificate with respect to any 
other poultry product inspected by him.
    (b) The original and one copy of each poultry inspection certificate 
shall be issued to the applicant who requested such certificate, and one 
copy shall be retained by the inspector for filing. The inspector who 
issues any inspection certificate is authorized to furnish an additional 
copy of such certificate upon the request of an interested party. The 
person who sold the live poultry involved to the official establishment 
is an interested party for purposes of this section.

[37 FR 9706, May 16, 1972, as amended at 39 FR 36000, Oct. 7, 1974]



Sec. 381.109  Form of official poultry inspection certificate.

    (a) The official poultry inspection certificate authorized by this 
subpart is a paper certificate (Form MP-505) for signature by an 
inspector, bearing the legend

   U.S. Department of Agriculture Animal and Plant Health Inspection 
               Service Meat and Poultry Inspection Program

                     poultry inspection certificate

and the seal of the U.S. Department of Agriculture, with a certification 
that the poultry described therein had been inspected in compliance with 
the Regulations of the Secretary of Agriculture Governing the Inspection 
of Poultry and Poultry Products.
    (b) The certificate also bears a serial number such as ``B 3208'' 
and shows the respective name and address of the applicant, the shipper 
or seller and the receiver or buyer and the net weight in pounds of 
amount passed, amount rejected or condemned, type of poultry, lot number 
and class, and such other information as the Administrator may prescribe 
or approve in specific cases.



Sec. 381.110  Erasures or alterations made on certificates.

    Erasures or alterations not initialed by the issuing inspector shall 
not be permitted on any official certificate or any copy thereof. All 
certificates rendered useless through clerical error or otherwise and 
all certificates canceled for whatever cause shall be voided and 
initialed, and one copy shall be retained in the inspector's file; and 
the original and all other copies shall be forwarded to the appropriate 
program supervisor.



Sec. 381.111  Data to be entered in proper spaces.

    All certificates shall be so executed that the data entered thereon 
will appear in the proper spaces on each copy of the certificate.



Sec. 381.112  Official mark for maintaining the identity and integrity 
of samples.

    The official mark for use in sealing containers of samples submitted 
under any requirements in this part and section 11(b) of the Poultry 
Products Inspection Act shall bear the designation ``Sample Seal'' 
accompanied by the official USDA logo as shown below. Any seal approved 
by the Administrator for applying such mark shall be deemed an official 
device for purposes of the Act. Such device shall be supplied to 
inspectors, compliance officers, and other designated Agency officials 
by the United States Department of Agriculture.
[GRAPHIC] [TIFF OMITTED] TC11SE91.041


[52 FR 41958, Nov. 2, 1987]



                    Subpart N_Labeling and Containers



Sec. 381.115  Containers of inspected and passed poultry products 
required to be labeled.

    Except as may be authorized in specific cases by the Administrator 
with respect to shipment of poultry products between official 
establishments,

[[Page 475]]

each shipping container and each immediate container of any inspected 
and passed poultry product shall at the time it leaves the official 
establishment bear a label which contains information, and has been 
approved, in accordance with this subpart.



Sec. 381.116  Wording on labels of immediate containers.

    (a) Each label for use on immediate containers for inspected and 
passed poultry products shall bear on the principal display panel 
(except as otherwise permitted in the regulations), the items of 
information required by this subpart. Such items of information shall be 
in distinctly legible form. Except as provided in Sec. 381.128, all 
words, statements and other information required by or under authority 
of the Act to appear on the label or labeling shall appear thereon in 
the English language: Provided, however, That in the case of products 
distributed solely in Puerto Rico, Spanish may be substituted for 
English for all printed matter except the USDA inspection legend.
    (b) The principal display panel shall be the part of a label that is 
most likely to be displayed, presented, shown, or examined under 
customary conditions of display for sale. The principal display panel 
shall be large enough to accommodate all the mandatory label information 
required to be placed thereon by the regulations with clarity and 
conspicuousness and without being obscured by design or vignettes, or 
crowding. Where packages bear alternate principal display panels, 
information required to be placed on the principal display panel shall 
be duplicated on each principal display panel. The area that is to bear 
the principal display panel shall be:
    (1) In the case of a rectangular package, one entire side, the area 
of which is the product of the height times the width of that side.
    (2) In the case of a cylindrical or nearly cylindrical container:
    (i) An area on the side of the container that is 40 percent of the 
product of the height of the container times the circumference, or
    (ii) A panel, the width of which is one-third of the circumference 
and the height of which is as high as the container: Provided, however, 
That there is, immediately to the right or left of such principal 
display panel, a panel which has a width not greater than 20 percent of 
the circumference and a height as high as the container, and which is 
reserved for information prescribed in Sec. Sec. 381.118, 381.122, and 
381.123. Such panel shall be known as the ``20 percent panel'' and such 
information may be shown on that panel in lieu of showing it on the 
principal display panel as provided in this Sec. 381.116.
    (3) In the case of a container of any other shape, 40 percent of the 
total surface of the container.

In determining the area of the principal display panel, exclude tops, 
bottoms, flanges at tops and bottoms of cans, and shoulders and necks of 
bottles or jars.
    (c) (1) The information panel is that part of a label that is the 
first surface to the right of the principal display panel as observed by 
an individual facing the principal display panel, with the following 
exceptions:
    (i) If the first surface to the right of the principal display panel 
is too small to accommodate the required information or is otherwise 
unusable label space, e.g., folded flaps, tear strips, opening flaps, 
heat-sealed flaps, the next panel to the right of this part of the label 
may be used.
    (ii) If the package has one or more alternate principal display 
panels, the information panel is to the right of any principal display 
panel.
    (iii) If the top of the container is the principal display panel and 
the package has no alternate principal display panel, the information 
panel is any panel adjacent to the principal display panel.
    (2) (i) Except as otherwise permitted in this part, all information 
required to appear on the principal display panel or permitted to appear 
on the information panel shall appear on the same panel unless there is 
insufficient space. In determining the sufficiency of the available 
space, except as otherwise prescribed in this part, any vignettes, 
designs, and any other nonmandatory information shall not be considered. 
If

[[Page 476]]

there is insufficient space for all required information to appear on a 
single panel, it may be divided between the principal display panel and 
the information panel, provided that the information required by any 
given provision of this part, such as the ingredients statement, is not 
divided and appears on the same panel.
    (ii) All information appearing on the information panel pursuant to 
this section shall appear in one place without intervening material, 
such as designs or vignettes.

[37 FR 9706, May 16, 1972, as amended at 40 FR 11347, Mar. 11, 1975; 59 
FR 40214, Aug. 8, 1994]



Sec. 381.117  Name of product and other labeling.

    (a) The label shall show the name of the product, which, in the case 
of a poultry product which purports to be or is represented as a product 
for which a definition and standard of identity or composition is 
prescribed in subpart P, shall be the name of the food specified in the 
standard, and in the case of any other poultry product shall be the 
common or usual name of the food, if any there be, and if there is none, 
a truthful descriptive designation.
    (b) The name of the product required to be shown on labels for fresh 
or frozen raw whole carcasses of poultry shall be in either of the 
following forms: The name of the kind (such as chicken, turkey, or duck) 
preceded by the qualifying term ``young'' or ``mature'' or ``old'', 
whichever is appropriate; or the appropriate class name as described in 
Sec. 381.170(a). The name of the kind may be used in addition to the 
class name, but the name of the kind alone without the qualifying age or 
class term is not acceptable as the name of the product, except that the 
name ``chicken'' may be used without such qualification with respect to 
a ready-to-cook pack of fresh or frozen cut-up young chickens, or a half 
of a young chicken, and the name ``duckling'' may be used without such 
qualification with respect to a ready-to-cook pack of fresh or frozen 
young ducks. The class name may be appropriately modified by changing 
the word form, such as using the term ``roasting chicken'', rather than 
``roaster.'' The appropriate names for cut-up parts are set forth in 
Sec. 381.170(b). When naming parts cut from young poultry, the identity 
of both the kind of poultry and the name of the part shall be included 
in the product name. The product name for parts or portions cut from 
mature poultry shall include, along with the part or portion name, the 
class name or the qualifying term ``mature.'' The name of the product 
for cooked or heat processed poultry products shall include the kind 
name of the poultry from which the product was prepared but need not 
include the class name or the qualifying term ``mature.''
    (c) Poultry products containing light and dark chicken or turkey 
meat in quantities other than the natural proportions, as indicated in 
Table 1 in this paragraph, must have a qualifying statement in 
conjunction with the name of the product indicating, as shown in Table 
1, the types of meat actually used, except that when the product 
contains less than 10 percent cooked deboned poultry meat or is 
processed in such a manner that the character of the light and dark meat 
is not distinguishable, the qualifying statement will not be required, 
unless the product bears a label referring to the light or dark meat 
content. In the latter case, the qualifying statement is required if the 
light and dark meat are not present in natural proportions. The 
qualifying statement must be in type at least one-half the size and of 
equal boldness as the name of the product; e.g., Boned Turkey (Dark 
Meat).

                                 Table 1
------------------------------------------------------------------------
                                                  Percent      Percent
               Label terminology                 light meat   dark meat
------------------------------------------------------------------------
Natural proportions...........................        50-65        50-35
Light or white meat...........................          100            0
Dark meat.....................................            0          100
Light and dark meat...........................        51-65        49-35
Dark and light meat...........................        35-49        65-51
Mostly white meat.............................   66 or more   34 or less
Mostly dark meat..............................   34 or less   66 or more
------------------------------------------------------------------------

    (d) Boneless poultry products shall be labeled in a manner that 
accurately describes their actual form and composition. The product name 
shall specify the form of the product (e.g., emulsified, finely chopped, 
etc.), and the kind name of the poultry, and if the product does not 
consist of natural

[[Page 477]]

proportions of skin and fat, as they occur in the whole carcass, shall 
also include terminology that describes the actual composition. If the 
product is cooked, it shall be so labeled. For the purpose of this 
paragraph, natural proportions of skin, as found on a whole chicken or 
turkey carcass, will be considered to be as follows:

------------------------------------------------------------------------
                                                             Percent
                                                       -----------------
                                                          Raw     Cooked
------------------------------------------------------------------------
Chicken...............................................       20       25
Turkey................................................       15       20
------------------------------------------------------------------------


Boneless poultry product shall not have a bone solids content of more 
than 1 percent, calculated on a weight basis.
    (e) On the label of any ``Mechanically Separated (Kind of Poultry) 
`` described in Sec. 381.173, the name of such product shall be 
followed immediately by the phrase: ``with excess skin'' unless such 
product is made from poultry product that does not include skin in 
excess of the natural proportion of skin present on the whole carcass, 
as specified in paragraph (d) of this section. Appropriate terminology 
on the label shall indicate if heat treatment has been used in the 
preparation of the product. The labeling information described in this 
paragraph shall be identified on the label before the product leaves the 
establishment at which it is manufactured.
    (f) The labels of sausages encased in natural casings made from meat 
or poultry viscera shall identify the type of meat or poultry from which 
the casings were derived, if the casings are from a different type of 
meat or poultry than the encased meat or poultry. The identity of the 
casing, if required, may be placed on the principal display panel or in 
the ingredient statement. Establishments producing, manufacturing, or 
using natural sausage casings are to maintain records documenting the 
meat or poultry source in accordance with subpart Q of this part.
    (g) The labels of sausages encased in regenerated collagen casings 
shall disclose this fact on the product label. The fact that the sausage 
is encased in collagen may be placed on the principal display panel or 
in the ingredient statement.

[37 FR 9706, May 16, 1972, as amended at 60 FR 55983, Nov. 3, 1995; 66 
FR 40845, Aug. 6, 2001]



Sec. 381.118  Ingredients statement.

    (a)(1) The label shall show a statement of the ingredients in the 
poultry product if the product is fabricated from two or more 
ingredients. Such ingredients shall be listed by their common or usual 
names in the order of their descending proportions, except as prescribed 
in paragraph (a)(2) of this section.
    (2)(i) Product ingredients which are present in individual amounts 
of 2 percent or less by weight may be listed in the ingredients 
statement in other than descending order of predominance: Provided, That 
such ingredients are listed by their common or usual names at the end of 
the ingredients statement and preceded by a quantifying statement, such 
as ``Contains ---------- percent or less of ---------- ,'' or ``Less 
than ---------- percent of ---------- .'' The percentage of the 
ingredient(s) shall be filled in with a threshold level of 2 percent, 
1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient 
to which the quantifying statement applies may be present in an amount 
greater than the stated threshold. Such a quantifying statement may also 
be utilized when an ingredients statement contains a listing of 
ingredients by individual components. Each component listing may utilize 
the required quantifying statement at the end of each component 
ingredients listing.
    (ii) Such ingredients may be adjusted in the product formulation 
without a change being made in the ingredients statement on the 
labeling, provided that the adjusted amount complies with Sec. 
381.147(f)(4) and subpart P of this part, and does not exceed the amount 
shown in the quantifying statement. Any such adjustments to the 
formulation shall be provided to the inspector-in-charge.
    (b) For the purpose of this paragraph, the term ``chicken meat,'' 
unless modified by an appropriate adjective, is construed to mean 
deboned white and dark meat; whereas the term ``chicken'' may

[[Page 478]]

include other edible parts such as skin and fat not in excess of their 
natural proportions, in addition to the chicken meat. If the term 
``chicken meat'' is listed and the product also contains skin, giblets, 
or fat, it is necessary to list each such ingredient. Similar principles 
shall be followed in listing ingredients of poultry products processed 
from other kinds of poultry.
    (c) The terms spice, natural flavor, natural flavoring, flavor or 
flavoring may be used in the following manner:
    (1) The term ``spice'' means any aromatic vegetable substance in the 
whole, broken, or ground form, with the exceptions of onions, garlic and 
celery, whose primary function in food is seasoning rather than 
nutritional and from which no portion of any volatile oil or other 
flavoring principle has been removed. Spices include the spices listed 
in 21 CFR 182.10, and 184.
    (2) The term ``natural flavor,'' ``natural flavoring,'' ``flavor'' 
or ``flavoring'' means the essential oil, oleoresin, essence or 
extractive, protein hydrolysate, distillate, or any product of roasting, 
heating or enzymolysis, which contains the flavoring constituents 
derived from a spice, fruit or fruit juice, vegetable or vegetable 
juice, edible yeast, herb, bark, bud, root, leaf or any other edible 
portions of a plant, meat, seafood, poultry, eggs, dairy products, or 
fermentation products thereof, whose primary function in food is 
flavoring rather than nutritional. Natural flavors include the natural 
essence or extractives obtained from plants listed in 21 CFR 182.10, 
182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR 
172.510. The term natural flavor, natural flavoring, flavor or flavoring 
may also be used to designate spices, powdered onion, powdered garlic, 
and powdered celery.
    (i) Natural flavor, natural flavoring, flavor or flavoring as 
described in paragraph (c)(1) and (2) of this section, which are also 
colors shall be designated as ``natural flavor and coloring,'' ``natural 
flavoring and coloring,'' ``flavor and coloring'' or ``flavoring and 
coloring'' unless designated by their common or usual name.
    (ii) Any ingredient not designated in paragraphs (c) (1) and (2) of 
this section whose function is flavoring, either in whole or in part, 
must be designated by its common or usual name. Those ingredients which 
are of livestock or poultry origin must be designated by names that 
include the species and livestock and poultry tissues from which the 
ingredients are derived.
    (d) On containers of frozen dinners, entrees, and pizzas, and 
similarly packaged products in cartons, the ingredient statement may be 
placed on the front riser panel: Provided, That the words ``see 
ingredients,'' followed immediately by an arrow pointing to the front 
riser panel, are placed on the principal display panel immediately above 
the location of such statement, without intervening printing or designs.
    (e) The ingredients statement may be placed on the information 
panel, except as otherwise permitted in this subchapter.
    (f) Establishments may interchange the identity of two kinds of 
poultry (e.g., chicken and turkey, chicken meat and turkey meat) used in 
a product formulation without changing the product's ingredient 
statement or product name under the following conditions:
    (1)(i) The two kinds of poultry used must comprise at least 70 
percent by weight of the poultry and the poultry ingredients [e.g. 
giblets, skin or fat in excess of natural proportions, or mechanically 
separated (kind)] used; and,
    (ii) Neither of the two kinds of poultry used can be less than 30 
percent by weight of the total poultry and poultry ingredients used;
    (2) The word ``and'' in lieu of a comma must be shown between the 
declaration of the two kinds of poultry in the ingredients statement and 
in the product name.

[37 FR 9706, May 16, 1972, as amended at 55 FR 7294, Mar. 1, 1990; 55 FR 
26422, June 28, 1990; 58 FR 38049, July 15, 1993; 59 FR 40215, Aug. 8, 
1994; 63 FR 11360, Mar. 9, 1998]



Sec. 381.119  Declaration of artificial flavoring or coloring.

    (a) When an artificial smoke flavoring or a smoke flavoring is added 
as an ingredient in the formula of any poultry product, there shall 
appear on the label, in prominent letters and contiguous to the name of 
the product, a

[[Page 479]]

statement such as ``Artificial Smoke Flavoring Added'' or ``Smoke 
Flavoring Added,'' as applicable, and the ingredient statement shall 
identify any artificial smoke flavoring or smoke flavoring added as an 
ingredient in the formula of the poultry product.
    (b) Any poultry product which bears or contains any artificial 
flavoring other than an artificial smoke flavoring or a smoke flavoring, 
or bears or contains any artificial coloring shall bear a statement 
stating that fact on the immediate container or, if there is none, on 
the product.



Sec. 381.120  Antioxidants; chemical preservatives; and other additives.

    When an antioxidant is added to a poultry product, there shall 
appear on the label in prominent letters and contiguous to the name of 
the product, a statement showing the name of the antioxidant and the 
purpose for which it is added, such as ``BHA added to help protect the 
flavor.'' Immediate containers of poultry products packed in, bearing, 
or containing any chemical preservative shall bear a label stating that 
fact and naming the additive and the purpose of its use. Immediate 
containers of poultry products packed in, bearing or containing any 
other chemical additive shall bear a label naming the additive and the 
purpose of its use when required by the Administrator in specific cases. 
When approved proteolytic enzymes as permitted in a regulation 
permitting that use in this subchapter or 9 CFR Chapter III, Subchapter 
E, or in 21 CFR Chapter I, Subchapter A or Subchapter B of this 
subchapter are used in mature poultry muscle tissue, there shall appear 
on the label, in a prominent manner, contiguous to the product name, the 
statement ``Tenderized with [approved enzyme],'' to indicate the use of 
such enzymes. Any other approved substance which may be used in the 
solution shall also be included in the statement. When approved 
inorganic chlorides as permitted in a regulation permitting that use in 
this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter 
I, Subchapter A or Subchapter B of this subchapter are used in mature 
poultry muscle tissue, there shall appear on the label, in a prominent 
manner, contiguous to the product name, the statement, ``Tenderized with 
(name of approved inorganic chloride(s))'' to indicate the use of such 
inorganic chlorides. Any other approved substance which may be used in 
the solution shall also be included in the statement.

[37 FR 9706, May 16, 1972, as amended at 45 FR 58820, Sept. 5, 1980; 49 
FR 18999, May 4, 1984; 64 FR 72175, Dec. 23, 1999]



Sec. 381.121  Quantity of contents.

    (a) The label shall bear a statement of the quantity of contents in 
terms of weight or measures as provided in paragraph (c)(5) of this 
section. However, the Administrator may approve the use of labels for 
certain types of consumer packages which do not bear a statement of the 
net weight that would otherwise be required under this subparagraph: 
Provided, That the shipping container bears a statement ``Net weight to 
be marked on consumer packages prior to display and sale'': And provided 
further, That the total net weight of the contents of the shipping 
container is marked on such container: And provided further, That the 
shipping container bears a statement ``Tare weight of consumer package'' 
and in close proximity thereto, the actual tare weight (weight of 
packaging material), weighed to the nearest one-eighth ounce or less, of 
the individual consumer package in the shipping container. The above-
specified statements may be added to approved shipping container labels 
upon approval by the inspector in charge.
    (b) When a poultry product and a nonpoultry product are separately 
wrapped and are placed in a single immediate container bearing the same 
name of both products, the net weight on such immediate container may be 
the total net weight of the products, or such immediate container may 
show the net weights of the poultry product and the nonpoultry product 
separately. Notwithstanding the other provisions of this paragraph, the 
label on consumer size retail packages of stuffed poultry and other 
stuffed poultry products must show the total net weight of the poultry 
product, and in close proximity thereto, a statement specifying

[[Page 480]]

the minimum weight of the poultry in the product.
    (c)(1) The statement of net quantity of contents shall appear 
(except as otherwise permitted under this paragraph (c)), on the 
principal display panel of all containers to be sold at retail intact, 
in conspicuous and easily legible boldface print or type, in distinct 
contrast to other matter on the container, and shall be declared in 
accordance with the provisions of this paragraph (c). An unused tare 
weight, as defined in section 381.121b of this subchapter, may be 
printed adjacent to the statement of net quantity of contents when the 
product is packaged totally with impervious packaging material and is 
packed with a usable medium.
    (2) The statement shall be placed on the principal display panel 
within the bottom 30 percent of the area of the panel, in lines 
generally parallel to the base: Provided, That on packages having a 
principal display panel of 5 square inches or less, the requirement for 
placement within the bottom 30 percent of the area of the label panel 
shall not apply when the statement meets the other requirements of this 
paragraph. The declaration may appear in more than one line.
    (3) The statement shall be in letters and numerals in type size 
established in relationship to the area of the principal display panel 
of the package and shall be uniform for all packages of substantially 
the same size by complying with the following type specifications:
    (i) Not less than one-sixteenth inch in height on containers, the 
principal display panel of which has an area of 5 square inches or less;
    (ii) Not less than one-eighth inch in height on containers, the 
principal display panel of which has an area of more than 5 but not more 
than 25 square inches;
    (iii) Not less than three-sixteenth inch in height on containers, 
the principal display panel of which has an area of more than 25 but not 
more than 100 square inches;
    (iv) Not less than one-quarter inch in height on containers, the 
principal display panel of which has an area of more than 100 but not 
more than 400 square inches;
    (v) Not less than one-half inch in height on containers, the 
principal display panel of which has an area of more than 400 square 
inches.
    (vi) The ratio of height to width of letters and numerals shall not 
exceed a differential of 3 units to 1 unit (no more than 3 times as high 
as it is wide). This height standard pertains to upper case or capital 
letters. When upper and lower case or all lower case letters are used, 
it is the lower case letter ``o'' or its equivalent that shall meet the 
minimum standards. When fractions are used, each component numeral shall 
meet one-half the height standards.
    (4) The statement shall appear as a distinct item on the principal 
display panel and shall be separated, from other label information 
appearing to the left or right of the statement, by a space at least 
equal in width to twice the width of the letter ``N'' of the style of 
type used in the quantity of contents statement and shall be separated 
from other label information appearing above or below the statement by a 
space at least equal in height to the height of the lettering used in 
the statement.
    (5) The terms ``net weight'' or ``net wt.'' shall be used when 
stating the net quantity of contents in terms of weight, and the term 
``net contents'' or ``contents'' when stating the net quantity of 
contents in terms of fluid measure. Except as provided in Sec. 381.128, 
the statement shall be expressed in terms of avoirdupois weight or 
liquid measure. Where no general consumer usage to the contrary exists, 
the statement shall be in terms of liquid measure, if the product is 
liquid, or in terms of weight if the product is solid, semisolid, 
viscous or a mixture of solid and liquid. On packages containing less 
than 1 pound or 1 pint, the statement shall be expressed in ounces or 
fractions of a pint, respectively. On packages containing 1 pound or 1 
pint or more, and less than 4 pounds or 1 gallon, the statement shall be 
expressed as a dual declaration both in ounces and (immediately 
thereafter in parenthesis) in pounds, with any remainder in terms of 
ounces or common or decimal fraction of the pound, or in the case of 
liquid measure, in the largest

[[Page 481]]

whole units with any remainder in terms of fluid ounces or common or 
decimal fraction of the pint or quart. For example, a declaration of 
three-fourths pound avoirdupois weight shall be expressed as ``Net Wt. 
12 oz.''; a declaration of 1\1/2\ pounds avoirdupois weight shall be 
expressed as ``Net Wt. 24 oz. (1 lb. 8 oz.),'' ``Net Wt. 24 oz. (1\1/2\ 
lb.),'' or ``Net Wt. 24 oz. (1.5 lbs.).'' However, on random weight 
packages the statement shall be expressed in terms of pounds and decimal 
fractions of the pound, for packages over 1 pound, and for packages 
which do not exceed 1 pound the statement may be in decimal fractions of 
the pound in lieu of ounces. The numbers may be written in provided the 
unit designation is printed. Paragraphs (c) (8) and (9) of this section 
permit certain exceptions to this paragraph for multi-unit packages, and 
random weight consumer size and small packages (less than \1/2\ ounce), 
respectively.
    (6) The statement as it is shown on a label shall not be false or 
misleading and shall express an accurate statement of the quantity of 
contents of the container. Reasonable variations caused by loss or gain 
of moisture during the course of good distribution practices or by 
unavoidable deviations in good manufacturing practices will be 
recognized. Variations from stated quantity of contents shall be as 
provided in section 381.121b of this subchapter. The statement shall not 
include any term qualifying a unit of weight, measure, or count such as 
``jumbo quart,'' ``full gallon,'' ``giant quart,'' ``when packed,'' 
``minimum,'' or words of similar importance except as provided in 
paragraph (b) of this section.
    (7) Labels for containers which bear any representation as to the 
number of servings contained therein shall bear, contiguous to such 
representation, and in the same size type as is used for such 
representation, a statement of the net quantity of each such serving.
    (8) On a multiunit retail package, a statement of the quantity of 
contents shall appear on the outside of the package and shall include 
the number of individual units, the quantity of each individual unit, 
and, in parentheses, the total quantity of contents of the multiunit 
package in terms of avoirdupois or fluid ounces, except that such 
declaration of total quantity need not be followed by an additional 
parenthetical declaration in terms of the largest whole units and 
subdivisions thereof, as otherwise required by this paragraph (c). ``A 
multiunit retail package'' is a package containing two or more 
individually packaged units of the identical commodity and in the same 
quantity, with the individual packages intended to be sold as part of 
the multiunit retail package but capable of being sold individually. 
Open multiunit retail packages that do not obscure the number of units 
and the labeling thereon are not subject to this paragraph (c) (8) if 
the labeling of each individual unit complies with the requirements of 
this paragraph (c).
    (9) The following exemptions from the requirements contained in this 
section are hereby established:
    (i) Individually wrapped, random weight consumer size packages of 
poultry products (as specified in paragraph (c)(10) of this section) and 
poultry products that are subject to shrinkage through moisture loss 
during good distribution practices and are designated as gray area type 
of products as defined in NBS handbook 133, section 3.18.2, need not 
bear a net weight statement when shipped from an official establishment 
provided a net weight shipping statement which meets the requirements of 
paragraph (c)(6) of this section is applied to the shipping container 
prior to shipping it from the official establishment. Net weight 
statements so applied to the shipping container are exempt from the type 
size, dual declaration, and placement requirements of this paragraph if 
an accurate statement of net weight is shown conspicuously on the 
principal display panel of the shipping container. The net weight also 
shall be applied directly to random weight consumer size packages prior 
to retail display and sale. The net weight statement of random weight 
consumer size packages for retail sale shall be exempt from the type 
size, dual declaration, and placement requirements of this paragraph if 
an accurate statement of net weight is shown conspicuously on the 
principal display panel of the package.

[[Page 482]]

    (ii) Individually wrapped and labeled packages of less than \1/2\ 
ounce net weight and random weight consumer size packages shall be 
exempt from the requirements of this paragraph if they are in a shipping 
container and the statement of net quantity of contents on the shipping 
container meets the requirements of paragraph (c)(6) of this section;
    (iii) Individually wrapped and labeled packages of less than \1/2\ 
ounce net weight bearing labels declaring net weight, price per pound, 
and total price, shall be exempt from the type size, dual declaration, 
and placement requirements of this paragraph if an accurate statement of 
net weight is shown conspicuously on the principal display panel of the 
package.
    (10) As used in this section a ``random weight consumer size 
package'' is one of a lot, shipment or delivery of packages of the same 
product, with varying weights and with no fixed weight pattern.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 53 FR 
28635, July 29, 1988; 55 FR 49835, Nov. 30, 1990]



Sec. 381.121a  Quantity of contents labeling.

    Sections 381.121a through 381.121e of this part prescribe the 
procedures to be followed for determining net weight compliance and 
prescribe the reasonable variations from the declared net weight on the 
labels of immediate containers of products in accordance with Sec. 
381.121 of this part.

[55 FR 49835, Nov. 30, 1990]



Sec. 381.121b  Definitions and procedures for determining net weight 
compliance.

    (a) For the purpose of Sec. 381.121b of this part, the reasonable 
variations allowed, definitions, and procedures to be used in 
determining net weight and net weight compliance are described in the 
National Institute of Standards and Technology (NIST) Handbook 133, 
``Checking the Net Contents of Packaged Goods,'' Third Edition, 
September 1988, and Supplements 1, 2, 3, and 4 dated September 1990, 
October 1991, October 1992, and October 1994, respectively, which are 
incorporated by reference, with the exception of the NIST Handbook 133 
and Supplements 1 and 3 requirements listed in paragraphs (b) and (c) of 
this section. Those provisions, incorporated by reference herein, are 
considered mandatory requirements. This incorporation was approved by 
the Director of the Federal Register in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. (These materials are incorporated as they exist on 
the date of approval.) Copies may be purchased from the Superintendent 
of Documents, U.S. Government Printing Office, Washington, DC 20402. It 
is also available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (b) The following NBS Handbook 133 requirements are not incorporated 
by reference.

                    Chapter 2--General Considerations

2.13.1 Polyethylene Sheeting and Film
2.13.2 Textiles
2.13.3 Mulch

        Chapter 3--Methods of Test for Packages Labeled by Weight

3.11. Aerosol Packages
3.14. Glazed Raw Seafood and Fish
3.15. Canned Coffee
3.16. Borax
3.17. Flour

        Chapter 4--Methods of Test for Packages Labeled by Volume

4.7. Milk
4.8. Mayonnaise and Salad Dressing
4.9. Paint, Varnish, and Lacquers--Nonaerosol
4.11. Peat Moss
4.12. Bark Mulch
4.15. Ice Cream Novelties

Chapter 5--Methods of Test for Packages Labeled by Count, Length, Area, 
                Thickness, or Combinations of Quantities

5.4. Polyethlene Sheeting
5.5. Paper Plates
5.6. Sanitary Paper Products
5.7. Pressed and Blown Glass Tumblers and Stemware

              Appendix D: Package Net Contents Regulations

D.1.1 U.S. Department of Health and Human Servcies, Food and Drug 
Administration

[[Page 483]]

D.1.2 U.S. Department of Agriculture, Food Safety and Inspection Servcie
D.1.3 Federal Trade Commission
D.1.4 Environmental Protection Agency
D.1.5 U.S. Department of the Treasury, Bureau of Alcohol, Tobacco, and 
Firearms

    (c) The following requirements of Supplement 1 dated September 1990, 
Supplement 3 dated October 1992, and Supplement 4 dated October 1994, of 
NIST Handbook 133 are not incorporated by reference.

                              Supplement 1

                    Chapter 2 General Considerations

2.13.1. Polyethylene Sheeting and Film
2.13.2. Textiles
2.13.3. Mulch

        Chapter 3 Methods of Test for Packages Labeled by Weight

3.11.4. Exhausting the Aerosol Container

        Chapter 4 Methods of Test for Packages Labeled by Volume

4.6.4. Method D: Determining the Net Contents of Compressed Gas in 
Cylinders
4.7. Milk
4.16. Fresh Oysters Labeled by Volume

 Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area, 
                Thickness, or Combinations of Quantities

5.4. Polyethylene Sheeting

                              Supplement 3

        Chapter 3 Methods of Test for Packages Labeled by Weight

3.17. Flour and Dry Pet Food

 Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area, 
                Thickness, or Combinations of Quantities

5.4. Polyethylene Sheeting
5.5. Paper Plates
65.8. Baler Twine

                    Appendix A. Forms and Worksheets

                              Supplement 4

3.11 Aerosol Packages
3.11.1 Equipment
3.11.2 Preparation for Test
3.11.3 The Determination of Net Contents: Part 1
3.11.4 Exhausting the Aerosol Container
3.11.5 The Determination of Net Contents: Part 2

[55 FR 49835, Nov. 30, 1990, as amended at 60 FR 12885, Mar. 9, 1995]



Sec. 381.121c  Scale requirements for accurate weights, repairs, 
adjustments, and replacement after inspection.

    (a) All scales used to weight poultry products sold or otherwise 
distributed in commerce in federally inspected poultry plants shall be 
installed, maintained, and operated to insure accurate weights. Such 
scales shall meet the applicable requirements contained in National 
Institute of Standards and Technology (NIST) Handbook 44, 
``Specifications, Tolerances, and Other Technical Requirements for 
Weighing and Measuring Devices'', 1999 Edition, November 1998, which is 
incorporated by reference. This incorporation was approved by the 
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51. (These materials are incorporated as they exist on the 
date of approval.) A notice of any change in the Handbook cited herein 
will be published in the Federal Register. Copies may be purchased from 
the Superintendent of Documents, U.S. Government Printing Office, 
Washington, DC 20402. It is also available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
    (b) All scales used to weigh poultry products sold or otherwise 
distributed in commerce or in State designated under section 5(c) of the 
Poultry Products Inspection Act, shall be of sufficient capacity to 
weigh the entire unit and/or package.
    (c) No scale shall be used at a federally inspected establishment to 
weigh poultry products unless it has been found upon test and inspection 
as specified in NIST Handbook 44 to provide accurate weight. If a scale 
is inspected or tested and found to be inaccurate, or if any repairs, 
adjustments or replacements are made to a scale, it shall not be used 
until it has been reinspected and retested by a USDA official, or a 
State or local government weights and measures official, or a State 
registered or licensed scale repair firm or person, and it must meet all 
accuracy requirements as specified in NIST Handbook

[[Page 484]]

44. If a USDA inspector has put a ``Retain'' tag on a scale it can only 
be removed by a USDA inspector. As long as the tag is on the scale, it 
shall not be used.

[55 FR 49836, Nov. 30, 1990, as amended at 60 FR 12885, Mar. 9, 1995; 64 
FR 53188, Oct. 1, 1999]



Sec. 381.121d  Scales; testing of.

    (a) The operator of each official establishment that weighs poultry 
food products shall cause such scales to be tested for accuracy in 
accordance with the technical requirements of NIST Handbook 44, at least 
once during the calendar year. In cases where the scales are found not 
to maintain accuracy between tests, more fequent tests may be required 
and monitored by an authorized USDA program official.
    (b) The operator of each official establishment shall display on or 
near each scale a valid certification of the scale's accuracy from a 
State or local government's weights and measures authority or from a 
State registered or licensed scale repair firm or person, or shall have 
alternative documented procedures showing that the scale has been tested 
for accuracy in accordance with the requirements of NIST Handbook 44.

[55 FR 49836, Nov. 30, 1990, as amended at 62 FR 45026, Aug. 25, 1997; 
65 FR 34390, May 30, 2000; 66 FR 52486, Oct. 16, 2001]



Sec. 381.121e  Handling of failed product.

    Any lot of product which is found to be out of compliance with net 
weight requirements upon testing in accordance with Sec. 381.121b of 
this subchapter shall be handled as follows:
    (a) A lot tested in an official establishment and found not to 
comply with net weight requirements may be reprocessed and must be 
reweighed and remarked to satisfy the net weight requirements of this 
section, and be reinspected in accordance with the requirements of this 
part.
    (b) A lot tested outside of an official establishment and found not 
to comply with net weight requirements must be reweighed and remarked 
with a proper net weight statement, provided that such reweighing and 
remarking shall not deface, cover, or destroy any other marking or 
labeling required under this subchapter and the net quantity of contents 
is shown with the same prominence as the most conspicuous feature of a 
label.

[55 FR 49836, Nov. 30, 1990]



Sec. 381.122  Identification of manufacturer, packer or distributor.

    The name and address, including zip code, of the manufacturer, 
packer, or distributor shall be shown on the label and if only the name 
and address of the distributor is shown, it shall be qualified by such 
term as ``packed for,'' ``distributed by,'' or ``distributors.'' The 
name and place of business of the manufacturer, packer, or distributor 
may be shown on the principal display panel, on the 20-percent panel of 
the principal display panel reserved for required information, on the 
front riser panel of frozen food cartons, or on the information panel.

[37 FR 9706, May 16, 1972, as amended at 59 FR 40215, Aug. 8, 1994]



Sec. 381.123  Official inspection mark; official establishment number.

    The immediate container of every inspected and passed poultry 
product shall bear:
    (a) The official inspection legend; and
    (b) The official establishment number of the official establishment 
in which the product was processed under inspection and placed as 
follows:
    (1) Within the official inspection legend in the form required by 
subpart M of this part; or
    (2) Outside the official inspection legend elsewhere on the exterior 
of the container or its labeling, e.g., the lid of a can, if shown in a 
prominent and legible manner in a size sufficient to insure easy 
visibility and recognition and accompanied by the prefix ``P''; or
    (3) Off the exterior of the container, e.g., on a metal clip used to 
close casings or bags, or on the back of a paper label of a canned 
product, or on other packaging or labeling in the container, e.g., on 
aluminum pans and trays placed within containers, when a statement of 
its location is printed contiguous to the official inspection legend, 
such as ``Plant No. on Package Closure'' or ``Plant No. on Pan'', if 
shown in a prominent and legible manner in a

[[Page 485]]

size sufficient to ensure easy visibility and recognition; or
    (4) On an insert label placed under a transparent covering if 
clearly visible and legible and accompanied by the prefix ``P''.

[47 FR 29515, July 7, 1982]



Sec. 381.124  Dietary food claims.

    If a product purports to be or is represented for any special 
dietary use by man, its label shall bear a statement concerning its 
vitamin, mineral, and other dietary properties upon which the claim for 
such use is based in whole or in part and shall be in conformity with 
regulations (21 CFR part 125) established pursuant to sections 403 and 
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).



Sec. 381.125  Special handling label requirements.

    (a) Packaged products which require special handling to maintain 
their wholesome condition shall have prominently displayed on the 
principal display panel of the label the statement: ``Keep 
Refrigerated,'' ``Keep Frozen,'' ``Keep Refrigerated or Frozen,'' 
``Perishable--Keep Under Refrigeration,'' or such similar statement as 
the Administrator may approve in specific cases. The immediate 
containers for products that are frozen during distribution and intended 
to be thawed prior to or during display for sale shall bear the 
statement ``Shipped/Stored and Handled Frozen for Your Protection, Keep 
Refrigerated or Freeze.'' For all canned perishable products, the 
statement shall be shown in upper case letters one-fourth inch in height 
for containers having a net weight of 3 pounds or less, and for 
containers having a net weight over 3 pounds, the statement shall be 
shown in letters one-half inch in height.
    (b) Safe handling instructions shall be provided for all poultry 
products not processed in accordance with the provisions of Sec. 
381.150(a) or that have not undergone other processing that would render 
them ready-to-eat, except as exempted under paragraph (b)(4) of this 
section.
    (1) (i) Safe handling instructions shall accompany the poultry 
products, specified in this paragraph (b), destined for household 
consumers, hotels, restaurants, or similar institutions and shall appear 
on the label. The information shall be in lettering no smaller than one-
sixteenth of an inch in size and shall be prominently placed with such 
conspicuousness (as compared with other words, statements, designs or 
devices in the labeling) as to render it likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use.
    (ii) The safe handling information shall be presented on the label 
under the heading ``Safe Handling Instructions'' which shall be set in 
type size larger than the print size of the rationale statement and 
handling statements as discussed in paragraphs (b)(2) and (b)(3) of this 
section. The safe handling information shall be set off by a border and 
shall be one color type printed on a single color contrasting background 
whenever practical.
    (2) (i) The labels of the poultry products, specified in this 
paragraph (b) and prepared from inspected and passed poultry, shall 
include the following rationale statement as part of the safe handling 
instructions, ``This product was prepared from inspected and passed meat 
and/or poultry. Some food products may contain bacteria that could cause 
illness if the product is mishandled or cooked improperly. For your 
protection, follow these safe handling instructions.'' This statement 
shall be placed immediately after the heading and before the safe 
handling statements.
    (ii) The labels of the poultry products, specified in this paragraph 
(b) and prepared pursuant to Sec. 381.10(a) (2), (5), (6), and (7), 
shall include the following rationale statement as part of the safe 
handling instructions, ``Some food products may contain bacteria that 
could cause illness if the product is mishandled or cooked improperly. 
For your protection, follow these safe handling instructions.'' This 
statement shall be placed immediately after the heading and before the 
safe handling statements.
    (3) Poultry products, specified in this paragraph (b), shall bear 
the labeling statements.

[[Page 486]]

    (i) Keep refrigerated or frozen. Thaw in refrigerator or microwave. 
(Any portion of this statement that is in conflict with the product's 
specific handling instructions may be omitted, e.g., instructions to 
cook without thawing.) (A graphic illustration of a refrigerator shall 
be displayed next to the statement.);
    (ii) Keep raw meat and poultry separate from other foods. Wash 
working surfaces (including cutting boards), utensils, and hands after 
touching raw meat or poultry. (A graphic illustration of soapy hands 
under a faucet shall be displayed next to the statement.);
    (iii) Cook thoroughly. (A graphic illustration of a skillet shall be 
displayed next to the statement.); and
    (iv) Keep hot foods hot. Refrigerate leftovers immediately or 
discard. (A graphic illustration of a thermometer shall be displayed 
next to the statement.)
    (4) Poultry products intended for further processing at another 
official establishment are exempt from the requirements prescribed in 
paragraphs (b)(1) through (b)(3) of this section.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR 
14540, Mar. 28, 1994; 64 FR 746, Jan. 6, 1999]



Sec. 381.126  Date of packing and date of processing; contents of cans.

    (a) Either the immediate container or the shipping container of all 
poultry food products shall be plainly and permanently marked by code or 
otherwise with the date of packing. If calendar dating is used, it must 
be accompanied by an explanatory statement, as provided in Sec. 
381.129(c)(2).
    (b) The immediate container for dressed poultry shall be marked with 
a lot number which shall be the number of the day of the year on which 
the poultry was slaughtered or a coded number.
    (c) All canned products shall be plainly and permanently marked, by 
code or otherwise, on the containers, with the identity of the contents 
and date of canning, except that canned products packed in glass 
containers are not required to be marked with the date of canning if 
such information appears on the shipping container. If calendar dating 
is used, it must be accompanied by an explanatory statement, as provided 
in Sec. 381.129(c)(2).
    (d) If any marking is by code, the inspector in charge shall be 
informed as to its meaning.

[37 FR 9706, May 16, 1972, as amended at 39 FR 28516, Aug. 8, 1974; 39 
FR 35784, Oct. 4, 1974]



Sec. 381.127  Wording on labels of shipping containers.

    (a) Each label for use on a shipping container for inspected and 
passed poultry products shall bear, in distinctly legible form, the 
following information:
    (1) The official inspection legend.
    (2) The official establishment number of the official establishment 
in which the poultry product was inspected, either within the official 
inspection mark, or elsewhere on the container clearly visible and in 
proximity to the official inspection mark.



Sec. 381.128  Labels in foreign languages.

    Any label to be affixed to a container of any dressed poultry or 
other poultry product for foreign commerce may be printed in a foreign 
language. However, the official inspection legend and establishment 
number shall appear on the label in English, but in addition, may be 
literally translated into such foreign language. Each such label shall 
be subject to the applicable provisions of Sec. Sec. 381.115 to 
381.141, inclusive. Deviations from the form of labeling required under 
the regulations may be approved by the Administrator in specific cases 
and such modified labeling may be used for poultry products to be 
exported: Provided, (a) That the proposed labeling accords to the 
specifications of the foreign purchaser, (b) that it is not in conflict 
with the Act or the laws of the country to which it is intended for 
export, and (c) that the outside of the shipping container is labeled to 
show that it is intended for export; but if such product is sold or 
offered for sale in domestic commerce, all the requirements of the 
regulations shall apply.

[[Page 487]]



Sec. 381.129  False or misleading labeling or containers.

    (a) No poultry product subject to the Act shall have any false or 
misleading labeling or any container that is so made, formed, or filled 
as to be misleading. However, established trade names and other labeling 
and containers which are not false or misleading and which are approved 
by the Administrator in the regulations or in specific cases are 
permitted.
    (b) No statement, word, picture, design, or device which is false or 
misleading in any particular or conveys any false impression or gives 
any false indication of origin, identity, or quality, shall appear on 
any label. For example:
    (1) Official grade designations such as the letter grades A, B, and 
C may be used in labeling individual carcasses of poultry or containers 
of poultry products only if such articles have been graded by a licensed 
grader of the Federal or Federal-State poultry grading service and found 
to qualify for the indicated grade.
    (2) Terms having geographical significance with reference to a 
particular locality may be used only when the product was produced in 
that locality.
    (3) ``Fresh frozen'', ``quick frozen'', ``frozen fresh'', and terms 
of similar import apply only to ready-to-cook poultry processed in 
accordance with Sec. 381.66(f)(1). Ready-to-cook poultry handled in any 
other manner and dressed poultry may be labeled ``frozen'' only if it is 
frozen in accordance with Sec. 381.66(f)(2) under Department 
supervision and is in fact in a frozen state. ``Individually quick 
frozen (Kind)'' and terms of similar import are applicable only to 
poultry products that are frozen as stated on the label and whose 
component parts can be easily separated at time of packing.
    (4) Poultry products labeled with a term quoted in any paragraph of 
Sec. 381.170(b) shall comply with the specifications in the applicable 
paragraph. However, parts of poultry may be cut in any manner the 
processor desires as long as the labeling appropriately reflects the 
contents of the container of such poultry.
    (5) The terms ``All,'' ``Pure,'' ``100%,'' and terms of similar 
connotation shall not be used on labels for products to identify 
ingredient content, unless the product is prepared solely from a single 
ingredient.
    (6)(i) Raw poultry product whose internal temperature has ever been 
below 26[deg]F may not bear a label declaration of ``fresh.'' Raw 
poultry product bearing a label declaration of ``fresh'' but whose 
internal temperature has ever been below 26[deg]F is mislabeled. The 
``fresh'' designation may be deleted from such product in accordance 
with Sec. 381.133(b)(9)(xxiv). The temperature of individual packages 
of raw poultry product within an official establishment may deviate 
below the 26[deg]F standard by 1[deg] (i.e., have a temperature of 
25[deg]F) and still be labeled ``fresh.'' The temperature of individual 
packages of raw poultry product outside an official establishment may 
deviate below the 26[deg]F standard by 2[deg] (i.e., have a temperature 
of 24[deg]F) and still be labeled ``fresh.'' The average temperature of 
poultry product lots of each specific product type must be 26[deg]F. 
Product described in this paragraph is not subject to the freezing 
procedures required in Sec. 381.66(f)(2) of this subchapter.
    (ii) Raw poultry product whose internal temperature has ever been at 
or below 0[deg]F must be labeled with the descriptive term ``frozen,'' 
except when such labeling duplicates or conflicts with the labeling 
requirements in Sec. 381.125 of this subchapter. The word 
``previously'' may be placed next to the term ``frozen'' on an optional 
basis. The descriptive term must be prominently displayed on the 
principal display panel of the label. If additional labeling containing 
the descriptive term is affixed to the label, it must be prominently 
affixed to the label. The additional labeling must be so conspicuous (as 
compared with other words, statements, designs, or devices in the 
labeling) that it is likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use. Product 
described in this paragraph is subject to the freezing procedures 
required in Sec. 381.66(f)(2) of this subchapter.
    (iii) Raw poultry product whose internal temperature has ever been 
below 26[deg]F, but is above 0[deg]F, is not required

[[Page 488]]

to bear any specific descriptive term. Raw poultry product whose 
internal temperature has ever been below 26[deg]F, but is above 0[deg]F, 
may bear labeling with an optional, descriptive term, provided the 
optional, descriptive term does not cause the raw poultry product to 
become misbranded. If used, an optional, descriptive term must be 
prominently displayed on the principal display panel of the label. If 
additional labeling containing the optional, descriptive term is affixed 
to the label, it must be prominently affixed on the label. The 
additional labeling must be so conspicuous (as compared with other 
words, statements, designs, or devices in the labeling) that it is 
likely to be read and understood by the ordinary individual under 
customary conditions of purchase and use.
    (iv) Handling and relabeling of products. (A) Except as provided 
under paragraph (b)(6)(iii)(C) of this section, when any inspected and 
passed product has become misbranded under this subpart after it has 
been transported from an official establishment, such product may be 
transported in commerce to an official establishment after oral 
permission is obtained from the Area Supervisor of the area in which 
that official establishment is located. The transportation of the 
product may be to the official establishment from which it had been 
transported or to another official establishment designated by the 
person desiring to handle the product. The transportation shall be 
authorized only for the purpose of the relabeling of the product. The 
Area Supervisor shall record the authorization and other information 
necessary to identify the product and shall provide a copy of the record 
to the inspector at the establishment receiving the product. The shipper 
shall be furnished a copy of the authorization record upon request.
    (B) Upon the arrival of the shipment at the official establishment, 
a careful inspection shall be made of the product by the inspector, and 
if it is found that the product is not adulterated, it may be received 
into the establishment; but if the product is found to be adulterated, 
it shall at once be condemned and disposed of in accordance with Sec. 
381.95 of this subchapter. Wholesome product will be relabeled in 
accordance with paragraph (b)(6) (i) or (ii) of this section, as 
appropriate.
    (C) When any inspected and passed product has become misbranded 
under this subpart after it has been transported from an official 
establishment, the owner may transport the product in commerce to a 
retail entity for relabeling in accordance with paragraph (b)(6) (i) or 
(ii) of this section, as appropriate, or to other end users, such as 
hotels, restaurants or similar institutions; or, relabel the product in 
accordance with paragraph (b)(6) (i) or (ii) of this section, as 
appropriate if the product is already at a retail entity. A hotel, 
restaurant or similar institution is not required to relabel product 
misbranded under this subpart; Provided, That the product is prepared in 
meals or as entrees only for sale or service directly to individual 
consumers at such institutions, and that the mark of inspection is 
removed or obliterated. Oral permission shall be obtained from the Area 
Officer-in-Charge of the Compliance Program for the area in which the 
product is located prior to such transportation or relabeling. The Area 
Officer-in-Charge shall record the authorization and other information 
necessary to identify the product, and shall furnish a copy of the 
authorization record upon request. Before being offered for sale at a 
retail entity, such product shall be relabeled.
    (c) A calendar date may be shown on labeling when declared in 
accordance with the provisions of this paragraph:
    (1) The calendar date shall express the month of the year and the 
day of the month for all products and also the year in the case of 
products hermetically sealed in metal or glass containers, dried or 
frozen products, or any other products that the Administrator finds 
should be labeled with the year because the distribution and marketing 
practices with respect to such products may cause a label without a year 
identification to be misleading.
    (2) Immediately adjacent to the calendar date shall be a phrase 
explaining the meaning of such date in terms of ``packing'' date, ``sell 
by'' date, or ``use before'' date, with or without a further qualifying 
phrase, e.g., ``For Maximum Freshness'' or ``For Best Quality'', and

[[Page 489]]

such phrases shall be approved by the Administrator as prescribed in 
Sec. 381.132.
    (d) When sodium alginate, calcium carbonate, lactic acid, and 
calcium lactate are used together in a dry binding matrix in ground and 
formed poultry products, as permitted in Sec. 381.147 of this 
subchapter, there shall appear on the label contiguous to the product 
name, a statement to indicate the use of sodium alginate, calcium 
carbonate, lactic acid, and calcium lactate.
    (e) When transglutaminase enzyme is used to bind pieces of poultry 
to form a cut of poultry, or to reform a piece of poultry from a 
multiple cuts of poultry, there shall appear on the label, as part of 
the product name, a statement that indicates that the product has been 
``formed'' or ``reformed,'' in addition to other preparation steps, 
e.g., ``Formed Turkey Thigh Roast'' or ``Reformed and Shaped Chicken 
Breast.''
    (f) Products identified as ``pizza'' that list a poultry component 
as part of the product name must bear a parenthetical statement 
contiguous to the ingredients statement that conveys the percent of the 
cooked, cured, or dried poultry component in the product. This paragraph 
shall expire on October 30, 2006.

[37 FR 9706, May 16, 1972, as amended at 39 FR 28516, Aug. 8, 1974; 39 
FR 42339, Dec. 5, 1974; 55 FR 5977, Feb. 21, 1990; 60 FR 44412, Aug. 25, 
1995; 61 FR 66200, Dec. 17, 1996; 61 FR 68821, Dec. 30, 1996; 66 FR 
54916, Oct. 31, 2001]

    Effective Date Note: At 68 FR 44870, July 31, 2003, Sec. 381.129 
was amended by adding paragraph (f), effective Oct. 22, 2003, through 
Oct. 24, 2006.



Sec. 381.130  False or misleading labeling or containers; orders to 
withhold from use.

    If the Administrator has reason to believe that any marking or other 
labeling or the size or form of any container in use or proposed for use 
with respect to any article subject to the Act is false or misleading in 
any particular, he may direct that the use of the article be withheld 
unless it is modified in such manner as the Administrator may prescribe 
so that it will not be false or misleading. If the person using or 
proposing to use the labeling or container does not accept the 
determination of the Administrator, he may request a hearing, but the 
use of the labeling or container shall, if the Administrator so directs, 
be withheld pending hearing and final determination by the Secretary in 
accordance with applicable rules of practice. Any such determination 
with respect to the matter by the Secretary shall be conclusive unless, 
within 30 days after the receipt of notice of such final determination, 
the person adversely affected thereby appeals to the U.S. Court of 
Appeals for the Circuit in which he has his principal place of business, 
or to the U.S. Court of Appeals for the District of Columbia Circuit. 
The provisions of section 204 of the Packers and Stockyards Act of 1921, 
as amended, shall be applicable to appeals taken under this section.



Sec. 381.131  Preparation of labeling or other devices bearing official 
inspection marks without advance approval prohibited; exceptions.

    (a) Except for the purposes of preparing and submitting a sample or 
samples of the same to the Administrator for approval, no brand 
manufacturer, printer, or other person shall cast, print, lithograph, or 
otherwise make any marking device containing any official mark or 
simulation thereof, or any label bearing any such mark or simulation, 
without the written authority therefor of the Administrator. However, 
when any such sample label, or other marking device, is approved by the 
Administrator, additional supplies of the approved label, or marking 
device, may be made for use in accordance with the regulations in this 
subchapter, without further approval by the Administrator. The 
provisions of this paragraph do not apply to marking devices containing 
the official inspection legend shown in Figure 5 of Sec. 381.102.
    (b) No brand manufacturer or other person shall cast or otherwise 
make, without an official certificate issued in quadruplicate by a 
Program employee, a marking device containing the official inspection 
legend shown in Figure 5 of Sec. 381.102 or any simulation of that 
legend.

[[Page 490]]

    (1) The certificate is a Food Safety and Inspection Service form for 
signature by a Program employee and the official establishment ordering 
the marking device, bearing a certificate serial number and a letterhead 
and the seal of the United States Department of Agriculture. The 
certificate authorizes the making of only the devices of the type and 
quantity listed on the certificate.
    (2) After signing the certificate, the Program employee and the 
establishment shall each keep a copy, and the remaining two copies shall 
be given to the marking device manufacturer.
    (3) The manufacturer of the marking devices shall engrave or 
otherwise mark each marking device with a permanent identifying serial 
number unique to it. The manufacturer shall list on each of the two 
copies of the certificate given to the manufacturer the number of each 
marking device authorized by the certificate. The manufacturer shall 
retain one copy of the certificate for the manufacturer's records and 
return the remaining copy with the marking devices to the Program 
employee whose name and address are given on the certificate as the 
recipient.
    (4) In order that all such marking devices bear identifying numbers, 
within one year after June 24, 1985, an establishment shall either 
replace each such marking device that does not bear an identifying 
number, or, under the direction of the inspector-in-charge, mark such 
marking device with a permanent identifying number.

(Recordkeeping requirements approved by the Office of Management and 
Budget under control number 0583-0015)

[50 FR 21423, May 24, 1985]



Sec. 381.132  Labeling approval.

    (a) No final labeling shall be used on any product unless the sketch 
labeling of such final labeling has been submitted for approval to the 
Food Labeling Division, Regulatory Programs, Food Safety and Inspection 
Service, and approved by such division, accompanied by FSIS Form, 
Application for Approval of Labels, Marking, and Devices, except for 
generically approved labeling authorized for use in Sec. 381.133(b) 
(2)-(9). The management of the official establishment or establishment 
certified under a foreign inspection system, in accordance with subpart 
T of this part, must maintain a copy of all labeling used, along with 
the product formulation and processing procedure, in accordance with 
subpart Q of this part. Such records shall be made available to any duly 
authorized representative of the Secretary upon request.
    (b) The Food Labeling Division shall permit submission for approval 
of only sketch labeling, as defined in Sec. 381.132(d), for all 
products, except as provided in Sec. 381.133(b) (2)-(9) and except for 
temporary use of final labeling as prescribed in paragraph (f) of this 
section.
    (c) All labeling required to be submitted for approval as set forth 
in Sec. 381.132(b) shall be submitted in duplicate to the Food Labeling 
Division, Regulatory Programs, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250. A parent company for a 
corporation may submit only one labeling application (in duplicate) for 
a product produced in other establishments that are owned by the 
corporation.
    (d) ``Sketch'' labeling is a printer's proof or equivalent which 
clearly shows all labeling features, size, location, and indication of 
final color, as specified in subpart N of this part. FSIS will accept 
sketches that are hand drawn, computer generated or other reasonable 
facsimiles that clearly reflect and project the final version of the 
labeling. Indication of final color may be met by: submission of a color 
sketch, submission of a sketch which indicates by descriptive language 
the final colors, or submission with the sketch of previously approved 
final labeling that indicates the final colors.
    (e) Inserts, tags, liners, pasters, and like devices containing 
printed or graphic matter and for use on, or to be placed within, 
containers and coverings of product shall be submitted for approval in 
the same manner as provided for labeling in Sec. 381.132(a), except 
that such devices which contain no reference to product and bear no 
misleading feature shall be used without submission for approval as 
prescribed in Sec. 381.133(b)(9).

[[Page 491]]

    (f)(1) Consistent with the requirements of this section, temporary 
approval for the use of a final label or other final labeling that may 
otherwise be deemed deficient in some particular may be granted by the 
Food Labeling Division. Temporary approvals may be granted for a period 
not to exceed 180 calendar days under the following conditions:
    (i) The proposed labeling would not misrepresent the product;
    (ii) The use of the labeling would not present any potential health, 
safety, or dietary problems to the consumer;
    (iii) Denial of the request would create undue economic hardship; 
and
    (iv) An unfair competitive advantage would not result from the 
granting of the temporary approval.
    (2) Extensions of temporary approvals may also be granted by the 
Food Labeling Division, provided that the applicant demonstrates that 
new circumstances, meeting the above criteria, have developed since the 
original temporary approval was granted.

[60 FR 67456, Dec. 29, 1995]



Sec. 381.133  Generically approved labeling.

    (a)(1) An official establishment or an establishment certified under 
a foreign inspection system, in accordance with subpart T of this part, 
is authorized to use generically approved labeling, as defined in 
paragraph (b) of this section, without such labeling being submitted for 
approval to the Food Safety and Inspection Service in Washington or the 
field, provided the labeling is in accord with this section and shows 
all mandatory features in a prominent manner as required in subpart N of 
this part, and is not otherwise false or misleading in any particular.
    (2) The Food Safety and Inspection Service shall select samples of 
generically approved labeling from the records maintained by official 
establishments and establishments certified under foreign inspection 
systems, in accordance with subpart T of this part, as required in Sec. 
381.132, to determine compliance with labeling requirements. Any finding 
of false or misleading labeling shall institute the proceedings 
prescribed in Sec. 381.233.
    (b) Generically approved labeling is labeling which complies with 
the following:
    (1) Labeling for a product which has a product standard as specified 
in subpart 381 of this subchapter or the Standards and Labeling Policy 
Book and which does not contain any special claims, such as quality 
claims, nutrient content claims, health claims, negative claims, 
geographical origin claims, or guarantees, or which is not a domestic 
product labeled in a foreign language;
    (2) Labeling for single-ingredient products (such as chicken legs or 
turkey breasts) which does not contain any special claims, such as 
quality claims, nutrient content claims, health claims, negative claims, 
geographical origin claims, or guarantees, or which is not a domestic 
product labeled with a foreign language;
    (3) Labeling for containers of products sold under contract 
specifications to Federal Government agencies, when such product is not 
offered for sale to the general public, provided that the contract 
specifications include specific requirements with respect to labeling, 
and are made available to the inspector-in-charge;
    (4) Labeling for shipping containers which contain fully labeled 
immediate containers, provided such labeling complies with Sec. 
381.127;
    (5) Labeling for products not intended for human food, provided they 
comply with Sec. Sec. 381.152(c) and 381.193, and labeling for poultry 
heads and feet for export for processing as human food if they comply 
with Sec. 381.190(b);
    (6) Poultry inspection legends, which comply with subpart M of this 
part;
    (7) Inserts, tags, liners, pasters, and like devices containing 
printed or graphic matter and for use on, or to be placed within 
containers, and coverings of products, provided such devices contain no 
reference to product and bear no misleading feature;
    (8) Labeling for consumer test products not intended for sale; and
    (9) Labeling which was previously approved by the Food Labeling 
Division as sketch labeling, and the final labeling was prepared without 
modification or with the following modifications:

[[Page 492]]

    (i) All features of the labeling are proportionately enlarged or 
reduced, provided that all minimum size requirements specified in 
applicable regulations are met and the labeling is legible;
    (ii) The substitution of any unit of measurement with its 
abbreviation or the substitution of any abbreviation with its unit of 
measurement, e.g., ``lb.'' for ``pound,'' or ``oz.'' for ``ounce,'' or 
of the word ``pound'' for ``lb.'' or ``ounce'' for ``oz.'';
    (iii) A master or stock label has been approved from which the name 
and address of the distributor are omitted and such name and address are 
applied before being used (in such case, the words ``prepared for'' or 
similar statement must be shown together with the blank space reserved 
for the insertion of the name and address when such labels are offered 
for approval);
    (iv) Wrappers or other covers bearing pictorial designs, emblematic 
designs or illustrations, e.g., floral arrangements, illustrations of 
animals, fireworks, etc. are used with approved labeling (the use of 
such designs will not make necessary the application of labeling not 
otherwise required);
    (v) A change in the language or the arrangement of directions 
pertaining to the opening of containers or the serving of the product;
    (vi) The addition, deletion, or amendment of a dated or undated 
coupon, a cents-off statement, cooking instructions, packer product code 
information, or UPC product code information;
    (vii) Any change in the name or address of the packer, manufacturer 
or distributor that appears in the signature line;
    (viii) Any change in the net weight, provided that the size of the 
net weight statement complies with Sec. 381.121;
    (ix) The addition, deletion, or amendment of recipe suggestions for 
the product;
    (x) Any change in punctuation;
    (xi) Newly assigned or revised establishment numbers for a 
particular establishment for which use of the labeling has been approved 
by the Food Labeling Division, Regulatory Programs;
    (xii) The addition or deletion of open dating information;
    (xiii) A change in the type of packaging material on which the label 
is printed;
    (xiv) Brand name changes, provided that there are no design changes, 
the brand name does not use a term that connotes quality or other 
product characteristics, the brand name has no geographic significance, 
and the brand name does not affect the name of the product;
    (xv) The deletion of the word ``new'' on new product labeling;
    (xvi) The addition, deletion, or amendment of special handling 
statements, provided that the change is consistent with Sec. 
381.125(a);
    (xvii) The addition of safe handling instructions as required by 
Sec. 381.125(b);
    (xviii) Changes reflecting a change in the quantity of an ingredient 
shown in the formula without a change in the order of predominance shown 
on the label, provided that the change in quantity of ingredients 
complies with any minimum or maximum limits for the use of such 
ingredients prescribed in Sec. 381.147 and subpart P of this part;
    (xix) Changes in the color of the labeling, provided that sufficient 
contrast and legibility remain;
    (xx) A change in the product vignette, provided that the change does 
not affect mandatory labeling information or misrepresent the content of 
the package;
    (xxi) The addition, deletion, or substitution of the official USDA 
poultry grade shield; (xxii) A change in the establishment number by a 
corporation or parent company for an establishment under its ownership;
    (xxiii) Changes in nutrition labeling that only involve quantitative 
adjustments to the nutrition labeling information, except for services 
sizes, provided the nutrition labeling information maintains its 
accuracy and consistency;
    (xxiv) Deletion of any claim, and the deletion of non-mandatory 
features or non-mandatory information;
    (xxv) The addition or deletion of a direct translation of the 
English language into a foreign language for products marked ``for 
export only''; and
    (xxvi) The use of the descriptive term ``fresh'' in accordance with 
Sec. 381.129(b)(6)(i) of this subchapter.

[[Page 493]]

    (xxvii) The use of the descriptive Term frozen as required by Sec. 
381.129(b)(6)(ii) of this subchapter.

[60 FR 67457, Dec. 29, 1995, as amended at 61 FR 66201, Dec. 17, 1996]



Sec. 381.134  Requirement of formulas.

    Copies of each label submitted for approval, shall when the 
Administrator requires in any specific case, be accompanied by a 
statement showing, by their common or usual names, the kinds and 
percentages of the ingredients comprising the poultry product and by a 
statement indicating the method or preparation of the product with 
respect to which the label is to be used. Approximate percentages may be 
given in cases where the percentages of ingredients may vary from time 
to time, if the limits of variation are stated.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR 
45196, Sept. 1, 1994. Redesignated at 60 FR 67457, Dec. 29, 1995]



Sec. 381.136  Affixing of official identification.

    (a) No official inspection legend or any abbreviation or other 
simulation thereof may be affixed to or placed on or caused to be 
affixed to or placed on any poultry product or container thereof, except 
by an inspector or under the supervision of an inspector or other person 
authorized by the Administrator, and no container bearing any such 
legend shall be filled except under such supervision.
    (b) No official inspection legend shall be used on any poultry 
product or other article which does not qualify for such mark under the 
regulations.



Sec. 381.137  Evidence of labeling and devices approval.

    No inspector shall authorize the use of any device bearing any 
official inspection legend unless he or she has on file evidence that 
such device has been approved in accordance with the provisions of this 
subpart.

[60 FR 67458, Dec. 29, 1995]



Sec. 381.138  Unauthorized use or disposition of approved labeling or 
devices.

    (a) Labeling and devices approved for use pursuant to Sec. 381.115 
shall be used only for the purpose for which approved, and shall not be 
disposed of from the official establishment for which approved except 
with written approval of the Administrator. Any unauthorized use or 
disposition of approved labeling or devices bearing official inspection 
marks is prohibited and may result in cancellation of the approval.
    (b) Labeling and containers bearing any official inspection marks, 
with or without the official establishment number, may be transported 
from one official establishment to any other official establishment, 
only if such shipments are made with the prior authorization of the 
inspector in charge at point of origin, who will notify the inspector in 
charge at destination concerning the date of shipment, quantity, and 
type of labeling material involved. Approved labeling and containers may 
be moved without restriction under this part between official 
establishments operated by the same person if such labeling and 
containers are approved for use at all such establishments. No such 
material shall be used at the establishment to which it is shipped 
unless such use conforms with the requirements of this subpart.



Sec. 381.139  Removal of official identifications.

    (a) Every person who receives any poultry product in containers 
which bear any official inspection legend shall remove or deface such 
legend or destroy the containers upon removal of such articles from the 
containers.
    (b) No person shall alter, detach, deface, or destroy any official 
identifications prescribed in subpart M that were applied pursuant to 
the regulations, unless he is authorized to do so by an inspector or 
this section; and no person shall fail to use any such official 
identification when required by this part.



Sec. 381.140  Relabeling poultry products.

    When it is claimed by the operator of an official establishment that 
some of its labeled poultry product, which has been transported to a 
location other

[[Page 494]]

than an official establishment, is in need of relabeling because the 
labeling has become mutilated or damaged, or for some other reason needs 
relabeling, the requests for relabeling the poultry product shall be 
sent to the Administrator and accompanied with a statement of the 
reasons therefor and the quantity of labeling required. Labeling 
material intended for relabeling inspected and passed product shall not 
be transported from an official establishment until permission has been 
received from the Administrator. The relabeling of inspected and passed 
product with official labels shall be done under the supervision of an 
inspector pursuant to the regulations in part 362 of this chapter. The 
establishment shall reimburse the Inspection Service for any cost 
involved in supervising the relabeling of such product as provided in 
said regulations.



Sec. Sec. 381.141-381.143  [Reserved]



Sec. 381.144  Packaging materials.

    (a) Edible products may not be packaged in a container which is 
composed in whole or in part of any poisonous or deleterious substances 
which may render the contents adulterated or injurious to health. All 
packaging materials must be safe for the intended use within the meaning 
of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended 
(FFDCA).
    (b) Packaging materials entering the official establishment must be 
accompanied or covered by a guaranty, or statement of assurance, from 
the packaging supplier under whose brand name and firm name the material 
is marketed to the official establishment. The guaranty shall state that 
the material's intended use complies with the FFDCA and all applicable 
food additive regulations. The guaranty must identify the material, 
e.g., by the distinguishing brand name or code designation appearing on 
the packaging material shipping container; must specify the applicable 
conditions of use, including temperature limits and other pertinent 
limits specified under the FFDCA and food additive regulations; and must 
be signed by an authorized official of the supplying firm. The guaranty 
may be limited to a specific shipment of an article, in which case it 
may be part of or attached to the invoice covering such shipment, or it 
may be general and continuing, in which case, in its application to any 
article or other shipment of an article, it shall be considered to have 
been given at the date such article was shipped by the person who gives 
the guaranty. Guaranties consistent with the Food and Drug 
Administration's regulations regarding such guaranties (21 CFR 7.12 and 
7.13) will be acceptable. The management of the establishment must 
maintain a file containing guaranties for all food contact packaging 
materials in the establishment. The file shall be made available to 
Program inspectors or other Department officials upon request. While in 
the official establishment, the identity of all packaging materials must 
be traceable to the applicable guaranty.
    (c) The guaranty by the packaging supplier will be accepted by 
Program inspectors to establish that the use of material complies with 
the FFDCA and all applicable food additive regulations.
    (d) The Department will monitor the use of packaging materials in 
official establishments to assure that the requirements of paragraph (a) 
of this section are met, and may question the basis for any guaranty 
described under paragraph (b) of this section. Official establishments 
and packaging suppliers providing written guaranties to those official 
establishments will be permitted an opportunity to provide information 
to designated Department officials as needed to verify the basis for any 
such guaranty. The required information will include, but is not limited 
to, manufacturing firm's name, trade name or code designation for the 
material, complete chemical composition, and use. Selection of a 
material for review does not in itself affect a material's 
acceptability. Materials may continue to be used during the review 
period. However, if information requested from the supplier is not 
provided within the time indicated in the request--a minimum of 30 
days--any applicable guaranty shall cease to be effective and approval 
to continue using the specified packaging material

[[Page 495]]

in official establishments may be denied. The Administrator may extend 
this time where reasonable grounds for extension are shown, as, for 
example, where data must be obtained from suppliers.
    (e) The Administrator may disapprove for use in official 
establishments packaging materials whose use cannot be confirmed as 
complying with the FFDCA and applicable food additive regulations. 
Before approval to use a packaging material is finally denied by the 
Administrator, the affected official establishment and the supplier of 
the material shall be given notice and the opportunity to present their 
views to the Administrator. If the official establishment and the 
supplier do not accept the Administrator's determination, a hearing in 
accordance with applicable rules of practice will be held to resolve 
such dispute. Approval to use the materials pending the outcome of the 
presentation of views or hearing shall be denied if the Administrator 
determines that such use may present an imminent hazard to public 
health.
    (f) Periodically, the Administrator will issue to inspectors a 
listing, by distinguishing brand name or code designation, of packaging 
materials that have been reviewed and that fail to meet the requirements 
of paragraph (a) of this section. Listed materials will not be permitted 
for use in official establishments. If a subsequent review of any 
material indicates that it meets the requirements of paragraph (a), the 
material will be deleted from the listing.
    (g) Nothing in this section shall affect the authority of Program 
inspectors to refuse a specific material if he/she determines the 
material may render products adulterated or injurious to health.

[49 FR 2236, Jan. 19, 1984]



  Subpart O_Entry of Articles Into Official Establishments; Processing 
       Inspection and Other Reinspections; Processing Requirements



Sec. 381.145  Poultry products and other articles entering or at 
official establishments; examination and other requirements.

    (a) No poultry product (including poultry broth for use in any 
poultry product in any official establishment) may be brought into any 
official establishment unless it has been processed in the United States 
only in an official establishment or imported from a foreign country 
listed in Sec. 381.196(b), and inspected and passed, in accordance with 
the regulations; and unless the container of such product is marked so 
as to identify the product as so inspected and passed, in accordance 
with Sec. 381.115 or Sec. 381.205, except that poultry products 
inspected and passed and identified as such under the laws of an ``at 
least equal'' State or territory listed in Sec. 381.187 may be brought 
into any official establishment solely for storage and distribution 
therefrom without repackaging, relabeling, or processing in such 
establishment. No carcass, part thereof, meat or meat food product of 
cattle, sheep, swine, goats, or equines may be brought into an official 
establishment unless it has been prepared in the United States only in 
an official meat packing establishment, or imported, and inspected and 
passed, in accordance with the Federal Meat Inspection Act, and the 
regulations under such Act (Subchapter A of this chapter) and is 
properly marked as so inspected and passed; or has been inspected and 
passed and is identified as such in accordance with the requirements of 
the law and regulations of a State not designated in Sec. 331.2 of this 
chapter; or is present in the official establishment by reason of an 
exemption allowed in the Federal Meat Inspection Act and the regulations 
under such Act (Subchapter A of this chapter) or the law and regulations 
of a State not so designated. However, such exempted articles may enter 
only under conditions approved by the Administrator in

[[Page 496]]

specific cases, including but not limited to, complete separation of 
inspected poultry products and processing and other operations with 
respect thereto from the exempted articles and operations with respect 
thereto, complete cleanup of facilities and equipment between processing 
of inspected poultry products and the exempted articles and no 
commingling of inspected and exempted articles in receiving, holding or 
storage areas.
    (b) All poultry products and all carcasses, parts thereof, meat and 
meat food products of cattle, sheep, swine, goats, or equines which 
enter any official establishment shall be identified by the operator of 
the official establishment at the time of receipt at the official 
establishment. All poultry products, and all carcasses, parts thereof, 
meat and meat food products of such animals, which are processed or 
otherwise handled at any official establishment shall be subject to 
examination by an inspector at the official establishment in such manner 
and at such times as may be deemed necessary by the inspector in charge 
to assure compliance with the regulations. Upon such examination, if any 
such article or portion thereof is found to be adulterated, such article 
or portion shall, in the case of poultry products, be condemned and 
disposed of as prescribed in Sec. 381.95, unless by reprocessing they 
may be made not adulterated, and shall, in the case of such other 
articles be disposed of according to applicable law.

Such examination may be accomplished through use of statistically sound 
sampling plans that assure a high level of confidence. The inspector in 
charge shall designate the type of plan and the program employee shall 
select the specific plan to be used in accordance with instructions 
issued by the Administrator. \1\
---------------------------------------------------------------------------

    \1\ Further information concerning sampling plans which have been 
adopted for specific products may be obtained from the Circuit 
Supervisor. These sampling plans are developed for individual products 
by the Washington staff and will be distributed for field use as they 
are developed. The type of plan applicable depends on factors such as 
whether the product is in containers, stage of preparation, and 
procedures followed by the establishment operator. The specific plan 
applicable depends on the kind of product involved.
---------------------------------------------------------------------------

    (c) Applying for Total Plant Quality Control. Any owner or operator 
of an official establishment preparing poultry product who has a total 
plant quality control system or plan for controlling such products, 
after ante-mortem and post-mortem inspection, through all stages of 
preparation, may request the Administrator to evaluate it to determine 
whether or not that system is adequate to result in product being in 
compliance with the requirements of the Act and therefore qualify as a 
U.S. Department of Agriculture (USDA) Total Plant Quality Control 
Establishment. Such a request shall, as a minimum, include:
    (1) A letter to the Administrator from the establishment owner or 
operator stating the company's basis and purpose for seeking an approved 
quality control system and willingness to adhere to the requirements of 
the system as approved by the Department; that all the establishment's 
data, analyses, and information generated by its quality control system 
will be maintained to enable the Department to monitor compliance and 
available to Department personnel; that plant quality control personnel 
will have authority to halt production or shipping of product in cases 
where the submitted quality control systems require it; and that the 
owner or operator (or his/her designee) will be available for 
consultation at any time Department personnel consider it necessary.
    (2) In the case of an establishment having one or more full-time 
persons whose primary duties are related to the quality control system, 
an organizational chart showing that such people ultimately report to an 
establishment official whose quality control responsibilities are 
independent of or not predominantly production responsibilities. In the 
case of a small establishment which does not have full-time quality 
control personnel, information indicating the nature of the duties and 
responsibilities of the person who will also be responsible for the 
quality control system.

[[Page 497]]

    (3) A list identifying those subparts and sections of the poultry 
products inspection regulations which are applicable to the operations 
of the establishment applying for approval of a quality control system. 
This list shall also identify which part of the system will serve to 
maintain compliance with the applicable regulations.
    (4) Detailed information concerning the manner in which the system 
will function. Such information should include, but not necessarily be 
limited to, questions of raw material control, the critical check or 
control points, the nature and frequency of tests to be made, the nature 
of charts and other records that will be used, the length of time such 
charts and records will be maintained in the custody of the official 
establishment, the nature of deficiencies the quality control system is 
designed to identify and control, the parameters of limits which will be 
used and the points at which corrective action will occur, and the 
nature of such corrective action--ranging from the least to most severe: 
Provided, That subsequent to approval of the total plant quality control 
system by the Administrator, the official establishment may produce a 
new product for test marketing provided labeling for the product has 
been approved by the Administrator, the inspector in charge has 
determined that the procedures for preparing the product will assure 
that all Federal requirements are met, and the production for test 
marketing does not exceed 6 months. Such new product shall not be 
produced at that establishment after the 6-month period unless approval 
of the quality control system for that product has been received from 
the Administrator.
    (d)-(e) [Reserved]
    (f) Labeling Logo. Owners and operators of official establishments 
having a total plant quality control system approved under the 
provisions of paragraph (c) of this section, may only use, as a part of 
any labeling, the following logo. Any labeling bearing the logo and any 
wording of explanation with respect to this logo shall be approved as 
required by subparts M and N of this part.
[GRAPHIC] [TIFF OMITTED] TC11SE91.043

    (g) Termination of Quality Control Systems. (1) The approval of a 
total plant quality control system may be terminated at any time by the 
owner or operator of the official establishment upon written notice to 
the Administrator.
    (2) The approval of a total plant quality control system or a 
quality control system for irradiation facilities may be terminated upon 
the establishment's receipt of a written notice from the Administrator 
under the following conditions:
    (i) If adulterated or misbranded poultry product is found by the 
Adminstrator to have been prepared for or distributed in commerce by the 
subject establishment. In such case, opportunity will be provided to the 
establishment owner or operator to present views to the Administrator 
within 30 days of the date of terminating the approval. In those 
instances where there is a conflict of facts, a hearing, under 
applicable Rules of Practice, will be afforded to the establishment 
owner or operator, if requested, to resolve the conflict, The 
Administrator's termination of approval shall remain in effect pending 
the final determination of the proceeding.
    (ii) If the establishment fails to comply with the quality control 
system to which it has agreed after being notified by letter from the 
Administrator or his designee. Prior to such termination, opportunity 
will be provided to the establishment owner or operator to present views 
to the Adminstrator

[[Page 498]]

within 30 days of the date of the letter. In those instances where there 
is a conflict of facts, a hearing, under applicable Rules of Practice, 
will be afforded to the establishment owner or operator, if requested, 
to resolve the conflict. The Administrator's termination of quality 
control approval shall remain in effect pending the final determination 
of the proceeding.
    (3) If approval of the total establishment quality control system 
has been terminated in accordance with the provisions of this section, 
an application and request for approval of the same or modified total 
establishment quality control system will not be evaluated by the 
Administrator for at least 6 months from the termination date.
    (4) If approval of a quality control system for irradiation 
facilities, as specified in section 381.149 of this subpart, has been 
terminated in accordance with the provisions of this section, a request 
for approval of the same or a modified quality control system will be 
evaluated by the Administrator upon receipt.
    (h)(1) Operating Schedule Under Total Plant Quality Control. An 
official establishment with an approved total plant quality control 
system may request approval for an operating schedule of up to 12 
consecutive hours per shift. Permissions will be granted provided that:
    (i) The official establishment has satisfactorily operated under a 
total plant quality control system for at least 1 year.
    (ii) All products prepared and packaged, or processed after the end 
of 8 hours of inspection shall only be a continuation of the processing 
monitored by the inspector and being conducted during the last hour of 
inspection.
    (iii) All immediate containers of products prepared and packaged 
shall bear code marks that are unique to any period of production beyond 
the 8 hours of inspection. The form of such code marks will remain 
constant from day to day, and a facsimile of the code marks and their 
meaning shall be provided to the inspector.
    (2) Application. Applications shall be submitted to the Regional 
Director and shall specify how the conditions in Sec. 381.145(h)(1) 
have been or will be met.
    (3) Monitoring by Inspectors. In order to verify that an 
establishment is preparing and shipping product in accordance with the 
approved total plant quality control system and the Act and regulations 
after the 8 hours of inspection, the official establishment may be 
provided overtime inspectiom services at the discretion of the circuit 
supervisor and charged for such services.
    (i) To ensure the safe use of preparations used in poultry scald 
water, the label or labeling on containers of such preparations shall 
bear adequate directions to ensure use in compliance with any 
limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter B 
or 9 CFR Chapter III, Subchapter A or Subchapter E.

(Recordkeeping requirements approved by the Office of Management and 
Budget under control number 0583-0015)

[37 FR 9706, May 16, 1972, as amended at 45 FR 54323, Aug. 15, 1980; 46 
FR 48904, Oct. 5, 1981; 50 FR 6, Jan. 2, 1985; 51 FR 32304, Sept. 11, 
1986; 57 FR 43598, Sept. 21, 1992; 62 FR 45026, Aug. 25, 1997; 62 FR 
54759, Oct. 22, 1997; 64 FR 72175, Dec. 23, 1999; 65 FR 34390, May 30, 
2000]



Sec. 381.146  Sampling at official establishments.

    Inspectors may take, without cost to the Department, such samples as 
are necessary of any poultry product, or other article for use as an 
ingredient of any poultry product, at any official establishment to 
determine whether it complies with the requirements of the regulations.



Sec. 381.148  Processing and handling requirements for frozen poultry 
products.

    Procedures with respect to processing of frozen ready-to-heat-and-
eat poultry products or stuffed ready-to-roast poultry shall be in 
accordance with sound operating practices and carried out in a manner 
which will assure freedom from adulteration of the products. Products to 
be frozen shall be moved into the freezer promptly under such 
supervision by an inspector as is necessary to assure preservation of 
the products by prompt and efficient freezing. Adequate freezing 
facilities shall be provided within the official establishment where 
products to be frozen

[[Page 499]]

are prepared, except that, upon written request, and under such 
conditions as may be prescribed by the Administrator in specific cases, 
such products may be moved from the official establishment prior to 
freezing: Provided, That the official establishment and freezer are so 
located and the necessary arrangements are made so that the Inspection 
Service will have access to the freezing room and adequate opportunity 
to determine that the products are being properly handled and frozen.



Sec. 381.150  Requirements for the production of fully cooked poultry 
products and partially cooked poultry breakfast strips.

    (a) Fully cooked poultry products must be produced using processes 
ensuring that the products meet the following performance standards:
    (1) Lethality. A 7-log10 reduction of Salmonella or an 
alternative lethality that achieves an equivalent probability that no 
viable Salmonella organisms remain in the finished product, as well as 
the reduction of other pathogens and their toxins or toxic metabolites 
necessary to prevent adulteration, must be demonstrated to be achieved 
throughout the product. The lethality process must include a cooking 
step. Controlled intermediate step(s) applied to raw product may form 
part of the basis for the equivalency.
    (2) Stabilization. There can be no multiplication of toxigenic 
microorganisms such as Clostridium botulinum, and no more than a 1 
log10 multiplication of Clostridium perfringens within the 
product.
    (b) Partially cooked poultry breakfast strips must be produced using 
processes ensuring that the products meet the performance standard 
listed in paragraph (a)(2) of this section. Labeling for these products 
must comply with Sec. 381.125. In addition, the statement ``Partially 
Cooked: For Safety, Cook Until Well Done'' must appear on the principal 
display panel in letters no smaller than \1/2\ the size of the largest 
letter in the product name. Detailed cooking instructions shall be 
provided on the immediate container of the products.
    (c) For each product produced using a process other than one 
conducted in accordance with the Hazard Analysis and Critical Control 
Point (HACCP) system requirements in part 417 of this chapter, an 
establishment must develop and have on file, available to FSIS, a 
process schedule, as defined in Sec. 381.1(b). Each process schedule 
must be approved in writing by a process authority for safety and 
efficacy in meeting the performance standards established for the 
product in question. A process authority must have access to an 
establishment in order to evaluate and approve the safety and efficacy 
of each process schedule.
    (d) Under the auspices of a processing authority, an establishment 
must validate new or altered process schedules by scientifically 
supportable means, such as information gleaned from the literature or by 
challenge studies conducted outside the plant.

[64 FR 746, Jan. 6, 1999]



Sec. 381.151  Adulteration of product by polluted water; procedure for 
handling.

    (a) In the event there is polluted water (including but not limited 
to flood water) in an official establishment, all poultry products and 
ingredients for use in the preparation of such products that have been 
rendered adulterated by the water shall be condemned.
    (b) After the polluted water has receded from an official 
establishment, all walls, ceilings, posts, and floors of the rooms and 
compartments involved, including the equipment therein, shall, under the 
supervision of an inspector, be cleaned thoroughly by the official 
establishment personnel. An adequate supply of hot water under pressure 
is essential to make such cleaning effective. After cleaning a solution 
of sodium hypochlorite containing approximately one-half of 1 percent 
available chlorine (5,000 p/m) or other equivalent disinfectant approved 
by the Administrator \1\ shall be applied to the surface of the rooms 
and equipment and rinsed with potable water before use.
---------------------------------------------------------------------------

    \1\ A list of approved disinfectants is available upon request to 
Scientific Services, Meat and Poultry Inspection Program, Food Safety 
and Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250.

---------------------------------------------------------------------------

[[Page 500]]

    (c) Hermetically sealed containers of poultry product which have 
been contaminated by polluted water shall be examined promptly by the 
official establishment under supervision of an inspector and rehandled 
as follows:
    (1) Separate and condemn all poultry products in damaged or 
extensively rusted containers.
    (2) Remove paper labels and wash the remaining containers in warm 
soapy water, using a brush where necessary to remove rust or other 
foreign material. Disinfect these containers by either of the following 
methods:
    (i) Immerse in a solution of sodium hypochlorite containing not less 
than 100 p/m of available chlorine or other equivalent disinfectant 
approved by the Administrator, \1\ rinse in potable water, and dry 
thoroughly; or
    (ii) Immerse in 212 [deg]F. water, bring temperature of the water 
back to 212 [deg]F. and maintain the temperature at 212 [deg]F. for 5 
minutes, then remove containers from water and cool them to 95 [deg]F. 
and dry thoroughly.
    (3) After handling as described in paragraph (c)(2) of this section, 
the containers may be relacquered, if necessary, and then relabeled with 
approved labels applicable to the product therein.
    (4) The identity of the canned poultry product shall be maintained 
throughout all stages of the rehandling operations, to insure correct 
labeling of containers.

[38 FR 34456, Dec. 14, 1973]



Sec. 381.152  Preparation in an official establishment of articles 
not for human food.

    (a) Requirements applicable when prepared in an edible products 
department. When an article (including, but not being limited to, animal 
food) that is not for use as human food is prepared in any room or 
compartment, in an official establishment where poultry products are 
prepared or handled (such room or compartment being herein referred to 
as an ``edible products department''), sufficient space and equipment 
shall be provided to assure that the preparation of the article in no 
way interferes with the preparation or other handling of the poultry 
products. Where necessary, separate equipment shall be provided for the 
preparation of the article. To assure the maintenance of the requisite 
sanitary conditions in the edible products department, the operations 
incident to the preparation of the article shall be subject to the same 
sanitary requirements as apply to the handling of poultry products in 
the edible products department. Preparation of the article shall be 
limited to those hours during which the official establishment operates 
under the supervision of an inspector. The ingredients used in the 
preparation of the article shall, unless otherwise approved by the 
Administrator in specific cases, be such as may be used in the 
preparation of a poultry product. The article may be stored in, and 
distributed from, the edible products department if the article is 
properly identified.
    (b) Requirements applicable when prepared in an inedible products 
department. When an article (including, but not being limited to, animal 
food) that is not for use as human food, is prepared in any part of an 
official establishment other than an edible products department (such 
part of the establishment being herein referred to as the ``inedible 
products department''), the area in which such article is prepared shall 
be distinctly separated from all edible products departments. Poultry 
products and inedible products may be brought from any edible products 
department into any inedible products department, but no poultry product 
or inedible product may be brought from an inedible products department 
into an edible products department except that any such articles as are 
in sealed containers or are handled under conditions prescribed or 
approved by the Administrator in specific cases may be brought into an 
edible products department. Diseased carcasses or diseased parts of any 
carcass shall not be used in the preparation of any animal food unless 
they have been treated in the manner prescribed in Sec. 381.95(a). 
Trucks or containers used for the transportation of poultry products or 
inedible products into an inedible products department shall be cleaned 
before being returned to or brought into an edible products department. 
Sufficient space shall be allotted and adequate equipment and facilities 
provided so that the

[[Page 501]]

preparation of the article does not interfere with the preparation of 
poultry products or the maintenance of the requisite sanitary conditions 
in the official establishment. The preparation of any such article shall 
be subject to supervision by an inspector.
    (c) Containers to be labeled. The immediate container of any such 
article that is prepared in an official establishment shall be 
conspicuously labeled so as to distinguish it from human food. Such 
articles are also subject to the requirements under the Federal Food, 
Drug, and Cosmetic Act.



Sec. 381.153  Accreditation of chemistry laboratories.

    (a) Definitions:
    Accreditation--Determination by FSIS that a laboratory is qualified 
to analyze official samples of product subject to regulations in this 
subchapter and subchapter A of this chapter for the presence and amount 
of all four food chemistry analytes (protein, moisture, fat, and salt); 
or a determination by FSIS that a laboratory is qualified to analyze 
official samples of product subject to regulations in this subchapter 
and subchapter A of this chapter for the presence and amount of one of 
several classes of chemical residue, in accordance with the requirements 
of the Accredited Laboratory Program. Accreditations are granted 
separately for the food chemistry analysis of official samples and for 
the analysis of such samples for any one of the several classes of 
chemical residue. A laboratory may hold more than one accreditation.
    Accredited laboratory--A non-Federal analytical laboratory that has 
met the requirements for accreditation specified in this section and 
hence, at an establishment's discretion, may be used in lieu of an FSIS 
laboratory for analyzing official regulatory samples. Payment for the 
analysis of official samples is to be made by the establishment using 
the accredited laboratory.
    AOAC methods--Methods of chemical analysis, Chapter 39, Association 
of Official Analytical Chemists published in the ``Official Methods of 
Analysis of the Association of Official Analytical Chemists'', 15th 
edition 1990.\1\ The ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 15th edition, 1990, is incorporated 
by reference with the approval of the Director of the Federal Register 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
---------------------------------------------------------------------------

    \1\ A copy of the ``Official Methods of Analysis of the Association 
of Analytical Chemists,'' 15th edition, 1990, is on file with the 
Director, Office of the Federal Register, and may be purchased from the 
Association of Official Analytical Chemists, 2200 Wilson Boulevard, 
Suite 400, Arlington, Virginia 22201. 15th edition, 1990, is 
incorporated by reference with the approval of the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
---------------------------------------------------------------------------

    Chemical residue misidentification--see ``Correct Chemical Residue 
Identification'' definition.
    Coefficient of variation (CV)--The standard deviation of a 
distribution of analytical values multipled by 100, and divided by the 
mean of those values.
    Comparison Mean--The average, for a sample, of all accredited and 
FSIS laboratories' average results, each of which has a large deviation 
measure of zero, except when only two laboratories perform the analysis, 
as in the case of split sample analysis by both an accredited laboratory 
and an FSIS laboratory. In the latter case, the comparison mean is the 
average of the two laboratories' results. For food chemistry, a result 
for a laboratory is the obtained analytical value; for chemical 
residues, a result is the logarithmic transformation of the obtained 
analytical value.
    Correct chemical residue identification--Correct identification by a 
laboratory of a chemical residue whose concentration, in a sample, is 
equal to or greater than the minimum reporting level for that residue, 
as determined by the median of all positive analytical values obtained 
by laboratories analyzing the sample. Failure of a laboratory to report 
the presence of such a chemical residue is considered a 
misidentification. In addition, reporting the presence of a residue at a 
level equal to or above the minimum reporting level that is not reported 
by 90 percent or more of all other laboratories

[[Page 502]]

analyzing the sample, is considered a misidentification.
    CUSUM--A class of statistical procedures for assessing whether or 
not a process is ``in control''. Each CUSUM value is constructed by 
accumulating incremental values obtained from observed results of the 
process, and then determined to either exceed or fall within acceptable 
limits for that process. The initial CUSUM values for each laboratory 
whose application for accreditation is accepted are set at zero. The 
four CUSUM procedures are:
    (1) Positive systematic laboratory difference CUSUM (COSUM-P)--
monitors how consistently an accredited laboratory gets numerically 
greater results than the comparison mean;
    (2) Negative systematic laboratory difference CUSUM (COSUM-N)--
monitors how consistently an accredited laboratory gets numerically 
smaller results than the comparison mean;
    (3) Variability CUSUM (COSUM-V)--monitors the average ``total 
discrepancy'' (i.e., the combination of the random fluctuations and 
systematic differences) between an accredited laboratory's results and 
the comparison mean;
    (4) Individual large discrepancy CUSUM (COSUM-D)--monitors the 
magnitude and frequency of large differences between the results of an 
accredited laboratory and the comparison mean.
    Individual large deviation--An analytical result from a non-Federal 
laboratory that differs from the sample comparison mean by more than 
would be expected assuming normal laboratory variability.
    Initial accreditation check sample--A sample prepared and sent by an 
FSIS laboratory to a non-Federal laboratory to ascertain if the non-
Federal laboratory's analytical capability meets the standards for 
granting accreditation.
    Interlaboratory accreditation maintenance check sample--A sample 
prepared and sent by FSIS to a non-Federal laboratory to assist in 
determining if acceptable levels of analytical capability are being 
maintained by the accredited laboratory.
    Large deviation measure--A measure that quantifies an unacceptably 
large difference between a non-Federal laboratory's analytical result 
and the sample comparison mean.
    Minimum proficiency level--The minimum concentration of a residue at 
which an analytical result will be used to assess a laboratory's 
quantification capability. This concentration is an estimate of the 
smallest concentration for which the average coefficient of variation 
(CV) for reproducibility (i.e., combined within and between laboratory 
variability) does not exceed 20 percent. (See Table 2)
    Minimum reporting level--The number such that if any obtained 
analytical value equals or exceeds this number, then the residue is 
reported together with the obtained analytical value.
    Official Sample--A sample selected by an inspector or inspection 
service employee in accordance with FSIS procedures for regulatory use.
    Probation--The period commencing with official notification to an 
accredited laboratory that its check or split sample results no longer 
satisfy the performance requirements specified in this rule, and ending 
with official notification that accreditation is either fully restored, 
suspended, or revoked.
    QA (quality assurance) recovery--The ratio of a laboratory's 
unadjusted analytical value of a check sample residue to the residue 
level fortified by the FSIS laboratory that prepared the sample, 
multiplied by 100. (See Table 2.)
    QC (quality control) recovery--The ratio of a laboratory's 
unadjusted analytical value of a quality control standard to the 
fortification level of the standard, multiplied by 100. (See Table 2.)
    Refusal of Accreditation--An action taken when a laboratory which is 
applying for accreditation is denied the accreditation.
    Responsibly connected.Any individual who or entity which is a 
partner, officer, director, manager, or owner of 10 per centum or more 
of the voting stock of the applicant or recipient of accreditation or an 
employee in a managerial or executive capacity or any employee who 
conducts or supervises the chemical analysis of FSIS official samples.

[[Page 503]]

    Revocation of Accreditation--An action taken against a laboratory 
which removes its right to analyze official samples.
    Split sample--An official sample divided into duplicate portions, 
one portion to be analyzed by an accredited laboratory (for official 
regulatory purposes) and the other portion by an FSIS laboratory (for 
comparison purposes).
    Standardizing Constant--The number which is the result of a 
mathematical adjustment to the ``standardized value.'' Specifically, the 
number equals the square root of the expected variance of the difference 
between the accredited or applying laboratory's result and the 
comparison mean on a sample, taking into consideration the standardizing 
value, the correlation and number of repeated results by a laboratory on 
a sample, and the number of laboratories that analyzed the sample.
    Standardized Difference--The quotient of the difference between a 
laboratory's result on a sample and the comparison mean of the sample 
divided by the standardizing constant.
    Standardizing Value--A number representing the performance standard 
deviation of an individual result (see Tables 1 and 2 and footnotes to 
the Tables for determining exact procedures for calculation).
    Suspension of Accreditation--Action taken against a laboratory which 
temporarily removes its right to analyze official samples. Suspension of 
accreditation ends when accreditation is either fully restored or 
revoked.
    Systematic laboratory difference--A comparison of one laboratory's 
results with the comparison means on samples that shows, on average, a 
consistent relationship. A laboratory that is reporting, on average, 
numerically greater results than the comparison mean has a positive 
systematic laboratory difference and, conversely, numerically smaller 
results indicate a negative systematic laboratory difference.
    Variability--Random fluctuations in a laboratory's processes that 
cause its analytical results to deviate from a true value.
    Variance--The expected average of the squared differences of sample 
results from an expected sample mean.

            Table 1--Standardizing Values for Food Chemistry
                              (By analyte)
------------------------------------------------------------------------
     Moisture          Protein \1\          Fat \2\          Salt \3\
------------------------------------------------------------------------
        0.57               0.060              0.26             0.127
                                            (0.30)
------------------------------------------------------------------------
\1\ To obtain the standardizing value for a sample the appropriate entry
  in this column is multiplied by X0.65 where X is the comparison mean
  of the sample.
\2\ To obtain the standardizing value for a sample, the appropriate
  entry in this column is multiplied by X0.25, where X is the comparison
  mean of the sample. The appropriate entry is equal to the value in
  parentheses when X is equal to or greater than 12.5 percent, otherwise
  it is equal to 0.26.
\3\ To obtain the standardizing value for a sample, when the comparison
  mean of the sample, X, is less than 1.0 percent, the standardizing
  value equals 0.127, otherwise the appropriate entry is multiplied by
  X0.25. When X is equal to or greater than 4.0 percent for dry salami
  and pepperoni products, the standardizing value equals 0.22.


   Table 2--Minimum Proficiency Levels, Percent Expected recoveries (QC and QA), and Standardizing Values for
                                                Chemical Residues
----------------------------------------------------------------------------------------------------------------
                                                                                    Percent
                                                                                    expected      Standardizing
             Class of residues                   Minimum proficiency level        recovery (QC      value \3\
                                                                                    and QA)
----------------------------------------------------------------------------------------------------------------
Chlorinated Hydrocarbons: \1\
    Aldrin................................  0.10 ppm                                     80-110             0.20
    Benzene Hexachloride..................  0.10. ppm                                    80-110             0.20
    Chlordane.............................  0.30 ppm                                     80-110             0.20
    Dieldrin..............................  0.10 ppm                                     80-110             0.20
    DDT...................................  0.15 ppm                                     80-110             0.20
    DDE...................................  0.10 ppm                                     80-110             0.20
    TDE...................................  0.15 ppm                                     80-110             0.20
    Endrin................................  0.10 ppm                                     80-110             0.20
    Heptachlor............................  0.10 ppm                                     80-110             0.20
    Heptachlor Epoxide....................  0.10 ppm                                     80-110             0.20
    Lindane...............................  0.10 ppm                                     80-110             0.20
    Methoxychlor..........................  0.50 ppm                                     80-110             0.20
    Toxaphene.............................  1.00 ppm                                     80-110             0.20
    Hexachlorobenzene.....................  0.10 ppm                                     80-110             0.20
    Mirex.................................  0.10 ppm                                     80-110             0.20
    Nonachlor.............................  0.15 ppm                                     80-110             0.20
Polychlorinated Biphenyls.................  0.50 ppm                                     80-110             0.20

[[Page 504]]

 
Arsenic \2\...............................  0.20 ppm                                     90-105             0.25
Sulfonamides \2\..........................  0.08 ppm                                     70-120             0.25
Volatile Nitrosamine \2\..................  5 ppb                                        70-110             0.25
----------------------------------------------------------------------------------------------------------------
\1\ Laboratory statistics are computed over all results (excluding PCB results), and for specific chemical
  residues.
\2\ Laboratory statistics are only computed for specific chemical residues.
\3\ The standardizing value of all initial accreditation and probationary check samples computations is 0.15.

    (b) Laboratories accredited for analysis of protein, moisture, fat, 
and salt content of poultry and poultry products--(1) Applying for 
accreditation. Application for accreditation shall be made on designated 
forms provided by FSIS, or otherwise in writing, by the owner or manager 
of a non-Federal analytical laboratory and sent to the Accredited 
Laboratory Program, Food Safety and Inspection Service, U.S. Department 
of Agriculture, Washington DC, 20250-3700, and shall specify the kinds 
of accreditation that are wanted by the owner or manager of the 
laboratory. A laboratory whose accreditation has been refused or revoked 
may reapply for accreditation after 60 days from the effective date of 
that action, and must provide written documentation specifying what 
corrections were made.
    (i) At the time that an Application for Accreditation is filed with 
the Accredited Laboratory Program, FSIS, and annually thereafter upon 
receipt of the bill issued by FSIS on the anniversary date of each 
accreditation, the management of a laboratory shall reimburse the 
program at the rate specified in 9 CFR 391.5 for the cost of each 
accreditation that is sought by the laboratory or that the laboratory 
holds.
    (ii) Simultaneously with the initial application for accreditation, 
the management of a laboratory shall forward a check, bank draft, or 
money order in the amount specified in 9 CFR 391.5 made payable to the 
U.S. Department of Agriculture along with the completed application for 
the accreditation(s) sought for the laboratory. Accreditation will not 
be granted or continued, without further procedure, for failure to pay 
the accreditation fee(s). The fee(s) paid shall be nonrefundable and 
shall be credited to the account from which the expenses of the 
laboratory accreditation program are paid.
    (iii) Annually on the anniversary date of each accreditation, FSIS 
will issue a bill in the amount specified in 9 CFR 391.5.
    (iv) Bills are payable upon receipt by check, bank draft, or money 
order made payable to the U.S. Department of Agriculture and become 
delinquent 30 days from the date of the bill. Accreditation will be 
terminated without further procedure for having a delinquent account. 
The fee(s) paid shall be nonrefundable and shall be credited to the 
account from which the expenses of the Accredited Laboratory Program are 
paid.
    (v) The accreditation of a laboratory that was accredited by FSIS on 
or before December 13, 1993 and was not on probation and whose 
accreditation on that date was not in suspension or revocation shall be 
continued, provided that such laboratory reapply for accreditation in 
accordance with the provisions of this paragraph (b)(1) by January 13, 
1994 (30 days of the effective date of this section), and that the 
reapplication be accepted by the Agency. The CUSUM values for such 
laboratory will be reset at zero upon acceptance of its reapplication. 
The accreditation of a laboratory that is on probation shall be 
continued, provided that the laboratory reapply for accreditation by 
February 11, 1994 (60 days of the effective date of this section), that 
the reapplication be accepted by the Agency, and that the laboratory 
satisfy the terms of the probation.
    (2) Criteria for obtaining accreditation. Non-Federal analytical 
laboratories may be accredited for the analyses of moisture, protein, 
fat, and salt content

[[Page 505]]

of poultry and poultry products. Accreditation will be given only if the 
applying laboratory successfully satisfies the requirements presented 
below, for all four analytes. This accreditation authorizes official 
FSIS acceptance of the analytical test results provided by these 
laboratories on official samples. To obtain FSIS accreditation for 
moisture, protein, fat, and salt analyses, a non-Federal analytical 
laboratory must:
    (i) Be supervised by a person holding, as a minimum, a bachelor's 
degree in either chemistry, food science, food technology, or a related 
field and having 1 year's experience in food chemistry, or equivalent 
qualifications, as determined by the Administrator.
    (ii) Demonstrate acceptable levels of systematic laboratory 
difference, variability, and individual large deviations in the analyses 
of moisture, protein, fat, and salt content using AOAC methods. An 
applying laboratory will successfully demonstrate these capabilities if 
its moisture, protein, fat, and salt results from a 36 check sample 
accreditation study each satisfy the criteria presented below.\2\ If the 
laboratory's analysis of an analyte (or analytes) from the first set of 
36 check samples does not meet the criteria for obtaining accreditation, 
a second set of 36 check samples will be provided within 30 days 
following the date of receipt by FSIS of a request from the applying 
laboratory. The second set of samples shall be analyzed for only the 
analyte(s) for which unacceptable initial results had been obtained by 
the laboratory. If the results of the second set of samples do not meet 
the accreditation criteria, the laboratory may reapply after a 60-day 
waiting period, commencing from the date of refusal of accreditation by 
FSIS. At that time, a new application, all fees, and all documentation 
of corrective action required for accreditation must be submitted.
---------------------------------------------------------------------------

    \2\ All statistical computations are rounded to the nearest tenth, 
except where otherwise noted.
---------------------------------------------------------------------------

    (A) Systematic laboratory difference: The absolute value of the 
average standardized difference must not exceed 0.73 minus the product 
of 0.17 and the standard deviation of the standardized differences.
    (B) Variability: The estimated standard deviation of the 
standardized differences must not exceed 1.15.
    (C) Individual large deviations: One hundred times the average of 
the large deviation measures of the individual samples must be less than 
5.0.\3\
---------------------------------------------------------------------------

    \3\ A result will have a large deviation measure equal to zero when 
the absolute value of the result's standardized difference, (d), is less 
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------

    (iii) Allow inspection of the laboratory by FSIS officials prior to 
the determination of granting accredited status.
    (iv) Pay the accreditation fee by the date required.
    (3) Criteria for maintaining accreditation. To maintain 
accreditation for moisture, protein, fat, and salt analyses, a non-
Federal analytical laboratory must:
    (i) Report analytical results of the moisture, protein, fat, and 
salt content of official samples, weekly, on designated forms to the 
FSIS Eastern Laboratory, College Station Road, P.O. Box 6085, Athens, GA 
30604, or to the address designated by the Assistant Administrator, 
Office of Public Health and Science.
    (ii) Maintain laboratory quality control records for the most recent 
3 years that samples have been analyzed under this Program.
    (iii) Maintain complete records of the receipt, analysis, and 
disposition of official samples for the most recent 3 years that samples 
have been analyzed under this Program.
    (iv) Maintain a standards book, which is a permanently bound book 
with sequentially numbered pages, containing all readings and 
calculations for standardization of solutions, determination of 
recoveries, and calibration of instruments. All entries are to be dated 
and signed by the analyst immediately upon completion of the entry and 
by his/her supervisor within 2 working days. The standards book is to be 
retained for a period of 3 years after the last entry is made.
    (v) Analyze interlaboratory accreditation maintenance check samples 
and return the results to FSIS within 3

[[Page 506]]

weeks of sample receipt. This must be done whenever requested by FSIS 
and at no cost to FSIS.
    (vi) Inform the Accredited Laboratory Program, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250-3700, by certified or registered mail, within 30 days of any 
change in the laboratory's ownership, officers, directors, supervisory 
personnel, or other responsibly connected individual or entity.
    (vii) Permit any duly authorized representative of the Secretary to 
perform both announced and unannounced on-site laboratory reviews of 
facilities and records during normal business hours, and to copy any 
records pertaining to the laboratory's participation in the Accredited 
Laboratory Program.
    (viii) Use official AOAC methods \4\ on official and check samples. 
The ``Official Methods of Analysis of the Association of Official 
Analytical Chemists,'' 15th edition, 1990, is incorporated by reference 
with the approval of the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51.
---------------------------------------------------------------------------

    \4\ A copy of the ``Official Methods of Analysis of the Association 
of Analytical Chemists,'' 15th edition, 1990, is on file with the 
Director, Office of the Federal Register, and may be purchased from the 
Association of Analytical Chemists, Inc., 2200 Wilson Boulevard, Suite 
400, Arlington, Virginia 22201.
---------------------------------------------------------------------------

    (ix) Demonstrate that acceptable limits of systematic laboratory 
difference, variability, and individual large deviations are being 
maintained in the analyses of moisture, protein, fat, and salt content. 
An accredited laboratory will successfully demonstrate the maintenance 
of these capabilities if its moisture, protein, fat, and salt results 
from interlaboratory accreditation maintenance check samples and/or 
split samples satisfy the criteria presented in this paragraph 
(b)(3)(ix).\5\
---------------------------------------------------------------------------

    \5\ All statistical computations are rounded to the nearest tenth, 
except where otherwise noted.
---------------------------------------------------------------------------

    (A) Systematic laboratory difference--(1) Positive systematic 
laboratory difference: The standardized difference between the 
accredited laboratory's result and that of the FSIS laboratory for each 
split or interlaboratory accreditation maintenance check sample is used 
to determine a CUSUM value, designated as COSUM-P. This value is 
computed and evaluated as follows:
    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 2.4,
-2.0, if the standardized difference is less than -1.6,

 or

the standardized difference minus 0.4, if the standardized difference 
lies between -1.6 and 2.4, inclusive.

    (ii) Compute the new COSUM-P value. The new COSUM-P value is 
obtained by adding, algebraically, the CUSUM increment to the last 
previously computed COSUM-P value. If this computation yields a value 
smaller than 0, the new COSUM-P value is set equal to 0. [COSUM-P values 
are initialized at zero; that is, the CUSUM-P value associated with the 
first sample is set equal to the CUSUM increment for that sample.]
    (iii) Evaluate the new COSUM-P value. The new COSUM-P value must not 
exceed 5.2.
    (2) Negative systematic laboratory difference: The standardized 
difference between the accredited laboratory's result and that of the 
FSIS laboratory for each split or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-N. This value is computed and evaluated as follows:
    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 1.6,
-2.0, if the standardized difference is less than -2.4,

 or

the standardized difference plus 0.4, if the standardized difference 
lies between -2.4 and 1.6, inclusive.

    (ii) Compute the new COSUM-N value. The new COSUM-N value is 
obtained by subtracting, algebraically, the CUSUM increment to the last 
previously computed COSUM-N value. If this computation yields a value 
smaller than 0, the new COSUM-N value is set equal to 0. [COSUM-N values 
are

[[Page 507]]

initialized at zero; that is, the COSUM-N value associated with the 
first sample is set equal to the CUSUM increment for that sample.]
    (iii) Evaluate the new COSUM-N value. The new COSUM-N value must not 
exceed 5.2.
    (B) Variability: The absolute value of the standardized difference 
between the accredited laboratory's result and that of the FSIS 
laboratory for each split sample or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-V. This value is computed and evaluated as follows:
    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the larger of -0.4 and the absolute value of 
the standardized difference minus 0.9. If this computation yields a 
value larger than 1.6, the increment is set equal to 1.6.
    (2) Compute the new COSUM-V value. The new COSUM-V value is obtained 
by adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-V value. If this computation yields a value less than 0, 
the new COSUM-V value is set equal to 0. [COSUM-V values are initialized 
at zero; that is, the COSUM-V value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-V value. The new COSUM-V value must not 
exceed 4.3.
    (C) Large deviations: The large deviation measure of the accredited 
laboratory's result for each split sample or interlaboratory 
accreditation maintenance check sample is used to determine a CUSUM 
value, designated as COSUM-D.\6\ This value is computed and evaluated as 
follows:
---------------------------------------------------------------------------

    \6\ See footnote 3.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the value of the large deviation measure minus 
0.025.
    (2) Compute the new COSUM-D value. The new COSUM-D value is obtained 
by adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-D value. If this computation yields a value less than 0, 
the new COSUM-D value is set equal to 0. [COSUM-D values are initialized 
at zero; that is, the COSUM-D value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-D value. The new COSUM-D value must not 
exceed 1.0.
    (x) Meet the following requirements if placed on probation pursuant 
to paragraph (e) of this section:
    (A) Send all official samples that have not been analyzed as of the 
date of written notification of probation to a specified FSIS laboratory 
by certified mail or private carrier or, as an alternative, to an 
accredited laboratory approved for food chemistry. Mailing expenses will 
be paid by FSIS.
    (B) Analyze a set of check samples similar to those used for initial 
accreditation, and submit the analytical results to FSIS within 3 weeks 
of receipt of the samples.
    (C) Satisfy criteria for check samples specified in paragraphs 
(b)(2)(ii) (A), (B), and (C) of this section.
    (xi) Expeditiously report analytical results of official samples to 
the FSIS Eastern Laboratory, College Station Road, P.O. Box 6085, 
Athens, GA 30604, or to the address designated by the Assistant 
Administrator, Office of Public Health and Science. The Federal 
inspector at any establishment may assign the analysis of official 
samples of an FSIS laboratory if, in the inspector's judgment, there are 
delays in receiving test results on official samples from an accredited 
laboratory.
    (xii) Pay the required accreditation fee when it is due.
    (c) Laboratories accredited for analysis of a class of chemical 
residues in poultry and poultry products--(1) Applying for 
accreditation. Application for accreditation shall be made on designated 
forms provided by FSIS, or otherwise in writing, by the owner or manager 
of the non-Federal analytical laboratory and sent to the Accredited 
Laboratory Program, Food Safety and Inspection Service, U.S. Department 
of Agriculture, Washington, DC 20250-3700, and shall specify the kinds 
of accreditation that are wanted by the owner or manager of the 
laboratory. A laboratory whose accreditation has been refused

[[Page 508]]

or revoked may reapply for accreditation after 60 days from the 
effective date of that action, and must provide written documentation 
specifying what corrections were made.
    (i) At the time that an Application for Accreditation is filed with 
the Accredited Laboratory Program, FSIS, and annually thereafter upon 
receipt of the bill issued by FSIS on the anniversary date of each 
accreditation, the management of a laboratory shall reimburse the 
program at the rate specified in 9 CFR 391.5 for the cost of each 
accreditation that is sought by the laboratory or that the laboratory 
holds.
    (ii) Simultaneously with the initial application for accreditation, 
the management of a laboratory shall forward a check, bank draft, or 
money order in the amount specified in 9 CFR 391.5 made payable to the 
U.S. Department of Agriculture along with the completed application for 
the accreditation(s) sought by the laboratory. Accreditation will not be 
granted or continued, without further procedure, for failure to pay the 
accreditation fee(s). The fee(s) paid shall be nonrefundable and shall 
be credited to the account from which the expenses of the laboratory 
accreditation program are paid.
    (iii) Annually on the anniversary date of each accreditation, FSIS 
will issue a bill in the amount specified in 9 CFR 391.5.
    (iv) Bills are payable upon receipt by check, bank draft, or money 
order made payable to the U.S. Department of Agriculture and become 
delinquent 30 days from the date of the bill. Accreditation will be 
terminated without further procedure for having a delinquent account. 
The fee(s) paid shall be nonrefundable and shall be credited to the 
account from which the expenses of the Accredited Laboratory Program are 
paid.
    (v) The accreditation of a laboratory that was accredited by FSIS on 
or before December 13, 1993 and was not on probation and whose 
accreditation on that date was not in suspension or revocation shall be 
continued, provided that such laboratory reapply for accreditation in 
accordance with the provisions of this paragraph (c)(1) by January 12, 
1994 (30 days of the effective date of this section), and that the 
reapplication be accepted by the Agency. The CUSUM values for such 
laboratory will be reset at zero upon acceptance of its reapplication. 
The accreditation of a laboratory that is on probation shall be 
continued, provided that the laboratory reapply for accreditation by 
February 11, 1994 (60 days of the effective date of this section), that 
the reapplication be accepted by the Agency, and that the laboratory 
satisfy the terms of the probation.
    (2) Criteria for obtaining accreditation. Non-Federal analytical 
laboratories may be accredited for the analysis of a class of chemical 
residues in poultry and poultry products. Accreditation will be given 
only if the applying laboratory successfully satisfies the requirements 
presented below. This accreditation authorizes official FSIS acceptance 
of the analytical test results provided by these laboratories on 
official samples. To obtain FSIS accreditation for the analysis of a 
class of chemical residues, a non-Federal analytical laboratory must:
    (i) Be supervised by a person holding, as a minimum, a bachelor's 
degree in either chemistry, food science, food technology, or a related 
field and either the supervisor or the analyst assigned to analyze the 
sample has 3 years' experience determining analytes at or below part per 
million levels, or equivalent qualifications, as determined by the 
Administrator.
    (ii) Demonstrate acceptable limits of systematic laboratory 
difference, variability, individual large deviations, recoveries, and 
proper identification in the analysis of the class of chemical residues 
for which application was made, using FSIS approved procedures. An 
applying laboratory will successfully demonstrate these capabilities if 
its analytical results for each specific chemical residue provided in a 
check sample accreditation study containing a minimum of 14 samples 
satisfy the criteria presented in this paragraph (c)(2)(ii).\7\ In 
addition, if the laboratory is requesting accreditation for the analysis 
of chlorinated hydrocarbons, all analytical results for the residue

[[Page 509]]

class must collectively satisfy the criteria. [Conformance to criteria 
(c)(2)(ii) (A), (B), (C), (D), (E), and (F) of this section will only be 
determined when six or more analytical results with associated 
comparison means at or above the logarithm of the minimum proficiency 
level are available.] If the results of the first set of check samples 
do not meet these criteria for obtaining accreditation, a second set of 
at least 14 samples will be provided within 30 days following the date 
of receipt by FSIS of a request from the applying laboratory. If the 
results of the second set of samples do not meet accreditation criteria, 
the laboratory may reapply after a 60-day waiting period, commencing 
from the date of refusal of accreditation by FSIS. At that time, a new 
application, all fees, and all documentation of corrective action 
required for accreditation must be submitted.
---------------------------------------------------------------------------

    \7\ All statistical computations are rounded to the nearest tenth, 
unless otherwise noted.
---------------------------------------------------------------------------

    (A) Systematic laboratory difference: The absolute value of the 
average standardized difference must not exceed 1.67 (2.00 if there are 
less than 12 analytical results) minus the product of 0.29 and the 
standard deviation of the standardized differences.
    (B) Variability: The standard deviation of the standardized 
differences must not exceed a computed limit. This limit is a function 
of the number of analytical results used in the computation of the 
standard deviation, and of the amount of variability associated with the 
results from the participating FSIS laboratories.
    (C) Individual large deviations: One hundred times the average of 
the large deviation measures of the individual analytical results must 
be less than 5.0.\8\
---------------------------------------------------------------------------

    \8\ A result will have a large deviation measure equal to zero when 
the absolute value of the result's standardized difference, (d), is less 
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------

    (D) QA recovery: The average of the QA recoveries of the individual 
analytical results must lie within the range given in Table 2 under the 
column entitled ``Percent Expected Recovery.''
    (E) QC recovery: All QC recoveries must lie within the range given 
in Table 2 under ``Percent Expected Recovery.'' Supporting documentation 
must be made available to FSIS upon request.
    (F) Correct identification: There must be correct identification of 
all chemical residues in all samples.
    (iii) Allow inspection of the laboratory by FSIS officials prior to 
the determination of granting accredited status.
    (iv) Pay the accreditation fee by the date required.
    (3) Criteria for maintaining accreditation. To maintain 
accreditation for analysis of a class of chemical residues, a non-
Federal analytical laboratory must:
    (i) [Reserved]
    (ii) Maintain laboratory quality control records for the most recent 
3 years that samples have been analyzed under this Program.
    (iii) Maintain complete records of the receipt, analysis, and 
disposition of official samples for the most recent 3 years that samples 
have been analyzed under the Program.
    (iv) Maintain a standards book, which is a permanently bound book 
with sequentially numbered pages, containing all readings and 
calculations for standardization of solutions, determination of 
recoveries, and calibration of instruments. All entries are to be dated 
and signed by the analyst immediately upon completion of the entry and 
by his/her supervisor within 2 working days. The standards book is to be 
retained for a period of 3 years after the last entry is made.
    (v) Analyze interlaboratory accreditation maintenance check samples 
and return the results to FSIS within 3 weeks of sample receipt. This 
must be done whenever requested by FSIS and at no cost to FSIS.
    (vi) Inform the Accredited Laboratory Program, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250-3700, by certified or registered mail, within 30 days when there 
is any change in the laboratory's ownership, officers, directors, 
supervisory personnel, or any other responsibly connected individual or 
entity.
    (vii) Permit any duly authorized representative of the Secretary to 
perform both announced and unannounced on-site laboratory reviews of 
facilities and

[[Page 510]]

records during normal business hours, and to copy any records pertaining 
to the laboratory's participation in the Accredited Laboratory Program.
    (viii) Use analytical procedures designated and approved by FSIS.
    (ix) Demonstrate that acceptable limits of systematic laboratory 
difference, variability, and individual large deviations are being 
maintained in the analysis of samples, in the chemical residue class for 
which accreditation was granted. A laboratory will successfully 
demonstrate the maintenance of these capabilities if its analytical 
results for each specific chemical residue found in interlaboratory 
accreditation maintenance check samples and/or split samples satisfy the 
criteria presented below.\9\ \10\ In addition, if the laboratory is 
accredited for the analysis of chlorinated hydrocarbons, all analytical 
results for the residue class must collectively satisfy the criteria.
---------------------------------------------------------------------------

    \9\ All statistical computations are rounded to the nearest tenth, 
except where otherwise noted.
    \10\ An analytical result will only be used in the statistical 
evaluation of the laboratory if the associated comparison mean is equal 
to or greater than the logarithm of the minimum proficiency level for 
the residue.
---------------------------------------------------------------------------

    (A) Systematic laboratory difference:
    (1) Positive systematic laboratory difference: The standardized 
difference between the accredited laboratory's result and that of the 
FSIS laboratory for each split and/or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-P.\11\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \11\ When determining compliance with this criterion for all 
chlorinated hydrocarbon results in a sample collectively, the following 
statistical procedure must be followed to account for the correlation of 
analytical results within a sample: the average of the standardized 
differences of the analytical results within the sample, divided by a 
constant, is used in place of a single standardized difference to 
determine the COSUM-P (or COSUM-N) value for the sample. The constant is 
a function of the number of analytical results used to compute the 
average standardized difference.
---------------------------------------------------------------------------

    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 2.5,
-2.0, if the standardized difference is less than -1.5,

 or

the standardized difference minus 0.5, if the standardized difference 
lies between -1.5 and 2.5, inclusive.

    (ii) Compute the new COSUM-P value. The new COSUM-P value is 
obtained by adding, algebraically, the CUSUM increment to the last 
previously computed COSUM-P value. If this computation yields a value 
smaller than 0, the new COSUM-P value is set equal to 0. [COSUM-P values 
are initialized at zero; that is, the COSUM-P value associated with the 
first sample is set equal to the CUSUM increment for that sample.]
    (iii) Evaluate the new COSUM-P value. The new COSUM-P value must not 
exceed 4.8.
    (2) Negative systematic laboratory difference: The standardized 
difference between the accredited laboratory's result and that of the 
FSIS laboratory for each split and/or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-N.\12\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \12\ See footnote 11.
---------------------------------------------------------------------------

    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 1.5,
-2.0, if the standardized difference is less than -2.5,

 or

the standardized difference plus 0.5, if the standardized difference 
lies between -2.5 and 1.5, inclusive.

    (ii) Compute the new COSUM-N value. The new COSUM-N value is 
obtained by subtracting, algebraically, the CUSUM increment to the last 
previously computed COSUM-N value. If this computation yields a value 
smaller than 0, the new COSUM-N value is set equal to 0. [COSUM-N values 
are initialized at zero; that is, the COSUM-N value associated with the 
first sample is set equal to the CUSUM increment for that sample.]

[[Page 511]]

    (iii) Evaluate the new COSUM-N value. The new COSUM-N value must not 
exceed 4.8.
    (B) Variability: The absolute value of the standardized difference 
between the accredited laboratory's result and that of the FSIS 
laboratory for each split and/or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-V.\13\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \13\ When determining compliance with this criterion for all 
chlorinated hydrocarbon results in a sample collectively, the following 
statistical procedure must be followed to account for the correlation of 
analytical results within a sample: the square root of the sum of the 
within sample variance and the average standardized difference of the 
sample, divided by a constant, is used in place of the absolute value of 
the standardized difference to determine the COSUM-V value for the 
sample. The constant is a function of the number of analytical results 
used to compute the average standardized difference.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the larger of -0.4 and the absolute value of 
the standardized difference minus 0.9. If this computation yields a 
value larger than 1.6, the increment is set equal to 1.6.
    (2) Compute the new COSUM-V value. The new COSUM-V value is obtained 
by adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-V value. If this computation yields a value less than 0, 
the new COSUM-V value is set equal to 0. [COSUM-V values are initialized 
at zero; that is, the COSUM-V value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-V value. The new COSUM-V value must not 
exceed 4.3.
    (C) Large Deviations: The large deviation measure of the accredited 
laboratory's result for each split and/or interlaboratory accreditation 
maintenance check sample is used to determine a CUSUM value, designated 
as COSUM-D.\14\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \14\ A result will have a large deviation measure equal to zero when 
the absolute value of the result's standardized difference, (d), is less 
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the large deviation measure minus 0.025.
    (2) Compute the new COSUM-D value. The new COSUM-D is obtained by 
adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-D value. If this computation yields a value less than 0, 
the new COSUM-D value is set equal to 0. [COSUM-D values are initialized 
at zero; that is, the COSUM-D value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-D value. The new COSUM-D value must not 
exceed 1.0.
    (x) Meet the following requirements if placed on probation pursuant 
to paragraph (e) of this section:
    (A) Send all official samples that have not been analyzed as of the 
date of written notification of probation to a specified FSIS Science 
Laboratory by certified mail or private carrier or, as an alternative, 
to an accredited laboratory accredited for this specific chemical 
residue. Mailing expenses will be paid by FSIS.
    (B) Analyze a set of check samples similar to those used for initial 
accreditation, and submit analytical results to FSIS within 3 weeks of 
receipt of the samples.
    (C) Satisfy criteria for check samples as specified in paragraphs 
(c)(2)(ii) (A), (B), (C), (D), (E), and (F) of this section.
    (xi) Expeditiously report analytical results of official samples to 
the FSIS Eastern Laboratory, College Station Road, P.O. Box 6085, 
Athens, GA 30604, or to the address designated by the Assistant 
Administrator, Office of Public Health and Science. The Federal 
inspector at any establishment may assign the analysis of official 
samples to an FSIS laboratory if, in the judgment of the inspector, 
there are delays in receiving test results on official samples from an 
accredited laboratory.
    (xii) Every QC recovery associated with reporting of official 
samples must be within the appropriate range given

[[Page 512]]

in Table 2 under ``Percent Expected Recovery.'' Supporting documentation 
must be made available to FSIS upon request.
    (xiii) Demonstrate that acceptable levels of systematic laboratory 
difference, variability, individual large deviations, recoveries, and 
proper identification are being maintained in the analysis of 
interlaboratory accreditation maintenance check samples, in the chemical 
residue class for which accreditation was granted. A laboratory will 
successfully demonstrate the maintenance of these capabilities if its 
analytical results for each specific chemical residue found in 
interlaboratory accreditation maintenance check samples satisfy the 
criteria presented below. In addition, if the laboratory is accredited 
for the analysis of chlorinated hydrocarbons, all analytical results for 
the residue class must collectively satisfy the criteria.
    (A) Systematic laboratory difference--(1) Positive systematic 
laboratory difference: The standardized difference between the 
accredited laboratory's result and the comparison mean for each 
interlaboratory accreditation maintenance check sample is used to 
determine a CUSUM value, designated as COSUM-P.\15\ This value is 
computed and evaluated as follows:
---------------------------------------------------------------------------

    \15\ See footnote 11.
---------------------------------------------------------------------------

    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 2.5,
-2.0, if the standardized difference is less than -1.5,

 or

the standardized difference minus 0.5, if the standardized difference 
lies between -1.5 and 2.5, inclusive.

    (ii) Compute the new COSUM-P value. The new COSUM-P value is 
obtained by adding, algebraically, the CUSUM increment to the last 
previously computed COSUM-P value. If this computation yields a value 
smaller than 0, the new COSUM-P value is set equal to 0. [COSUM-P values 
are initialized at zero; that is, the COSUM-P value associated with the 
first sample is set equal to the CUSUM increment for that sample.]
    (iii) Evaluate the new COSUM-P value. The new COSUM-P value must not 
exceed 4.8.
    (2) Negative systematic laboratory difference: The standardized 
difference between the accredited laboratory's result and the comparison 
mean for each interlaboratory accreditation maintenance check sample is 
used to determine a CUSUM value, designated as COSUM-N.\16\ This value 
is computed and evaluated as follows:
---------------------------------------------------------------------------

    \16\ See footnote 11.
---------------------------------------------------------------------------

    (i) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to:

2.0, if the standardized difference is greater than 1.5,
-2.0, if the standardized difference is less than -2.5,

 or

the standardized difference plus 0.5, if the standardized difference 
lies between -2.5 and 1.5, inclusive.

    (ii) Compute the new COSUM-N value. The new COSUM-N value is 
obtained by subtracting, algebraically, the CUSUM increment to the last 
previously computed COSUM-N value. If this computation yields a value 
smaller than 0, the new COSUM-N value is set equal to 0. [COSUM-N values 
are initialized at zero; that is, the COSUM-N value associated with the 
first sample is set equal to the CUSUM increment for that sample.]
    (iii) Evaluate the new COSUM-N value. The new COSUM-N value must not 
exceed 4.8.
    (B) Variability: The absolute value of the standardized difference 
between the accredited laboratory's result and the comparison mean for 
each interlaboratory accreditation maintenance check sample is used to 
determine a CUSUM value, designated as COSUM-V.\17\ This value is 
computed and evaluated as follows:
---------------------------------------------------------------------------

    \17\ See footnote 13.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the larger of -0.4 or the absolute value of 
the standardized difference minus 0.9. If this computation yields a 
value larger than 1.6, the increment is set equal to 1.6.
    (2) Compute the new COSUM-V value. The new COSUM-V value is obtained 
by

[[Page 513]]

adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-V value. If this computation yields a value less than 0, 
the new COSUM-V value is set equal to 0. [COSUM-V values are initialized 
at zero; that is, the COSUM-V value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-V value. The new COSUM-V value must not 
exceed 4.3.
    (C) Large deviations: The large deviation measure of the accredited 
laboratory's result for each interlaboratory accreditation maintenance 
check sample is used to determine a CUSUM value, designated as COSUM-
D.\18\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

    \18\ A result will have a large deviation measure equal to zero when 
the absolute value of the result's standardized difference, (d), is less 
than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.
---------------------------------------------------------------------------

    (1) Determine the CUSUM increment for the sample. The CUSUM 
increment is set equal to the value of the large deviation measure minus 
0.025.
    (2) Compute the new COSUM-D value The new COSUM-D is obtained by 
adding, algebraically, the CUSUM increment to the last previously 
computed COSUM-D value. If this computation yields a value less than 0, 
the new COSUM-D value is set equal to 0. [COSUM-D values are initialized 
at zero; that is, the COSUM-D value associated with the first sample is 
set equal to the CUSUM increment for that sample.]
    (3) Evaluate the new COSUM-D value. The new COSUM-D value must not 
exceed 1.0.
    (D) Each QC Recovery is within the range given in Table 2 under 
``Percent Expected Recovery''. Supporting documentation must be made 
available to FSIS upon request.
    (E) Not more than 1 residue misidentification in any 2 consecutive 
check samples.
    (F) Not more than 2 residue misidentifications in any 8 consecutive 
check samples.
    (xiv) Pay the accreditation fee when it is due.
    (d) Refusal of accreditation. Upon a determination by the 
Administrator, a laboratory will be refused accreditation for the 
following reasons:
    (1) A laboratory shall be refused accreditation for moisture, 
protein, fat, and salt analysis for failure to meet the requirements of 
paragraph (b)(1) or (b)(2) of this section.
    (2) A laboratory shall be refused accreditation for chemical residue 
analysis for failure to meet the requirements of paragraph (c)(1) or 
(c)(2) of this section.
    (3) A laboratory shall be refused subsequent accreditation for 
failure to return to an FSIS laboratory, by certified mail or private 
carrier, all official samples which have not been analyzed as of the 
notification of a loss of accreditation.
    (4) A laboratory shall be refused accreditation if the applicant or 
any individual or entity responsibly connected with the applicant has 
been convicted of or is under indictment or if charges on an information 
have been brought against the applicant or responsibly connected 
individual or entity in any Federal or State court concerning the 
following violations of law:
    (i) Any felony.
    (ii) Any misdemeanor based upon acquiring, handling, or distributing 
of unwholesome, misbranded, or deceptively packaged food or upon fraud 
in connection with transactions in food.
    (iii) Any misdemeanor based upon a false statement to any 
governmental agency.
    (iv) Any misdemeanor based upon the offering, giving or receiving of 
a bribe or unlawful gratuity.
    (e) Probation of accreditation. Upon a determination by the 
Administrator, a laboratory shall be placed on probation for the 
following reasons:
    (1) If the laboratory fails to complete more than one 
interlaboratory accreditation maintenance check sample analysis within 
12 consecutive months as required by paragraphs (b)(3)(v) and (c)(3)(v) 
of this section, unless written permission is granted by the 
Administrator to exceed the time limit.
    (2) If the laboratory fails to meet any of the criteria set forth in 
paragraphs (b)(3)(v) and (b)(3)(ix) and (c)(3)(v) and (c)(3)(ix) of this 
section.

[[Page 514]]

    (f) Suspension of accreditation. The accreditation of a laboratory 
shall be suspended if the laboratory or any individual or entity 
responsibly connected with the laboratory is indicted or if charges on 
an information have been brought against the laboratory or responsibly 
connected individual or entity in any Federal or State court concerning 
any of the following violations of law:
    (1) Any felony.
    (2) Any misdemeanor based upon acquiring, handling or distributing 
of unwholesome, misbranded, or deceptively packaged food or upon fraud 
in connection with transactions in food.
    (3) Any misdemeanor based upon a false statement to any governmental 
agency.
    (4) Any misdemeanor based upon the offering, giving or receiving of 
a bribe or unlawful gratuity.
    (g) Revocation of accreditation. The accreditation of a laboratory 
shall be revoked for the following reasons:
    (1) An accredited laboratory which is accredited to perform analysis 
under paragraph (b) of this section shall have its accreditation revoked 
for failure to meet any of the requirements of paragraph (b)(3) except 
for the following circumstances. If the accredited laboratory fails to 
meet the criteria for reporting the analytical results on 
interlaboratory accreditation maintenance check samples as set forth in 
paragraph (b)(3)(v) of this section or if, at any time, the CUSUM 
results from the analysis of such interlaboratory accreditation 
maintenance check samples and/or split samples have not satisfied the 
criteria specified in paragraph (b)(3)(ix) of this section and there 
have been, during the previous 12 months, no other occasions on which 
such CUSUM results have not satisfied such criteria, the laboratory 
shall be placed on probation; but if there have been such other 
occasions during those 12 months, the laboratory's accreditation will be 
revoked.
    (2) An accredited laboratory which is accredited to perform analysis 
for a class of chemical residues under paragraph (c) of this section 
shall have the accreditation to perform this analysis revoked if it 
fails to meet any of the requirements in paragraph (c)(3) of this 
section except for the following circumstances. If the accredited 
laboratory fails to meet any of the criteria set forth in paragraphs 
(c)(3)(v), (c)(3)(ix), and (c)(3)(xiii) of this section and it has not 
so failed during the 12 months preceding its failure to meet the 
criteria, it shall be placed on probation, but if it has so failed at 
any time during those 12 months, its accreditation will be revoked.
    (3) An accredited laboratory shall have its accreditation revoked if 
the Administrator determines that the laboratory or any responsibly 
connected individual or any agent or employee has:
    (i) Altered any official sample or analytical finding, or,
    (ii) Substituted any analytical result from any other laboratory for 
its own.
    (4) An accredited laboratory shall have its accreditation revoked if 
the laboratory or any individual or entity responsibly connected with 
the laboratory is convicted in a Federal or State court of any of the 
following violations of law:
    (i) Any felony.
    (ii) Any misdemeanor based upon acquiring, handling, or distributing 
of unwholesome, misbranded, or deceptively packaged food or upon fraud 
in connection with transactions in food.
    (iii) Any misdemeanor based upon a false statement to any 
governmental agency.
    (iv) Any misdemeanor based upon the offering, giving or receiving of 
a bribe or unlawful gratuity.
    (h) Notification and hearings. Accreditation of any laboratory shall 
be refused, suspended, or revoked under the conditions previously 
described herein. The owner or operator of the laboratory shall be sent 
written notice of the refusal, suspension, or revocation of 
accreditation by the Administrator. In such cases, the laboratory owner 
or operator will be provided an opportunity to present, within 30 days 
of the date of the notification, a statement challenging the merits or 
validity of such action and to request an oral hearing with respect to 
the denial, suspension, or revocation decision. An oral hearing shall be 
granted if there is any dispute of material fact joined in such 
responsive statement. The proceeding shall

[[Page 515]]

thereafter be conducted in accordance with the applicable rules of 
practice which shall be adopted for the proceeding. Any such refusal, 
suspension, or revocation shall be effective upon the receipt by the 
laboratory of the notification and shall continue in effect until final 
determination of the matter by the Administrator.

(Reporting and recordkeeping requirements approved by the Office of 
Management and Budget under control number 0583-0015)

[52 FR 2192, Jan. 20, 1987, as amended at 58 FR 65264, 65266-65268, Dec. 
13, 1993; 59 FR 33642, 33643, June 30, 1994; 59 FR 66448, Dec. 27, 1994; 
60 FR 10305, Feb. 24, 1995; 69 FR 255, Jan. 5, 2004]



     Subpart P_Definitions and Standards of Identity or Composition



Sec. 381.155  General.

    (a) Authorization to establish specifications. (1) The Administrator 
is authorized to establish specifications or definitions and standards 
of identity or composition, covering the principal constituents of any 
poultry product with respect to which a specified name of the product or 
other labeling terminology may be used, whenever he determines such 
action is necessary to prevent sale of the product under false or 
misleading labeling. Further, the Administrator is authorized to 
prescribe definitions and standards of identity or composition for 
poultry products whenever he determines such action is otherwise 
necessary for the protection of the public. The requirements of this 
subpart are hereby found to be necessary for these purposes and 
standards are hereby established as set forth in this subpart.
    (2) Where cooked poultry meat is specified in this subpart as an 
ingredient of poultry products, this means poultry meat derived from 
poultry processed, cooked, and cooled in a manner approved by the 
Administrator in specific cases without use of liquid or moisture in 
direct contact with the poultry meat following the cooking and cooling 
of the poultry.
    (3) If, following cooking and cooling of poultry meat to be used in 
poultry products, liquid or moisture is used in direct contact with such 
poultry meat and the percentage of solids, excluding salt, in the 
poultry meat is found to be below 34 percent when such poultry meat is 
tested by acceptable methods, the percentage of poultry meat required by 
this section for any poultry product shall be increased in proportion to 
the deficiency, or the meat shall be so processed as to raise the solids 
content, excluding salt, to 34 percent. The official establishment shall 
furnish adequate facilities for such testing.
    (b) Any binder or antimicrobial agent that has been found to be safe 
and suitable by the Food and Drug Administration and the Food Safety and 
Inspection Service may be used in the production of poultry products 
with standards of identity in this part, where the product standards and 
applicable Federal regulations already permit the use of these types of 
ingredients.

[37 FR 9706, May 16, 1972, as amended at 68 FR 22578, Apr. 29, 2003]



Sec. 381.156  Poultry meat content standards for certain poultry products.

    Poultry products with labeling terminology as set forth in Table I 
shall comply with the specifications for percent light meat and percent 
dark meat set forth in said table.

                                 Table I
------------------------------------------------------------------------
        Label terminology         Percent light meat   Percent dark meat
------------------------------------------------------------------------
Natural proportions.............  50-65.............  50-35.
Light or white meat.............  100...............  0.
Dark meat.......................  0.................  100.
Light and dark meat.............  51-65.............  49-35.
Dark and light meat.............  35-49.............  65-51.
Mostly white meat...............  66 or more........  34 or less.
Mostly dark meat................  34 or less........  66 or more.
------------------------------------------------------------------------


[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]



Sec. 381.157  Canned boned poultry and baby or geriatric food.

    (a) Canned boned poultry shall, unless otherwise specified in this 
section, be prepared from cooked deboned poultry meat and may contain 
skin and fat not in excess of natural whole carcass proportions. 
Gelatin, stabilizers, or similar solidifying or emulsifying agents shall 
not be added to product labeled ``Boned (Kind)--Solid Pack,'' but

[[Page 516]]

may be added in quantities not in excess of a total of 0.5 percent of 
the total ingredients in the preparation of other canned boned poultry 
products and in such cases the common name of the substance shall be 
included in the name of the product, e.g., ``Boned Chicken with Broth--
Gelatin Added.''
    (b) Canned boned poultry, except poultry within paragraph (c) of 
this section, shall meet the requirements set forth in Table II. The 
percentages in Table II shall be calculated on the basis of the total 
ingredients used in the preparation of the product.
    (c) Canned boned poultry with natural juices (Boned (Kind) with 
natural juices) shall be prepared from either raw boned poultry or a 
mixture of raw boned poultry and cooked boned poultry and shall have no 
liquid added during the preparation of the product.
    (d) Canned shredded poultry (Shredded Kind), consists of poultry 
meat reduced to a shredded appearance, from the kind of poultry 
indicated, with meat, skin, and fat not in excess of the natural whole 
carcass proportions. Canned shredded poultry from specific parts may 
include skin or fat in excess of the proportions normally found on a 
whole carcass, but not in excess of the proportions of skin and fat 
normal to the particular part or parts; and such product shall be 
labeled in accordance with Sec. 381.117(d).
    (e) Canned boned poultry shall be prepared as set forth in Table II, 
items 1, 2, 3, or 4, whichever is applicable.

                                Table II
------------------------------------------------------------------------
                                                   Minimum
                                                   percent
                                                   cooked,
                                                   deboned      Maximum
                                                   poultry      percent
                  Product name                     meat of      liquid
                                                     kind      that may
                                                  indicated,   be added
                                                  with skin,      \1\
                                                   fat, and
                                                  seasoning
------------------------------------------------------------------------
1. Boned (Kind)--solid pack....................           95           5
2. Boned (Kind)................................           90          10
3. Boned (Kind) with broth \2\.................           80          20
4. Boned (Kind) (----) percent broth \2, 3\....           50          50
------------------------------------------------------------------------
\1\ Liquid may be in the form of, but is not limited to, broth or
  extractives.
\2\ Alternatively, product may be prepared from raw boned poultry in
  combination with cooked boned poultry so long as the product complies
  with the specified standard.
\3\ Total amount of liquid added shall be included in the name of the
  product; e.g., ``Boned Chicken with 25 percent broth.''

    (f) Poultry products intended for infant or geriatric use and 
represented as having a ``high meat'' content shall contain not less 
than 18.75 percent cooked, deboned poultry meat of the kind indicated, 
with seasoning.

                                Table IIa
------------------------------------------------------------------------
                                                   Minimum
                                                   percent
                                                   cooked,      Maximum
                                                   deboned,     percent
                                                   poultry      liquid
                  Product name                     meat of     that may
                                                     kind      be added
                                                  indicated,      \1\
                                                     with
                                                  seasoning
------------------------------------------------------------------------
1. Strained or chopped (Kind) with broth \2, 3\           43          57
2. High meat dinner \3\........................        18.75
------------------------------------------------------------------------
\1\ Liquid may be in the form of, but not limited to, broth or
  extractives.
\2\ Alternatively, product may be prepared from raw boned poultry meat
  in combination with cooked bone poultry meat so long as the product
  complies with the specified standard.
\3\ Label must indicate in some manner that product is for infant or
  geriatric servings.


[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]



Sec. 381.158  Poultry dinners (frozen) and pies.

    Poultry dinners (frozen) and pies shall meet the requirements set 
forth in Table III of this section and the percentage or weight 
specified therein shall be calculated on the basis of total ingredients 
used in the preparation of the poultry product.

                                Table III
------------------------------------------------------------------------
                                   Minimum cooked    Minimum raw deboned
                                  deboned poultry      poultry meat of
                                    meat of kind        kind indicated
                                     indicated      --------------------
                               ---------------------
                                Percent    Weight    Percent    Weight
------------------------------------------------------------------------
(Kind) Pies...................      14    or 1\1/8\      25     or 2 oz.
                                         oz. per 8-            per 8-oz.
                                            oz. pie              pie.\1\
                                                \1\
(Kind) Dinners................      18   or 2 oz.2,  .......  ..........
                                                  3
------------------------------------------------------------------------
\1\ 14 percent or 1\1/8\ oz., whichever is greater; or 25 percent or 2
  oz., whichever is greater.
\2\ Excluding weight of appetizers, desserts, etc.
\3\ 18 percent or 2 oz., whichever is greater. A minimum of 45 percent,
  or 5 ounces per dinner, whichever is greater, of cooked poultry
  including bone and breading may be used in lieu of minimum 18 percent
  or 2 ounces of cooked deboned poultry meat and the cooked poultry
  including bone and breading shall not contain more than 30 percent
  breading.



Sec. 381.159  Poultry rolls.

    (a) Binders or extenders may be added in accordance with a 
regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or in 
21 CFR Chapter

[[Page 517]]

I, Subchapter A or Subchapter B. In addition to the binders referred to 
in the preceding sentence, the following substances are permitted for 
use as binders in poultry rolls: transglutaminase enzyme at up to 65 
ppm. When binding agents are added in excess of 3 percent for cooked 
rolls and 2 percent for raw rolls, the common name of the agent or the 
term ``Binders Added'' shall be included in the name of the product; 
e.g., ``Turkey Roll-Gelatin Added.''
    (b) With respect to heat processed rolls, 2 percent or less liquid 
based on the weight of the finished product without liquid may remain 
with or be returned to product labeled as ``(Kind) Roll.''
    (c) Heat processed rolls which have more than 2 percent liquid 
remaining with or returned to the product shall be labeled as ``(Kind) 
Roll with Natural Juices.'' If more than 2 percent of any liquid other 
than natural cookout juices is added, the product must be labeled to 
indicate that fact; e.g., ``Turkey Roll with Broth.'' Liquid shall not 
be returned or added to product within this paragraph graph in excess of 
the amount normally cooked out during preparation.

[37 FR 9706, May 16, 1972, as amended at 55 FR 34684, Aug. 24, 1990; 66 
FR 54916, Oct. 31, 2001]



Sec. 381.160  (Kind) burgers; (Kind) patties.

    Such product consists of 100 percent poultry of the kind indicated, 
with skin and fat not in excess of natural proportions. Product 
containing fillers or binders shall be named ``(Kind) Patties.''



Sec. 381.161  ``(Kind) A La Kiev.''

    Such product consists of poultry meat of the kind indicated, stuffed 
with butter which may be seasoned and the product may be wrapped in 
sufficient skin to cover the meat. It may be dipped in batter, fried, 
and frozen.



Sec. 381.162  ``(Kind) steak or fillet.''

    Such product consists of a boneless slice or strip of poultry meat 
of the kind indicated.



Sec. 381.163  ``(Kind) baked'' or ``(Kind) roasted.''

    Such product consists of ready-to-cook poultry of the kind 
indicated, that has been cooked in dry source heat, e.g., oven roasted 
or oven baked.



Sec. 381.164  ``(Kind) barbecued.''

    Such product consists of ready-to-cook poultry of the kind 
indicated, that has been cooked in dry heat and basted with a seasoned 
sauce.



Sec. 381.165  ``(Kind) barbecued prepared with moist heat.''

    Such product consists of ready-to-cook poultry of the kind indicated 
that has been cooked by the action of moist heat in a barbecue sauce.



Sec. 381.166  Breaded products.

    ``Breaded'' is a term applicable to any poultry product which is 
coated with breading or a batter and breading in an amount not to exceed 
30 percent of the weight of the finished breaded product.



Sec. 381.167  Other poultry dishes and specialty items.

    Poultry dishes and specialty items listed in Table IV of this 
paragraph shall meet the requirements set forth in said table, 
irrespective of the type of packaging, and the percentages in Table IV 
shall be calculated on a ready-to-serve basis, except that soup bases in 
institutional packs which are prepared for sale to institutional users 
shall have a minimum of 15 percent cooked deboned poultry meat based on 
the weight of the soup base product.

                                Table IV
------------------------------------------------------------------------
                                                  Minimum      Minimum
                                                  percent      percent
                                                   cooked       cooked
                                                  deboned     poultry of
               Product name \1\                   poultry        kind
                                                  meat of     indicated,
                                                    kind      indicating
                                                 indicated       bone
------------------------------------------------------------------------
(Kind) Ravioli................................            2  ...........
(Kind) Soup...................................            2  ...........
Chop Suey with (Kind).........................            2  ...........
(Kind) Chop Suey..............................            4  ...........
(Kind) Chow Mein without noodles..............            4  ...........
(Kind) Tamales................................            6  ...........
Noodles or Dumplings with (Kind) \2\..........            6  ...........
(Kind) Stew...................................           12  ...........
(Kind) Fricassee of Wings.....................  ...........           40

[[Page 518]]

 
(Kind) Noodles or Dumplings \2\...............           15           30
(Kind) with Vegetables........................           15  ...........
Gravy with sliced (Kind)......................           15  ...........
(Kind) Tetrazzini.............................           15  ...........
(Kind) chili with beans.......................           17  ...........
Creamed (Kind)................................           20  ...........
(Kind) Cacciatore.............................           20           40
(Kind) Fricassee..............................           20           40
(Kind) A-La-King..............................           20  ...........
(Kind) croquettes.............................           25  ...........
Slice (Kind) with Gravy and Dressing..........           25  ...........
(Kind) Salad \3\..............................           25  ...........
(Kind) chili..................................           28  ...........
(Kind) Hash...................................           30  ...........
Sliced (Kind) with Gravy......................           35  ...........
Minced (Kind) Barbecue........................           40  ...........
------------------------------------------------------------------------
\1\ The product name may contain other appropriate descriptive terms
  such as ``noodle''; e.g., ``Chicken Noodle Soup.''
\2\ This standard also applies to products named (Kind) with rice or
  similar starches.
\3\ The 25 percent-standard listed includes poultry meat plus
  proportions of skin and fat natural to the poultry used.


[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]



Sec. 381.168  Maximum percent of skin in certain poultry products.

    The poultry products listed in Table V shall have not more than the 
percent of skin specified in the table, when raw and when cooked.

                                 Table V
------------------------------------------------------------------------
                                                          Percent skin
                     Product name                      -----------------
                                                          Raw     Cooked
------------------------------------------------------------------------
Boneless Turkey Breast
    or
Boneless Turkey Breast Roll...........................       14
Boneless Turkey Thigh
    or
Boneless Turkey Thigh Roll............................        8
Boneless Turkey
    or
Turkey Roll...........................................       15
Boneless Chicken Breast
    or
Boneless Chicken Breast Roll..........................       18       20
Boneless Chicken
    or
Chicken Roll..........................................       20       25
------------------------------------------------------------------------



Sec. 381.169  Ready-to-cook poultry products to which solutions are added.

    (a) Butter alone, or solutions of poultry broth, poultry stock, 
water, or edible fats, or mixtures thereof, in which are included 
functional substances such as spices, flavor enhancers, emulsifiers, 
phosphates, coloring materials, or other substances, approved by the 
Administrator in specific cases, may be introduced by injection into the 
thick muscles (breast and legs) of ready-to-cook poultry carcasses and 
may be introduced by injection or marinating into any separate bone-in 
part therefrom, for the purpose of providing a basting medium or similar 
function. The ingredients of the added materials and the manner of 
addition to the products must be found acceptable by the Administrator, 
in all cases. The introduction of the added materials shall increase the 
weight of the processed product by approximately 3 percent over the 
weight of the raw product after washing and chilling in compliance with 
Sec. 381.66. The weight of the added materials introduced into the 
poultry products as provided in this paragraph shall be included as part 
of the weight of the poultry for purposes of the net weight labeling 
provisions in Sec. 381.121(b).
    (b) A raw poultry product, into which added materials are introduced 
as provided in paragraph (a) of this section must be labeled with a 
conspicuous, legible, and descriptive name, including terms that 
concisely describe the method of addition and function of the added 
material. All major terms in the product name must be printed with the 
same prominence, except that the words which describe the function of 
the added materials (such as ``Injected for Flavored Basting'') may be 
more prominent, provided this does not detract from the conspicuousness 
of the other terms in the product name (such as ``Young Turkey''). The 
label must also bear a statement, in bold type, immediately below and 
adjacent to the product name, listing the common or usual names of the 
added materials in descending order of predominance. The first part of 
this statement must consist of terms adequate to inform consumers about 
the amount and manner of introduction of the solution (such as 
``Injected with approximately 3 percent of a solution of ----------''), 
and must be printed at least one-fourth the size of the most prominent 
letter in the product name, with a minimum size of one-fourth inch for a 
ready-to-cook

[[Page 519]]

turkey and proportionately smaller for other poultry products. The 
remainder of the solution ingredients shall be declared in type at least 
one-eighth inch in height. The entire statement must be printed in a 
color that contrasts with the background and be displayed on the 
principal display panel.
    (c) Approval for use of a label for product under this section 
depends upon the ability of the processor to control the finished 
product, within a range of three-tenths of 1 percent accuracy, so that 
the average percent of basting material in each outgoing lot is not 
greater than 3.3 percent or less than 2.7 percent of basting material 
when tested by an approved plant control procedure would be in 
compliance. As used in this section, ``a lot'' may be any reasonable 
portion of production designated by the operator of the official 
establishment, with a maximum of an entire shift's production from one 
production line. The control procedures to be eligible for approval by 
the Administrator must:
    (1) Assure compliance with all labeling requirements.
    (2) Control the variability of the amount of added approved solution 
within the limits defined above.
    (3) Provide for the disposition in accordance with the regulations 
of all products not in compliance with this section.
    (4) Incorporate a system of raw weight identification of a 
sufficient number of poultry and/or poultry parts to allow effective 
monitoring of the system by Federal inspectors and official 
establishment employees.

[37 FR 9706, May 16, 1972, as amended at 39 FR 36000, Oct. 7, 1974]



Sec. 381.170  Standards for kinds and classes, and for cuts of raw 
poultry.

    (a) The following standards specify the various classes of the 
specified kinds of poultry, and the requirements for each class:
    (1) Chickens--(i) Rock Cornish game hen or Cornish game hen. A Rock 
Cornish game hen or Cornish game hen is a young immature chicken 
(usually 5 to 6 weeks of age) weighing not more than 2 pounds ready-to-
cook weight, which was prepared from a Cornish chicken or the progeny of 
a Cornish chicken crossed with another breed of chicken.
    (ii) Rock Cornish fryer, roaster, or hen. A Rock Cornish fryer, 
roaster, or hen is the progeny of a cross between a purebred Cornish and 
a purebred Rock chicken, without regard to the weight of the carcass 
involved; however, the term ``fryer,'' ``roaster,'' or ``hen'' shall 
apply only if the carcasses are from birds with ages and characteristics 
that qualify them for such designation under paragraph (a)(1) (iii) or 
(iv) of this section.
    (iii) Broiler or fryer. A broiler or fryer is a young chicken 
(usually under 13 weeks of age), of either sex, that is tender-meated 
with soft, pliable, smooth-textured skin and flexible breastbone 
cartilage.
    (iv) Roaster or roasting chicken. A bird of this class is a young 
chicken (usually 3 to 5 months of age), of either sex, that is tender-
meated with soft, pliable, smooth-textured skin and breastbone cartilage 
that may be somewhat less flexible than that of a broiler or fryer.
    (v) Capon. A capon is a surgically unsexed male chicken (usually 
under 8 months of age) that is tender-meated with soft, pliable, smooth-
textured skin.
    (vi) Hen, fowl, or baking or stewing. A bird of this class is a 
mature female chicken (usually more than 10 months of age) with meat 
less tender than that of a roaster, or roasting chicken and nonflexible 
breastbone tip.
    (vii) Cock or rooster. A cock or rooster is a mature male chicken 
with coarse skin, toughened and darkened meat, and hardened breastbone 
tip.
    (2) Turkeys--(i) Fryer-roaster turkey. A fryer-roaster turkey is a 
young immature turkey (usually under 16 weeks of age), of either sex, 
that is tender-meated with soft, pliable, smooth-textured skin, and 
flexible breastbone cartilage.
    (ii) Young turkey. A young turkey is a turkey (usually under 8 
months of age) that is tender-meated with soft, pliable, smooth-textured 
skin, and breastbone cartilage that is somewhat less flexible than in a 
fryer-roaster turkey. Sex designation is optional.
    (iii) Yearling turkey. A yearling turkey is a fully matured turkey 
(usually

[[Page 520]]

under 15 months of age) that is reasonably tender-meated and with 
reasonably smooth-textured skin. Sex designation is optional.
    (iv) Mature turkey or old turkey (hen or tom). A mature or old 
turkey is an old turkey of either sex (usually in excess of 15 months of 
age) with coarse skin and toughened flesh.
    (3) Ducks--(i) Broiler duckling or fryer duckling. A broiler 
duckling or fryer duckling is a young duck (usually under 8 weeks of 
age), of either sex, that is tender-meated and has a soft bill and soft 
windpipe.
    (ii) Roaster duckling. A roaster duckling is a young duck (usually 
under 16 weeks of age), of either sex, that is tender-meated and has a 
bill that is not completely hardened and a windpipe that is easily 
dented.
    (iii) Mature duck or old duck. A mature duck or an old duck is a 
duck (usually over 6 months of age), of either sex, with toughened 
flesh, hardened bill, and hardened windpipe.
    (4) Geese--(i) Young goose. A young goose may be of either sex, is 
tender-meated, and has a windpipe that is easily dented.
    (ii) Mature goose or old goose. A mature goose or old goose may be 
of either sex and has toughened flesh and hardened windpipe.
    (5) Guineas--(i) Young guinea. A young guinea may be of either sex, 
is tender-meated, and has a flexible breastbone cartilage.
    (ii) Mature guinea or old guinea. A mature guinea or an old guinea 
may be of either sex, has toughened flesh, and a hardened breastbone.
    (b) The following standards specify the requirements for the 
specified cuts of poultry:
    (1) ``Breasts'' shall be separated from the back at the shoulder 
joint and by a cut running backward and downward from that point along 
the junction of the vertebral and sternal ribs. The ribs may be removed 
from the breasts, and the breasts may be cut along the breastbone to 
make two approximately equal halves; or the wishbone portion, as 
described in paragraph (b)(3) of this section, may be removed before 
cutting the remainder along the breastbone to make three parts. Pieces 
cut in this manner may be substituted for lighter or heavier pieces for 
exact weight-making purposes and the package may contain two or more of 
such parts without affecting the appropriateness of the labeling as 
e.g., ``chicken breasts.'' Neck skin shall not be included with the 
breasts, except that ``turkey breasts'' may include neck skin up to the 
whisker.
    (2) ``Breasts with ribs'' shall be separated from the back at the 
junction of the vertebral ribs and back. Breasts with ribs may be cut 
along the breastbone to make two approximately equal halves; or the 
wishbone portion, as described in paragraph (b)(3) of this section, may 
be removed before cutting the remainder along the breastbone to make 
three parts. Pieces cut in this manner may be substituted for lighter or 
heavier pieces for exact weight-making purposes and the package may 
contain two or more of such parts without affecting the appropriateness 
of the labeling as ``breasts with ribs.'' Neck skin shall not be 
included, except that ``turkey breasts with ribs'' may include neck skin 
up to the whisker.
    (3) ``Wishbones'' (Pulley Bones), with covering muscle and skin 
tissue, shall be severed from the breast approximately halfway between 
the end of the wishbone (hypocledium) and front point of the breastbone 
(cranial process of the sternal crest) to a point where the wishbone 
joins the shoulder. Neck skin shall not be included with the wishbone.
    (4) ``Drumsticks'' shall be separated from the thigh by a cut 
through the knee joint (femorotibial and patellar joint) and from the 
hock joint (tarsal joint).
    (5) ``Thighs'' shall be disjointed at the hip joint and may include 
the pelvic meat, but shall not include the pelvic bones. Back skin shall 
not be included.
    (6) ``(Kind) legs'' shall be the poultry product which includes the 
thigh and the drumstick, i.e., the whole leg, and may include the pelvic 
meat, but shall not include the pelvic bones. Back skin shall not be 
included.
    (7) ``Wings'' shall include the entire wing with all muscle and skin 
tissue intact, except that the wingtip may be removed.

[[Page 521]]

    (8) ``Backs'' shall include the pelvic bones and all the vertebrae 
posterior to the shoulder joint. The meat shall not be peeled from the 
pelvic bones. The vertebral ribs and/or scapula may be removed or 
included without affecting the appropriateness of the name. Skin shall 
be substantially intact.
    (9) ``Stripped backs'' shall include the vertebrae from the shoulder 
joint to the tail, and include the pelvic bones. The meat may be 
stripped off of the pelvic bones.
    (10) ``Necks'', with or without neck skin, shall be separated from 
the carcass at the shoulder joint.
    (11) ``Halves'' are prepared by making a full-length back and breast 
split of an eviscerated poultry carcass so as to produce approximately 
equal right and left sides.
    (12) ``Quarters'' consist of the entire eviscerated poultry carcass, 
which has been cut into four equal parts, but excluding the neck.
    (13) ``Breast quarter'' consists of half a breast with the wing and 
a portion of the back attached.
    (14) ``Breast quarter without wing'' consists of a front quarter of 
a poultry carcass, from which the wing has been removed.
    (15) ``Leg quarter'' consists of a poultry thigh and drumstick, with 
a portion of the back attached.
    (16) ``Thigh with back portion'' consists of a poultry thigh with 
back portion attached.
    (17) ``Legs with pelvic bone'' consists of a poultry leg with 
adhering meat and skin and pelvic bone.
    (18) ``Wing drummette'' consists of the humerus of a poultry wing 
with adhering skin and meat attached.
    (19) ``Wing portion'' consists of a poultry wing except that the 
drummette has been removed.
    (20) ``Cut-up Poultry'' is any cut-up or disjointed portion of 
poultry or any edible part thereof, as described in this section.
    (21) ``Giblets'' consist of approximately equal numbers of hearts, 
gizzards, and livers, as determined on a count basis.
    (22) ``Major portions'' of eviscerated poultry carcasses are either 
carcasses from which parts may be missing, or the front or rear portions 
of transversely-split carcasses.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 63 FR 
48960, Sept. 11, 1998]



Sec. 381.171  Definition and standard for ``Turkey Ham.''

    (a) ``Turkey Ham'' shall be fabricated from boneless, turkey thigh 
meat with skin and the surface fat attached to the skin removed. The 
thighs shall be that cut of poultry described in Sec. 381.170(b)(5) of 
this part.
    (b) The product may or may not be smoked, and shall be cured using 
one or more of the approved curing agents as provided in a regulation 
permitting that use in this subchapter or 9 CFR Chapter III, Subchapter 
E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. The product may 
also contain cure accelerators, phosphates, and flavoring agents as 
provided in a regulation permitting that use in this subchapter or 9 CFR 
Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or 
Subchapter B; common salt, sugars, spices, spice extractives, dehydrated 
garlic, and dehydrated onions; and water for purpose of dissolving and 
dispersing the substances specified above.
    (c) The cooked finished product weight shall be no more than the 
original weight of the turkey thigh meat used prior to curing.
    (d) The product name on the label shall show the word ``Turkey'' in 
the same size, style, color, and with the same background as the word 
``Ham'' and shall precede and be adjacent to it.
    (e) The product name shall be qualified with the statement ``Cured 
Turkey Thigh Meat.'' The qualifying statement shall be contiguous to the 
product name, without intervening type or designs, shall be not less 
than one-half the size of the product name but not less than one-eighth 
inch in height, and shall be in the same style and color and with the 
same background as the product name.
    (f) If the product is fabricated from pieces of turkey thigh meat 
that result from the cutting through the muscle (as opposed the whole 
thighs intact or whole thighs with some incidental separation of muscle 
tissue during removal of the bone), the product name

[[Page 522]]

shall be further qualified by a descriptive statement. The product name 
of product fabricated from such pieces of turkey thigh meat equivalent 
in size to a one-half inch cube or greater shall be further qualified to 
specify that the product is ``Chunked and Formed.'' The product name of 
product fabricated from such pieces of turkey thigh meat smaller than 
the equivalent of a one-half inch cube shall be further qualified to 
specify that the product is ``Ground and Formed'' or ``Chopped and 
Formed'' as appropriate. The qualifying statement shall immediately 
follow and be contiguous to the statement required in paragraph (e) of 
this section, and shall be not less than one-half the size of the 
product name but not less than one-eighth inch in height, and shall be 
in the same style and color and with the same background as the product 
name.

[44 FR 51190, Aug. 31, 1979; 64 FR 72175, Dec. 23, 1999]



Sec. 381.172  Requirements for substitute standardized poultry products 
named by use of an expressed nutrient content claim and a standardized 
term.

    (a) Description. The poultry products prescribed by this general 
definition and standard of identity are those products that substitute, 
in accordance with Sec. 381.413(d), for a standardized product defined 
in this subpart and use the name of that standardized product in their 
statements of identity, but that do not comply with the established 
standard because of a compositional deviation that results from 
reduction of a constituent that is described by an expressed nutrient 
content claim that has been defined by regulation in this subpart. The 
expressed nutrient content claim shall comply with the requirements of 
Sec. 381.413 and with the requirements in subpart Y of this part which 
define the particular nutrient content claim that is used. The poultry 
product shall comply with the relevant standard in this part in all 
other respects, except as provided in paragraphs (b) and (c) of this 
section.
    (b) Performance characteristics. The performance characteristics, 
such as physical properties, functional properties, and shelf-life, of 
the poultry product shall be similar to those of the standardized 
poultry product produced under subpart P of this part. If there is a 
significant difference in a performance characteristic that materially 
limits the use of the product compared to the use of the standardized 
product defined in subpart P of this part, the label shall include a 
statement in accordance with Sec. 381.413(d)(1) and (2) of this part, 
that informs the consumer of such differences (e.g., if appropriate, 
``not recommended for frozen storage'' or ``not suitable for roller 
grilling''). Deviations from the ingredient provisions of the standard 
must be the minimum necessary to qualify for the nutrient content claim, 
while maintaining similar performance characteristics.
    (c) Ingredients used in substitute products. (1) Ingredients used in 
the product shall be those ingredients provided for in the standard as 
defined in subpart P of this part, except that safe and suitable 
ingredients permitted for use in poultry products as provided in a 
regulation permitting that use in this subchapter or in 9 CFR Chapter 
III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, 
may be used at the minimum level necessary to improve texture and 
prevent syneresis, so that the substitute product is not inferior in 
performance characteristics from the standardized product defined in 
subpart P of this part for which it is a substitute.
    (2) An ingredient that is specifically required by the standard 
prescribed in subpart P of this part shall not be replaced or exchanged 
with a similar ingredient from another source, for example, extruded 
turnips shall not replace noodles in poultry with noodles.
    (3) An ingredient that is specifically prohibited from use in any 
poultry product by subpart P of this part shall not be added to the 
substitute poultry product under this section.
    (4) Unless otherwise specified in this part, a substitute poultry 
product must meet all other requirements of the applicable standards of 
identity or composition.
    (5) Water and fat-replacers (e.g., binders), in combination, may be 
added to

[[Page 523]]

replace fat in accordance with paragraph (c) of this section.
    (6) Textured vegetable protein may be used by itself or in 
combination with other binders and water as a fat replacer in accordance 
with paragraph (c) of this section.
    (d) Nomenclature. The name of a substitute poultry product that 
complies with this section is the appropriate expressed nutrient content 
claim and the applicable standardized term.
    (e) Label declaration. (1) Each of the ingredients used in the 
substitute poultry product shall be declared on the label as required by 
this section and subpart N of this part.
    (2) Ingredients not provided for, and ingredients used in excess of 
those levels provided for, by the standard as defined in subpart P of 
this part, shall be identified as such with an asterisk in the 
ingredients statement. The statement ``*Ingredients not in regular--'' 
(the blank shall be filled in with the name of the traditional 
standardized product) or ``**Ingredients in excess of amounts permitted 
in regular--'' (the blank shall be filled in with the name of the 
traditional standardized product), or both, as appropriate, shall 
immediately follow the ingredients statement in the same type and size.

    Effective Date Note: At 70 FR 33818, June 10, 2005, Sec. 381.172 
was added, effective Jan. 1, 2008.



Sec. 381.173  Mechanically Separated (Kind of Poultry).

    (a) ``Mechanically Separated (Kind of Poultry)'' is any product 
resulting from the mechanical separation and removal of most of the bone 
from attached skeletal muscle and other tissue of poultry carcasses and 
parts of carcasses that has a paste-like form and consistency, that may 
or may not contain skin with attached fat and meeting the other 
provisions of this section. Examples of such product are ``Mechanically 
Separated Chicken'' and ``Mechanically Separated Turkey.''
    (b) ``Mechanically Separated (Kind of Poultry)'' shall not have a 
bone solids content of more than 1 percent. At least 98 percent of the 
bone particles present in ``Mechanically Separated (Kind of Poultry) `` 
shall have a maximum size no greater than 1.5 mm (millimeter) in their 
greatest dimension and there shall be no bone particles larger than 2.0 
mm in their greatest dimension.
    (c) ``Mechanically Separated (Kind of Poultry)'' shall not have a 
calcium content exceeding 0.235 percent when made from mature chickens 
or from turkeys as defined in Sec. 381.170(a)(l)(vi) and (vii) and 
(a)(2), respectively, or 0.175 percent when made from other poultry, 
based on the weight of product that has not been heat treated, as a 
measure of a bone solids content of not more than 1 percent.
    (d) ``Mechanically Separated (Kind of Poultry)'' may be used in the 
formulation of poultry products in accordance with Sec. 381.174 and 
meat food products in accordance with subchapter A of this chapter.
    (e) Product resulting from the mechanical separation process that 
fails to meet the bone particle size or calcium content requirements for 
``Mechanically Separated (Kind of Poultry)'' shall be used only in 
producing poultry extractives, including fats, stocks, and broths and 
labeled as ``Mechanically Separated (Kind of Poultry) for Further 
Processing.''

[60 FR 55983, Nov. 3, 1995]



Sec. 381.174  Limitations with respect to use of Mechanically Separated 
(Kind of Poultry).

    (a) A poultry product required to be prepared from a particular kind 
of poultry (e.g., chicken) shall not contain ``Mechanically Separated 
(Kind of Poultry)'' described in Sec. 381.173, that is made from any 
other kind of poultry (e.g., Mechanically Separated Turkey).
    (b) ``Mechanically Separated (Kind of Poultry)'' described in Sec. 
381.173 may be used in the formulation of any poultry or meat food 
product, provided such use conforms with any applicable requirements of 
the definitions and standards of identity or composition in this 
subchapter or part 319 of this chapter, and provided that it is 
identified as ``Mechanically Separated (Kind of Poultry).''

[60 FR 55983, Nov. 3, 1995]

[[Page 524]]



              Subpart Q_Records, Registration, and Reports



Sec. 381.175  Records required to be kept.

    (a) Every person within any of the classes specified in paragraph 
(a) (1), (2), or (3) of this section is required by the Act to keep such 
records as are properly necessary for the effective enforcement of the 
Act:
    (1) Any person that engages in the business of slaughtering any 
poultry or processing, freezing, packaging, or labeling any carcasses, 
or parts or products of carcasses, of any poultry, for commerce, for use 
as human food or animal food;
    (2) Any person that engages in the business of buying or selling (as 
a poultry products broker, wholesaler, or otherwise) or transporting, in 
commerce, or storing in or for commerce, or importing, any carcasses, or 
parts or products of carcasses, of any poultry;
    (3) Any person that engages in business, in or for commerce, as a 
renderer, or engages in the business of buying, selling, or transporting 
in commerce, or importing, any dead, dying, disabled, or diseased 
poultry or parts of the carcasses of any poultry that died otherwise 
than by slaughter.
    (b) The required records are:
    (1) Records, such as bills of sale, invoices, bills of lading, and 
receiving and shipping papers, giving the following information with 
respect to each transaction in which any poultry or poultry carcass, or 
part or product of a poultry carcass, is purchased, sold, shipped, 
received, transported, or otherwise handled by said person in connection 
with any business subject to the Act.
    (i) The name or description of the poultry or other articles;
    (ii) The net weight of the poultry or other articles;
    (iii) The number of outside containers;
    (iv) The name and address of the buyer of the poultry or other 
articles sold by such person, and the name and address of the seller of 
the poultry or other articles purchased by such person;
    (v) The name and address of the consignee or receiver (if other than 
the buyer);
    (vi) The method of shipment;
    (vii) The date of shipment; and
    (viii) The name and address of the carrier.
    (2) Guaranties provided by suppliers of packaging materials under 
Sec. 381.144.
    (3) Records of canning as required by subpart X of this part 381, of 
subchapter C, 9 CFR chapter III.
    (4) Records of irradiation as required by sections 381.149 of this 
part.
    (5) Records of nutrition labeling as required by subpart Y of this 
part.
    (6) Records of all labeling, along with the product formulation and 
processing procedures, as prescribed in Sec. Sec. 381.132 and 381.133.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[37 FR 9706, May 16, 1972, as amended at 47 FR 746, Jan. 7, 1982; 49 FR 
2236, Jan. 19, 1984; 51 FR 45633, Dec. 19, 1986; 57 FR 43600, Sept. 21, 
1992; 58 FR 675, Jan. 6, 1993; 60 FR 67458, Dec. 29, 1995]



Sec. 381.176  Place of maintenance of records.

    Every person engaged in any business described in Sec. 381.175(a) 
shall maintain the records required by Sec. 381.175 at the place of 
business where such business is conducted, except that, if such person 
conducts such business at multiple locations, he may maintain such 
records at his headquarters' office. When not in actual use, all such 
records shall be kept in a safe place at the prescribed location in 
accordance with good commercial practices.



Sec. 381.177  Record retention period.

    (a) Every record required to be maintained under this subpart shall 
be retained for a period not to exceed 2 years after December 31 of the 
year in which the transaction to which the record relates has occurred, 
and for such further period as the Administrator may require for 
purposes of any investigation or litigation under the Act, by written 
notice to the person required to keep such record under this subpart.
    (b) Records of canning as required by subpart X of this part 381, 
subchapter C, 9 CFR chapter III, shall be retained as required in Sec. 
381.307; except that records required by Sec. 381.302 (b) and (c)

[[Page 525]]

shall be retained as required by those sections.

[37 FR 9706, May 16, 1972, as amended at 51 FR 45633, Dec. 19, 1986]



Sec. 381.178  Access to and inspection of records, facilities and 
inventory; copying and sampling.

    Representatives of the Secretary afforded access to a business 
specified in Sec. 381.175 of this part (see Sec. 300.6(b)(2) of this 
chapter) also must be afforded any necessary facilities (other than 
reproduction equipment) for the examination and copying of records and 
the examination and sampling of inventory.

[69 FR 255, Jan. 5, 2004]



Sec. 381.179  Registration.

    (a) Except as provided in paragraph (c) of this section, every 
person that engages in business, in or for commerce, as a poultry 
products broker, renderer, or animal food manufacturer, or engages in 
business in commerce as a wholesaler of any carcasses, or parts or 
products of the carcasses, of any poultry, whether intended for human 
food or other purposes, or engages in the business as a public 
warehouseman storing any such articles in or for commerce, or engages in 
the business of buying, selling, or transporting in commerce, or 
importing, any dead, dying, disabled, or diseased poultry, or parts of 
the carcasses of any poultry that died otherwise than by slaughter, 
shall register with the Administrator, giving such information as is 
required, including his name, and the address of each place of business 
at which, and all trade names under which he conducts such business. 
Such persons shall register under this section by filing with the 
Administrator, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250, a form containing such information, 
within 90 days after the effective date hereof or after such later date 
as he begins to engage in such business if not engaged therein upon said 
effective date. All information submitted shall be current and correct. 
The registration form shall be obtained from District Enforcement 
Operations, Field Operations, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250 or by calling the 
District Office.
    (b) Whenever any change is made in the name of, or address of any 
place of business at which, or any trade name under which a registrant 
conducts his business, he shall report such change in writing to the 
Administrator within 15 days after making the change.
    (c) The registration requirements prescribed in this section shall 
not apply to persons conducting any of the businesses specified in this 
section only at an official establishment.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 57 FR 
53982, Nov. 16, 1992; 69 FR 255, Jan. 5, 2004]



Sec. 381.180  Information and reports required from official 
establishment operators.

    (a) The operator of each official establishment shall furnish to 
Program employees accurate information as to all matters needed by them 
for making their daily reports of the amount of products prepared or 
handled in the departments of the establishment to which they are 
assigned and such reports concerning sanitation, mandatory 
microbiological testing, and other aspects of the operations of the 
establishment and the conduct of inspection thereat, as may be required 
by the Administrator in special cases.
    (b) The operator of each official establishment shall also make such 
other reports as the Administrator may from time to time require under 
the Act.

[37 FR 9706, May 16, 1972, as amended at 61 FR 38868, July 25, 1996]



Sec. 381.181  Reports by consignees of allegedly adulterated or misbranded 
products; sale or transportation as violations.

    Whenever the consignee of any poultry product which bears an 
official inspection legend refuses to accept delivery of such product on 
the grounds that it is adulterated or misbranded, the consignee shall 
notify the appropriate program supervisor, Meat and Poultry Inspection 
Program, Food Safety and Inspection Service, U.S. Department of 
Agriculture, of the kind, quantity, source and present location of the 
product and the respects in which it is

[[Page 526]]

alleged to be adulterated or misbranded, and it will be a violation of 
the Act for any person to sell or transport, or offer for sale or 
transportation or receive for transportation, in commerce, any such 
product which is capable of use as human food and is in fact adulterated 
or misbranded at the time of such sale, transportation, offer, or 
receipt: Provided, That any such allegedly adulterated or misbranded 
product may be transported to any official establishment for 
reinspection.



Sec. 381.182  Reports of inspection work.

    Reports of the inspection work carried on within official 
establishments shall be forwarded to the Administrator by the inspector 
in charge in such a manner as may be specified by the Administrator.



  Subpart R_Cooperation With States and Territories; Certification of 
   State and Territorial Programs as at Least Equal to Federal Program



Sec. 381.185  Assistance to State and Territorial programs.

    (a) The Administrator is authorized, under paragraph (a) of section 
5 of the Act, when he determines it would effectuate the purposes of the 
Act, to cooperate with any State (including Puerto Rico) or any 
organized territory in developing and administering the poultry product 
inspection program of such jurisdiction, with a view to assuring that it 
imposes and enforces requirements at least equal to those under sections 
2 through 4, 6 through 10, and 12 through 22 of the Act, with respect to 
establishments at which poultry are slaughtered or poultry products are 
processed for use as human food, solely for distribution within such 
jurisdiction, and with respect to the poultry products of such 
establishments. Such cooperation is authorized if the jurisdiction has 
enacted a mandatory law imposing ante mortem and post mortem inspection, 
reinspection, and sanitation requirements (at least equal to those under 
the Federal Act), with respect to all or certain classes of persons 
engaged in slaughtering poultry or otherwise processing poultry products 
for use as human food solely for distribution within such jurisdiction.
    (b) The Administrator is also authorized under paragraph (a) of 
section 5 of the Act, to cooperate with any State (including Puerto 
Rico) or any organized territory in developing and administering 
programs under the laws of such jurisdiction containing authorities at 
least equal to those provided in section 11 of the Act (relating to 
records; registration of specified classes of operators; dead, dying, 
disabled, or diseased poultry; and products not intended for human food) 
when he determines that such cooperation would effectuate the purposes 
of the Act.
    (c) Such cooperation may include advisory assistance, technical and 
laboratory assistance and training, and financial aid. The Federal 
contribution to any State (or territory) for any year shall not exceed 
50 percent of the estimated total cost of the cooperative State (or 
territorial) program. A cooperative program under this section is called 
a State-Federal program.



Sec. 381.186  Cooperation of States and other jurisdictions in Federal 
programs.

    Under the ``Talmadge-Aiken Act'' of September 28, 1962 (7 U.S.C. 
450), the Administrator is authorized under stated conditions to utilize 
employees and facilities of any State in carrying out Federal functions 
under the Poultry Products Inspection Act. A cooperative program for 
this purpose is called a Federal-State program. Under paragraph (a) of 
section 5 of the Poultry Products Inspection Act, the Administrator is 
also authorized to conduct examinations, investigations, and inspections 
under the Act through any officer or employee of any State or territory 
or the District of Columbia commissioned by him for such purpose.

[[Page 527]]



  Subpart S_Transportation; Exportation; or Sale of Poultry or Poultry 
                                Products



Sec. 381.189  Provisions inapplicable to specimens for laboratory 
examination, etc., or to naturally inedible articles.

    The provisions of this subpart do not apply:
    (a) To dead, dying, disabled or diseased poultry and specimens of 
undenatured, uninspected or adulterated carcasses, parts, or products of 
poultry sent to or by the Department of Agriculture or divisions thereof 
in Washington, DC, or elsewhere, for laboratory examination, exhibition 
purposes, or other official use;
    (b) To dead, dying, disabled or diseased poultry and specimens of 
undenatured, uninspected or adulterated carcasses, parts, or products of 
poultry thereof for educational, research, or other nonfood purposes 
shipped under permit issued by the inspector in charge upon his 
determination that collection and movement thereof will not interfere 
with inspection or sanitary conditions at the establishment, and the 
specimens are for nonfood purposes. The person desiring such specimens 
shall make a written application to the inspector in charge for such 
permit on Form MP-112 and shall obtain permission from the operator of 
the official establishment to obtain the specimens. Permits shall be 
issued for a period not longer than one year. The permit may be revoked 
by the inspector in charge if he determines after notice and opportunity 
to present views is afforded to the permittee that any such specimens 
were not used as stated in the application, or if the collection or 
handling of the specimens interferes with inspection or the maintenance 
of sanitary conditions in the establishment. The specimens referred to 
in this paragraph shall be collected and handled only at such time and 
place and in such manner as not to interfere with the inspection or to 
cause any objectionable condition and shall be identified as inedible 
when they leave the establishment.
    (c) To parts of poultry carcasses that are naturally inedible by 
humans, such as entrails and feathers in their natural state.

[40 FR 55310, Nov. 28, 1975]



Sec. 381.190  Transactions in slaughtered poultry and other poultry 
products restricted; vehicle sanitation requirements.

    (a) No person shall sell, transport, offer for sale or 
transportation, or receive for transportation, in commerce or from any 
official establishment, any slaughtered poultry from which the blood, 
feathers, feet, head, or viscera have not been removed in accordance 
with the regulations.
    (b)(1) No person shall sell, transport, offer for sale or 
transportation, or receive for transportation, in commerce, any 
slaughtered poultry or other poultry product which is capable of use as 
human food and is adulterated or fails to bear an official inspection 
legend or is otherwise misbranded at the time of such sale, 
transportation, offer or receipt, except as otherwise provided in this 
paragraph (b) and subpart C or T.
    (2)(i) Poultry heads and feet that are collected and handled at an 
official establishment in an acceptable manner may be shipped from the 
official establishment directly for export as human food, if they have 
been examined and found to be suitable for such purpose, by an inspector 
and are labeled as prescribed in this paragraph.
    (ii) The containers of all such products shall bear a label showing: 
(A) The name of the products; (B) the name and address of the packer or 
distributor, and, when the name of the distributor is shown, it shall be 
qualified by such terms as ``packed for,'' ``distributed by,'' or 
``distributors''; and (C) the official establishment number of the 
establishment where packed.
    (iii) Such products shall not bear the official inspection legend.
    (3)(i) Poultry heads and feet that are collected and handled at an 
official establishment in an acceptable manner may be shipped from the 
official establishment and in commerce directly to another official 
establishment for processing before export, provided the receiving 
establishment maintains records that:
    (A) Identify the source of the incoming undenatured poultry product;

[[Page 528]]

    (B) Identify the location of the product at all times during 
processing and preparation for export; and
    (C) Contain a written certification from an official of the 
receiving establishment that the undenatured poultry product intended 
for export has not been, and will not be, commingled with any product 
intended for consumption in the United States.
    (ii) The receiving establishment may only ship the undenatured 
poultry product intended for export in accordance with the inspection 
and labeling requirements of paragraph (b)(2) of this section.
    (c) No person, engaged in the business of buying, selling, freezing, 
storing, or transporting, in or for commerce, poultry products capable 
of use as human food, or importing such articles, shall transport, offer 
for transportation, or receive for transportation, in commerce or in any 
State designated under Sec. 381.221, any poultry product which is 
capable of use as human food and is not wrapped, packaged, or otherwise 
enclosed to prevent adulteration by airborne contaminants, unless the 
railroad car, truck, or other means of conveyance in which the product 
is contained or transported is completely enclosed with tight fitting 
doors or other covers for all openings. In all cases, the means of 
conveyance shall be reasonably free of foreign matter (such as dust, 
dirt, rust, or other articles or residues), and free of chemical 
residues, so that product placed therein will not become adulterated. 
Any cleaning compound, lye, soda solution, or other chemical used in 
cleaning the means of conveyance must be thoroughly removed from the 
means of conveyance prior to its use. Such means of conveyance onto 
which product is loaded, being loaded, or intended to be loaded, shall 
be subject to inspection by an inspector at any official establishment. 
The decision whether or not to inspect a means of conveyance in a 
specific case, and the type and extent of such inspection shall be at 
the Inspection Service's discretion and shall be adequate to determine 
if poultry product in such conveyance is, or when moved could become, 
adulterated.

Circumstances of transport that can be reasonably anticipated shall be 
considered in making said determination. These include, but are not 
limited to, weather conditions, duration and distance of trip, nature of 
product covering, and effect of restowage at stops en route. Any means 
of conveyance found upon such inspection to be in such condition that 
poultry product placed therein could become adulterated shall not be 
used until such condition which could cause adulteration is corrected. 
Poultry product placed in any means of conveyance that is found by the 
inspector to be in such condition that the poultry product may have 
become adulterated shall be removed from the means of conveyance and 
handled in accordance with Sec. 381.145(b).

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 40 FR 
42338, Sept. 12, 1975; 41 FR 23700, June 11, 1976; 60 FR 43358, Aug. 21, 
1995]



Sec. 381.191  Distribution of inspected products to small lot buyers.

    For the purpose of facilitating the distribution in commerce of 
inspected poultry products to small lot buyers (such as small 
restaurants), distributors or jobbers may remove inspected and passed 
non-consumer-packaged poultry carcasses or consumer-packaged poultry 
products from shipping containers or immediate containers, other than 
consumer packages, and place them into other containers which do not 
bear an official inspection mark: Provided, That the individual non-
consumer-packaged carcasses bear the official inspection legend and the 
official establishment number of the establishment that processed the 
articles; and the consumer-packaged articles are fully labeled in 
accordance with subpart N: And provided further, That the other 
container is marked with the name and address of the distributor or 
jobber and bears the statement ``The poultry product contained herein 
was inspected by the U.S.D.A.'' in the case of poultry products 
processed in the United States, or the statement ``The poultry products 
contained herein have been approved for importation under P.P.I.A.'' in 
the case of imported poultry products.

[[Page 529]]



Sec. 381.192  Penalties inapplicable to carriers.

    No carrier shall be subject to the penalties of the Act, other than 
the penalties for violation of section 11, by reason of his receipt, 
carriage, holding, or delivery, in the usual course of business, as a 
carrier, of poultry or poultry products, owned by another person, unless 
the carrier has knowledge, or is in possession of facts which would 
cause a reasonable person to believe that such poultry or poultry 
products were not inspected or marked in accordance with the provisions 
of the Act or where otherwise not eligible for transportation under the 
Act, or unless the carrier refuses to furnish on request of a 
representative of the Secretary, the name and address of the person from 
whom he received such poultry or poultry products, and copies of all 
documents, if any there be, pertaining to the delivery of the poultry or 
poultry products to such carrier.



Sec. 381.193  Poultry carcasses, etc., not intended for human food.

    (a) Except as provided in paragraph (b) of this section, poultry 
carcasses, and parts and products thereof, that are not intended for use 
as human food may, after they have been denatured as prescribed in Sec. 
381.95, be bought, sold, transported, offered for sale or 
transportation, or received for transportation, in commerce, or 
imported, even though they do not comply with all the provisions of the 
regulations, provided they are marked ``Not fit for human food.'' These 
requirements do not apply to parts of poultry carcasses that are 
naturally inedible by humans, such as entrails.
    (b)(1) Except as provided in paragraphs (b) (2), (3), and (4) of 
this section, no animal food processed, in whole or in part, from 
materials derived from the carcasses of poultry in an official 
establishment or elsewhere, shall be bought, sold, transported, offered 
for sale or transportation, or received for transportation in commerce, 
or imported, unless:
    (i) It is properly identified as animal food;
    (ii) It is not represented as being a human food; and
    (iii) It has been denatured as prescribed in Sec. 381.95 so as to 
be readily distinguishable from an article of human food.
    (2) Notwithstanding the provisions of paragraph (b)(1) of this 
section, an animal food that consists of less than 5 percent of parts or 
products of the carcasses of poultry and that is not represented by 
labeling or appearance or otherwise as being a human food or as a 
product of the poultry industry need not be denatured in accordance with 
Sec. 381.95.
    (3) Notwithstanding the provisions of paragraph (b)(1) of this 
section, animal food packed in hermetically sealed, retort processed, 
conventional retail-size containers, and retail-size packages of semi-
moist animal food need not be denatured in accordance with Sec. 381.95 
if the name of the article clearly conveys the article's intended use 
for animal food and appears on the label in a conspicuous manner.
    (i) Except as provided in paragraph (ii) of paragraph (b)(3) of this 
section, the name of the article must be stated on the label as ``Animal 
Food,'' ``Pet Food,'' or ``(name of species) Food'' (e.g., ``Dog Food'' 
or ``Cat Food''). To be considered conspicuous, the name of the article, 
wherever it appears on the label, must be stated in letters at least 
twice as high, wide, and thick as the letters indicating the presence in 
the article of any ingredients derived from carcasses of poultry.
    (ii) Notwithstanding the provisions of paragraph (i) of paragraph 
(b)(3) of this section, the article's name may be stated on the label to 
show that it is or contains poultry carcass-source material and that the 
article is for animals; e.g., ``Chicken for Pets'' or ``Turkey Dinner 
for Cats'': Provided, That the entire name of the article is stated, 
wherever it appears on the label, as an individual, contiguous unit, 
whether stated on a single line or more than one line, and the letters 
denoting the article's intended use for animal food are at least as 
high, wide, and thick as the letters indicating the presence of material 
derived from any poultry carcass. However, when the label bears on its 
principal display panel a vignette which pictures, in clearly 
recognizable form and size, one or more animals of

[[Page 530]]

the species for which the article's name indicates the article is 
intended, the letters used to state the article's intended use shall be 
at least one-half as high, wide, and thick as the letters used in the 
article's name or other letters indicating the presence of material 
derived from any poultry carcass, but shall not be less than \1/8\ inch 
high. The letters used to state the article's intended use may be 
separated from the article's name by the vignette.
    (iii) Letters used to denote the intended use of the article must 
contrast as markedly with their background as the letters indicating the 
presence in the article of poultry carcass-source material contrast with 
their background.
    (4) The requirements of this part do not apply to livestock or 
poultry feed manufactured from processed poultry byproducts (such as 
poultry byproduct meal, hydrolyzed poultry feathers, and hydrolyzed 
poultry byproducts aggregate), or to processed dry animal food.

[49 FR 47479, Dec. 5, 1984]



Sec. 381.194  Transportation and other transactions concerning dead, 
dying, disabled, or diseased poultry, and parts of carcasses of poultry 
that died otherwise than by slaughter.

    No person engaged in the business of buying, selling, or 
transporting in commerce, or importing any dead, dying, disabled, or 
diseased poultry or parts of the carcasses of any poultry that died 
otherwise than by slaughter shall:
    (a) Sell, transport, offer for sale or transportation or receive for 
transportation, in commerce, any dead, dying, disabled, or diseased 
poultry, or parts of the carcasses of any poultry that died otherwise 
than by slaughter, unless such poultry and parts are consigned and 
delivered, without avoidable delay, to establishments of animal food 
manufacturers, renderers, or collection stations that are registered as 
required by Sec. 381.179, or to official establishments that operate 
under Federal inspection, or to establishments that operate under a 
State or Territorial inspection system approved by the Secretary as one 
that imposes requirements at least equal to the Federal requirements for 
purposes of section 5(c) of the Act.
    (b) Buy in commerce or import any dead, dying, disabled, or diseased 
poultry or parts of the carcasses of any poultry that died otherwise 
than by slaughter, unless he is an animal food manufacturer or renderer 
and is registered as required by Sec. 381.179, or is the operator of an 
establishment inspected as required by paragraph (a) of this section and 
such poultry or parts of carcasses are to be delivered to establishments 
eligible to receive them under paragraph (a) of this section.
    (c) Unload en route to any establishment eligible to receive them 
under paragraph (a) of this section, any dead, dying, disabled, or 
diseased poultry or parts of the carcasses of any poultry that died 
otherwise than by slaughter, which are transported in commerce or 
imported by any such person: Provided, That any such dead, dying, 
disabled, or diseased poultry, or parts of carcasses may be unloaded 
from a means of conveyance en route where necessary in case of a wreck 
or otherwise extraordinary emergency, and may be reloaded into another 
means of conveyance; but in all such cases, the carrier shall 
immediately report the facts by telegraph or telephone to the Director, 
Compliance Staff, Meat and Poultry Inspection Program, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250.

[40 FR 55310, Nov. 28, 1975]



                   Subpart T_Imported Poultry Products



Sec. 381.195  Definitions; requirements for importation into the United 
States.

    (a) When used in this part, the following terms shall be construed 
to mean:
    (1) Import (Imported). To bring within the territorial limits of the 
United States whether that arrival is accomplished by land, air, or 
water.
    (2) For product from eligible countries other than Canada:
    (i) Offer(ed) for entry. The point at which the importer presents 
the imported product to the Program for reinspection.

[[Page 531]]

    (ii) Entry (entered). The point at which imported product offered 
for entry receives reinspection and is marked with the official mark of 
inspection in accordance with Sec. 327.26 of this part.
    (3) For product from Canada:
    (i) Offer(ed) for entry from establishments participating in the 
``streamlined'' inspection procedures. The point at which an official of 
the Canadian inspection system contacts the Import Field Office for an 
inspection assignment.
    (ii) Offer(ed) for entry from nonparticipating establishments. The 
point at which the importer presents the imported product to the Program 
for reinspection.
    (iii) Entry (entered) for product not subject to reinspection. When 
the containers or the products themselves if not in containers are 
marked with the Canadian export stamp and upon the filing of Customs 
Form 7533 at the port of entry or at the nearest customshouse in 
accordance with 19 CFR part 123.
    (iv) Entry (entered) for product subject to reinspection. When the 
containers or the products themselves if not in containers are marked 
with the Canadian export stamp and the foreign inspection certificate 
accompanying the product is stamped as ``Inspected and Passed'' by the 
import inspector.
    (b) No slaughtered poultry, or parts or products thereof, shall be 
imported into the United States unless they are healthful, wholesome, 
fit for human food, not adulterated, and contain no dye, chemical, 
preservative, or ingredient which renders them unhealthful, unwholesome, 
adulterated, or unfit for human food and they also comply with the 
regulations prescribed in this subpart to assure that they comply with 
the standards provided for in the Act: Provided, That the provisions of 
this subpart apply to such articles only if they are capable of use as 
human food.
    (c) Except as provided in Sec. 381.207, slaughtered poultry and 
other poultry products may be imported only if they were processed 
solely in countries listed in Sec. 381.196(b). Slaughtered poultry may 
be imported only if it qualifies as ready-to-cook poultry.

[37 FR 9706, May 16, 1972, as amended at 40 FR 42338, Sept. 12, 1975; 54 
FR 41049, Oct. 5, 1989]



Sec. 381.196  Eligibility of foreign countries for importation of poultry 
products into the United States.

    (a)(1) Whenever it shall be determined by the Administrator that the 
system of poultry inspection maintained by any foreign country, with 
respect to establishments preparing products in such country for export 
to the United States, insures compliance of such establishments and 
their poultry products, with requirements equivalent to all the 
provisions of the Act and the regulations in this part which are applied 
to official establishments in the United States, and their poultry 
products, and that reliance can be placed upon certificates required 
under this subpart from authorities of such foreign country, notice of 
that fact will be given by including the name of such foreign country in 
paragraph (b) of this section. Thereafter, poultry products processed in 
such establishments which are certified and approved in accordance with 
paragraph (a)(3) of this section shall be eligible, so far as the 
regulations in this part are concerned, for importation into the United 
States from such foreign country after applicable requirements of this 
part have been met.
    (2) The determination of acceptability of a foreign poultry 
inspection system for purposes of this section shall be based on an 
evaluation of the foreign program in accordance with the following 
requirements and procedures:
    (i) The system shall have a program organized and administered by 
the national government of the foreign country. The system as 
implemented must provide standards equivalent to those of the Federal 
system of poultry inspection in the United States with respect to:
    (A) Organizational structure and staffing, so as to insure uniform 
enforcement of the requisite laws and regulations in all establishments 
throughout the system at which poultry products are processed for export 
to the United States;

[[Page 532]]

    (B) Ultimate control and supervision by the national government over 
the official activities of all employees or licensees of the system;
    (C) The assignment of competent, qualified inspectors;
    (D) Authority and responsibility of national inspection officials to 
enforce the requisite laws and regulations governing poultry inspection 
and to certify or refuse to certify poultry products intended for 
export;
    (E) Adequate administrative and technical support;
    (F) The inspection, sanitation, quality, species verification, and 
residue standards applied to products produced in the United States.
    (G) Other requirements of adequate inspection service as required by 
the regulations.
    (ii) The legal authority for the system and the regulations 
thereunder shall impose requirements equivalent to those governing the 
system of poultry inspection organized and maintained in the United 
States with respect to:
    (A) Ante mortem inspection of poultry for slaughter, which shall be 
performed by veterinarians or by other employees or licensees of the 
system under the direct supervision of veterinarians;
    (B) Post mortem inspection of carcasses and parts thereof at time of 
slaughter, performed by veterinarians or other employees or licensees of 
the system under the direct supervision of veterinarians;
    (C) Official controls by the national government over establishment 
construction, facilities, and equipment;
    (D) Direct and continuous official supervision of slaughtering of 
poultry and processing of poultry products, by the assignment of 
inspectors to establishments certified under paragraph (a)(3) of this 
section to assure that adulterated or misbranded poultry products are 
not processed for export to the United States;
    (E) Complete separation of establishments certified under 
subparagraph (3) of this paragraph from establishments not certified, 
and the maintenance of a single standard of inspection and sanitation 
throughout all certified establishments;
    (F) Requirements for sanitation at certified establishments and for 
sanitary handling of poultry products;
    (G) Official controls over condemned material until destroyed or 
removed and thereafter excluded from the establishment;
    (H) A Hazard Analysis and Critical Control Point (HACCP) system, as 
set forth in part 417 of this chapter.
    (I) Other matters for which requirements are contained in the Act or 
the regulations in this part.
    (iii) Countries desiring to establish eligibility for importation of 
poultry products into the United States may request a determination of 
eligibility by presenting copies of the laws and regulations on which 
the foreign poultry inspection system is based and such other 
information as the Administrator may require with respect to matters 
enumerated in paragraphs (a)(2) (i) and (ii). Determination of 
eligibility is based on a study of the documents and other information 
presented and an initial review of the system in operation by a 
representative of the Department using the criteria listed in paragraphs 
(a)(2) (i) and (ii) of this section. Maintenance of eligibility of a 
country for importation of poultry products into the United States 
depends on the results of periodic reviews of the foreign poultry 
inspection system in operation by a representative of the Department, 
and the timely submission of such documents and other information 
related to the conduct of the foreign inspection system as the 
Administrator may find pertinent to and necessary for the determinations 
required by this section.
    (iv) The foreign inspection system must maintain a program to assure 
that the requirements referred to in this section, equivalent to those 
applicable to the Federal system in the United States, are being met. 
The program as implemented must provide for the following:
    (A) Periodic supervisory visits by a representative of the foreign 
inspection system not less frequently than one such visit per month to 
each establishment certified in accordance with paragraph (a)(3) of this 
section to assure that requirements referred to in paragraphs 
(a)(2)(ii)(A) through (a)(2)(ii)(H)

[[Page 533]]

of this section are being met: Provided, that such visits are not 
required with respect to any establishment during a period when the 
establishment is not operating or is not engaged in producing products 
for exportation to the United States;
    (B) Written reports prepared by the representative of the foreign 
inspection system who has conducted a supervisory visit, documenting his 
or her findings with respect to the requirements referred to in 
paragraphs (a)(2)(ii)(A) through (a)(2)(ii)(H) of this section, copies 
of which shall be made available to the representative of the Department 
at the time of the representative's review upon request by that 
representative to a responsible foreign inspection official: Provided, 
that such reports are not required during a period when the 
establishment is not operating or not engaged in producing products for 
exportation to the United States.
    (C) Random sampling and testing at the point of slaughter of 
carcasses, including internal organs and fat, for residues identified by 
the exporting country's inspection authorities or by this Agency as 
potential contaminants, in accordance with sampling and analytical 
techniques approved by the Administrator: Provided, that such testing is 
required only on samples taken of carcasses from which poultry or 
poultry products intended for importation into the United States are 
produced.
    (3) Only those establishments that are determined and certified to 
the Department by a responsible official of the foreign poultry 
inspection system as fully meeting the requirements of paragraphs (a)(2) 
(i) and (ii) of this section are eligible to have their products 
imported into the United States. Eligibility of certified establishments 
is subject to review by the Department (including observations of the 
establishments by Program representatives at times prearranged with the 
officials of the foreign inspection system). Certifications of 
establishments must be renewed annually. Notwithstanding certification 
by a foreign official, the Administrator may, at his discretion, 
terminate the eligibility of any foreign establishment for importation 
of its poultry products into the United States if he has information 
that such establishment does not comply with the requirements listed in 
paragraphs (a)(2) (i) and (ii) of this section or if he cannot obtain 
current information concerning such establishment. The Administrator 
will provide reasonable notice to the foreign government of the proposed 
termination of eligibility of any foreign establishment for importation 
of its poultry products into the United States unless, in his judgment, 
delay in terminating its eligibility could result in the importation of 
any adulterated or misbranded poultry products. Certifications of 
official establishments by the responsible official of the foreign 
poultry inspection system shall be in the following form:

           Foreign Official Poultry Establishment Certificate

    I hereby certify that the establishment(s) listed below fully 
complies (comply) with requirements of (specify foreign country) 
equivalent to all the provisions of the Poultry Products Inspection Act 
and regulations issued thereunder, which apply to official 
establishments in the United States, and their poultry products, as 
provided in Sec. 381.196(a)(2)(i) and (ii) of the poultry products 
inspection regulations of the United States.

                      Control numbers Name Address

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

    Date------------.
                                            ----------------------------
                                                             (Signature)
                                            ----------------------------
                                                        (Official title)

    (4) Poultry products from foreign countries not listed in paragraph 
(b) of this section are not eligible for importation into the United 
States, except as provided by Sec. Sec. 381.207 and 381.209. The 
listing of any foreign country under this section may be withdrawn 
whenever it shall be determined by the Administrator that the system of 
poultry inspection maintained by such foreign country does not assure 
compliance with requirements equivalent to all the requirements of the 
Act and the regulations as applied to official establishments in the 
United States; or that reliance cannot be placed upon certificates 
required under this subpart from

[[Page 534]]

authorities of such foreign country; or that, for lack of current 
information concerning the system of poultry inspection being maintained 
by such foreign country, such foreign country should be required to 
reestablish its eligibility for listing.
    (b) It has been determined that poultry products from the following 
countries, covered by foreign poultry inspection certificates of the 
country of origin as required by Sec. 381.197, are eligible under the 
regulations in this subpart for entry into the United States, after 
inspection and marking as required by the applicable provisions of this 
subpart: \1\
---------------------------------------------------------------------------

    \1\ Listing of any country in this section does not relieve the 
poultry products of such country from applicable requirements under 
other Federal laws.

Australia (ratites only).
Canada.
France.
Great Britain.
Hong Kong.
Israel.
Mexico.\2\
---------------------------------------------------------------------------

    \2\ May export to the United States only processed poultry products 
slaughtered under Federal inspection in the United States or in a 
country eligible to export slaughtered poultry products to the United 
States.
---------------------------------------------------------------------------

 New Zealand (ratites only).

[37 FR 9706, May 16, 1972, as amended at 43 FR 8117, Feb. 28, 1978; 52 
FR 23021, June 17, 1987; 54 FR 41049, Oct. 5, 1989; 54 FR 43951, Oct. 
30, 1989; 60 FR 38668, July 28, 1995; 61 FR 38868, July 25, 1996; 64 FR 
49645, Sept. 14, 1999; 68 FR 37071, June 23, 2003]



Sec. 381.197  Imported products; foreign inspection certificates required.

    (a) Except as provided in Sec. Sec. 381.207 and 381.209, each 
consignment containing any slaughtered poultry or other poultry product 
consigned to the United States from a foreign country shall be 
accompanied with a foreign inspection certificate substantially in the 
form illustrated in paragraph (b) of this section.
    (b) The form of foreign poultry product inspection certificate shall 
be as follows:

             Foreign Poultry Product Inspection Certificate

Place___________________________________________________________________
                                                                  (City)
                                            ----------------------------
                                                               (Country)
Date____________________________________________________________________

    I hereby certify that the poultry products herein described were 
derived from poultry which received ante mortem and post mortem 
inspections at the time of slaughter; and that such poultry products are 
sound, healthful, wholesome, clean and otherwise fit for human food, and 
are not adulterated and have not been treated with and do not contain 
any dye, chemical, preservative, or ingredient not permitted by the 
regulations governing the inspection of poultry and poultry products of 
the U.S. Department of Agriculture, filed with me, and that said poultry 
products have been handled only in a sanitary manner in this country; 
and are otherwise in compliance with requirements at least equal to 
those in the Poultry Products Inspection Act and said regulations.

                             Kind of Product

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

                   Number of pieces or packages Weight

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Identification marks on containers______________________________________
Consignor_______________________________________________________________
Address_________________________________________________________________
Consignee_______________________________________________________________
Destination_____________________________________________________________
Shipping marks__________________________________________________________
 (Signature)____________________________________________________________
(Name of official of national foreign government authorized to issue 
inspection certificates for poultry products exported to the United 
States)

 (Official title)_______________________________________________________

[37 FR 9706, May 16, 1972, as amended at 40 FR 42338, Sept. 12, 1975]



Sec. 381.198  Importer to make application for inspection of poultry 
products offered for entry.

    (a) Each person who wishes to offer for entry any slaughtered 
poultry or other poultry product shall make application for inspection 
to the import supervisor of the import field office at the port where 
the poultry product is to be offered for entry, or to the Administrator, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250, as long

[[Page 535]]

as possible in advance of the anticipated arrival of each consignment of 
such product, except in the case of poultry product exempted from 
inspection by Sec. Sec. 381.207 or 381.209. Each application shall 
state the approximate date on which the consignment is due to arrive in 
the United States, the name of the ship or other carrier transporting 
it, the name of the country where the product was processed, the name of 
the country from which the product was shipped, the place of 
destination, the quantity and kind of product, whether fresh, frozen, 
cured, or canned, and the point of first arrival in the United States.
    (b) For participating Canadian establishments, an official of the 
Canadian meat inspection system shall contact the Import Field Office 
for an inspection assignment (see Sec. 301.2(yyy)).
    (1) If the Automated Import Information System (AIIS) does not 
designate the consignment for reinspection, the consignment may be 
transported to its consignee for further distribution.
    (2) If the AIIS designates the consignment for reinspection, the 
official shall:
    (i) Select samples in accordance with USDA sampling tables.
    (ii) Identify and place samples in the vehicle for easy removal and 
reinspection by a Program import inspector.
    (3) In the event that any one of the requirements provided in 
paragraph (d)(2) of this section is not met, inspection of the 
consignment shall be conduced by a Program import inspector in 
accordance with established procedures provided for in the regulations 
for other imported products.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 51 FR 
37710, Oct. 24, 1986; 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. 5, 
1989]



Sec. 381.199  Inspection of poultry products offered for entry.

    (a)(1) Except as provided in Sec. Sec. 381.198(b)(1) and 381.209 of 
this part, and paragraph (c) of this section, all slaughtered poultry 
and poultry products offered for entry from any foreign country shall be 
reinspected by a Program import inspector before they shall be allowed 
entry into the United States.
    (2) Every lot of product shall routinely be given visual inspection 
for appearance and condition, and checked for certification and label 
compliance, except as provided in Sec. 381.198(b)(1).
    (3) The computerized Automated Import Information System (AIIS) 
shall be consulted for reinspection instructions. The AIIS will assign 
inspection levels and procedures based on established sampling plans or 
established product and plant history and established sampling plans.
    (b) Inspectors may take, without cost to the United States, from 
each consignment of poultry products offered for entry, such samples of 
the products as are deemed necessary to determine the eligibility of the 
products for entry into the commerce of the United States.
    (c) Poultry products imported under Sec. 381.207 shall not be 
sampled and inspected under this section unless there is reason for 
suspecting the presence therein of a substance in violation of that 
section, and in such case they shall be sampled and inspected in 
accordance with paragraph (a) of this section.
    (d) In addition to the provisions specified in paragraphs (a), (b), 
and (c) of this section, the following requirements apply to imported 
canned product.
    (1) Imported canned products are required to be sound, healthful, 
properly labeled, wholesome, and otherwise not adulterated at the time 
the products are offered for importation into the United States. 
Provided other requirements of this part are met, the determination of 
the acceptability of the product and the condition of the containers 
shall be based on the results of an examination of a statistical sample 
drawn from the consignment as provided in paragraph (a) of this section. 
If the inspector determines, on the basis of the sample examination, 
that the product does not meet the requirements of the Act and 
regulations thereunder, the consignment shall be refused entry. However, 
a consignment rejected for container defects but otherwise acceptable 
may be reoffered for inspection under the following conditions:

[[Page 536]]

    (i) If the defective containers are not indicative of an unsafe or 
unstable product as determined by the Administrator;
    (ii) If the number and kinds of container defects found in the 
original sample do not exceed the limits specified for this purpose in 
FSIS guidelines; and
    (iii) If the defective containers in the consignment have been 
sorted out and exported or destroyed under the supervision of an 
inspector.
    (2) Representative samples of canned product designated by the 
Administrator in instructions to inspectors shall be incubated under the 
supervision of such inspectors in accordance with Sec. 381.309 
(d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii), and 
(d)(1)(viii) of this subchapter. The importer or his/her agent shall 
provide the necessary incubation facilities in accordance with Sec. 
381.309(d)(1)(i) of this subchapter.
    (3) Sampling plans and acceptance levels as prescribed in paragraphs 
(d)(1) and (d)(2) of this section may be obtained, upon request, from 
International Programs, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250.

[37 FR 9706, May 16, 1972, as amended at 49 FR 36819, Sept. 20, 1984; 51 
FR 45633, Dec. 19, 1986; 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. 5, 
1989]



Sec. 381.200  Poultry products offered for entry, retention in customs 
custody; delivery under bond; movement prior to inspection; handling; 
facilities and assistance.

    (a) No slaughtered poultry or other poultry product required by this 
subpart to be inspected shall be released from customs custody prior to 
inspection, but such product may be delivered to the consignee, or his 
agent, prior to inspection, if the consignee shall furnish a bond, in 
form prescribed by the Secretary of the Treasury, conditioned that the 
product shall be returned, if demanded, to the collector of the port 
where the same is offered for clearance through the customs.
    (b) Except as provided in paragraph (a) of this section, no product 
required by this subpart to be inspected shall be moved, prior to 
inspection, from the port of arrival where first unloaded, and if 
arriving by water, from the wharf where first unloaded at such port, to 
any place other than the place designated in accordance with this 
subpart as the place where the same shall be inspected; and no product 
shall be conveyed in any manner other than in compliance with this 
subpart.
    (c) The consignee, or his agent, shall furnish such facilities and 
shall provide such assistance for handling and marking poultry products 
offered for entry as the inspector may require.

[37 FR 9706, May 16, 1972, as amended at 51 FR 37710, Oct. 24, 1986; 54 
FR 41050, Oct. 5, 1989; 56 FR 65180, Dec. 16, 1991]



Sec. 381.201  Means of conveyance and equipment used in handling poultry 
products offered for entry to be maintained in sanitary condition.

    Compartments of steamships, railroad cars, and other means of 
conveyance transporting any poultry product to the United States, and 
all chutes, platforms, racks, tables, tools, utensils, and all other 
devices used in moving and handling any poultry product offered for 
entry into the United States, shall be maintained in a sanitary 
condition.



Sec. 381.202  Poultry products offered for entry; reporting of findings 
to customs; handling of articles refused entry; appeals, how made; 
denaturing procedures.

    (a)(1) Program inspectors shall report their findings as to any 
product which has been inspected in accordance with this part, to the 
Director of Customs at the original port of entry.
    (2) When product has been identified as ``U.S. refused entry,'' the 
inspector shall request the Director of Customs to refuse admission to 
such product and to direct that it be exported by the owner or consignee 
within the time specified in this section, unless the owner or 
consignee, within the specified time, causes it to be destroyed by 
disposing of it under the supervision of a Program employee so that the 
product can no longer be used as human food, or by converting it to 
animal food uses, if permitted by the Food and Drug Administration. The 
owner or consignee of the refused entry product shall not transfer legal 
title to such

[[Page 537]]

product, except to a foreign consignee for direct and immediate 
exportation, or an end user, e.g., an animal food manufacturer or a 
renderer, for destruction for human food purposes. ``Refused entry'' 
product must be delivered to and used by the manufacturer or renderer 
within the 45-day time limit. Even if such title is illegally 
transferred, the subsequent purchaser will still be required to export 
the product or have it destroyed as specified in the notice under 
paragraph (a)(4) of this section.
    (3) No lot of product which has been refused entry may be subdivided 
during disposition pursuant to paragraph (a)(2) of this section, except 
that removal and destruction of any damaged or otherwise unsound product 
from a lot destined for reexportation is permitted under supervision of 
USDA prior to exportation. Additionally, such refused entry lot may not 
be shipped for export from any port other than that through which the 
product came into the United States without the expressed consent of the 
Administrator, based on full information concerning the product's 
disposition, including the name of the vessel and the date of export. 
For the purposes of this paragraph, the term ``lot'' shall refer to that 
product identified on MP Form 410 in the original request for inspection 
for importation pursuant to Sec. 381.198.
    (4) The owner or consignee shall have 45 days after notice is given 
by FSIS to the Director of Customs at the original port of entry to take 
the action required in paragraph (a)(2) of this section for ``refused 
entry'' product. Extension beyond the 45-day period may be granted by 
the Administrator when extreme circumstances warrant it; e.g., a dock 
workers' strike or an unforeseeable vessel delay.
    (5) If the owner or consignee fails to take the required action 
within the time specified under paragraph (a)(4) of this section, the 
Department will take such actions as may be necessary to effectuate its 
order to have the product destroyed for human food purposes. The 
Department shall seek court costs and fees, storage, and proper expenses 
in the appropriate forum.
    (6) No product which has been refused entry and exported to another 
country pursuant to paragraph (a)(2) of this section may be returned to 
the United States under any circumstance. Any such product so returned 
to the United States shall be subject to administrative detention in 
accordance with section 19 of the Act, and seizure and condemnation in 
accordance with section 20 of the Act.
    (b) Upon the request of the Director of Customs at the port where a 
product is offered for clearance through the customs, the consignee of 
the product shall, at the consignee's own expense, immediately return to 
the Director any product which has been delivered to consignee under 
this subpart and subsequently designated ``U.S. Refused Entry'' or found 
in any request not to comply with the requirements in this subpart.
    (c) Except as provided in Sec. 381.200(a) or (b), no person shall 
remove or cause to be removed from any place designated as the place of 
inspection, any poultry product which the regulations in this subpart 
require to be marked in any way, unless the same has been clearly and 
legibly marked in compliance with this subpart.
    (d) Any person receiving inspection service may, if dissatisfied 
with any decision of an inspector relating to any inspection, file an 
appeal from such decision: Provided, That such appeal is filed within 48 
hours from the time the decision was made. Any such appeal from a 
decision of an inspector shall be made to his/her immediate supervisor 
having jurisdiction over the subject matter of the appeal, and such 
supervisor shall determine whether the inspector's decision was correct. 
Review of such appeal determination, when requested, shall be made by 
the immediate supervisor of the employee of the Department making the 
appeal determination. The cost of any such appeal shall be borne by the 
appellant if the Administrator determines that the appeal is frivolous. 
The charges for such frivolous appeal shall be at the rate of $9.28 per 
hour for the time required to make the appeal inspection. The poultry or 
poultry products involved in any appeal shall be identified by U.S. 
retained tags and segregated in a manner

[[Page 538]]

approved by the inspector pending completion of an appeal inspection.
    (e) All condemned carcasses, or condemned parts of carcasses, or 
other condemned poultry products, except those condemned for biological 
residues, shall be disposed of by one of the following methods, under 
the supervision of an inspector of the Inspection Service. (Facilities 
and materials for carrying out the requirements in this section shall be 
furnished by the official establishments.)
    (1) Steam treatment (which shall be accomplished by processing the 
condemned product in a pressure tank under at least 40 pounds of steam 
pressure) or thorough cooking in a kettle or vat, a sufficient time to 
effectively destroy the product for human food purposes and preclude 
dissemination of disease through consumption by animals. (Tanks and 
equipment used for this purpose or for rendering or preparing inedible 
products shall be in rooms or compartments separate from those used for 
the preparation of edible products. There shall be no direct connection 
by means of pipes, or otherwise, between tanks containing inedible 
products and those containing edible products.)
    (2) Incineration or complete destruction by burning.
    (3) Chemical denaturing, which shall be accomplished by the liberal 
application to all carcasses and parts thereof, of:
    (i) Crude carbolic acid,
    (ii) Kerosene, fuel oil, or used crankcase oil, or
    (iii) Any phenolic disinfectant conforming to commercial standards 
CS 70-41 or CS 71-41 which shall be used in at least 2 percent emulsion 
or solution.
    (4) Any other substances or method that the Administrator approves 
in specific cases, which will denature the poultry product to the extent 
necessary to accomplish the purposes of this section.
    (5) Carcasses and parts of carcasses condemned for biological 
residue shall be disposed of in accordance with paragraph (e)(2) of this 
section or by burying under the supervision of an inspector.

[37 FR 9706, May 16, 1972, as amended at 48 FR 15890, Apr. 13, 1983; 50 
FR 19908, May 13, 1985; 51 FR 37709, Oct. 24, 1986; 53 FR 17015, May 13, 
1988; 54 FR 50735, Dec. 11, 1989; 60 FR 67458, Dec. 29, 1995]



Sec. 381.203  Products offered for entry; charges for storage, cartage, 
and labor with respect to products which are refused entry.

    All charges for storage, cartage, and labor with respect to any 
product offered for entry which is refused entry pursuant to the 
regulations shall be paid by the owner or consignee and, in default of 
such payment, shall constitute a lien against any other products offered 
for entry thereafter by or for such owner or consignee.

[54 FR 41050, Oct. 5, 1989]



Sec. 381.204  Marking of poultry products offered for entry; official 
import inspection marks and devices.

    (a) Except for products offered for entry from Canada, poultry 
products which upon reinspection are found to be acceptable for entry 
into the United States shall be marked with the official inspection 
legend shown in paragraph (b) of this section. Such inspection legend 
shall be placed upon such products only after completion of official 
import inspection and product acceptance.
    (b) The official mark for marking poultry products offered for entry 
as ``U.S. inspected and passed'' shall be in the following form, and any 
device approved by the Administrator for applying such mark shall be an 
official device.\2\
---------------------------------------------------------------------------

    \2\ The number ``I-42'' is given as an example only. The 
establishment number of the official establishment or official import 
inspection establishment where the product was inspected shall be shown 
on each stamp impression.

---------------------------------------------------------------------------

[[Page 539]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.044

                                Figure 1
    (c) When products are refused entry into the United States, the 
official mark to be applied to the products refused entry shall be in 
the following form:
[GRAPHIC] [TIFF OMITTED] TC11SE91.045

                                Figure 2
    (d) The import warning notice prescribed in Sec. 381.200(c) is an 
official mark.
    (e) The ordering and manufacture of brands shall be in accordance 
with the provisions contained in Sec. 317.3(c) of the Federal meat 
inspection regulations.
    (f) The inspection legend may be placed on containers of product 
before completion of official import inspection if the containers are 
being inspected by an import inspector who reports to an Import Field 
Office Supervisor, the product is not required to be held at the 
establishment pending the receipt of laboratory test results; and a 
written procedure for controlled stamping, submitted by the import 
establishment and approved by the Director, Import Inspection Division, 
is on file at the import inspection facility where the inspection is to 
be performed.
    (1) The written procedure for controlled pre-stamping should be in 
the form of a letter and shall include the following:
    (i) That stamping under this subpart will be limited to those lots 
of product which can be inspected on the day that certificates for the 
product are examined;
    (ii) That all products which have been pre-stamped will be stored in 
the facility where the import inspection will occur;
    (iii) That inspection marks applied under this part will be removed 
from any lot of product subsequently refused entry on the day the 
product is rejected; and
    (iv) That the establishment will maintain a daily stamping log 
containing the following information for each lot of product: the date 
of inspection, the country of origin, the foreign establishment number, 
the product name, the number of units, the shipping container marks, and 
the MP-410 number covering the product to be inspected. The daily 
stamping log must be retained by the establishment in accordance with 
the requirements of Sec. 381.177.
    (2) An establishment's controlled pre-stamping privilege may be 
cancelled orally or in writing by the inspector who is supervising its 
enforcement whenever the inspector finds that the establishment has 
failed to comply with the provisions of this subpart or any conditions 
imposed pursuant thereto. If the cancellation is oral, the decision and 
the reasons therefor shall be confirmed in writing, as promptly as 
circumstances allow. Any person whose controlled pre-stamping privilege 
has been cancelled may appeal the decision to the Administrator, in 
writing, within ten (10) days after receiving written notification of 
the cancellation. The appeal shall state all of the facts and reasons 
upon which the person relies to show that the controlled pre-stamping 
was wrongfully cancelled. The Administrator shall grant or deny the 
appeal, in writing, stating the reasons for such decision, as promptly 
as circumstances allow. If there is a conflict as to any material fact, 
a hearing shall be held

[[Page 540]]

to resolve such conflict. Rules of practice concerning such a hearing 
will be adopted by the Administrator. The cancellation of the controlled 
pre-stamping privilege will be in effect until there is a final 
determination in the proceeding.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[51 FR 37710, Oct. 24, 1986, as amended at 53 FR 17015, May 13, 1988; 54 
FR 41050, Oct. 5, 1989]



Sec. 381.205  Labeling of immediate containers of poultry products 
offered for entry.

    (a) Immediate containers of poultry products imported into the 
United States shall bear a label printed in English showing in 
accordance with subpart N of this part all information required by that 
section (except that the inspection mark and establishment number 
assigned by the foreign poultry inspection system and certified to the 
Inspection Service shall be shown instead of the official dressed 
poultry identification mark or other official inspection legend, and 
official establishment number); and in addition the label shall show the 
name of the country of origin preceded by the words ``Product of,'' 
which statement shall appear immediately under the name of the product.
    (b) The labels shall not be false or misleading in any respect.
    (c) All marks and other labeling for use on or with immediate 
containers shall be approved for use by the Food Safety and Inspection 
Service in accordance with Sec. Sec. 381.132 and 381.133 before 
products bearing such marks and other labeling will be permitted for 
entry into the United States.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 54 FR 
41050, Oct. 5, 1989; 60 FR 67458, Dec. 29, 1995]



Sec. 381.206  Labeling of shipping containers of poultry products offered 
for entry.

    Shipping containers of imported poultry products are required to 
bear in a prominent and legible manner the name of the product, the name 
of the country of origin, the foreign inspection system establishment 
number of the establishment in which the product was processed, and the 
inspection mark of the country of origin. Labeling on shipping 
containers shall be examined at the time of inspection in the United 
States and if found to be false or misleading, the product shall be 
refused entry. All labeling used with a shipping container of imported 
poultry products must be approved in accordance with subpart N of this 
part.

[37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989; 60 
FR 67458, Dec. 29, 1995]



Sec. 381.207  Small importations for consignee's personal use, display, 
or laboratory analysis.

    Any poultry product (other than one which is forbidden entry by 
other Federal law or regulation) from any country in quantities of less 
than 50 pounds net weight, exclusively for the personal use of the 
consignee, or for display or laboratory analysis by the consignee, and 
not for sale or distribution; which is sound, healthful, wholesome, and 
fit for human food, and which is not adulterated and contains no 
substance not permitted by the Act or regulations, may be imported into 
the United States without a foreign inspection certificate, and such 
product is not required to be inspected upon arrival in the United 
States and may be shipped to the consignee without further restriction 
under this part, except as provided in Sec. 381.199(c): And provided, 
That the Department may with respect to any specific importation, 
require that the consignee certify that such product is exclusively for 
the personal use of said consignee, or for display or laboratory 
analysis by said consignee, and not for sale or distribution.

[37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989]



Sec. 381.208  Poultry products offered for entry and entered to be 
handled and transported as domestic; entry into official establishments; 
transportation.

    (a) All poultry products, after entry into the United States in 
compliance with this subpart, shall be deemed and treated and, except as 
provided in Sec. 381.207, shall be handled and transported as domestic 
products, and shall be subject to the applicable provisions

[[Page 541]]

of this part and to the provisions of the Poultry Products Inspection 
Act and the Federal Food, Drug, and Cosmetic Act.
    (b) Poultry products entered in accordance with this subpart may, 
subject to the provisions of the regulations, be taken into official 
establishments and be mixed with or added to poultry products that are 
inspected and passed or exempted from inspection in such establishments.
    (c) Imported poultry products which have been inspected, passed, and 
marked under this subpart may be transported in commerce, only upon 
compliance with the applicable regulations.

[37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989]



Sec. 381.209  Returned United States inspected and marked poultry 
products; exemption.

    Poultry products which have been inspected and passed by the U.S. 
Department of Agriculture and are so marked, and are returned from 
foreign countries, may be imported if they are not adulterated or 
misbranded at the time of such return. Such products are exempted from 
further requirements under this part. Such returned shipments shall be 
reported to the Administrator by letter prior to arrival at the United 
States port of entry.



    Subpart U_Detention; Seizure and Condemnation; Criminal Offenses



Sec. 381.210  Poultry and other articles subject to administrative 
detention.

    Any poultry carcass, or part thereof; or any product made wholly or 
in part from any poultry carcass or part thereof; or any dead, dying, 
disabled, or diseased poultry is subject to detention for a period not 
to exceed 20 days when found by any authorized representative of the 
Secretary upon any premises where it is held for purposes of, or during 
or after distribution in commerce or otherwise subject to the Act, and 
there is reason to believe that any such poultry or other article is 
adulterated or misbranded and is capable of use as human food or has not 
been inspected, in violation of the provisions of the Act, any other 
Federal law, or the laws of any State or territory, or the District of 
Columbia; or that it has been or is intended to be distributed in 
violation of the provisions of the Act, any other Federal law, or the 
laws of any State or territory, or the District of Columbia.



Sec. 381.211  Method of detention; form of detention tag.

    An authorized representative of the Secretary shall detain any 
poultry or other article to be detained under this subpart, by affixing 
an official ``U.S. Detained'' tag (FSIS Form 8400-2) to such article.

[55 FR 47843, Nov. 16, 1990]



Sec. 381.212  Notification of detention to the owner of the poultry or 
other article, or the owner's agent, and person having custody.

    (a) When any poultry or other article is detained under this 
subpart, an authorized representative of the Secretary shall:
    (1) Orally notify the immediate custodian of the poultry or other 
article detained, and
    (2) Promptly furnish a copy of a completed ``Notice of Detention'' 
(FSIS Form 8080-1) to the immediate custodian of the detained poultry or 
other article.
    (b) If the owner of the detained poultry or other article, or the 
owner's agent, is not the immediate custodian at the time of detention 
and if the owner, or owner's agent, can be ascertained and notified, an 
authorized representative of the Secretary shall furnish a copy of the 
completed ``Notice of Detention'' to the owner, or the owner's agent. 
Such copy shall be served, as soon as possible, by delivering the 
notification to the owner, or the owner's agent, or by certifying and 
mailing the notification to the owner, or the owner's agent, at his or 
her last known residence or principal office or place of business.

[55 FR 47843, Nov. 16, 1990]



Sec. 381.213  Notification of governmental authorities having jurisdiction 
over article detained; form of written notification.

    Within 48 hours after the detention of any poultry or other article 
pursuant

[[Page 542]]

to Sec. 381.211, an authorized representative of the Secretary shall 
give oral or written notification of such detention to any Federal 
authorities not connected with the Inspection Service, and any State or 
other governmental authorities, having jurisdiction over such article. 
In the event notification is given orally, it shall be confirmed in 
writing, as promptly as circumstances permit.



Sec. 381.214  Movement of poultry or other article detained; removal 
of official marks.

    (a) No poultry or other article detained in accordance with the 
provisions in this subpart shall be moved by any person from the place 
at which it is located when so detained, until released by an authorized 
representative of the Secretary: Provided, That any such article may be 
moved from the place at which it is located when so detained, for 
refrigeration or freezing, or storage purposes if such movement has been 
approved by an authorized representative of the Secretary and the 
article so moved will be further detained by an authorized 
representative of the Secretary after such movement.
    (b) Upon terminating the detention of such article, an authorized 
representative of the Secretary shall:
    (1) Orally notify the immediate custodian of the released article, 
and
    (2) Furnish copies of a completed ``Notice of Termination of 
Detention'' (FSIS Form 8400-1) to the persons notified when the article 
was detained. The notice shall be served by either delivering the notice 
to such persons or by certifying and mailing the notice to such persons 
at their last known residences or principal offices or places of 
business.
    (c) All official marks may be required by such representative to be 
removed from such article before it is released unless it appears to the 
satisfaction of the representative that the article is eligible to 
retain such marks.

[37 FR 9706, May 16, 1972, as amended at 55 FR 47843, Nov. 16, 1990]



Sec. 381.215  Poultry or other articles subject to judicial seizure 
and condemnation.

    Any poultry carcass, or part thereof, or any product made wholly or 
in part from any poultry carcass or part thereof; except those exempted 
from the definition of a poultry product in Sec. 381.15, or any dead, 
dying, disabled, or diseased poultry, that is being transported in 
commerce or is otherwise subject to the Act, or is held for sale in the 
United States after such transportation, is subject to seizure and 
condemnation, in a judicial proceeding pursuant to section 20 of the Act 
if such poultry or other article:
    (a) Is or has been processed, sold, transported, or otherwise 
distributed or offered or received for distribution in violation of the 
Act; or
    (b) Is capable of use as human food and is adulterated or 
misbranded; or
    (c) In any other way is in violation of the Act.



Sec. 381.216  Procedure for judicial seizure, condemnation, and 
disposition.

    Any poultry or other article subject to seizure and condemnation 
under this subpart is liable to be proceeded against and seized and 
condemned, and disposed of, at any time, on an appropriate pleading in 
any U.S. district court, or other proper court specified in section 21 
of the Act, within the jurisdiction of which the article is found.



Sec. 381.217  Authority for condemnation or seizure under other 
provisions of law.

    The provisions of this subpart relating to detention, seizure, 
condemnation and disposition of poultry or other articles do not 
derogate from authority for retention, condemnation, or seizure 
conferred by other provisions of the Act, or other laws.



Sec. 381.218  Criminal offenses.

    The Act contains criminal provisions with respect to numerous 
offenses specified in the Act, including but not limited to forcible 
assaults on, or other interference with, any person while engaged in, or 
on account of the performance of, his official duties under the Act. 
Criminal provisions with respect

[[Page 543]]

to gifts or offers of bribes to such persons and related offenses are 
contained in the general criminal code (18 U.S.C. 201).



  Subpart V_Special Provisions for Designated States and Territories; 

 Criteria and Procedure for Designat ing Establishments With Operations 
 Which Would Clearly Endanger the Public Health; Disposition of Poultry 
                            Products Therein



Sec. 381.220  Definition of ``State''.

    For purposes of this subpart, the term ``State'' means any State 
(including the Commonwealth of Puerto Rico) or organized territory.



Sec. 381.221  Designation of States under paragraph 5(c) of the Act.

    Each of the following States has been designated, under paragraph 
5(c) of the Act, as a State in which the provisions of sections 1 
through 4, 6 through 10, and 12 through 22 of the Act shall apply to 
operations and transactions wholly within the State. The Federal 
provisions apply, effective on the dates shown below:

------------------------------------------------------------------------
                                                  Effective date of
                  States                       application of Federal
                                                     provisions
------------------------------------------------------------------------
Alaska....................................  July 31, 1999.
Arkansas..................................  Jan. 2, 1971.
California................................  Apr. 1, 1976.
Colorado..................................  Jan. 2, 1971.
Connecticut...............................  Oct. 1, 1975.
Florida...................................  Dec. 2, 1997.
Georgia...................................  Jan. 2, 1971.
Guam......................................  Jan. 21, 1972.
Hawaii....................................  Nov. 1, 1995.
Idaho.....................................  Jan. 2, 1971.
Kentucky..................................  July 28, 1971.
Maryland..................................  Mar. 31, 1991.
Massachusetts.............................  Jan. 12, 1976.
Michigan..................................  Jan. 2, 1971.
Nebraska..................................  July 28, 1971.
Nevada....................................  July 1, 1973.
New Hampshire.............................  Aug. 6, 1978
New Jersey................................   Do.
New York..................................  Apr. 10, 1977.
Northern Mariana Islands..................  Oct. 29, 1979.
Oregon....................................  Jan. 2, 1971.
Pennsylvania..............................  Oct. 31, 1971.
Puerto Rico...............................  Jan. 17, 1972.
Rhode Island..............................  Oct. 1, 1981.
South Dakota..............................  Jan. 2, 1971.
Tennessee.................................  Oct. 1, 1975.
Virgin Islands............................  Nov. 27, 1971.
Washington................................  June 1, 1973.
------------------------------------------------------------------------


[42 FR 2949, Jan. 14, 1977, as amended at 42 FR 13270, Mar. 10, 1977; 43 
FR 29269, July 7, 1978; 44 FR 55809, Sept. 28, 1979; 46 FR 43829, Sept. 
1, 1981; 53 FR 20101, June 2, 1988; 55 FR 36609, Sept. 6, 1990; 56 FR 
8909, Mar. 4, 1991; 60 FR 49495, Sept. 26, 1995; 60 FR 54414, Oct. 24, 
1995; 62 FR 61010, Nov. 14, 1997; 64 FR 37667, July 13, 1999; 65 FR 
6887, Feb. 11, 2000; 66 FR 2207, Jan. 11, 2001; 67 FR 61768, Oct. 2, 
2002; 70 FR 35166, June 17, 2005]



Sec. 381.222  States designated under paragraph 5(c) of the Act; 
application of regulations.

    The provisions of the regulations in this part apply to operations 
and transactions wholly within each State designated in Sec. 381.221 
under paragraph 5(c) of the Act, except as otherwise provided in this 
section. (The provisions of the regulations apply in all respects to 
operations and transactions in or for commerce.)
    (a) Each establishment located in such a designated State, shall be 
granted inspection required under Sec. 381.6(b) only if it is found, 
upon a combined evaluation of its premises, facilities, and operating 
procedures, to be capable of producing products that are not adulterated 
or misbranded.
    (b) Section 381.26 will apply to establishments required to have 
inspection under Sec. 381.6(b), except that existing interconnections 
between official and unofficial establishments or between official 
establishments will be permitted if it is determined in specific cases 
that the interconnections are such that transfer of inedible poultry 
product into the official establishment would be difficult or unusual, 
and any such transfers are strictly prohibited, except as permitted 
under other provisions of the regulations. It is essential that 
separation of facilities be maintained to the extent necessary to assure 
that inedible poultry product does not enter the official establishment 
contrary to the regulations.
    (c) Sections 381.49 and 381.51 shall apply to such establishments, 
except that separate facilities for men and women workers will not be 
required when the majority of the workers in the establishment are 
related by blood or marriage, provided that this will not conflict with 
municipal or State requirements; and except that separation of toilet 
soil lines from house drainage

[[Page 544]]

lines to a point outside the buildings will not be required in existing 
construction when positive acting backflow devices are installed.
    (d) Subpart N of this part shall apply to such establishments except 
as provided in this paragraph (d).
    (1) The operator of each such establishment shall, prior to the 
inauguration of inspection, identify all labeling and marking devices in 
use, or proposed for use (upon the date of inauguration of inspection) 
to the Circuit Supervisor in which the establishment is located. 
Temporary approval, pending formal approval under Sec. 381.132, will be 
granted by the Circuit Supervisor for labeling and marking devices that 
he determines are neither false nor misleading, provided the official 
inspection legend bearing the official establishment number is applied 
to the principal display panel of each label, either by a mechanical 
printing device or a self-destructive pressure sensitive sticker, and 
provided the label shows the true product name, an accurate ingredient 
statement, the name and address of the manufacturer, packer, or 
distributor, and any other features required by paragraph 4(h) of the 
Act.
    (2) The Circuit Supervisor will forward one copy of each item of 
labeling and a description of each marking device for which he has 
granted temporary approval to the Washington, DC; office of the Labels 
and Packaging Staff and will retain one copy in a temporary approval 
file for the establishment.
    (3) The operator of the official establishment shall promptly 
forward a copy of each item of labeling and a description of each 
marking device for which temporary approval has been granted by the 
Circuit Supervisor (showing any modifications required by the Circuit 
Supervisor) to the Labels and Packaging Staff, Meat and Poultry 
Inspection Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250, accompanied by the formula and 
details of preparation and packaging for each product. Within 90 days 
after inauguration of inspection, all labeling material and marking 
devices temporarily approved by the Circuit Supervisor must receive 
approval as required by Sec. 381.132 or their use must be discontinued.
    (4) The Circuit Supervisor will also review all shipping containers 
to insure that they do not have any false or misleading labeling and are 
otherwise not misbranded. Modifications of unacceptable information on 
labeling material by the use of pressure sensitive tape of a type that 
cannot be removed without visible evidence of such removal, or by 
blocking out with an ink stamp will be authorized on a temporary basis 
to permit the maximum allowable use of all labeling materials on hand. 
All unacceptable labeling material which is not modified to comply with 
the requirements of the regulations must be destroyed or removed from 
the official establishment.
    (e) Sections 381.175 through 381.179 apply to operations and 
transactions not in or for commerce in a State designated under 
paragraph 5(c) only if the State is also designated under section 11 of 
the Act and if such provisions are applicable as shown in Sec. 381.224.
    (f) Section 381.185(a) will not apply to States designated under 
paragraph 5(c) of the Act.
    (g) Provisions of this part relating to exports and imports do not 
apply to operations and transactions solely in or for intrastate 
commerce.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 62 FR 
45027, Aug. 25, 1997]



Sec. 381.223  Control and disposition of nonfederally inspected poultry 
products in States designated under paragraph 5(c) of the Act.

    Upon the effective date of designation of a State under paragraph 
5(c) of the Act, no poultry products can be processed within the State 
unless they are prepared under inspection pursuant to the regulations or 
are exempted from the requirement of inspection under Sec. 381.10, and 
no unexempted poultry products which were processed without any 
inspection can lawfully be distributed within the State. For a period of 
90 days from the effective date of such designation, poultry products 
which were processed in any State listed in Sec. 381.187 and inspected 
and passed under the supervision of a responsible

[[Page 545]]

State or local inspection agency or exempted from State inspection can 
be distributed solely within the State, provided they are not 
adulterated or misbranded, except that the official inspection legend 
shall not be used. Such products may not enter official establishments. 
After said 90-day period, only federally inspected and passed products 
may be distributed within the designated State, except as provided in 
Sec. 381.10.



Sec. 381.224  Designation of States under section 11 of the Act; 
application of sections of the Act and the regulations.

    Each of the following States has been designated, effective on the 
date shown below, under section 11 of the Act, as a State in which the 
provisions of the sections of the Act and regulations specified below 
shall apply to operators engaged, other than in or for commerce, in the 
kinds of business indicated below:

----------------------------------------------------------------------------------------------------------------
Paragraphs of act and regulations         Classes of operators                State             Effective date
----------------------------------------------------------------------------------------------------------------
Act, 11(b): Sec. Sec. 381.175-  Persons engaged (not in or for     Alaska...............  July 31, 1999.
 381.178.                           commerce) in (1) the business of  Arkansas.............  Apr. 1, 1976.
                                    slaughtering any poultry or       California...........  July 1, 1975.
                                    processing, freezing, packaging,  Colorado.............  Oct. 1, 1975.
                                    or labeling any poultry           Connecticut..........  Nov. 12, 1976.
                                    carcasses, or parts or products   Georgia..............  Nov. 19, 1976.
                                    thereof, for use as human food    Guam.................  Nov. 12, 1976.
                                    or animal food; (2) the business  Idaho................  Apr. 18, 1973.
                                    of buying or selling (as a        Kentucky.............  Nov. 12, 1976.
                                    poultry products broker,          Maryland.............  Jan. 12, 1976.
                                    wholesaler, or otherwise),        Massachusetts........  Nov. 12, 1976.
                                    transporting or storing any       Michigan.............  Jan. 31, 1975.
                                    poultry carcasses, or parts or    Nebraska.............  Jan. 31, 1975.
                                    products thereof; or (3)          Nevada...............  Oct. 29, 1979.
                                    business as a renderer or in the  New Hampshire........  July 1, 1975.
                                    business of buying, selling, or   New Jersey...........  July 16, 1975.
                                    transporting any dead, dying,     New York.............  July 23, 1973.
                                    disabled, or diseased poultry or  Northern Mariana       Oct. 29, 1979.
                                    parts of carcasses of any          Islands.              Jan. 31, 1975.
                                    poultry that died otherwise than  Oregon...............  ...................
                                    by slaughter.                     Pennsylvania.........  May 2, 1974.
                                                                      Puerto Rico..........  Nov. 19, 1976.
                                                                      Rhode Island.........  Mar. 29, 1982.
                                                                      South Dakota.........  Nov. 12, 1976.
                                                                      Tennessee............  Oct. 1, 1975.
                                                                      Virgin Islands.......  Nov. 19, 1976.
                                                                      Washington...........  Jan. 31, 1975.
                                                                                             Nov. 12, 1976.

[[Page 546]]

 
Act, 11(c); Sec. 381.179.......  Persons engaged (not in or for     Alaska...............  July 31, 1999.
                                    commerce) in business as a        Arkansas.............  Apr. 1, 1976.
                                    poultry products broker;          California...........  July 1, 1975.
                                    renderer; animal food             Colorado.............  Oct. 1, 1975.
                                    manufacturer; wholesaler or       Connecticut..........  Nov. 12, 1976.
                                    public warehouseman of poultry    Georgia..............  Nov. 19, 1976.
                                    carcasses, or parts or products   Guam.................  Nov. 12, 1976.
                                    thereof; or buying, selling, or   Idaho................  Apr. 18, 1973.
                                    transporting dead, dying,         Kentucky.............  Nov. 12, 1976.
                                    disabled, or diseased poultry or  Maryland.............  Jan. 12, 1976.
                                    parts of carcasses of any         Massachusetts........  Nov. 12, 1976.
                                    poultry that died otherwise than  Michigan.............  Jan. 31, 1975.
                                    by slaughter.                     Nebraska.............  Jan. 31, 1975.
                                                                      Nevada...............  Oct. 29, 1979.
                                                                      New Hampshire........  July 1, 1975.
                                                                      New Jersey...........  July 16, 1975.
                                                                      New York.............  July 23, 1973.
                                                                      Northern Mariana       Oct. 29, 1979.
                                                                       Islands.              Jan. 31, 1975.
                                                                      Oregon...............  ...................
                                                                      Pennsylvania.........  May 2, 1974.
                                                                      Puerto Rico..........  Nov. 19, 1976.
                                                                      Rhode Island.........  Mar. 29, 1982.
                                                                      South Dakota.........  Nov. 12, 1976.
                                                                      Tennessee............  Oct. 1, 1975.
                                                                      Virgin Islands.......  Nov. 19, 1976.
                                                                      Washington...........  Jan. 31, 1975.
                                                                                             Nov. 12, 1976.
Act, 11(d); 381.194..............  Persons engaged (not in or for     Alaska...............  July 31, 1999.
                                    commerce) in the business of      Arkansas.............  Nov. 12, 1976.
                                    buying, selling or transporting   Georgia..............  Nov. 19, 1976.
                                    any dead, dying, disabled or      Guam.................  Nov. 12, 1976.
                                    diseased poultry, or parts or     Idaho................  Nov. 12, 1976.
                                    carcasses of any poultry that     Maryland.............  Nov. 12, 1976.
                                    died otherwise than by slaughter. Michigan.............  Oct. 29, 1979.
                                                                      New Hampshire........  Oct. 29, 1979.
                                                                      Northern Mariana       Nov. 19, 1976.
                                                                       Islands.              ...................
                                                                      Puerto Rico..........  Mar. 29, 1982.
                                                                      Rhode Island.........  Nov. 12, 1976.
                                                                      South Dakota.........  Nov. 19, 1976.
                                                                      Virgin Islands.......  Nov. 12, 1976.
----------------------------------------------------------------------------------------------------------------


[37 FR 9706, May 16, 1972; 65 FR 6888, Feb. 11, 2000]

    Editorial Note: For Federal Register citations affecting Sec. 
381.224, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 381.225  Criteria and procedure for designating establishments with 
operations which would clearly endanger the public health; disposition 
of poultry products therein.

    (a) An establishment in any State not listed in Sec. 381.221 that 
is preparing poultry products solely for distribution within such State 
shall be designated as one producing adulterated products which would 
clearly endanger the public health, if:
    (1) Any poultry product processed at the establishment is 
adulterated in any of the following respects:
    (i) It bears or contains a pesticide chemical, food additive, or 
color additive, that is ``unsafe'' within the meaning of section 408, 
409, or 706 of the Federal Food, Drug, and Cosmetic Act or was 
intentionally subjected to radiation in a manner not permitted under 
section 409 of said Act; or if it bears or contains any other added 
poisonous or

[[Page 547]]

added deleterious substance which may render it injurious to health or 
make it unfit for human food; or
    (ii) It consists in whole or in part of any filthy, putrid or 
decomposed substance or is for any other reason unsound, unhealthful, 
unwholesome, or otherwise unfit for human food (for example, it was 
prepared from a poultry carcass or other ingredients exhibiting spoilage 
characteristics); or it is, or was prepared from, a poultry carcass 
which would be required to be condemned under subpart K at official 
establishments; or
    (iii) It has been prepared, packed or held under insanitary 
conditions whereby it may have become contaminated with filth or may 
have been rendered injurious to health (for example, if insects or 
vermin are not effectively controlled at the establishment, or 
insanitary water is used in preparing poultry products for human food); 
or
    (iv) It is, in whole or in part, the product of poultry that died 
otherwise than by slaughter; or
    (v) Its container is composed, in whole or in part, of any poisonous 
or deleterious substance which may render the contents injurious to 
health; and
    (2) Such adulterated articles are intended to be or are distributed 
from the establishment while capable of use as human food.
    (b) When any such establishment is identified by an inspector as one 
producing adulterated poultry products which would clearly endanger 
public health under the criteria in paragraph (a) of this section, the 
following procedure will be followed:
    (1) The inspector will informally advise the operator of the 
establishment concerning the deficiencies found by him and report his 
findings to the appropriate Regional Director for the Inspection 
Service. When it is determined by the Regional Director that any 
establishment preparing poultry products solely for distribution within 
any State is producing adulterated poultry products for distribution 
within such State which would clearly endanger the public health, 
written notification thereof will be issued to the appropriate State 
officials, including the Governor of the State and the appropriate 
Advisory Committee, for effective action under State or local law to 
prevent such endangering of the public health. Such written notification 
shall clearly specify the deficiencies deemed to result in the 
production of adulterated poultry products and shall specify a 
reasonable time for such action under State or local law.
    (2) If effective action is not taken under State or local law within 
the specified time, written notification shall be issued by the Regional 
Director to the operator of the establishment, specifying the 
deficiencies involved and allowing him 10 days to present his views or 
make the necessary corrections, and notifying him that failure to 
correct such deficiencies may result in designation of the establishment 
and operator thereof as subject to the provisions of sections 1 through 
4, 6 through 10, and 12 through 22 of the Act as though engaged in 
commerce.
    (3) Thereafter the inspector shall survey the establishment and 
designate it if he determines, in consultation with the Regional 
Director, that it is producing adulterated poultry products, which would 
clearly endanger the public health, and formal notice of such 
designation will be issued to the operator of the establishment by the 
Regional Director.
    (c) Poultry products on hand at the time of designation of an 
establishment under this section are subject to retention or detention, 
and seizure and condemnation in accordance with Sec. 381.145 or subpart 
U of this part: Provided, That poultry products that have been federally 
inspected and so identified and that have not been further prepared at 
any nonfederally inspected establishment may be released for 
distribution if the products appear to be not adulterated or misbranded 
at the time of such release.
    (d) No establishment designated under this section can lawfully 
prepare any poultry products unless it first obtains inspection or 
qualifies for exemption under Sec. 381.10 of this subpart. All other 
provisions of the regulations shall apply to establishments designated 
under this section to the same extent and in the same manner as if

[[Page 548]]

they were engaged in commerce, except that the exceptions provided for 
in Sec. 381.222 shall apply to such establishments.



                  Subpart X_Canning and Canned Products

    Source: 51 FR 45634, Dec. 19, 1986, unless otherwise noted.



Sec. 381.300  Definitions.

    (a) Abnormal container. A container with any sign of swelling or 
product leakage or any evidence that the contents of the unopened 
container may be spoiled.
    (b) Acidified low acid product. A canned product which has been 
formulated or treated so that every component of the finished product 
has a pH of 4.6 or lower within 24 hours after the completion of the 
thermal process unless data are available from the establishment's 
processing authority demonstrating that a longer time period is safe.
    (c) Bleeders. Small orifices on a retort through which steam, other 
gasses, and condensate are emitted from the retort throughout the entire 
thermal process.
    (d) Canned product. A poultry food product with a water activity 
above 0.85 which receives a thermal process either before or after being 
packed in a hermetically sealed container. Unless otherwise specified, 
the term ``product'' as used in this subpart G shall mean ``canned 
product.''
    (e) Closure technician. The individual(s) identified by the 
establishment as being trained to perform specific container integrity 
examinations as required by this subpart and designated by the 
establishment to perform such examinations.
    (f) Code lot. All production of a particular product in a specific 
size container marked with a specific container code.
    (g) Come-up time. The elapsed time, including venting time (if 
applicable), between the introduction of the heating medium into a 
closed retort and the start of process timing.
    (h) Critical factor. Any characteristic, condition or aspect of a 
product, container, or procedure that affects the adequacy of the 
process schedule. Critical factors are established by processing 
authorities.
    (i) Headspace. That portion of a container not occupied by the 
product.
    (1) Gross headspace. The vertical distance between the level of the 
product (generally the liquid surface) in an upright rigid container and 
the top edge of the container (i.e., the flange of an unsealed can, the 
top of the double seam on a sealed can, or the top edge of an unsealed 
jar).
    (2) Net headspace. The vertical distance between the level of the 
product (generally the liquid surface) in an upright rigid container and 
the inside surface of the lid.
    (j) Hermetically sealed containers. Air-tight containers which are 
designed and intended to protect the contents against the entry of 
microorganisms during and after thermal processing.
    (1) Rigid container. A container, the shape or contour of which, 
when filled and sealed, is neither affected by the enclosed product nor 
deformed by external mechanical pressure of up to 10 pounds per square 
inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger pressure).
    (2) Semirigid container. A container, the shape or contour of which, 
when filled and sealed, is not significantly affected by the enclosed 
product under normal atmospheric temperature and pressure, but can be 
deformed by external mechanical pressure of less than 10 pounds per 
square inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger pressure).
    (3) Flexible container. A container, the shape or contour of which, 
when filled and sealed, is significantly affected by the enclosed 
product.
    (k) Incubation tests. Tests in which the thermally processed product 
is kept at a specific temperature for a specified period of time in 
order to determine if outgrowth of microorganisms occurs.
    (l) Initial temperature. The temperature, determined at the 
initiation of a thermal process cycle, of the contents of the coldest 
container to be processed.
    (m) Low acid product. A canned product in which any component has a 
pH value above 4.6.

[[Page 549]]

    (n) Process schedule. The thermal process and any specified critical 
factors for a given canned product required to achieve shelf stability.
    (o) Process temperature. The minimum temperature(s) of the heating 
medium to be maintained as specified in the process schedule.
    (p) Process time. The intended time(s) a container is to be exposed 
to the heating medium while the heating medium is at or above the 
process temperature(s).
    (q) Processing authority. The person(s) or organization(s) having 
expert knowledge of thermal processing requirements for foods in 
hermetically sealed containers, having access to facilities for making 
such determinations, and designated by the establishment to perform 
certain functions as indicated in this subpart.
    (r) Program employee. Any inspector or other individual employed by 
the Department or any cooperating agency who is authorized by the 
Secretary to do any work or perform any duty in connection with the 
Program (see Sec. 301.2(f)).
    (s) Retort. A pressure vessel designed for thermal processing of 
product packed in hermetically sealed containers.
    (t) Seals. Those parts of a semirigid container and lid or of a 
flexible container that are fused together in order to hermetically 
close the container.
    (u) Shelf stability. The condition achieved by application of heat, 
sufficient, alone or in combination with other ingredients and/or 
treatments, to render the product free of microorganisms capable of 
growing in the product at nonrefrigerated conditions (over 50 [deg]F or 
10 [deg]C) at which the product is intended to be held during 
distribution and storage. Shelf stability and shelf stable are 
synonymous with commercial sterility and commercially sterile, 
respectively.
    (v) Thermal process. The heat treatment necessary to achieve shelf 
stability as determined by the establishment's processing authority. It 
is quantified in terms of:
    (1) Time(s) and temperature(s); or
    (2) Minimum product temperature.
    (w) Venting. The removal of air from a retort before the start of 
process timing.
    (x) Water activity. The ratio of the water vapor pressure of the 
product to the vapor pressure of pure water at the same temperature.



Sec. 381.301  Containers and closures.

    (a) Examination and cleaning of empty containers. (1) Empty 
containers, closures, and flexible pouch roll stock shall be evaluated 
by the establishment to ensure that they are clean and free of 
structural defects and damage that may affect product or container 
integrity. Such an examination should be based upon a statistical 
sampling plan.
    (2) All empty containers, closures, and flexible pouch roll stock 
shall be stored, handled, and conveyed in such a manner that will 
prevent soiling and damage that could affect the hermetic condition of 
the sealed container.
    (3) Just before filling, rigid containers shall be cleaned to 
prevent incorporation of foreign matter into the finished product. 
Closures, semirigid containers, preformed flexible pouches, and flexible 
pouch roll stock contained in original wrappings do not need to be 
cleaned before use.
    (b) Closure examinations for rigid containers (cans). (1) Visual 
examinations. A closure technician shall visually examine the double 
seams formed by each closing machine head. When seam defects (e.g., 
cutovers, sharpness, knocked down flanges, false seams, droops) are 
observed, necessary corrective actions, such as adjusting or repairing 
the closing machine, shall be taken. In addition to the double seams, 
the entire container shall be examined for product leakage or obvious 
defects. A visual examination shall be performed on at least one 
container from each closing machine head, and the observations, along 
with any corrective actions, shall be recorded. Visual examinations 
shall be recorded. Visual examinations shall be conducted with 
sufficient frequency to ensure proper closure and should be conducted at 
least every 30 minutes of continuous closing machine operation. 
Additional visual examinations shall be made by the closure technician 
at the beginning

[[Page 550]]

of production, immediately following every jam in the closing machine 
and after closing machine adjustment (including adjustment for changes 
in container size).
    (2) Teardown examinations. Teardown examinations of double seams 
formed by each closing machine head shall be performed by a closure 
technician at a frequency sufficient to ensure proper closure. These 
examinations should be made at intervals of not more than 4 hours of 
continuous closing machine operation. At least one container from each 
closing head shall be examined on the packer's end during each regular 
examination period. Examination results along with any necessary 
corrective actions, such as adjusting or repairing the closing machine, 
shall be promptly recorded by the closure technician. The establishment 
shall have container specification guidelines for double seam integrity 
on file and available for review by Program employees. A teardown 
examination of the can maker's end shall be performed on at least one 
container selected from each closing machine during each examination 
period except when teardown examinations are made on incoming empty 
containers or when, in the case of self-manufactured containers, the 
containers are made in the vicinity of the establishment and the 
container plant records are made available to Program employees. 
Additional teardown examinations on the packer's end should be made at 
the beginning of production, immediately following every jam in a 
closing machine and after closing machine adjustment (including 
adjustment for a change in container size). The following procedures 
shall be used in teardown examinations of double seams:
    (i) One of the following two methods shall be employed for 
dimensional measurements of the double seam.
    (a) Micrometer measurement. For cylindrical containers, measure the 
following dimensions (Figure 1) at three points approximately 120 
degrees apart on the double seam excluding and at least one-half inch 
from the side seam juncture:
    (1) Double seam length--W;
    (2) Double seam thickness--S;
    (3) Body hook length--BH; and
    (4) Cover hook length--CH.

Maximum and minimum values for each dimensional measurement shall be 
recorded by the closure technician.
[GRAPHIC] [TIFF OMITTED] TC11SE91.046

    (b) Seamscope or seam projector. Required measurements of the seam 
include thickness, body hook, and overlap. Seam thickness shall be 
obtained by micrometer. For cylindrical containers, at least two 
locations, excluding the side seam juncture, shall be used to obtain the 
required measurements.
    (ii) Seam tightness. Regardless of the dimensional measurement 
method used to measure seam dimensions, at a minimum, the seam(s) 
examined shall be stripped to assess the degree of wrinkling.
    (iii) Side seam juncture rating. Regardless of the dimensional 
measurement method used to measure seam dimensions, the cover hook shall 
be stripped to examine the cover hook droop at the juncture for 
containers having side seams.
    (iv) Examination of noncylindrical containers. Examination of 
noncylindrical containers (e.g., square, rectangular, ``D''-shaped, and 
irregularly-shaped) shall be conducted as described in paragraphs (b)(2) 
(i), (ii), and (iii) of this section except that the required 
dimensional measurements shall be made on the double seam at the points 
listed in

[[Page 551]]

the establishment's container specification guidelines.
    (c) Closure examinations for glass containers--(1) Visual 
examinations. A closure technician shall visually assess the adequacy of 
the closures formed by each closing machine. When closure defects, such 
as loose or cocked caps, fractured or cracked containers and low vacuum 
jars, are observed, necessary corrective actions, such as adjusting or 
repairing the closing machine, shall be taken and recorded. In addition 
to the closures, the entire container shall be examined for defects. 
Visual examinations shall be made with sufficient frequency to ensure 
proper closure and should be conducted at least every 30 minutes of 
continuous closing machine operation. Additional visual examinations 
shall be made by the closure technician and the observations recorded at 
the beginning of production, immediately following every jam in the 
closing machine, and after closing machine adjustment (including 
adjustment for a change in container size).
    (2) Closure examinations and tests. Depending upon the container and 
closure, tests shall be performed by a closure technician at a frequency 
sufficient to ensure proper closure. These examinations should be made 
either before or after thermal processing and at intervals of not more 
than 4 hours of continuous closing machine operation. At least one 
container from each closing machine shall be examined during each 
regular examination period. Examination results along with any necessary 
corrective actions, such as adjusting or repairing the closing machine, 
shall be promptly recorded by the closure technician. The establishment 
shall have specification guidelines for closure integrity on file and 
available for review by Program employees. Additional closure 
examinations should be made at the beginning of production, immediately 
following every jam in the closing machine and after closing machine 
adjustment (including adjustment for a change in container size).
    (d) Closure examinations for semirigid and flexible containers--(1) 
Heat seals--(i) Visual examinations. A closure technician shall visually 
examine the seals formed by each sealing machine. When sealing defects 
are observed, necessary corrective actions, such as adjusting or 
repairing the sealing machine, shall be taken and recorded. In addition 
to examining the heat seals, the entire container shall be examined for 
product leakage or obvious defects. Visual examinations shall be 
performed before and after the thermal processing operation with 
sufficient frequency to ensure proper closure. These examinations should 
be conducted at least in accordance with a statistical sampling plan. 
All defects noted and corrective actions taken shall be promptly 
recorded.
    (ii) Physical tests. Tests determined by the establishment as 
necessary to assess container integrity shall be conducted by the 
closure technician at a frequency sufficient to ensure proper closure. 
These tests shall be performed after the thermal processing operation 
and should be made at least every 2 hours of continuous production. The 
establishment's acceptance guidelines for each test procedure shall be 
on file and available for review by Program employees. Test results 
along with any necessary corrective actions, such as adjusting or 
repairing the sealing machine, shall be recorded.
    (2) Double seams on semirigid or flexible containers shall be 
examined and the results recorded as provided in paragraph (b) of this 
section. Any additional measurements specified by the container 
manufacturer shall also be made and recorded.
    (e) Container coding. Each container shall be marked with a 
permanent, legible, identifying code mark. The mark shall, at a minimum, 
identify in code the product (unless the product name is lithographed or 
printed elsewhere on the container) and the day and year the product was 
packed.
    (f) Handling of containers after closure. (1) Containers and 
closures shall be protected from damage which may cause defects that are 
likely to affect the hermetic condition of the containers. The 
accumulation of stationary containers on moving conveyors should be 
minimized to avoid damage to the containers.

[[Page 552]]

    (2) The maximum time lapse between closing and initiation of thermal 
processing shall be 2 hours. However, the Administrator may specify a 
shorter period of time when considered necessary to ensure product 
safety and stability. A longer period of time between closing and the 
initiation of thermal processing may be permitted by the Administrator.

(Approved by the Office of Management and Budget under control number 
0583-0015)



Sec. 381.302  Thermal processing.

    (a) Process schedules. Prior to the processing of canned product for 
distribution in commerce, an establishment shall have a process schedule 
(as defined in Sec. 381.300(n) of this subpart) for each canned poultry 
product to be packed by the establishment.
    (b) Source of process schedules. (1) Process schedules used by an 
establishment shall be developed or determined by a processing 
authority.
    (2) Any change in product formulation, ingredients, or treatments 
that are not already incorporated in a process schedule and that may 
adversely affect either the product heat penetration profile or 
sterilization value requirements shall be evaluated by the 
establishment's processing authority. If it is determined that any such 
change adversely affects the adequacy of the process schedule, the 
processing authority shall amend the process schedule accordingly.
    (3) Complete records concerning all aspects of the development or 
determination of a process schedule, including any associated incubation 
tests, shall be made available by the establishment to the Program 
employee upon request.
    (c) Submittal of process information. (1) Prior to the processing of 
canned product for distribution in commerce, the establishment shall 
provide the inspector at the establishment with a list of the process 
schedules (including alternate schedules) along with any additional 
applicable information, such as the retort come-up operating procedures 
and critical factors.
    (2) Letters or other written communications from a processing 
authority recommending all process schedules shall be maintained on file 
by the establishment. Upon request by Program employees, the 
establishment shall make available such letters or written 
communications (or copies thereof). If critical factors are identified 
in the process schedule, the establishment shall provide the inspector 
with a copy of the procedures for measuring, controlling, and recording 
these factors, along with the frequency of such measurements, to ensure 
that the critical factors remain within the limits used to establish the 
process schedule. Once submitted, the process schedules and associated 
critical factors and the procedures for measuring (including the 
frequency), controlling, and recording of critical factors shall not be 
changed without the prior written submittal of the revised procedures 
(including supporting documentation) to the inspector at the 
establishment.

(Approved by the Office of Management and Budget under control number 
0583-0015)



Sec. 381.303  Critical factors and the application of the process 
schedule.

    Critical factors specified in the process schedule shall be 
measured, controlled and recorded by the establishment to ensure that 
these factors remain within the limits used to establish the process 
schedule. Examples of factors that are often critical to process 
schedule adequacy may include:
    (a) General. (1) Maximum fill-in weight or drained weight;
    (2) Arrangement of pieces in the container;
    (3) Container orientation during thermal processing;
    (4) Product formulation;
    (5) Particle size;
    (6) Maximum thickness for flexible, and to some extent semirigid 
containers during thermal processing;
    (7) Maximum pH;
    (8) Percent salt;
    (9) Ingoing (or formulated) nitrite level (ppm);
    (10) Maximum water activity; and
    (11) Product consistency or viscosity.
    (b) Continuous rotary and batch agitating retorts. (1) Minimum 
headspace; and
    (2) Retort reel speed.
    (c) Hydrostatic retorts. (1) Chain or conveyor speed.

[[Page 553]]

    (d) Steam/air retorts. (1) Steam/air ratio; and
    (2) Heating medium flow rate.

(Approved by the Office of Management and Budget under control number 
0583-0015)



Sec. 381.304  Operations in the thermal processing area.

    (a) Posting of processes. Process schedules (or operating process 
schedules) for daily production, including minimum initial temperatures 
and operating procedures for thermal processing equipment, shall be 
posted in a conspicuous place near the thermal processing equipment. 
Alternatively, such information shall be available to the thermal 
processing system operator and the inspector.
    (b) Process indicators and retort traffic control. A system for 
product traffic control shall be established to prevent product from 
bypassing the thermal processing operation. Each basket, crate or 
similar vehicle containing unprocessed product, or at least one visible 
container in each vehicle, shall be plainly and conspicuously marked 
with a heat sensitive indicator that will visually indicate whether such 
unit has been thermally processed. Exposed heat sensitive indicators 
attached to container vehicles shall be removed before such vehicles are 
refilled with unprocessed product. Container loading systems for 
crateless retorts shall be designed to prevent unprocessed product from 
bypassing the thermal processing operation.
    (c) Initial temperature. The initial temperature of the contents of 
the coldest container to be processed shall be determined and recorded 
by the establishment at the time the processing cycle begins to assure 
that the temperature of the contents of every container to be processed 
is not lower than the minimum initial temperature specified in the 
process schedule. Thermal processing systems which subject the filled 
and sealed containers to water at any time before process timing begins 
shall be operated to assure that such water will not lower the 
temperature of the product below the minimum initial temperature 
specified in the process schedule.
    (d) Timing devices. Devices used to time applicable thermal 
processing operation functions or events, such as process schedule time, 
come-up time and retort venting, shall be accurate to assure that all 
such functions or events are achieved. Pocket watches and wrist watches 
are not considered acceptable timing devices. Analog and digital clocks 
are considered acceptable. If such clocks do not display seconds, all 
required timed functions or events shall have at least a 1-minute safety 
factor over the specified thermal processing operation times. 
Temperature/time recording devices shall correspond within 15 minutes to 
the time of the day recorded on written records required by Sec. 
381.306.
    (e) Measurement of pH. Unless other methods are approved by the 
Administrator, potentiometric methods using electronic instruments (pH 
meters) shall be used for making pH determinations when a maximum pH 
value is specified as a critical factor in a process schedule.



Sec. 381.305  Equipment and procedures for heat processing systems.

    (a) Instruments and controls common to different thermal processing 
systems--(1) Indicating temperature devices. Each retort shall be 
equipped with at least one indicating temperature device that measures 
the actual temperature within the retort. The indicating temperature 
device, not the temperature/time recording device, shall be used as the 
reference instrument for indicating the process temperature.
    (i) Mercury-in-glass thermometers. A mercury-in-glass thermometer 
shall have divisions that are readable to 1 [deg]F (or 0.5 [deg]C) and 
whose scale contains not more than 17 [deg]F/inch (or 4.0 [deg]C/cm) of 
graduated scale. Each mercury-in-glass thermometer shall be tested for 
accuracy against a known accurate standard upon installation and at 
least once a year to ensure its accuracy. Records that specify the date, 
standard used, test method, and the person or testing authority 
performing the test shall be maintained on file by the establishment and 
made available to Program employees. A mercury-in-glass thermometer that 
has a divided mercury column or that cannot be adjusted to

[[Page 554]]

the standard shall be repaired and tested for accuracy before further 
use, or replaced.
    (ii) Other devices. Temperature-indicating devices used in lieu of 
mercury-in-glass thermometers, such as resistance temperature detectors, 
shall meet known, accurate standards for such devices when tested for 
accuracy. The records of such testing shall be available to FSIS program 
employees.
    (2) Temperature/time recording devices. Each thermal processing 
system shall be equipped with at least one temperature/time recording 
device to provide a permanent record of temperatures within the thermal 
processing system. This recording device may be combined with the steam 
controller and may be a recording/controlling instrument. When compared 
to the known accurate indicating temperature device, the recording 
accuracy shall be equal to or better than 1 [deg]F (or 0.5 [deg]C) at 
the process temperature. The temperature recording chart should be 
adjusted to agree with, but shall never be higher than, the known 
accurate indicating temperature device. A means of preventing 
unauthorized changes in the adjustment shall be provided. For example, a 
lock or a notice from management posted at or near the recording device 
warning that only authorized persons are permitted to make adjustments, 
are satisfactory means for preventing unauthorized changes. Air-operated 
temperature controllers shall have adequate filter systems to ensure a 
supply of clean, dry air. The recorder timing mechanism shall be 
accurate.
    (i) Chart-type devices. Devices using charts shall be used only with 
the correct chart. Each chart shall have a working scale of not more 
than 55 [deg]F/inch (or 12 [deg]C/cm) within a range of 20 [deg]F (or 11 
[deg]C) of the process temperature. Chart graduations shall not exceed 2 
[deg]F (or 1 [deg]C) within a range of 10 [deg]F (or 5 [deg]C) of the 
process temperature. Multipoint plotting chart-type devices shall print 
temperature readings at intervals that will assure that the parameters 
of the process time and process temperature have been met. The frequency 
of recording should not exceed 1-minute intervals.
    (ii) Other devices. Temperature/time recording devices or procedures 
used in lieu of chart-type devices must meet known accurate standards 
for such devices or procedures when tested for accuracy. Such a device 
must be accurate enough for ensuring that process time and temperature 
parameters have been met.
    (3) Steam controllers. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording/controlling instrument when combined with a temperature/
time recording device.
    (4) Air valves. All air lines connected to the retorts designed for 
pressure processing in steam shall be equipped with a globe valve or 
other equivalent-type valve or piping arrangement that will prevent 
leakage of air into the retort during the process cycle.
    (5) Water valves. All retort water lines that are intended to be 
closed during a process cycle shall be equipped with a globe valve or 
other equivalent-type valve or piping arrangement that will prevent 
leakage of water into the retort during the process cycle.
    (b) Pressure processing in steam--(1) Batch still retorts. (i) The 
basic requirements and recommendations for indicating temperature 
devices and temperature/time recording devices are described in 
paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths 
or probes of indicating temperature devices and probes of temperature/
time recording devices shall be installed either within the retort shell 
or in external wells attached to the retort. External wells shall be 
connected to the retort through at least a \3/4\ inch (1.9 cm) diameter 
opening and equipped with a \1/16\ inch (1.6 mm) or larger bleeder 
opening so located as to provide a constant flow of steam past the 
length of the bulb or probe. The bleeder for external wells shall emit 
steam continuously during the entire thermal processing period.
    (ii) Steam controllers are required as described in paragraph (a)(3) 
of this section.
    (iii) Steam inlet. The steam inlet to each retort shall be large 
enough to provide steam for proper operation of the retort, and shall 
enter at a point to facilitate air removal during venting.

[[Page 555]]

    (iv) Crate supports. Vertical still retorts with bottom steam entry 
shall employ bottom retort crate supports. Baffle plates shall not be 
used in the bottom of retorts.
    (v) Steam spreader. Perforated steam spreaders, if used, shall be 
maintained to ensure they are not blocked or otherwise inoperative. 
Horizontal still retorts shall be equipped with perforated steam 
spreaders that extend the full length of the retort unless the adequacy 
of another arrangement is documented by heat distribution data or other 
documentation from a processing authority. Such information shall be 
maintained on file by the establishment and made available to Program 
employees for review.
    (vi) Bleeders and condensate removal. Bleeders, except those for 
external wells of temperature devices, shall have \1/8\ inch (or 3 mm) 
or larger openings and shall be wide open during the entire process 
including the come-up time. For horizontal still retorts, bleeders shall 
be located within approximately 1 foot (or 30 cm) of the outermost 
locations of containers at each end along the top of the retort. 
Additional bleeders shall be located not more than 8 feet (2.4 m) apart 
along the top. Bleeders may be installed at positions other than those 
specified above, as long as the establishment has heat distribution data 
or other documentation from the manufacturer or from a processing 
authority demonstrating that the bleeders accomplish removal of air and 
circulate the steam within the retort. This information shall be 
maintained on file by the establishment and made available to Program 
employees for review. All bleeders shall be arranged in a way that 
enables the retort operator to observe that they are functioning 
properly. Vertical retorts shall have at least one bleeder opening 
located in the portion of the retort opposite the steam inlet. All 
bleeders shall be arranged so that the retort operator can observe that 
they are functioning properly. In retorts having a steam inlet above the 
level of the lowest container, a bleeder shall be installed in the 
bottom of the retort to remove condensate. The condensate bleeder shall 
be so arranged that the retort operator can observe that it is 
functioning properly. The condensate bleeder shall be checked with 
sufficient frequency to ensure adequate removal of condensate. Visual 
checks should be performed at intervals of not more than 15 minutes and 
the results recorded. Intermittent condensate removal systems shall be 
equipped with an automatic alarm system that will serve as a continuous 
monitor of condensate bleeder functioning. The automatic alarm system 
shall be tested at the beginning of each shift for proper functioning 
and the results recorded. If the alarm system is not functioning 
properly, it must be repaired before the retort is used.
    (vii) Stacking equipment. (a) Equipment for holding or stacking 
containers in retorts. Crates, trays, gondolas, carts, and other 
vehicles for holding or stacking product containers in the retort shall 
be so constructed to ensure steam circulation during the venting, come-
up, and process times. The bottom of each vehicle shall have 
perforations at least 1 inch (2.5 cm) in diameter on 2 inch (or 5 cm) 
centers or the equivalent unless the adequacy of another arrangement is 
documented by heat distribution data or other documentation from a 
processing authority and such information is maintained on file by the 
establishment and made available to Program employees for review.
    (b) Divider plates. Whenever one or more divider plates are used 
between any two layers of containers or placed on the bottom of a retort 
vehicle, the establishment shall have on file documentation that the 
venting procedure allows the air to be removed from the retort before 
timing of the thermal process is started. Such documentation shall be in 
the form of heat distribution data or documentation from a processing 
authority. This information shall be made available to Program employees 
for review.
    (viii) Bleeder and vent mufflers. If mufflers are used on bleeders 
or vent systems, the establishment shall have on file documentation that 
the mufflers do not impede the removal of air from the retort. Such 
documentation shall consist of either heat distribution data or 
documentation from the muffler

[[Page 556]]

manufacturer or from a processing authority. This information shall be 
made available to Program employees for review.
    (ix) Vents. (a) Vents shall be located in that portion of the retort 
opposite the steam inlet and shall be designed, installed, and operated 
in such a way that air is removed from the retort before timing of the 
thermal process is started. Vents shall be controlled by a gate, plug 
cock, or other full-flow valve which shall be fully opened to permit 
rapid removal of air from retorts during the venting period.
    (b) Vents shall not be connected to a closed drain system without an 
atmospheric break in the line. Where a retort manifold connects several 
pipes from a single retort, the manifold shall be controlled by a gate, 
plug cock, or other full-flow valve and the manifold shall be of a size 
such that the cross-sectional area of the manifold is larger than the 
total cross-sectional area of all connecting vents. The discharge shall 
not be connected to a closed drain without an atmospheric break in the 
line. A manifold header connecting vents or manifolds from several still 
retorts shall lead to the atmosphere. The manifold header shall not be 
controlled by a valve and shall be of a size such that the cross-
sectional area is at least equal to the total cross-sectional area of 
all connecting retort manifold pipes from the maximum number of retorts 
to be vented simultaneously.
    (c) Some typical installations and operating procedures are 
described below. Other retort installations, vent piping arrangements, 
operating procedures or auxiliary equipment such as divider plates may 
be used provided there is documentation that the air is removed from the 
retort before the process is started. Such documentation shall be in the 
form of heat distribution data or other documentation from the equipment 
manufacturer or processing authority. This information shall be 
maintained on file by the establishment and made available to Program 
employees for review.
    (d) For crateless retort installations, the establishment shall have 
heat distribution data or other documentation from the equipment 
manufacturer or from a processing authority that demonstrates that the 
venting procedure used accomplishes the removal of air and condensate. 
This information shall be maintained on file by the establishment and 
made available to Program employees for review.
    (e) Examples of typical installations and operating procedures that 
comply with the requirements of this section are as follows:
    (1) Venting horizontal retorts.
    (i) Venting through multiple 1 inch (2.5 cm) vents discharging 
directly to the atmosphere.
[GRAPHIC] [TIFF OMITTED] TC11SE91.047

    Specifications (Figure 1): One, 1-inch (2.5 cm) vent for every 5 
feet (1.5 m) of retort length, equipped with a gate, plug cock, or other 
full-flow valve and discharging to atmosphere. The end vents shall not 
be more than 2\1/2\ feet (or 75 cm) from ends of retort.
    Venting method (Figure 1): Vent valves shall be wide open for at 
least 5 minutes and to at least 225 [deg]F (or 107 [deg]C), or at least 
7 minutes and to at least 220 [deg]F (or 104.5 [deg]C).

    (ii) Venting through multiple 1 inch (2.5 cm) vents discharging 
through a manifold to the atmosphere.
[GRAPHIC] [TIFF OMITTED] TC11SE91.048

    Specifications (Figure 2): One, 1-inch (2.5 cm) vent for every 5 
feet (1.5 m) of retort length; vents not over 2\1/2\ feet (or 75 cm) 
from ends of retort; size of manifold for retorts less than 15 feet (4.6 
m) in length, 2\1/2\ inches (6.4 cm), and for retorts 15 feet (4.6 m) 
and over in length, 3 inches (7.6 cm).
    Venting method (Figure 2): The manifold vent gate, plug cock, or 
other full-flow valve shall be wide open for at least 6 minutes and

[[Page 557]]

to at least 225 [deg]F (or 107 [deg]C) or for at least 8 minutes and to 
at least 220 [deg]F (or 104.5 [deg]C).

    (iii) Venting through water spreaders.
    [GRAPHIC] [TIFF OMITTED] TC11SE91.049
    
    Specifications (Figure 3): Size of vent and vent valve. For retorts 
less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 
feet (4.6 m) and over in length, 2\1/2\ inches (6.4 cm).
    Size of water spreader (Figure 3): For retorts less than 15 feet 
(4.6 m) in length, 1\1/2\ inches (3.8 cm); for retorts 15 feet (4.6 m) 
and over in length 2 inches (or 5 cm). The number of holes shall be such 
that their total cross-sectional area is equal to the cross-sectional 
area of the vent pipe inlet.
    Venting method (Figure 3): The gate, plug cock, or other full-flow 
valve on the water spreader vent shall be wide open for at least 5 
minutes and to at least 225 [deg]F (or 107 [deg]C), or for at least 7 
minutes and to at least 220 [deg]F (or 104.5 [deg]C).

    (iv) Venting through a single 2\1/2\ inch (6.4 cm) top vent for 
retorts not exceeding 15 feet (4.6 m) in length.
[GRAPHIC] [TIFF OMITTED] TC11SE91.050

    Specifications (Figure 4): A 2\1/2\ inch (6.4 cm) vent equipped with 
a 2\1/2\ inch (6.4 cm) gate, plug cock, or other full-flow valve and 
located within 2 feet (61 cm) of the center of the retort.
    Venting method (Figure 4): The vent valve shall be wide open for at 
least 4 minutes and to at least 220 [deg]F (or 104.5 [deg]C).

    (2) Venting vertical retorts.
    (i) Venting through a 1\1/2\ inch (3.8 cm) overflow.
    [GRAPHIC] [TIFF OMITTED] TC11SE91.051
    
    Specifications (Figure 5): A 1\1/2\ inch (3.8 cm) overflow pipe 
equipped with a 1\1/2\ inch (3.8 cm) gate, plug cock, or other full-flow 
valve and with not more than 6 feet (1.8 m) of 1\1/2\ inch (3.8 cm) pipe 
beyond the valve before a break to the atmosphere or to a manifold 
header.
    Venting method (Figure 5): The vent valve shall be wide open for at 
least 4 minutes and to at least 218 [deg]F (or 103.5 [deg]C), or for at 
least 5 minutes and to at least 215 [deg]F (or 101.5 [deg]C).

    (ii) Venting through a single 1 inch (2.5 cm) side or top vent.

[[Page 558]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.052

    Specifications (Figure 6 or 7): A 1 inch (2.5 cm) vent in lid or top 
side, equipped with a gate, plug cock, or other full-flow valve and 
discharging directly into the atmosphere or to a manifold header.
    Venting method (Figure 6 or 7): The vent valve shall be wide open 
for at least 5 minutes and to at least 230 [deg]F (110 [deg]C), or for 
at least 7 minutes and to at least 220 [deg]F (or 104.5 [deg]C).

    (2) Batch agitating retorts. (i) The basic requirements for 
indicating temperature devices and temperature/time recording devices 
are described in paragraphs (a) (1) and (2) of this section. 
Additionally, bulb sheaths or probes of indicating temperature devices 
and probes of temperature/time recording devices shall be installed 
either within the retort shell or in external wells attached to the 
retort. External wells shall be connected to the retort through at least 
a \3/4\ inch (1.9 cm) diameter opening and equipped with a \1/16\ (1.6 
mm) or larger bleeder opening so located as to provide a constant flow 
of steam past the length of the bulbs or probes. The bleeder for 
external wells shall emit steam continuously during the entire thermal 
processing period.
    (ii) Steam controllers are required as described in paragraph (a)(3) 
of this section.
    (iii) Steam inlet. The steam inlet to each retort shall be large 
enough to provide steam for proper operation of the retort and shall 
enter at a point(s) to facilitate air removal during venting.
    (iv) Bleeders. Bleeders, except those for external wells of 
temperature devices, shall be \1/8\ inch (or 3 mm) or larger and shall 
be wide open during the entire process including the come-up time. 
Bleeders shall be located within approximately 1 foot (or 30 cm) of the 
outermost location of containers, at each end along the top of the 
retort. Additional bleeders shall be located not more than 8 feet (2.4 
m) apart along the top. Bleeders may be installed at positions other 
than those specified above, as long as the establishment has heat 
distribution data or other documentation from the manufacturer or from a 
processing authority that the

[[Page 559]]

bleeders accomplish removal of air and circulate the steam within the 
retort. This information shall be maintained on file by the 
establishment and made available to Program employees for review. All 
bleeders shall be arranged in a way that enables the retort operator to 
observe that they are functioning properly.
    (v) Venting and condensate removal. The air in the retort shall be 
removed before processing is started. Heat distribution data or other 
documentation from the manufacturer or from the processing authority who 
developed the venting procedure shall be kept on file by the 
establishment and made available to Program employees for review. At the 
time the steam is turned on, the drain shall be opened to remove steam 
condensate from the retort. A bleeder shall be installed in the bottom 
of the retort to remove condensate during retort operation. The 
condensate bleeder shall be so arranged that the retort operator can 
observe that it is functioning properly. The condensate bleeder shall be 
checked with sufficient frequency to ensure adequate removal of 
condensate. Visual checks should be performed at intervals of not more 
than 15 minutes and the results recorded. Intermittent condensate 
removal systems shall be equipped with an automatic alarm system that 
will serve as a continuous monitor of condensate bleeder functioning. 
The automatic alarm system shall be tested at the beginning of each 
shift for proper functioning and the results recorded. If the alarm 
system is not functioning properly, it must be repaired before the 
retort is used.
    (vi) Retort or reel speed timing. The retort or reel speed shall be 
checked before process timing begins and, if needed, adjusted as 
specified in the process schedule. In addition, the rotational speed 
shall be determined and recorded at least once during process timing of 
each retort load processed. Alternatively, a recording tachometer can be 
used to provide a continuous record of the speed. The accuracy of the 
recording tachometer shall be determined and recorded at least once per 
shift by checking the retort or reel speed using an accurate stopwatch. 
A means of preventing unauthorized speed changes on retorts shall be 
provided. For example, a lock or a notice from management posted at or 
near the speed adjustment device warning that only authorized persons 
are permitted to make adjustments are satisfactory means of preventing 
unauthorized changes.
    (vii) Bleeder and vent mufflers. If mufflers are used on bleeders or 
vent systems, the establishment shall have documentation that the 
mufflers do not impede the removal of air from the retort. Such 
documentation shall consist of either heat distribution data or 
documentation from the muffler manufacturer or from a processing 
authority. This information shall be maintained on file by the 
establishment and made available to Program employees for review.
    (3) Continuous rotary retorts. (i) The basic requirements for 
indicating temperature devices and temperature/time recording devices 
are described in paragraphs (a) (1) and (2) of this section. 
Additionally, bulb sheaths or probes of indicating temperature devices 
and probes of temperature/time recording devices shall be installed 
either within the retort shell or in external wells attached to the 
retort. External wells shall be connected to the retort through at least 
a \3/4\ inch (1.9 cm) diameter opening and equipped with a \1/16\ inch 
(1.6 mm) or larger bleeder opening so located as to provide a constant 
flow of steam past the length of the bulbs or probes. The bleeder for 
external wells shall emit steam continuously during the entire thermal 
processing period.
    (ii) Steam controllers are required as described in paragraph (a)(3) 
of this section.
    (iii) Steam inlet. The steam inlet to each retort shall be large 
enough to provide steam for proper operation of the retort, and shall 
enter at a point(s) to facilitate air removal during venting.
    (iv) Bleeders. Bleeders, except those for external wells of 
temperature devices, shall be \1/8\ inch (3.2 mm) or larger and shall be 
wide open during the entire process, including the come-up time. 
Bleeders shall be located within approximately 1 foot (or 30 cm) of the 
outermost location of containers at each end along the top of the 
retort.

[[Page 560]]

Additional bleeders shall be located not more than 8 feet (2.4 m) apart 
along the top of the retort. Bleeders may be installed at positions 
other than those specified above, as long as the establishment has heat 
distribution data or other documentation from the manufacturer or a 
processing authority that the bleeders accomplish removal of air and 
circulate the steam within the retort. This information shall be 
maintained on file by the establishment and made available to Program 
employees for review. All bleeders shall be arranged so that the retort 
operator can observe that they are functioning properly.
    (v) Venting and condensate removal. The air in the retort shall be 
removed before processing is started. Heat distribution data or other 
documentation from the manufacturer or from the processing authority who 
developed the venting procedure shall be kept on file by the 
establishment and made available to Program employees for review. At the 
time the steam is turned on, the drain shall be opened to remove steam 
condensate from the retort. A bleeder shall be installed in the bottom 
of the shell to remove condensate during the retort operation. The 
condensate bleeder shall be so arranged that the retort operator can 
observe that it is functioning properly. The condensate bleeder shall be 
checked with sufficient frequency to ensure adequate removal of 
condensate. Visual checks should be performed at intervals of not more 
than 15 minutes and the results recorded. Intermittent condensate 
removal systems shall be equipped with an automatic alarm system that 
will serve as a continuous monitor of condensate bleeder functioning. 
The automatic alarm system shall be tested at the beginning of each 
shift for proper functioning and the results recorded. If the alarm 
system is not functioning properly, it must be repaired before the 
retort is used.
    (vi) Retort speed timing. The rotational speed of the retort shall 
be specified in the process schedule. The speed shall be adjusted as 
specified, and recorded by the establishment when the retort is started, 
and checked and recorded at intervals not to exceed 4 hours to ensure 
that the correct retort speed is maintained. Alternatively, a recording 
tachometer may be used to provide a continuous record of the speed. If a 
recording tachometer is used, the speed shall be manually checked 
against an accurate stopwatch at least once per shift and the results 
recorded. A means of preventing unauthorized speed changes on retorts 
shall be provided. For example, a lock or a notice from management 
posted at or near the speed adjustment device warning that only 
authorized persons are permitted to make adjustments are satisfactory 
means of preventing unauthorized changes.
    (vii) Bleeders and vent mufflers. If mufflers are used on bleeders 
or vent systems, the establishment shall have documentation that the 
mufflers do not impede the removal of air from the retort. Such 
documentation shall consist of either heat distribution data or other 
documentation from the muffler manufacturer or from a processing 
authority. This information shall be maintained on file by the 
establishment and made available to Program employees for review.
    (4) Hydrostatic retorts. (i) The basic requirements for indicating 
temperature devices and temperature/time recording devices are described 
in paragraphs (a) (1) and (2) of this section. Additionally, indicating 
temperature devices shall be located in the steam dome near the steam/
water interface. Where the process schedule specifies maintenance of 
particular water temperatures in the hydrostatic water legs, at least 
one indicating temperature device shall be located in each hydrostatic 
water leg so that it can accurately measure water temperature and be 
easily read. The temperature/time recorder probe shall be installed 
either within the steam dome or in a well attached to the dome. Each 
probe shall have a \1/16\ inch (1.6 mm) or larger bleeder opening which 
emits steam continuously during the processing period. Additional 
temperature/time recorder probes shall be installed in the hydrostatic 
water legs if the process schedule specifies maintenance of particular 
temperatures in these water legs.
    (ii) Steam controllers are required as described in paragraph (a)(3) 
of this section.

[[Page 561]]

    (iii) Steam inlet. The steam inlets shall be large enough to provide 
steam for proper operation of the retort.
    (iv) Bleeders. Bleeder openings \1/4\ inch (or 6 mm) or larger shall 
be located in the steam chamber(s) opposite the point of steam entry. 
Bleeders shall be wide open and shall emit steam continuously during the 
entire process, including the come-up time. All bleeders shall be 
arranged in such a way that the operator can observe that they are 
functioning properly.
    (v) Venting. Before the start of processing operations, the retort 
steam chamber(s) shall be vented to ensure removal of air. Heat 
distribution data or other documentation from the manufacturer or from a 
processing authority demonstrating that the air is removed from the 
retort prior to processing shall be kept on file at the establishment 
and made available to Program employees for review.
    (vi) Conveyor speed. The conveyor speed shall be calculated to 
obtain the required process time and recorded by the establishment when 
the retort is started. The speed shall be checked and recorded at 
intervals not to exceed 4 hours to ensure that the correct conveyor 
speed is maintained. A recording device may be used to provide a 
continuous record of the conveyor speed. When a recording device is 
used, the speed shall be manually checked against an accurate stopwatch 
at least once per shift by the establishment. A means of preventing 
unauthorized speed changes of the conveyor shall be provided. For 
example, a lock or a notice from management posted at or near the speed 
adjustment device warning that only authorized persons are permitted to 
make adjustments are satisfactory means of preventing unauthorized 
changes.
    (vii) Bleeders and vent mufflers. If mufflers are used on bleeders 
or vent systems, the establishment shall have documentation that the 
mufflers do not impede the removal of air from the retort. Such 
documentation shall consist of either heat distribution data or other 
documentation from the muffler manufacturer or from a processing 
authority. This information shall be maintained on file by the 
establishment and made available to Program employees for review.
    (c) Pressure processing in water--(1) Batch still retorts. (i) The 
basic requirements for indicating temperature devices and temperature/
time recording devices are described in paragraphs (a)(1) and (2) of 
this section. Additionally, bulbs or probes of indicating temperature 
devices shall be located in such a position that they are beneath the 
surface of the water throughout the process. On horizontal retorts, the 
indicating temperature device bulb or probe shall be inserted directly 
into the retort shell. In both vertical and horizontal retorts, the 
indicating temperature device bulb or probe shall extend directly into 
the water a minimum of 2 inches (or 5 cm) without a separable well or 
sleeve. In vertical retorts equipped with a recorder/controller, the 
controller probe shall be located at the bottom of the retort below the 
lowest crate rest in such a position that the steam does not strike it 
directly. In horizontal retorts so equipped, the controller probe shall 
be located between the water surface and the horizontal plane passing 
through the center of the retort so that there is no opportunity for 
direct steam impingement on the controller probe. Air-operated 
temperature controllers shall have filter systems to ensure a supply of 
clean, dry air.
    (ii) Pressure recording device. Each retort shall be equipped with a 
pressure recording device which may be combined with a pressure 
controller.
    (iii) Steam controllers are required as described in paragraph 
(a)(3) of this section.
    (iv) Heat distribution. Heat distribution data or other 
documentation from the equipment manufacturer or a processing authority 
demonstrating uniform heat distribution within the retort shall be kept 
on file at the establishment and made available to Program employees for 
review.
    (v) Crate supports. A bottom crate support shall be used in vertical 
retorts. Baffle plates shall not be used in the bottom of the retort.
    (vi) Stacking equipment. For filled flexible containers and, where 
applicable, semirigid containers, stacking equipment shall be designed 
to ensure

[[Page 562]]

that the thickness of the filled containers does not exceed that 
specified in the process schedule and that the containers do not become 
displaced and overlap or rest on one another during the thermal process.
    (vii) Drain valve. A nonclogging, water-tight drain valve shall be 
used. Screens shall be installed over all drain openings.
    (viii) Water level. There shall be a means of determining the water 
level in the retort during operation (i.e., by using a gauge, electronic 
sensor, or sight glass indicator). For retorts requiring complete 
immersion of containers, water shall cover the top layer of containers 
during the entire come-up time and thermal processing periods and should 
cover the top layer of containers during cooling. For retorts using 
cascading water or water sprays, the water level shall be maintained 
within the range specified by the retort manufacturer or processing 
authority during the entire come-up, thermal processing, and cooling 
periods. A means to ensure that water circulation continues as specified 
throughout the come-up, thermal processing, and cooling periods shall be 
provided. The retort operator shall check and record the water level at 
intervals to ensure it meets the specified processing parameters.
    (ix) Air supply and controls. In both horizontal and vertical still 
retorts, a means shall be provided for introducing compressed air or 
steam at the pressure required to maintain container integrity. 
Compressed air and steam entry shall be controlled by an automatic 
pressure control unit. A nonreturn valve shall be provided in the air 
supply line to prevent water from entering the system. Overriding air or 
steam pressure shall be maintained continuously during the come-up, 
thermal processing, and cooling periods. If air is used to promote 
circulation, it shall be introduced into the steam line at a point 
between the retort and the steam control valve at the bottom of the 
retort. The adequacy of the air circulation for maintaining uniform heat 
distribution within the retort shall be documented by heat distribution 
data or other documentation from a processing authority, and such data 
shall be maintained on file by the establishment and made available to 
Program employees for review.
    (x) Water recirculation. When a water recirculation system is used 
for heat distribution, the water shall be drawn from the bottom of the 
retort through a suction manifold and discharged through a spreader that 
extends the length or circumference of the top of the retort. The holes 
in the water spreader shall be uniformly distributed. The suction 
outlets shall be protected with screens to keep debris from entering the 
recirculation system. The pump shall be equipped with a pilot light or a 
similar device to warn the operator when it is not running, and with a 
bleeder to remove air when starting operations. Alternatively, a flow-
meter alarm system can be used to ensure proper water circulation. The 
adequacy of water circulation for maintaining uniform heat distribution 
within the retort shall be documented by heat distribution data or other 
documentation from a processing authority and such data shall be 
maintained on file by the establishment and made available to Program 
employees for review. Alternative methods for recirculation of water in 
the retort may be used, provided there is documentation in the form of 
heat distribution data or other documentation from a processing 
authority maintained on file by the establishment and made available to 
Program employees for review.
    (xi) Cooling water entry. In retorts for processing product packed 
in glass jars, the incoming cooling water should not directly strike the 
jars, in order to minimize glass breakage by thermal shock.
    (2) Batch agitating retorts. (i) The basic requirements and 
recommendations for indicating temperature devices and temperture/time 
recording devices are described in paragraphs (a) (1) and (2) of this 
section. Additionally, the indicating temperature device bulb or probe 
shall extend directly into the water without a separable well or sleeve. 
The recorder/controller probe shall be located between the water surface 
and the horizontal plane passing through the center of the retort so 
that

[[Page 563]]

there is no opportunity for steam to directly strike the controller bulb 
or probe.
    (ii) Pressure recording device. Each retort shall be equipped with a 
pressure recording device which may be combined with a pressure 
controller.
    (iii) Steam controllers are required as described in paragraph 
(a)(3) of this section.
    (iv) Heat distribution. Heat distribution data or other 
documentation from the equipment manufacturer or a processing authority 
shall be kept on file by the establishment and made available to Program 
employees for review.
    (v) Stacking equipment. All devices used for holding product 
containers (e.g., crates, trays, divider plates) shall be so constructed 
to allow the water to circulate around the containers during the come-up 
and thermal process periods.
    (vi) Drain valve. A nonclogging, water-tight drain valve shall be 
used. Screens shall be installed over all drain openings.
    (vii) Water level. There shall be a means of determining the water 
level in the retort during operation (i.e., by using a gauge, electronic 
sensor, or sight glass indicator). Water shall completely cover all 
containers during the entire come-up, thermal processing, and cooling 
periods. A means to ensure that water circulation continues as specified 
throughout the come-up, thermal processing, and cooling periods shall be 
provided. The retort operator shall check and record the adequacy of the 
water level with sufficient frequency to ensure it meets the specified 
processing parameters.
    (viii) Air supply and controls. Retorts shall be provided with a 
means for introducing compressed air or steam at the pressure required 
to maintain container integrity. Compressed air and steam entry shall be 
controlled by an automatic pressure control unit. A nonreturn valve 
shall be provided in the air supply line to prevent water from entering 
the system. Overriding air or steam pressure shall be maintained 
continuously during the come-up, thermal processing, and cooling 
periods. If air is used to promote circulation, it shall be introduced 
into the steam line at a point between the retort and the steam control 
valve at the bottom of the retort. The adequacy of the air circulation 
for maintaining uniform heat distribution within the retort shall be 
documented by heat distribution data or other documentation from a 
processing authority, and such data shall be maintained on file by the 
establishment and made available to Program employees for review.
    (ix) Retort or reel speed timing. The retort or reel speed timing 
shall be checked before process timing begins and, if needed, adjusted 
as specified in the process schedule. In addition, the rotational speed 
shall be determined and recorded at least once during process timing of 
each retort load processed. Alternatively, a recording tachometer can be 
used to provide a continuous record of the speed. The accuracy of the 
recording tachometer shall be determined and recorded at least once per 
shift by the establishment by checking the retort or reel speed using an 
accurate stopwatch. A means of preventing unauthorized speed changes on 
retorts shall be provided. For example, a lock or a notice from 
management posted at or near the speed adjustment device warning that 
only authorized persons are permitted to make adjustments are 
satisfactory means of preventing unauthorized changes.
    (x) Water recirculation. If a water recirculation system is used for 
heat distribution, it shall be installed in such a manner that water 
will be drawn from the bottom of the retort through a suction manifold 
and discharged through a spreader which extends the length of the top of 
the retort. The holes in the water spreader shall be uniformly 
distributed. The suction outlets shall be protected with screens to keep 
debris from entering the recirculation system. The pump shall be 
equipped with a pilot light or a similar device to warn the operator 
when it is not running and with a bleeder to remove air when starting 
operations. Alternatively, a flow-meter alarm system can be used to 
ensure proper water circulation. The adequacy of water circulation for 
maintaining uniform heat distribution within the retort shall be 
documented by heat distribution data or other documentation from a 
processing authority and such data shall be maintained

[[Page 564]]

on file by the establishment and made available to Program employees for 
review. Alternative methods for recirculation of water in the retort may 
be used provided there is documentation in the form of heat distribution 
data or other documentation from a processing authority maintained on 
file by the establishment and made available to Program employees for 
review.
    (xi) Cooling water entry. In retorts for processing product packed 
in glass jars, the incoming cooling water should not directly strike the 
jars, in order to minimize glass breakage by thermal shock.
    (d) Pressure processing with steam/air mixtures in batch retorts. 
(1) The basic requirements for indicating temperature devices and 
temperature/time recording devices are described in paragraphs (a) (1) 
and (2) of this section. Additionally, bulb sheaths or probes for 
indicating temperature devices and temperature/time recording devices or 
controller probes shall be inserted directly into the retort shell in 
such a position that steam does not strike them directly.
    (2) Steam controllers are required as described in paragraph (a)(3) 
of this section.
    (3) Recording pressure controller. A recording pressure controller 
shall be used to control the air inlet and the steam/air mixture outlet.
    (4) Circulation of steam/air mixture. A means shall be provided for 
the circulation of the steam/air mixture to prevent formation of low-
temperature pockets. The efficiency of the circulation system shall be 
documented by heat distribution data or other documentation from a 
processing authority, and such data shall be maintained on file by the 
establishment and made available to Program employees for review. The 
circulation system shall be checked to ensure its proper functioning and 
shall be equipped with a pilot light or a similar device to warn the 
operator when it is not functioning. Because of the variety of existing 
designs, reference shall be made to the equipment manufacturer for 
details of installation, operation and control.
    (e) Atmospheric cookers--(1) Temperature/time recording device. Each 
atmospheric cooker (e.g., hot water bath) shall be equipped with at 
least one temperature/time recording device in accordance with the basic 
requirements described in paragraph (a)(2) of this section.
    (2) Heat distribution. Each atmospheric cooker shall be equipped and 
operated to ensure uniform heat distribution throughout the processing 
system during the thermal process. Heat distribution data or other 
documentation from the manufacturer or a processing authority 
demonstrating uniform heat distribution within the cooker shall be kept 
on file by the establishment and made available to Program employees for 
review.
    (f) Other systems. All other systems not specifically delineated in 
this section and used for the thermal processing of canned product shall 
be adequate to produce shelf-stable products consistently and uniformly.
    (g) Equipment maintenance. (1) Upon installation, all 
instrumentation and controls shall be checked by the establishment for 
proper functioning and accuracy and, thereafter, at any time their 
functioning or accuracy is suspect.
    (2) At least once a year each thermal processing system shall be 
examined by an individual not directly involved in daily operations to 
ensure the proper functioning of the system as well as all auxiliary 
equipment and instrumentation. In addition, each thermal processing 
system should be examined before the resumption of operation following 
an extended shutdown.
    (3) Air and water valves that are intended to be closed during 
thermal processing shall be checked by the establishment for leaks. 
Defective valves shall be repaired or replaced as needed.
    (4) Vent and bleeder mufflers shall be checked and maintained or 
replaced by the establishment to prevent any reduction in vent or 
bleeder efficiency.
    (5) When water spreaders are used for venting, a maintenance 
schedule shall be developed and implemented to assure that the holes are 
maintained at their original size.
    (6) Records shall be kept on all maintenance items that could affect 
the adequacy of the thermal process. Records shall include the date and 
type

[[Page 565]]

of maintenance performed and the person conducting the maintenance.
    (h) Container cooling and cooling water. (1) Potable water shall be 
used for cooling except as provided for in paragraphs (h) (2) and (3) of 
this section.
    (2) Cooling canal water shall be chlorinated or treated with a 
chemical approved by the Administrator as having a bactericidal effect 
equivalent to chlorination. There shall be a measurable residual of the 
sanitizer in the water at the discharge point of the canal. Cooling 
canals shall be cleaned and replenished with potable water to prevent 
the buildup of organic matter and other materials.
    (3) Container cooling waters that are recycled or reused shall be 
handled in systems that are so designed, operated, and maintained so 
there is no buildup of microorganisms, organic matter, and other 
materials in the systems and in the waters. System equipment, such as 
pipelines, holding tanks and cooling towers, shall be constructed and 
installed so that they can be cleaned and inspected. In addition, the 
establishment shall maintain, and make available to Program employees 
for review, information on at least the following:
    (i) System design and construction;
    (ii) System operation including the rates of renewal with fresh, 
potable water and the means for treating the water so that there is a 
measurable residual of an acceptable sanitizer, per paragraph (h)(2) of 
this section, in the water at the point where the water exits the 
container cooling vessel;
    (iii) System maintenance including procedures for the periodic 
cleaning and sanitizing of the entire system; and
    (iv) Water quality standards, such as microbiological, chemical and 
physical, monitoring procedures including the frequency and site(s) of 
sampling, and the corrective actions taken when water quality standards 
are not met.
    (i) Post-process handling of containers. Containers shall be handled 
in a manner that will prevent damage to the hermetic seal area. All worn 
and frayed belting, can retarders, cushions, and the like shall be 
replaced with nonporous materials. To minimize container abrasions, 
particularly in the seal area, containers should not remain stationary 
on moving conveyors. All post-process container handling equipment 
should be kept clean so there is no buildup of microorganisms on 
surfaces in contact with the containers.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000]



Sec. 381.306  Processing and production records.

    At least the following processing and production information shall 
be recorded by the establishment: Date of production; product name and 
style; container code; container size and type; and the process 
schedule, including the minimum initial temperature. Measurements made 
to satisfy the requirements of Sec. 381.303 regarding the control of 
critical factors shall be recorded. In addition, where applicable, the 
following information and data shall also be recorded:
    (a) Processing in steam--(1) Batch still retorts. For each retort 
batch, record the retort number or other designation, the approximate 
number of containers or the number of retort crates per retort load, 
product initial temperature, time steam on, the time and temperature 
vent closed, the start of process timing, time steam off, and the actual 
processing time. The indicating temperature device and the temperature 
recorder shall be read at the same time at least once during process 
timing and the observed temperatures recorded.
    (2) Batch agitating retorts. In addition to recording the 
information required for batch, still steam retorts in paragraph (a)(1) 
of this section, record the functioning of the condensate bleeder(s) and 
the retort or reel speed.
    (3) Continuous rotary retorts. Record the retort system number, the 
approximate total number of containers retorted, product initial 
temperature, time steam on, the time and temperature vent closed, time 
process temperature reached, the time the first can enters and the time 
the last can exits the retort. The retort or reel speed shall be 
determined and recorded at intervals not to exceed 4 hours. Readings of 
the indicating temperature device(s) and

[[Page 566]]

temperature recorder(s) shall be made and recorded at the time the first 
container enters the retort and thereafter with sufficient frequency to 
ensure compliance with the process schedule. These observations should 
be made and recorded at intervals not exceeding 30 minutes of continuous 
retort operation. Functioning of the condensate bleeder(s) shall be 
observed and recorded at the time the first container enters the retort 
and thereafter as specified in Sec. 381.305(b)(3)(v).
    (4) Hydrostatic retorts. Record the retort system number, the 
approximate total number of containers retorted, product initial 
temperature, time steam on, the time and temperature vent(s) closed, 
time process temperature reached, time first containers enter the 
retort, time last containers exit the retort, and, if specified in the 
process schedule, measurements of temperatures in the hydrostatic water 
legs. Readings of the temperature indicating device, which is located in 
the steam/water interface, and the temperature recording device shall be 
observed and the temperatures recorded at the time the first containers 
enter the steam dome. Thereafter, these instruments shall be read and 
the temperatures recorded with sufficient frequency to ensure compliance 
with the temperature specified in the process schedule and should be 
made at least every hour of continuous retort operation. Container 
conveyor speed, and for agitating hydrostatic retorts, the rotative 
chain speed, shall be determined and recorded at intervals of sufficient 
frequency to ensure compliance with the process schedule and should be 
performed at least every 4 hours.
    (b) Processing in water--(1) Batch still retorts. For each retort 
batch, record the retort number or other designation, the approximate 
number of containers or number of retort crates per retort load, product 
initial temperature, time steam on, the start of process timing, water 
level, water recirculation rate (if critical), overriding pressure 
maintained, time steam off, and actual processing time. The indicating 
temperature device and the temperature recorder shall be read at the 
same time at least once during process timing and the observed 
temperatures recorded.
    (2) Batch agitating retorts. In addition to recording the 
information required in paragraph (b)(1) of this section, record the 
retort or reel speed.
    (c) Processing in steam/air mixtures. For each retort batch, record 
the retort number or other designation, the approximate number of 
containers or number of retort crates per retort load, product initial 
temperature, time steam on, venting procedure, if applicable, the start 
of process timing, maintenance of circulation of the steam/air mixture, 
air flow rate or forced recirculation flow rate (if critical), 
overriding pressure maintained, time steam off, and actual processing 
time. The indicating temperature device and the temperature recorder 
shall be read at the same time at least once during process timing and 
the observed temperatures recorded.
    (d) Atmospheric cookers--(1) Batch-type systems. For each cooker 
batch, record the cooker number or other designation and the approximate 
number of containers. In addition, record all critical factors of the 
process schedule such as cooker temperature, initial temperature, the 
time the thermal process cycle begins and ends, hold time, and the final 
internal product temperature.
    (2) Continuous-type systems. Record the cooker number or other 
designation, the time the first containers enter and the last containers 
exit a cooker, and the approximate total number of containers processed. 
In addition, record all critical factors of the process schedule such as 
the initial temperature, cooker speed, and final internal product 
temperature.

(Approved by the Office of Management and Budget under control number 
0583-0015)



Sec. 381.307  Record review and maintenance.

    (a) Process records. Charts from temperature/time recording devices 
shall be identified by production date, container code, processing 
vessel number or other designation and other data as necessary to enable 
correlation with the records required in Sec. 381.306. Each entry on a 
record shall be made at the time the specific event occurs, and the

[[Page 567]]

recording individual shall sign or initial each record form. No later 
than 1 working day after the actual process, the establishment shall 
review all processing and production records to ensure completeness and 
to determine if all product received the process schedule. All records, 
including the temperature/time recorder charts and critical factor 
control records, shall be signed or initialed and dated by the person 
conducting the review. All processing and production records required in 
this subpart shall be made available to Program employees for review.
    (b) Automated process monitoring and recordkeeping. Automated 
process monitoring and recordkeeping systems shall be designed and 
operated in a manner which will ensure compliance with the applicable 
requirements of Sec. 381.306.
    (c) Container closure records. Written records of all container 
closure examinations shall specify the container code, the date and time 
of container closure examination, the measurement(s) obtained, and any 
corrective actions taken. Records shall be signed or initialed by the 
container closure technician and shall be reviewed and signed by the 
establishment within 1 working day after the actual production to ensure 
that the records are complete and that the closing operations have been 
properly controlled. All container closure examination records required 
in this subpart shall be made available to Program employees for review.
    (d) Distribution of product. Records shall be maintained by the 
establishment identifying initial distribution of the finished product 
to facilitate, if necessary, the segregation of specific production lots 
that may have been contaminated or are otherwise unsound for their 
intended use.
    (e) Retention of records. Copies of all processing and production 
records required in Sec. 381.306 shall be retained for no less than 1 
year at the establishment, and for an additional 2 years at the 
establishment or other location from which the records can be made 
available to Program employees within 3 working days.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000]



Sec. 381.308  Deviations in processing.

    (a) Whenever the actual process is less than the process schedule or 
when any critical factor does not comply with the requirements for that 
factor as specified in the process schedule, it shall be considered a 
deviation in processing.
    (b) Deviations in processing (or process deviations) must be handled 
according to:
    (1)(i) A HACCP plan for canned product that addresses hazards 
associated with microbial contamination, or,
    (ii) Alternative documented procedures that will ensure that only 
safe and stable product is shipped in commerce; or
    (iii) Paragraph (d) of this section.
    (2) Paragraph (d) of this section.
    (c) [Reserved]
    (d) Procedures for handling process deviations where the HACCP plan 
for thermally processed/commercially sterile product does not address 
food safety hazards associated with microbial contamination, where there 
is no approved total quality control system, or where the establishment 
has no alternative documented procedures for handling process 
deviations.
    (1) Deviations identified in-process. If a deviation is noted at any 
time before the completion of the intended process schedule, the 
establishment shall:
    (i) Immediately reprocess the product using the full process 
schedule; or,
    (ii) Use an appropriate alternate process schedule provided such a 
process schedule has been established in accordance with Sec. 381.302 
(a) and (b) and is filed with the inspector in accordance with Sec. 
381.302(c); or,
    (iii) Hold the product involved and have the deviation evaluated by 
a processing authority to assess the safety and stability of the 
product. Upon completion of the evaluation, the establishment shall 
provide the inspector the following:

[[Page 568]]

    (a) A complete description of the deviation along with all necessary 
supporting documentation;
    (b) A copy of the evaluation report; and,
    (c) A description of any product disposition actions, either taken 
or proposed.
    (iv) Product handled in accordance with paragraph (d)(1)(iii) of 
this section shall not be shipped from the establishment until the 
Program has reviewed all of the information submitted and approved the 
product disposition actions.
    (v) If an alternate process schedule is used that is not on file 
with the inspector or if an alternate process schedule is immediately 
calculated and used, the product shall be set aside for further 
evaluation in accordance with paragraphs (d)(1) (iii) and (iv) of this 
section.
    (vi) When a deviation occurs in a continuous rotary retort, the 
product shall be handled in accordance with paragraphs (d)(1) (iii) and 
(iv) of this section or in accordance with the following procedures:
    (a) Emergency stops.
    (1) When retort jams or breakdowns occur during the processing 
operations, all containers shall be given an emergency still process 
(developed per Sec. 381.302(b)) before the retort is cooled or the 
retort shall be cooled promptly and all containers removed and either 
reprocessed, repacked and reprocessed, or destroyed. Regardless of the 
procedure used, containers in the retort intake valve and in transfer 
valves between retort shells at the time of a jam or breakdown shall be 
removed and either reprocessed, repacked and reprocessed, or destroyed. 
Product to be destroyed shall be handled as ``U.S. Inspected and 
Condemned'', as defined in Sec. 301.2(ee) of this chapter, and disposed 
of in accordance with part 314 of this chapter.
    (2) The time the retort reel stopped and the time the retort is used 
for an emergency still retort process shall be noted on the temperature/
time recording device and entered on the other production records 
required in Sec. 381.306.
    (b) Temperature drops. When the retort temperature drops below the 
temperature specified in the process schedule, the reel shall be stopped 
and the following actions shall be taken:
    (1) For temperature drops of less than 10 [deg]F (or 5.5 [deg]C) 
either (i) all containers in the retort shall be given an emergency 
still process (developed per Sec. 381.302(b)) before the reel is 
restarted; (ii) container entry to the retort shall be prevented and an 
emergency agitating process (developed per Sec. 381.302(b)) shall be 
used before container entry to the retort is restarted; or (iii) 
container entry to the retort shall be prevented and the reel restarted 
to empty the retort. The discharged containers shall be reprocessed, 
repacked and reprocessed, or destroyed. Product to be destroyed shall be 
handled as ``U.S. Inspected and Condemned'', as defined in Sec. 
301.2(ee) of this chapter, and disposed of in accordance with part 314 
of this chapter.
    (2) For temperature drops of 10 [deg]F (or 5.5 [deg]C) or more, all 
containers in the retort shall be given an emergency still process 
(developed per Sec. 381.302(b)). The time the reel was stopped and the 
time the retort was used for a still retort process shall be marked on 
the temperature/time recording device by the establishment and entered 
on the other production records required in Sec. 381.306. 
Alternatively, container entry to the retort shall be prevented and the 
reel restarted to empty the retort. The discharged containers shall be 
either reprocessed, repacked and reprocessed, or destroyed. Product to 
be destroyed shall be handled as ``U.S. Inspected and Condemned'' as 
defined in Sec. 301.2(ee) of this chapter, and disposed of in 
accordance with part 314 of this chapter.
    (2) Deviations identified through record review. Whenever a 
deviation is noted during review of the processing and production 
records required by Sec. 381.307 (a) and (b), the establishment shall 
hold the product involved and the deviation shall be handled in 
accordance with paragraphs (d)(1) (iii) and (iv) of this section.
    (e) Process deviation file. The establishment shall maintain full 
records regarding the handling of each deviation. Such records shall 
include, at a minimum, the appropriate processing and production 
records, a full description of the corrective actions taken, the 
evaluation procedures and results, and the

[[Page 569]]

disposition of the affected product. Such records shall be maintained in 
a separate file or in a log that contains the appropriate information. 
The file or log shall be retained in accordance with Sec. 381.307(e) 
and shall be made available to Program employees upon request.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[51 FR 45634, Dec. 19, 1986, as amended at 62 FR 45027, Aug. 25, 1997; 
65 FR 34390, May 30, 2000; 65 FR 53533, Sept. 5, 2000]



Sec. 381.309  Finished product inspection.

    (a) Finished product inspections must be handled according to:
    (1) A HACCP plan for canned product that addresses hazards 
associated with microbiological contamination; or
    (2) An FSIS-approved total quality control system; or
    (3) Alternative documented procedures that will ensure that only 
product that is safe and stable is shipped in commerce; or
    (4) Paragraph (d) of this section.
    (b)-(c) [Reserved]
    (d) Procedures for finished product inspections where the HACCP plan 
for thermally processed/commercially sterile product does not address 
food safety hazards associated with microbial contamination, where there 
is no approved total quality control system, or where the establishment 
has no alternative documented procedures for handling process 
deviations.
    (1) Incubation of shelf stable canned product--(i) Incubator. The 
establishment shall provide incubation facilities which include an 
accurate temperature/time recording device, an indicating temperature 
device, a means for the circulation of the air inside the incubator to 
prevent temperature variations, and a means to prevent unauthorized 
entry into the facility. The Program is responsible for the security of 
the incubator.
    (ii) Incubation temperature. The incubation temperature shall be 
maintained at 955 [deg]F (352.8 [deg]C). If the incubation temperature falls below 
90 [deg]F (or 32 [deg]C) or exceeds 100 [deg]F (or 38 [deg]C) but does 
not reach 103 [deg]F (or 39.5 [deg]C), the incubation temperature shall 
be adjusted within the required range and the incubation time extended 
for the time the sample containers were held at the deviant temperature. 
If the incubation temperature is at or above 103 [deg]F (or 39.5 [deg]C) 
for more than 2 hours, the incubation test(s) shall be terminated, the 
temperature lowered to within the required range, and new sample 
containers incubated for the required time.
    (iii) Product requiring incubation. Shelf stable product requiring 
incubation includes:
    (a) Low acid products as defined in Sec. 381.300(m); and
    (b) Acidified low acid products as defined in Sec. 381.300(b).
    (iv) Incubation samples. (a) From each load of product processed in 
a batch-type thermal processing system (still or agitation), the 
establishment shall select at least one container for incubation.
    (b) For continuous rotary retorts, hydrostatic retorts, or other 
continuous-type thermal processing systems, the establishment shall 
select at least one container per 1,000 for incubation.
    (c) Only normal-appearing containers shall be selected for 
incubation.
    (v) Incubation time. Canned product requiring incubation shall be 
incubated for not less than 10 days (240 hours) under the conditions 
specified in paragraph (d)(1)(ii) of this section.
    (vi) Incubation checks and record maintenance. Designated 
establishment employees shall visually check all containers under 
incubation each working day and the inspector shall be notified when 
abnormal containers are detected. All abnormal containers should be 
allowed to cool before a final decision on their condition is made. For 
each incubation test the establishment shall record at least the product 
name, container size, container code, number of containers incubated, in 
and out dates, and incubation results. The establishment shall retain 
such records, along with copies of the temperature/time recording 
charts, in accordance with Sec. 381.307(e).
    (vii) Abnormal containers. The finding of abnormal containers (as 
defined in Sec. 381.300(a)) among incubation samples is cause to 
officially retain at least the code lot involved.
    (viii) Shipping. No product shall be shipped from the establishment 
before

[[Page 570]]

the end of the required incubation period except as provided in this 
paragraph or paragraph (b) or (c) of this section. An establishment 
wishing to ship product prior to the completion of the required 
incubation period shall submit a written proposal to the area 
supervisor. Such a proposal shall include provisions that will assure 
that shipped product will not reach the retail level of distribution 
before sample incubation is completed and that product can be returned 
promptly to the establishment should such action be deemed necessary by 
the incubation test results. Upon receipt of written approval from the 
area supervisor, product may be routinely shipped provided the 
establishment continues to comply with all requirements of this subpart.
    (2) Container condition. (i) Normal containers. Only normal-
appearing containers shall be shipped from an establishment as 
determined by an appropriate sampling plan or other means acceptable to 
Program employees.
    (ii) Abnormal containers. When abnormal containers are detected by 
any means other than incubation, the establishment shall inform the 
inspector and the affected code lot(s) shall not be shipped until the 
Program has determined that the product is safe and stable. Such a 
determination will take into account the cause and level of abnormals in 
the affected lot(s) as well as any product disposition actions either 
taken or proposed by the establishment.

(Approved by the Office of Management and Budget under control number 
0583-0015)

[51 FR 45634, Dec. 19, 1986, as amended at 57 FR 37872, Aug. 21, 1992; 
57 FR 55443, Nov. 25, 1992; 62 FR 45027, Aug. 25, 1997; 65 FR 34391, May 
30, 2000; 65 FR 53533, Sept. 5, 2000]



Sec. 381.310  Personnel and training.

    All operators of thermal processing systems specified in Sec. 
381.305 and container closure technicians shall be under the direct 
supervision of a person who has successfully completed a school of 
instruction that is generally recognized as adequate for properly 
training supervisors of canning operations.

[51 FR 45634, Dec. 19, 1986]



Sec. 381.311  Recall procedure.

    Establishments shall prepare and maintain a current procedure for 
the recall of all canned product covered by this subpart. Upon request, 
the recall procedure shall be made available to Program employees for 
review.

(Approved by the Office of Management and Budget under control number 
0583-0015)



                      Subpart Y_Nutrition Labeling

    Source: 58 FR 675, Jan. 6, 1993, unless otherwise noted.



Sec. 381.400  Nutrition labeling of poultry products.

    (a) Nutrition labeling shall be provided for all poultry products 
intended for human consumption and offered for sale, except single-
ingredient, raw products, in accordance with the requirements of Sec. 
381.409, except as exempted under Sec. 381.500 of this subpart.
    (b) Nutrition labeling may be provided for single-ingredient, raw 
poultry products in accordance with the requirements of Sec. Sec. 
381.409 and 381.445. Significant participation in voluntary nutrition 
labeling shall be measured by the Agency in accordance with Sec. Sec. 
381.443 and 381.444 of this subpart.

[58 FR 675, Jan. 6, 1993, as amended at 60 FR 197, Jan. 3, 1995]



Sec. 381.401  [Reserved]



Sec. 381.402  Location of nutrition information.

    (a) Nutrition information on a label of a packaged poultry product 
shall appear on the label's principal display panel or on the 
information panel, except as provided in paragraphs (b) and (c) of this 
section.
    (b) Nutrition information for gift packs may be shown at a location 
other than on the product label, provided that the labels for these 
products bear no nutrition claim. In lieu of on the product label, 
nutrition information may be provided by alternate means such as product 
label inserts.
    (c) Poultry products in packages that have a total surface area 
available to bear labeling greater than 40 square inches but whose 
principal display panel and information panel do not

[[Page 571]]

provide sufficient space to accommodate all required information may use 
any alternate panel that can be readily seen by consumers for the 
nutrition information. In determining the sufficiency of available space 
for the nutrition information, the space needed for vignettes, designs, 
and other nonmandatory label information on the principal display panel 
may be considered.

[58 FR 675, Jan. 6, 1993, as amended at 59 FR 40215, Aug. 8, 1994]



Sec. Sec. 381.403-381.407  [Reserved]



Sec. 381.408  Labeling of poultry products with number of servings.

    The label of any package of a poultry product that bears a 
representation as to the number of servings contained in such package 
shall meet the requirements of Sec. 381.121(c)(7).



Sec. 381.409  Nutrition label content.

    (a) All nutrient and food component quantities shall be declared in 
relation to a serving as defined in this section.
    (b)(1) The term ``serving'' or ``serving size'' means an amount of 
food customarily consumed per eating occasion by persons 4 years of age 
or older, which is expressed in a common household measure that is 
appropriate to the product. When the product is specially formulated or 
processed for use by infants or by toddlers, a serving or serving size 
means an amount of food customarily consumed per eating occasion by 
infants up to 12 months of age or by children 1 through 3 years of age, 
respectively.
    (2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of 
this section and for products that are intended for weight control and 
are available only through a weight-control or weight-maintenance 
program, the serving size declared on a product label shall be 
determined from the ``Reference Amounts Customarily Consumed Per Eating 
Occasion--General Food Supply'' (Reference Amount(s)) that appear in 
Sec. 381.412(b) using the procedures described in this paragraph (b). 
For products that are both intended for weight control and available 
only through a weight-control program, a manufacturer may determine the 
serving size that is consistent with the meal plan of the program. Such 
products must bear a statement, ``for sale only through the ------ 
program'' (fill in the blank with the name of the appropriate weight-
control program, e.g., Smith's Weight Control), on the principal display 
panel. However, the Reference Amounts in Sec. 381.412(b) shall be used 
for purposes of evaluating whether weight-control products that are 
available only through a weight-control program qualify for nutrition 
claims.
    (3) The declaration of nutrient and food component content shall be 
on the basis of the product ``as packaged'' for all products, except 
that single-ingredient, raw products may be declared on the basis of the 
product ``as consumed'' as set forth in Sec. 381.445(a)(1). In addition 
to the required declaration on the basis of ``as packaged'' for products 
other than single ingredient, raw products, the declaration may also be 
made on the basis of ``as consumed,'' provided that preparation and 
cooking instructions are clearly stated.
    (4) For products in discrete units (e.g., chicken wings, and 
individually packaged products within a multi-serving package), and for 
products which consist of two or more foods packaged and presented to be 
consumed together where the ingredient represented as the main 
ingredient is in discrete units (e.g., chicken wings and barbecue 
sauce), the serving size shall be declared as follows:
    (i) If a unit weighs 50 percent or less of the Reference Amount, the 
serving size shall be the number of whole units that most closely 
approximates the Reference Amount for the product category.
    (ii) If a unit weighs more than 50 percent but less than 67 percent 
of the Reference Amount, the manufacturer may declare one unit or two 
units as the serving size.
    (iii) If a unit weighs 67 percent or more but less than 200 percent 
of the Reference Amount, the serving size shall be one unit.
    (iv) If a unit weighs 200 percent or more of the Reference Amount, 
the manufacturer may declare one unit as the serving size if the whole 
unit can

[[Page 572]]

reasonably be consumed at a single eating occasion.
    (v) For products that have Reference Amounts of 100 grams (or 
milliliter) or larger and are individual units within a multi-serving 
package, if a unit contains more than 150 percent but less than 200 
percent of the Reference Amount, the manufacturer may decide whether to 
declare the individual unit as 1 or 2 servings.
    (vi) For products which consist of two or more foods packaged and 
presented to be consumed together where the ingredient represented as 
the main ingredient is in discrete units (e.g., chicken wings and 
barbecue sauce), the serving size may be the number of discrete units 
represented as the main ingredient plus proportioned minor ingredients 
used to make the Reference Amount for the combined product as determined 
in Sec. 381.412(c).
    (vii) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving containers), 
the serving size shall be 1 unit.
    (5) For products in large discrete units that are usually divided 
for consumption (e.g., pizza, pan of poultry lasagna), for unprepared 
products where the entire contents of the package is used to prepare 
large discrete units that are usually divided for consumption (e.g., 
pizza kit), and for products which consist of two or more foods packaged 
and presented to be consumed together where the ingredient represented 
as the main ingredient is a large discrete unit usually divided for 
consumption, the serving size shall be the fractional slice of the 
ready-to-eat product (e.g., \1/8\ quiche, \1/4\ pizza) that most closely 
approximates the Reference Amount for the product category. The serving 
size may be the fraction of the package used to make the Reference 
Amount for the unprepared product determined in Sec. 381.412(d) or the 
fraction of the large discrete unit represented as the main ingredient 
plus proportioned minor ingredients used to make the Reference Amount of 
the combined product determined in Sec. 381.412(c). In expressing the 
fractional slice, manufacturers shall use \1/2\, \1/3\, \1/4\, \1/5\, 
\1/6\, or smaller fractions that can be generated by further division by 
2 or 3.
    (6) For nondiscrete bulk products (e.g., whole turkey, turkey 
breast, ground poultry), and for products which consist of two or more 
foods packaged and presented to be consumed together where the 
ingredient represented as the main ingredient is a bulk product (e.g., 
turkey breast and gravy), the serving size shall be the amount in 
household measure that most closely approximates the Reference Amount 
for the product category and may be the amount of the bulk product 
represented as the main ingredient plus proportioned minor ingredients 
used to make the Reference Amount for the combined product determined in 
Sec. 381.412(c).
    (7) For labeling purposes, the term ``common household measure'' or 
``common household unit'' means cup, tablespoon, teaspoon, piece, slice, 
fraction (e.g., \1/4\ pizza), ounce (oz), or other common household 
equipment used to package food products (e.g., jar or tray). In 
expressing serving size in household measures, except as specified in 
paragraphs (b)(7)(iv), (v), and (vi) of this section, the following 
rules shall be used:
    (i) Cups, tablespoons, or teaspoons shall be used wherever possible 
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup 
increments, tablespoons in whole number of tablespoons for quantities 
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp), 
1, 1\1/3\, 1\1/2\, or 1\2/3\ tbsp for quantities less than 2 tbsp but 
greater than or equal to 1 tbsp, and teaspoons in whole number of 
teaspoons for quantities less than 1 tbsp but greater than or equal to 1 
teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 1 
tsp.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If cups, tablespoons and teaspoons, or units such as piece, 
slice, tray, jar, or fraction are not applicable, ounces may be used. 
Ounce measurements shall be expressed in 0.5-ounce

[[Page 573]]

increments most closely approximating the Reference Amount with rounding 
indicated by the use of the term ``about'' (e.g., about 2.5 ounces).
    (iv) A description of the individual container or package shall be 
used for single-serving containers and for individually packaged 
products within multi-serving containers (e.g., can, box, package, meal, 
or dinner). A description of the individual unit shall be used for other 
products in discrete units (e.g., wing, slice, link, or patty).
    (v) For unprepared products where the entire contents of the package 
is used to prepare large discrete units that are usually divided for 
consumption (e.g., pizza kit), the fraction or portion of the package 
may be used.
    (vi) For products that consist of two or more distinct ingredients 
or components packaged and presented to be consumed together (e.g., 
chicken wings with a glaze packet), the nutrition information may be 
declared for each component or as a composite. The serving size may be 
provided in accordance with the provisions of paragraphs (b)(4), (b)(5), 
and (b)(6) of this section.
    (vii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz 
in weight means 28 grams (g).
    (viii) When a serving size, determined from the Reference Amount in 
Sec. 381.412(b) and the procedures described in this section, falls 
exactly half way between two serving sizes (e.g., 2.5 tbsp), 
manufacturers shall round the serving size up to the next incremental 
size.
    (8) A product that is packaged and sold individually and that 
contains less than 200 percent of the applicable Reference Amount shall 
be considered to be a single-serving container, and the entire content 
of the product shall be labeled as one serving, except for products that 
have Reference Amounts of 100 g (or mL) or larger, manufacturers may 
decide whether a package that contains more than 150 percent but less 
than 200 percent of the Reference Amount is 1 or 2 servings. Packages 
sold individually that contain 200 percent or more of the applicable 
Reference Amount may be labeled as a single-serving if the entire 
content of the package can reasonably be consumed at a single-eating 
occasion.
    (9) A label statement regarding a serving shall be the serving size 
expressed in common household measures as set forth in paragraphs (b)(2) 
through (b)(8) of this section and shall be followed by the equivalent 
metric quantity in parenthesis (fluids in milliliters and all other 
foods in grams), except for single-serving containers.
    (i) For a single-serving container, the parenthetical metric 
quantity, which will be presented as part of the net weight statement on 
the principal display panel, is not required except where nutrition 
information is required on a drained weight basis according to paragraph 
(b)(11) of this section. However, if a manufacturer voluntarily provides 
the metric quantity on products that can be sold as single servings, 
then the numerical value provided as part of the serving size 
declaration must be identical to the metric quantity declaration 
provided as part of the net quantity of contents statement.
    (ii) The gram or milliliter quantity equivalent to the household 
measure should be rounded to the nearest whole number except for 
quantities that are less than 5 g (mL). The gram (mL) quantity between 2 
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) 
quantity less than 2 g (mL) should be expressed in 0.1-g (mL) 
increments.
    (iii) In addition, serving size may be declared in ounce, in 
parenthesis, following the metric measure separated by a slash where 
other common household measures are used as the primary unit for serving 
size, e.g., 1 slice (28 g/1 oz) for sliced chicken roll. The ounce 
quantity equivalent to the metric quantity should be expressed in 0.1-oz 
increments.
    (iv) If a manufacturer elects to use abbreviations for units, the 
following abbreviations shall be used: tbsp for tablespoon, tsp for 
teaspoon, g for gram, mL for milliliter, and oz for ounce.
    (10) Determination of the number of servings per container shall be 
based on the serving size of the product determined by following the 
procedures described in this section.

[[Page 574]]

    (i) The number of servings shall be rounded to the nearest whole 
number except for the number of servings between 2 and 5 servings and 
random weight products. The number of servings between 2 and 5 servings 
shall be rounded to the nearest 0.5 serving. Rounding should be 
indicated by the use of the term ``about'' (e.g., about 2 servings; 
about 3.5 servings).
    (ii) When the serving size is required to be expressed on a drained 
solids basis and the number of servings varies because of a natural 
variation in unit size, the manufacturer may state the typical number of 
servings per container (e.g., usually 5 servings).
    (iii) For random weight products, a manufacturer may declare 
``varied'' for the number of servings per container provided the 
nutrition information is based on the Reference Amount expressed in 
ounces. The manufacturer may provide the typical number of servings in 
parenthesis following the ``varied'' statement (e.g., varied 
(approximately 8 servings per pound)).
    (iv) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving containers), 
the number of servings shall be the number of individual packages within 
the total package.
    (v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by multiplying 
the number of individual multi-serving units in the total package by the 
number of servings in each individual unit.
    (11) The declaration of nutrient and food component content shall be 
on the basis of product as packaged or purchased with the exception of 
products that are packed or canned in water, brine, or oil but whose 
liquid packing medium is not customarily consumed. Declaration of the 
nutrient and food component content of products that are packed in 
liquid which is not customarily consumed shall be based on the drained 
solids.
    (12) The serving size for meal-type products and main-dish products 
as defined in Sec. 381.413(l) and Sec. 381.413 (m) in single-serve 
containers will be the entire edible content of the package. Serving 
size for meal-type products and main-dish products in multi-serve 
containers will be based on the reference amount applicable to the 
product in Sec. 381.412(b) if the product is listed in Sec. 
381.412(b). Serving size for meal-type products and main-dish products 
in multi-serve containers that are not listed in Sec. 381.412(b) will 
be based on the reference amount according to Sec. 381.412(c), (d), and 
(e).
    (13) Another column of figures may be used to declare the nutrient 
and food component information in the same format as required by Sec. 
381.409(e),
    (i) Per 100 grams, 100 milliliters, or 1 ounce of the product as 
packaged or purchased.
    (ii) Per one unit if the serving size of a product in discrete units 
in a multi-serving container is more than one unit.
    (14) If a product consists of assortments of poultry products (e.g., 
variety packs) in the same package, nutrient content shall be expressed 
on the entire package contents or on each individual product.
    (15) If a product is commonly combined with other ingredients or is 
cooked or otherwise prepared before eating, and directions for such 
combination or preparations are provided, another column of figures may 
be used to declare the nutrient contents on the basis of the product as 
consumed for the product alone (e.g., a cream soup mix may be labeled 
with one set of Daily Values for the dry mix (per serving), and another 
set for the serving of the final soup when prepared (e.g., per serving 
of cream soup mix and 1 cup of vitamin D fortified whole milk)): 
Provided, that the type and quantity of the other ingredients to be 
added to the product by the user and the specific method of cooking and 
other preparation shall be specified prominently on the label.
    (c) The declaration of nutrition information on the label or in 
labeling of a poultry product shall contain information about the level 
of the following nutrients, except for those nutrients whose inclusion, 
and the declaration of amounts, is voluntary as set forth in this 
paragraph. No nutrients or food

[[Page 575]]

components other than those listed in this paragraph as either mandatory 
or voluntary may be included within the nutrition label. Except as 
provided for in paragraph (f) or (g) of this section, nutrient 
information shall be presented using the nutrient names specified and in 
the following order in the formats specified in paragraph (d) or (e) of 
this section.
    (1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A 
statement of the caloric content per serving, expressed to the nearest 
5-calorie increment up to and including 50 calories, and 10-calorie 
increment above 50 calories, except that amounts less than 5 calories 
may be expressed as zero. Energy content per serving may also be 
expressed in kilojoule units, added in parenthesis immediately following 
the statement of the caloric content.
    (i) Caloric content may be calculated by the following methods. 
Where either specific or general food factors are used, the factors 
shall be applied to the actual amount (i.e., before rounding) of food 
components (e.g., fat, carbohydrate, protein, or ingredients with 
specific food factors) present per serving.
    (A) Using specific Atwater factors (i.e., the Atwater method) given 
in Table 13, page 25, ``Energy Value of Foods--Basis and Derivation,'' 
by A. L. Merrill and B. K. Watt, United States Department of Agriculture 
(USDA), Agriculture Handbook No. 74 (Slightly revised February 1973), 
which is incorporated by reference. Table 13 of the ``Energy Value of 
Foods--Basis and Derivation,'' Agriculture Handbook No. 74 is 
incorporated as it exists on the date of approval. This incorporation by 
reference was approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for 
inspection at the office of the FSIS Docket Clerk, Room 3171, South 
Building, 14th and Independence Avenue, SW., Washington, DC, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. Copies of the incorporation by 
reference are available from the Product Assessment Division, Regulatory 
Programs, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Room 329, West End Court Building, Washington, DC 20250-
3700;
    (B) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate, and total fat, respectively, as described 
in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), 
pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture 
Handbook No. 74 is incorporated as it exists on the date of approval. 
This incorporation by reference was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
(The availability of this incorporation by reference is given in 
paragraph (c)(1)(i)(A) of this section.);
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate less the amount of insoluble dietary fiber, 
and total fat, respectively, as described in USDA's Agriculture Handbook 
No. 74 (Slightly revised February 1973), pages 9-11, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. (The availability of this incorporation by reference is given 
in paragraph (c)(1)(i)(A) of this section.); or
    (D) Using data for specific food factors for particular foods or 
ingredients approved by the Food and Drug Administration (FDA) and 
provided in parts 172 or 184 of 21 CFR, or by other means, as 
appropriate.
    (ii) ``Calories from fat'': A statement of the caloric content 
derived from total fat as defined in paragraph (c)(2) of this section 
per serving, expressed to the nearest 5-calorie increment, up to and 
including 50 calories, and the nearest 10-calorie increment above 50 
calories, except that label declaration of ``calories from fat'' is not 
required on products that contain less than 0.5 gram of fat per serving 
and amounts less than 5 calories may be expressed as zero. This 
statement shall be declared as provided in paragraph (d)(5) of this 
section.
    (iii) ``Calories from saturated fat'' or ``Calories from saturated'' 
(VOLUNTARY): A statement of the caloric

[[Page 576]]

content derived from saturated fat as defined in paragraph (c)(2)(i) of 
this section per serving may be declared voluntarily, expressed to the 
nearest 5-calorie increment, up to and including 50 calories, and the 
nearest 10-calorie increment above 50 calories, except that amounts less 
than 5 calories may be expressed as zero. This statement shall be 
indented under the statement of calories from fat as provided in 
paragraph (d)(5) of this section.
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat per serving defined as total lipid fatty acids and 
expressed as triglycerides. Amounts shall be expressed to the nearest 
0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content shall be expressed as zero.
    (i) ``Saturated fat'' or ``Saturated'': A statement of the number of 
grams of saturated fat per serving defined as the sum of all fatty acids 
containing no double bonds, except that label declaration of saturated 
fat content information is not required for products that contain less 
than 0.5 gram of total fat per serving if no claims are made about fat 
or cholesterol content, and if ``calories from saturated fat'' is not 
declared. Saturated fat content shall be indented and expressed as grams 
per serving to the nearest 0.5 (\1/2\)-gram increment below 5 grams and 
to the nearest gram increment above 5 grams. If the serving contains 
less than 0.5 gram, the content shall be expressed as zero.
    (A) ``Stearic Acid'' (VOLUNTARY): A statement of the number of grams 
of stearic acid per serving may be declared voluntarily, except that 
when a claim is made about stearic acid, label declaration shall be 
required. Stearic acid content shall be indented under saturated fat and 
expressed to the nearest 0.5 (\1/2\)-gram increment below 5 grams and 
the nearest gram increment above 5 grams. If the serving contains less 
than 0.5 gram, the content shall be expressed as zero.
    (B) [Reserved]
    (ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A 
statement of the number of grams of polyunsaturated fat per serving 
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may 
be declared voluntarily, except that when monounsaturated fat is 
declared, or when a claim about fatty acids or cholesterol is made on 
the label or in labeling of a product other than one that meets the 
criteria in Sec. 381.462(b)(1) for a claim for ``fat free,'' label 
declaration of polyunsaturated fat is required. Polyunsaturated fat 
content shall be indented and expressed as grams per serving to the 
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content shall be expressed as zero.
    (iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A 
statement of the number of grams of monounsaturated fat per serving 
defined as cis-monounsaturated fatty acids may be declared voluntarily, 
except that when polyunsaturated fat is declared, or when a claim about 
fatty acids or cholesterol is made on the label or in labeling of a 
product other than one that meets the criteria in Sec. 381.462(b)(1) 
for a claim for ``fat free,'' label declaration of monounsaturated fat 
is required. Monounsaturated fat content shall be indented and expressed 
as grams per serving to the nearest 0.5 (\1/2\)-gram increment below 5 
grams and to the nearest gram increment above 5 grams. If the serving 
contains less than 0.5 gram, the content shall be expressed as zero.
    (3) ``Cholesterol'': A statement of the cholesterol content per 
serving expressed in milligrams to the nearest 5-milligram increment, 
except that label declaration of cholesterol information is not required 
for products that contain less than 2 milligrams of cholesterol per 
serving and make no claim about fat, fatty acids, or cholesterol 
content, or such products may state the cholesterol content as zero. If 
the product contains 2 to 5 milligrams of cholesterol per serving, the 
content may be stated as ``less than 5 milligrams.''
    (4) ``Sodium'': A statement of the number of milligrams of sodium 
per serving expressed as zero when the serving contains less than 5 
milligrams of sodium, to the nearest 5-milligram increment when the 
serving contains 5 to 140 milligrams of sodium, and to the

[[Page 577]]

nearest 10-milligram increment when the serving contains greater than 
140 milligrams.
    (5) ``Potassium'' (VOLUNTARY): A statement of the number of 
milligrams of potassium per serving may be declared voluntarily, except 
that when a claim is made about potassium content, label declaration 
shall be required. Potassium content shall be expressed as zero when the 
serving contains less than 5 milligrams of potassium, to the nearest 5-
milligram increment when the serving contains 5 to 140 milligrams of 
potassium, and to the nearest 10-milligram increment when the serving 
contains greater than 140 milligrams.
    (6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement 
of the number of grams of total carbohydrate per serving expressed to 
the nearest gram, except that if a serving contains less than 1 gram, 
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may 
be used as an alternative, or, if the serving contains less than 0.5 
gram, the content may be expressed as zero. Total carbohydrate content 
shall be calculated by subtraction of the sum of the crude protein, 
total fat, moisture, and ash from the total weight of the product. This 
calculation method is described in USDA's Agriculture Handbook No. 74 
(Slightly revised February 1973), pages 2 and 3, which is incorporated 
by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated 
as it exists on the date of approval. This incorporation by reference 
was approved by the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this 
incorporation by reference is given in paragraph (c)(1)(i)(A) of this 
section.).
    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber per serving, indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, declaration of 
dietary fiber is not required, or, alternatively, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and 
if the serving contains less than 0.5 gram, the content may be expressed 
as zero.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber per serving may be declared voluntarily 
except when a claim is made on the label or in labeling about soluble 
fiber, label declaration shall be required. Soluble fiber content shall 
be indented under dietary fiber and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of 
grams of insoluble dietary fiber per serving may be declared voluntarily 
except when a claim is made on the label or in labeling about insoluble 
fiber, label declaration shall be required. Insoluble fiber content 
shall be indented under dietary fiber and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (ii) ``Sugars'': A statement of the number of grams of sugars per 
serving, except that label declaration of sugars content is not required 
for products that contain less than 1 gram of sugars per serving if no 
claims are made about sweeteners, sugars, or sugar alcohol content. 
Sugars shall be defined as the sum of all free mono- and disaccharides 
(such as glucose, fructose, lactose, and sucrose). Sugars content shall 
be indented and expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero.
    (iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols per serving may be declared voluntarily on the 
label, except that when a claim is made on the label or in labeling 
about sugar alcohol or sugars when sugar alcohols are present in the 
product, sugar alcohol content

[[Page 578]]

shall be declared. For nutrition labeling purposes, sugar alcohols are 
defined as the sum of saccharide derivatives in which a hydroxyl group 
replaces a ketone or aldehyde group and whose use in the food is listed 
by FDA (e.g., mannitol or xylitol) or is generally recognized as safe 
(e.g., sorbitol). In lieu of the term ``sugar alcohol,'' the name of the 
specific sugar alcohol (e.g., ``xylitol'') present in the product may be 
used in the nutrition label, provided that only one sugar alcohol is 
present in the product. Sugar alcohol content shall be indented and 
expressed to the nearest gram, except that if a serving contains less 
than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 
1 gram'' may be used as an alternative, and if the serving contains less 
than 0.5 gram, the content may be expressed as zero.
    (iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number 
of grams of other carbohydrate per serving may be declared voluntarily. 
Other carbohydrate shall be defined as the difference between total 
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, 
except that if sugar alcohol is not declared (even if present), it shall 
be defined as the difference between total carbohydrate and the sum of 
dietary fiber and sugars. Other carbohydrate content shall be indented 
and expressed to the nearest gram, except that if a serving contains 
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less 
than 1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero.
    (7) ``Protein'': A statement of the number of grams of protein per 
serving expressed to the nearest gram, except that if a serving contains 
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less 
than 1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero. When the 
protein in products represented or purported to be for adults and 
children 4 or more years of age has a protein quality value that is a 
protein digestibility-corrected amino acid score of less than 20 
expressed as a percent, or when the protein in a product represented or 
purported to be for children greater than 1 but less than 4 years of age 
has a protein quality value that is a protein digestibility-corrected 
amino acid score of less than 40 expressed as a percent, either of the 
following shall be placed adjacent to the declaration of protein content 
by weight: The statement ``not a significant source of protein,'' or a 
listing aligned under the column headed ``Percent Daily Value'' of the 
corrected amount of protein per serving, as determined in paragraph 
(c)(7)(ii) of this section, calculated as a percentage of the Daily 
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, 
for protein and expressed as percent of Daily Value. When the protein 
quality in a product as measured by the Protein Efficiency Ratio (PER) 
is less than 40 percent of the reference standard (casein) for a product 
represented or purported to be for infants, the statement ``not a 
significant source of protein'' shall be placed adjacent to the 
declaration of protein content. Protein content may be calculated on the 
basis of the factor of 6.25 times the nitrogen content of the food as 
determined by appropriate methods of analysis in accordance with Sec. 
381.409(h), except when the procedure for a specific food requires 
another factor.
    (i) A statement of the corrected amount of protein per serving, as 
determined in paragraph (c)(7)(ii) of this section, calculated as a 
percentage of the RDI or DRV for protein, as appropriate, and expressed 
as percent of Daily Value, may be placed on the label, except that such 
a statement shall be given if a protein claim is made for the product, 
or if the product is represented or purported to be for infants or 
children under 4 years of age. When such a declaration is provided, it 
shall be placed on the label adjacent to the statement of grams of 
protein and aligned under the column headed ``Percent Daily Value,'' and 
expressed to the nearest whole percent. However, the percentage of the 
RDI for protein shall not be declared if the product is represented or 
purported to be for infants and the protein quality value is less than 
40 percent of the reference standard.

[[Page 579]]

    (ii) The corrected amount of protein (grams) per serving for 
products represented or purported to be for adults and children 1 or 
more years of age is equal to the actual amount of protein (grams) per 
serving multiplied by the amino acid score corrected for protein 
digestibility. If the corrected score is above 1.00, then it shall be 
set at 1.00. The protein digestibility-corrected amino acid score shall 
be determined by methods given in sections 5.4.1, 7.2.1, and 8 in 
``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert 
Consultation on Protein Quality Evaluation,'' Rome, 1990, which is 
incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the ``Report 
of the Joint FAO/WHO Expert Consultation on Protein Quality 
Evaluation,'' as published by the Food and Agriculture Organization of 
the United Nations/World Health Organization, is incorporated as it 
exists on the date of approval. This incorporation by reference was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the 
office of the FSIS Docket Clerk, Room 3171, South Building, 14th and 
Independence Avenue, SW., Washington, DC, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. Copies of the incorporation by reference are available 
from the Product Assessment Division, Regulatory Programs, Food Safety 
and Inspection Service, U.S. Department of Agriculture, Room 329, West 
End Court Building, Washington, DC 20250-3700. For products represented 
or purported to be for infants, the corrected amount of protein (grams) 
per serving is equal to the actual amount of protein (grams) per serving 
multiplied by the relative protein quality value. The relative protein 
quality value shall be determined by dividing the subject product's 
protein PER value by the PER value for casein. If the relative protein 
value is above 1.00, it shall be set at 1.00.
    (iii) For the purpose of labeling with a percent of the DRV or RDI, 
a value of 50 grams of protein shall be the DRV for adults and children 
4 or more years of age, and the RDI for protein for children less than 4 
years of age, infants, pregnant women, and lactating women shall be 16 
grams, 14 grams, 60 grams, and 65 grams, respectively.
    (8) Vitamins and minerals: A statement of the amount per serving of 
the vitamins and minerals as described in this paragraph, calculated as 
a percent of the RDI and expressed as percent of Daily Value.
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d) through (g) of this section, products 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women shall use the RDI's 
that are specified for the intended group. For products represented or 
purported to be for use by both infants and children under 4 years of 
age, the percent of Daily Value shall be presented by separate 
declarations according to paragraph (e) of this section based on the RDI 
values for infants from birth to 12 months of age and for children under 
4 years of age. Similarly, the percent of Daily Value based on both the 
RDI values for pregnant women and for lactating women shall be declared 
separately on products represented or purported to be for use by both 
pregnant and lactating women. When such dual declaration is used on any 
label, it shall be included in all labeling, and equal prominence shall 
be given to both values in all such labeling. All other products shall 
use the RDI for adults and children 4 or more years of age.
    (ii) The declaration of vitamins and minerals as a percent of the 
RDI shall include vitamin A, vitamin C, calcium, and iron, in that 
order, and shall include any of the other vitamins and minerals listed 
in paragraph (c)(8)(iv) of this section when they are added, or when a 
claim is made about them. Other vitamins and minerals need not be 
declared if neither the nutrient nor the component is otherwise referred 
to on the label or in labeling or advertising and the vitamins and 
minerals are:
    (A) Required or permitted in a standardized food (e.g., thiamin, 
riboflavin,

[[Page 580]]

and niacin in enriched flour) and that standardized food is included as 
an ingredient (i.e., component) in another product; or
    (B) Included in a product solely for technological purposes and 
declared only in the ingredients statement. The declaration may also 
include any of the other vitamins and minerals listed in paragraph 
(c)(8)(iv) of this section when they are naturally occurring in the 
food. The additional vitamins and minerals shall be listed in the order 
established in paragraph (c)(8)(iv) of this section.
    (iii) The percentages for vitamins and minerals shall be expressed 
to the nearest 2-percent increment up to and including the 10-percent 
level, the nearest 5-percent increment above 10 percent and up to and 
including the 50-percent level, and the nearest 10-percent increment 
above the 50-percent level. Amounts of vitamins and minerals present at 
less than 2 percent of the RDI are not required to be declared in 
nutrition labeling but may be declared by a zero or by the use of an 
asterisk (or other symbol) that refers to another asterisk (or symbol) 
that is placed at the bottom of the table and that is followed by the 
statement ``Contains less than 2 percent of the Daily Value of this 
(these) nutrient (nutrients).'' Alternatively, if vitamin A, vitamin C, 
calcium, or iron is present in amounts less than 2 percent of the RDI, 
label declaration of the nutrient(s) is not required if the statement 
``Not a significant source of -------- (listing the vitamins or minerals 
omitted)'' is placed at the bottom of the table of nutrient values.
    (iv) The following RDI's and nomenclature are established for the 
following vitamins and minerals which are essential in human nutrition:

Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1.0 gram
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 0.4 milligram
Vitamin B12, 6 micrograms
Biotin, 0.3 milligram
Pantothenic acid, 10 milligrams
Phosphorus, 1.0 gram
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Copper, 2.0 milligrams

    (v) The following synonyms may be added in parenthesis immediately 
following the name of the nutrient or dietary component:

Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folacin
Calories--Energy

    (vi) A statement of the percent of vitamin A that is present as 
beta-carotene may be declared voluntarily. When the vitamins and 
minerals are listed in a single column, the statement shall be indented 
under the information on vitamin A. When vitamins and minerals are 
arrayed horizontally, the statement of percent shall be presented in 
parenthesis following the declaration of vitamin A and the percent of 
Daily Value of vitamin A in the product (e.g., ``Percent Daily Value: 
Vitamin A 50 (90 percent as beta-carotene)''). When declared, the 
percentages shall be expressed in the same increments as are provided 
for vitamins and minerals in paragraph (c)(8)(iii) of this section.
    (9) For the purpose of labeling with a percent of the DRV, the 
following DRV's are established for the following food components based 
on the reference caloric intake of 2,000 calories:

------------------------------------------------------------------------
            Food component                 Unit of measurement      DRV
------------------------------------------------------------------------
Fat...................................  grams (g)...............      65
Saturated fatty acids.................  ......do................      20
Cholesterol...........................  milligrams (mg).........     300
Total carbohydrate....................  grams (g)...............     300
Fiber.................................  ......do................      25
Sodium................................  milligrams (mg).........    2400
Potassium.............................  ......do................    3500
Protein...............................  grams (g)...............      50
------------------------------------------------------------------------

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on products in the following format, except 
on products on which dual columns of nutrition information are declared 
as provided for in paragraph (e) of this section, on those products on 
which the simplified format is permitted to be used as provided for in

[[Page 581]]

paragraph (f) of this section, on products for infants and children less 
than 4 years of age as provided for in Sec. 381.500(c), and on products 
in packages that have a total surface area available to bear labeling of 
40 or less square inches as provided for in paragraph (g) of this 
section.
    (i) The nutrition information shall be set off in a box by use of 
hairlines and shall be all black or one color type, printed on a white 
or other neutral contrasting background whenever practical.
    (ii) All information within the nutrition label shall utilize:
    (A) A single easy-to-read type style,
    (B) Upper and lower case letters,
    (C) At least one point leading (i.e., space between two lines of 
text) except that at least four points leading shall be utilized for the 
information required by paragraphs (d)(7) and (d)(8) of this section, 
and
    (D) Letters should never touch.
    (iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and 
(d)(8) of this section shall be in type size no smaller than 8 point. 
Except for the heading ``Nutrition Facts,'' the information required in 
paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other 
information contained within the nutrition label shall be in type size 
no smaller than 6 point. When provided, the information described in 
paragraph (d)(10) of this section shall also be in type no smaller than 
6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) 
of this section (i.e., ``Nutrition Facts,'' ``Amount Per Serving,'' and 
``% Daily Value*''), the names of all nutrients that are not indented 
according to requirements of paragraph (c) of this section (i.e., 
Calories, Total fat, Cholesterol, Sodium, Potassium, Total carbohydrate, 
and Protein), and the percentage amounts required by paragraph 
(d)(7)(ii) of this section shall be highlighted by bold or extra bold 
type or other highlighting (reverse printing is not permitted as a form 
of highlighting) that prominently distinguishes it from other 
information. No other information shall be highlighted.
    (v) A hairline rule that is centered between the lines of text shall 
separate ``Amount Per Serving'' from the calorie statements required in 
paragraph (d)(5) of this section and shall separate each nutrient and 
its corresponding percent of Daily Value required in paragraphs 
(d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent 
of Daily Value above and below it.
    (2) The information shall be presented under the identifying heading 
of ``Nutrition Facts'' which shall be set in a type size larger than all 
other print size in the nutrition label and, except for labels presented 
according to the format provided for in paragraph (d)(11) of this 
section, unless impractical, shall be set the full width of the 
information provided under paragraph (d)(7) of this section.
    (3) Information on serving size shall immediately follow the 
heading. Such information shall include:
    (i) ``Serving Size'': A statement of the serving size as specified 
in paragraph (b)(9) of this section.
    (ii) ``Servings Per Container'': The number of servings per 
container, except that this statement is not required on single-serving 
containers as defined in paragraph (b)(8) of this section.
    (4) A subheading ``Amount Per Serving'' shall be separated from 
serving size information by a bar.
    (5) Information on calories shall immediately follow the heading 
``Amount Per Serving'' and shall be declared in one line, leaving 
sufficient space between the declaration of ``Calories'' and ``Calories 
from fat'' to allow clear differentiation, or, if ``Calories from 
saturated fat'' is declared, in a column with total ``Calories'' at the 
top, followed by ``Calories from fat'' (indented), and ``Calories from 
saturated fat'' (indented).
    (6) The column heading ``% Daily Value,'' followed by an asterisk 
(e.g., ``% Daily Value*''), shall be separated from information on 
calories by a bar. The position of this column heading shall allow for a 
list of nutrient names and amounts as described in paragraph (d)(7) of 
this section to be to the left of, and below, this column heading. The 
column heading ``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may 
be substituted for ``% Daily Value.''
    (7) Except as provided for in paragraph (g) of this section, and 
except as

[[Page 582]]

permitted by Sec. 381.500(d)(2), nutrient information for both 
mandatory and any voluntary nutrients listed in paragraph (c) of this 
section that are to be declared in the nutrition label, except vitamins 
and minerals, shall be declared as follows:
    (i) The name of each nutrient, as specified in paragraph (c) of this 
section, shall be given in a column and followed immediately by the 
quantitative amount by weight for that nutrient appended with a ``g'' 
for grams or ``mg'' for milligrams.
    (ii) A listing of the percent of the DRV as established in 
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a 
column aligned under the heading ``% Daily Value'' established in 
paragraph (d)(6) of this section with the percent expressed to the 
nearest whole percent for each nutrient declared in the column described 
in paragraph (d)(7)(i) of this section for which a DRV has been 
established, except that the percent for protein may be omitted as 
provided in paragraph (c)(7) of this section. The percent shall be 
calculated by dividing either the amount declared on the label for each 
nutrient or the actual amount of each nutrient (i.e., before rounding) 
by the DRV for the nutrient, except that the percent for protein shall 
be calculated as specified in paragraph (c)(7)(ii) of this section. The 
numerical value shall be followed by the symbol for percent (i.e., %).
    (8) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, 
Iron 4%) or may be listed in two columns, except that when more than 
four vitamins and minerals are declared, they may be declared vertically 
with percentages listed under the column headed ``% Daily Value.''
    (9) A footnote, preceded by an asterisk, shall be placed beneath the 
list of vitamins and minerals and shall be separated from that list by a 
hairline.
    (i) The footnote shall state: Percent Daily Values are based on a 
2,000 calorie diet. Your daily values may be higher or lower depending 
on your calorie needs.

------------------------------------------------------------------------
                                   Calories        2,000        2,500
------------------------------------------------------------------------
Total fat.....................  Less than.....  65 g         80 g
Saturated fat.................  Less than.....  20 g         25 g
Cholesterol...................  Less than.....  300 mg       300 mg
Sodium........................  Less than.....  2400 mg      2400 mg
Total carbohydrate............  ..............  300 g        375 g
Dietary fiber.................  ..............  25 g         30 g
------------------------------------------------------------------------

    (ii) If the percent of Daily Value is given for protein in the 
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of 
this section, protein shall be listed under dietary fiber, and a value 
of 50 g shall be inserted on the same line in the column headed 
``2,000'' and value of 65 g in the column headed ``2,500.''
    (iii) If potassium is declared in the column described in paragraph 
(d)(7)(i) of this section, potassium shall be listed under sodium and 
the DRV established in paragraph (c)(9) of this section shall be 
inserted on the same line in the numeric columns.
    (iv) The abbreviations established in paragraph (g)(2) of this 
section may be used within the footnote.
    (10) Caloric conversion information on a per-gram basis for fat, 
carbohydrate, and protein may be presented beneath the information 
required in paragraph (d)(9), separated from that information by a 
hairline. This information may be presented horizontally (i.e., 
``Calories per gram: Fat 9, Carbohydrate 4, Protein 4'') or vertically 
in columns.
    (11)(i) If the space beneath the information on vitamins and 
minerals is not adequate to accommodate the information required in 
paragraph (d)(9) of this section, the information required in paragraph 
(d)(9) may be moved to the right of the column required in paragraph 
(d)(7)(ii) of this section and set off by a line that distinguishes it 
and sets it apart from the percent of Daily Value information. The 
caloric conversion information provided for in paragraph (d)(10) of this 
section may be presented beneath either side or along the full length of 
the nutrition label.
    (ii) If the space beneath the mandatory declaration of iron is not 
adequate to accommodate any remaining vitamins and minerals to be 
declared or the information required in paragraph (d)(9) of this 
section, the remaining information may be moved to the right

[[Page 583]]

and set off by a line that distinguishes it and sets it apart from the 
percent of Daily Value information given to the left. The caloric 
conversion information provided for in paragraph (d)(10) of this section 
may be presented beneath either side or along the full length of the 
nutrition label.
    (iii) If there is not sufficient continuous vertical space (i.e., 
approximately 3 inches) to accommodate the required components of the 
nutrition label up to and including the mandatory declaration of iron, 
the nutrition label may be presented in a tabular display in which the 
footnote required by paragraph (d)(9) of the section is given to the far 
right of the label, and additional vitamins and minerals beyond the four 
that are required (i.e., vitamin A, vitamin C, calcium, and iron) are 
arrayed horizontally following declarations of the required vitamins and 
minerals.
    (12) The following sample label illustrates the provisions of 
paragraph (d) of this section:

[[Page 584]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.053

    (13)(i) Nutrition labeling on the outer label of packages of poultry 
products that contain two or more products in the same packages (e.g., 
variety packs) or of packages that are used interchangeably for the same 
type of food (e.g., poultry salad containers) may use an aggregate 
display.
    (ii) Aggregate displays shall comply with format requirements of 
paragraph

[[Page 585]]

(d) of this section to the maximum extent possible, except that the 
identity of each food shall be specified to the right of the ``Nutrition 
Facts'' title, and both the quantitative amount by weight (i.e., g/mg 
amounts) and the percent Daily Value for each nutrient shall be listed 
in separate columns under the name of each food.
    (14) When nutrition labeling appears in a second language, the 
nutrition information may be presented in a separate nutrition label for 
each language or in one nutrition label with the information in the 
second language following that in English. Numeric characters that are 
identical in both languages need not be repeated (e.g., ``Protein/
Proteinas 2 g''). All required information must be included in both 
languages.
    (e) Nutrition information may be presented for two or more forms of 
the same product (e.g., both ``raw'' and ``cooked'') or for common 
combinations of foods as provided for in paragraph (b) of this section, 
or for different units (e.g., per 100 grams) as provided for in 
paragraph (b) of this section, or for two or more groups for which RDI's 
are established (e.g., both infants and children less than 4 years of 
age) as provided for in paragraph (c)(8)(i) of this section. When such 
dual labeling is provided, equal prominence shall be given to both sets 
of values. Information shall be presented in a format consistent with 
paragraph (d) of this section, except that:
    (1) Following the subheading of ``Amount Per Serving,'' there shall 
be two or more column headings accurately describing the forms of the 
same product (e.g., ``raw'' and ``roasted''), the combinations of foods, 
the units, or the RDI groups that are being declared. The column 
representing the product as packaged and according to the label serving 
size based on the Reference Amount in Sec. 381.412(b) shall be to the 
left of the numeric columns.
    (2) When the dual labeling is presented for two or more forms of the 
same product, for combinations of foods, or for different units, total 
calories and calories from fat (and calories from saturated fat, when 
declared) shall be listed in a column and indented as specified in 
paragraph (d)(5) of this section with quantitative amounts declared in 
columns aligned under the column headings set forth in paragraph (e)(1) 
of this section.
    (3) Quantitative information by weight required in paragraph 
(d)(7)(i) of this section shall be specified for the form of the product 
as packaged and according to the label serving size based on the 
Reference Amount in Sec. 381.412(b).
    (i) Quantitative information by weight may be included for other 
forms of the product represented by the additional column(s) either 
immediately adjacent to the required quantitative information by weight 
for the product as packaged and according to the label serving size 
based on the Reference Amount in Sec. 381.412(b) or as a footnote.
    (A) If such additional quantitative information is given immediately 
adjacent to the required quantitative information, it shall be declared 
for all nutrients listed and placed immediately following and 
differentiated from the required quantitative information (e.g., 
separated by a comma). Such information shall not be put in a separate 
column.
    (B) If such additional quantitative information is given in a 
footnote, it shall be declared in the same order as the nutrients are 
listed in the nutrition label. The additional quantitative information 
may state the total nutrient content of the product identified in the 
second column or the nutrient amounts added to the product as packaged 
for only those nutrients that are present in different amounts than the 
amounts declared in the required quantitative information. The footnote 
shall clearly identify which amounts are declared. Any subcomponents 
declared shall be listed parenthetically after principal components 
(e.g., \1/2\ cup skim milk contributes an additional 40 calories, 65 mg 
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
    (ii) Total fat and its quantitative amount by weight shall be 
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'') 
referring to another asterisk (or symbol) at the bottom of the nutrition 
label identifying the form(s) of the product for which quantitative 
information is presented.

[[Page 586]]

    (4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this 
section shall be presented under the subheading ``% DAILY VALUE'' and in 
columns directly under the column headings set forth in paragraph (e)(1) 
of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:

[[Page 587]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.054

    (f)(1) Nutrition information may be presented in a simplified format 
as set forth herein when any required nutrients, other than the core 
nutrients (i.e., calories, total fat, sodium, total carbohydrate, and 
protein), are present in insignificant amounts. An insignificant amount 
shall be defined as that

[[Page 588]]

amount that may be rounded to zero in nutrition labeling, except that 
for total carbohydrate, dietary fiber, sugars and protein, it shall be 
an amount less than 1 gram.
    (2) The simplified format shall include information on the following 
nutrients:
    (i) Total calories, total fat, total carbohydrate, sodium, and 
protein;
    (ii) Any of the following that are present in more than 
insignificant amounts: Calories from fat, saturated fat, cholesterol, 
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
    (iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of 
this section when they are added in fortified or fabricated foods.
    (3) Other nutrients that are naturally present in the product in 
more than insignificant amounts may be voluntarily declared as part of 
the simplified format.
    (4) Any required nutrient, other than a core nutrient, that is 
present in an insignificant amount may be omitted from the tabular 
listing, provided that the following statement is included at the bottom 
of the nutrition label, ``Not a significant source of --------.'' The 
blank shall be filled in with the appropriate nutrient or food 
component. Alternatively, amounts of vitamins and minerals present in 
insignificant amounts may be declared by the use of an asterisk (or 
symbol) that is placed at the bottom of the table of nutrient values and 
that is followed by the statement ``Contains less than 2 percent of the 
Daily Value of this (these) nutrient (nutrients).''
    (5) Except as provided for in paragraph (g) of this section and in 
Sec. 381.500(c) and (d), nutrient information declared in the 
simplified format shall be presented in the same manner as specified in 
paragraphs (d) or (e) of this section, except that the footnote required 
in paragraph (d)(9) of this section is not required. When the footnote 
is omitted, an asterisk shall be placed at the bottom of the label 
followed by the statement ``Percent Daily Values are based on a 2,000 
calorie diet'' and, if the term ``Daily Value'' is not spelled out in 
the heading, a statement that ``DV'' represents ``Daily Value.''
    (g) Foods in packages that have a total surface area available to 
bear labeling of 40 or less square inches may modify the requirements of 
paragraphs (c) through (f) of this section and Sec. 381.402(a) by one 
or more of the following means:
    (1)(i) Presenting the required nutrition information in a tabular or 
linear (i.e., string) fashion, rather than in vertical columns if the 
product has a total surface area available to bear labeling of less than 
12 square inches, or if the product has a total surface area available 
to bear labeling of 40 or less square inches and the package shape or 
size cannot accommodate a standard vertical column or tabular display on 
any label panel. Nutrition information may be given in a linear fashion 
only if the package shape or size will not accommodate a tabular 
display.
    (ii) When nutrition information is given in a linear display, the 
nutrition information shall be set off in a box by the use of a 
hairline. The percent Daily Value is separated from the quantitative 
amount declaration by the use of parenthesis, and all nutrients, both 
principal components and subcomponents, are treated similarly. Bolding 
is required only on the title ``Nutrition Facts'' and is allowed for 
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
    (2) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb

    (3) Omitting the footnote required in paragraph (d)(9) of this 
section and placing another asterisk at the bottom of the label followed 
by the statement ``Percent Daily Values are based on a 2,000 calorie 
diet'' and, if the term ``Daily Value'' is not spelled out in the

[[Page 589]]

heading, a statement that ``DV'' represents ``Daily Value.''
    (4) Presenting the required information on any other label panel.
    (h) Compliance with this section shall be determined as follows:
    (1) A production lot is a set of food production consumer units that 
are from one production shift. Alternatively, a collection of consumer 
units of the same size, type, and style produced under conditions as 
nearly uniform as possible, designated by a common container code or 
marking, constitutes a production lot.
    (2) The sample for nutrient analysis shall consist of a composite of 
a minimum of six consumer units, each from a production lot. 
Alternatively, the sample for nutrient analysis shall consist of a 
composite of a minimum of six consumer units, each randomly chosen to be 
representative of a production lot. In each case, the units may be 
individually analyzed and the results of the analyses averaged, or the 
units would be composited and the composite analyzed. In both cases, the 
results, whether an average or a single result from a composite, will be 
considered by the Agency to be the nutrient content of a composite. All 
analyses shall be performed by appropriate methods and procedures used 
by the Department for each nutrient in accordance with the ``Chemistry 
Laboratory Guidebook,'' or, if no USDA method is available and 
appropriate for the nutrient, by appropriate methods for the nutrient in 
accordance with the 1990 edition of the ``Official Methods of Analysis'' 
of the AOAC International, formerly Association of Official Analytical 
Chemists, 15th ed., which is incorporated by reference, unless a 
particular method of analysis is specified in Sec. 381.409(c), or, if 
no USDA, AOAC, or specified method is available and appropriate, by 
other reliable and appropriate analytical procedures as so determined by 
the Agency. The ``Official Methods of Analysis'' is incorporated as it 
exists on the date of approval. This incorporation by reference was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC 
International, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201. It is 
also available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (3) Two classes of nutrients are defined for purposes of compliance:
    (i) Class I. Added nutrients in fortified or fabricated foods; and
    (ii) Class II. Naturally occurring (indigenous) nutrients. If any 
ingredient which contains a naturally occurring (indigenous) nutrient is 
added to a food, the total amount of such nutrient in the final food 
product is subject to Class II requirements unless the same nutrient is 
also added, which would make the total amount of such nutrient subject 
to Class I requirements.
    (4) A product with a label declaration of a vitamin, mineral, 
protein, total carbohydrate, dietary fiber, other carbohydrate, 
polyunsaturated or monounsaturated fat, or potassium shall be deemed to 
be misbranded under section 4(h) of the Poultry Products Inspection Act 
(21 U.S.C. 453(h)(4)) unless it meets the following requirements:
    (i) Class I vitamin, mineral, protein, dietary fiber, or potassium. 
The nutrient content of the composite is at least equal to the value for 
that nutrient declared on the label.
    (ii) Class II vitamin, mineral, protein, total carbohydrate, dietary 
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or 
potassium. The nutrient content of the composite is at least equal to 80 
percent of the value for that nutrient declared on the label; Provided, 
That no regulatory action will be based on a determination of a nutrient 
value which falls below this level by an amount less than the 
variability generally recognized for the analytical method used in that 
product at the level involved, and inherent nutrient variation in a 
product.
    (5) A product with a label declaration of calories, sugars, total 
fat, saturated fat, cholesterol, or sodium shall be deemed to be 
misbranded under section 4(h) of the Poultry Products Inspection Act (21 
U.S.C. 453(h)(4)) if the nutrient content of the composite is greater

[[Page 590]]

than 20 percent in excess of the value for that nutrient declared on the 
label; Provided, That no regulatory action will be based on a 
determination of a nutrient value which falls above this level by an 
amount less than the variability generally recognized for the analytical 
method used in that product at the level involved, and inherent nutrient 
variation in a product.
    (6) The amount of a vitamin, mineral, protein, total carbohydrate, 
dietary fiber, other carbohydrate, polyunsaturated or monounsaturated 
fat, or potassium may vary over labeled amounts within good 
manufacturing practice. The amount of calories, sugars, total fat, 
saturated fat, cholesterol, or sodium may vary under labeled amounts 
within good manufacturing practice.
    (7) Compliance will be based on the metric measure specified in the 
label statement of serving size.
    (8) The management of the establishment must maintain records to 
support the validity of nutrient declarations contained on product 
labels. Such records shall be made available to the inspector or any 
duly authorized representative of the Agency upon request.
    (9) The compliance provisions set forth in paragraph (h)(1) through 
(8) of this section shall not apply to single-ingredient, raw poultry 
products, including those that have been previously frozen, when 
nutrition labeling is based on the most current representative data base 
values contained in USDA's National Nutrient Data Bank or its published 
form, the Agriculture Handbook No. 8 series.

(Paperwork requirements were approved by the Office of Management and 
Budget under control number 0583-0088.)

[58 FR 675, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 
FR 47628, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 197, Jan. 3, 
1995; 60 FR 10304, Feb. 24, 1995; 69 FR 58802, Oct. 1, 2004]



Sec. Sec. 381.410-381.411  [Reserved]



Sec. 381.412  Reference amounts customarily consumed per eating occasion.

    (a) The general principles followed in arriving at the reference 
amounts customarily consumed per eating occasion (Reference Amount(s)), 
as set forth in paragraph (b) of this section, are:
    (1) The Reference Amounts are calculated for persons 4 years of age 
or older to reflect the amount of food customarily consumed per eating 
occasion by persons in this population group. These Reference Amounts 
are based on data set forth in appropriate national food consumption 
surveys.
    (2) The Reference Amounts are calculated for an infant or child 
under 4 years of age to reflect the amount of food customarily consumed 
per eating occasion by infants up to 12 months of age or by children 1 
through 3 years of age, respectively. These Reference Amounts are based 
on data set forth in appropriate national food consumption surveys. Such 
Reference Amounts are to be used only when the product is specially 
formulated or processed for use by an infant or by a child under 4 years 
of age.
    (3) An appropriate national food consumption survey includes a large 
sample size representative of the demographic and socioeconomic 
characteristics of the relevant population group and must be based on 
consumption data under actual conditions of use.
    (4) To determine the amount of food customarily consumed per eating 
occasion, the mean, median, and mode of the consumed amount per eating 
occasion were considered.
    (5) When survey data were insufficient, FSIS took various other 
sources of information on serving sizes of food into consideration. 
These other sources of information included:
    (i) Serving sizes used in dietary guidance recommendations or 
recommended by other authoritative systems or organizations;
    (ii) Serving sizes recommended in comments;
    (iii) Serving sizes used by manufacturers and grocers; and
    (iv) Serving sizes used by other countries.
    (6) Because they reflect the amount customarily consumed, the 
Reference Amount and, in turn, the serving size declared on the product 
label are based on only the edible portion of food, and not bone, seed, 
shell, or other inedible components.

[[Page 591]]

    (7) The Reference Amount is based on the major intended use of the 
product (e.g., a mixed dish measurable with a cup as a main dish and not 
as a side dish).
    (8) The Reference Amounts for products that are consumed as an 
ingredient of other products, but that may also be consumed in the form 
in which they are purchased (e.g., ground poultry), are based on use in 
the form purchased.
    (9) FSIS sought to ensure that foods that have similar dietary 
usage, product characteristics, and customarily consumed amounts have a 
uniform Reference Amount.
    (b) The following Product Categories and Reference Amounts shall be 
used as the basis for determining serving sizes for specific products:

  Table 1--Reference Amounts Customarily Consumed per Eating Occasion--
                    Infant and Toddler Foods 1, 2, 3
------------------------------------------------------------------------
                                                               Reference
                      Product category                          amount
------------------------------------------------------------------------
Infant & Toddler Foods:
  Dinner Dry Mix............................................        15 g
  Dinner, ready-to-serve, strained type.....................        60 g
  Dinner, soups, ready-to-serve junior type.................       110 g
  Dinner, stew or soup ready-to-serve toddlers..............       170 g
  Plain poultry and poultry sticks, ready-to-serve..........        55 g
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
  eating occasion and were primarily derived from the 1977-1978 and the
  1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the Reference
  Amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (i.e., heat and serve). If not listed separately, the
  Reference Amount for the unprepared form (e.g., dehydrated cereal) is
  the amount required to make one Reference Amount of the prepared form.
\3\ Manufacturers are required to convert the Reference Amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures established by the regulation.


     Table 2--Reference Amounts Customarily Consumed per Eating Occasion--General Food Supply 1, 2, 3, 4, 5
----------------------------------------------------------------------------------------------------------------
                                                   Reference Amount                    Reference Amount
            Product category             -----------------------------------------------------------------------
                                                    Ready-to-serve                       Ready-to-cook
----------------------------------------------------------------------------------------------------------------
Egg mixtures, (western style omelet,      110 g                               n/a
 souffle, egg foo young with poultry).
Salad and potato toppers; e.g., poultry   7 g                                 n/a
 bacon bits.
Bacon; e.g., poultry breakfast strips...  15 g                                26 g = bacon.
                                                                              18 g = breakfast strips
Dried; e.g., poultry jerky, dried         30 g                                n/a
 poultry, poultry sausage products with
 a moisture/protein ratio of less than
 2:1.
Snacks; e.g., poultry snack food sticks.  30 g                                n/a
Luncheon products, poultry bologna,       55 g                                n/a
 poultry Canadian style bacon, poultry
 crumbles, poultry luncheon loaf, potted
 poultry products, poultry taco filings.
Linked poultry sausage products, poultry  55 g                                n/a
 franks, poultry Polish sausage, smoked                                       69 g = uncooked sausage.
 or pickled poultry meat, poultry smoked
 sausage.
Entrees without sauce, poultry cuts,      85 g                                114g
 ready to cook poultry cuts, including
 marinated, tenderized, injected cuts of
 poultry, poultry corn dogs, poultry
 croquettes, poultry fritters, cured
 poultry ham products, adult pureed
 poultry.
Canned poultry, canned chicken, canned    55 g                                n/a
 \4\ turkey.
Entrees with sauce, turkey and gravy....  140 g                               n/a
Mixed dishes NOT measurable with a cup;   140 g (plus 55 g for products       n/a
 \5\ e.g., poultry burrito, poultry        toppings)
 enchiladas, poultry pizza, poultry
 quiche, all types of poultry
 sandwiches, cracker and poultry lunch-
 type packages, poultry gyro, poultry
 stromboli, poultry frank on a bun,
 poultry burger on a bun, poultry taco,
 chicken cordon bleu, poultry calzone,
 stuffed vegetables with poultry,
 poultry kabobs.
Mixed dishes, measurables with a cup;     1 cup                               n/a
 e.g., poultry casserole, macaroni and
 cheese with poultry, poultry pot pie,
 poultry spaghetti with sauce, poultry
 chili, poultry chili with beans,
 poultry hash, creamed dried poultry,
 poultry ravioli in sauce, poultry a la
 king, poultry stew, poultry goulash,
 poultry lasagna, poultry-filled pasta.
Salads--pasta or potato, potato salad     140 g                               n/a
 with poultry, macaroni and poultry
 salad.
Salads--all other, poultry salads,        100 g                               n/a
 chicken salad, turkey salad.
Soups--all varieties....................  245 g                               n/a
Major main entree type sauce; e.g.,       125 g                               n/a
 spaghetti sauce with poultry.
Minor main entree sauce; e.g., pizza      \1/4\ cup                           n/a
 sauce with poultry, gravy.
Seasoning mixes dry, freeze dry,
 dehydrated, concentrated soup mixes,
 bases, extracts, dried broths and stock/
 juice, freeze dry trail mix products
 with poultry.

[[Page 592]]

 
As reconstituted: Amount to make one
 Reference Amount of the final dish;
 e.g.--
    Gravy...............................  \1/4\ cup                           n/a
    Major main entree type sauce........  125 g                               n/a
    Soup................................  245 g                               n/a
    Entree measurable with a cup........  1 cup                               n/a
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per eating occasion and were primarily
  derived from the 1977-78 and the 1987-88 Nationwide Food Consumption Surveys conducted by the U.S. Department
  of Agriculture.
\2\ Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure
  most appropriate to their specific product using the procedures established by regulation.
\3\ Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist
  manufacturers in identifying appropriate product Reference Amount.
\4\ If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which
  both the solids and liquids are customarily consumed.
\5\ Pizza sauce is part of the pizza and is not considered to be a sauce topping.

    (c) For products that have no Reference Amount listed in paragraph 
(b) of this section for the unprepared or the prepared form of the 
product and that consist of two or more foods packaged and presented to 
be consumed together (e.g., poultry lunch meat with cheese and 
crackers), the Reference Amount for the combined product shall be 
determined using the following rules:
    (1) For bulk products, the Reference Amount for the combined product 
shall be the Reference Amount, as established in paragraph (b) of this 
section, for the ingredient that is represented as the main ingredient 
plus proportioned amounts of all minor ingredients.
    (2) For products where the ingredient represented as the main 
ingredient is one or more discrete units, the Reference Amount for the 
combined product shall be either the number of small discrete units or 
the fraction of the large discrete unit that is represented as the main 
ingredient that is closest to the Reference Amount for that ingredient 
as established in paragraph (b) of this section plus proportioned 
amounts of all minor ingredients.
    (3) If the Reference Amounts are in compatible units, they shall be 
summed (e.g., ingredients in equal volumes such as tablespoons). If the 
Reference Amounts are in incompatible units, the weights of the 
appropriate volumes should be used (e.g., grams of one ingredient plus 
gram weight of tablespoons of a second ingredient).
    (d) If a product requires further preparation, e.g., cooking or the 
addition of water or other ingredients, and if paragraph (b) of this 
section provides a Reference Amount for the product in the prepared 
form, then the Reference Amount for the unprepared product shall be 
determined using the following rules:
    (1) Except as provided for in paragraph (d)(2) of this section, the 
Reference Amount for the unprepared product shall be the amount of the 
unprepared product required to make the Reference Amount for the 
prepared product as established in paragraph (b) of this section.
    (2) For products where the entire contents of the package is used to 
prepare one large discrete unit usually divided for consumption, the 
Reference Amount for the unprepared product shall be the amount of the 
unprepared product required to make the fraction of the large discrete 
unit closest to the Reference Amount for the prepared product as 
established in paragraph (b) of this section.
    (e) The Reference Amount for an imitation or substitute product or 
altered product as defined in Sec. 381.413(d), such as a ``low 
calorie'' version, shall be the same as for the product for which it is 
offered as a substitute.
    (f) The Reference Amounts set forth in paragraphs (b) through (e) of 
this section shall be used in determining whether a product meets the 
criteria for nutritional claims. If the serving

[[Page 593]]

size declared on the product label differs from the Reference Amount, 
and the product meets the criteria for the claim only on the basis of 
the Reference Amount, the claim shall be followed by a statement that 
sets forth the basis on which the claim is made. That statement shall 
include the Reference Amount as it appears in paragraph (b) of this 
section followed, in parenthesis, by the amount in common household 
measure if the Reference Amount is expressed in measures other than 
common household measures.
    (g) The Administrator, on his or her own initiative or on behalf of 
any interested person who has submitted a labeling application, may 
issue a proposal to establish or amend a Product Category or Reference 
Amount identified in paragraph (b) of this section.
    (1) Labeling applications and supporting documentation to be filed 
under this section shall be submitted in quadruplicate, except that the 
supporting documentation may be submitted on a computer disc copy. If 
any part of the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
labeling application shall state the applicant's post office address.
    (2) Pertinent information will be considered as part of an 
application on the basis of specific reference to such information 
submitted to and retained in the files of the Food Safety and Inspection 
Service. However, any reference to unpublished information furnished by 
a person other than the applicant will not be considered unless use of 
such information is authorized (with the understanding that such 
information may in whole or part be subject to release to the public) in 
a written statement signed by the person who submitted it. Any reference 
to published information should be accompanied by reprints or 
photostatic copies of such references.
    (3) The availability for public disclosure of labeling applications, 
along with supporting documentation, submitted to the Agency under this 
section will be governed by the rules specified in subchapter D, title 
9.
    (4) Data accompanying the labeling application, such as food 
consumption data, shall be submitted on separate sheets, suitably 
identified. If such data has already been submitted with an earlier 
labeling application from the applicant, the present labeling 
application must provide the data.
    (5) The labeling application must be signed by the applicant or by 
his or her attorney or agent, or (if a corporation) by an authorized 
official.
    (6) The labeling application shall include a statement signed by the 
person responsible for the labeling application, that to the best of his 
or her knowledge, it is a representative and balanced submission that 
includes unfavorable information, as well as favorable information, 
known to him or her pertinent to the evaluation of the labeling 
application.
    (7) Labeling applications for a new Reference Amount and/or Product 
Category shall be accompanied by the following data which shall be 
submitted in the following form to the Director, Food Labeling Division, 
Regulatory Programs, Food Safety and Inspection Service, Washington, DC 
20250:

________________________________________________________________________
(Date)

    The undersigned, ------------ submits this labeling application 
pursuant to 9 CFR 381.412 with respect to Reference Amount and/or 
Product Category.
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement of the objective of the labeling application;
    (ii) A description of the product;
    (iii) A complete sample product label including nutrition label, 
using the format established by regulation;
    (iv) A description of the form in which the product will be 
marketed;
    (v) The intended dietary uses of the product with the major use 
identified (e.g., turkey as a luncheon meat);
    (vi) If the intended use is primarily as an ingredient in other 
foods, list of foods or food categories in which the product will be 
used as an ingredient with information on the prioritization of the use;
    (vii) The population group for which the product will be offered for 
use (e.g., infants, children under 4 years of age);
    (viii) The names of the most closely-related products (or in the 
case of foods for special dietary use and imitation or substitute foods, 
the names of the products for which they are offered as substitutes);

[[Page 594]]

    (ix) The suggested Reference Amount (the amount of edible portion of 
food as consumed, excluding bone, skin or other inedible components) for 
the population group for which the product is intended with full 
description of the methodology and procedures that were used to 
determine the suggested Reference Amount. In determining the Reference 
Amount, general principles and factors in paragraph (a) of this section 
should be followed.
    (x) The suggested Reference Amount shall be expressed in metric 
units. Reference Amounts for foods shall be expressed in grams except 
when common household units such as cups, tablespoons, and teaspoons are 
more appropriate or are more likely to promote uniformity in serving 
sizes declared on product labels. For example, common household measures 
would be more appropriate if products within the same category differ 
substantially in density such as mixed dishes measurable with a cup.
    (A) In expressing the Reference Amount in grams, the following 
general rules shall be followed:
    (1) For quantities greater than 10 grams, the quantity shall be 
expressed in nearest 5 grams increment.
    (2) For quantities less than 10 grams, exact gram weights shall be 
used.
    (B) [Reserved]
    (xi) A labeling application for a new subcategory of food with its 
own Reference Amount shall include the following additional information:
    (A) Data that demonstrate that the new subcategory of food will be 
consumed in amounts that differ enough from the Reference Amount for the 
parent category to warrant a separate Reference Amount. Data must 
include sample size, and the mean, standard deviation, median, and modal 
consumed amount per eating occasion for the product identified in the 
labeling application and for other products in the category. All data 
must be derived from the same survey data.
    (B) Documentation supporting the difference in dietary usage and 
product characteristics that affect the consumption size that 
distinguishes the product identified in the labeling application from 
the rest of the products in the category.
    (xii) In conducting research to collect or process food consumption 
data in support of the labeling application, the following general 
guidelines should be followed.
    (A) Sampled population selected should be representative of the 
demographic and socioeconomic characteristics of the target population 
group for which the food is intended.
    (B) Sample size (i.e., number of eaters) should be large enough to 
give reliable estimates for customarily consumed amounts.
    (C) The study protocol should identify potential biases and describe 
how potential biases are controlled for or, if not possible to control, 
how they affect interpretation of results.
    (D) The methodology used to collect or process data including study 
design, sampling procedures, materials used (e.g., questionnaire, 
interviewer's manual), procedures used to collect or process data, 
methods or procedures used to control for unbiased estimates, and 
procedures used to correct for nonresponse, should be fully documented.
    (xiii) A statement concerning the feasibility of convening 
associations, corporations, consumers, and other interested parties to 
engage in negotiated rulemaking to develop a proposed rule.

 Yours very truly,

 Applicant______________________________________________________________

 By_____________________________________________________________________
 (Indicate authority)

    (8) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (9) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (10) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
Reference Amount and/or Product Category is false or misleading. The 
notification letter shall inform the applicant that the applicant may 
submit a written statement by way of answer to the notification, and 
that the applicant shall have the right to request a hearing with 
respect to the merits or validity of the Administrator's decision to 
deny the use of the proposed Reference Amount and/or Product Category.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the

[[Page 595]]

initial determination to be correct, the Administrator shall file with 
the Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (11) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish in the Federal Register a 
proposed rule to amend the regulations to authorize the use of the 
Reference Amount and/or Product Category. The proposal shall also 
summarize the labeling application, including where the supporting 
documentation can be reviewed. The Administrator's proposed rule shall 
seek comment from consumers, the industry, consumer and industry groups, 
and other interested persons on the labeling application and the use of 
the proposed Reference Amount and/or Product Category. After public 
comment has been received and reviewed by the Agency, the Administrator 
shall make a determination on whether the proposed Reference Amount and/
or Product Category shall be approved for use on the labeling of poultry 
products.
    (i) If the Reference Amount and/or Product Category is denied by the 
Administrator, the Agency shall notify the applicant, in writing, of the 
basis for the denial, including the reason why the Reference Amount and/
or Product Category on the labeling was determined by the Agency to be 
false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed Reference 
Amount and/or Product Category.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia.
    (ii) If the Reference Amount and/or Product Category is approved, 
the Agency shall notify the applicant, in writing, and shall also 
publish in the Federal Register a final rule amending the regulations to 
authorize the use of the Reference Amount and/or Product Category.

(Paperwork requirements were approved by the Office of Management and 
Budget under control number 0583-0088.)

[58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58 
FR 47628, Sept. 10, 1993; 59 FR 45198, Sept. 1, 1994; 60 FR 207, Jan. 3, 
1995]



Sec. 381.413  Nutrient content claims; general principles.

    (a) This section applies to poultry products that are intended for 
human consumption and that are offered for sale.

[[Page 596]]

    (b) A claim which, expressly or by implication, characterizes the 
level of a nutrient (nutrient content claim) of the type required in 
nutrition labeling pursuant to Sec. 381.409, may not be made on a label 
or in labeling of that product unless the claim is made in accordance 
with the applicable provisions in this subpart.
    (1) An expressed nutrient content claim is any direct statement 
about the level (or range) of a nutrient in the product, e.g., ``low 
sodium'' or ``contains 100 calories.''
    (2) An implied nutrient content claim is any claim that:
    (i) Describes the product or an ingredient therein in a manner that 
suggests that a nutrient is absent or present in a certain amount (e.g., 
``high in oat bran''); or
    (ii) Suggests that the product, because of its nutrient content, may 
be useful in maintaining healthy dietary practices and is made in 
association with an explicit claim or statement about a nutrient (e.g., 
``healthy, contains 3 grams (g) of fat'').
    (3) Except for claims regarding vitamins and minerals described in 
paragraph (q)(3) of this section, no nutrient content claims may be made 
on products intended specifically for use by infants and children less 
than 2 years of age unless the claim is specifically provided for in 
subpart Y of this part.
    (4) Reasonable variations in the spelling of the terms defined in 
applicable provisions in this subpart and their synonyms are permitted 
provided these variations are not misleading (e.g., ``hi'' or ``lo'').
    (c) Information that is required or permitted by Sec. 381.409 to be 
declared in nutrition labeling, and that appears as part of the 
nutrition label, is not a nutrient content claim and is not subject to 
the requirements of this section. If such information is declared 
elsewhere on the label or in labeling, it is a nutrient content claim 
and is subject to the requirements for nutrient content claims.
    (d) A ``substitute'' product is one that may be used interchangeably 
with another product that it resembles, i.e., that it is 
organoleptically, physically, and functionally (including shelf life) 
similar to, and that it is not nutritionally inferior to unless it is 
labeled as an ``imitation.''
    (1) If there is a difference in performance characteristics that 
materially limits the use of the product, the product may still be 
considered a substitute if the label includes a disclaimer adjacent to 
the most prominent claim as defined in paragraph (j)(2)(iii) of this 
section, informing the consumer of such difference (e.g., ``not 
recommended for frying'').
    (2) This disclaimer shall be in easily legible print or type and in 
a size no less than that required by Sec. 381.121(c) for the net 
quantity of contents statement, except where the size of the claim is 
less than two times the required size of the net quantity of contents 
statement, in which case the disclaimer statement shall be no less than 
one-half the size of the claim but no smaller than \1/16\-inch minimum 
height, except as permitted by Sec. 381.500(d)(2).
    (e)(1) Because the use of a ``free'' or ``low'' claim before the 
name of a product implies that the product differs from other products 
of the same type by virtue of its having a lower amount of the nutrient, 
only products that have been specially processed, altered, formulated, 
or reformulated so as to lower the amount of the nutrient in the 
product, remove the nutrient from the product, or not include the 
nutrient in the product, may bear such a claim (e.g., ``low sodium 
chicken noodle soup'').
    (2) Any claim for the absence of a nutrient in a product, or that a 
product is low in a nutrient when the product has not been specially 
processed, altered, formulated, or reformulated to qualify for that 
claim shall indicate that the product inherently meets the criteria and 
shall clearly refer to all products of that type and not merely to the 
particular brand to which the labeling attaches (e.g., ``chicken breast 
meat, a low sodium food'').
    (f) A nutrient content claim shall be in type size and style no 
larger than two times that of the statement of identity and shall not be 
unduly prominent in type style compared to the statement of identity.
    (g) Labeling information required in Sec. Sec. 381.413, 381.454, 
381.456, 381.460, 381.461, 381.462, and 381.480, whose type size is

[[Page 597]]

not otherwise specified, is required to be in letters and/or numbers no 
less than \1/16\ inch in height, except as permitted by Sec. 
381.500(d)(2).
    (h) [Reserved]
    (i) Except as provided in Sec. 381.409 or in paragraph (q)(3) of 
this section, the label or labeling of a product may contain a statement 
about the amount or percentage of a nutrient if:
    (1) The use of the statement on the product implicitly characterizes 
the level of the nutrient in the product and is consistent with a 
definition for a claim, as provided in subpart Y of this part, for the 
nutrient that the label addresses. Such a claim might be, ``less than 10 
g of fat per serving;''
    (2) The use of the statement on the product implicitly characterizes 
the level of the nutrient in the product and is not consistent with such 
a definition, but the label carries a disclaimer adjacent to the 
statement that the product is not ``low'' in or a ``good source'' of the 
nutrient, such as ``only 200 milligrams (mg) sodium per serving, not a 
low sodium product.'' The disclaimer must be in easily legible print or 
type and in a size no less than required by Sec. 381.121(c) for the net 
quantity of contents, except where the size of the claim is less than 
two times the required size of the net quantity of contents statement, 
in which case the disclaimer statement shall be no less than one-half 
the size of the claim but no smaller than \1/16\-inch minimum height, 
except as permitted by Sec. 381.500(d)(2);
    (3) The statement does not in any way implicitly characterize the 
level of the nutrient in the product and it is not false or misleading 
in any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which 
case no disclaimer is required.
    (4) ``Percent fat free'' claims are not authorized by this 
paragraph. Such claims shall comply with Sec. 381.462(b)(6).
    (j) A product may bear a statement that compares the level of a 
nutrient in the product with the level of a nutrient in a reference 
product. These statements shall be known as ``relative claims'' and 
include ``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more'' 
claims.
    (1) To bear a relative claim about the level of a nutrient, the 
amount of that nutrient in the product must be compared to an amount of 
nutrient in an appropriate reference product as specified in this 
paragraph (j).
    (i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the 
reference product may be a dissimilar product within a product category 
that can generally be substituted for one another in the diet or a 
similar product.
    (B) For ``light,'' ``reduced,'' and ``added'' claims, the reference 
product shall be a similar product, and
    (ii)(A) For ``light'' claims, the reference product shall be 
representative of the type of product that includes the product that 
bears the claim. The nutrient value for the reference product shall be 
representative of a broad base of products of that type; e.g., a value 
in a representative, valid data base; an average value determined from 
the top three national (or regional) brands, a market basket norm; or, 
where its nutrient value is representative of the product type, a market 
leader. Firms using such a reference nutrient value as a basis for a 
claim, are required to provide specific information upon which the 
nutrient value was derived, on request, to consumers and appropriate 
regulatory officials.
    (B) For relative claims other than ``light,'' including ``less'' and 
``more'' claims, the reference product may be the same as that provided 
for ``light'' in paragraph (j)(1)(ii)(A) of this section or it may be 
the manufacturer's regular product, or that of another manufacturer, 
that has been offered for sale to the public on a regular basis for a 
substantial period of time in the same geographic area by the same 
business entity or by one entitled to use its trade name, provided the 
name of the competitor is not used on the labeling of the product. The 
nutrient values used to determine the claim when comparing a single 
manufacturer's product to the labeled product shall be either

[[Page 598]]

the values declared in nutrition labeling or the actual nutrient values, 
provided that the resulting labeling is internally consistent (i.e., 
that the values stated in the nutrition information, the nutrient values 
in the accompanying information, and the declaration of the percentage 
of nutrient by which the product has been modified are consistent and 
will not cause consumer confusion when compared), and that the actual 
modification is at least equal to the percentage specified in the 
definition of the claim.
    (2) For products bearing relative claims:
    (i) The label or labeling must state the identity of the reference 
product and the percent (or fraction) of the amount of the nutrient in 
the reference product by which the nutrient has been modified, (e.g., 
``50 percent less fat than `reference product' '' or ``\1/3\ fewer 
calories than `reference product' ''); and
    (ii) This information shall be immediately adjacent to the most 
prominent claim in easily legible boldface print or type, in distinct 
contrast to other printed or graphic matter, that is no less than that 
required by Sec. 381.121(c) for net quantity of contents, except where 
the size of the claim is less than two times the required size of the 
net quantity of contents statement, in which case the referral statement 
shall be no less than one-half the size of the claim, but no smaller 
than \1/16\-inch minimum height, except as permitted by Sec. 
381.500(d)(2).
    (iii) The determination of which use of the claim is in the most 
prominent location on the label or labeling will be made based on the 
following factors, considered in order:
    (A) A claim on the principal display panel adjacent to the statement 
of identity;
    (B) A claim elsewhere on the principal display panel;
    (C) A claim on the information panel; or
    (D) A claim elsewhere on the label or labeling.
    (iv) The label or labeling must also bear:
    (A) Clear and concise quantitative information comparing the amount 
of the subject nutrient in the product per labeled serving size with 
that in the reference product; and
    (B) This statement shall appear adjacent to the most prominent claim 
or to the nutrition information.
    (3) A relative claim for decreased levels of a nutrient may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the requirement for a ``low'' claim for that 
nutrient.
    (k) The term ``modified'' may be used in the statement of identity 
of a product that bears a relative claim that complies with the 
requirements of this part, followed immediately by the name of the 
nutrient whose content has been altered (e.g., ``modified fat `product' 
''). This statement of identity must be immediately followed by the 
comparative statement such as ``contains 35 percent less fat than 
`reference product'.'' The label or labeling must also bear the 
information required by paragraph (j)(2) of this section in the manner 
prescribed.
    (l) For purposes of making a claim, a ``meal-type'' product will be 
defined as a product that:
    (1) Makes a major contribution to the diet by:
    (i) Weighing at least 10 ounces per labeled serving; and
    (ii) Containing not less than three 40 gram portions of food, or 
combinations of foods, from two or more of the following four food 
groups, except as noted in paragraph (l)(1)(ii)(E) of this section:
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (l)(1)(ii)(A) through (D) of this section, that 
are in the sauces), gravies, condiments, relishes, pickles, olives, 
jams, jellies, syrups, breadings, or garnishes; and
    (2) Is represented as, or is in the form commonly understood to be, 
a breakfast, lunch, dinner, meal, or entr[egrave]e. Such representations 
may be made by statements, photographs, or vignettes.
    (m) For purposes of making a claim, a ``main-dish'' product will be 
defined as a food that:

[[Page 599]]

    (1) Makes a major contribution to the meal by:
    (i) Weighing at least 6 ounces per labeled serving; and
    (ii) Containing not less than 40 grams of food, or combinations of 
foods, from two or more of the following four food groups, except as 
noted in paragraph (m)(1)Iii)(E) of this section.
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (m)(1)(ii)(A) through (D) of this section, that 
are in the sauces), gravies, condiments, relishes, pickles, olives, 
jams, jellies, syrups, breadings, or garnishes; and
    (2) Is represented as, or is in a form commonly understood to be, a 
main dish (e.g., not a beverage or a dessert). Such representations may 
be made by statements, photographs, or vignettes.
    (n) Nutrition labeling in accordance with Sec. 381.409 shall be 
provided for any food for which a nutrient content claim is made.
    (o) Compliance with requirements for nutrient content claims shall 
be in accordance with Sec. 381.409(h).
    (p)(1) Unless otherwise specified, the reference amount customarily 
consumed set forth in Sec. 381.412(b) through (e) shall be used in 
determining whether a product meets the criteria for a nutrient content 
claim. If the serving size declared on the product label differs from 
the reference amount customarily consumed, and the amount of the 
nutrient contained in the labeled serving does not meet the maximum or 
minimum amount criterion in the definition for the descriptor for that 
nutrient, the claim shall be followed by the criteria for the claim as 
required by Sec. 381.412(f) (e.g., ``very low sodium, 35 mg or less per 
55 grams'').
    (2) The criteria for the claim shall be immediately adjacent to the 
most prominent claim in easily legible print or type and in a size that 
is no less than that required by Sec. 381.121(c) for net quantity of 
contents, except where the size of the claim is less than two times the 
required size of the net quantity of contents statement, in which case 
the criteria statement shall be no less than one-half the size of the 
claim but no smaller than 1/16-inch minimum height, except as permitted 
by Sec. 381.500(d)(2).
    (q) The following exemptions apply:
    (1) Nutrient content claims that have not been defined by regulation 
and that appear as part of a brand name that was in use prior to 
November 27, 1991, may continue to be used as part of that brand name, 
provided they are not false or misleading under section 4(h) of the Act 
(21 U.S.C. 453(h)(4)).
    (2) [Reserved]
    (3) A statement that describes the percentage of a vitamin or 
mineral in the food, including foods intended specifically for use by 
infants and children less than 2 years of age, in relation to a 
Reference Daily Intake (RDI) as defined in Sec. 381.409 may be made on 
the label or in the labeling of a food without a regulation authorizing 
such a claim for a specific vitamin or mineral.
    (4) The requirements of this section do not apply to infant formulas 
and medical foods, as described in 21 CFR 101.13(q)(4).
    (5) [Reserved]
    (6) Nutrient content claims that were part of the name of a product 
that was subject to a standard of identity as of November 27, 1991, are 
not subject to the requirements of paragraph (b) of this section whether 
or not they meet the definition of the descriptive term.
    (7) Implied nutrient content claims may be used as part of a brand 
name, provided that the use of the claim has been authorized by FSIS. 
Labeling applications requesting approval of such a claim may be 
submitted pursuant to Sec. 381.469.

[58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58 
FR 47628, Sept. 10, 1993; 59 FR 40215, Aug. 8, 1994; 59 FR 45198, Sept. 
1, 1994; 60 FR 208, Jan. 3, 1995; 69 FR 58802, Oct. 1, 2004]



Sec. Sec. 381.414-381.442  [Reserved]



Sec. 381.443  Significant participation for voluntary nutrition labeling.

    (a) In evaluating significant participation for voluntary nutrition 
labeling, FSIS will consider only the major cuts

[[Page 600]]

of single-ingredient, raw poultry products, as identified in Sec. 
381.444, including those that have been previously frozen.
    (b) FSIS will judge a food retailer to be participating at a 
significant level if the retailer provides nutrition labeling 
information for at least 90 percent of the major cuts of single-
ingredient, raw poultry products, listed in Sec. 381.444, that it 
sells, and if the nutrition label is consistent in content and format 
with the mandatory program, or nutrition information is displayed at 
point-of-purchase in an appropriate manner.
    (c) To determine whether there is significant participation by 
retailers under the voluntary nutrition labeling guidelines, FSIS will 
select a representative sample of companies allocated by type and size.
    (d) FSIS will find that significant participation by food retailers 
exists if at least 60 percent of all companies that are evaluated are 
participating in accordance with the guidelines.
    (e) FSIS will evaluate significant participation of the voluntary 
program every 2 years beginning in May 1995.
    (1) If significant participation is found, the voluntary nutrition 
labeling guidelines shall remain in effect.
    (2) If significant participation is not found, FSIS shall initiate 
rulemaking to require nutrition labeling on those products under the 
voluntary program.



Sec. 381.444  Identification of major cuts of poultry products.

    The major cuts of single-ingredient, raw poultry products are: Whole 
chicken (without neck and giblets), chicken breast, chicken wing, 
chicken drumstick, chicken thigh, whole turkey (without necks and 
giblets; separate nutrient panels for white and dark meat permitted as 
an option), turkey breast, turkey wing, turkey drumstick, and turkey 
thigh.



Sec. 381.445  Guidelines for voluntary nutrition labeling of 
single-ingredient, raw products.

    (a) Nutrition information on the cuts of single-ingredient, raw 
poultry products, including those that have been previously frozen, 
shall be provided in the following manner:
    (1) If a retailer or manufacturer chooses to provide nutrition 
information on the label of these products, these products shall be 
subject to all requirements of the mandatory nutrition labeling program, 
except that nutrition labeling may be declared on the basis of either 
``as consumed'' or ``as packaged.'' In addition, the declaration of the 
number of servings per container need not be included in nutrition 
labeling of single-ingredient, raw poultry products, including those 
that have been previously frozen.
    (2) A retailer may choose to provide nutrition information at the 
point-of-purchase, such as by posting a sign, or by making the 
information readily available in brochures, notebooks, or leaflet form 
in close proximity to the food. The nutrition labeling information may 
also be supplemented by a video, live demonstration, or other media. If 
a nutrition claim is made on point-of-purchase materials all of the 
requirements of the mandatory nutrition labeling program apply. However, 
if only nutrition information--and not a nutrition claim--is supplied on 
point-of-purchase materials:
    (i) The requirements of the mandatory nutrition labeling program 
apply, but the nutrition information may be supplied on an ``as 
packaged'' or ``as consumed,'' basis;
    (ii) The listing of percent of Daily Value for the nutrients (except 
vitamins and minerals specified in Sec. 381.409(c)(8)) and footnote 
required by Sec. 381.409(d)(9) may be omitted; and
    (iii) The point-of-purchase materials are not subject to any of the 
format requirements.
    (b) [Reserved]
    (c) The declaration of nutrition information may be presented in a 
simplified format as specified in Sec. 381.409(f) for the mandatory 
nutrition labeling program.
    (d) The nutrition label data should be based on either raw or cooked 
edible portions of poultry cuts with skin. If data are based on cooked 
portions, the methods used to cook the products must be specified and 
should be those which do not add nutrients from other ingredients such 
as flour, breading, and salt. Additional nutritional data may be 
presented on an optional basis for the raw or cooked edible portions of 
the skinless poultry meat.

[[Page 601]]

    (e) Nutrient data that are the most current representative data base 
values contained in USDA's National Nutrient Data Bank or its published 
form, the Agriculture Handbook No. 8 series, may be used for nutrition 
labeling of single-ingredient, raw poultry products, including those 
that have been previously frozen. These data may be composite data that 
reflect different classes of turkey or other variables affecting 
nutrient content. Alternatively, data that reflect specific classes or 
other variables may be used, except that if data are used on labels 
attached to a product which is labeled as to class of poultry or other 
variables, the data must represent the product in the package when such 
data are contained in the representative data base. When data are used 
on labels attached to a product, the data must represent the edible 
poultry tissues present in the package.
    (f) If the nutrition information is in accordance with paragraph (e) 
of this section, a nutrition label or labeling will not be subject to 
the Agency compliance review under Sec. 381.409(h), unless a nutrition 
claim is made on the basis of the representative data base values.
    (g) Retailers may use data bases that they believe reflect the 
nutrient content of single-ingredient, raw poultry products, including 
those that have been previously frozen; however, such labeling shall be 
subject to the compliance procedures of paragraph (e) of this section 
and the requirements specified in this subpart for the mandatory 
nutrition labeling program.

[58 FR 675, Jan. 6, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 60 
FR 209, Jan. 3, 1995]



Sec. Sec. 381.446-381.453  [Reserved]



Sec. 381.454  Nutrient content claims for ``good source,'' ``high,'' 
and ``more.''

    (a) General requirements. Except as provided in paragraph (e) of 
this section, a claim about the level of a nutrient in a product in 
relation to the Reference Daily Intake (RDI) or Daily Reference Value 
(DRV), established for that nutrient (excluding total carbohydrate) in 
Sec. 381.409(c), may only be made on the label or in labeling of the 
product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 381.413; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 381.409.
    (b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or 
``excellent source of'' may be used on the label or in labeling of 
products, except meal-type products as defined in Sec. 381.413(l) and 
main-dish products as defined in Sec. 381.413(m), provided that the 
product contains 20 percent or more of the RDI or the DRV per reference 
amount customarily consumed.
    (2) The terms defined in paragraph (b)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains a food that meets the definition of 
``high'' in paragraph (b)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., ``the serving of broccoli in this meal is 
high in vitamin C'').
    (c) ``Good Source'' claims. (1) The terms ``good source,'' 
``contains,'' or ``provides'' may be used on the label or in labeling of 
products, except meal-type products as described in Sec. 381.413(l) and 
main-dish products as defined in Sec. 317.313(m), provided that the 
product contains 10 to 19 percent of the RDI or the DRV per reference 
amount customarily consumed.
    (2) The terms defined in paragraph (c)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains a food that meets the definition of ``good 
source'' in paragraph (c)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., ``the serving of sweet potatoes in this meal 
is a good source of fiber'').
    (d) Fiber claims. (1) If a nutrient content claim is made with 
respect to the level of dietary fiber, i.e., that the

[[Page 602]]

product is high in fiber, a good source of fiber, or that the product 
contains ``more'' fiber, and the product is not ``low'' in total fat as 
defined in Sec. 381.462(b)(2) or, in the case of a meal-type product or 
in a main-dish product, is not ``low'' in total fat as defined in Sec. 
381.462(b)(3), then the labeling shall disclose the level of total fat 
per labeled serving size (e.g., ``contains 12 grams (g) of fat per 
serving''); and
    (2) The disclosure shall appear in immediate proximity to such claim 
and be in a type size no less than one-half the size of the claim.
    (e) ``More'' claims. (1) A relative claim using the terms ``more'' 
and ``added'' may be used on the label or in labeling to describe the 
level of protein, vitamins, minerals, dietary fiber, or potassium in a 
product, except meal-type products as defined in Sec. 381.413(l) and 
main-dish products as defined in Sec. 381.413(m), provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per reference amount 
customarily consumed than an appropriate reference product as described 
in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber than `reference 
product' ''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``fiber content of `reference product' 
is 1 g per serving; `this product' contains 4 g per serving'').
    (2) A relative claim using the terms ``more'' and ``added'' may be 
used on the label or in labeling to describe the level of protein, 
vitamins, minerals, dietary fiber, or potassium in meal-type products as 
defined in Sec. 381.413(l) and main-dish products as defined in Sec. 
381.413(m), provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per 100 g of product than an 
appropriate reference product as described in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber per 3 ounces 
(oz) than does `reference product' ''), and
    (B) Quantitative information comparing the level of the nutrient in 
the meal-type product or in a main-dish product per specified weight 
with that of the reference product that it replaces is declared adjacent 
to the most prominent claim or to the nutrition information (e.g., 
``fiber content of `reference product' is 2 g per 3 oz; `this product' 
contains 5 g per 3 oz'').

[60 FR 210, Jan. 3, 1995, as amended at 69 FR 58803, Oct. 1, 2004]



Sec. 381.455  [Reserved]



Sec. 381.456  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. A claim using the terms ``light'' or 
``lite'' to describe a product may only be made on the label or in 
labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 381.413; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 381.409.
    (b) ``Light'' claims. The terms ``light'' or ``lite'' may be used on 
the label or in labeling of products, except meal-type products as 
defined in Sec. 381.413(l) and main-dish products as defined in Sec. 
381.413(m), without further qualification, provided that:
    (1) If the product derives 50 percent or more of its calories from 
fat, its fat

[[Page 603]]

content is reduced by 50 percent or more per reference amount 
customarily consumed compared to an appropriate reference product as 
described in Sec. 381.413(j)(1); or
    (2) If the product derives less than 50 percent of its calories from 
fat:
    (i) The number of calories is reduced by at least one-third (33\1/3\ 
percent) per reference amount customarily consumed compared to an 
appropriate reference product as described in Sec. 381.413(j)(1); or
    (ii) Its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to the appropriate reference 
product as described in Sec. 381.413(j)(1); and
    (3) As required in Sec. 381.413(j)(2) for relative claims:
    (i) The identity of the reference product and the percent (or 
fraction) that the calories and the fat were reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``\1/3\ 
fewer calories and 50 percent less fat than the market leader''); and
    (ii) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference product that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``lite `this 
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving''); and
    (iii) If the labeled product contains less than 40 calories or less 
than 3 g fat per reference amount customarily consumed, the percentage 
reduction for that nutrient need not be declared.
    (4) A ``light'' claim may not be made on a product for which the 
reference product meets the definition of ``low fat'' and ``low 
calorie.''
    (c)(1)(i) A product for which the reference product contains 40 
calories or less and 3 g fat or less per reference amount customarily 
consumed may use the terms ``light'' or ``lite'' without further 
qualification if it is reduced by 50 percent or more in sodium content 
compared to the reference product; and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50 percent less 
sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., ``lite `this product'--500 milligrams (mg) sodium per 
serving; regular `reference product'--1,000 mg sodium per serving'').
    (2)(i) A product for which the reference product contains more than 
40 calories or more than 3 g fat per reference amount customarily 
consumed may use the terms ``light in sodium'' or ``lite in sodium'' if 
it is reduced by 50 percent or more in sodium content compared to the 
reference product, provided that ``light'' or ``lite'' is presented in 
immediate proximity with ``in sodium'' and the entire term is presented 
in uniform type size, style, color, and prominence; and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50 percent less 
sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., or ``lite `this product'--170 mg sodium per serving; 
regular `reference product'--350 mg per serving'').
    (3) Except for meal-type products as defined in Sec. 381.413(l) and 
main-dish products as defined in Sec. 381.413(m), a ``light in sodium'' 
claim may not be made on a product for which the reference product meets 
the definition of ``low in sodium.''
    (d)(1) The terms ``light'' or ``lite'' may be used on the label or 
in labeling of a meal-type product as defined in Sec. 381.413(l) and 
main-dish product as defined in Sec. 381.413(m), provided that:
    (i) The product meets the definition of:

[[Page 604]]

    (A) ``Low in calories'' as defined in Sec. 381.460(b)(3); or
    (B) ``Low in fat'' as defined in Sec. 381.462(b)(3); and
    (ii)(A) A statement appears on the principal display panel that 
explains whether ``light'' is used to mean ``low fat,'' ``low 
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
    (B) The accompanying statement is no less than one-half the type 
size of the ``light'' or ``lite'' claim.
    (2)(i) The terms ``light in sodium'' or ``lite in sodium'' may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that the product meets the definition of ``low in sodium'' as 
defined in Sec. 381.461(b)(5)(i); and
    (ii) ``Light'' or ``lite'' and ``in sodium'' are presented in 
uniform type size, style, color, and prominence.
    (3) The terms ``light'' or ``lite'' may be used in the brand name of 
a product to describe the sodium content, provided that:
    (i) The product is reduced by 50 percent or more in sodium content 
compared to the reference product;
    (ii) A statement specifically stating that the product is ``light in 
sodium'' or ``lite in sodium'' appears:
    (A) Contiguous to the brand name; and
    (B) In uniform type size, style, color, and prominence as the 
product name; and
    (iii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim; and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information.
    (e) Except as provided in paragraphs (b) through (d) of this 
section, the terms ``light'' or ``lite'' may not be used to refer to a 
product that is not reduced in fat by 50 percent, or, if applicable, in 
calories by \1/3\ or, when properly qualified, in sodium by 50 percent 
unless:
    (1) It describes some physical or organoleptic attribute of the 
product such as texture or color and the information (e.g., ``light in 
color'' or ``light in texture'') so stated, clearly conveys the nature 
of the product; and
    (2) The attribute (e.g., ``color'' or ``texture'') is in the same 
style, color, and at least one-half the type size as the word ``light'' 
and in immediate proximity thereto.
    (f) If a manufacturer can demonstrate that the word ``light'' has 
been associated, through common use, with a particular product to 
reflect a physical or organoleptic attribute to the point where it has 
become part of the statement of identity, such use of the term ``light'' 
shall not be considered a nutrient content claim subject to the 
requirements in this part.
    (g) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is normally added to the 
reference product as described in Sec. 381.413(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in Sec. 381.461(b)(4), the statement ``not a low sodium food,'' 
shall appear adjacent to the nutrition information and the information 
required to accompany a relative claim shall appear on the label or 
labeling as specified in Sec. 381.413(j)(2).

[60 FR 210, Jan. 3, 1995, as amended at 69 FR 58803, Oct. 1, 2004]



Sec. Sec. 381.457-381.459  [Reserved]



Sec. 381.460  Nutrient content claims for calorie content.

    (a) General requirements. A claim about the calorie or sugar content 
of a product may only be made on the label or in labeling of the product 
if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 381.413; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 381.409.
    (b) Calorie content claims. (1) The terms ``calorie free,'' ``free 
of calories,''

[[Page 605]]

``no calories,'' ``zero calories,'' ``without calories,'' ``trivial 
source of calories,'' ``negligible source of calories,'' or ``dietarily 
insignificant source of calories'' may be used on the label or in 
labeling of products, provided that:
    (i) The product contains less than 5 calories per reference amount 
customarily consumed and per labeled serving size; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low calorie,'' ``few calories,'' ``contains a small 
amount of calories,'' ``low source of calories,'' or ``low in calories'' 
may be used on the label or in labeling of products, except meal-type 
products as defined in Sec. 381.413(l) and main-dish products as 
defined in Sec. 318.413(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does 
not provide more than 40 calories per reference amount customarily 
consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and does not provide more than 40 calories per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 381.409(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains 120 calories or less per 100 g of product; 
and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the calorie content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which it attaches.
    (4) The terms ``reduced calorie,'' ``reduced in calories,'' 
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower 
in calories'' may be used on the label or in labeling of products, 
except meal-type products as defined in Sec. 381.413(l) and main-dish 
products as defined in Sec. 318.413(m), provided that:
    (i) The product contains at least 25 percent fewer calories per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., lower 
calorie `product'--``33 \1/3\ percent fewer calories than our regular 
`product' ''); and
    (B) Quantitative information comparing the level of calories in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``calorie content has been reduced from 150 
to 100 calories per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of products if the reference product 
meets the definition for ``low calorie.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains at least 25 percent fewer calories per 100 
g of product than an appropriate reference product as described in Sec. 
381.413(j)(1); and

[[Page 606]]

    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``calorie 
reduced `product', 25% less calories per ounce (oz) (or 3 oz) than our 
regular `product' ''); and
    (B) Quantitative information comparing the level of calories in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``calorie content has been reduced from 110 
calories per 3 oz to 80 calories per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of products if the reference product 
meets the definition for ``low calorie.''
    (c) Sugar content claims. (1) Terms such as ``sugar free,'' ``free 
of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,'' 
``sugarless,'' ``trivial source of sugar,'' ``negligible source of 
sugar,'' or ``dietarily insignificant source of sugar'' may reasonably 
be expected to be regarded by consumers as terms that represent that the 
product contains no sugars or sweeteners, e.g., ``sugar free,'' or ``no 
sugar,'' as indicating a product which is low in calories or 
significantly reduced in calories. Consequently, except as provided in 
paragraph (c)(2) of this section, a product may not be labeled with such 
terms unless:
    (i) The product contains less than 0.5 g of sugars, as defined in 
Sec. 381.409(c)(6)(ii), per reference amount customarily consumed and 
per labeled serving size or, in the case of a meal-type product or a 
main-dish product, less than 0.5 g of sugars per labeled serving size;
    (ii) The product contains no ingredient that is a sugar or that is 
generally understood by consumers to contain sugars unless the listing 
of the ingredient in the ingredients statement is followed by an 
asterisk that refers to the statement below the list of ingredients, 
which states: ``Adds a trivial amount of sugar,'' ``adds a negligible 
amount of sugar,'' or ``adds a dietarily insignificant amount of 
sugar;'' and
    (iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or 
bears a relative claim of special dietary usefulness labeled in 
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this 
section; or
    (B) Such term is immediately accompanied, each time it is used, by 
either the statement ``not a reduced calorie product,'' ``not a low 
calorie product,'' or ``not for weight control.''
    (2) The terms ``no added sugar,'' ``without added sugar,'' or ``no 
sugar added'' may be used only if:
    (i) No amount of sugars, as defined in Sec. 381.409(c)(6)(ii), or 
any other ingredient that contains sugars that functionally substitute 
for added sugars is added during processing or packaging;
    (ii) The product does not contain an ingredient containing added 
sugars such as jam, jelly, or concentrated fruit juice;
    (iii) The sugars content has not been increased above the amount 
present in the ingredients by some means such as the use of enzymes, 
except where the intended functional effect of the process is not to 
increase the sugars content of a product, and a functionally 
insignificant increase in sugars results;
    (iv) The product that it resembles and for which it substitutes 
normally contains added sugars; and
    (v) The product bears a statement that the product is not ``low 
calorie'' or ``calorie reduced'' (unless the product meets the 
requirements for a ``low'' or ``reduced calorie'' product) and that 
directs consumers' attention to the nutrition panel for further 
information on sugar and calorie content.
    (3) Paragraph (c)(1) of this section shall not apply to a factual 
statement that a product, including products intended specifically for 
infants and children less than 2 years of age, is unsweetened or 
contains no added sweeteners in the case of a product that contains 
apparent substantial inherent sugar content, e.g., juices.
    (4) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar 
reduced,'' ``less sugar,'' ``lower sugar,'' or ``lower in sugar'' may be 
used on the label or in labeling of products, except meal-type products 
as defined in Sec. 381.413(l) and

[[Page 607]]

main-dish products as defined in Sec. 318.413(m), provided that:
    (i) The product contains at least 25 percent less sugars per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``this 
product contains 25 percent less sugar than our regular product''); and
    (B) Quantitative information comparing the level of the sugar in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sugar content has been lowered from 8 g 
to 6 g per serving'').
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains at least 25 percent less sugars per 100 g 
of product than an appropriate reference product as described in Sec. 
381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``reduced 
sugar `product'--

25% less sugar than our regular `product' ''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sugar content has been reduced from 17 g 
per 3 oz to 13 g per 3 oz'').

[60 FR 211, Jan. 3, 1995, as amended at 69 FR 58803, Oct. 1, 2004]



Sec. 381.461  Nutrient content claims for the sodium content.

    (a) General requirements. A claim about the level of sodium in a 
product may only be made on the label or in labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 381.413; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 381.409.
    (b) Sodium content claims. (1) The terms ``sodium free,'' ``free of 
sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' ``trivial 
source of sodium,'' ``negligible source of sodium,'' or ``dietarily 
insignificant source of sodium'' may be used on the label or in labeling 
of products, provided that:
    (i) The product contains less than 5 milligrams (mg) of sodium per 
reference amount customarily consumed and per labeled serving size or, 
in the case of a meal-type product or a main-dish product, less than 5 
mg of sodium per labeled serving size;
    (ii) The product contains no ingredient that is sodium chloride or 
is generally understood by consumers to contain sodium unless the 
listing of the ingredient in the ingredients statement is followed by an 
asterisk that refers to the statement below the list of ingredients, 
which states: ``Adds a trivial amount of sodium,'' ``adds a negligible 
amount of sodium'' or ``adds a dietarily insignificant amount of 
sodium;'' and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``very low sodium'' or ``very low in sodium'' may be 
used on the label or in labeling of products, except meal-type products 
as defined in Sec. 381.413(l) and main-dish products as defined in 
Sec. 381.413(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and 
contains 35 mg or

[[Page 608]]

less sodium per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 35 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 381.409(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains 35 mg or less of sodium per 100 g of 
product; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``low sodium,'' ``low in sodium,'' ``little sodium,'' 
``contains a small amount of sodium,'' or ``low source of sodium'' may 
be used on the label and in labeling of products, except meal-type 
products as defined in Sec. 381.413(l) and main-dish products as defined 
in Sec. 381.413(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tbsp and contains 140 mg or less 
sodium per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 140 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 381.409(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains 140 mg or less sodium per 100 g of product; 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium 
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium'' may 
be used on the label or in labeling of products, except meal-type 
products as defined in Sec. 381.413(l) and main-dish products as 
defined in Sec. 381.413(m), provided that:
    (i) The product contains at least 25 percent less sodium per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 381.413(j)(l); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium differs between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``reduced 
sodium `product', 50 percent less sodium than regular `product' ''); and
    (B) Quantitative information comparing the level of sodium in the 
product per labeled serving size with that of the reference product that 
it replaces

[[Page 609]]

is declared adjacent to the most prominent claim or to the nutrition 
information (e.g., ``sodium content has been lowered from 300 to 150 mg 
per serving'').
    (iii) Claims described in paragraph (b)(6) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low sodium.''
    (7) The terms defined in paragraph (b)(6) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains at least 25 percent less sodium per 100 g 
of product than an appropriate reference product as described in Sec. 
381.413(j)(l); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium differs between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``reduced 
sodium `product'--30% less sodium per 3 oz than our `regular product' 
''); and
    (B) Quantitative information comparing the level of sodium in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sodium content has been reduced from 220 
mg per 3 oz to 150 mg per 3 oz'').
    (iii) Claims described in paragraph (b)(7) of this section may not 
be made on the label or in labeling of products if the nutrient content 
of the reference product meets the definition for ``low sodium.''
    (c) The term ``salt'' is not synonymous with ``sodium.'' Salt refers 
to sodium chloride. However, references to salt content such as 
``unsalted,'' ``no salt,'' ``no salt added'' are potentially misleading.
    (1) The term ``salt free'' may be used on the label or in labeling 
of products only if the product is ``sodium free'' as defined in 
paragraph (b)(1) of this section.
    (2) The terms ``unsalted,'' ``without added salt,'' and ``no salt 
added'' may be used on the label or in labeling of products only if:
    (i) No salt is added during processing;
    (ii) The product that it resembles and for which it substitutes is 
normally processed with salt; and
    (iii) If the product is not sodium free, the statement ``not a 
sodium free product'' or ``not for control of sodium in the diet'' 
appears adjacent to the nutrition information of the product bearing the 
claim.
    (3) Paragraph (c)(2) of this section shall not apply to a factual 
statement that a product intended specifically for infants and children 
less than 2 years of age is unsalted, provided such statement refers to 
the taste of the product and is not false or otherwise misleading.

[60 FR 213, Jan. 3, 1995; 60 FR 5762, Jan. 30, 1995, as amended at 69 FR 
58803, Oct. 1, 2004]



Sec. 381.462  Nutrient content claims for fat, fatty acids, and 
cholesterol content.

    (a) General requirements. A claim about the level of fat, fatty 
acid, and cholesterol in a product may only be made on the label or in 
labeling of products if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 381.413; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 381.409.
    (b) Fat content claims. (1) The terms ``fat free,'' ``free of fat,'' 
``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial source 
of fat,'' ``negligible source of fat,'' or ``dietarily insignificant 
source of fat'' may be used on the label or in labeling of products, 
provided that:
    (i) The product contains less than 0.5 gram (g) of fat per reference 
amount customarily consumed and per labeled serving size or, in the case 
of a meal-type product or a main-dish product, less than 0.5 g of fat 
per labeled serving size;
    (ii) The product contains no added ingredient that is a fat or is 
generally understood by consumers to contain fat unless the listing of 
the ingredient

[[Page 610]]

in the ingredients statement is followed by an asterisk that refers to 
the statement below the list of ingredients, which states: ``Adds a 
trivial amount of fat,'' ``adds a negligible amount of fat,'' or ``adds 
a dietarily insignificant amount of fat''; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label attaches.
    (2) The terms ``low fat,'' ``low in fat,'' ``contains a small amount 
of fat,'' ``low source of fat,'' or ``little fat'' may be used on the 
label and in labeling of products, except meal-type products as defined 
in Sec. 381.413(l) and main-dish products as defined in Sec. 
381.413(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g 
or less of fat per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 3 g or less of fat per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec. 381.409(f)(1), 
of all nutrients per reference amount customarily consumed, the per-50-g 
criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains 3 g or less of total fat per 100 g of 
product and not more than 30 percent of calories from fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label attaches.
    (4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,'' 
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the 
label or in labeling of products, except meal-type products as defined 
in Sec. 381.413(l) and main-dish products as defined in Sec. 
381.413(m), provided that:
    (i) The product contains at least 25 percent less fat per reference 
amount customarily consumed than an appropriate reference product as 
described in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two products are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
fat--50 percent less fat than our regular `product' ''); and
    (B) Quantitative information comparing the level of fat in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``fat content has been reduced from 8 g to 
4 g per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low fat.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains at least 25 percent less fat per 100 g of 
product than an appropriate reference product as described in Sec. 
381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:

[[Page 611]]

    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two products are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
fat `product', 33 percent less fat per 3 oz than our regular `product' 
''); and
    (B) Quantitative information comparing the level of fat in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent such claim or to the 
nutrition information (e.g., ``fat content has been reduced from 8 g per 
3 oz to 5 g per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low fat.''
    (6) The term ``------------ percent fat free'' may be used on the 
label or in labeling of products, provided that:
    (i) The product meets the criteria for ``low fat'' in paragraph 
(b)(2) or (b)(3) of this section;
    (ii) The percent declared and the words ``fat free'' are in uniform 
type size; and
    (iii) A ``100 percent fat free'' claim may be made only on products 
that meet the criteria for ``fat free'' in paragraph (b)(1) of this 
section, that contain less than 0.5 g of fat per 100 g, and that contain 
no added fat.
    (iv) A synonym for ``------ percent fat free'' is ``------ percent 
lean.''
    (c) Fatty acid content claims. (1) The terms ``saturated fat free,'' 
``free of saturated fat,'' ``no saturated fat,'' ``zero saturated fat,'' 
``without saturated fat,'' ``trivial source of saturated fat,'' 
``negligible source of saturated fat,'' or ``dietarily insignificant 
source of saturated fat'' may be used on the label or in labeling of 
products, provided that:
    (i) The product contains less than 0.5 g of saturated fat and less 
than 0.5 g trans fatty acids per reference amount customarily consumed 
and per labeled serving size or, in the case of a meal-type product or a 
main-dish product, less than 0.5 g of saturated fat and less than 0.5 g 
trans fatty acids per labeled serving size;
    (ii) The product contains no ingredient that is generally understood 
by consumers to contain saturated fat unless the listing of the 
ingredient in the ingredients statement is followed by an asterisk that 
refers to the statement below the list of ingredients, which states: 
``Adds a trivial amount of saturated fat,'' ``adds a negligible amount 
of saturated fat,'' or ``adds a dietarily insignificant amount of 
saturated fat;'' and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low in saturated fat,'' ``low saturated fat,'' 
``contains a small amount of saturated fat,'' ``low source of saturated 
fat,'' or ``a little saturated fat'' may be used on the label or in 
labeling of products, except meal-type products as defined in Sec. 
381.413(l) and main-dish products as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains 1 g or less of saturated fat per reference 
amount customarily consumed and not more than 15 percent of calories 
from saturated fat; and
    (ii) If the product meets these conditions without benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (c)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains 1 g or less of saturated fat per 100 g and 
less than 10 percent calories from saturated fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products of 
its type and not merely

[[Page 612]]

to the particular brand to which the label attaches.
    (4) The terms ``reduced saturated fat,'' ``reduced in saturated 
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower 
saturated fat,'' or ``lower in saturated fat'' may be used on the label 
or in labeling of products, except meal-type products as defined in 
Sec. 381.413(l) and main-dish products as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains at least 25 percent less saturated fat per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat `product', contains 50 percent less saturated 
fat than the national average for `product' ''); and
    (B) Quantitative information comparing the level of saturated fat in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``saturated fat reduced from 3 g to 1.5 
g per serving'').
    (iii) Claims described in paragraph (c)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low saturated fat.''
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains at least 25 percent less saturated fat per 
100 g of product than an appropriate reference product as described in 
Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat `product', 50 percent less saturated fat than 
our regular `product' ''); and
    (B) Quantitative information comparing the level of saturated fat in 
the product per specified weight with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``saturated fat content has been reduced 
from 2.5 g per 3 oz to 1.5 g per 3 oz'').
    (iii) Claims described in paragraph (c)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low saturated fat.''
    (d) Cholesterol content claims. (1) The terms ``cholesterol free,'' 
``free of cholesterol,'' ``zero cholesterol,'' ``without cholesterol,'' 
``no cholesterol,'' ``trivial source of cholesterol,'' ``negligible 
source of cholesterol,'' or ``dietarily insignificant source of 
cholesterol'' may be used on the label or in labeling of products, 
provided that:
    (i) The product contains less than 2 milligrams (mg) of cholesterol 
per reference amount customarily consumed and per labeled serving size 
or, in the case of a meal-type product as defined in Sec. 381.413(l) 
and main-dish product as defined in Sec. 381.413(m), less than 2 mg of 
cholesterol per labeled serving size;
    (ii) The product contains no ingredient that is generally understood 
by consumers to contain cholesterol, unless the listing of the 
ingredient in the ingredients statement is followed by an asterisk that 
refers to the statement below the list of ingredients, which states: 
``Adds a trivial amount of cholesterol,'' ``adds a negligible amount of 
cholesterol,'' or ``adds a dietarily insignificant amount of 
cholesterol'';
    (iii) The product contains 2 g or less of saturated fat per 
reference amount customarily consumed or, in the case of a meal-type 
product as defined in Sec. 381.413(l) and main-dish product as defined 
in Sec. 381.413(m), 2 g or less of saturated fat per labeled serving 
size; and
    (iv) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to

[[Page 613]]

the particular brand to which it attaches; or
    (v) If the product meets these conditions only as a result of 
special processing, alteration, formulation, or reformulation, the 
amount of cholesterol is reduced by 25 percent or more from the 
reference product it replaces as described in Sec. 381.413(j)(1) and 
for which it substitutes as described in Sec. 381.413(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``cholesterol free 
`product', contains 100 percent less cholesterol than `reference 
product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``contains no cholesterol compared with 
30 mg in one serving of `reference product' '').
    (2) The terms ``low in cholesterol,'' ``low cholesterol,'' 
``contains a small amount of cholesterol,'' ``low source of 
cholesterol,'' or ``little cholesterol'' may be used on the label or in 
labeling of products, except meal-type products as defined in Sec. 
381.413(l) and main-dish products as defined in Sec. 381.413(m), 
provided that:
    (i)(A) If the product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tbsp:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed; and
    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed; or
    (B) If the product has a reference amount customarily consumed of 30 
g or less or 2 tbsp or less:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec. 381.409(f)(1), 
of all nutrients per reference amount customarily consumed, the per-50-g 
criterion refers to the ``as prepared'' form); and
    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed.
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches; or
    (iii) If the product contains 20 mg or less of cholesterol only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is reduced by 25 percent or more from the 
reference product it replaces as described in Sec. 381.413(j)(1) and 
for which it substitutes as described in Sec. 381.413(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``low 
cholesterol `product', contains 85 percent less cholesterol than our 
regular `product'''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 30 mg to 5 
mg per serving'').
    (3) The terms defined in paragraph (d)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product contains 20 mg or less of cholesterol per 100 g of 
product;
    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or

[[Page 614]]

reformulation to lower cholesterol content, it is labeled to clearly 
refer to all products of its type and not merely to the particular brand 
to which the label attaches.
    (4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,'' 
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' or 
``lower in cholesterol'' may be used on the label or in labeling of 
products or products that substitute for those products as specified in 
Sec. 381.413(d), excluding meal-type products as defined in Sec. 
381.413(l) and main-dish products as defined in Sec. 381.413(m), 
provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec. 381.413(j)(1) and 
for which it substitutes as described in Sec. 381.413(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;
    (ii) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed; and
    (iii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25 percent 
less cholesterol than `reference product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 55 mg to 30 
mg per serving'').
    (iv) Claims described in paragraph (d)(4) of this section may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the definition for ``low cholesterol.''
    (5) The terms defined in paragraph (d)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l) and main-dish product as defined in Sec. 381.413(m), 
provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec. 381.413(j)(1) and 
for which it substitutes as described in Sec. 381.413(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;
    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25% less 
cholesterol than `reference product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``cholesterol content has been reduced from 
35 mg per 3 oz to 25 mg per 3 oz).
    (iv) Claims described in paragraph (d)(5) of this section may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the definition for ``low cholesterol.''
    (e) ``Lean'' and ``Extra Lean'' claims. (1) The term ``lean'' may be 
used on the label or in labeling of a product, provided that the product 
contains less than 10 g of fat, 4.5 g or less of saturated fat, and less 
than 95 mg of cholesterol per 100 g of product and per reference amount 
customarily consumed for individual foods, and per 100 g of product and 
per labeled serving size for meal-type products as defined in Sec. 
381.413(l) and main-dish products as defined in Sec. 381.413(m).
    (2) The term ``extra lean'' may be used on the label or in labeling 
of a product, provided that the product contains less than 5 g of fat, 
less than 2 g of saturated fat, and less than 95 mg of cholesterol per 
100 g of product and per reference amount customarily consumed for 
individual foods, and per 100 g of product and per labeled serving size 
for meal-type products as defined

[[Page 615]]

in Sec. 381.413(l) and main-dish products as defined in Sec. 
381.413(m).

[60 FR 214, Jan. 3, 1995, as amended at 69 FR 58803, Oct. 1, 2004]



Sec. 381.463  Nutrient content claims for ``healthy.''

    (a) The term ``healthy,'' or any other derivative of the term 
``health,'' may be used on the labeling of any poultry product, provided 
that the product is labeled in accordance with Sec. 381.409 and Sec. 
381.413.
    (b)(1) The product shall meet the requirements for ``low fat'' and 
``low saturated fat,'' as defined in Sec. 381.462, except that single-
ingredient, raw products may meet the total fat and saturated fat 
criteria for ``extra lean'' in Sec. 381.462.
    (2) The product shall not contain more than 60 milligrams (mg) of 
cholesterol per reference amount customarily consumed, per labeled 
serving size, and, only for foods with reference amounts customarily 
consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50 
g, and, for dehydrated products that must be reconstituted with water or 
a diluent containing an insignificant amount, as defined in Sec. 
381.409(f)(1), of all nutrients, the per-50-g criterion refers to the 
prepared form, except that:
    (i) A main-dish product, as defined in Sec. 381.413(m), and meal-
type product, as defined in Sec. 381.413(l), and including meal-type 
products that weigh more than 12 ounces (oz) per serving (container), 
shall not contain more than 90 mg of cholesterol per labeled serving 
size; and
    (ii) Single-ingredient, raw products may meet the cholesterol 
criterion for ``extra lean'' in Sec. 381.462.
    (3) The product shall not contain more than 360 mg of sodium, except 
that it shall not contain more than 480 mg of sodium effective through 
January 1, 2006, per reference amount customarily consumed, per labeled 
serving size, and, only for foods with reference amounts customarily 
consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for 
dehydrated products that must be reconstituted with water or a diluent 
containing an insignificant amount, as defined in Sec. 381.409(f)(1), 
of all nutrients, the per-50-g criterion refers to the prepared form, 
except that:
    (i) A main-dish product, as defined in Sec. 381.413(m), and meal-
type product, as defined in Sec. 381.413(l), and including meal-type 
products that weigh more than 12 oz per serving (container), shall not 
contain more than 480 mg of sodium, except that it shall not contain 
more than 600 mg of sodium effective through January 1, 2006, per 
labeled serving size; and
    (ii) The requirements of this paragraph (b)(3) do not apply to 
single-ingredient, raw products.
    (4) The product shall contain 10 percent or more of the Reference 
Daily Intake or Daily Reference Value as defined in Sec. 381.409 for 
vitamin A, vitamin C, iron, calcium, protein, or fiber per reference 
amount customarily consumed prior to any nutrient addition, except that:
    (i) A main-dish product, as defined in Sec. 381.413(m), and 
including meal-type products that weigh less than 10 oz per serving 
(container), shall meet the level for two of the nutrients per labeled 
serving size; and
    (ii) A meal-type product, as defined in Sec. 381.413(l), shall meet 
the level for three of the nutrients per labeled serving size.

[59 FR 24228, May 10, 1994, as amended at 60 FR 217, Jan. 3, 1995; 63 FR 
7281, Feb. 13, 1998; 64 FR 72492, Dec. 28, 1999; 68 FR 463, Jan. 6, 
2003; 69 FR 58803, Oct. 1, 2004]



Sec. Sec. 381.464-381.468  [Reserved]



Sec. 381.469  Labeling applications for nutrient content claims.

    (a) This section pertains to labeling applications for claims, 
express or implied, that characterize the level of any nutrient required 
to be on the label or in labeling of product by this subpart.
    (b) Labeling applications included in this section are:
    (1) Labeling applications for a new (heretofore unauthorized) 
nutrient content claim,
    (2) Labeling applications for a synonymous term (i.e., one that is 
consistent with a term defined by regulation) for characterizing the 
level of a nutrient, and
    (3) Labeling applications for the use of an implied claim in a brand 
name.

[[Page 616]]

    (c) Labeling applications and supporting documentation to be filed 
under this section shall be submitted in quadruplicate, except that the 
supporting documentation may be submitted on a computer disc copy. If 
any part of the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
labeling application shall state the applicant's post office address.
    (d) Pertinent information will be considered as part of an 
application on the basis of specific reference to such information 
submitted to and retained in the files of the Food Safety and Inspection 
Service. However, any reference to unpublished information furnished by 
a person other than the applicant will not be considered unless use of 
such information is authorized (with the understanding that such 
information may in whole or part be subject to release to the public) in 
a written statement signed by the person who submitted it. Any reference 
to published information should be accompanied by reprints or 
photostatic copies of such references.
    (e) If nonclinical laboratory studies accompany a labeling 
application, the applicant shall include, with respect to each 
nonclinical study included with the application, either a statement that 
the study has been, or will be, conducted in compliance with the good 
laboratory practice regulations as set forth in part 58 of chapter 1, 
title 21, or, if any such study was not conducted in compliance with 
such regulations, a brief statement of the reason for the noncompliance.
    (f) If clinical investigations accompany a labeling application, the 
applicant shall include, with respect to each clinical investigation 
included with the application, either a statement that the investigation 
was conducted in compliance with the requirements for institutional 
review set forth in part 56 of chapter 1, title 21, or was not subject 
to such requirements in accordance with Sec. 56.194 or Sec. 56.105, 
and that it was conducted in compliance with the requirements for 
informed consents set forth in part 50 of chapter 1, title 21.
    (g) The availability for public disclosure of labeling applications, 
along with supporting documentation, submitted to the Agency under this 
section will be governed by the rules specified in subchapter D, title 
9.
    (h) The data specified under this section to accompany a labeling 
application shall be submitted on separate sheets, suitably identified. 
If such data has already been submitted with an earlier labeling 
application from the applicant, the present labeling application must 
provide the data.
    (i) The labeling application must be signed by the applicant or by 
his or her attorney or agent, or (if a corporation) by an authorized 
official.
    (j) The labeling application shall include a statement signed by the 
person responsible for the labeling application, that to the best of his 
or her knowledge, it is a representative and balanced submission that 
includes unfavorable information, as well as favorable information, 
known to him or her pertinent to the evaluation of the labeling 
application.
    (k)(1) Labeling applications for a new nutrient content claim shall 
be accompanied by the following data which shall be submitted in the 
following form to the Director, Food Labeling Division, Regulatory 
Programs, Food Safety and Inspection Service, Washington, DC 20250:

________________________________________________________________________
(Date)

    The undersigned, ------------ submits this labeling application 
pursuant to 9 CFR 381.469 with respect to (statement of the claim and 
its proposed use).
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement identifying the nutrient content claim and the 
nutrient that the term is intended to characterize with respect to the 
level of such nutrient. The statement shall address why the use of the 
term as proposed will not be misleading. The statement shall provide 
examples of the nutrient content claim as it will be used on labels or 
labeling, as well as the types of products on which the claim will be 
used. The statement shall also specify the level at which the nutrient 
must be present or what other conditions concerning the product must be 
met for the appropriate use of the term in labels or labeling, as well 
as any factors that would make the use of the term inappropriate.
    (ii) A detailed explanation supported by any necessary data of why 
use of the food

[[Page 617]]

component characterized by the claim is of importance in human nutrition 
by virtue of its presence or absence at the levels that such claim would 
describe. This explanation shall also state what nutritional benefit to 
the public will derive from use of the claim as proposed and why such 
benefit is not available through the use of existing terms defined by 
regulation. If the claim is intended for a specific group within the 
population, the analysis shall specifically address nutritional needs of 
such group, and scientific data sufficient for such purpose, and data 
and information to the extent necessary to demonstrate that consumers 
can be expected to understand the meaning of the term under the proposed 
conditions of use.
    (iii) Analytical data that demonstrates the amount of the nutrient 
that is present in the products for which the claim is intended. The 
assays should be performed on representative samples in accordance with 
381.409(h). If no USDA or AOAC methods are available, the applicant 
shall submit the assay method used, and data establishing the validity 
of the method for assaying the nutrient in the particular food. The 
validation data shall include a statistical analysis of the analytical 
and product variability.
    (iv) A detailed analysis of the potential effect of the use of the 
proposed claim on food consumption, and any corresponding changes in 
nutrient intake. The analysis shall specifically address the intake of 
nutrients that have beneficial and negative consequences in the total 
diet. If the claim is intended for a specific group within the 
population, the above analysis shall specifically address the dietary 
practices of such group, and shall include data sufficient to 
demonstrate that the dietary analysis is representative of such group.

 Yours very truly,

 Applicant______________________________________________________________

 By_____________________________________________________________________
 (Indicate authority)

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
nutrient content claim is false or misleading. The notification letter 
shall inform the applicant that the applicant may submit a written 
statement by way of answer to the notification, and that the applicant 
shall have the right to request a hearing with respect to the merits or 
validity of the Administrator's decision to deny the use of the proposed 
nutrient content claim.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish in the Federal Register a 
proposed rule to amend the regulations to authorize the use of the 
nutrient content claim. The proposal shall also summarize the labeling 
application, including where the supporting documentation can be 
reviewed. The Administrator's proposed rule shall seek comment from 
consumers, the industry, consumer and

[[Page 618]]

industry groups, and other interested persons on the labeling 
application and the use of the proposed nutrient content claim. After 
public comment has been received and reviewed by the Agency, the 
Administrator shall make a determination on whether the proposed 
nutrient content claim shall be approved for use on the labeling of 
poultry products.
    (i) If the claim is denied by the Administrator, the Agency shall 
notify the applicant, in writing, of the basis for the denial, including 
the reason why the claim on the labeling was determined by the Agency to 
be false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed nutrient 
content claim.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the claim is approved, the Agency shall notify the 
applicant, in writing, and shall also publish in the Federal Register a 
final rule amending the regulations to authorize the use of the claim.
    (l)(1) Labeling applications for a synonymous term shall be 
accompanied by the following data which shall be submitted in the 
following form to the Director, Food Labeling Division, Regulatory 
Programs, Food Safety and Inspection Service, Washington, DC 20250:

________________________________________________________________________
(Date)

    The undersigned, ------------ submits this labeling application 
pursuant to 9 CFR 381.469 with respect to (statement of the synonymous 
term and its proposed use in a nutrient content claim that is consistent 
with an existing term that has been defined under subpart Y of part 
381).
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement identifying the synonymous term, the existing term 
defined by a regulation with which the synonymous term is claimed to be 
consistent, and the nutrient that the term is intended to characterize 
the level of. The statement shall address why the use of the synonymous 
term as proposed will not be misleading. The statement shall provide 
examples of the nutrient content claim as it will be used on labels or 
labeling, as well as the types of products on which the claim will be 
used. The statement shall also specify whether any limitations not 
applicable to the use of the defined term are intended to apply to the 
use of the synonymous term.
    (ii) A detailed explanation supported by any necessary data of why 
use of the proposed term is requested, including whether the existing 
defined term is inadequate for the purpose of effectively characterizing 
the level of a nutrient. This explanation shall also state what 
nutritional benefit to the public will derive from use of the claim as 
proposed, and why such benefit is not available through use of existing 
terms defined by regulation. If the claim is intended for a specific 
group within the population, the analysis shall specifically address 
nutritional needs of such group, scientific data sufficient for such 
purpose, and data and information to the extent necessary to demonstrate 
that consumers can be expected to understand the meaning of the term 
under the proposed conditions of use.

 Yours very truly,

 Applicant______________________________________________________________

 By_____________________________________________________________________
 (Indicate authority)

    (2) Upon receipt of the labeling application and supporting 
documentation,

[[Page 619]]

the applicant shall be notified, in writing, of the date on which the 
labeling application was received. Such notice shall inform the 
applicant that the labeling application is undergoing Agency review and 
that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
synonymous term is false or misleading. The notification letter shall 
inform the applicant that the applicant may submit a written statement 
by way of answer to the notification, and that the applicant shall have 
the right to request a hearing with respect to the merits or validity of 
the Administrator's decision to deny the use of the proposed synonymous 
term.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the claim is approved, the Agency shall notify the applicant, 
in writing, and shall publish in the Federal Register a notice informing 
the public that the synonymous term has been approved for use.
    (m)(1) Labeling applications for the use of an implied nutrient 
content claim in a brand name shall be accompanied by the following data 
which shall be submitted in the following form to the Director, Food 
Labeling Division, Regulatory Programs, Food Safety and Inspection 
Service, Washington, DC 20250:

________________________________________________________________________
(Date)

    The undersigned, ------------ submits this labeling application 
pursuant to 9 CFR 381.469 with respect to (statement of the implied 
nutrient content claim and its proposed use in a brand name).
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement identifying the implied nutrient content claim, the 
nutrient the claim is intended to characterize, the corresponding term 
for characterizing the level of such nutrient as defined by a 
regulation, and the brand name of which the implied claim is intended to 
be a part. The statement shall address why the use of the brand-name as 
proposed will not be misleading. The statement shall provide examples of 
the types of products on which the brand name will appear. It shall also 
include data showing that the actual level of the nutrient in the food 
would qualify the label of the product to bear the corresponding term 
defined by regulation. Assay methods used to determine the level of a 
nutrient shall meet the requirements stated under labeling application 
format in paragraph (k)(1)(iii) of this section.
    (ii) A detailed explanation supported by any necessary data of why 
use of the proposed brand name is requested. This explanation shall also 
state what nutritional benefit to the public will derive from use of the 
brand name as proposed. If the branded product is intended for a 
specific group within the population, the analysis shall specifically 
address nutritional needs of such group and scientific data sufficient 
for such purpose.

 Yours very truly,

 Applicant______________________________________________________________

 By_____________________________________________________________________


[[Page 620]]

________________________________________________________________________
    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
implied nutrient content claim is false or misleading. The notification 
letter shall inform the applicant that the applicant may submit a 
written statement by way of answer to the notification, and that the 
applicant shall have the right to request a hearing with respect to the 
merits or validity of the Administrator's decision to deny the use of 
the proposed implied nutrient content claim.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish a notice of the labeling 
application in the Federal Register seeking a comment on the use of the 
implied nutrient content claim. The notice shall also summarize the 
labeling application, including where the supporting documentation can 
be reviewed. The Administrator's notice shall seek comment from 
consumers, the industry, consumer and industry groups, and other 
interested persons on the labeling application and the use of the 
implied nutrient content claim. After public comment has been received 
and reviewed by the Agency, the Administrator shall make a determination 
on whether the implied nutrient content claim shall be approved for use 
on the labeling of poultry products.
    (i) If the claim is denied by the Administrator, the Agency shall 
notify the applicant, in writing, of the basis for the denial, including 
the reason why the claim on the labeling was determined by the Agency to 
be false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed implied 
nutrient content claim.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the

[[Page 621]]

Department's Judicial Officer, who shall make the final determination 
for the Secretary. Any such determination by the Secretary shall be 
conclusive unless, within 30 days after receipt of the notice of such 
final determination, the applicant appeals to the United States Court of 
Appeals for the circuit in which the applicant has its principal place 
of business or to the United States Court of Appeals for the District of 
Columbia Circuit.
    (ii) If the claim is approved, the Agency shall notify the 
applicant, in writing, and shall also publish in the Federal Register a 
notice informing the public that the implied nutrient content claim has 
been approved for use.

(Paperwork requirements were approved by the Office of Management and 
Budget under control number 0583-0088.)

[58 FR 675, Jan. 6, 1993, as amended at 59 FR 45198, Sept. 1, 1994; 60 
FR 217, Jan. 3, 1995]



Sec. Sec. 381.470-381.479  [Reserved]



Sec. 381.480  Label statements relating to usefulness in reducing or 
maintaining body weight.

    (a) General requirements. Any product that purports to be or is 
represented for special dietary use because of usefulness in reducing 
body weight shall bear:
    (1) Nutrition labeling in conformity with Sec. 381.409 of this 
subpart, unless exempt under that section, and
    (2) A conspicuous statement of the basis upon which the product 
claims to be of special dietary usefulness.
    (b) Nonnutritive ingredients. (1) Any product subject to paragraph 
(a) of this section that achieves its special dietary usefulness by use 
of a nonnutritive ingredient (i.e., one not utilized in normal 
metabolism) shall bear on its label a statement that it contains a 
nonnutritive ingredient and the percentage by weight of the nonnutritive 
ingredient.
    (2) A special dietary product may contain a nonnutritive sweetener 
or other ingredient only if the ingredient is safe for use in the 
product under the applicable law and regulations of this chapter. Any 
product that achieves its special dietary usefulness in reducing or 
maintaining body weight through the use of a nonnutritive sweetener 
shall bear on its label the statement required by paragraph (b)(1) of 
this section, but need not state the percentage by weight of the 
nonnutritive sweetener. If a nutritive sweetener(s) as well as 
nonnutritive sweetener(s) is added, the statement shall indicate the 
presence of both types of sweetener; e.g., ``Sweetened with nutritive 
sweetener(s) and nonnutritive sweetener(s).''
    (c)``Low calorie'' foods. A product purporting to be ``low calorie'' 
must comply with the criteria set forth for such foods in Sec. 381.460.
    (d) ``Reduced calorie'' foods and other comparative claims. A 
product purporting to be ``reduced calorie'' or otherwise containing 
fewer calories than a reference food must comply with the criteria set 
forth for such foods in Sec. 387.460(b) (4) and (5).
    (e) ``Label terms suggesting usefulness as low calorie or reduced 
calorie foods''. (1) Except as provided in paragraphs (e)(2) and (e)(3) 
of this section, a product may be labeled with terms such as ``diet,'' 
``dietetic,'' ``artificially sweetened,'' or ``sweetened with 
nonnutritive sweetener'' only if the claim is not false or misleading, 
and the product is labeled ``low calorie'' or ``reduced calorie'' or 
bears another comparative calorie claim in compliance with the 
applicable provisions in this subpart.
    (2) Paragraph (e)(1) of this section shall not apply to any use of 
such terms that is specifically authorized by regulation governing a 
particular food, or, unless otherwise restricted by regulation, to any 
use of the term ``diet'' that clearly shows that the product is offered 
solely for a dietary use other than regulating body weight, e.g., ``for 
low sodium diets.''
    (3) Paragraph (e)(1) of this section shall not apply to any use of 
such terms on a formulated meal replacement or other product that is 
represented to be of special dietary use as a whole meal, pending the 
issuance of a regulation governing the use of such terms on foods.
    (f) ``Sugar free'' and ``no added sugar''. Criteria for the use of 
the

[[Page 622]]

terms ``sugar free'' and ``no added sugar'' are provided for in Sec. 
381.460(c).

[58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58 
FR 47628, Sept. 10, 1993; 60 FR 217, Jan. 3, 1995]



Sec. Sec. 381.481-381.499  [Reserved]



Sec. 381.500  Exemption from nutrition labeling.

    (a) The following poultry products are exempt from nutrition 
labeling:
    (1) Food products produced by small businesses, provided that the 
labels for these products bear no nutrition claims or nutrition 
information,
    (i) A food product, for purposes of the small business exemption, is 
defined as a formulation, not including distinct flavors which do not 
significantly alter the nutritional profile, sold in any size package in 
commerce.
    (ii) For purposes of this paragraph, a small business is any single-
plant facility or multi-plant company/firm that employs 500 or fewer 
people and produces no more than the following amounts of pounds of the 
product qualifying the firm for exemption from this subpart:
    (A) During the first year of implementation of nutrition labeling, 
from July 1994 to July 1995, 250,000 pounds or less,
    (B) During the second year of implementation of nutrition labeling, 
from July 1995 to July 1996, 175,000 pounds or less, and
    (C) During the third year of implementation and subsequent years 
thereafter, 100,000 pounds or less.
    (iii) For purposes of this paragraph, calculation of the amount of 
pounds shall be based on the most recent 2-year average of business 
activity. Where firms have been in business less than 2 years or where 
products have been produced for less than 2 years, reasonable estimates 
must indicate that the annual pounds produced will not exceed the 
amounts specified.
    (2) Products intended for further processing, provided that the 
labels for these products bear no nutrition claims or nutrition 
information,
    (3) Products that are not for sale to consumers, provided that the 
labels for these products bear no nutrition claims or nutrition 
information,
    (4) Products in small packages that are individually wrapped 
packages of less than \1/2\ ounce net weight, provided that the labels 
for these products bear no nutrition claims or nutrition information,
    (5) Products custom slaughtered or prepared,
    (6) Products intended for export, and
    (7) The following products prepared and served or sold at retail 
provided that the labels or the labeling of these products bear no 
nutrition claims or nutrition information:
    (i) Ready-to-eat products that are packaged or portioned at a retail 
store or similar retail-type establishment; and
    (ii) Multi-ingredient products (e.g. sausage) processed at a retail 
store or similar retail-type establishment.
    (b) Restaurant menus generally do not constitute labeling or fall 
within the scope of these regulations.
    (c)(1) Foods represented to be specifically for infants and children 
less than 2 years of age shall bear nutrition labeling as provided in 
paragraph (c)(2) of this section, except such labeling shall not include 
calories from fat, calories from saturated fat, saturated fat, stearic 
acid, polyunsaturated fat, monounsaturated fat, and cholesterol.
    (2) Foods represented or purported to be specifically for infants 
and children less than 4 years of age shall bear nutrition labeling 
except that:
    (i) Such labeling shall not include declarations of percent of Daily 
Value for total fat, saturated fat, cholesterol, sodium, potassium, 
total carbohydrate, and dietary fiber;
    (ii) Nutrient names and quantitative amounts by weight shall be 
presented in two separate columns;
    (iii) The heading ``Percent Daily Value'' required in Sec. 
381.409(d)(6) shall be placed immediately below the quantitative 
information by weight for protein;
    (iv) The percent of the Daily Value for protein, vitamins, and 
minerals shall be listed immediately below the heading ``Percent Daily 
Value''; and
    (v) Such labeling shall not include the footnote specified in Sec. 
381.409(d)(9).
    (d)(1) Products in packages that have a total surface area available 
to bear labeling of less than 12 square inches

[[Page 623]]

are exempt from nutrition labeling, provided that the labeling for these 
products bear no nutrition claims or other nutrition information. The 
manufacturer, packer, or distributor shall provide, on the label of 
packages that qualify for and use this exemption, an address or 
telephone number that a consumer can use to obtain the required 
nutrition information (e.g., ``For nutrition information call 1-800-123-
4567'').
    (2) When such products bear nutrition labeling, either voluntarily 
or because nutrition claims or other nutrition information is provided, 
all required information shall be in a type size no smaller than 6 point 
or all upper case type of \1/16\-inch minimum height, except that 
individual serving-size packages of poultry products that have a total 
area available to bear labeling of 3 square inches or less may provide 
all required information in a type size no smaller than \1/32\-inch 
minimum height.

[58 FR 675, Jan. 6, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 59 
FR 45198, Sept. 1, 1994; 60 FR 217, Jan. 3, 1995]



                       SUBCHAPTERS B-C [RESERVED]



[[Page 624]]



     SUBCHAPTER D_FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE 
                               PROVISIONS





PART 390_FREEDOM OF INFORMATION AND PUBLIC INFORMATION--Table of Contents




Sec.
390.1 Scope and purpose.
390.2 Published materials.
390.3 Indexes, reference guide, and handbook.
390.4 Facilities for inspection and copying.
390.5 Requests for records.
390.6 Fee schedule.
390.7 Appeals.
390.8 Agency response to requests.
390.9 Communications with State and other Federal government agencies.

    Authority: 5 U.S.C. 301, 552; 7 CFR 1.3, 2.7.

    Source: 64 FR 43903, Aug. 12, 1999, unless otherwise noted.



Sec. 390.1  Scope and purpose.

    This part is issued pursuant to the Freedom of Information Act 
(FOIA) as amended (5 U.S.C. 552), and in accordance with the directives 
of the Department of Agriculture regulations in part 1, subpart A, of 
Title 7. The availability of records, including electronic records 
created on or after November 1, 1996, of the Food Safety and Inspection 
Service (FSIS), and the procedures by which the public may request such 
information, will be governed by the FOIA and by the Department 
regulations as implemented and supplemented by the regulations in this 
part.



Sec. 390.2  Published materials.

    FSIS rules and regulations relating to its regulatory 
responsibilities and administrative procedures are published and made 
available to the public in the Federal Register and codified in chapter 
III, title 9, of the Code of Federal Regulations. FSIS also issues 
numerous publications relating to Agency programs, which implement the 
laws listed in the Delegation of Authority, 7 CFR 2.15(a). Most of these 
publications are available free from the USDA Publications Division, 
Office of Governmental and Public Affairs, or at established rates from 
the Superintendent of Documents, U.S. Government Printing Office, 
Washington, 20402-9328.



Sec. 390.3  Indexes, reference guide, and handbook.

    (a) Pursuant to the regulations in 7 CFR 1.4(c), FSIS will maintain 
and make available for public inspection and copying an index providing 
identifying information regarding the materials required to be published 
or made available under the Freedom of Information Act (5 U.S.C. 
552(a)(2)). The Agency will make the index available by computer 
telecommunications by December 31, 1999. Quarterly publication of the 
index is unnecessary and impractical, since the material is voluminous 
and does not change often enough to justify the expense of quarterly 
publication. The Agency will provide copies of any index, upon request, 
at a cost not to exceed direct cost of duplication.
    (b) FSIS is responsible for preparing reference material or a guide 
for requesting records or information from the Agency. This guide also 
will include an index of all major information systems and a description 
of major information and record locator systems.
    (c) FSIS will prepare a handbook for obtaining information from the 
Agency. The handbook will be available on paper and through electronic 
means, and will discuss how the public can use it to access Agency FOIA 
annual reports. Similarly, the annual reports will refer to the handbook 
and how to obtain it.



Sec. 390.4  Facilities for inspection and copying.

    Facilities for public inspection and copying of the material 
described in Sec. Sec. 390.2 and 390.3 of this part will be provided by 
FSIS pursuant to 7 CFR 1.5(a) in a reading area, on business days 
between the hours of 8:30 a.m. and 4:30 p.m., upon request to the 
Freedom of Information Coordinator or designee at the following address:


[[Page 625]]


Freedom of Information Act Coordinator (FOIA), Food Safety and 
Inspection Service, Department of Agriculture, Washington, DC 20250-3700



Sec. 390.5  Request for records.

    (a) The FOIA Coordinator of FSIS is authorized to receive requests 
and to exercise authority under 7 CFR 1.3(a) to--
    (1) Make determinations to grant or deny such requests,
    (2) Extend the 20-day deadline,
    (3) Make discretionary releases of exempt records, except where 
disclosure is specifically prohibited by Executive Order, statute, and 
applicable regulations,
    (4) Consider expedited processing when appropriate,
    (5) Make determinations regarding the charging of fees pursuant to 
the established schedule, and
    (6) Determine the applicability of 7 CFR 1.5 to requests for 
records.
    (b) Requests for FSIS records or information will be made in writing 
in accordance with 7 CFR 1.5 and submitted to the FSIS Freedom of 
Information Act Coordinator at the following address:

Freedom of Information Act Coordinator (FOIA Request), Food Safety and 
Inspection Service, Department of Agriculture, Washington, DC 20250-3700

    The submitter will identify each record with reasonable specificity 
as prescribed in 7 CFR 1.3. All requests to inspect or obtain copies of 
any record or to obtain a fee waiver must be submitted in writing.
    (c) In exercising authority under 7 CFR 1.3(a)(3) to grant and deny 
requests, the Coordinator or designee will comply with subsection (b) of 
the Freedom of Information Act (5 U.S.C. 552(b)), as amended, which 
requires that any reasonably segregated portion of a document will be 
provided to a person requesting the document after deletion of any 
portions within the scope of the request for which an exemption is being 
claimed under the Act. Therefore, unless the disclosable and 
nondisclosable portions are so inextricably linked that it is not 
reasonably possible to separate them, the document will be released with 
the nondisclosable portions deleted. The Coordinator or designee may 
exercise discretion as limited by 7 CFR l.15 to release the entire 
document or make only a minimum number of deletions. If portions of a 
document in electronic format have been redacted, the Agency must 
indicate, on the released portion of the document, the amount of 
information that has been deleted from a record, unless that indication 
would harm an interest protected by an applicable exemption.



Sec. 390.6  Fee schedule.

    Department regulations provide for a schedule of reasonable standard 
charges for document search and duplication. See 7 CFR 1.17. Fees to be 
charged are in 7 CFR part 1, subpart A, appendix A.



Sec. 390.7  Appeals.

    (a) If the request for information or for a waiver of search or 
duplication is denied, in whole or in part, the FOIA Coordinator or 
designee will explain in the letter of response the grounds for any 
denial of access and offer the requester an opportunity to file an 
administrative appeal, pursuant to 7 CFR 1.3(a)(4). The appeal should be 
filed in writing within 45 days of the date of denial (departmental 
regulations, 7 CFR 1.14) and addressed as follows:

Administrator, Food Safety and Inspection Service (FOIA Appeals), 
Department of Agriculture, Washington, DC 20250-3700

    (b) The FSIS Administrator is authorized under 7 CFR 1.3(a)(4) to 
extend the 20-day deadline, make discretionary releases, and make 
determinations regarding the charging of fees.



Sec. 390.8  Agency response to requests.

    (a) The response to Freedom of Information requests and appeals by 
officials named in Sec. Sec. 390.5 and 390.7 of this part shall be 
governed by and made in accordance with 7 CFR 1.7 and the regulations in 
this part.
    (b) If requests for records and information are received by field 
offices, the field office will immediately notify the FOIA Coordinator 
or designee by telephone and transmit the request to the FOIA office. In 
rare instances, the FOIA Coordinator or designee will authorize a 
release of the requested

[[Page 626]]

records to the field office receiving the request. The request will be 
considered as having been received on the date of arrival in the office 
of the Coordinator or designee. Any person whose request for records has 
been granted may inspect and copy the records (or copies) at the office 
listed in Sec. 390.4 of this part in accordance with the provisions of 
that section and with Sec. 390.6. Copies also may be obtained by mail.



Sec. 390.9  Communications with State and other Federal government 
agencies.

    (a) The Administrator of the Food Safety and Inspection Service 
(FSIS), or designee, may authorize the disclosure of distribution lists 
(records that show where and when product was shipped) obtained from a 
firm recalling products, or incorporated into agency-prepared records, 
to State and other Federal government agencies to verify the removal of 
the recalled product, provided that:
    (1) The State agency has provided both a written statement 
establishing its authority to protect confidential distribution lists 
from public disclosure and a written commitment not to disclose any 
information provided by FSIS, without the written permission of the 
submitter of the information or written confirmation by FSIS that the 
information no longer has confidential status. Federal government 
agencies must provide a written commitment not to disclose the 
information and to refer any request for distribution lists to FSIS for 
response; and
    (2) The Administrator of FSIS or designee determines that disclosure 
would be in the interest of public health.
    (b) This provision does not authorize the disclosure to State or 
other Federal government agencies of trade secret information, unless 
otherwise provided by law or pursuant to an express written 
authorization provided by the submitter of the information.
    (c) Information disclosed under this section is not a disclosure of 
information to the public. Disclosures made under this section do not 
waive any FOIA exemption protection.

[67 FR 20013, Apr. 24, 2002]



PART 391_FEES AND CHARGES FOR INSPECTION SERVICES AND LABORATORY 
ACCREDITATION--Table of Contents




Sec.
391.1 Scope and purpose.
391.2 Base time rate.
391.3 Overtime and holiday rate.
391.4 Laboratory service rate.
391.5 Laboratory accreditation fees.

    Authority: 7 U.S.C. 138f; 7 U.S.C. 394, 1622, 1624; 21 U.S.C. 451 et 
seq.; 21 U.S.C. 601-695; 7 CFR 2.17 (g) and (i), 2.55.



Sec. 391.1  Scope and purpose.

    Fees shall be charged by the Agency for certain specified inspection 
services provided on a holiday, on an overtime basis, and/or which are 
voluntary inspection services.

[54 FR 6390, Feb. 10, 1989]



Sec. 391.2  Base time rate.

    The base time rate for inspection services provided pursuant to 
Sec. Sec. 350.7, 351.8, 351.9, 352.5, 354.101, 355.12, and 362.5 is 
$43.64 per hour per program employee.

[68 FR 37956, June 26, 2003]



Sec. 391.3  Overtime and holiday rate.

    The overtime and holiday rate for inspection services provided 
pursuant to Sec. Sec. 307.5, 350.7, 351.8, 351.9, 352.5, 354.101, 
355.12, 362.5 and 381.38 is $50.04 per hour per program employee.

[68 FR 37956, June 26, 2003]



Sec. 391.4  Laboratory services rate.

    The rate for laboratory services provided pursuant to Sec. Sec. 
350.7, 351.9, 352.5, 354.101, 355.12, and 362.5 is $61.80 per hour per 
program employee.

[68 FR 37956, June 26, 2003]



Sec. 391.5  Laboratory accreditation fees.

    (a) The annual fee for the initial accreditation and maintenance of 
accreditation provided pursuant to Sec. Sec. 318.21 and 381.153 shall 
be $1,500 per accreditation.
    (b) Laboratories that request special onsite inspections shall pay 
FSIS the actual cost of reasonable travel and other expenses necessary 
to perform

[[Page 627]]

the unscheduled or non-routine onsite inspections.

[58 FR 65269, Dec. 13, 1993 as amended at 59 FR 66449, Dec 27, 1994; 64 
FR 19868, Apr. 23, 1999]

[[Page 628]]



 SUBCHAPTER E_REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION 
               ACT AND THE POULTRY PRODUCTS INSPECTION ACT





PART 416_SANITATION--Table of Contents




Sec.
416.1 General rules.
416.2 Establishment grounds and facilities.
416.3 Equipment and utensils.
416.4 Sanitary operations.
416.5 Employee hygiene.
416.6 Tagging insanitary equipment, utensils, rooms or compartments.
416.11 General rules.
416.12 Development of sanitation SOP's.
416.13 Implementation of SOP's.
416.14 Maintenance of Sanitation SOP's.
416.15 Corrective Actions.
416.16 Recordkeeping requirements.
416.17 Agency verification.

    Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906; 7 
CFR 2.18, 2.53.

    Source: 61 FR 38868, July 25, 1996, unless otherwise noted.



Sec. 416.1  General rules.

    Each official establishment must be operated and maintained in a 
manner sufficient to prevent the creation of insanitary conditions and 
to ensure that product is not adulterated.

[64 FR 56417, Oct. 20, 1999]



Sec. 416.2  Establishment grounds and facilities.

    (a) Grounds and pest control. The grounds about an establishment 
must be maintained to prevent conditions that could lead to insanitary 
conditions, adulteration of product, or interfere with inspection by 
FSIS program employees. Establishments must have in place a pest 
management program to prevent the harborage and breeding of pests on the 
grounds and within establishment facilities. Pest control substances 
used must be safe and effective under the conditions of use and not be 
applied or stored in a manner that will result in the adulteration of 
product or the creation of insanitary conditions.
    (b) Construction. (1) Establishment buildings, including their 
structures, rooms, and compartments must be of sound construction, be 
kept in good repair, and be of sufficient size to allow for processing, 
handling, and storage of product in a manner that does not result in 
product adulteration or the creation of insanitary conditions.
    (2) Walls, floors, and ceilings within establishments must be built 
of durable materials impervious to moisture and be cleaned and sanitized 
as necessary to prevent adulteration of product or the creation of 
insanitary conditions.
    (3) Walls, floors, ceilings, doors, windows, and other outside 
openings must be constructed and maintained to prevent the entrance of 
vermin, such as flies, rats, and mice.
    (4) Rooms or compartments in which edible product is processed, 
handled, or stored must be separate and distinct from rooms or 
compartments in which inedible product is processed, handled, or stored, 
to the extent necessary to prevent product adulteration and the creation 
of insanitary conditions.
    (c) Light. Lighting of good quality and sufficient intensity to 
ensure that sanitary conditions are maintained and that product is not 
adulterated must be provided in areas where food is processed, handled, 
stored, or examined; where equipment and utensils are cleaned; and in 
hand-washing areas, dressing and locker rooms, and toilets.
    (d) Ventilation. Ventilation adequate to control odors, vapors, and 
condensation to the extent necessary to prevent adulteration of product 
and the creation of insanitary conditions must be provided.
    (e) Plumbing. Plumbing systems must be installed and maintained to:
    (1) Carry sufficient quantities of water to required locations 
throughout the establishment;
    (2) Properly convey sewage and liquid disposable waste from the 
establishment;
    (3) Prevent adulteration of product, water supplies, equipment, and 
utensils and prevent the creation of insanitary conditions throughout 
the establishment;
    (4) Provide adequate floor drainage in all areas where floors are 
subject to

[[Page 629]]

flooding-type cleaning or where normal operations release or discharge 
water or other liquid waste on the floor;
    (5) Prevent back-flow conditions in and cross-connection between 
piping systems that discharge waste water or sewage and piping systems 
that carry water for product manufacturing; and
    (6) Prevent the backup of sewer gases.
    (f) Sewage disposal. Sewage must be disposed into a sewage system 
separate from all other drainage lines or disposed of through other 
means sufficient to prevent backup of sewage into areas where product is 
processed, handled, or stored. When the sewage disposal system is a 
private system requiring approval by a State or local health authority, 
the establishment must furnish FSIS with the letter of approval from 
that authority upon request.
    (g) Water supply and water, ice, and solution reuse. (1) A supply of 
running water that complies with the National Primary Drinking Water 
regulations (40 CFR part 141), at a suitable temperature and under 
pressure as needed, must be provided in all areas where required (for 
processing product, for cleaning rooms and equipment, utensils, and 
packaging materials, for employee sanitary facilities, etc.). If an 
establishment uses a municipal water supply, it must make available to 
FSIS, upon request, a water report, issued under the authority of the 
State or local health agency, certifying or attesting to the potability 
of the water supply. If an establishment uses a private well for its 
water supply, it must make available to FSIS, upon request, 
documentation certifying the potability of the water supply that has 
been renewed at least semi-annually.
    (2) Water, ice, and solutions (such as brine, liquid smoke, or 
propylene glycol) used to chill or cook ready-to-eat product may be 
reused for the same purpose, provided that they are maintained free of 
pathogenic organisms and fecal coliform organisms and that other 
physical, chemical, and microbiological contamination have been reduced 
to prevent adulteration of product.
    (3) Water, ice, and solutions used to chill or wash raw product may 
be reused for the same purpose provided that measures are taken to 
reduce physical, chemical, and microbiological contamination so as to 
prevent contamination or adulteration of product. Reuse that which has 
come into contact with raw product may not be used on ready-to-eat 
product.
    (4) Reconditioned water that has never contained human waste and 
that has been treated by an onsite advanced wastewater treatment 
facility may be used on raw product, except in product formulation, and 
throughout the facility in edible and inedible production areas, 
provided that measures are taken to ensure that this water meets the 
criteria prescribed in paragraph (g)(1) of this section. Product, 
facilities, equipment, and utensils coming in contact with this water 
must undergo a separate final rinse with non-reconditioned water that 
meets the criteria prescribed in paragraph (g)(1) of this section.
    (5) Any water that has never contained human waste and that is free 
of pathogenic organisms may be used in edible and inedible product 
areas, provided it does not contact edible product. For example, such 
reuse water may be used to move heavy solids, to flush the bottom of 
open evisceration troughs, or to wash antemortem areas, livestock pens, 
trucks, poultry cages, picker aprons, picking room floors, and similar 
areas within the establishment.
    (6) Water that does not meet the use conditions of paragraphs (g)(1) 
through (g)(5) of this section may not be used in areas where edible 
product is handled or prepared or in any manner that would allow it to 
adulterate edible product or create insanitary conditions.
    (h) Dressing rooms, lavatories, and toilets. (1) Dressing rooms, 
toilet rooms, and urinals must be sufficient in number, ample in size, 
conveniently located, and maintained in a sanitary condition and in good 
repair at all times to ensure cleanliness of all persons handling any 
product. They must be separate from the rooms and compartments in which 
products are processed, stored, or handled.
    (2) Lavatories with running hot and cold water, soap, and towels, 
must be placed in or near toilet and urinal

[[Page 630]]

rooms and at such other places in the establishment as necessary to 
ensure cleanliness of all persons handling any product.
    (3) Refuse receptacles must be constructed and maintained in a 
manner that protects against the creation of insanitary conditions and 
the adulteration of product.

[64 FR 56417, Oct. 20, 1999]



Sec. 416.3  Equipment and utensils.

    (a) Equipment and utensils used for processing or otherwise handling 
edible product or ingredients must be of such material and construction 
to facilitate thorough cleaning and to ensure that their use will not 
cause the adulteration of product during processing, handling, or 
storage. Equipment and utensils must be maintained in sanitary condition 
so as not to adulterate product.
    (b) Equipment and utensils must not be constructed, located, or 
operated in a manner that prevents FSIS inspection program employees 
from inspecting the equipment or utensils to determine whether they are 
in sanitary condition.
    (c) Receptacles used for storing inedible material must be of such 
material and construction that their use will not result in the 
adulteration of any edible product or in the creation of insanitary 
conditions. Such receptacles must not be used for storing any edible 
product and must bear conspicuous and distinctive marking to identify 
permitted uses.

[64 FR 56417, Oct. 20, 1999]



Sec. 416.4  Sanitary operations.

    (a) All food-contact surfaces, including food-contact surfaces of 
utensils and equipment, must be cleaned and sanitized as frequently as 
necessary to prevent the creation of insanitary conditions and the 
adulteration of product.
    (b) Non-food-contact surfaces of facilities, equipment, and utensils 
used in the operation of the establishment must be cleaned and sanitized 
as frequently as necessary to prevent the creation of insanitary 
conditions and the adulteration of product.
    (c) Cleaning compounds, sanitizing agents, processing aids, and 
other chemicals used by an establishment must be safe and effective 
under the conditions of use. Such chemicals must be used, handled, and 
stored in a manner that will not adulterate product or create insanitary 
conditions. Documentation substantiating the safety of a chemical's use 
in a food processing environment must be available to FSIS inspection 
program employees for review.
    (d) Product must be protected from adulteration during processing, 
handling, storage, loading, and unloading at and during transportation 
from official establishments.

[64 FR 56417, Oct. 20, 1999]



Sec. 416.5  Employee hygiene.

    (a) Cleanliness. All persons working in contact with product, food-
contact surfaces, and product-packaging materials must adhere to 
hygienic practices while on duty to prevent adulteration of product and 
the creation of insanitary conditions.
    (b) Clothing. Aprons, frocks, and other outer clothing worn by 
persons who handle product must be of material that is disposable or 
readily cleaned. Clean garments must be worn at the start of each 
working day and garments must be changed during the day as often as 
necessary to prevent adulteration of product and the creation of 
insanitary conditions.
    (c) Disease control. Any person who has or appears to have an 
infectious disease, open lesion, including boils, sores, or infected 
wounds, or any other abnormal source of microbial contamination, must be 
excluded from any operations which could result in product adulteration 
and the creation of insanitary conditions until the condition is 
corrected.

[64 FR 56417, Oct. 20, 1999]



Sec. 416.6  Tagging insanitary equipment, utensils, rooms or compartments.

    When an FSIS program employee finds that any equipment, utensil, 
room, or compartment at an official establishment is insanitary or that 
its use could cause the adulteration of product, he will attach to it a 
``U.S.

[[Page 631]]

Rejected'' tag. Equipment, utensils, rooms, or compartments so tagged 
cannot be used until made acceptable. Only an FSIS program employee may 
remove a ``U.S. Rejected'' tag.

[64 FR 56417, Oct. 20, 1999]



Sec. 416.11  General rules.

    Each official establishment shall develop, implement, and maintain 
written standard operating procedures for sanitation (Sanitation SOP's) 
in accordance with the requirements of this part.



Sec. 416.12  Development of Sanitation SOP's.

    (a) The Sanitation SOP's shall describe all procedures an official 
establishment will conduct daily, before and during operations, 
sufficient to prevent direct contamination or adulteration of 
product(s).
    (b) The Sanitation SOP's shall be signed and dated by the individual 
with overall authority on-site or a higher level official of the 
establishment. This signature shall signify that the establishment will 
implement the Sanitation SOP's as specified and will maintain the 
Sanitation SOP's in accordance with the requirements of this part. The 
Sanitation SOP's shall be signed and dated upon initially implementing 
the Sanitation SOP's and upon any modification to the Sanitation SOP's.
    (c) Procedures in the Sanitation SOP's that are to be conducted 
prior to operations shall be identified as such, and shall address, at a 
minimum, the cleaning of food contact surfaces of facilities, equipment, 
and utensils.
    (d) The Sanitation SOP's shall specify the frequency with which each 
procedure in the Sanitation SOP's is to be conducted and identify the 
establishment employee(s) responsible for the implementation and 
maintenance of such procedure(s).



Sec. 416.13  Implementation of SOP's.

    (a) Each official establishment shall conduct the pre-operational 
procedures in the Sanitation SOP's before the start of operations.
    (b) Each official establishment shall conduct all other procedures 
in the Sanitation SOP's at the frequencies specified.
    (c) Each official establishment shall monitor daily the 
implementation of the procedures in the Sanitation SOP's.



Sec. 416.14  Maintenance of Sanitation SOP's.

    Each official establishment shall routinely evaluate the 
effectiveness of the Sanitation SOP's and the procedures therein in 
preventing direct contamination or adulteration of product(s) and shall 
revise both as necessary to keep them effective and current with respect 
to changes in facilities, equipment, utensils, operations, or personnel.



Sec. 416.15  Corrective Actions.

    (a) Each official establishment shall take appropriate corrective 
action(s) when either the establishment or FSIS determines that the 
establishment's Sanitation SOP's or the procedures specified therein, or 
the implementation or maintenance of the Sanitation SOP's, may have 
failed to prevent direct contamination or adulteration of product(s).
    (b) Corrective actions include procedures to ensure appropriate 
disposition of product(s) that may be contaminated, restore sanitary 
conditions, and prevent the recurrence of direct contamination or 
adulteration of product(s), including appropriate reevaluation and 
modification of the Sanitation SOP's and the procedures specified 
therein or appropriate improvements in the execution of the Sanitation 
SOP's or the procedures specified therein.

[61 FR 38868, July 25, 1996, as amended at 62 FR 26219, May 13, 1997]



Sec. 416.16  Recordkeeping requirements.

    (a) Each official establishment shall maintain daily records 
sufficient to document the implementation and monitoring of the 
Sanitation SOP's and any corrective actions taken. The establishment 
employee(s) specified in the Sanitation SOP's as being responsible for 
the implementation and monitoring of the procedure(s) specified in

[[Page 632]]

the Sanitation SOP's shall authenticate these records with his or her 
initials and the date.
    (b) Records required by this part may be maintained on computers 
provided the establishment implements appropriate controls to ensure the 
integrity of the electronic data.
    (c) Records required by this part shall be maintained for at least 6 
months and made accesable available to FSIS. All such records shall be 
maintained at the official establishment for 48 hours following 
completion, after which they may be maintained off-site provided such 
records can be made available to FSIS within 24 hours of request.



Sec. 416.17  Agency verification.

    FSIS shall verify the adequacy and effectiveness of the Sanitation 
SOP's and the procedures specified therein by determining that they meet 
the requirements of this part. Such verification may include:
    (a) Reviewing the Sanitation SOP's;
    (b) Reviewing the daily records documenting the implementation of 
the Sanitation SOP's and the procedures specified therein and any 
corrective actions taken or required to be taken;
    (c) Direct observation of the implementation of the Sanitation SOP's 
and the procedures specified therein and any corrective actions taken or 
required to be taken; and
    (d) Direct observation or testing to assess the sanitary conditions 
in the establishment.



PART 417_HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
--Table of Contents




Sec.
417.1 Definitions.
417.2 Hazard Analysis and HACCP plan.
417.3 Corrective actions.
417.4 Validation, Verification, Reassessment.
417.5 Records.
417.6 Inadequate HACCP Systems.
417.7 Training.
417.8 Agency verification.

    Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 U.S.C. 1901-
1906; 7 CFR 2.18, 2.53.

    Source: 61 FR 38868, July 25, 1996, unless otherwise noted.



Sec. 417.1  Definitions.

    For purposes of this part, the following definitions shall apply:
    Corrective action. Procedures to be followed when a deviation 
occurs.
    Critical control point. A point, step, or procedure in a food 
process at which control can be applied and, as a result, a food safety 
hazard can be prevented, eliminated, or reduced to acceptable levels.
    Critical limit. The maximum or minimum value to which a physical, 
biological, or chemical hazard must be controlled at a critical control 
point to prevent, eliminate, or reduce to an acceptable level the 
occurrence of the identified food safety hazard.
    Food safety hazard. Any biological, chemical, or physical property 
that may cause a food to be unsafe for human consumption.
    HACCP System. The HACCP plan in operation, including the HACCP plan 
itself.
    Hazard. SEE Food Safety Hazard.
    Preventive measure. Physical, chemical, or other means that can be 
used to control an identified food safety hazard.
    Process-monitoring instrument. An instrument or device used to 
indicate conditions during processing at a critical control point.
    Responsible establishment official. The individual with overall 
authority on-site or a higher level official of the establishment.



Sec. 417.2  Hazard Analysis and HACCP Plan.

    (a) Hazard analysis. (1) Every official establishment shall conduct, 
or have conducted for it, a hazard analysis to determine the food safety 
hazards reasonably likely to occur in the production process and 
identify the preventive measures the establishment can apply to control 
those hazards. The hazard analysis shall include food safety hazards 
that can occur before, during, and after entry into the establishment. A 
food safety hazard that is reasonably likely to occur is one for which a 
prudent establishment would establish controls because it historically 
has occurred, or because there is a reasonable possibility that it will 
occur in the

[[Page 633]]

particular type of product being processed, in the absence of those 
controls.
    (2) A flow chart describing the steps of each process and product 
flow in the establishment shall be prepared, and the intended use or 
consumers of the finished product shall be identified.
    (3) Food safety hazards might be expected to arise from the 
following:
    (i) Natural toxins;
    (ii) Microbiological contamination;
    (iii) Chemical contamination;
    (iv) Pesticides;
    (v) Drug residues;
    (vi) Zoonotic diseases;
    (vii) Decomposition;
    (viii) Parasites;
    (ix) Unapproved use of direct or indirect food or color additives; 
and
    (x) Physical hazards.
    (b) The HACCP plan. (1) Every establishment shall develop and 
implement a written HACCP plan covering each product produced by that 
establishment whenever a hazard analysis reveals one or more food safety 
hazards that are reasonably likely to occur, based on the hazard 
analysis conducted in accordance with paragraph (a) of this section, 
including products in the following processing categories:
    (i) Slaughter--all species.
    (ii) Raw product--ground.
    (iii) Raw product--not ground.
    (iv) Thermally processed--commercially sterile.
    (v) Not heat treated--shelf stable.
    (vi) Heat treated--shelf stable.
    (vii) Fully cooked--not shelf stable.
    (viii) Heat treated but not fully cooked--not shelf stable.
    (ix) Product with secondary inhibitors--not shelf stable.
    (2) A single HACCP plan may encompass multiple products within a 
single processing category identified in this paragraph, if the food 
safety hazards, critical control points, critical limits, and procedures 
required to be identified and performed in paragraph (c) of this section 
are essentially the same, provided that any required features of the 
plan that are unique to a specific product are clearly delineated in the 
plan and are observed in practice.
    (3) HACCP plans for thermally processed/commercially sterile 
products do not have to address the food safety hazards associated with 
microbiological contamination if the product is produced in accordance 
with the requirements of part 318, subpart G, or part 381, subpart X, of 
this chapter.
    (c) The contents of the HACCP plan. The HACCP plan shall, at a 
minimum:
    (1) List the food safety hazards identified in accordance with 
paragraph (a) of this section, which must be controlled for each 
process.
    (2) List the critical control points for each of the identified food 
safety hazards, including, as appropriate:
    (i) Critical control points designed to control food safety hazards 
that could be introduced in the establishment, and
    (ii) Critical control points designed to control food safety hazards 
introduced outside the establishment, including food safety hazards that 
occur before, during, and after entry into the establishment;
    (3) List the critical limits that must be met at each of the 
critical control points. Critical limits shall, at a minimum, be 
designed to ensure that applicable targets or performance standards 
established by FSIS, and any other requirement set forth in this chapter 
pertaining to the specific process or product, are met;
    (4) List the procedures, and the frequency with which those 
procedures will be performed, that will be used to monitor each of the 
critical control points to ensure compliance with the critical limits;
    (5) Include all corrective actions that have been developed in 
accordance with Sec. 417.3(a) of this part, to be followed in response 
to any deviation from a critical limit at a critical control point; and
    (6) Provide for a recordkeeping system that documents the monitoring 
of the critical control points. The records shall contain the actual 
values and observations obtained during monitoring.
    (7) List the verification procedures, and the frequency with which 
those procedures will be performed, that the establishment will use in 
accordance with Sec. 417.4 of this part.
    (d) Signing and dating the HACCP plan. (1) The HACCP plan shall be 
signed and dated by the responsible establishment individual. This 
signature

[[Page 634]]

shall signify that the establishment accepts and will implement the 
HACCP plan.
    (2) The HACCP plan shall be dated and signed:
    (i) Upon initial acceptance;
    (ii) Upon any modification; and
    (iii) At least annually, upon reassessment, as required under Sec. 
417.4(a)(3) of this part.
    (e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an 
establishment to develop and implement a HACCP plan that complies with 
this section, or to operate in accordance with the requirements of this 
part, may render the products produced under those conditions 
adulterated.

[61 FR 38868, July 25, 1996, as amended at 62 FR 61009, Nov. 14, 1997]



Sec. 417.3  Corrective actions.

    (a) The written HACCP plan shall identify the corrective action to 
be followed in response to a deviation from a critical limit. The HACCP 
plan shall describe the corrective action to be taken, and assign 
responsibility for taking corrective action, to ensure:
    (1) The cause of the deviation is identified and eliminated;
    (2) The CCP will be under control after the corrective action is 
taken;
    (3) Measures to prevent recurrence are established; and
    (4) No product that is injurious to health or otherwise adulterated 
as a result of the deviation enters commerce.
    (b) If a deviation not covered by a specified corrective action 
occurs, or if another unforeseen hazard arises, the establishment shall:
    (1) Segregate and hold the affected product, at least until the 
requirements of paragraphs (b)(2) and (b)(3) of this section are met;
    (2) Perform a review to determine the acceptability of the affected 
product for distribution;
    (3) Take action, when necessary, with respect to the affected 
product to ensure that no product that is injurious to health or 
otherwise adulterated, as a result of the deviation, enters commerce;
    (4) Perform or obtain reassessment by an individual trained in 
accordance with Sec. 417.7 of this part, to determine whether the newly 
identified deviation or other unforeseen hazard should be incorporated 
into the HACCP plan.
    (c) All corrective actions taken in accordance with this section 
shall be documented in records that are subject to verification in 
accordance with Sec. 417.4(a)(2)(iii) and the recordkeeping 
requirements of Sec. 417.5 of this part.



Sec. 417.4  Validation, Verification, Reassessment.

    (a) Every establishment shall validate the HACCP plan's adequacy in 
controlling the food safety hazards identified during the hazard 
analysis, and shall verify that the plan is being effectively 
implemented.
    (1) Initial validation. Upon completion of the hazard analysis and 
development of the HACCP plan, the establishment shall conduct 
activities designed to determine that the HACCP plan is functioning as 
intended. During this HACCP plan validation period, the establishment 
shall repeatedly test the adequacy of the CCP's, critical limits, 
monitoring and recordkeeping procedures, and corrective actions set 
forth in the HACCP plan. Validation also encompasses reviews of the 
records themselves, routinely generated by the HACCP system, in the 
context of other validation activities.
    (2) Ongoing verification activities. Ongoing verification activities 
include, but are not limited to:
    (i) The calibration of process-monitoring instruments;
    (ii) Direct observations of monitoring activities and corrective 
actions; and
    (iii) The review of records generated and maintained in accordance 
with Sec. 417.5(a)(3) of this part.
    (3) Reassessment of the HACCP plan. Every establishment shall 
reassess the adequacy of the HACCP plan at least annually and whenever 
any changes occur that could affect the hazard analysis or alter the 
HACCP plan. Such changes may include, but are not limited to, changes 
in: raw materials or source of raw materials; product formulation; 
slaughter or processing methods or systems; production volume; 
personnel; packaging; finished product distribution systems; or, the 
intended use or consumers of the finished product. The reassessment 
shall be performed by an individual trained

[[Page 635]]

in accordance with Sec. 417.7 of this part. The HACCP plan shall be 
modified immediately whenever a reassessment reveals that the plan no 
longer meets the requirements of Sec. 417.2(c) of this part.
    (b) Reassessment of the hazard analysis. Any establishment that does 
not have a HACCP plan because a hazard analysis has revealed no food 
safety hazards that are reasonably likely to occur shall reassess the 
adequacy of the hazard analysis whenever a change occurs that could 
reasonably affect whether a food safety hazard exists. Such changes may 
include, but are not limited to, changes in: raw materials or source of 
raw materials; product formulation; slaughter or processing methods or 
systems; production volume; packaging; finished product distribution 
systems; or, the intended use or consumers of the finished product.



Sec. 417.5  Records.

    (a) The establishment shall maintain the following records 
documenting the establishment's HACCP plan:
    (1) The written hazard analysis prescribed in Sec. 417.2(a) of this 
part, including all supporting documentation;
    (2) The written HACCP plan, including decisionmaking documents 
associated with the selection and development of CCP's and critical 
limits, and documents supporting both the monitoring and verification 
procedures selected and the frequency of those procedures.
    (3) Records documenting the monitoring of CCP's and their critical 
limits, including the recording of actual times, temperatures, or other 
quantifiable values, as prescribed in the establishment's HACCP plan; 
the calibration of process-monitoring instruments; corrective actions, 
including all actions taken in response to a deviation; verification 
procedures and results; product code(s), product name or identity, or 
slaughter production lot. Each of these records shall include the date 
the record was made.
    (b) Each entry on a record maintained under the HACCP plan shall be 
made at the time the specific event occurs and include the date and time 
recorded, and shall be signed or initialed by the establishment employee 
making the entry.
    (c) Prior to shipping product, the establishment shall review the 
records associated with the production of that product, documented in 
accordance with this section, to ensure completeness, including the 
determination that all critical limits were met and, if appropriate, 
corrective actions were taken, including the proper disposition of 
product. Where practicable, this review shall be conducted, dated, and 
signed by an individual who did not produce the record(s), preferably by 
someone trained in accordance with Sec. 417.7 of this part, or the 
responsible establishment official.
    (d) Records maintained on computers. The use of records maintained 
on computers is acceptable, provided that appropriate controls are 
implemented to ensure the integrity of the electronic data and 
signatures.
    (e) Record retention. (1) Establishments shall retain all records 
required by paragraph (a)(3) of this section as follows: for slaughter 
activities for at least one year; for refrigerated product, for at least 
one year; for frozen, preserved, or shelf-stable products, for at least 
two years.
    (2) Off-site storage of records required by paragraph (a)(3) of this 
section is permitted after six months, if such records can be retrieved 
and provided, on-site, within 24 hours of an FSIS employee's request.
    (f) Official review. All records required by this part and all plans 
and procedures required by this part shall be available for official 
review and copying.



Sec. 417.6  Inadequate HACCP Systems.

    A HACCP system may be found to be inadequate if:
    (a) The HACCP plan in operation does not meet the requirements set 
forth in this part;
    (b) Establishment personnel are not performing tasks specified in 
the HACCP plan;
    (c) The establishment fails to take corrective actions, as required 
by Sec. 417.3 of this part;
    (d) HACCP records are not being maintained as required in Sec. 
417.5 of this part; or
    (e) Adulterated product is produced or shipped.

[[Page 636]]



Sec. 417.7  Training.

    (a) Only an individual who has met the requirements of paragraph (b) 
of this section, but who need not be an employee of the establishment, 
shall be permitted to perform the following functions:
    (1) Development of the HACCP plan, in accordance with Sec. 417.2(b) 
of this part, which could include adapting a generic model that is 
appropriate for the specific product; and
    (2) Reassessment and modification of the HACCP plan, in accordance 
with Sec. 417.3 of this part.
    (b) The individual performing the functions listed in paragraph (a) 
of this section shall have successfully completed a course of 
instruction in the application of the seven HACCP principles to meat or 
poultry product processing, including a segment on the development of a 
HACCP plan for a specific product and on record review.



Sec. 417.8  Agency verification.

    FSIS will verify the adequacy of the HACCP plan(s) by determining 
that each HACCP plan meets the requirements of this part and all other 
applicable regulations. Such verification may include:
    (a) Reviewing the HACCP plan;
    (b) Reviewing the CCP records;
    (c) Reviewing and determining the adequacy of corrective actions 
taken when a deviation occurs;
    (d) Reviewing the critical limits;
    (e) Reviewing other records pertaining to the HACCP plan or system;
    (f) Direct observation or measurement at a CCP;
    (g) Sample collection and analysis to determine the product meets 
all safety standards; and
    (h) On-site observations and record review.



PART 424_PREPARATION AND PROCESSING OPERATIONS--Table of Contents




                            Subpart A_General

Sec.
424.1 Purpose and scope.

           Subpart C_Food Ingredients and Sources of Radiation

424.21 Use of food ingredients and sources of radiation.
424.22 Certain other permitted uses.
424.23 Prohibited uses.

    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470, 601-695; 7 
CFR 2.18, 2.53.

    Source: 64 FR 72175, Dec. 23, 1999, unless otherwise noted.



                            Subpart A_General



Sec. 424.1  Purpose and scope.

    This part of the regulations prescribes rules for the preparation of 
meat and the processing of poultry products. The rules in this part 
further the purposes of the Federal Meat Inspection Act (FMIA) and the 
Poultry Products Inspection Act (PPIA) by, among other things, 
preventing the adulteration or misbranding of meat and poultry products 
at official establishments. 9 CFR Chapter III, Subchapter A, Parts 318 
and 319, Subpart C of this part, and 21 CFR Chapter I, Subchapter A or 
Subchapter B, specify rules for the use of certain food ingredients 
(e.g., food additives and color additives) and sources of radiation that 
may render meat or poultry products adulterated or misbranded.



           Subpart C_Food Ingredients and Sources of Radiation



Sec. 424.21  Use of food ingredients and sources of radiation.

    (a)(1) General. No meat or poultry product shall bear or contain any 
food ingredient that would render it adulterated or misbranded, or which 
is not approved in this part, part 318 or part 319 of this chapter, or 
by the Administrator in specific cases.
    (2)(i) Poultry products and poultry broth used in the processing of 
poultry products shall have been processed in the United States only in 
an official establishment or imported from a foreign country listed in 
Sec. 381.196(b), and have been inspected and passed in accordance with 
the regulations. Detached ova and offal shall not be used in the 
processing of any poultry products, except that poultry feet may be 
processed

[[Page 637]]

for use as human food in a manner approved by the Administrator in 
specific cases and detached ova may be used in the processing of poultry 
products if the processor demonstrates that such ova comply with the 
requirements of the Federal Food, Drug, and Cosmetic Act.
    (ii) Liquid, frozen, and dried egg products used in the processing 
of any poultry product shall have been prepared under inspection and be 
so marked in accordance with the Egg Products Inspection Act.
    (3)(i) Carcasses, parts thereof, and products of cattle, sheep, 
swine, goats, or equines may be used in the processing of poultry 
products only if they were prepared in the United States in an official 
meat packing establishment or imported from a foreign country listed in 
Sec. 327.2(b), were inspected and passed in accordance with the Federal 
Meat Inspection Act and the regulations under such Act (subchapter A of 
this chapter), and are so marked.
    (ii) Pork from carcasses or carcass parts used as an ingredient in 
poultry products that has been found free of trichinae, as described 
under Sec. 318.10 (a)(2), (e) and (f) of the Federal meat inspection 
regulations (9 CFR 318.10 (a)(2), (e) and (f)), is not required to be 
treated for the destruction of trichinae.
    (iii) Poultry products containing pork muscle tissue which the 
Administrator determines at the time the labeling for the product is 
submitted for approval in accordance with part 381 of the regulations in 
subchapter A or upon subsequent reevaluation of the product would be 
prepared in such a manner that the product might be eaten rare or 
without thorough cooking because of the appearance of the finished 
product or otherwise, shall be effectively heated, refrigerated, or 
cured to destroy any possible live trichinae, as prescribed in Sec. 
318.10(c) of this chapter, at the official establishment where such 
products are prepared. In lieu of such treatment of poultry products 
containing pork, the pork ingredient may be so treated.
    (b)(1) Food ingredients and sources of radiation. Food ingredients 
and sources of radiation listed or approved for use in the production of 
meat or poultry products in 21 CFR chapter I, subchapter A or subchapter 
B, shall be listed for such use under this chapter, subject to 
declaration requirements in parts 316 and 317, or subparts M and N, of 
part 381 of this chapter, unless precluded from such use or further 
restricted in parts 318 or 319, or subparts O and P, of part 381 of this 
chapter, or unless such use otherwise results in the adulteration or 
misbranding of meat or poultry products. Food ingredients and sources of 
radiation listed or approved for use in the production of meat or 
poultry products in 21 CFR Chapter I, subchapter A or subchapter B, may 
be listed or approved for such use under this chapter by the 
Administrator in Sec. 424.21, subject to declaration requirements in 
parts 316 and 317, or subparts M and N, of part 381 of this chapter.
    (2) No food ingredients or sources of radiation may be used in the 
preparation of any meat or poultry product, for any purpose, unless the 
use is listed or approved in 21 CFR chapter I as a direct food additive 
(21 CFR part 172), a secondary direct food additive (21 CFR part 173), 
indirect food additive (21 CFR parts 174-178), radiation source (21 CFR 
part 179), an interim-listed direct food additive (21 CFR part 180), a 
prior-sanctioned substance (21 CFR part 181), a Generally Recognized As 
Safe (GRAS) substance (21 CFR parts 182 or 184), or by a regulation in 
this chapter. Part 319 of this chapter also specifies other food 
ingredients that are acceptable in preparing specified products.
    (3) No food ingredient, the intended use of which is to impart color 
in any meat or poultry product, shall be used unless such use is 
approved in 21 CFR Chapter I as a color additive (21 CFR Parts 73, 74, 
81, and 82) or in a regulation in this chapter.
    (4) Petitions to amend 21 CFR chapter I to provide for uses of food 
additives, or other substances or sources of radiation necessary in the 
preparation of meat or poultry products, or food ingredients used to 
impart color to product, should be sent to the Food and Drug 
Administration, in accordance with the provisions of 21 CFR parts 71 or 
171, as appropriate.
    (5) Inquiries concerning the regulatory status under the Federal 
Food, Drug, and Cosmetic Act of any articles

[[Page 638]]

intended for use as components of, or in contact with, meat or poultry 
products, may be addressed to the Food and Drug Administration, Center 
for Food Safety and Applied Nutrition, 200 C Street, SW, Washington, DC 
20204, or the Department of Agriculture, Food Safety and Inspection 
Service, Office of Policy, Program Development and Evaluation, 
Washington, DC 20250-3700.
    (6) Inquiries concerning the use in specific meat or poultry 
products of substances that are not affirmed by the Food and Drug 
Administration as Generally Recognized as Safe (GRAS) or otherwise 
listed in 21 CFR Part 182 or Part 184, or of food or color additives 
listed in 21 CFR regulations for general use in foods or for use in 
meat, or poultry products, generally, including mixtures of such 
substances or additives, should be addressed to the Department of 
Agriculture, Food Safety and Inspection Service, Office of Policy, 
Program Development and Evaluation, Washington, DC 20250-3700.
    (c) The food ingredients specified in the following chart are 
approved for use in the preparation of meat products, provided they are 
used for the purposes indicated, within the limit of the amounts stated, 
and under other conditions specified in this part and Part 317 of this 
chapter. Part 319 of this chapter specifies other food ingredients that 
are acceptable in preparing specified meat products. This chart also 
contains food ingredients that are acceptable for use in poultry 
products, provided they are used for the purpose indicated, within the 
limits of the amounts stated and under other conditions specified in 
this part. No meat or poultry product shall bear or contain any food 
ingredient that would render it adulterated or misbranded, or which is 
not approved in this part, or by the Administrator in specific cases.

----------------------------------------------------------------------------------------------------------------
       Class of substance              Substance            Purpose            Products             Amount
----------------------------------------------------------------------------------------------------------------
Acidifiers......................  Acetic acid.......  To adjust acidity.  Various meat and    Sufficient for
                                                                           poultry products    purpose.\3\
                                                                           \2\.
                                  Citric acid.......  ......do..........  ......do..........   Do.
                                  Glucono delta-      ......do..........  ......do..........   Do.
                                   lactone.
                                  Lactic acid.......  ......do..........  ......do..........   Do.
                                  Phosphoric acid...  ......do..........  ......do..........   Do.
                                  Tartaric acid.....  ......do..........  ......do..........   Do.
Anti-coagulants.................  Citric acid.......  To prevent          Fresh blood of      0.2 percent with
                                                       clotting.           livestock.          or without water.
                                                                                               When water is
                                                                                               used to make a
                                                                                               solution of
                                                                                               citric acid added
                                                                                               to the blood of
                                                                                               livestock, not
                                                                                               more than 2 parts
                                                                                               of water to 1
                                                                                               part of citric
                                                                                               acid shall be
                                                                                               used.
                                  Sodium citrate....  ......do..........  ......do..........  Not to exceed 0.5
                                                                                               percent based on
                                                                                               the ingoing
                                                                                               weight of the
                                                                                               product. When
                                                                                               water is used to
                                                                                               make a solution
                                                                                               of sodium citrate
                                                                                               added to
                                                                                               livestock blood,
                                                                                               not more than 2
                                                                                               parts of water to
                                                                                               1 part of sodium
                                                                                               citrate shall be
                                                                                               used.
Antifoaming agent...............  Methyl              To retard foaming.  Soups (meat and     10 ppm.
                                   polysilicone.                           poultry).
                                                      ......do..........  Rendered fats        Do.
                                                                           (meat and
                                                                           poultry).
                                                      ......do..........  Curing pickle       50 ppm.
                                                                           (meat and
                                                                           poultry).
Antimicrobial Agents............  Potassium lactate.  To inhibit          Various meat and    4.8% by weight of
                                                       microbial growth.   poultry products,   total
                                                                           except infant       formulation.
                                                                           formulas and
                                                                           infant food.
                                  Sodium diacetate..  ......do..........  ......do..........  0.25% by weight of
                                                                                               total
                                                                                               formulation.
                                  Sodium lactate....  ......do..........  ......do..........  4.8% by weight of
                                                                                               total
                                                                                               formulation.

[[Page 639]]

 
                                  Trisodium           To reduce           Raw, chilled        8 to 12 percent;
                                   phosphate.          microbial levels.   poultry carcasses.  solution to be
                                                                                               maintained at 45
                                                                                               [deg]F. to 55
                                                                                               [deg]F. and
                                                                                               applied by
                                                                                               spraying or
                                                                                               dipping carcasses
                                                                                               for up to 15
                                                                                               seconds when used
                                                                                               in accordance
                                                                                               with 21 CFR
                                                                                               182.1778.
Antioxidants and oxygen           Ascorbyl palmitate  To retard           Margarine or        0.02 percent (by
 interceptors.                                         rancidity.          oleomargarine.      wt. of finished
                                                                                               product)
                                                                                               individually or
                                                                                               in combination
                                                                                               with other
                                                                                               antioxidants
                                                                                               approved for use
                                                                                               in margarine.
                                  Ascorbyl stearate.
                                  BHA (butylated
                                   hydroxyanisole).
                                  ......do..........  Dry sausage.......  0.003 based on      0.006 percent in
                                                                           total weight.       combination with
                                                                                               other anti-
                                                                                               oxidants for use
                                                                                               in meat.
                                  ......do..........  Rendered animal     0.01 percent......  0.02 percent in
                                                       fat or a                                combination with
                                                       combination of                          other anti-
                                                       such fat and                            oxidants for use
                                                       vegetable fat.                          in meat.
                                  ......do..........  Fresh pork,         0.01 percent based  0.02 percent in
                                                       sausage, brown      on fat content.     combination with
                                                       and serve                               other anti-
                                                       sausages, fresh                         oxidants for use
                                                       Italian sausage                         in meat, based on
                                                       products,                               fat content.
                                                       pregrilled beef
                                                       patties, fresh
                                                       sausage made from
                                                       beef or beef and
                                                       pork, cooked or
                                                       raw pizza topping
                                                       and cooked or raw
                                                       meatballs.
                                  ......do..........  Dried meats.......  0.01 percent based  0.01 percent in
                                                                           on total weight.    combination with
                                                                                               other anti-
                                                                                               oxidants for use
                                                                                               in meat.
                                  ......do..........  Margarine or        0.02 percent (by
                                                       oleomargarine.      wt. of the
                                                                           finished product)
                                                                           individually or
                                                                           in combination
                                                                           with other
                                                                           antioxidants
                                                                           approved for use
                                                                           in margarine..
                                  ......do..........  Various poultry     0.01 percent based
                                                       products.           on fat content
                                                                           (0.02 percent in
                                                                           combination with
                                                                           any other
                                                                           antioxidant for
                                                                           use in poultry)
                                                                           based on fat
                                                                           content..
                                  BHT (butylated      ......do..........  Dry sausage.......  0.003 percent
                                   hydroxytoluene).                                            based on total
                                                                                               weight 0.006
                                                                                               percent in
                                                                                               combination with
                                                                                               other anti-
                                                                                               oxidants for use
                                                                                               in meat.
                                  ......do..........  Rendered animal     0.01 percent......  0.02 percent in
                                                       fat or a                                combination with
                                                       combination of                          other anti-
                                                       such fat and                            oxidants for use
                                                       vegetable fat.                          in meat.

[[Page 640]]

 
                                  ......do..........  Fresh pork,         0.01 percent based  0.02 percent in
                                                       sausage, brown      on fat content.     combination with
                                                       and serve                               other anti-
                                                       sausages, fresh                         oxidants for use
                                                       Italian sausage                         in meat, based on
                                                       products,                               fat content.
                                                       pregrilled beef
                                                       patties, fresh
                                                       sausage made from
                                                       beef or beef and
                                                       pork, cooked or
                                                       raw pizza topping
                                                       and cooked or raw
                                                       meatballs.
                                  ......do..........  Dried meats.......  0.01 percent based  0.01 percent in
                                                                           on total weight.    combination with
                                                                                               other anti-
                                                                                               oxidants for use
                                                                                               in meat.
                                  ......do..........  Margarine or        0.02 percent (by
                                                       oleomargarine.      wt. of the
                                                                           finished product)
                                                                           individually or
                                                                           in combination
                                                                           with other
                                                                           antioxidants
                                                                           approved for use
                                                                           in margarine..
                                  ......do..........  Various poultry     0.01 percent based
                                                       products.           on fat content
                                                                           (0.02 percent in
                                                                           combination with
                                                                           any other
                                                                           antioxidant for
                                                                           use in poultry)
                                                                           based on fat
                                                                           content..
                                  Dodecyl gallate...  ......do..........  Margarine or        0.02 percent (by
                                                                           oleomargarine.      wt. of the
                                                                                               finished product)
                                                                                               individually or
                                                                                               in combination
                                                                                               with other
                                                                                               antioxidants
                                                                                               approved for use
                                                                                               in margarine.
                                  Glycine...........  ......do..........  Rendered animal     0.01 percent 0.02
                                                                           fat or a            percent in
                                                                           combination of      combination with
                                                                           such fat and        other anti-
                                                                           vegetable fat.      oxidants for use
                                                                                               in meat.
                                  Octyl gallate.....  ......do..........  Margarine or        0.02 percent (by
                                                                           oleomargarine.      wt. of the
                                                                                               finished product)
                                                                                               individually or
                                                                                               in combination
                                                                                               with other
                                                                                               antioxidants
                                                                                               approved for use
                                                                                               in margarine.
                                  Propyl gallate....  ......do..........  Dry sausage.......  0.003 percent
                                                                                               based on total
                                                                                               weight 0.006
                                                                                               percent in
                                                                                               combination with
                                                                                               other anti-
                                                                                               oxidants for use
                                                                                               in meat.
                                  ......do..........  Rendered animal     0.01 percent......  0.02 percent in
                                                       fat or a                                combination with
                                                       combination of                          other anti-
                                                       such fat and                            oxidants for use
                                                       vegetable fat.                          in meat.
                                  ......do..........  Fresh pork,         0.01 percent based  0.02 percent in
                                                       sausage, brown      on fat content.     combination with
                                                       and serve                               other anti-
                                                       sausages, fresh                         oxidants for use
                                                       Italian sausage                         in meat, based on
                                                       products,                               fat content.
                                                       pregrilled beef
                                                       patties, fresh
                                                       sausage made from
                                                       beef or beef and
                                                       pork, cooked or
                                                       raw pizza topping
                                                       and cooked or raw
                                                       meatballs.
                                  ......do..........  Dried meats.......  0.01 percent based  0.01 percent in
                                                                           on total weight.    combination with
                                                                                               other anti-
                                                                                               oxidants for use
                                                                                               in meat.

[[Page 641]]

 
                                  ......do..........  Margarine or oleo-  0.02 percent (by
                                                       margarine.          wt. of the
                                                                           finished product)
                                                                           individually or
                                                                           in combination
                                                                           with other
                                                                           antioxidants
                                                                           approved for use
                                                                           in margarine..
                                  ......do..........  Various poultry     0.01 percent based
                                                       products.           on fat content
                                                                           (0.02 percent in
                                                                           combination with
                                                                           any other
                                                                           antioxidant for
                                                                           use in poultry,
                                                                           except TBHQ,
                                                                           based on fat
                                                                           content)..
                                  Resin guaiac......  ......do..........  Rendered animal     0.02 percent in
                                                                           fat or a            combination with
                                                                           combination of      other
                                                                           such fat and        antioxidants for
                                                                           vegetable fat       use in meat.
                                                                           0.01 percent.
                                  TBHQ (tertiary      ......do..........  Dry sausage 0.003   0.006 percent in
                                   butylhydroquinone                       percent based on    combina-tion only
                                   ).                                      weight.             with BHA and/or
                                                                                               BHT.
                                  ......do..........  Rendered animal     0.01 percent......  0.02 percent in
                                                       fat or a                                combina-tion only
                                                       combination of                          with BHA or BHT.
                                                       such fat and
                                                       vegetable fat.
                                  ......do..........  Fresh pork,         0.01 percent based  0.02 percent in
                                                       sausage, brown      on fat content.     combin-ation only
                                                       and serve                               with BHA and/ or
                                                       sausages, fresh                         BHT, based on fat
                                                       Italian sausage                         content.
                                                       products,
                                                       pregrilled beef
                                                       patties, fresh
                                                       sausage made from
                                                       beef or beef and
                                                       pork, cooked or
                                                       raw pizza topping
                                                       and cooked or raw
                                                       meatballs.
                                  ......do..........  Dried meats.......  0.01 percent based  0.01 percent in
                                                                           on total weight.    combina-tion only
                                                                                               with BHA and/or
                                                                                               BHT.
                                                      ......do..........  Margarine or oleo-  0.02 percent alone
                                                                           margarine.          or in combination
                                                                                               only with BHA and/
                                                                                               or BHT, based on
                                                                                               oil or fat
                                                                                               content.
                                                      ......do..........  Various poultry     0.01 percent based
                                                                           products.           on fat content
                                                                                               (0.02 percent in
                                                                                               combination only
                                                                                               with BHA and/or
                                                                                               BHT, based on fat
                                                                                               content).
                                  Tocopherols.......  ......do..........  Rendered animal     0.03 percent. A 30
                                                                           fat or a            percent
                                                                           combination of      concentration of
                                                                           such fat and        tocopherols in
                                                                           vegetable fat.      vegetable oils
                                                                                               shall be used
                                                                                               when added as an
                                                                                               antioxidant to
                                                                                               products
                                                                                               designated as
                                                                                               ``lard'' or
                                                                                               ``rendered pork
                                                                                               fat.''
                                                      ......do..........  Dry sausage,        Not to exceed 0.03
                                                                           semidry sausage,    percent based on
                                                                           dried meats,        fat content. Not
                                                                           uncooked or         used in
                                                                           cooked fresh        combination with
                                                                           sausage made with   other
                                                                           beef and/or pork,   antioxidants.
                                                                           uncooked or
                                                                           cooked Italian
                                                                           sausage products,
                                                                           uncooked or
                                                                           cooked meatballs,
                                                                           uncooked or
                                                                           cooked meat pizza
                                                                           toppings, brown
                                                                           and serve
                                                                           sausages,
                                                                           pregrilled beef
                                                                           patties, and
                                                                           restructured
                                                                           meats.

[[Page 642]]

 
                                                      ......do..........  Various poultry     0.03 percent based
                                                                           products.           on fat content
                                                                                               (0.02 percent in
                                                                                               combination with
                                                                                               any other
                                                                                               antioxidant for
                                                                                               use in poultry,
                                                                                               except TBHQ,
                                                                                               based on fat
                                                                                               content).
Artificial Sweeteners...........  Saccharin.........  To sweeten product  Bacon.............  0.01 percent.
Binders and Extenders...........  Agar-agar.........  To stabilize and    Thermally           0.25 percent of
                                                       thicken.            processed canned    finished product.
                                                                           and jellied meat
                                                                           food products.
                                  Algin.............  To extend and       Breading mix;       Sufficient for
                                                       stabilize product.  sauces (meat        purpose in
                                                                           only) and various   accordance with
                                                                           poultry products.   21 CFR 172.5.
                                  A mixture of        To bind meat        Restructured meat   Sodium alginate
                                   sodium alginate,    pieces.             food products.      not to exceed 1.0
                                   calcium carbonate                                           percent; calcium
                                   and calcium                                                 carbonate not to
                                   lactate/lactic                                              exceed 0.2
                                   acid (or glucono                                            percent; and
                                   delta lactone).                                             lactic acid/
                                                                                               calcium lactate
                                                                                               (or glucono delta-
                                                                                               lactone) not to
                                                                                               exceed 0.3
                                                                                               percent of
                                                                                               product
                                                                                               formulation.
                                                                                               Added mixture may
                                                                                               not exceed 1.5
                                                                                               percent of
                                                                                               product at
                                                                                               formulation.
                                                                                               Mixture
                                                                                               ingredients must
                                                                                               be added dry.
                                  A mixture of        To bind poultry     Ground and formed   Sodium alginate
                                   sodium alginate,    pieces.             raw or cooked       not more than 0.8
                                   calcium                                 poultry pieces.     percent, calcium
                                   carbonate, lactic                                           carbonate not
                                   acid, and calcium                                           more than 0.15
                                   lactate.                                                    percent; lactic
                                                                                               acid and calcium
                                                                                               lactate, in
                                                                                               combination, not
                                                                                               more than 0.6
                                                                                               percent of
                                                                                               product
                                                                                               formulation.
                                                                                               Added mixture may
                                                                                               not exceed 1.55
                                                                                               percent of
                                                                                               product at
                                                                                               formulation. The
                                                                                               mixture must be
                                                                                               added in dry
                                                                                               form.
                                  Bread.............  To bind and extend  Bockwurst.........  3.5 percent
                                                       product.                                individually or
                                                                                               collectively with
                                                                                               other binders for
                                                                                               use in meat.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders for
                                                                                               use in meat.
                                                      ......do..........  Spaghetti with      12 percent
                                                                           meat balls and      individually or
                                                                           sauce, spaghetti    collectively with
                                                                           with meat and       other binders for
                                                                           sauce and similar   use in meat.
                                                                           products.
                                  Carboxymethyl       To extend and       Baked pies (meat    Sufficient for
                                   cellulose           stabilize product.  only) and various   purpose in
                                   (cellulose gum).                        poultry products.   accordance with
                                                                                               21 CFR 172.5.
                                  Carrageenan.......  To extend and       Breading mix;       Sufficient for
                                                       stabilize product.  sauces (meat        purpose in
                                                                           only) and various   accordance with
                                                                           poultry products.   21 CFR 172.5.
                                                      To prevent purging  Cured pork          Not to exceed 1.5
                                                       of brine solution.  products as         percent of
                                                                           provided in 9 CFR   product
                                                                           319.104(d).         formulation;
                                                                                               permitted in
                                                                                               combination only
                                                                                               with soy protein
                                                                                               concentrate,
                                                                                               combination not
                                                                                               to exceed 1.5
                                                                                               percent of
                                                                                               product
                                                                                               formulation; in
                                                                                               accordance with
                                                                                               21 CFR 172.620,
                                                                                               172.623, and
                                                                                               172.626.

[[Page 643]]

 
                                  Carrageenan,        ......do..........  ......do..........  In combination,
                                   Locust bean gum,                                            not to exceed 0.5
                                   and Xanthan gum                                             percent of
                                   blend.                                                      formulation; not
                                                                                               permitted in
                                                                                               combination with
                                                                                               other binders
                                                                                               approved for use
                                                                                               in cured pork
                                                                                               products; in
                                                                                               accordance with
                                                                                               21 CFR 172.620,
                                                                                               172.623, 172.626,
                                                                                               184.1343, and
                                                                                               172.695.
                                  Cereal............  To bind and extend  Sausages as         3.5 percent
                                                       product.            provided in 9 CFR   individually or
                                                                           Part 319,           collectively with
                                                                           bockwurst.          other binders for
                                                                                               use in meat.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders for
                                                                                               use in meat.
                                  Dried milk........  ......do..........  Sausages as         3.5 percent
                                                                           provided for in 9   individually or
                                                                           CFR Part 319.       collectively with
                                                                                               other binders for
                                                                                               use in meat
                                  Dried skim milk,    ......do..........  Sausages as          Do.
                                   calcium reduced.                        provided in 9 CFR
                                                                           9 CFR Part 319.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders for
                                                                                               use in meat.
                                  Enzyme (rennet)     ......do..........  Sausages as         3.5 percent total
                                   treated with                            provided for in 9   finished product
                                   calcium reduced                         CFR Part 319.       (calcium lactate
                                   dried skim milk                                             required at rate
                                   and calcium                                                 of 10 percent of
                                   lactate.                                                    binder.)
                                                      ......do..........  Imitation           Sufficient for
                                                                           sausages;           purpose in
                                                                           nonspecific         accordance with
                                                                           loaves; soups,      21 CFR 172.5
                                                                           stews (meat only)   (calcium lactate
                                                                           and various         required at a
                                                                           poultry products.   rate of 10
                                                                                               percent of
                                                                                               binder).
                                  Enzyme (rennet)     ......do..........  Imitation           Sufficient for
                                   treated with                            sausages;           purpose in
                                   sodium caseinate                        nonspecific         accordance with
                                   and calcium                             loaves; soups,      21 CFR 172.5
                                   lactate.                                stews (meat only)   (calcium lactate
                                                                           and various         required at a
                                                                           poultry products.   rate of 25
                                                                                               percent of
                                                                                               binder).
                                  Food starch         To prevent purging  Cured pork          Not to exceed 2
                                   modified.           of brine solution.  products as         percent of
                                                                           provided for in 9   product
                                                                           CFR 319.104(d).     formulation in
                                                                                               ``Ham Water
                                                                                               Added'' and ``Ham
                                                                                               with Natural
                                                                                               Juices''
                                                                                               products; not to
                                                                                               exceed 3.5
                                                                                               percent of
                                                                                               product
                                                                                               formulation in
                                                                                               ``Ham and Water
                                                                                               Product--X
                                                                                               percent of Weight
                                                                                               is Added
                                                                                               Ingredients''
                                                                                               products;
                                                                                               permitted in
                                                                                               combination only
                                                                                               with soy protein
                                                                                               concentrate, with
                                                                                               combination of
                                                                                               modified food
                                                                                               starch at 3
                                                                                               percent of
                                                                                               product
                                                                                               formulation and
                                                                                               soy protein
                                                                                               concentrate at
                                                                                               0.5 percent of
                                                                                               product
                                                                                               formulation; in
                                                                                               accordance with
                                                                                               21 CFR 172.892.
                                  Gelatin...........  To bind and extend  Various poultry     Sufficient for
                                                       product.            products.           purpose in
                                                                                               accordance with
                                                                                               21 CFR 172.5.
                                  Gums, vegetable...  ......do..........  Egg roll (meat      Sufficient for
                                                                           only) and various   purpose in
                                                                           poultry products.   accordance with
                                                                                               21 CFR 172.5.
                                  Isolated soy        ......do..........  Sausage as          2 percent.
                                   protein.                                provided for in 9
                                                                           CFR Part 319,
                                                                           bockwurst.

[[Page 644]]

 
                                                      ......do..........  Imitation           Sufficient for
                                                                           sausages;           purpose in
                                                                           nonspecific         accordance with
                                                                           loaves; soups;      21 CFR 172.5.
                                                                           stews (meat only)
                                                                           and various
                                                                           poultry products.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders for
                                                                                               use in meat.
                                                      ......do..........  Spaghetti with      12 percent
                                                                           meatballs and       individually or
                                                                           sauce, spaghetti    collectively with
                                                                           with meat and       other binders and
                                                                           sauce and similar   extenders for use
                                                                           products.           in meat.
                                                      To prevent purging  Cured pork          Not to exceed 2
                                                       of brine solution.  products as         percent of
                                                                           provided for in 9   product
                                                                           CFR 319.104(d).     formulation, not
                                                                                               permitted in
                                                                                               combination with
                                                                                               other binders
                                                                                               approved for use
                                                                                               in cured pork
                                                                                               products.
                                  Methyl cellulose..  To extend and       Meat and vegetable  0.15 percent.
                                                       stabilize product   patties; various
                                                       (also carrier).     poultry products.
                                  Sodium caseinate..  To bind and extend  Imitation           Sufficient for
                                                       product.            sausages,           purpose in
                                                                           nonspecific         accordance with
                                                                           loaves, soups,      21 CFR 182.1748
                                                                           stews (meat only).  and 21 CFR 172.5.
                                                      ......do..........  Sausages as         2 percent in
                                                                           provided for in 9   accordance with
                                                                           CFR Part 319.       21 CFR 182.1748.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders and
                                                                                               extenders for use
                                                                                               in meat in
                                                                                               accordance with
                                                                                               21 CFR 182.1748.
                                                      ......do..........  Spaghetti with      12 percent
                                                                           meatballs and       individually or
                                                                           sauce, spaghetti    collectively with
                                                                           with meat and       other binders and
                                                                           sauce and similar   extenders for use
                                                                           products.           in meat in
                                                                                               accordance with
                                                                                               21 CFR 182.1748.
                                                      To prevent purging  Cured pork          Not to exceed 2
                                                       of brine solution.  products as         percent of
                                                                           provided for in 9   product
                                                                           CFR 319.104(d).     formulation; not
                                                                                               permitted in
                                                                                               combination with
                                                                                               other binders
                                                                                               approved for use
                                                                                               in cured pork
                                                                                               products, in
                                                                                               accordance with
                                                                                               21 CFR 182.1748.
                                                      To bind and extend  Various poultry     3 percent in
                                                       product.            products.           cooked product, 2
                                                                                               percent in raw
                                                                                               product, in
                                                                                               accordance with
                                                                                               21 CFR 172.5 and
                                                                                               182.1748.
                                  Soy flour.........  ......do..........  Sausages as         3.5 percent
                                                                           provided for in 9   individually or
                                                                           CFR Part 319,       collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                                      ......do..........  Spaghetti with      12 percent
                                                                           meatballs and       individually or
                                                                           sauce, spaghetti    collectively with
                                                                           with meat and       other binders and
                                                                           sauce and similar   extenders for use
                                                                           products.           in meat.
                                  Soy protein         ......do..........  Sausage as          3.5 percent
                                   concentrate.                            provided for in 9   individually or
                                                                           CFR Part 319,       collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                                      ......do..........  Spaghetti with      12 percent
                                                                           meatballs and       individually or
                                                                           sauce, spaghetti    collectively with
                                                                           with meat and       other binders and
                                                                           sauce and similar   extenders for use
                                                                           products.           in meat.

[[Page 645]]

 
                                                      To prevent purging  Cured pork          Not to exceed 3.5
                                                       of brine solution.  products as         percent of
                                                                           provided for in 9   product
                                                                           CFR 319.104(d).     formulation;
                                                                                               permitted in
                                                                                               combination only
                                                                                               with modified
                                                                                               food starch, with
                                                                                               combination of
                                                                                               modified food
                                                                                               starch at 3
                                                                                               percent of
                                                                                               product
                                                                                               formulation and
                                                                                               soy protein
                                                                                               concentrate at
                                                                                               0.5 percent of
                                                                                               product
                                                                                               formulation; in
                                                                                               combination only
                                                                                               with carrageenan,
                                                                                               combination not
                                                                                               to exceed 1.5
                                                                                               percent of
                                                                                               product
                                                                                               formulation.
                                  Starchy vegetable   To bind and extend  Sausage as          3.5 percent
                                   flour.              product.            provided for in 9   individually or
                                                                           CFR Part 319,       collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                  Tapioca dextrin...  ......do..........  Sausage as          3.5 percent
                                                                           provided for in 9   individually or
                                                                           CFR Part 319,       collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat, in
                                                                                               accordance with
                                                                                               21 CFR 184.1277.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders and
                                                                                               extenders for use
                                                                                               in meat, in
                                                                                               accordance with
                                                                                               21 CFR 184.1277.
                                                      ......do..........  Spaghetti with      12 individually or
                                                                           meatballs and       collectively with
                                                                           sauce, spaghetti    other binders and
                                                                           with meat and       extenders for use
                                                                           sauce and similar   in meat, in
                                                                           products.           accordance with
                                                                                               21 CFR 184.1277.
                                                      ......do..........  Various poultry     Sufficient for
                                                                           products.           purpose in
                                                                                               accordance with
                                                                                               21 CFR 184.1277.
                                  Vegetable starch..  ......do..........  Sausage as          3.5 percent
                                                                           provided for in 9   individually or
                                                                           CFR Part 319,       collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                  Wheat gluten......  To bind and extend  Sausage as          3.5 percent
                                                       product.            provided for in 9   individually or
                                                                           CFR Part 319,       collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat, in
                                                                                               accordance with
                                                                                               21 CFR 184.1322.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans.         collectively with
                                                                                               other binders for
                                                                                               use in meat, in
                                                                                               accordance with
                                                                                               21 CFR 184.1322.
                                                      ......do..........  Spaghetti with      12 percent
                                                                           meatballs and       individually or
                                                                           sauce, spaghetti    collectively with
                                                                           with meat and       other binders and
                                                                           sauce and similar   extenders for use
                                                                           products.           in meat, in
                                                                                               accordance with
                                                                                               21 CFR 184.1322.
                                                      ......do..........  Various poultry     Sufficient for
                                                                           products.           purpose in
                                                                                               accordance with
                                                                                               21 CFR 184.1322.

[[Page 646]]

 
                                  Whey, Dry or dried  To bind or thicken  Sausage as          3.5 percent
                                                                           provided for in 9   individually or
                                                                           CFR Part 319,       collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                                      ......do..........  Imitation           8 percent
                                                                           sausages,           individually or
                                                                           nonspecific         collectively with
                                                                           loaves, soups,      other binders and
                                                                           stews (meat only).  extenders for use
                                                                                               in meat.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans, pork    collectively with
                                                                           or beef with        other binders and
                                                                           barbecue sauce.     extenders for use
                                                                                               in meat.
                                                      ......do..........  Various poultry     Sufficient for
                                                                           products.           purpose in
                                                                                               accordance with
                                                                                               21 CFR 184.1322.
                                  Whey, Reduced       To bind or thicken  Sausage as          3.5 percent
                                   lactose.                                provided for in 9   individually or
                                                                           CFR Part 319,       collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                                      ......do..........  Imitation           Sufficient for
                                                                           sausages,           purpose in
                                                                           nonspecific         accordance with
                                                                           loaves, soups,      21 CFR 172.5.
                                                                           stews (meat only).
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans, pork    collectively with
                                                                           or beef with        other binders and
                                                                           barbecue sauce.     extenders for use
                                                                                               in meat.
                                  Whey, Reduced       ......do..........  Sausage as          3.5 percent
                                   minerals.                               provided for in 9   individually or
                                                                           CFR Part 319,       collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat.
                                                      ......do..........  Imitation           Sufficient for
                                                                           sausages,           purpose in
                                                                           nonspecific         accordance with
                                                                           loaves, soups,      21 CFR 172.5.
                                                                           stews (meat only).
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans, pork    collectively with
                                                                           or beef with        other binders and
                                                                           barbecue sauce.     extenders for use
                                                                                               in meat.
                                  Whey protein        ......do..........  Sausage as          3.5 percent
                                   concentrate.                            provided in 9 CFR   individually or
                                                                           Part 319,           collectively with
                                                                           bockwurst.          other binders and
                                                                                               extenders for use
                                                                                               in meat, in
                                                                                               accordance with
                                                                                               21 CFR 184.1979c.
                                                      ......do..........  Imitation           Sufficient for
                                                                           sausages,           purpose in
                                                                           nonspecific         accordance with
                                                                           loaves, soups,      21 CFR 184.1979c.
                                                                           stews.
                                                      ......do..........  Chili con carne,    8 percent
                                                                           chili con carne     individually or
                                                                           with beans, pork    collectively with
                                                                           or beef with        other binders and
                                                                           barbecue sauce.     extenders for use
                                                                                               in meat, in
                                                                                               accordance with
                                                                                               21 CFR 184.1979c
                                                      To bind meat        Restructured meat   3.5 percent
                                                       pieces.             food products,      individually or
                                                                           whole muscle meat   collectively with
                                                                           cuts.               other binders and
                                                                                               extenders for use
                                                                                               in meat, in
                                                                                               accordance with
                                                                                               21 CFR 184.1979c.
                                  Xanthan gum.......  To maintain:        Meat sauces,        Sufficient for
                                                       uniform             gravies or sauces   purpose in
                                                       viscosity;          and meats, canned   accordance with
                                                       suspension of       or frozen and/or    21 CFR 172.5.
                                                       particulate         refrigerated meat
                                                       matter, emulsion    salads, canned or
                                                       stability; freeze-  frozen meat
                                                       thaw stability.     stews, canned
                                                                           chili or chili
                                                                           with beans, pizza
                                                                           topping mixes and
                                                                           batter or
                                                                           breading mixes.
                                                      ......do..........  Various poultry     Sufficient for
                                                                           products, except    purpose
                                                                           uncooked products
                                                                           or sausages or
                                                                           other products
                                                                           with a moisture
                                                                           limitation
                                                                           established by
                                                                           Subpart P of Part
                                                                           381.

[[Page 647]]

 
Bleaching Agent.................  Hydrogen peroxide.  To remove color...  Tripe (substance    Sufficient for
                                                                           must be removed     purpose.
                                                                           from product by
                                                                           rinsing with
                                                                           clear water).
Catalysts (substances must be     Nickel............  To accelerate       Rendered animal      Do.
 eliminated during process).                           chemical reaction.  fats or a
                                                                           combination of
                                                                           such fats and
                                                                           vegetable fats.
                                  Sodium amide......  Rearrangement of    ......do..........   Do.
                                                       fatty acid
                                                       radicals.
                                  Sodium methoxide..  ......do..........  ......do..........  ..................
Chilling Media..................  Salt (NaCl).......  To aid in chilling  Raw poultry         700 lbs. to 10,000
                                                                           products.           gallons of water.
Coloring Agents (artificial)....  Coal tar dyes       To color products.  Various poultry     Sufficient for
                                   (FD&C certified).                       products.           purpose.
                                  Color additives     To color casings    Sausage casings,    Sufficient for
                                   listed in 21 CFR    or rendered fats;   oleomargarine,      purpose (may be
                                   Part 74, Subpart    marking and         shortening,         mixed with
                                   A of Part 82,       branding product.   marking or          approved natural
                                   Subpart B                               branding ink on     coloring matters
                                   (operator must                          product (meat       or harmless inert
                                   furnish evidence                        only).              material such as
                                   to inspector in                                             common salt and
                                   charge that color                                           sugar).
                                   additive has been
                                   certified for use
                                   in connection
                                   with foods by the
                                   Food and Drug
                                   Administration).
                                  Titanium oxide....  To whiten.........  Canned ham salad    0.5 percent.
                                                                           spread and
                                                                           creamed-type
                                                                           canned meat
                                                                           products. Poultry
                                                                           salads and
                                                                           poultry spreads.
Coloring Agents (natural).......  Alkanet, annatto,   To color casings    Sausage casings,    Sufficient for
                                   carotene,           or rendered fats;   oleomargarine,      purpose (may be
                                   cochineal, green    marking and         shortening,         mixed with
                                   chlorophyll,        branding product.   marking or          approved
                                   saffron and                             branding ink on     artificial dyes
                                   tumeric.                                product (meat       or harmless inert
                                                                           only).              material such as
                                                                                               common salt and
                                                                                               sugar).
                                  Annatto, carotene.  To color products.  Various poultry     Sufficient for
                                                                           products.           purpose.
Curing accelerators (must be      Ascorbic acid.....  To accelerate       Cured pork and      75 oz to 100 gal
 used only in combination with                         color fixing or     beef cuts, cured    pickle at 10
 curing agents).                                       preserve color      poultry, cured      percent pump
                                                       during storage.     comminuted          level; \3/4\ oz
                                                                           poultry and meat    to 100 lb meat,
                                                                           food products.      meat byproduct or
                                                                                               poultry product;
                                                                                               10 percent
                                                                                               solution to
                                                                                               surfaces of cured
                                                                                               meat cuts or
                                                                                               poultry products
                                                                                               prior to
                                                                                               packaging. (The
                                                                                               use of such
                                                                                               solution shall
                                                                                               not result in the
                                                                                               addition of a
                                                                                               significant
                                                                                               amount of
                                                                                               moisture to the
                                                                                               product).
                                  Citric acid or      To accelerate       Cured pork and      May be used in
                                   sodium citrate.     color fixing or     beef cuts, cured    cured meat
                                                       preserve color      comminuted meat     products or in 10
                                                       during storage.     food product,       percent solution
                                                                           cured comminuted    used to spray
                                                                           poultry or          surfaces of cured
                                                                           poultry products.   meat cuts prior
                                                                                               to packaging to
                                                                                               replace up to 50
                                                                                               percent of the
                                                                                               ascorbic acid,
                                                                                               erythorbic acid,
                                                                                               sodium ascorbate,
                                                                                               or sodium
                                                                                               erythorbate that
                                                                                               is used. May be
                                                                                               used in cured
                                                                                               poultry products
                                                                                               to replace 50
                                                                                               percent of the
                                                                                               ascorbic acid or
                                                                                               sodium ascorbate
                                                                                               that is used.

[[Page 648]]

 
                                  Erythorbic acid...  To accelerate       Cured pork and      75 oz to 100 gal
                                                       color fixing or     beef cuts, cured    pickle at 10
                                                       preserve color      poultry, cured      percent pump
                                                       during storage.     comminuted          level; 3/4 oz to
                                                                           poultry and meat    100 lb meat, meat
                                                                           food products.      byproduct or
                                                                                               poultry product;
                                                                                               10 percent
                                                                                               solution to
                                                                                               surfaces of cured
                                                                                               meat cuts or
                                                                                               poultry products
                                                                                               prior to
                                                                                               packaging. (The
                                                                                               use of such
                                                                                               solution shall
                                                                                               not result in the
                                                                                               addition of a
                                                                                               significant
                                                                                               amount of
                                                                                               moisture to the
                                                                                               product).
                                  Fumaric acid......  ......do..........  Cured, comminuted   0.065 percent (or
                                                                           meat, poultry or    1 oz to 100 lb)
                                                                           meat and poultry    of the weight of
                                                                           products.           the meat, poultry
                                                                                               or the meat or
                                                                                               poultry
                                                                                               byproducts before
                                                                                               processing.
                                  Glucono delta       ......do..........  Cured, comminuted   8 oz to each 100
                                   lactone.                                meat or meat food   lb of meat or
                                                                           product.            meat byproduct.
                                                      ......do..........  Genoa salami......  16 oz to 100 lb of
                                                                                               meat (1.0
                                                                                               percent).
                                  Sodium acid         ......do..........  Frankfurters,       Not to exceed
                                   pyrophosphate.                          wieners, vienna,    alone or in
                                                                           bologna, garlic     combination with
                                                                           bologna,            other curing
                                                                           knockwurst and      accelerators for
                                                                           similar products.   use in meat the
                                                                                               following: 8 oz
                                                                                               in 100 lb of
                                                                                               meat, or meat and
                                                                                               meat byproducts,
                                                                                               content of the
                                                                                               formula; nor 0.5
                                                                                               percent in the
                                                                                               finished product.
                                  Sodium ascorbate..  To accelerate       Cured pork and      87.5 oz to 100 gal
                                                       color fixing or     beef cuts, cured    pickle at 10
                                                       preserve color      comminuted meat     percent pump
                                                       during storage.     food product,       level; \7/8\ oz
                                                                           cured comminuted    to 100 lb meat,
                                                                           poultry or          meat byproduct or
                                                                           poultry products.   poultry product;
                                                                                               10 percent
                                                                                               solution to
                                                                                               surfaces of cured
                                                                                               meat cuts or
                                                                                               poultry products
                                                                                               prior to
                                                                                               packaging. (The
                                                                                               use of such
                                                                                               solution shall
                                                                                               not result in the
                                                                                               addition of a
                                                                                               significant
                                                                                               amount of
                                                                                               moisture to the
                                                                                               product).
                                  Sodium erythorbate  To accelerate       Cured pork and      87.5 oz to 100 gal
                                                       color fixing or     beef cuts, cured    pickle at 10
                                                       preserve color      comminuted meat     percent pump
                                                       during storage.     food products,      level; \7/8\ oz
                                                                           cured comminuted    to 100 lb meat,
                                                                           poultry or          meat byproduct or
                                                                           poultry products.   poultry product;
                                                                                               10 percent
                                                                                               solution to
                                                                                               surfaces of cured
                                                                                               meat cuts or
                                                                                               poultry products
                                                                                               prior to
                                                                                               packaging. (The
                                                                                               use of such
                                                                                               solution shall
                                                                                               not result in the
                                                                                               addition of a
                                                                                               significant
                                                                                               amount of
                                                                                               moisture to the
                                                                                               product.)
Curing Agents...................  Sodium or           Source of nitrite.  Cured meat          7 lb to 100 gal
                                   potassium nitrate.                      products other      pickle; 3\1/2\ oz
                                                                           than bacon.         to 100 lb meat or
                                                                           Nitrates may not    poultry product
                                                                           be used in baby,    (dry cure); 2\3/
                                                                           junior, and         4\ oz to 100 lb
                                                                           toddler foods.      chopped meat or
                                                                           Cured, comminuted   poultry.
                                                                           poultry or
                                                                           poultry products.

[[Page 649]]

 
                                  Sodium or           To fix color......  Cured meat and      2 lb to 100 gal
                                   potassium nitrite                       poultry products.   pickle at 10
                                   (supplies of                            Nitrites may not    percent pump
                                   sodium nitrite                          be used in baby,    level; 1 oz to
                                   and potassium                           junior, or          100 lb meat or
                                   nitrite and                             toddler foods.      poultry product
                                   mixtures                                                    (dry cure); \1/4\
                                   containing them                                             oz to 100 lb
                                   must be kept                                                chopped meat,
                                   under the care of                                           meat byproduct or
                                   a responsible                                               poultry product.
                                   employee of the                                             The use of
                                   establishment.                                              nitrites,
                                   The specific                                                nitrates or
                                   nitrite content                                             combination shall
                                   of such supplies                                            not result in
                                   must be known and                                           more than 200 ppm
                                   clearly marked                                              of nitrite,
                                   accordingly).                                               calculated as
                                                                                               sodium nitrite in
                                                                                               finished product,
                                                                                               except that
                                                                                               nitrites may be
                                                                                               used in bacon
                                                                                               only in
                                                                                               accordance with
                                                                                               paragraph (b) of
                                                                                               this section.
Denuding Agents (may be used in   Lime (calcium       To denude mucous    Tripe.............  Sufficient for
 combination. Must be removed      oxide, calcium      membranes.                              purpose.
 from tripe by rinsing with        hydroxide).
 potable water.).
                                  Sodium carbonate..  ......do..........  ......do..........   Do.
                                  Sodium citrate....  ......do..........  ......do..........   Do.
                                  Sodium gluconate..  ......do..........  ......do..........   Do.
                                  Sodium hydroxide..  ......do..........  ......do..........   Do.
                                  Sodium persulfate.  ......do..........  ......do..........   Do.
                                  Sodium silicates    ......do..........  ......do..........   Do.
                                   (ortho, meta, and
                                   sesqui).
                                  Trisodium           ......do..........  ......do..........   Do.
                                   phosphate.
Emulsifying Agents..............  Actylated           To emulsify         Shortening and      Sufficient for
                                   monoglycerides.     product.            various poultry     purpose.
                                                                           products.
                                  Diacetyl tartaric   ......do..........  ......do..........   Do.
                                   acid esters of
                                   mono-and
                                   diglycerides.
                                  Glycerol-lacto      ......do..........  ......do..........   Do.
                                   stearate, oleate,
                                   or palmitate.
                                  Lecithin..........  To emulsify         Oleomargarine,      0.5 percent in
                                                       product (also as    shortening,         oleomargarine,
                                                       an antioxidant).    various meat and    use in other
                                                                           poultry products.   products--suffici
                                                                                               ent amount for
                                                                                               emulsification.
                                  Mono and            To emulsify         Rendered animal     Sufficient for
                                   diglycerides        product.            fat or a            purpose in lard
                                   (glycerol                               combination of      and shortening;
                                   palmitate, etc.).                       such fat with       0.5 percent in
                                                                           vegetable fat;      oleomargarine.
                                                                           oleomargarine.
                                                      ......do..........  Various poultry     Sufficient for
                                                                           products.           purpose.
                                  Mono and            ......do..........  Margarine or        0.5 percent.
                                   diglycerides of                         oleomargarine.
                                   fatty acids
                                   esterified with
                                   any of the
                                   following acids:
                                   acetic,
                                   acetyltartaric,
                                   citric, lactic,
                                   tartaric, and
                                   their sodium and
                                   calcium salts;
                                   the sodium
                                   sulfoacetate
                                   derivatives of
                                   these mono and
                                   diglycerides.

[[Page 650]]

 
                                  Polyglycerol        ......do..........  Rendered animal     Sufficient for
                                   esters of fatty                         fat or a            purpose for
                                   acids                                   combination of      rendered animal
                                   (polyglycerol                           such fat with       fat or
                                   esters of fatty                         vegetable fat       combination with
                                   acids are                               when use is not     vegetable fat;
                                   restricted to                           precluded by        0.5 percent for
                                   those up to and                         standards of        oleomargarine.
                                   including the                           identity of
                                   decaglycerol                            composition;
                                   esters and                              oleomargarine.
                                   otherwise meeting
                                   the requirements
                                   of Sec.
                                   172.854(a) of the
                                   Food Additive
                                   Regulations).
                                  Polysorbate 60      ......do..........  Shortening for use  1 percent when
                                   (polyoxyethylene                        in                  used alone. If
                                   (20) sorbitan                           nonstandardized     used with
                                   monostearate).                          baked goods,        polysorbate 80
                                                                           baking mixes,       the combined
                                                                           icings, fillings,   total shall not
                                                                           and toppings and    exceed 1 percent.
                                                                           in the frying of
                                                                           foods (meat
                                                                           only). Rendered
                                                                           poultry fat or a
                                                                           combination of
                                                                           such fat with
                                                                           vegetable fat.
                                  Polysorbate 80      ......do..........  Shortening for use  1 percent when
                                   (polyoxyethylene                        in                  used alone. If
                                   (20) sorbitan                           nonstandardized     used with
                                   monooleate).                            baked goods,        polysorbate 60
                                                                           baking mixes,       the combined
                                                                           icings, fillings,   total shall not
                                                                           and toppings and    exceed 1 percent.
                                                                           in the frying of
                                                                           foods (meat
                                                                           only). Various
                                                                           poultry products.
                                  1,2-propylene       ......do..........  Margarine or        2.0 percent.
                                   glycol esters of                        oleomargarine.
                                   fatty acids.
                                  Propylene glycol    ......do..........  Rendered animal or  Sufficient for
                                   mono and diesters                       poultry fat or a    purpose.
                                   of fats and fatty                       combination of
                                   acids.                                  such fat with
                                                                           vegetable fat.
                                  Stearyl-2-lactylic  ......do..........  Shortening to be    3.0 percent.
                                   acid.                                   used for cake
                                                                           icings and
                                                                           fillings (meat
                                                                           only).
                                  Stearyl             ......do..........  Shortening........  Sufficient for
                                   monoglyceridyl                                              purpose
                                   citrate.
Film Forming Agents.............  A mixture           To reduce cooler    Freshly dressed     Formulation may
                                   consisting of       shrinkage and       meat carcasses.     not exceed 1.5
                                   water, sodium       help protect        Such carcasses      percent of hot
                                   alginate, calcium   surface.            must bear a         carcass weight
                                   chloride, sodium                        statement           when applied.
                                   carboxymethyl-                          ``Protected with    Chilled weight
                                   cellulose, and                          a film of water,    may not exceed
                                   corn syrup solids.                      corn syrup          hot weight.
                                                                           solids, sodium
                                                                           alginate, calcium
                                                                           chloride and
                                                                           sodium
                                                                           carboxymethyl-
                                                                           cellulose.''.
Flavoring Agents; Protectors and  Artificial smoke    To flavor product.  Various (meat and   Sufficient for
 Developers.                       flavoring.                              poultry) \2\.       purpose.
                                  Autolyzed yeast     ......do..........  ......do..........   Do.
                                   extract.
                                  Benzoic acid        To retard flavor    Margarine or        0.1 percent
                                   (sodium,            reversion.          oleomargarine.      individually, or
                                   potassium and                                               if used in
                                   calcium salts).                                             combination with
                                                                                               other flavoring
                                                                                               agents for use in
                                                                                               meat or with
                                                                                               sorbic acid and
                                                                                               its salts, 0.2
                                                                                               percent
                                                                                               (expressed as the
                                                                                               acids in the wt.
                                                                                               of the finished
                                                                                               foods).
                                  Calcium lactate...  To protect flavor.  Cooked semi-dry     0.6 percent in
                                                                           and dry products    product
                                                                           including           formulation.
                                                                           sausage,
                                                                           imitation
                                                                           sausage, and
                                                                           nonspecific meat
                                                                           food sticks.
                                  Citric acid.......  ......do..........  Various poultry     Sufficient for
                                                                           products.           purpose.
                                                      Flavoring.........  Chili con carne...   Do.

[[Page 651]]

 
                                  Corn syrup solids;  To flavor product.  Various poultry      Do.
                                   corn syrup;                             products,
                                   glucose syrup.                          sausage,
                                                                           hamburger, meat
                                                                           loaf, luncheon
                                                                           meat, chopped or
                                                                           pressed ham.
                                  Dextrose..........  ......do..........  Sausage, ham and     Do.
                                                                           cured products.
                                  Diacetyl..........  ......do..........  Oleomargarine.....   Do.
                                  Disodium guanylate  ......do..........  Various meat and
                                                                           poultry
                                                                           products.\2\
                                  Disodium inosinate  ......do..........  ......do..........   Do.
                                  Harmless bacteria   To develop flavor.  Dry sausage, pork   0.5 percent.
                                   starters of the                         roll, thuringer,
                                   acidophilus type,                       lebanon bologna,
                                   lactic acid                             cervelat, and
                                   starter or                              salami.
                                   culture of
                                   Pediococcus
                                   cerevisiae.
                                  Harmless lactic     To prevent the      Bacon.............  Sufficient for
                                   acid producing      growth of                               purpose.
                                   bacteria.           Clostridium
                                                       botulinum.
                                  Hydrolyzed plant    To flavor product.  Various meat and     Do.
                                   protein.                                poultry
                                                                           products.\2\
                                  Isopropyl citrate.  To protect flavor.  Oleomargarine.....  0.02 percent.
                                  Malt syrup........  To flavor product.  Cured meat          2.5 percent.
                                                                           products.
                                                      ......do..........  Various poultry     Sufficient for
                                                                           products.           purpose.
                                  Milk protein        ......do..........  Various meat and     Do.
                                   hydrolysate.                            poultry
                                                                           products.\2\
                                  Monoammonium        ......do..........  ......do..........   Do.
                                   glutamate.
                                  Monosodium          ......do..........  ......do..........   Do.
                                   glutamate.
                                  Potassium lactate.  ......do..........  Various meat and    Not to exceed 2
                                                                           meat food           percent of
                                                                           products, poultry   formulation; in
                                                                           and poultry food    accordance with
                                                                           products, except    21 CFR 184.1639.
                                                                           infant formula
                                                                           and infant
                                                                           food.\2\
                                  Smoke flavoring...  To flavor product.  Various meat and    Sufficient for
                                                                           poultry products.   purpose.
                                  Sodium acetate....  To flavor products  Various meat and    Not to exceed
                                                                           poultry products.   0.25% of
                                                                                               formulate in
                                                                                               accordance with
                                                                                               21 CFR 184.1721.
                                  Sodium diacetate..  ......do..........  ......do..........  Not to exceed
                                                                                               0.25% of
                                                                                               formulate in
                                                                                               accordance with
                                                                                               21 CFR 184.1754.
                                  Sodium lactate....  ......do..........  Various meat and    Not to exceed 2
                                                                           meat food           percent of
                                                                           products, poultry   formulation in
                                                                           and poultry food    accordance with
                                                                           products, except    21 CFR 184.1768.
                                                                           infant formula
                                                                           and infant
                                                                           food.\2\
                                  Sodium              ......do..........  Various meat and    0.5 percent.
                                   sulfoacetate                            poultry
                                   derivative of                           products.\2\
                                   mono and
                                   diglycerids.
                                  Sodium              To help protect     ``Fresh Beef,''     0.5 percent of
                                   tripolyphosphate.   flavor.             \2\ ``Beef for      total product.
                                                                           further cooking,
                                                                           ``Cooked Beef,''
                                                                           Beef Patties,
                                                                           Meat Loaves, Meat
                                                                           Toppings, and
                                                                           similar products
                                                                           derived from
                                                                           pork, lamb, veal,
                                                                           mutton, and goat
                                                                           meat which are
                                                                           cooked or frozen
                                                                           after processing.
                                  Sodium              ......do..........  ......do..........   Do.
                                   tripolyphosphate
                                   and sodium
                                   mixtures,
                                   metaphosphate,
                                   insoluble; and
                                   sodium
                                   polyphosphates,
                                   glassy.

[[Page 652]]

 
                                  Sorbitol..........  To flavor, to       Cooked sausage      Not to exceed 2
                                                       facilitate the      labeled             percent of the
                                                       removal of          frankfurter,        weight of the
                                                       casings from        frank, furter,      formula excluding
                                                       product, and to     wiener, and         the formula
                                                       reduce              knockwurst; cured   weight of water
                                                       caramelization      pork and pork       or ice, when used
                                                       and charring.       products, as        in accordance
                                                                           provided for in 9   with 21 CFR
                                                                           CFR Part 319.       184.1835.
                                  Starter distillate  To help protect     Oleomargarine.....  Sufficient for
                                                       flavor.                                 purpose.
                                  Stearyl citrate...  ......do..........  ......do..........  0.15 percent.
                                  Sugars (sucrose     To flavor product.  Various meat and    Sufficient for
                                   and dextrose).                          poultry products.   purpose.
Gases...........................  Carbon dioxide      Contact freezing..  Various poultry      Do.
                                   liquid.                                 products.
                                  Carbon dioxide      To cool product...  Chopping of meat,   Sufficient for
                                   solid (dry ice).                        packing of          purpose.
                                                                           product.
                                                      To cool product or  Various poultry      Do.
                                                       facilitate          products.
                                                       chopping or
                                                       packaging.
                                  Nitrogen..........  To exclude oxygen   Various meat and     Do.
                                                       from sealed         poultry products.
                                                       containers.
                                  Nitrogen, liquid..  Contact freezant..  ......do..........   Do.
Hog Scald Agents (must be         Caustic soda......  To remove hair....  Hog carcasses.....  Sufficient for
 removed by subsequent cleaning                                                                purpose.
 operations).
                                  Dicotyl sodium      ......do..........  ......do..........   Do.
                                   sulfosuccinate.
                                  Dimethylpolysiloxa  ......do..........  ......do..........   Do.
                                   ne.
                                  Disodium-calcium    ......do..........  ......do..........   Do.
                                   ethylenediaminete
                                   tra-acetate.
                                  Disodium phosphate  ......do..........  ......do..........   Do.
                                  Ethylenediaminetet  ......do..........  ......do..........   Do.
                                   ra-acetic acid
                                   (sodium salts).
                                  Lime (calcium       ......do..........  ......do..........   Do.
                                   oxide, calcium
                                   hydroxide).
                                  Potassium                                                    Do.
                                   hydroxide.
                                  Propylene glycol..  ......do..........  ......do..........   Do.
                                  Soap (prepared by   ......do..........  ......do..........   Do.
                                   the reaction of
                                   calcium,
                                   potassium, or
                                   sodium with rosin
                                   or fatty acids of
                                   natural fats and
                                   oils).
                                  Sodium acid         ......do..........  ......do..........   Do.
                                   pyrophosphate.
                                  Sodium carbonate..  ......do..........  ......do..........   Do.
                                  Sodium              ......do..........  ......do..........   Do.
                                   dodecylbenzene
                                   sulfonate.
                                  Sodium gluconate..  ......do..........  ......do..........   Do.
                                  Sodium              ......do..........  ......do..........   Do.
                                   hexametaphosphate.
                                  Sodium lauryl       ......do..........  ......do..........   Do.
                                   sulfate.
                                  Sodium mono and     ......do..........  ......do..........   Do.
                                   dimethylnaphthale
                                   ne sulfonate
                                   (molecular weight
                                   245-260).

[[Page 653]]

 
                                  Sodium n-           ......do..........  ......do..........   Do.
                                   alkylbenzene
                                   sulfonate (alkyl
                                   group
                                   predominantly C12
                                   and C13 and not
                                   less than 95
                                   percent C10 and
                                   C16).
                                  Sodium              ......do..........  ......do..........   Do.
                                   pyrophosphate.
                                  Sodium silicates    ......do..........  ......do..........   Do.
                                   (ortho, meta, and
                                   sesqui).
                                  Sodium sulfate....  ......do..........  ......do..........   Do.
                                  Sodium              ......do..........  ......do..........   Do.
                                   tripolyphosphate.
                                  Sucrose...........  ......do..........  ......do..........   Do.
                                  Triethanolamine     ......do..........  ......do..........   Do.
                                   dodecylbenzene
                                   sulfonate.
                                  Trisodium           ......do..........  ......do..........   Do.
                                   phosphate.
Miscellaneous...................  Adipic acid.......  To acidify........  Margarine or        Sufficient for
                                                                           oleomargarine.      purpose.
                                  Ascorbic acid,      To delay            Fresh beef cuts,    Not to exceed,
                                   erythorbic acid,    discoloration.      fresh lamb cuts,    singly or in
                                   citric acid,                            and fresh pork      combination, 500
                                   sodium ascorbate                        cuts.               ppm or 1.8 mg/sq
                                   and sodium                                                  inch of product
                                   citrate, singly                                             surface of
                                   or in combination.                                          ascorbic acid (in
                                                                                               accordance with
                                                                                               21 CFR 182.3013),
                                                                                               erythorbic acid
                                                                                               (in accordance
                                                                                               with 21 CFR
                                                                                               182.3041), or
                                                                                               sodium ascorbate
                                                                                               (in accordance
                                                                                               with 21 CFR
                                                                                               182.3731); and/or
                                                                                               not to exceed,
                                                                                               singly or in
                                                                                               combination, 250
                                                                                               ppm or 0.9 mg/sq
                                                                                               inch of product
                                                                                               surface of citric
                                                                                               acid (in
                                                                                               accordance with
                                                                                               21 CFR 182.6033),
                                                                                               or sodium citrate
                                                                                               (in accordance
                                                                                               with 21 CFR
                                                                                               182.6751).
                                  Calcium disodium,   To preserve         Margarine or        75 ppm by weight
                                   EDTA (calcium       product and to      oleomargarine.      of the finished
                                   disodium ethylene-  protect flavor.                         oleomargarine or
                                   diaminetetraaceta                                           margarine.
                                   te.
                                  Calcium propionate  To retard mold      Pizza crust.......  0.32 percent alone
                                                       growth.                                 or in combination
                                                                                               based on weight
                                                                                               of the flour
                                                                                               brace used.
                                                      ......do..........  Fresh pie dough     0.3 percent of
                                                                           (poultry only).     calcium
                                                                                               propionate or
                                                                                               sodium propionate
                                                                                               alone, or in
                                                                                               combination,
                                                                                               based on weight
                                                                                               of flour used.
                                  Citric acid.......  To preserve cured   Cured pork cuts...  Not to exceed 30
                                                       color during                            percent in water
                                                       storage.                                solution used to
                                                                                               spray surfaces of
                                                                                               cured cuts, prior
                                                                                               to packaging, in
                                                                                               accordance with
                                                                                               21 CFR 184.1033.
                                                                                               (The use of such
                                                                                               solution shall
                                                                                               not result in the
                                                                                               addition of a
                                                                                               significant
                                                                                               amount of
                                                                                               moisture to the
                                                                                               product and shall
                                                                                               be applied only
                                                                                               once to product).
                                  Citric acid         To acidify........  Margarine and       Sufficient for
                                   (sodium and                             oleomargarine.      purpose.
                                   potassium salts).
                                  d- and dl-alpha-    To inhibit          Pump-cured bacon..  500 ppm; by
                                   tocopherol.         nitrosamine                             injection or
                                                       formation.                              surface
                                                                                               application.

[[Page 654]]

 
                                  Dipotassium         To decrease the     Meat food products  For meat food
                                   phosphate.          amount of cooked    except where        products, 5
                                                       out juices.         otherwise           percent of
                                                                           prohibited by the   phosphate in
                                                                           meat inspection     pickle at 10
                                                                           regulations and     percent pump
                                                                           poultry food        level; 0.5
                                                                           products except     percent of
                                                                           where otherwise     phosphate in meat
                                                                           prohibited by the   food product
                                                                           poultry products    (only clear
                                                                           inspection          solution may be
                                                                           regulations..       injected into
                                                                                               meat food
                                                                                               product). For
                                                                                               poultry food
                                                                                               products, 0.5
                                                                                               percent of total
                                                                                               product.
                                  Disodium phosphate  ......do..........  ......do..........   Do.
                                  Glycerine.........  Humectant.........  Shelf stable meat   Not to exceed 2
                                                                           snacks.             percent of the
                                                                                               formulation
                                                                                               weight of the
                                                                                               product in
                                                                                               accordance with
                                                                                               21 CFR 182.1320.
                                  Hydrochloric acid.  To acidify........  Margarine or        Sufficient for
                                                                           oleomargarine.      purpose.
                                  Lactic acid         ......do..........  ......do..........   Do.
                                   (sodium and
                                   potassium salts).
                                  L-Tartaric acid     ......do..........  ......do..........   Do.
                                   (sodium and
                                   sodium potassium
                                   salts).
                                  Monopotassium       To decrease the     Meat food products  For meat food
                                   phosphate.          amount of cooked    except where        products, 5
                                                       out juices.         otherwise           percent of
                                                                           prohibited by the   phosphate in
                                                                           meat inspection     pickle at 10
                                                                           regulations and     percent pump
                                                                           poultry food        level; 0.5
                                                                           products except     percent of
                                                                           where otherwise     phosphate in meat
                                                                           prohibited by the   food product
                                                                           poultry products    (only clear
                                                                           inspection          solution may be
                                                                           regulations..       injected into
                                                                                               meat food
                                                                                               product). For
                                                                                               poultry products,
                                                                                               0.5 percent of
                                                                                               total product.
                                  Monosodium          ......do..........  ......do..........   Do.
                                   phosphate.
                                  Phosphoric acid...  To acidify........  Margarine or        Sufficient for
                                                                           oleomargarine.      purpose.
                                  Potassium           To alkalize.......  Margarine or        Sufficient for
                                   bicarbonate.                            oleomargarine.      purpose.
                                  Potassium           ......do..........  ......do..........   Do.
                                   carbonate.
                                  Potassium           To decrease the     Meat food products  5 percent of
                                   pyrophosphate.      amount of cooked    except where        phosphate in
                                                       out juices.         otherwise           pickle at 10
                                                                           prohibited by the   percent pump
                                                                           meat inspection     level; 0.5
                                                                           regulations and     percent of
                                                                           poultry food        phosphate in meat
                                                                           products except     food product
                                                                           where otherwise     (only clear
                                                                           prohibited by the   solution may be
                                                                           poultry products    injected into
                                                                           inspection          meat food
                                                                           regulations..       product). For
                                                                                               poultry food
                                                                                               products, 0.5
                                                                                               percent of total
                                                                                               product.
                                  Potassium sorbate.  To retard mold      Dry sausage.......  10 percent in
                                                       growth.                                 water solution
                                                                                               may be applied to
                                                                                               casings after
                                                                                               stuffing or
                                                                                               casings may be
                                                                                               dipped in
                                                                                               solution prior to
                                                                                               stuffing.
                                  Potassium           To decrease the     Meat food products  5 percent of
                                   tripolyphosphate.   amount of cooked    except where        phosphate in
                                                       out juices.         otherwise           pickle at 10
                                                                           prohibited by the   percent pump
                                                                           meat inspection     level; 0.5
                                                                           regulations and     percent of
                                                                           poultry food        phosphate in meat
                                                                           products except     food product
                                                                           where otherwise     (only clear
                                                                           prohibited by the   solution may be
                                                                           poultry products    injected into
                                                                           inspection          meat food
                                                                           regulations.        product). For
                                                                                               poultry food
                                                                                               products, 0.5
                                                                                               percent of total
                                                                                               product.
                                  Propyl paraben      To retard mold      Dry sausage.......  3.5 percent in
                                   (propyl p-hydroxy-  growth.                                 water solution
                                   benzoate).                                                  may be applied to
                                                                                               casings after
                                                                                               stuffing or
                                                                                               casings may be
                                                                                               dipped in
                                                                                               solution prior to
                                                                                               stuffing.
                                  Silicon dioxide...  Processing aid/     Tocopherol          At level not to
                                                       dispersant.         containing bacon    exceed 4.0
                                                                           curing mixes.       percent in the
                                                                                               dry mix.

[[Page 655]]

 
                                  Sodium acid         To decrease the     Meat food products  For meat food
                                   pyrophosphate.      amount of cooked    except where        products, 5
                                                       out juices.         other prohibited    percent of
                                                                           by the meat         phosphate in
                                                                           inspection          pickle at 10
                                                                           regulations and     percent pump
                                                                           poultry food        level; 0.5
                                                                           products except     percent of
                                                                           where otherwise     phosphate in meat
                                                                           prohibited by the   food product
                                                                           poultry products    (only clear
                                                                           inspection          solution may be
                                                                           regulations..       injected into
                                                                                               meat food
                                                                                               product). For
                                                                                               poultry products,
                                                                                               0.5 percent of
                                                                                               total product.
                                  Sodium bicarbonate  To neutralize       Rendered fats,      Sufficient for
                                                       excess acidity,     soups, curing       purpose.
                                                       cleaning            pickle (meat and
                                                       vegetables.         poultry).
                                                      To alkalize.......  Margarine or         Do.
                                                                           oleomargarine.
                                  Sodium carbonate..  ......do..........  ......do..........   Do.
                                  Sodium citrate      To inhibit the      Cured and uncured,  Not to exceed 1.3
                                   buffered with       growth of micro-    processed whole     percent of the
                                   citric acid to a    organisms and       muscle meat and     formulation
                                   pH of 5.6.          retain product      poultry food        weight of the
                                                       flavor during       products, e.g.,     product in
                                                       storage.            ham, chicken        accordance with
                                                                           breasts.            21 CFR 184.1751.
                                  Sodium hydroxide..  To alkalize.......  Margarine or        Sufficient for
                                                                           oleomargarine.      purpose.
                                                      To decrease the     Poultry food        May be used only
                                                       amount of cooked    products            in combination
                                                       out juices.         containing          with phosphate in
                                                                           phosphates.         a ratio not to
                                                                                               exceed one part
                                                                                               sodium hydroxide
                                                                                               to four parts
                                                                                               phosphate.
                                                      ......do..........  Meat food products  May be used only
                                                                           containing          in combination
                                                                           phosphates.         with phosphates
                                                                                               in a ratio not to
                                                                                               exceed one part
                                                                                               sodium hydroxide
                                                                                               to four parts
                                                                                               phosphate; the
                                                                                               combination shall
                                                                                               not exceed 5
                                                                                               percent in pickle
                                                                                               at 10 percent
                                                                                               pump level; 0.5
                                                                                               percent in
                                                                                               product.
                                  Sodium              ......do..........  Meat food products  For meat food
                                   metaphosphate,                          except where        products, 5
                                   insoluble.                              other prohibited    percent of
                                                                           by the meat         phosphate in
                                                                           inspection          pickle at 10
                                                                           regulations, and    percent pump
                                                                           poultry food        level; 0.5
                                                                           products except     percent of
                                                                           where otherwise     phosphate in meat
                                                                           prohibited by the   food product
                                                                           poultry products    (only clear
                                                                           inspection          solution may be
                                                                           regulations.        injected into
                                                                                               meat food
                                                                                               product). For
                                                                                               poultry products,
                                                                                               0.5 percent of
                                                                                               total product.
                                  Sodium              ......do..........  ......do..........   Do.
                                   polyphosphate,
                                   glassy.
                                  Sodium proprionate  To retard mold      Pizza crust.......  0.32 percent alone
                                                       growth.                                 or in combination
                                                                                               based on weight
                                                                                               of the flour
                                                                                               brace used.
                                                      ......do..........  Fresh pie dough     0.3 percent of
                                                                           (poultry only).     calcium
                                                                                               proprionate or
                                                                                               sodium
                                                                                               proprionate
                                                                                               alone, or in
                                                                                               combination,
                                                                                               based on weight
                                                                                               of flour used.
                                  Sodium              To decrease the     Meat food products  For meat food
                                   pryophosphate.      amount of cooked    except where        products, 5
                                                       out juices.         otherwise           percent of
                                                                           prohibited by the   phosphate in
                                                                           meat inspection     pickle at 10
                                                                           regulations and     percent pump
                                                                           poultry food        level; 0.5
                                                                           products except     percent of
                                                                           where otherwise     phosphate in meat
                                                                           prohibited by the   food product
                                                                           poultry products    (only clear
                                                                           inspection          solution may be
                                                                           regulations.        injected into
                                                                                               meat food
                                                                                               product). For
                                                                                               poultry products,
                                                                                               0.5 percent of
                                                                                               total product.
                                  Sodium              ......do..........  ......do..........   Do.
                                   tripolyphosphate.

[[Page 656]]

 
                                  Sorbic acid         To preserve         Margarine or        0.1 percent
                                   (sodium,            product and to      oleomargarine.      individually, or
                                   potassium, and      retard mold                             if used in
                                   calcium salts).     growth.                                 combination or
                                                                                               with benzoic acid
                                                                                               or its salts, 0.2
                                                                                               percent
                                                                                               (expressed as the
                                                                                               acids in the wt.
                                                                                               of the finished
                                                                                               foods).
                                  Tricalcium          To preserve         Mechanically        Not to exceed 2
                                   phosphate.          product color       deboned chicken     percent of the
                                                       during              to be dehydrated.   weight of the
                                                       dehydration                             mechanically
                                                       process.                                deboned chicken
                                                                                               prior to
                                                                                               dehydration, in
                                                                                               accordance with
                                                                                               21 CFR 182.1217.
Poultry scald agents (must be     Alpha-hydro-omega-  To remove feathers  Poultry carcasses.  Not to exceed 0.05
 removed by subsequent cleaning    hydroxy-poly                                                percent by weight
 operations).                      (oxyethylene)                                               in scald water.
                                   poly
                                   (oxypropylene)
                                   (minimum 15
                                   moles) poly
                                   (oxyethylene)
                                   block copolymer
                                   (poloxamer).
                                  Dimethylpolysiloxa  ......do..........  ......do..........  Sufficient for
                                   ne.                                                         purpose.
                                  Dioctyl sodium      ......do..........  ......do..........   Do.
                                   sulfosuccinate.
                                  Dipotassium         ......do..........  ......do..........   Do.
                                   phosphate.
                                  Ethylenediaminetet  ......do..........  ......do..........   Do.
                                   ra-acetic acid
                                   (sodium salts).
                                  Lime (calcium       ......do..........  ......do..........   Do.
                                   oxide, calcium
                                   hydroxide).
                                  Polyoxyethylene     ......do..........  ......do..........  Not to exceed
                                   (20) sorbitan                                               0.0175 percent in
                                   monooleate.                                                 scald water.
                                  Potassium           ......do..........  ......do..........  Sufficient for
                                   hydroxide.                                                  purpose.
                                  Propylene glycol..  ......do..........  ......do..........   Do.
                                  Sodium acid         ......do..........  ......do..........   Do.
                                   phosphate.
                                  Sodium acid         ......do..........  ......do..........   Do.
                                   pyrophosphate.
                                  Sodium bicarbonate  ......do..........  ......do..........   Do.
                                  Sodium carbonate..  ......do..........  ......do..........   Do.
                                  Sodium              ......do..........  ......do..........   Do.
                                   dodecylbenzene-
                                   sulfonate.
                                  Sodium-2-           ......do..........  ......do..........   Do.
                                   ethylhexyl
                                   sulfate.
                                  Sodium              ......do..........  ......do..........   Do.
                                   hexametaphosphate.
                                  Sodium hydroxide..  ......do..........  ......do..........   Do.
                                  Sodium lauryl       ......do..........  ......do..........   Do.
                                   sulfate.
                                  Sodium phosphate    ......do..........  ......do..........   Do.
                                   (mono-, di-,
                                   tribasic).
                                  Sodium              ......do..........  ......do..........   Do.
                                   pyrophosphate.
                                  Sodium              ......do..........  ......do..........   Do.
                                   sesquicarbonate.
                                  Sodium sulfate....  ......do..........  ......do..........   Do.
                                  Sodium              ......do..........  ......do..........   Do.
                                   tripolyphosphate.
                                  Tetrasodium         ......do..........  ......do..........   Do.
                                   pyrophosphate.

[[Page 657]]

 
Proteolytic Enzymes.............  Aspergillus flavus  To soften tissue..  Raw poultry muscle  Solutions
                                   oryzae group.                           tissue of hen,      consisting of
                                                                           cock, mature        water and
                                                                           turkey, mature      approved
                                                                           duck, mature        proteolytic
                                                                           goose, and mature   enzyme applied or
                                                                           guinea, and raw     injected into raw
                                                                           meat cuts.          meat or poultry
                                                                                               tissue shall not
                                                                                               result in a gain
                                                                                               of more than 3
                                                                                               percent above the
                                                                                               weight of the
                                                                                               untreated
                                                                                               product.
                                  Aspergillus oryzae  ......do..........  ......do..........   Do.
                                  Bromelin..........  ......do..........  ......do..........   Do.
                                  Ficin.............  ......do..........  ......do..........   Do.
                                  Papain............  ......do..........  ......do..........   Do.
Refining Agents (must be          Acetic acid.......  To separate fatty   Rendered fats       Sufficient for
 eliminated during process of                          acids and           (meat only).        purpose.
 manufacturing).                                       glycerol.
                                  Bicarbonate of      ......do..........  ......do..........   Do.
                                   soda.
                                  Carbon (purified    To aid in refining  ......do..........   Do.
                                   charcoal).          of animal fats.
                                  Caustic soda        To refine fats....  ......do..........   Do.
                                   (sodium
                                   hydroxide).
                                  Diatomaceous        ......do..........  ......do..........   Do.
                                   earth; Fuller's
                                   earth.
                                  Sodium carbonate..  ......do..........  ......do..........   Do.
                                  Tannic acid.......  ......do..........  ......do..........   Do.
Rendering agents................  Tricalcium          To aid rendering..  Animal fats.......   Do.
                                   phosphate.
                                  Trisodium           ......do..........  ......do..........   Do.
                                   phosphate.
Synergists (used in combination   Citric acid.......  To increase         Any meat product    Not to exceed 0.01
 with antioxidants).                                   effectiveness of    permitted to        percent based on
                                                       antioxidants.       contain             fat content.
                                                                           antioxidants as
                                                                           provided for in
                                                                           this part.
                                                      ......do..........  Poultry fats......  0.01 percent alone
                                                                                               or in combination
                                                                                               with antioxidants
                                                                                               in poultry fats.
                                  Malic acid........  ......do..........  Lard and            0.01 percent based
                                                                           shortening.         on total weight
                                                                                               in combination
                                                                                               with antioxidants
                                                                                               for use in meat
                                                                                               products only.
                                                      ......do..........  Poultry fats......  0.01 percent alone
                                                                                               or in combination
                                                                                               with antioxidants
                                                                                               in poultry fats.
                                  Monoglyceride       ......do..........  Lard, shortening,   0.02 percent.
                                   citrate.                                fresh pork
                                                                           sausage, dried
                                                                           meats and poultry
                                                                           fats.
                                  Monoisopropyl       ......do..........  Lard, shortening,    Do.
                                   citrate.                                oleomargarine,
                                                                           fresh pork
                                                                           sausage, dried
                                                                           meats.
                                                      ......do..........  Poultry fats......  0.01 percent
                                                                                               poultry fats.
                                  Phosphoric acid...  ......do..........  Lard, shortening,   0.01 percent.
                                                                           and poultry fats.
Tenderizing agents..............  Aspergillus flavus  To soften tissue..  Raw poultry muscle  Solutions
                                   oryzae group.                           tissue of hen,      consisting of
                                                                           cock, mature        water and
                                                                           turkey, mature      approved
                                                                           duck, mature        proteolytic
                                                                           goose, and mature   enzyme applied or
                                                                           guinea, and raw     injected into raw
                                                                           meat cuts.          meat or poultry
                                                                                               tissue shall not
                                                                                               result in a gain
                                                                                               of more than 3
                                                                                               percent above the
                                                                                               weight of the
                                                                                               untreated
                                                                                               product.
                                  Aspergillus oryzae  ......do..........  ......do..........  Not more than 3
                                                                                               percent of a 0.8
                                                                                               molar solution.
                                  Bromelin..........  ......do..........  ......do..........   Do.
                                  Calcium chloride..  ......do..........  ......do..........   Do.
                                  Magnesium chloride  ......do..........  ......do..........   Do.

[[Page 658]]

 
                                  Papain............  To soften tissue..  Raw poultry muscle  Solutions
                                                                           tissue of hen,      consisting of
                                                                           cock, mature        water and
                                                                           turkey, mature      approved
                                                                           duck, mature        proteolytic
                                                                           goose, and mature   enzyme applied or
                                                                           guinea, and raw     injected into raw
                                                                           meat cuts.          meat or poultry
                                                                                               tissue shall not
                                                                                               result in a gain
                                                                                               of more than 3
                                                                                               percent above the
                                                                                               weight of the
                                                                                               untreated
                                                                                               product.
                                  Potassium chloride  ......do..........  ......do..........  Not more than 3
                                                                                               percent of a 2.0
                                                                                               molar solution.
                                  Potassium,          ......do..........  ......do..........  A solution of
                                   magnesium or                                                approved
                                   calcium chloride.                                           inorganic
                                                                                               chlorides
                                                                                               injected into or
                                                                                               applied to raw
                                                                                               meats or poultry
                                                                                               cuts shall not
                                                                                               result in a gain
                                                                                               of more than 3
                                                                                               percent above the
                                                                                               weight of the
                                                                                               untreated
                                                                                               product.
----------------------------------------------------------------------------------------------------------------
\1\ [Reserved]
\2\ Information as to the specific products for which use of this additive is approved may be obtained upon
  inquiry addressed to the Labeling and Additives Policy Division, Food Safety and Inspection Service, U.S.
  Department of Agriculture, Washington, DC 20250.
\3\ Provided, that its use is functional and suitable for the product and it is permitted for use at the lowest
  level necessary to accomplish the desired technical effect as determined in specific cases prior to label
  approval under Sec. Sec. 317.4 or 381.32.
\4\ Special labeling requirements are prescribed in 381.120 for raw poultry chilled in a medium with more than
  70 lbs. of salt to 10,000 gals. of water.


[64 FR 72175, Dec. 23, 1999, as amended at 65 FR 3123, Jan. 20, 2000; 65 
FR 34391, May 30, 2000]



Sec. 424.22  Certain other permitted uses.

    (a) Under appropriate declaration as required in parts 316 and 317 
of this chapter, the following substances may be added to meat:
    (1) General. Common salt, approved sugars (sucrose, cane or beet 
sugar), maple sugar, dextrose, invert sugar, honey, corn syrup solids 
(corn syrup, glucose syrup and fructose), wood smoke, vinegar, 
flavorings, spices, sodium nitrate, sodium nitrite, potassium nitrate, 
potassium nitrite, and other food and color additives specified in the 
chart in paragraph (c) of this section may be added to meat under 
conditions, if any, specified in this part or in part 317 of this 
chapter.
    (2) Artificial flavorings. Other harmless artificial flavorings may 
be added to meat, with the approval of the Administrator in specific 
cases.
    (3) Coloring matter and dyes. Coloring matter and dyes, other than 
those specified in a regulation permitting that use in this chapter or 
in 21 CFR Chapter I, Subchapter A and Subchapter B, may be applied to 
meat mixed with rendered fat, applied to natural and artificial casings, 
and applied to such casings enclosing products, if approved by the 
Administrator in specific cases. When any coloring matter or dye is 
applied to casings, there shall be no penetration of coloring into the 
product.
    (b) Use of nitrite and sodium ascorbate or sodium erythorbate 
(isoascorbate) in bacon.
    (1) Pumped bacon. With respect to bacon injected with curing 
ingredients and massaged bacon, sodium nitrite shall be used at 120 
parts per million (ppm) ingoing or an equivalent amount of potassium 
nitrite shall be used (148 ppm ingoing); and 550 ppm of sodium ascorbate 
or sodium erythorbate (isoascorbate) shall be used. Sodium ascorbate or 
sodium erythorbate have a molecular weight of approximately 198. 
Hydrated forms of these substances shall be adjusted to attain the 
equivalent of 550 ppm of sodium ascorbate or sodium erythorbate.
    (i) The Department shall collect samples of pumped bacon from 
producing plants and analyze them for the level of nitrosamines by the 
Thermal Energy Analyzer (TEA). In the event that a TEA analysis 
indicates that a confirmable level of nitrosamines might be present, 
additional samples shall be collected and analyzed by gas 
chromatography. Presumptive positive results

[[Page 659]]

must be confirmed by mass spectrometry before being considered positive. 
If during the interval required for the Department to analyze the 
confirmatory samples by gas chromatography and mass spectrometry, 
changes are made in processing procedures which are expected to result 
in no confirmable levels of nitrosamines in pumped bacon produced by 
these new procedures, an establishment may submit samples to USDA for 
analysis upon prior notification and arrangements with USDA. If, 
however, an establishment furnishes USDA with laboratory results from 
testing five consecutive lots of pumped bacon produced under the new 
procedures and the testing is performed by the USDA methodology and 
procedures, those results will be utilized in making the determination 
concerning the product produced under the new procedures. Should the 
results of these tests reveal that confirmable levels of nitrosamines 
are not indicated in any of the five consecutive lots, the confirmation 
analysis by USDA shall be terminated and the establishment shall revert 
to normal monitoring status. In the event the test results continue to 
indicate nitrosamines, however, USDA shall proceed in its confirmation 
analysis on the original samples taken for confirmation. If any one of 
the original samples collected by USDA for confirmation is found to 
contain confirmable levels of nitrosamines, all pumped bacon in the 
producing establishment and all future production will be retained. The 
Department shall sample and analyze such retained pumped bacon for 
nitrosamines on a lot by lot basis. A production lot shall be that 
pumped bacon produced by the establishment in any single shift. Samples 
from any lot of pumped bacon under retention found to contain 
nitrosamines at a confirmable level shall cause the lot of pumped bacon 
to be disposed of in a manner to ensure it will not form nitrosamines 
when cooked. Such disposal may include incorporation of the uncooked 
pumped bacon as an ingredient of another meat provided it is processed 
for eating without further preparation in a manner to preclude the 
formation of nitrosamines. Bacon subsequently produced shall not be 
retained because of nitrosamines if the operator of the establishment 
makes adjustments in the processing of the product and laboratory 
results obtained by TEA analysis of samples from five consecutive normal 
sized lots of pumped bacon indicates that the product being produced 
contains no confirmable levels of nitrosamines. These tests from five 
consecutive normal sized lots of pumped bacon shall be conducted by the 
Department. However, if the establishment furnishes the Department with 
the results of tests conducted under the methodology and procedures used 
by the Department, such test results will be utilized in making the 
determination concerning the nitrosamine content of the product. All 
tests of pumped bacon for nitrosamines under this paragraph (b)(1)(i) 
shall be made on pumped bacon cooked at 340 degrees F. for 3 minutes on 
each side. In order to determine that no confirmable levels of 
nitrosamines are present in a sample tested, the testing must be 
performed by methodology and procedures that would detect the presence 
of any nitrosamines at 10 ppb.
    (ii) Notwithstanding the provisions of paragraph (b)(1)(i) of this 
section, sodium nitrite may be used at:
    (A) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 550 
ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be used; 
or
    (B) A predetermined level between 40 and 80 ppm (potassium nitrite 
at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium 
erythorbate (isoascorbate); and additional sucrose or other similar 
fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of 
lactic acid producing bacteria such as Pediococcus acetolactii or other 
bacteria demonstrated to be equally effective in preventing the 
production of botulinum toxin at a level sufficient for the purpose of 
preventing the production of botulinum toxin.
    (C) The Department shall collect samples of bacon from 
establishments producing under paragraph (b)(1)(ii) of this section and 
analyze them for the level of nitrosamines. Samples shall be randomly 
selected throughout the production of a lot. The actual sampling

[[Page 660]]

plans and methods of analysis that are used will result in approximately 
the same likelihood as under paragraph (b)(1)(i) of this section of 
having a presumptive positive result when the true mean level of 
nitrosamines in a production lot is 10 ppb. In the event of a 
presumptive positive result, the establishment shall become subject to 
the provisions of paragraph (b)(1)(i) of this section.
    (2) Immersion cured bacon. Immersion cured bacon may be placed in a 
brine solution containing salt, nitrite and flavoring material or in a 
container with salt, nitrite and flavoring material. Sodium nitrite 
shall not exceed 120 ppm ingoing or an equivalent amount of potassium 
nitrite (148 ppm ingoing) based on the actual or estimated skin-free 
green weight of the bacon bellies.
    (3) Bacon made with dry curing materials. With respect to bacon made 
with dry curing materials, the product shall be cured by applying a 
premeasured amount of cure mixture to the bacon belly surfaces, 
completely covering the surfaces. Sodium nitrite shall not exceed 200 
ppm ingoing or an equivalent amount of potassium nitrite (246 ppm 
ingoing) in dry cured bacon based on the actual or estimated skin-free 
green weight of the bacon belly.
    (c) Irradiation of meat food and poultry products.
    (1) General requirements. Meat food and poultry products may be 
treated to reduce foodborne pathogens and to extend product shelf-life 
by the use of sources of ionizing radiation as identified in 21 CFR 
179.26(a). Official establishments must irradiate meat food and poultry 
products in accordance with 21 CFR 179.26(b), the Hazard Analysis and 
Critical Control Point (HACCP) system requirements in part 417 of this 
chapter, and the provisions of this section.
    (2) Dosimetry. Official establishments that irradiate meat food and 
poultry products must have the following procedures in place:
    (i) Laboratory operation procedures for determining the absorbed 
dose value from the dosimeter.
    (ii) Calibration criteria for verifying the accuracy and consistency 
of any means of measurement (e.g., time clocks and weight scales).
    (iii) Calibration and accountability criteria for verifying the 
traceability and accuracy of dosimeters for the intended purpose, and 
the verification of calibration at least every 12 months. To confirm 
traceability, establishments must relate, through documentation, the end 
point measurement of a dosimeter to recognized standards.
    (iv) Procedures for ensuring that the product unit is dose mapped to 
identify the regions of minimum and maximum absorbed dose and such 
regions are consistent from one product unit to another of like product.
    (v) Procedures for accounting for the total absorbed dose received 
by the product unit (e.g., partial applications of the absorbed dose 
within one production lot).
    (vi) Procedures for verifying routine dosimetry, i.e., assuring each 
production lot receives the total absorbed dose. Establishments may 
either position one dosimeter at the regions of minimum and maximum 
absorbed dose (or at one region verified to represent such) on at least 
the first, middle, and last product unit in each production lot or use 
statistically based validation and dose mapping to determine the number 
and placement of dosimeters in each production lot.
    (vii) Procedures for verifying the relationship of absorbed dose as 
measured by the dosimeter to time exposure of the product unit to the 
radiation source.
    (viii) Procedures for verifying the integrity of the radiation 
source and processing procedure. Aside from expected and verified 
radiation source activity decay for radionuclide sources, the radiation 
source or processing procedure must not be altered, modified, 
replenished, or adjusted without repeating dose mapping of product units 
to redefine the regions of minimum and maximum absorbed dose.
    (3) Documentation. Official establishments that irradiate meat food 
or poultry products must have the following documentation on premises, 
available to FSIS:
    (i) Documentation that the irradiation facility is licensed or 
possesses gamma radiation sources registered

[[Page 661]]

with the Nuclear Regulatory Commission (NRC) or the appropriate State 
government acting under authority granted by the NRC.
    (ii) Documentation that the machine radiation source irradiation 
facility is registered with the appropriate State government, if 
applicable.
    (iii) Documentation that a worker safety program addressing OSHA 
regulations (29 CFR chapter XVII) is in place.
    (iv) Citations or other documents that relate to incidences in which 
the establishment was found not to comply with Federal or State agency 
requirements for irradiation facilities.
    (v) A certification by the operator that the irradiation facility 
personnel will only operate under supervision of a person who has 
successfully completed a course of instruction for operators of food 
irradiation facilities.
    (vi) A certification by the operator that the key irradiation 
personnel, who monitor or control daily operations, have been trained in 
food technology, irradiation processing, and radiation health and 
safety.
    (vii) Guarantees from the suppliers of all food-contact packaging 
materials that may be subject to irradiation that those materials comply 
with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
    (4) Labeling. (i) The labels on packages of meat food and poultry 
products irradiated in their entirety, in conformance with this section 
and with 21 CFR 179.26(a) and (b), must bear the logo shown at the end 
of this paragraph (c)(4)(i). Unless the word ``Irradiated'' is part of 
the product name, labels also must bear a statement such as ``Treated 
with radiation'' or ``Treated by irradiation.'' The logo must be placed 
in conjunction with the required statement, if the statement is used. 
The statement is not required to be more prominent than the declaration 
of ingredients required under Sec. 317.2(c)(2). Any label bearing the 
logo or any wording of explanation with respect to this logo must be 
approved as required by Section 317.4. of this chapter or subparts M and 
N of part 381.
[GRAPHIC] [TIFF OMITTED] TR23DE99.000

    (ii) For meat food or poultry products that have been irradiated in 
their entirety, but that are not sold in packages, the required logo 
must be displayed to the purchaser with either the labeling of the bulk 
container plainly in view or a counter sign, card, or other appropriate 
device bearing the information that the product has been treated with 
radiation. In either case, the information must be prominently and 
conspicuously displayed to purchasers. Unless the word ``Irradiated'' is 
part of the product name, the labeling counter sign, card, or other 
device also must bear a statement such as ``Treated with radiation'' or 
``Treated by irradiation.'' The logo must be placed in conjunction with 
the required statement, if the statement is used.
    (iii) The inclusion of an irradiated meat food or poultry product 
ingredient in any multi-ingredient meat food or poultry product must be 
reflected in the ingredient statement on the finished product labeling.
    (iv) Optional labeling statements about the purpose for radiation 
processing may be included on the product label in addition to the 
stated requirements elsewhere in this section, provided that such 
statements are not false or misleading. Statements that there has been a 
specific reduction in microbial pathogens must be substantiated by 
processing documentation.

[64 FR 72175, Dec. 23, 1999, as amended at 64 FR 72165, Dec. 23, 1999; 
65 FR 34391, May 30, 2000]



Sec. 424.23  Prohibited uses.

    (a) Substances that conceal damage or inferiority or make products 
appear better or of greater value. No substance may be used in or on any 
meat if it conceals damage or inferiority or makes the

[[Page 662]]

product appear to be better or of greater value than it is. Therefore:
    (1) Paprika or oleoresin paprika may not be used in or on fresh 
meat, such as steaks, or comminuted fresh meat, such as chopped and 
formed steaks or patties; or in any other meat consisting of fresh meat 
(with or without seasoning).
    (2) Paprika or oleoresin paprika may be used in or on chorizo 
sausage and other meat in which paprika or oleoresin paprika is 
permitted as an ingredient in a standard of identity or composition in 
part 319 of this subchapter.
    (3) Sorbic acid, calcium sorbate, sodium sorbate, and other salts of 
sorbic acid shall not be used in cooked sausages or any other meat; 
sulfurous acid and salts of sulfurous acid shall not be used in or on 
any meat; and niacin or nicotinamide shall not be used in or on fresh 
meat product; except that potassium sorbate, propylparaben (propyl p-
hydroxybenzoate), calcium propionate, sodium propionate, benzoic acid, 
and sodium benzoate may be used in or on any product, only as provided 
in 9 CFR Chapter III.
    (b) Nitrates. Nitrates shall not be used in curing bacon.



PART 430_REQUIREMENTS FOR SPECIFIC CLASSES OF PRODUCT--Table of Contents




Sec.
430.1 Definitions.
430.4 Control of Listeria monocytogenes in post-lethality exposed ready-
          to-eat products.

    Authority: 7 U.S.C. 450; 7 U.S.C. 1901-1906; 21 U.S.C. 451-470, 601-
695; 7 CFR 2.18, 2.53.

    Source: 68 FR 34224, June 6, 2003, unless otherwise noted.



Sec. 430.1  Definitions.

    Antimicrobial agent. A substance in or added to an RTE product that 
has the effect of reducing or eliminating a microorganism, including a 
pathogen such as L. monocytogenes, or that has the effect of suppressing 
or limiting growth of L. monocytogenes in the product throughout the 
shelf life of the product. Examples of antimicrobial agents added to RTE 
products are potassium lactate and sodium diacetate.
    Antimicrobial process. An operation, such as freezing, applied to an 
RTE product that has the effect of suppressing or limiting the growth of 
a microorganism, such as L. monocytogenes, in the product throughout the 
shelf life of the product.
    Deli product. A ready-to-eat meat or poultry product that typically 
is sliced, either in an official establishment or after distribution 
from an official establishment, and typically is assembled in a sandwich 
for consumption.
    Hotdog product. A ready-to-eat meat or poultry frank, frankfurter, 
or wiener, such as a product defined in 9 CFR 319.180 and 319.181.
    Lethality treatment. A process, including the application of an 
antimicrobial agent, that eliminates or reduces the number of pathogenic 
microorganisms on or in a product to make the product safe for human 
consumption. Examples of lethality treatments are cooking or the 
application of an antimicrobial agent or process that eliminates or 
reduces pathogenic microorganisms.
    Post-lethality exposed product. Ready-to-eat product that comes into 
direct contact with a food contact surface after the lethality treatment 
in a post-lethality processing environment.
    Post-lethality processing environment. The area of an establishment 
into which product is routed after having been subjected to an initial 
lethality treatment. The product may be exposed to the environment in 
this area as a result of slicing, peeling, re-bagging, cooling semi-
permeable encased product with a brine solution, or other procedures.
    Post-lethality treatment. A lethality treatment that is applied or 
is effective after post-lethality exposure. It is applied to the final 
product or sealed package of product in order to reduce or eliminate the 
level of pathogens resulting from contamination from post-lethality 
exposure.
    Prerequisite program. A procedure or set of procedures that is 
designed to provide basic environmental or operating conditions 
necessary for the production of safe, wholesome food. It is called 
``prerequisite'' because it is considered by scientific experts to be 
prerequisite to a HACCP plan.
    Ready-to-eat (RTE) product. A meat or poultry product that is in a 
form that

[[Page 663]]

is edible without additional preparation to achieve food safety and may 
receive additional preparation for palatability or aesthetic, epicurean, 
gastronomic, or culinary purposes. RTE product is not required to bear a 
safe-handling instruction (as required for non-RTE products by 9 CFR 
317.2(l) and 381.125(b)) or other labeling that directs that the product 
must be cooked or otherwise treated for safety, and can include frozen 
meat and poultry products.



Sec. 430.4  Control of Listeria monocytogenes in post-lethality exposed 
ready-to-eat products.

    (a) Listeria monocytogenes can contaminate RTE products that are 
exposed to the environment after they have undergone a lethality 
treatment. L. monocytogenes is a hazard that an establishment producing 
post-lethality exposed RTE products must control through its HACCP plan 
or prevent in the processing environment through a Sanitation SOP or 
other prerequisite program. RTE product is adulterated if it contains L. 
monocytogenes or if it comes into direct contact with a food contact 
surface which is contaminated with L. monocytogenes.
    (b) In order to maintain the sanitary conditions necessary to meet 
this requirement, an establishment producing post-lethality exposed RTE 
product must comply with the requirements included in one of the three 
following alternatives:
    (1) Alternative 1. Use of a post-lethality treatment (which may be 
an antimicrobial agent) that reduces or eliminates microorganisms on the 
product and an antimicrobial agent or process that suppresses or limits 
the growth of L. monocytogenes. If an establishment chooses this 
alternative:
    (i) The post-lethality treatment must be included in the 
establishment's HACCP plan. The antimicrobial agent or process used to 
suppress or limit the growth of the pathogen must be included in either 
the establishment's HACCP plan or its Sanitation SOP or other 
prerequisite program.
    (ii) The establishment must validate the effectiveness of the post-
lethality treatment incorporated in its HACCP plan in accordance with 
Sec. 417.4. The establishment must document, either in its HACCP plan 
or in its Sanitation SOP or other prerequisite program, that the 
antimicrobial agent or process, as used, is effective in suppressing or 
limiting growth of L. monocytogenes.
    (2) Alternative 2. Use of either a post-lethality treatment (which 
may be an antimicrobial agent) that reduces or eliminates microorganisms 
on the product or an antimicrobial agent or process that suppresses or 
limits growth of L. monocytogenes. If an establishment chooses this 
alternative:
    (i) The post-lethality treatment must be included in the 
establishment's HACCP plan. The antimicrobial agent or process used to 
suppress or limit growth of the pathogen must be included in either the 
establishment's HACCP plan or its Sanitation SOP or other prerequisite 
program.
    (ii) The establishment must validate the effectiveness of a post-
lethality treatment incorporated in its HACCP plan in accordance with 
Sec. 417.4. The establishment must document in its HACCP plan or in its 
Sanitation SOP or other prerequisite program that the antimicrobial 
agent or process, as used, is effective in suppressing or limiting 
growth of L. monocytogenes.
    (iii) If an establishment chooses this alternative and chooses to 
use only an antimicrobial agent or process that suppresses or limits the 
growth of L. monocytogenes, its sanitation program must:
    (A) Provide for testing of food contact surfaces in the post-
lethality processing environment to ensure that the surfaces are 
sanitary and free of L. monocytogenes or of an indicator organism;
    (B) Identify the conditions under which the establishment will 
implement hold-and-test procedures following a positive test of a food-
contact surface for L. monocytogenes or an indicator organism;
    (C) State the frequency with which testing will be done;
    (D) Identify the size and location of the sites that will be 
sampled; and
    (E) Include an explanation of why the testing frequency is 
sufficient to ensure that effective control of L. monocytogenes or of 
indicator organisms is maintained.

[[Page 664]]

    (iv) An establishment that chooses this alternative and uses a post-
lethality treatment of product will likely be subject to more frequent 
verification testing by FSIS than if it had chosen Alternative 1. An 
establishment that chooses this alternative and uses an antimicrobial 
agent or process that suppresses or limits the growth of L. 
monocytogenes will likely be subject to more frequent FSIS verification 
testing than if it uses a post-lethality treatment.
    (3) Alternative 3. Use of sanitation measures only.
    (i) If an establishment chooses this alternative, its sanitation 
program must:
    (A) Provide for testing of food contact surfaces in the post-
lethality processing environment to ensure that the surfaces are 
sanitary and free of L. monocytogenes or of an indicator organism;
    (B) Identify the conditions under which the establishment will 
implement hold-and-test procedures following a positive test of a food-
contact surface for L. monocytogenes or an indicator organism;
    (C) State the frequency with which testing will be done;
    (D) Identify the size and location of the sites that will be 
sampled; and
    (E) Include an explanation of why the testing frequency is 
sufficient to ensure that effective control of L. monocytogenes or of 
indicator organisms is maintained.
    (ii) An establishment producing a deli product or a hotdog product, 
in addition to meeting the requirements of paragraph (b)(3)(i) of this 
section, must meet the following requirements:
    (A) The establishment must verify that the corrective actions that 
it takes with respect to sanitation after an initial positive test for 
L. monocytogenes or an indicator organism on a food contact surface in 
the post-lethality processing environment are effective by conducting 
follow-up testing that includes a targeted test of the specific site on 
the food contact surface area that is the most likely source of 
contamination by the organism and such additional tests in the 
surrounding food contact surface area as are necessary to ensure the 
effectiveness of the corrective actions.
    (B) During this follow-up testing, if the establishment obtains a 
second positive test for L. monocytogenes or an indicator organism, the 
establishment must hold lots of product that may have become 
contaminated by contact with the food contact surface until the 
establishment corrects the problem indicated by the test result.
    (C) Further, in order to be able to release into commerce the lots 
of product that may have become contaminated with L. monocytogenes, the 
establishment must sample and test the lots for L. monocytogenes or an 
indicator organism using a sampling method and frequency that will 
provide a level of statistical confidence that ensures that each lot is 
not adulterated with L. monocytogenes. The establishment must document 
the results of this testing. Alternatively, the establishment may rework 
the held product using a process that is destructive of L. monocytogenes 
or the indicator organism.
    (iii) An establishment that chooses Alternative 3 is likely to be 
subject to more frequent verification testing by FSIS than an 
establishment that has chosen Alternative 1 or 2. An establishment that 
chooses Alternative 3 and that produces deli meat or hotdog products is 
likely to be subject to more frequent verification testing than one that 
does not produce such products.
    (c) For all three alternatives in paragraph (b):
    (1) Establishments may use verification testing that includes tests 
for L. monocytogenes or an indicator organism, such as Listeria species, 
to verify the effectiveness of their sanitation procedures in the post-
lethality processing environment.
    (2) Sanitation measures for controlling L. monocytogenes and 
procedures for antimicrobial agents or processes that suppress or limit 
the growth of the pathogen may be incorporated either in the 
establishment's HACCP plan or in its Sanitation SOP or other 
prerequisite program. When these control procedures are incorporated 
into the Sanitation SOP or prerequisite program, and not as a CCP in the 
HACCP

[[Page 665]]

plan, the establishment must have documentation that supports the 
decision in its hazard analysis that L. monocytogenes is not a hazard 
that is reasonably likely to occur.
    (3) The establishment must maintain sanitation in the post-lethality 
processing environment in accordance with part 416.
    (4) If L. monocytogenes control measures are included in the HACCP 
plan, the establishment must validate and verify the effectiveness of 
measures for controlling L. monocytogenes included in its HACCP plan in 
accordance with Sec. 417.4.
    (5) If L. monocytogenes control measures are included in the 
Sanitation SOP, the effectiveness of the measures must be evaluated in 
accordance with Sec. 416.14.
    (6) If the measures for addressing L. monocytogenes are addressed in 
a prerequisite program other than the Sanitation SOP, the establishment 
must include the program and the results produced by the program in the 
documentation that the establishment is required to maintain under 9 CFR 
417.5.
    (7) The establishment must make the verification results that 
demonstrate the effectiveness of the measures it employs, whether under 
its HACCP plan or its Sanitation SOP or other prerequisite program, 
available upon request to FSIS inspection personnel.
    (d) An establishment that produces post-lethality exposed RTE 
product shall provide FSIS, at least annually, or more often, as 
determined by the Administrator, with estimates of annual production 
volume and related information for the types of meat and poultry 
products processed under each of the alternatives in paragraph (b) of 
this section.
    (e) An establishment that controls L. monocytogenes by using a post-
lethality treatment or an antimicrobial agent or process that eliminates 
or reduces, or suppresses or limits the growth of the organism may 
declare this fact on the product label provided that the establishment 
has validated the claim.



PART 441_CONSUMER PROTECTION STANDARDS: RAW PRODUCTS--Table of Contents




    Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906; 7 
CFR 2.18, 2.53.

    Source: 66 FR 1771, Jan. 9, 2001, unless otherwise noted.



Sec. 441.10  Retained water.

    (a) Raw livestock and poultry carcasses and parts will not be 
permitted to retain water resulting from post-evisceration processing 
unless the establishment preparing those carcasses and parts 
demonstrates to FSIS, with data collected in accordance with a written 
protocol, that any water retained in the carcasses or parts is an 
unavoidable consequence of the process used to meet applicable food 
safety requirements.
    (b) Raw livestock and poultry carcasses and parts that retain water 
from post-evisceration processing and that are sold, transported, 
offered for sale or transportation, or received for transportation, in 
commerce, must bear a statement on the label in prominent letters and 
contiguous to the product name or elsewhere on the principal display 
panel of the label stating the maximum percentage of water that may be 
retained (e.g., ``up to X% retained water,'' ``less than X% retained 
water,'' ``up to X% water added from processing''). The percent water 
statement need not accompany the product name on other parts of the 
label. Raw livestock and poultry carcasses and parts that retain no 
water may bear a statement that no water is retained.
    (c)(1) An establishment subject to paragraph (a) of this section 
must maintain on file and available to FSIS its written data-collection 
protocol. The protocol must explain how data will be collected and used 
to demonstrate the amount of retained water in the product covered by 
the protocol that is an unavoidable consequence of the process used to 
meet specified food safety requirements.
    (2) The establishment must notify FSIS as soon as it has a new or 
revised protocol available for review by the Agency. Within 30 days 
after receipt of this notification, FSIS may object to

[[Page 666]]

or require the establishment to make changes in the protocol.
    (d) Expected elements of a protocol for gathering water retention 
data:
    (1) Purpose statement. The primary purpose of the protocol should be 
to determine the amount or percentage of water absorption and retention 
that is unavoidable using a particular chilling system while achieving 
the regulatory pathogen reduction performance standard for Salmonella as 
set forth in the PR/HACCP regulations (9 CFR 310.25(b), 381.94(b)) and 
the time/temperature requirements set forth in 9 CFR 381.66. Additional 
purposes that could be included are determining chilling system 
efficiency and evaluating product quality.
    (2) Type of washing and chilling system used by the establishment. 
Any post-evisceration washing or chilling processes that affect water 
retention levels in and microbial loads on raw products should be 
described. For poultry establishments, the main chiller types, 
identified by the mechanism used to transport the birds through the 
chiller or to agitate the water in the chiller, are the drag-through, 
the screw type, and the rocker-arm type.
    (3) Configuration and any modifications of the chiller system 
components. A description of chiller-system configurations and 
modifications should be provided. The description should include the 
number and type of chillers in a series and arrangements of chilling 
system components, and the number of evisceration lines feeding into a 
chiller system. If there is a pre-chilling step in the process, its 
purpose and the type of equipment used should be accurately described. 
Any mechanical or design changes made to the chilling equipment should 
be described.
    (4) Special features in the chilling process. Any special features 
in the chilling process, such as antimicrobial treatments, should be 
described. Also, the length and velocity of the dripping line should be 
described, as well as the total time allowed for dripping. Any special 
apparatus, such as a mechanism for squeezing excessive water from 
chilled birds, should be explained.
    (5) Description of variable factors in the chilling system. The 
protocol should describe variable factors that affect water absorption 
and retention. In poultry processing, such factors are typically 
considered to be the time in chiller water, the water temperature, and 
agitation. The protocol should consider air agitation, where applicable. 
Additional factors that may affect water absorption and retention are 
scalding temperature and the pressure or amount of buffeting applied to 
birds by feather removal machinery, and the resultant loosening of the 
skin. Another factor that should be considered is the method used to 
open the bird for evisceration.
    (6) Standards to be met by the chilling system. For example, the 
chilling system may be designed simply to achieve a reduction in 
temperature of ready-to-cook poultry to less than 40 [deg]F within the 
time limit specified by the regulations, or in less time. As to the 
standard for pathogen minimization, the Salmonella pathogen reduction 
standards, as set forth in the PR/HACCP final rule, have been suggested. 
Although there is not yet an applicable Salmonella standard for turkeys, 
establishments are free to adopt practicable criteria for use in 
gathering data on turkeys under the protocols here suggested. Additional 
microbiological targets, such as E. coli or Campylobacter levels, or 
reductions in numbers of other microorganisms, may also be used.
    (7) Testing methods to be employed. The protocol should detail the 
testing methods to be used both for measuring water absorption and 
retention and for sampling and testing product for pathogen reductions. 
The protocol should call for water retention and pathogen reduction 
tests at various chilling equipment settings and chilling time-and-
temperature combinations. The method to be used in calculating water 
absorption and retention should be reproducible and statistically 
verifiable. With respect to the pathogen-reduction aspect of the 
testing, FSIS recommends the methods used for E. coli and Salmonella 
testing under the PR/HACCP regulations. The number of samples, the type 
of samples, the sampling time period, and the type of testing or 
measurement should be included in the protocol.

[[Page 667]]

    (8) Reporting of data and evaluation of results. The protocol should 
explain how data obtained are to be reported and summarized. The 
criteria for evaluating the results and the basis for conclusions to be 
drawn should be explained.
    (9) Conclusions. The protocol should provide for a statement of what 
the data obtained demonstrate and what conclusions were reached.



PART 500_RULES OF PRACTICE--Table of Contents




Sec.
500.1 Definitions.
500.2 Regulatory control action.
500.3 Withholding or suspension of inspection without prior 
          notification.
500.4 Withholding action or suspension of inspection with prior 
          notification.
500.5 Notification, appeals, and actions held in abeyance.
500.6 Withdrawal of inspection.
500.7 Refusal to grant inspection.
500.8 Procedures for rescinding or refusing approval of marks, labels, 
          sizes, and containers.

    Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906; 7 
CFR 2.18, 2.53.

    Source: 64 FR 66546, Nov. 29, 1999, unless otherwise noted.



Sec. 500.1  Definitions.

    (a) A ``regulatory control action'' is the retention of product, 
rejection of equipment or facilities, slowing or stopping of lines, or 
refusal to allow the processing of specifically identified product.
    (b) A ``withholding action'' is the refusal to allow the marks of 
inspection to be applied to products. A withholding action may affect 
all product in the establishment or product produced by a particular 
process.
    (c) A ``suspension'' is an interruption in the assignment of program 
employees to all or part of an establishment.



Sec. 500.2  Regulatory control action.

    (a) FSIS may take a regulatory control action because of:
    (1) Insanitary conditions or practices;
    (2) Product adulteration or misbranding;
    (3) Conditions that preclude FSIS from determining that product is 
not adulterated or misbranded; or
    (4) Inhumane handling or slaughtering of livestock.
    (b) If a regulatory control action is taken, the program employee 
will immediately notify the establishment orally or in writing of the 
action and the basis for the action.
    (c) An establishment may appeal a regulatory control action, as 
provided in Sec. Sec. 306.5 and 381.35 of this chapter.



Sec. 500.3  Withholding action or suspension without prior notification.

    (a) FSIS may take a withholding action or impose a suspension 
without providing the establishment prior notification because:
    (1) The establishment produced and shipped adulterated or misbranded 
product as defined in 21 U.S.C. 453 or 21 U.S.C. 602;
    (2) The establishment does not have a HACCP plan as specified in 
Sec. 417.2 of this chapter;
    (3) The establishment does not have Sanitation Standard Operating 
Procedures as specified in Sec. Sec. 416.11-416.12 of this chapter;
    (4) Sanitary conditions are such that products in the establishment 
are or would be rendered adulterated;
    (5) The establishment violated the terms of a regulatory control 
action;
    (6) An establishment operator, officer, employee, or agent 
assaulted, threatened to assault, intimidated, or interfered with an 
FSIS employee; or
    (7) The establishment did not destroy a condemned meat or poultry 
carcass, or part or product thereof, in accordance with part 314 or part 
381, subpart L, of this chapter within three days of notification.
    (b) FSIS also may impose a suspension without providing the 
establishment prior notification because the establishment is handling 
or slaughtering animals inhumanely.



Sec. 500.4  Withholding action or suspension with prior notification.

    FSIS may take a withholding action or impose a suspension after an 
establishment is provided prior notification and the opportunity to 
demonstrate or achieve compliance because:
    (a) The HACCP system is inadequate, as specified in Sec. 417.6 of 
this chapter,

[[Page 668]]

due to multiple or recurring noncompliances;
    (b) The Sanitation Standard Operating Procedures have not been 
properly implemented or maintained as specified in Sec. Sec. 416.13 
through 416.16 of this chapter;
    (c) The establishment has not maintained sanitary conditions as 
prescribed in Sec. Sec. 416.2-416.8 of this chapter due to multiple or 
recurring noncompliances;
    (d) The establishment did not collect and analyze samples for 
Escherichia coli Biotype I and record results in accordance with Sec. 
310.25(a) or Sec. 381.94(a) of this chapter;
    (e) The establishment did not meet the Salmonella performance 
standard requirements prescribed in Sec. 310.25(b) or Sec. 381.94(b) 
of this chapter.



Sec. 500.5  Notification, appeals, and actions held in abeyance.

    (a) If FSIS takes a withholding action or imposes a suspension, the 
establishment will be notified orally and, as promptly as circumstances 
permit, in writing. The written notification will:
    (1) State the effective date of the action(s),
    (2) Describe the reasons for the action(s),
    (3) Identify the products or processes affected by the action(s),
    (4) Provide the establishment an opportunity to present immediate 
and corrective action and further planned preventive action; and
    (5) Advise the establishment that it may appeal the action as 
provided in Sec. Sec. 306.5 and 381.35 of this chapter.
    (b) The prior notification provided for in Sec. 500.4 of this part 
will:
    (1) State the type of action that FSIS may take;
    (2) Describe the reason for the proposed action;
    (3) Identify the products or processes affected by the proposed 
action;
    (4) Advise the establishment of its right to contact FSIS to contest 
the basis for the proposed action or to explain how compliance has been 
or will be achieved; and
    (5) Advise the establishment that it will have three business days 
from receipt of the written notification to respond to FSIS unless the 
time period is extended by FSIS.
    (c) An establishment may appeal the withholding action or 
suspension, as provided in Sec. Sec. 306.5 and 381.35 of this chapter.
    (d) If FSIS suspends inspection and does not hold the suspension 
action in abeyance as provided in paragraph (e) of this section, the 
establishment may request a hearing pursuant to the Uniform Rules of 
Practice, 7 CFR Subtitle A, part 1, subpart H. Upon such request, the 
Administrator will file a complaint that will include a request for an 
expedited hearing.
    (e) FSIS may hold a suspension in abeyance and allow the 
establishment to operate under the conditions agreed to by FSIS and the 
establishment.



Sec. 500.6  Withdrawal of inspection.

    The FSIS Administrator may file a complaint to withdraw a grant of 
Federal inspection in accordance with the Uniform Rules of Practice, 7 
CFR Subtitle A, part 1, subpart H because:
    (a) An establishment produced and shipped adulterated product;
    (b) An establishment did not have or maintain a HACCP plan in 
accordance with part 417 of this chapter;
    (c) An establishment did not have or maintain Sanitation Standard 
Operating Procedures in accordance with part 416 of this chapter;
    (d) An establishment did not maintain sanitary conditions;
    (e) An establishment did not collect and analyze samples for 
Escherichia coli Biotype I and record results as prescribed in Sec. 
310.25(a) or Sec. 381.94(a) of this chapter;
    (f) An establishment did not comply with the Salmonella performance 
standard requirements as prescribed in Sec. Sec. 310.25(b) and 
381.94(b) of this chapter;
    (g) An establishment did not slaughter or handle livestock humanely;
    (h) An establishment operator, officer, employee, or agent 
assaulted, threatened to assault, intimidated, or interfered with an 
FSIS program employee; or
    (i) A recipient of inspection or anyone responsibly connected to the 
recipient is unfit to engage in any business requiring inspection as 
specified

[[Page 669]]

in section 401 of the FMIA or section 18(a) of the PPIA.



Sec. 500.7  Refusal to grant inspection.

    (a) The FSIS Administrator may refuse to grant Federal inspection 
because an applicant:
    (1) Does not have a HACCP plan as required by part 417 of this 
chapter;
    (2) Does not have Sanitation Standard Operating Procedures as 
required by part 416 of this chapter;
    (3) Has not demonstrated that adequate sanitary conditions exist in 
the establishment as required by part 308 or part 381, subpart H, and 
part 416 of this chapter;
    (4) Has not demonstrated that livestock will be handled and 
slaughtered humanely; or
    (5) Is unfit to engage in any business requiring inspection as 
specified in section 401 of the FMIA or section 18(a) of the PPIA.
    (b) If the Administrator refuses to grant inspection, the applicant 
will be provided the opportunity for a hearing in accordance with the 
Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H.



Sec. 500.8  Procedures for rescinding or refusing approval of marks, 
labels, and containers.

    (a) FSIS may rescind or refuse approval of false or misleading 
marks, labels, or sizes or forms of any container for use with any meat 
or poultry product under section 7 of the FMIA or under section 8 of the 
PPIA.
    (b) FSIS will provide written notification that:
    (1) Explains the reason for rescinding or refusing the approval;
    (2) Provides an opportunity for the establishment to modify the 
marking, labeling, or container so that it will no longer be false or 
misleading; and
    (3) Advises the establishment of its opportunity to submit a written 
statement to respond to the notification and to request a hearing.
    (c) If FSIS rescinds or refuses approval of false or misleading 
marks, labels, or sizes or forms of any container for use with any meat 
or poultry product, an opportunity for a hearing will be provided in 
accordance with the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, 
subpart H.

[[Page 670]]



                  SUBCHAPTER I_EGG PRODUCTS INSPECTION





PART 590_INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT)
--Table of Contents




                               Definitions

Sec.
590.1 Meaning of words.
590.5 Terms defined.

                             Administration

590.10 Authority.
590.13 Federal and State cooperation.
590.17 Nondiscrimination.
590.18 OMB control numbers assigned pursuant to the Paperwork Reduction 
          Act.

                           Scope of Inspection

590.20 Inspection in accordance with methods prescribed or approved.
590.22 Basis of service.
590.24 Egg products plants requiring continuous inspection.
590.26 Egg products entering or prepared in official plants.
590.28 Other inspections.

                      Relation to Other Authorities

590.30 At official plants.
590.35 Eggs and egg products outside official plants.

            Eggs and Egg Products Not Intended for Human Food

590.40 Continuous inspection not provided.
590.45 Prohibition on eggs and egg products not intended for use as 
          human food.

                       Refrigeration of Shell Eggs

590.50 Temperature and labeling requirements.

                               Exemptions

590.100 Specific exemptions.
590.105 Suspension or termination of exemptions.

                         Performance of Service

590.110 Licensed inspectors.
590.112 Suspension of license or authority; revocation.
590.114 Surrender of license.
590.116 Activities of inspectors.
590.118 Identification.
590.119 Political activity.
590.120 Financial interest of inspectors.
590.122 Time of inspection.
590.124 Schedule of operation of official plants.
590.126 Overtime inspection service.
590.128 Holiday inspection service.
590.130 Basis of billing plants.
590.132 Access to plants.
590.134 Accessibility of product and cooler rooms.
590.136 Facilities and equipment to be furnished by official plants for 
          use of inspectors in performing service.

                         Application for Service

590.140 How application shall be made.
590.142 Filing of application.
590.144 Authority of applicant.
590.146 Application for continuous inspection in official plants; 
          approval.
590.148 Order of service.

                         Inauguration of Service

590.150 Official plant numbers.
590.155 Inauguration of service.

                            Denial of Service

590.160 Refusal, suspension, or withdrawal of service.
590.161 Termination of plant approval.

Records and Related Requirements for Eggs and Egg Products Handlers and 
                           Related Industries

590.200 Records and related requirements.
590.220 Information and assistance to be furnished to inspectors.

                        Administrative Detention

590.240 Detaining product.

                   Appeal of an Inspection or Decision

590.300 Who may request an appeal inspection or review of an inspector's 
          decision.
590.310 Where to file an appeal.
590.320 How to file an appeal.
590.330 When an application for an appeal inspection may be refused.
590.340 Who shall perform the appeal.
590.350 Procedures for selecting appeal samples.
590.360 Appeal inspection certificates.
590.370 Cost of appeals.

                              Certificates

590.400 Form of certificates.
590.402 Egg products inspection certificates.
590.404 Erasures or alterations made on official certificates.
590.406 Disposition of official certificates.

                     Identifying and Marking Product

590.410 Shell eggs and egg products required to be labeled.
590.411 Requirement of formulas and approval of labels for use in 
          official egg products plants.

[[Page 671]]

590.412 Form of official identification symbol and inspection mark.
590.414 Products bearing the official inspection mark.
590.415 Use of other official identification.
590.417 Unauthorized use or disposition of approved labels.
590.418 Supervision of marking and packaging.
590.419 Reuse of containers bearing official identification prohibited.

          Inspection, Reinspection, Condemnation, and Retention

590.420 Inspection.
590.422 Condemnation.
590.424 Reinspection.
590.426 Retention.

          Entry of Materials Into Official Egg Products Plants

590.430 Limitation on entry of material.
590.435 Wholesomeness and approval of materials.
590.440 Processing ova.

             Sanitary, Processing, and Facility Requirements

590.500 Plant requirements.
590.502 Equipment and utensils; PCB-containing equipment.
590.504 General operating procedures.
590.506 Candling and transfer-room facilities and equipment.
590.508 Candling and transfer-room operations.
590.510 Classifications of shell eggs used in the processing of egg 
          products.
590.515 Egg cleaning operations.
590.516 Sanitizing and drying of shell eggs prior to breaking.
590.520 Breaking room facilities.
590.522 Breaking room operations.
590.530 Liquid egg cooling.
590.532 Liquid egg holding.
590.534 Freezing facilities.
590.536 Freezing operations.
590.538 Defrosting facilities.
590.539 Defrosting operations.
590.540 Spray process drying facilities.
590.542 Spray process drying operations.
590.544 Spray process powder; definitions and requirements.
590.546 Albumen flake process drying facilities.
590.547 Albumen flake process drying operations.
590.548 Drying, blending, packaging, and heat treatment rooms and 
          facilities.
590.549 Dried egg storage.
590.550 Washing and sanitizing room or area facilities.
590.552 Cleaning and sanitizing requirements.
590.560 Health and hygiene of personnel.
590.570 Pasteurization of liquid eggs.
590.575 Heat treatment of dried whites.

                               Laboratory

590.580 Laboratory tests and analyses.

                      Exempted Egg Products Plants

590.600 Application for exemption.
590.610 Criteria for exemption.
590.620 Authority of applicant.
590.630 Filing of application.
590.640 Application for exemption; approval.
590.650 Exempted plant registration number.
590.660 Inspection of exempted plants.
590.670 Termination of exemption.
590.680 Approval of labeling for egg products processed in exempted egg 
          products processing plants.

Identification of Restricted Eggs or Egg Products Not Intended for Human 
                               Consumption

590.800 Identification of restricted eggs.
590.840 Identification of inedible, unwhole some, or adulterated egg 
          products.
590.860 Identification wording.

                                 Imports

590.900 Requirements for importation of egg products or restricted eggs 
          into the United States.
590.905 Importation of restricted eggs or eggs containing more 
          restricted eggs than permitted in the official standards for 
          U.S. Consumer Grade B.
590.910 Eligibility of foreign countries for importation of egg products 
          into the United States.
590.915 Foreign inspection certification required.
590.920 Importer to make application for inspection of imported eggs and 
          egg products.
590.925 Inspection of imported egg products.
590.930 Imported egg products; retention in customs custody; delivery 
          under bond; movement prior to inspection; sealing; handling; 
          facilities, and assistance.
590.935 Means of conveyance and equipment used in handling egg products 
          to be maintained in sanitary condition.
590.940 Marking of egg products offered for importation.
590.945 Foreign egg products offered for importation; reporting of 
          findings to customs; handling of products refused entry.
590.950 Labeling of containers of eggs or egg products for importation.
590.955 Labeling of shipping containers of eggs or egg products for 
          importation.
590.956 Relabeling of imported egg products.
590.960 Small importations for consignee's personal use, display, or 
          laboratory analysis.
590.965 Returned U.S. inspected and marked products; not importations.

[[Page 672]]

590.970 Charges for storage, cartage, and labor with respect to products 
          imported contrary to the Act.

    Authority: 21 U.S.C. 1031-1056.

    Source: 36 FR 9814, May 28, 1971, unless otherwise noted. 
Redesignated at 42 FR 32514, June 27, 1977 and 46 FR 63203, Dec. 31, 
1981. Further redesignated at 63 FR 72353, Dec. 31, 1998.

                               Definitions



Sec. 590.1  Meaning of words.

    Under these regulations, words in the singular shall be deemed to 
mean the plural and vice versa, as the case may demand.



Sec. 590.5  Terms defined.

    For the purpose of these regulations, unless the context otherwise 
requires, the following terms shall be construed, respectively, as 
follows:
    Acceptable means suitable for the purpose intended and acceptable to 
the Administrator.
    Act means the applicable provisions of the Egg Products Inspection 
Act (Pub. L. 91-597, 84 Stat. 1620 et seq.).
    Administrator means the Administrator of the Agricultural Marketing 
Service of the Department or any other officer or employee of the 
Department to whom there has heretofore been delegated, or to whom there 
may hereafter be delegated the authority to act in his stead.
    Adulterated means any egg or egg product under one or more of the 
following circumstances:
    (a) If it bears or contains any poisonous or deleterious substance 
which may render it injurious to health; but in case the substance is 
not an added substance, such article shall not be considered adulterated 
under this clause if the quantity of such substance in or on such 
article does not ordinarily render it injurious to health;
    (b)(1) If it bears or contains any added poisonous or added 
deleterious substance (other than one which is (i) a pesticide chemical 
in or on a raw agricultural commodity; (ii) a food additive; or (iii) a 
color additive) which may in the judgment of the Secretary, make such 
article unfit for human food;
    (2) If it is, in whole or in part, a raw agricultural commodity and 
such commodity bears or contains a pesticide chemical which is unsafe 
within the meaning of section 408 of the Federal Food, Drug, and 
Cosmetic Act;
    (3) If it bears or contains any food additive which is unsafe within 
the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act;
    (4) If it bears or contains any color additive which is unsafe 
within the meaning of section 706 of the Federal Food, Drug, and 
Cosmetic Act: Provided, that an article which is not otherwise deemed 
adulterated under paragraph (b)(2), (3), or (4) of this definition shall 
nevertheless be deemed adulterated if use of the pesticide chemical, 
food additive, or color additive, in or on such article, is prohibited 
by regulations of the Secretary in official plants;
    (c) If it consists in whole or in part of any filthy, putrid, or 
decomposed substance, or if it is otherwise unfit for human food;
    (d) If it has been prepared, packaged, or held under insanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health;
    (e) If it is an egg which has been subjected to incubation or the 
product of any egg which has been subjected to incubation;
    (f) If its container is composed, in whole or in part of any 
poisonous or deleterious substance which may render the contents 
injurious to health;
    (g) If it has been intentionally subjected to radiation, unless the 
use of the radiation was in conformity with a regulation or exemption in 
effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic 
Act; or
    (h) If any valuable constituent has been, in whole or in part, 
omitted or abstracted therefrom; or if any substance has been 
substituted, wholly or in part therefor; or if damage or inferiority has 
been concealed in any manner; or if any substance has been added thereto 
or mixed or packed therewith so as to increase its bulk or weight, or 
reduce its quality or strength, or make it appear better or of greater 
value than it is.

[[Page 673]]

    Ambient temperature means the air temperature maintained in an egg 
storage facility or transport vehicle.
    Applicant means any person who requests any inspection service as 
authorized under the Act or the regulations of this part.
    Capable of use as human food means any egg or egg product, unless it 
is denatured, or otherwise identified, as required by these regulations 
to deter its use as human food.
    Chief of the Grading Branch means Chief of the Poultry Grading 
Branch, Poultry Division, Agricultural Marketing Service.
    Class means any subdivision of a product based on essential physical 
characteristics that differentiate between major groups of the same 
kind, type, or method of processing.
    Commerce means interstate, foreign, or intrastate commerce.
    Condition means any condition (including, but not being limited to, 
the state of preservation, cleanliness, soundness, wholesomeness, or 
fitness for human food) of any product which affects its 
merchantability; or any condition, including but not being limited to, 
the processing, handling, or packaging which affects such product.
    Container or Package includes for egg products, any box, can, tin, 
plastic, or other receptacle, wrapper, or cover and for shell eggs, any 
carton, basket, case, cart, pallet, or other receptacle.
    (a) Immediate container means any package or other container in 
which egg products or shell eggs are packed for household or other 
ultimate consumers.
    (b) Shipping container means any container used in packing an 
immediate container.
    Department means the U.S. Department of Agriculture.
    Dirty egg or Dirties means an egg(s) that has an unbroken shell with 
adhering dirt or foreign material.
    Egg means the shell egg of the domesticated chicken, turkey, duck, 
goose, or guinea. Some of the terms applicable to shell eggs are as 
follows:
    (a) Check means an egg that has a broken shell or crack in the shell 
but has its shell membranes intact and contents not leaking.
    (b) Clean and sound shell egg means any egg whose shell is free of 
adhering dirt or foreign material and is not cracked or broken.
    (c) Dirty egg or Dirties means an egg(s) that has a shell that is 
unbroken and has adhering dirt, foreign material, or prominent stains.
    (d) Incubator reject means an egg that has been subjected to 
incubation and has been removed from incubation during the hatching 
operations as infertile or otherwise unhatchable.
    (e) Inedible means eggs of the following descriptions: Black rots, 
yellow rots, white rots, mixed rots, sour eggs, eggs with green whites, 
eggs with stuck yolks, moldy eggs, musty eggs, eggs showing blood rings, 
and eggs containing embryo chicks (at or beyond the blood ring stage).
    (f) Leaker means an egg that has a crack or break in the shell and 
shell membranes to the extent that the egg contents are exposed or are 
exuding or free to exude through the shell.
    (g) Loss means an egg that is unfit for human food because it is 
smashed or broken so that its contents are leaking; or overheated, 
frozen, or contaminated; or an incubator reject; or because it contains 
a bloody white, large meat spots, a large quantity of blood, or other 
foreign material.
    (h) Restricted egg means any check, dirty egg, incubator reject, 
inedible, leaker, or loss.
    Egg handler means any person, excluding the ultimate consumer, who 
engages in any business in commerce that involves buying or selling any 
eggs (as a poultry producer or otherwise), or processing any egg 
products, or otherwise using any eggs in the preparation of human food.
    Egg product means any dried, frozen, or liquid eggs, with or without 
added ingredients, excepting products which contain eggs only in a 
relatively small proportion or historically have not been, in the 
judgment of the Secretary, considered by consumers as products of the 
egg food industry, and which may be exempted by the Secretary under such 
conditions as he may prescribe to assure that the egg ingredients are 
not adulterated and such products are not represented as egg products. 
For the purposes of this part, the following

[[Page 674]]

products, among others, are exempted as not being egg products: Freeze-
dried products, imitation egg products, egg substitutes, dietary foods, 
dried no-bake custard mixes, egg nog mixes, acidic dressings, noodles, 
milk and egg dip, cake mixes, French toast, and sandwiches containing 
eggs or egg products, provided, such products are prepared from 
inspected egg products or eggs containing no more restricted eggs than 
are allowed in the official standards for U.S. Consumer Grade B shell 
eggs. Balut and other similar ethnic delicacies are also exempted from 
inspection under this part.
    Eggs of current production means shell eggs which have moved through 
the usual marketing channels since the time they were laid and are not 
in excess of 60 days old.
    Fair Packaging and Labeling Act means the Act so entitled, approved 
November 3, 1966 (80 Stat. 1296), and Acts amendatory thereof or 
supplementary thereto.
    Federal Food, Drug, and Cosmetic Act means the Act so entitled, 
approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or 
supplementary thereto.
    Inspection means the application of such inspection methods and 
techniques as are deemed necessary by the responsible Secretary to carry 
out the provisions of the Egg Products Inspection Act and the 
regulations under this part.
    Inspection service means the official service within the Department 
having the responsibility for carrying out the provisions of the Egg 
Products Inspection Act. Inspection service also means the activities 
performed, including official reporting by such official service.
    Inspector/Grader means:
    (a) Any employee or official of the United States Government 
authorized to inspect eggs or egg products under the authority of this 
part; or
    (b) Any employee or official of the government of any State or local 
jurisdiction authorized by the Secretary to inspect eggs or egg products 
under the authority of this part, under an agreement entered into 
between the Secretary and the appropriate State or other agency.
    Interested party means any person financially interested in a 
transaction involving any inspection or appeal inspection of any 
product, or the decision of an inspector.
    Label means a display of any printed, graphic, or other method of 
identification upon the shipping container, if any, or upon the 
immediate container, including but not limited to, an individual 
consumer package of eggs and egg products, or accompanying such product.
    Misbranded means any egg products which are not labeled and packaged 
in accordance with the requirements prescribed by regulations of the 
Administrator under this part.
    National Supervisor means:
    (a) The officer in charge of the inspection service; and
    (b) Such other employee of the Service as may be designated by him.
    Nest-run eggs means eggs which are packed as they come from the 
production facilities without having been washed, sized and/or candled 
for quality, with the exception that some checks, dirties, or other 
obvious undergrades may have been removed.
    Official certificate means any certificate prescribed by regulations 
of the Administrator for issuance by an inspector or other person 
performing official functions under this part.
    Official device means any device prescribed or authorized by the 
Secretary for use in applying any official mark.
    Official identification means the official inspection mark or any 
other symbol prescribed by regulations of this part to identify the 
status of any article.
    Official inspection mark means any symbol prescribed by the 
regulations of the Administrator showing that egg products were 
inspected in accordance with this part.
    Official standard means the standards of quality, grades, and weight 
classes for eggs.
    Office of inspection means the office of any inspector.
    Pasteurize means the subjecting of each particle of egg products to 
heat or other treatments to destroy harmful viable microorganisms by 
such processes as may be prescribed by these regulations.

[[Page 675]]

    Person means any individual, partnership, corporation, association, 
or other business unit.
    Pesticide chemical, Food additive, Color additive, and Raw 
agricultural commodity shall have the same meaning for purposes of this 
part as under the Federal Food, Drug, and Cosmetic Act.
    Plant means any place of business where egg products are processed:
    (a) Exempted plant means any plant where the Administrator has 
determined the facilities and operating procedures meet such standards 
as may be prescribed by this part, and where the eggs received or used 
in the manufacture of egg products contain no more restricted eggs than 
are allowed by the official standards of U.S. Consumer Grade B for shell 
eggs, and where an exemption has been granted.
    (b) Official plant means any plant in which the plant facilities, 
methods of operation and sanitary procedures have been found suitable 
and adequate by the Administrator for the continuous inspection of egg 
products in accordance with this part and in which inspection service is 
carried on.
    Potable water means water that has been approved by a State health 
authority or other agency or laboratory acceptable to the Administrator 
as safe for drinking and suitable for food processing.
    Processing means manufacturing of egg products, including breaking 
eggs or filtering, mixing, blending, pasteurizing, stabilizing, cooling, 
freezing or drying, or packaging egg products at official plants.
    Producer-packer means any producer who sorts eggs only from his own 
production and packs them into their various qualities.
    Quality means the inherent properties of any product which determine 
its relative degree of excellence.
    Regional Director means any employee of the Department in charge of 
inspection service in a designated geographical region.
    Regulations means the provisions in this part.
    Regulatory inspector means any employee of the U.S. Government, or 
State or local jurisdiction, who is authorized by the Secretary to make 
such inspections as required in Sec. 590.28 of these regulations.
    Sampling means the act of taking samples of any product for 
inspection or analyses.
    Sanitize means the application of a bactericidal treatment which is 
approved as being effective in destroying microorganisms, including 
pathogens.
    Secretary means the Secretary of Agriculture or his delegate.
    Service means the Agricultural Marketing Service (AMS) of the 
Department.
    Shell egg packer (grading station) means any person engaged in the 
sorting of eggs from sources other than or in addition to his own 
production into their various qualities, either mechanically or by other 
means.
    Stabilization means the subjection of any egg product to a 
desugaring process.
    State means any State of the United States, the Commonwealth of 
Puerto Rico, the Virgin Islands of the United States, and the District 
of Columbia.
    Ultimate consumer means any household consumer, restaurant, 
institution, or any other party who has purchased or received shell eggs 
or egg products for consumption.
    United States means the States.
    Washed ungraded eggs means eggs which have been washed but not sized 
or segregated for quality.
    White or albumen means, for the purpose of this part, the product 
obtained from the egg as broken from the shell and separated from the 
yolk.

[36 FR 9814, May 28, 1971, as amended at 37 FR 6657, Apr. 4, 1972; 40 FR 
20057, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, as 
amended at 43 FR 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, Dec. 
31, 1981, as amended at 47 FR 46070, Oct. 15, 1982; 47 FR 54421, Dec. 3, 
1982; 54 FR 37289, Sept. 8, 1989; 60 FR 49168, Sept. 21, 1995; 60 FR 
58199, Nov. 27, 1995; 63 FR 45674, Aug. 27, 1998; 63 FR 69971, Dec. 17, 
1998]

                             Administration



Sec. 590.10  Authority.

    The Administrator shall perform, for and under the supervision of 
the Secretary, such duties as the Secretary may require in the 
enforcement or administration of the provisions of the Act, and this 
part. The Administrator

[[Page 676]]

may waive for a limited period any particular provisions of the 
regulations to permit experimentation so that new procedures, equipment, 
and processing techniques may be tested to facilitate definite 
improvements and at the same time to maintain full compliance with the 
spirit and intent of the regulations. The Agricultural Marketing Service 
and its officers and employees shall not be liable in damages through 
acts of commission or omission in the administration of this part.

[42 FR 2971, Jan. 14, 1977. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981]



Sec. 590.13  Federal and State cooperation.

    The Secretary shall, whenever he determines that it would effectuate 
the purposes of the Act, authorize the Administrator to cooperate with 
appropriate State and other governmental agencies in carrying out any 
provisions of the Egg Products Inspection Act and these regulations. In 
carrying out the provisions of the Act and the regulations, the 
Secretary may conduct such examinations, investigations, and inspections 
as he determines practicable through any officer or employee of any such 
agency commissioned by him for such purpose. The Secretary shall 
reimburse the States and other agencies for the services rendered by 
them in such cooperative programs as agreed to in the cooperative 
agreements as signed by the Administrator and the duly authorized agent 
of the State or other agency.



Sec. 590.17  Nondiscrimination.

    The conduct of all services and the licensing of graders and 
inspectors under these regulations shall be accomplished without 
discrimination as to race, color, religion, sex, national origin, age, 
or disability.

[40 FR 20057, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977. 
Further redesignated at 46 FR 63203, Dec. 31, 1981, and amended at 60 FR 
49169, Sept. 21, 1995]



Sec. 590.18  OMB control numbers assigned pursuant to the Paperwork 
Reduction Act.

    (a) Purpose. This section collects and displays the control numbers 
assigned to information collection requirements by the Office of 
Management and Budget contained in 7 CFR 590 pursuant to the Paperwork 
Reduction Act of 1980, Pub. L. 96-511.
    (b) Display.

------------------------------------------------------------------------
                                                            Current OMB
      7 CFR section where identified and described        control number
------------------------------------------------------------------------
Sec. 590.10...........................................       0581-0113
Sec. 590.13...........................................       0581-0113
Sec. 590.22...........................................       0581-0113
Sec. 590.28(a)(1).....................................       0581-0113
Sec. 590.40...........................................       0581-0113
Sec. 590.45(c)(1).....................................       0581-0113
Sec. 590.45(c)(3).....................................       0581-0113
Sec. 590.45(d)........................................       0581-0113
Sec. 590.110(a).......................................       0581-0113
Sec. 590.112..........................................       0581-0113
Sec. 590.122..........................................       0581-0113
Sec. 590.124..........................................       0581-0113
Sec. 590.126..........................................       0581-0113
Sec. 590.128(a).......................................       0581-0113
Sec. 590.140..........................................       0581-0113
Sec. 590.144..........................................       0581-0113
Sec. 590.146(b).......................................       0581-0113
Sec. 590.146(d).......................................       0581-0113
Sec. 590.155..........................................       0581-0113
Sec. 590.160(c).......................................       0581-0113
Sec. 590.160(d).......................................       0581-0113
Sec. 590.160(f)(3)....................................       0581-0113
Sec. 590.160(f)(4)....................................       0581-0113
Sec. 590.200(a).......................................       0581-0113
Sec. 590.200(b).......................................       0581-0113
Sec. 590.220..........................................       0581-0113
Sec. 590.240..........................................       0581-0113
Sec. 590.320..........................................       0581-0113
Sec. 590.402(a).......................................       0581-0113
Sec. 590.411(a).......................................       0581-0113
Sec. 590.411(b).......................................       0581-0113
Sec. 590.411(e).......................................       0581-0113
Sec. 590.411(f).......................................       0581-0113
Sec. 590.418(c).......................................       0581-0113
Sec. 590.430(b).......................................       0581-0113
Sec. 590.435(b).......................................       0581-0113
Sec. 590.435(c).......................................       0581-0113
Sec. 590.440(c).......................................       0581-0113
Sec. 590.500(h).......................................       0581-0113
Sec. 590.504(c).......................................       0581-0113
Sec. 590.504(d).......................................       0581-0113
Sec. 590.504(h).......................................       0581-0113
Sec. 590.504(k).......................................       0581-0113
Sec. 590.504(o)(1)....................................       0581-0113
Sec. 590.504(o)(2)....................................       0581-0113
Sec. 590.504(o)(3)(i).................................       0581-0113
Sec. 590.504(o)(3)(iii)...............................       0581-0113
Sec. 590.504(o)(3)(iv)................................       0581-0113
Sec. 590.504(o)(3)(v).................................       0581-0113
Sec. 590.515(a)(8)....................................       0581-0113
Sec. 590.520(h).......................................       0581-0113
Sec. 590.522(f).......................................       0581-0113
Sec. 590.522(x).......................................       0581-0113
Sec. 590.522(aa)(2)...................................       0581-0113
Sec. 590.530(d).......................................       0581-0113
Sec. 590.534(a).......................................       0581-0113
Sec. 590.544(b).......................................       0581-0113
Sec. 590.544(c).......................................       0581-0113
Sec. 590.544(d).......................................       0581-0113
Sec. 590.552(a)(3)....................................       0581-0113
Sec. 590.552(b)(1)(i).................................       0581-0113
Sec. 590.552(b)(2)....................................       0581-0113
Sec. 590.570(c).......................................       0581-0113
Sec. 590.575(b)(3)....................................       0581-0113
Sec. 590.575(d).......................................       0581-0113

[[Page 677]]

 
Sec. 590.580(c).......................................       0581-0113
Sec. 590.600..........................................       0581-0113
Sec. 590.610(a).......................................       0581-0113
Sec. 590.620..........................................       0581-0113
Sec. 590.640(b)(1)....................................       0581-0113
Sec. 590.680(a).......................................       0581-0113
Sec. 590.800..........................................       0581-0113
Sec. 590.840..........................................       0581-0113
Sec. 590.905(a).......................................       0581-0113
Sec. 590.915(a).......................................       0581-0113
Sec. 590.915(b).......................................       0581-0113
Sec. 590.920..........................................       0581-0113
Sec. 590.930(f).......................................       0581-0113
Sec. 590.950(a).......................................       0581-0113
Sec. 590.960..........................................       0581-0113
Sec. 590.965..........................................       0581-0113
------------------------------------------------------------------------


[48 FR 34238, July 28, 1983, as amended at 50 FR 23270, June 3, 1985; 54 
FR 37290, Sept. 8, 1989]

                           Scope of Inspection



Sec. 590.20  Inspection in accordance with methods prescribed or approved.

    Inspection of eggs and egg products shall be rendered pursuant to 
these regulations and under such conditions and in accordance with such 
methods as may be prescribed or approved by the Administrator.



Sec. 590.22  Basis of service.

    These regulations provide for inspection services pursuant to the 
Egg Products Inspection Act. Eggs and egg products shall be inspected in 
accordance with such standards, methods, and instructions as may be 
issued or approved by the Administrator. Inspection services shall be 
subject to supervision at all times by the applicable Federal-State 
supervisor, egg products supervisor, Regional Director, and National 
Supervisor.



Sec. 590.24  Egg products plants requiring continuous inspection.

    No plant in which egg products processing operations are conducted 
shall process egg products without continuous inspection under these 
regulations, except as expressly exempted in Sec. 590.100.



Sec. 590.26  Egg products entering or prepared in official plants.

    Eggs and egg products processed in an official plant shall be 
inspected, processed, marked, and labeled as required by these 
regulations. Egg products entering an official plant shall have been 
inspected, processed, marked, and labeled as required by these 
regulations.



Sec. 590.28  Other inspections.

    (a) Periodic inspections shall be made of:
    (1) The records of all persons engaged in the business of 
transporting, shipping, or receiving any eggs or egg products.
    (2) Exempted plants to determine that such plants are operating 
pursuant to these regulations.
    (b) Inspections shall be made of imported eggs and egg products as 
required in this part.

[36 FR 9814, May 28, 1971, as amended at 40 FR 20057, May 8, 1975. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981, as and amended at 60 FR 49169, Sept. 21, 
1995; 63 FR 45675, Aug. 27, 1998; 63 FR 69971, Dec. 17, 1998]

                      Relation to Other Authorities



Sec. 590.30  At official plants.

    (a) Requirements within the scope of the Act with respect to 
premises, facilities, and operations of any official plant which are in 
addition to or different than those made under this part may not be 
imposed by any State or local jurisdiction except that any such 
jurisdiction may impose recordkeeping and other requirements within the 
scope of Sec. 590.200, if consistent therewith, with respect to any 
such plant.
    (b) Labeling, packaging, or ingredient requirements in addition to 
or different than those made under this part, the Federal Food, Drug, 
and Cosmetic Act and the Fair Packaging and Labeling Act may not be 
imposed by any State or local jurisdiction with respect to egg products 
processed at any official plant in accordance with the requirements 
under this part and such Acts.



Sec. 590.35  Eggs and egg products outside official plants.

    Any State or local jurisdiction may exercise jurisdiction with 
respect to eggs and egg products for the purpose of preventing the 
distribution for human food purposes of any such articles which are 
outside of the official

[[Page 678]]

plant and are in violation of this part or any of said Federal Acts or 
any State or local law consistent therewith.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 63 
FR 69971, Dec. 17, 1998]

            Eggs and Egg Products Not Intended for Human Food



Sec. 590.40  Continuous inspection not provided.

    Continuous inspection shall not be provided under this part at any 
plant for the processing of any egg products which are not intended for 
use as human food, but such articles prior to their offer for sale or 
transportation in commerce shall be denatured or decharacterized unless 
shipped under seal as authorized in Sec. Sec. 590.504(c), and 
identified as prescribed by the regulations in this part to prevent 
their use for human food. Periodic inspections shall be made of such 
operations and records to assure compliance with the Act and the 
regulations in this part.

[37 FR 6657, Apr. 1, 1972. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 63 
FR 69971, Dec. 17, 1998]



Sec. 590.45  Prohibition on eggs and egg products not intended for 
use as human food.

    (a) No person shall buy, sell, or transport or offer to buy or sell, 
or offer or receive for transportation in commerce, any eggs or egg 
products which are not intended for use as human food, unless they are 
denatured or decharacterized, unless shipped under seal as authorized in 
paragraphs (c) and (d) of this section or in Sec. Sec. 590.504(c) and 
590.720(a) and identified as required by the regulations in this part.
    (b) No person shall import or export shell eggs classified as loss, 
inedible, or incubator rejects or any egg products which are 
unwholesome, adulterated, or are otherwise unfit for human food 
purposes, except as provided in paragraphs (c) and (d) of this section, 
unless they are denatured or decharacterized and identified as required 
by the regulations in this part.
    (c) Egg products which are unwholesome, adulterated, or are 
otherwise unfit for human food purposes that are not denatured or 
decharacterized may be exported to foreign countries for industrial use 
or animal food under the following provisions:
    (1) Authorized government official of the foreign country shall 
approve the importation of such products into that country.
    (2) The egg products shall be shipped under U.S. Government seal and 
identified as required in Sec. 590.840.
    (3) Provisions for the control of such inedible product in the 
foreign country to preclude its use as human food must be established 
and approved by the Administrator. Such control may consist of, but not 
be limited to, receipt and inspection by an appropriate U.S. Government 
official, an official of an approved meat, poultry, or egg products 
inspection system of the foreign government, or, when acceptable to the 
Administrator, a foreign government official including other foreign 
health authorities.
    (d) Foreign governments may petition the Administrator for approval 
to import into this country egg products which are unwholesome, 
adulterated, or otherwise unfit for human food purposes that are not 
denatured or decharacterized for industrial use or animal food 
requirements. Such products shall be subject to the provisions of this 
part and other applicable laws and regulations for importation into the 
United States.

[48 FR 34238, July 28, 1983]

                       Refrigeration of Shell Eggs



Sec. 590.50  Temperature and labeling requirements.

    (a) No shell egg handler shall possess any shell eggs that are 
packed into containers destined for the ultimate consumer unless they 
are stored and transported under refrigeration at an ambient temperature 
of no greater than 45[deg]F (7.2[deg]C).
    (b) No shell egg handler shall possess any shell eggs that are 
packed into containers destined for the ultimate consumer unless they 
are labeled to indicate that refrigeration is required.

[[Page 679]]

    (c) Any producer-packer with an annual egg production from a flock 
of 3,000 or fewer hens is exempt from the temperature and labeling 
requirements of this section.

[63 FR 45675, Aug. 27, 1998]

                               Exemptions



Sec. 590.100  Specific exemptions.

    The following are exempt to the extent prescribed as to the 
provision for continuous inspection of processing operations in section 
5(a) of the Act: Provided, That the conditions for exemption and 
provisions of these regulations are met:
    (a) [Reserved]
    (b) Subject to the approval of the Administrator as provided in 
Sec. Sec. 590.600 through 590.670, the processing of egg products 
without continuous inspection at any plant where the facilities, 
sanitation, and operating procedures are the same as are required in 
this part for official plants and where the eggs received or used in the 
manufacture of egg products contain no more restricted eggs than are 
allowed by the official standards for U.S. Consumer Grade B shell eggs, 
and the egg products processed at such plant;
    (c)-(d) [Reserved]
    (e) The processing and sale of egg products by any poultry producer 
from eggs of his own flock's production when sold directly to a 
household consumer exclusively for use by such consumer and members of 
his household and his nonpaying guests and employees;
    (f) [Reserved]
    (g) The processing in nonofficial plants, including but not limited 
to bakeries, restaurants, and other food processors, without continuous 
inspection, of certain categories of food products which contain eggs or 
egg products as an ingredient, and the sale and possession of such 
products: Provided, That such products are manufactured from inspected 
egg products processed in accordance with this part or from eggs 
containing no more restricted eggs than are allowed in the official 
standards for U.S. Consumer Grade B shell eggs;

[36 FR 9814, May 28, 1971, as amended at 40 FR 20057, May 8, 1975. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981, as amended at 63 FR 69971, Dec. 17, 1998]



Sec. 590.105  Suspension or termination of exemptions.

    (a) The Administrator may immediately suspend or terminate any 
exemption under Sec. 590.100(b) at any time with respect to any person, 
if the conditions of exemption prescribed by this section are not being 
met. The Administrator may modify or revoke any regulation of this part, 
granting exemptions whenever he determines such action appropriate to 
effectuate the purposes of the Act.
    (b) Failure to comply with the condition of the exemptions contained 
in Sec. 590.100 shall subject such person to the penalties provided for 
in the Act and in this part.

[36 FR 9814, May 28, 1971, as amended at 40 FR 20057, May 8, 1975. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981]

                         Performance of Service



Sec. 590.110  Licensed inspectors.

    (a) Any person who is a Federal or State employee, or the employee 
of a local jurisdiction possessing proper qualifications as determined 
by an examination for competency and who is to perform services pursuant 
to this part, may be licensed by the Secretary as an inspector.
    (b) Licenses issued by the Secretary are to be countersigned by the 
Administrator or by any other designated official of the Service.
    (c) No person may be licensed to inspect any product in which he is 
financially interested.

[36 FR 9814, May 28, 1971; 36 FR 10841, June 4, 1971. Redesignated at 42 
FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 
31, 1981]



Sec. 590.112  Suspension of license or authority; revocation.

    Pending final action by the Secretary, any person authorized to 
countersign a license to perform inspection

[[Page 680]]

services may, whenever he deems such action necessary to assure that any 
inspection service is properly performed, suspend any license to perform 
inspection services issued pursuant to this part by giving notice of 
such suspension to the respective licensee, accompanied by a statement 
of the reasons therefor. Within 7 days after the receipt of the 
aforesaid notice and statement of reasons by the licensee, he may file 
an appeal in writing, with the Secretary, supported by any argument or 
evidence that he may wish to offer as to why his license should not be 
suspended or revoked. After the expiration of the aforesaid 7-day period 
and consideration of such argument and evidence, the Secretary will take 
such action as he deems appropriate with respect to such suspension or 
revocation. When no appeal is filed within the prescribed 7 days, the 
license is revoked or suspended.



Sec. 590.114  Surrender of license.

    Upon termination of his services as an inspector or whenever his 
license has been suspended or revoked, the licensee shall surrender his 
license and other items of identification furnished by the Department 
immediately to the inspection service.



Sec. 590.116  Activities of inspectors.

    Inspectors at official plants shall confine their activities to 
those duties necessary in the rendering of inspection service and such 
closely related activities as may be approved by the Administrator.



Sec. 590.118  Identification.

    Inspectors shall have in their possession at all times while on 
duty, and present upon request, the means of identification furnished by 
the Department to such persons.

[36 FR 9814, May 28, 1971; 36 FR 10841, June 4, 1971. Redesignated at 42 
FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 
31, 1981]



Sec. 590.119  Political activity.

    Inspectors are forbidden during the period of their respective 
appointments, or licenses, to take an active part in political 
management or in political campaigns. Political activity in city, 
county, State, or national elections, whether primary or regular, or in 
behalf of any party or candidate, except as authorized by law or 
regulation of the Department, is prohibited. This applies to all 
appointees, including but not being limited to temporary and cooperative 
employees and employees on leave of absence with or without pay. Willful 
violation of this section or Sec. 590.120 will constitute grounds for 
dismissal in the case of appointees and revocation of licenses in the 
case of licensees.

[36 FR 9814, May 28, 1971, as amended at 42 FR 2971, Jan. 14, 1977. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981]



Sec. 590.120  Financial interest of inspectors.

    No inspector shall inspect any product in which he is financially 
interested.



Sec. 590.122  Time of inspection.

    The inspector who is to perform the inspection in an official plant 
shall be given reasonable advance notice by plant management of the 
hours when such inspection will be required.

[60 FR 49169, Sept. 21, 1995]



Sec. 590.124  Schedule of operation of official plants.

    Operating schedules for an official plant shall be subject to 
approval of the Administrator. The normal operating schedule shall 
consist of a continuous 8-hour period per day (excluding not to exceed 1 
hour for lunch), 5 consecutive days per week, within the administrative 
workweek, Sunday through Saturday, for each full shift required. Clock 
hours of daily operations need not be specified in a schedule, although 
as a condition of continuance of approval of a schedule, the hours of 
operation must be reasonably uniform from day to day.

[48 FR 20683, May 9, 1983]



Sec. 590.126  Overtime inspection service.

    When operations in an official plant require the services of 
inspection personnel beyond their regularly assigned tour of duty on any 
day or on a day outside the established schedule, such

[[Page 681]]

services are considered as overtime work. The official plant must give 
reasonable advance notice to the inspector of any overtime service 
necessary and must pay the Agency for such overtime at an hourly rate of 
$50.04.

[68 FR 37957, June 26, 2003]



Sec. 590.128  Holiday inspection service.

    (a) When an official plant requires inspection service on a holiday 
or a day designated in lieu of a holiday, such service is considered 
holiday work. The official plant must, in advance of such holiday work, 
request the inspector in charge to furnish inspection service during 
such period and must pay the Agency for such holiday work at an hourly 
rate of $50.04.
    (b) The term ``holiday'' shall mean the legal public holidays 
specified by the Congress in paragraph (a) of section 6103, title 5 of 
the United States Code. Information on legal holidays may be obtained 
from the supervisor.

[37 FR 6657, Apr. 1, 1972. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 46 FR 9, Jan. 2, 1981. Redesignated at 46 FR 63203, Dec. 
31, 1981, as amended at 47 FR 46071, Oct. 15, 1982; 59 FR 52637, Oct. 
18, 1994; 65 FR 60095, Oct. 10, 2000; 67 FR 3430, Jan. 24, 2002; 68 FR 
37957, June 26, 2003]



Sec. 590.130  Basis of billing plants.

    Overtime and/or holiday services shall be billed to the official 
plant on the basis of each 15 minutes of overtime and/or holiday service 
performed by each inspector providing such service to the plant, except 
that when an official plant requires the services of an inspector after 
he has completed his day's assignment and left the plant or when he is 
called back to duty on a day outside the established normal operating 
schedule or on a holiday, the official plant shall pay for a minimum of 
2 hours service at the applicable established rate. Extra travel expense 
incurred while rendering overtime or holiday service shall be billed to 
the official plant. Bills are payable upon receipt and become delinquent 
30 days from date of billing. Overtime or holiday inspection service 
will not be performed at any plant that is delinquent, and processing 
operations shall be confined to the regular operating schedule of the 
plant. In addition, fees will be charged and collected for 
certifications requested by and provided for the official plant that are 
not within the scope of these regulations.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 
FR 49169, Sept. 21, 1995; 65 FR 44950, July 20, 2000]



Sec. 590.132  Access to plants.

    Access shall not be refused to any representative of the Secretary 
to any plant, place of business, or transport vehicle subject to 
inspection under the provisions of this part upon presentation of proper 
credentials.

[63 FR 45675, Aug. 27, 1998]



Sec. 590.134  Accessibility of product and cooler rooms.

    (a) Each product for which inspection service is required shall be 
so placed as to disclose fully its class, quality, quantity, and 
condition as the circumstances may warrant.
    (b) The perimeter of each cooler room used to store shell eggs 
packed in containers destined for the ultimate consumer shall be made 
accessible in order for the Secretary's representatives to determine the 
ambient temperature under which shell eggs are stored.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 63 
FR 45675, Aug. 27, 1998]



Sec. 590.136  Facilities and equipment to be furnished by official 
plants for use of inspectors in performing service.

    (a) Such facilities and equipment shall include but not be limited 
to a room or area suitable for sampling product, and acceptable candling 
light, flashlight, heavy duty, high speed drill with an eleven 
sixteenths-inch or larger bit of sufficient length to reach the bottom 
of containers used for frozen eggs, metal stem thermometer(s), test 
thermometer(s), stop watch, test weighing scale(s) and test weight(s), 
test kit for determining the bactericidal strength of sanitizing 
solutions, and stationary or adequately secured storage box or cage 
(capable of being

[[Page 682]]

locked only by the inspector) for holding official samples.
    (b) Furnished office space and equipment, including but not being 
limited to a desk (equipped with a satisfactory locking device), lockers 
or cabinets suitable for the protection and storage of supplies, and 
facilities suitable for inspectors to change clothing.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 
FR 49169, Sept. 21, 1995]

                         Application for Service



Sec. 590.140  How application shall be made.

    The proprietor or operator of each plant processing egg products, 
unless exempted by Sec. 590.100, shall make application to the 
Administrator for inspection service. The application shall be made in 
writing on forms furnished by the inspection service. In cases of change 
of name or ownership or change of location, a new application shall be 
made.



Sec. 590.142  Filing of application.

    An application for inspection service shall be regarded as filed 
only when it has been filled in completely and signed by the applicant 
and has been received in the office of the Chief of the Grading Branch.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 43 FR 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, 
Dec. 31, 1981]



Sec. 590.144  Authority of applicant.

    Proof of authority of any person applying for inspection service may 
be required at the discretion of the Administrator.



Sec. 590.146  Application for continuous inspection in official plants; 
approval.

    Any person desiring to process egg products under continuous 
inspection service must receive approval of such plant and facilities as 
an official plant prior to the installation of such service. An 
application for continuous inspection service to be installed in an 
official plant shall be approved according to the following procedure:
    (a) Initial survey: When an application for continuous inspection in 
a plant has been filed, a supervisory egg products inspector will make a 
survey and inspection of the premises and plant to determine if the 
facilities and methods of operation therein are suitable and adequate 
for service in accordance with:
    (1) These regulations, and
    (2) Such other administrative instructions as may be issued from 
time to time by the Service and which are in effect at the time of the 
aforesaid survey and inspection.
    (b) Drawings and specifications to be furnished:
    (1) Applicants may obtain information or assistance as to the 
requirements before submitting prints of drawings, specifications, and 
supplemental information from the inspection service.
    (2) Three copies of each print drawing as specified in this section 
of the complete floor plan, plot plan, supplemental information, and 
specifications shall be submitted. Sheet size of the print shall not 
exceed 34 by 44 inches, the wording shall be legible, all lines sharp 
and clear, and properly drawn to scale. Each print shall show the scale 
used, north point of the compass, and the firm name, street, city, 
state, and zip code or an accurate description of the location.
    (3) Plot plan of entire premises shall include location of all 
buildings, railroads, roadways, alleys, wells, reservoirs, drains, catch 
basins, nearby buildings adjoining property, drainage and slope of 
terrain, character and surfacing of roadways, driveways, and vehicular 
loading areas. The plot plan may be drawn to a scale of one-thirty-
second inch per foot.
    (4) Floor plan prints shall include all space on each floor of the 
official plant, accurately illustrating and describing the facilities. 
Detailed drawings of processing area shall be drawn to a scale of one-
fourth inch per foot. Prints showing only nonprocessing areas may be 
drawn to a scale of one-eighth inch per foot.
    (5) Floor plans shall show the location of such features as walls, 
partitions, posts, doorways, windows, floor drains and channel drains, 
air systems,

[[Page 683]]

ventilation fans, principal pieces of equipment, storage tanks, hose 
connections for cleaning purposes, hand-washing facilities, lockers, and 
toilets. The prints shall show slope of floors to drains.
    (6) The official plant shall include all processing rooms and other 
rooms used in the official plant, including but not being limited to the 
breaking room, equipment washing and sanitizing rooms, shell egg washing 
rooms, packaging rooms, shell egg and egg products storage rooms 
(including coolers, freezers, hot rooms), drying rooms, toilet and 
dressing rooms, storerooms for supplies, and all other rooms, 
compartments, or passageways where products or any ingredients to be 
used in the preparation of products under this service will be handled 
or kept and may include other rooms located in the building comprising 
the official plant. Except in public warehouses, all rooms, 
compartments, etc., of the building not to be considered as part of the 
official plant shall not have direct access into any part of the 
official plant.
    (7) Supplemental information may be shown as notations on the 
drawings or on supplemental sheets. Supplemental information shall 
include clarifying information such as sequence of processing edible 
products, handling of inedible product, shell disposal, handling of 
packaging material, liquid pumping systems, cleaned-in-place systems, 
description of pasteurizer, description of drier, type and efficiency of 
air filtration, hot water facilities, sewage disposal, and such other 
notations as may be required.
    (8) Specification sheets shall include height of ceilings and type 
construction, type of floors, and wall construction, wall and partition 
material, and number of employees who will use each toilet room and 
facilities.
    (c) Upon approval of the prints of drawing, supplemental 
information, and specifications, the application for service may be 
approved.
    (d) Changes and revisions of official plant: When changes are 
planned in official plant construction, facilities, and equipment 
covered by previously approved prints, revised prints shall be submitted 
for review and approval prior to making the changes by: A completely 
revised sheet(s) showing proposed alterations and additions or an 
overlay print drawn to same scale as print to be modified or revised. A 
final survey of the completed alterations and additions shall be made by 
the supervisory egg products inspector to determine if the changes are 
in accordance with approved drawings and the regulations.
    (e) Final survey and plant approval: Prior to the inauguration of 
continuous inspection service, a final survey of the plant and premises 
shall be made by the supervisory egg products inspector to determine if 
the plant is constructed and facilities are installed in accordance with 
the approved drawings and these regulations. The plant may be approved 
only when these requirements have been met.

[36 FR 9814, May 28, 1971; 36 FR 10841, June 4, 1971. Redesignated at 42 
FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 
31, 1981]



Sec. 590.148  Order of service.

    Inspection service shall be performed, insofar as practicable, in 
the order in which applications therefor are made.

[36 FR 9814, May 28, 1971, as amended at 42 FR 2971, Jan. 14, 1977. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981]

                         Inauguration of Service



Sec. 590.150  Official plant numbers.

    An official plant number shall be assigned to each plant granted 
inspection service. Such plant number shall be used to identify all 
containers of inspected products prepared in the plant which are capable 
of use as human food. A plant shall not have more than one plant number.



Sec. 590.155  Inauguration of service.

    Prior to the inauguration of service, the proprietor or operator of 
the plant shall be knowledgeable of the requirements of these 
regulations.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 
FR 49169, Sept. 21, 1995]

[[Page 684]]

                            Denial of Service



Sec. 590.160  Refusal, suspension, or withdrawal of service.

    (a) The Administrator (for such period, or indefinitely, as he deems 
necessary to effectuate the purposes of the Act) may refuse to provide 
or may withdraw inspection service under this part with respect to any 
plant if he determines after opportunity for a hearing (following the 
procedures of 7 CFR, part 1, subpart H) is accorded to the applicant 
for, or recipient of, such service, that such applicant or recipient is 
unfit to engage in any business requiring inspection under the Act or 
this part, because the applicant or recipient or anyone responsibly 
connected with such person has been convicted in any Federal or State 
court, within the previous 10 years, of (1) any felony or more than one 
misdemeanor under any law based upon the acquiring, handling, or 
distributing of adulterated, mislabeled, or deceptively packaged food or 
fraud in connection with transactions in food or (2) any felony, 
involving, fraud, bribery, extortion, or any other act or circumstances 
indicating a lack of the integrity needed for the conduct of operations 
affecting the public health.
    (b) For the purpose of this section, a person shall be deemed to be 
responsibly connected with the business if he is a partner, officer, 
director, holder, or owner of 10 percentum or more of its voting stock, 
or employee in a managerial or executive capacity.
    (c) The determination and order of the Administrator with respect 
thereto under this section shall be final and conclusive unless the 
affected applicant for, or recipient of, inspection service files 
application for judicial review within 30 days after the effective date 
of such order in the U.S. Court of Appeals for the circuit in which such 
applicant or recipient has its principal place of business or in the 
U.S. Court of Appeals for the District of Columbia Circuit. Judicial 
review of any such order shall be upon the record upon which the 
determination and order are based. The provisions of section 204 of the 
Packers and Stockyards Act, 1921, as amended (7 U.S.C. 194) shall be 
applicable to appeals taken under this section. This section shall not 
affect in any way other provisions of the Act or these regulations for 
refusal of inspection services.
    (d) Any applicant for inspection at a plant where the operations 
thereof may result in any discharge into the navigable waters in the 
United States is required by subsection 401(a)(1) (33 U.S.C. 1341) of 
the Clean Water Act as amended (86 Stat. 816, 91 Stat. 1566; 33 U.S.C. 
1251 et seq.), to provide the Administrator with a certification, as 
prescribed in said subsection, that any such discharge will comply with 
the applicable provisions of sections 301, 302, 303, 306, and 307 of the 
Act (33 U.S.C. 1311, 1312, 1313, 1316, and 1317). No grant of inspection 
can be issued unless such certification has been obtained, or is waived, 
because of failure or refusal of the State, interstate agency, or the 
Administrator of the Environmental Protection Agency to act on a request 
for certification within a reasonable period (which shall not exceed 1 
year after receipt of such request). Further, upon receipt of an 
application for inspection and a certification as required by subsection 
401(a)(1) of the Clean Water Act, the Administrator (as defined in Sec. 
590.5) is required by subparagraph (2) of said subsection to notify the 
Administrator of the Environmental Protection Agency for proceedings in 
accordance with that subsection. No grant of inspection can be made 
until the requirements of 401(a) (1) and (2) have been met.
    (e) Inspection may be suspended or revoked and plant approval 
terminated as provided in subsection 401(a) (4) and (5) of the Clean 
Water Act, as amended (33 U.S.C. 1341(a) (4) and (5)).
    (f) Suspension of plant approval and withdrawal of service:
    (1) Any plant approval given pursuant to these regulations may be 
suspended by the Administrator for (i) failure to maintain premises, 
facilities, and equipment in a satisfactory state of repair; (ii) the 
use of operating procedures or practices which are not in accordance 
with the regulations; (iii) the alterations of buildings, facilities, or 
equipment which have not been approved in accordance with the 
regulations; or (iv) assaulting, intimidating, impeding, obstructing, or 
interfering

[[Page 685]]

with any person engaged in or on account of the performance of his 
official duties.
    (2) During such period of suspension, no processing of egg products 
for commerce shall be carried on in the official plant. If the plant 
facilities or methods of operation are not brought into compliance 
within a reasonable period of time, to be specified by the 
Administrator, inspection service shall be withdrawn from the official 
plant. Upon withdrawal of inspection service in an official plant, the 
plant approval for processing egg products shall also become terminated.
    (3) The operator shall be notified of the withdrawal action and the 
reasons therefor and afforded an opportunity to present his views 
informally prior to the effective date of such withdrawal, and upon 
written request, he shall be afforded an opportunity for a hearing in 
accordance with the applicable rules of practice (7 CFR, part 1, subpart 
H), with respect to the merits or validity of the withdrawal, but such a 
suspension or other withdrawal shall continue in effect pending the 
outcome of any such hearing unless otherwise ordered by the 
Administrator.
    (4) In any case where inspection service is suspended under this 
paragraph (f) of this section, such service, after appropriate 
corrective action is taken, will be restored immediately, or as soon 
thereafter as an inspector can be made available. In any case where 
inspection service is withdrawn for a specified period under this 
paragraph (f) of this section, the person concerned may, after said 
specified period has expired, apply for inspection service as provided 
in Sec. Sec. 590.140 through 590.146.

[36 FR 9814, May 28, 1971, as amended at 37 FR 6657, Apr. 1, 1972. 
Redesignated at 42 FR 32514, June 27, 1977, as amended at 43 FR 60138, 
Dec. 26, 1978; 45 FR 23640, Apr. 8, 1980. Redesignated at 46 FR 63203, 
Dec. 31, 1981]



Sec. 590.161  Termination of plant approval.

    When inspection service is not performed at any plant for a period 
of at least 90 days, plant approval shall terminate upon notice by the 
Administrator without further proceedings; provided, however, that this 
section shall not apply to any plant where the Administrator determines 
that such a plant operates on a seasonal basis and the inspection 
service has not been used as a result of such seasonal operation, or 
where operations have ceased due to extraordinary circumstances 
determined by the Administrator as not warranting termination of plant 
approval.

[45 FR 23641, Apr. 8, 1980. Redesignated at 46 FR 63203, Dec. 31, 1981]

Records and Related Requirements for Eggs and Egg Products Handlers and 
                           Related Industries



Sec. 590.200  Records and related requirements.

    (a) Persons engaged in the business of transporting, shipping, or 
receiving any eggs or egg products in commerce, or holding such articles 
so received, and all egg handlers, including hatcheries, shall maintain 
records showing, for a period of 2 years, to the extent that they are 
concerned therewith, the receipt, delivery, sale, movement, and 
disposition of all eggs and egg products handled by them, and shall, 
upon the request of an authorized representative of the Secretary, 
permit him, at reasonable times, to have access to and to copy all such 
records.
    (b) Production records by categories of eggs such as graded eggs, 
nest-run eggs, dirties, checks, leakers, loss, inedible, etc., bills of 
sale, inventories, receipts, shipments, shippers, receivers, dates of 
shipment and receipt, carrier names, etc., as determined by the 
Administrator, shall be maintained by all egg processing operations, 
except that, official egg products plants which use all shell eggs 
received and do not reship any shell eggs need only to maintain records 
indicating the amount of eggs received, date received, and the name and 
address of the shipper.

[37 FR 6657, Apr. 1, 1972. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 47 
FR 745, Jan. 7, 1982; 63 FR 69971, Dec. 17, 1998]



Sec. 590.220  Information and assistance to be furnished to inspectors.

    When inspection service is performed at any plant, the plant 
operator shall

[[Page 686]]

furnish the inspector such information and assistance as may be required 
for the performance of inspection functions, preparing certificates, 
reports, and for other official duties.

                        Administrative Detention



Sec. 590.240  Detaining product.

    Whenever any eggs or egg products subject to the Act are found by 
any authorized representative of the Secretary upon any premises, and 
there is reason to believe that they are or have been processed, bought, 
sold, possessed, used, transported, or offered or received for sale or 
transportation in violation of the Act or the regulations in this part, 
or that they are in any other way in violation of the Act, such articles 
may be detained by such representative for a period not to exceed 20 
days, as more fully provided in section 19 of the Act. A detention tag 
or other similar device shall be used to identify detained product, and 
the custodian or owner shall be given a written notice of such 
detention. Only authorized representatives of the Secretary shall affix 
or remove detention identification. The provisions of this section shall 
in no way derogate from authority for condemnation or seizure conferred 
by other provisions of the Act, the regulations in this part, or other 
laws.

[37 FR 6658, Apr. 1, 1972. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 63 
FR 69972, Dec. 17, 1998]

                   Appeal of an Inspection or Decision



Sec. 590.300  Who may request an appeal inspection or review of an 
inspector's decision.

    Any appeal inspection may be requested by any interested party who 
is dissatisfied with the determination by an inspector of the class, 
quantity, or condition of any product, and a review may be requested by 
the operator of an official plant with respect to an inspector's 
decision or on any other matter related to inspection in the official 
plant.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 
FR 49169, Sept. 21, 1995]



Sec. 590.310  Where to file an appeal.

    (a) Appeal of resident inspector's inspection or decision in an 
official plant. Any interested party who is not satisfied with the 
determination of the class, quantity, or condition of product which was 
inspected by an inspector in an official plant and has not left such 
plant, and the operator of any official plant who is not satisfied with 
a decision by an inspector on any other matter relating to inspection in 
such plant may request an appeal inspection or review of the decision by 
the inspector by filing such request with the inspector's immediate 
supervisor.
    (b) All other appeal requests. Any interested party who is not 
satisfied with the determination of the class, quantity, or condition of 
product which has left the official plant where it was inspected may 
request an appeal inspection by filing such request with the Regional 
Director in the region where the product is located or with the Chief of 
the Grading Branch.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 43 FR 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, 
Dec. 31, 1981, as amended at 60 FR 49169, Sept. 21, 1995; 63 FR 69972, 
Dec. 17, 1998]



Sec. 590.320  How to file an appeal.

    The request for an appeal inspection or review of an inspector's 
decision may be made orally or in writing. If made orally, written 
confirmation may be required. The applicant shall clearly state the 
identity of the product, the decision which is questioned, and the 
reason(s) for requesting the appeal service. If such appeal request is 
based on the results stated on an official certificate, the original and 
all copies of the certificate available at the appeal inspection site 
shall be provided to the inspector assigned to make the appeal 
inspection.

[60 FR 49169, Sept. 21, 1995]

[[Page 687]]



Sec. 590.330  When an application for an appeal inspection may be refused.

    When it appears to the official with whom an appeal request is filed 
that the reasons given in the request are frivolous or not substantial, 
or that the condition of the product has undergone a material change 
since the original inspection, or that the original lot has changed in 
some manner, or the Act or the regulations in this part have not been 
complied with, the applicant's request for the appeal inspection may be 
refused. In such case, the applicant shall be promptly notified of the 
reason(s) for such refusal.

[60 FR 49169, Sept. 21, 1995, as amended at 63 FR 69972, Dec. 17, 1998]



Sec. 590.340  Who shall perform the appeal.

    (a) An appeal inspection or review of a decision requested under 
Sec. 590.310(a) shall be made by the inspector's immediate supervisor 
or by a licensed inspector assigned by the immediate supervisor other 
than the inspector whose inspection or decision is being appealed.
    (b) The assignment of the inspector(s) who will make the appeal 
inspection under Sec. 590.310(b) shall be made by the Regional Director 
or the Chief of the Grading Branch, Poultry Division, Agricultural 
Marketing Service.



Sec. 590.350  Procedures for selecting appeal samples.

    (a) Prohibition on movement of product. Products shall not have been 
moved from the place where the inspection being appealed was performed 
and must have been maintained under adequate refrigeration when 
applicable.
    (b) Laboratory analyses. The appeal sample shall consist of product 
taken from the original sample containers plus an equal number of 
containers selected at random. When the original sample containers 
cannot be located, the appeal sample shall consist of product taken at 
random from double the number of original sample containers.
    (c) Condition inspection. The appeal sample shall consist of product 
taken from the original sample containers plus an equal number of 
containers selected at random. A condition appeal cannot be made unless 
all originally sampled containers are available.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 
FR 49169, Sept. 21, 1995]



Sec. 590.360  Appeal inspection certificates.

    Immediately after an appeal inspection is completed, an appeal 
certificate shall be issued to show that the original inspection was 
sustained or was not sustained. Such certificate shall supersede any 
previously issued certificate for the product involved and shall clearly 
identify the number and date of the superseded certificate. The issuance 
of the appeal certificate may be withheld until any previously issued 
certificate and all copies have been returned when such action is deemed 
necessary to protect the interest of the Government. When the appeal 
inspector assigns a different class to the lot or determines that a net 
weight shortage exists, the lot shall be retained pending correction of 
the labeling or approval of the product disposition by the National 
Supervisor.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 
FR 49169, Sept. 21, 1995]



Sec. 590.370  Cost of appeals.

    (a) There shall be no cost to the appellant when the appeal 
inspection discloses a material error was made in the original 
determination.
    (b) The costs of an appeal shall be borne by the appellant at an 
hourly rate of $27.36, including travel time and expenses if the appeal 
was frivolous, including but not being limited to the following: The 
appeal inspection discloses that no material error was made in the 
original inspection, the condition of the product has undergone a 
material change since the original inspection, the original lot has 
changed in some manner, or the Act or these regulations have not been 
complied with.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 46 FR 49571, Oct. 7, 1981. Redesignated at 46 FR 63203, 
Dec. 31, 1981, as amended at 58 FR 57539, Oct. 26, 1993; 59 FR 52636, 
Oct. 18, 1994]

[[Page 688]]

                              Certificates



Sec. 590.400  Form of certificates.

    All certificates shall be issued on forms approved by the 
Administrator.



Sec. 590.402  Egg products inspection certificates.

    (a) Upon request of the applicant or the Service, any inspector is 
authorized to issue an egg products inspection certificate with respect 
to any lot of egg products inspected by him. In addition, an inspector 
is authorized to issue an inspection certificate covering product 
inspected in whole or in part by another inspector when the inspector 
has knowledge that the product is eligible for certification based on 
personal examination of the product or official inspection records.
    (b) Each egg products inspection certificate shall show the name and 
address of the processor, the class and quantity of the egg products 
covered by such certificate, such shipping marks as are necessary to 
identify such products, all pertinent information concerning the 
wholesomeness thereof, and such other information as the Administrator 
may prescribe or approve.



Sec. 590.404  Erasures or alterations made on official certificates.

    Erasures or alterations shall be initialed by the issuing inspector 
on the original certificate and any copy thereof. All certificates made 
useless through clerical error or otherwise and all certificates 
canceled for whatever cause shall be voided and initialed and the 
original and all other copies shall be forwarded as prescribed by the 
Administrator.



Sec. 590.406  Disposition of official certificates.

    The original and up to two copies of each official certificate shall 
be issued to the applicant or person designated by him. Other copies 
shall be filed and retained in accordance with the disposition schedule 
for inspection program records.

                     Identifying and Marking Product



Sec. 590.410  Shell eggs and egg products required to be labeled.

    (a) All shell eggs packed into containers destined for the ultimate 
consumer shall be labeled to indicate that refrigeration is required, 
e.g., ``Keep Refrigerated,'' or words of similar meaning.
    (b) Containers and portable tanks of edible egg products, prior to 
leaving the official plant, shall be labeled in accordance with 
Sec. Sec. 590.411 through 590.415 and shall bear the official 
identification shown in Figure 2 of Sec. 590.412 or Figure 3 or 4 of 
Sec. 590.415. Bulk transport shipments of liquid pasteurized egg 
products to nonofficial outlets need not be sealed. Bulk shipments of 
liquid egg products transported from one official plant to another shall 
be sealed and accompanied by an official certificate.

[40 FR 20058, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 63 
FR 45675, Aug. 27, 1998]



Sec. 590.411  Requirement of formulas and approval of labels for use 
in official egg products plants.

    (a) No label, container, or packaging material which bears official 
identification may bear any statement that is false or misleading. Any 
label, container, or packaging material which bears any official 
identification shall be used only in such manner as the Administrator 
may prescribe. No label, container, or packaging material bearing 
official identification may be used unless it is approved by the 
Administrator in accordance with paragraph (b) of this section. The use 
of finished labels must be approved as prescribed by the Administrator. 
If the label is printed on or otherwise applied directly to the 
container or packaging material, the principal display panel thereof 
shall be considered as the label.
    (b) No label, container, or packaging material bearing official 
identification may be printed or prepared for use until the printers' or 
other final proof has been approved by the Administrator in accordance 
with the regulations in this part, the Egg Products Inspection Act, the 
Federal Food, Drug,

[[Page 689]]

and Cosmetic Act, the Fair Packaging and Labeling Act, and the 
regulations promulgated under these acts. Copies of each label submitted 
for approval shall be accompanied by:
    (1) A statement showing by their common or usual names the kinds and 
percentages of the ingredients comprising the egg product. A range may 
be given in cases where the percentages may vary from time to time. 
Formulas are to be expressed in terms of a liquid product except for 
products which are dry blended. Also, for products to be dried, the 
label may show the ingredients in the order of descending proportions by 
weight in the dried form. However, the formula submitted must include 
the percentage of ingredients in both liquid and dried form.
    (2) When required, scientific data demonstrating that the substance 
or mixture is safe and effective for its intended use and does not 
promote deception or cause the product to be otherwise adulterated or 
misbranded.
    (c) Containers of product bearing official identification shall 
display the following information:
    (1) The common or usual name, if any, and if the product is 
comprised of two or more ingredients, such ingredients shall be listed 
in the order of descending proportions by weight in the form in which 
the product is to be marketed (sold), except that ingredients in dried 
products (other than dry blended) may be listed in either liquid or 
dried form. When water (excluding that used to reconstitute dehydrated 
ingredients back to their normal composition) is added to a liquid or 
frozen egg product or to an ingredient of such products (in excess of 
the normal water content of that ingredient), the total amount of water 
added, including the water content of any cellulose or vegetable gums 
used, shall be expressed as a percentage of the total product weight in 
the ingredient statement on the label.
    (2) The name, address, and ZIP code of the packer or distributor. 
When the distributor is shown, it shall be qualified by such terms as 
``packed for,'' ``distributed by,'' or ``distributors'';
    (3) The lot number or approved alternative code number indicating 
date of production;
    (4) The net contents;
    (5) Official identification and plant number;
    (6) Egg products which are produced in an official plant from edible 
shell eggs of other than current production or from other egg products 
produced from shell eggs of other than current production, shall be 
clearly and distinctly labeled in close proximity to the common or usual 
name of the product, e.g., ``Manufactured from eggs of other than 
current production'';
    (7) Egg products produced from edible shell eggs or the egg product 
produced from such shell eggs of the turkey, duck, goose, or guinea 
shall be clearly and distinctly labeled as to the common or usual name 
of the product indicating the type of eggs or egg products used in the 
product, e.g., ``Frozen whole turkey eggs,'' ``Frozen whole chicken and 
turkey eggs.'' Egg products labeled without qualifying words as to the 
type of shell egg used in the product shall be produced only from the 
edible shell egg of the domesticated chicken or the egg product produced 
from such shell eggs.
    (d) Liquid or frozen egg products identified as whole eggs and 
prepared other than in natural proportions, as broken from the shell, 
shall have a total egg solids content of 24.20 percent or greater.
    (e) Nutrition information may be included on labels used to identify 
egg products, providing such labeling complies with the provisions of 21 
CFR part 101, promulgated under the Federal Food, Drug, and Cosmetic Act 
and the Fair Packaging and Labeling Act. Since these regulations have 
different requirements for consumer packaged products than for bulk 
packaged egg products not for sale or distribution to household 
consumers, label submission shall be accompanied with information 
indicating whether the label covers consumer packaged or bulk packaged 
product. Nutrition labeling is required when nutrients, such as 
proteins, vitamins, and minerals are added to the product, or when a 
nutritional claim or information is presented on the labeling, except 
for the following which are exempt from nutrition labeling requirements:
    (1) Egg products shipped in bulk form for use solely in the 
manufacture of

[[Page 690]]

other food and not for distribution to household consumers in such bulk 
form or containers.
    (2) Products containing an added vitamin, mineral, or protein, or 
for which a nutritional claim is made on the label, or in advertising, 
which is supplied for institutional food use only: Provided, That the 
manufacturer or distributor provides the required nutrition information 
directly to those institutions.
    (3) Any nutrient(s) included in product solely for technological 
purpose may be declared solely in the ingredients statement, without 
complying with nutrition labeling, if the nutrient(s) is otherwise not 
referred to in labeling or in advertising. All labels showing nutrition 
information or claims are subject to review by the Food and Drug 
Administration prior to approval by the Department.
    (f) If the Administrator has reason to believe that the statement on 
formulation shows the product to be adulterated or misbranded or that 
any labeling, or the size or form of any container in use or proposed 
for use in respect to egg products at any official plant is false or 
misleading in any way, he may direct that such use be withheld unless 
the labeling or container is modified in such a manner as he may 
prescribe so that it will not be false or misleading, and/or the 
formulation of the product is altered in such a manner that he may 
prescribe so that it is not adulterated, or would not cause misbranding. 
Any person so denied the approval of any label shall be notified 
promptly of the reasons for the denial on a form approved by the 
Administrator. If the person using or proposing to use the label does 
not accept the determination of the Administrator, he may request a 
hearing by filing with the Administrator within 10 days after receiving 
the notice of denial, a written application for a hearing setting forth 
specifically, the errors alleged to have been made by the Administrator 
in denying approval of the label. The use of the label shall be withheld 
pending hearing and final determination by the Administrator if the 
Administrator so directs. Hearings held pursuant to this subsection 
shall be presided at by the Administrator. The applicant shall be given 
the opportunity to present evidence both oral and written in support of 
his allegation that the Administrator erred in denying approval of the 
label. The notice of denial together with all other available data and 
information used as a basis for such denial shall be considered part of 
the record. The Administrator may take official notice of such matters 
as are judicially noticed by the Courts of the United States and of any 
other matter of technical, scientific, or commercial fact of established 
character. The Administrator shall make his final determination with 
respect to the matter upon the basis of evidence before him. Such 
determination shall be conclusive unless, within 30 days after the 
receipt of notice of such final determination, the person adversely 
affected thereby appeals to the U.S. Court of Appeals for the circuit in 
which he has his principal place of business, or to the U.S. Court of 
Appeals for the District of Columbia Circuit. The provisions of section 
204 of the Packers and Stockyards Act of 1921, as amended, shall be 
applicable to appeals taken under this section.

[37 FR 6658, Apr. 1, 1972, as amended at 40 FR 20058, May 8, 1975. 
Redesignated at 42 FR 32514, June 27, 1977, as amended at 45 FR 23641, 
Apr. 8, 1980. Redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 
53 FR 23751, June 24, 1988; 60 FR 49169, Sept. 21, 1995]



Sec. 590.412  Form of official identification symbol and inspection mark.

    (a) The shield set forth in Figure 1 containing the letters ``USDA'' 
shall be the official identification symbol for purposes of this part 
and, when used, imitated, or simulated in any manner in connection with 
a product, shall be deemed to constitute a representation that the 
product has been officially inspected.
    (b) The inspection mark which is to be used on containers of edible 
egg products shall be contained within the outline of a shield and with 
the wording and design set forth in Figure 2 of this section, except the 
plant number may be preceded by the letter ``P'' in lieu of the word 
``plant''. Alternatively, it may be omitted from the official shield if 
applied on the container's

[[Page 691]]

principal display panel or other prominent location and preceded by the 
letter ``P'' or the word ``Plant''.
[GRAPHIC] [TIFF OMITTED] TC25SE91.018

[GRAPHIC] [TIFF OMITTED] TC25SE91.019


[36 FR 9814, May 28, 1971, as amended at 40 FR 20058, May 8, 1975. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49170, Sept. 21, 1995]



Sec. 590.414  Products bearing the official inspection mark.

    Egg products which are permitted to bear the inspection mark shall 
be processed in an official plant from edible shell eggs or other edible 
egg products and may contain other edible ingredients. The official mark 
shall be printed or lithographed and applied as a part of the principal 
display panel of the container but shall not be applied to a detachable 
cover.



Sec. 590.415  Use of other official identification.

    Other official identification as shown in this section shall be 
printed or lithographed and applied as a part of the principal display 
panel, but shall not be applied to a detachable cover. The plant number 
may be omitted from the identification if applied elsewhere on the 
container's principal display panel or other prominent location and 
preceded by the letter ``P'' or the word ``plant''. Such products shall 
meet all requirements for egg products which are permitted to bear the 
official inspection mark shown in Sec. 590.412, except for 
pasteurization, heat treatment, or other such methods of treatment 
approved by the Administrator. Such products shall not be released into 
consuming channels until they have been subjected to pasteurization, 
heat treatment, or other approved methods of treatment.
    (a) All nonpasteurized egg products, except as provided in paragraph 
(b) of this section, shipped from an official plant in packaged form 
shall be marked with the identification set forth in Figure 3 of this 
section. After pasteurization or treatment, the product may bear the 
official inspection mark as shown in Sec. 590.412.
[GRAPHIC] [TIFF OMITTED] TC25SE91.020

    (b) All nonpasteurized egg products, containing 10 percent or more 
added salt, shipped from an official plant in packaged form to an acidic 
dressing manufacturer shall be marked with the identification set forth 
in Figure 4 of this section.

[[Page 692]]

[GRAPHIC] [TIFF OMITTED] TC25SE91.021


[36 FR 9814, May 28, 1971; 36 FR 10841, June 4, 1971. Redesignated at 42 
FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 
31, 1981, as amended at 60 FR 49170, Sept. 21, 1995]



Sec. 590.417  Unauthorized use or disposition of approved labels.

    (a) Containers or labels which bear official identification approved 
for use pursuant to Sec. 590.411 shall be used only for the purpose for 
which approved. Any unauthorized use or disposition of approved 
containers or labels which bear any official identification may result 
in cancellation of the approval and denial of the use of containers or 
labels bearing official identification and may subject such violator to 
the penalties and denial of the benefits of the Act;
    (b) The use of simulations or imitations of any official 
identification by any person is prohibited;
    (c) Upon termination of inspection service in an official plant 
pursuant to these regulations, all labels or packaging materials 
indicating product packed by the plant which bear official 
identification shall either be destroyed under the supervision of the 
Service or, if used in another location, modified in a manner acceptable 
to the Service before use.

[36 FR 9814, May 28, 1971, as amended at 40 FR 20059, May 8, 1975; 42 FR 
2971, Jan. 14, 1977. Redesignated at 42 FR 32514, June 27, 1977, and 
further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 FR 
49170, Sept. 21, 1995]



Sec. 590.418  Supervision of marking and packaging.

    (a) Evidence of label approval. No inspector shall authorize the use 
of official identification on any inspected product unless he has on 
file evidence that such official identification or packaging material 
bearing such official identification has been approved in accordance 
with the provisions of Sec. 590.411.
    (b) Affixing of official identification. No official identification 
shall be, or caused to be affixed to or placed on any product or 
container except by an inspector or under the supervision of an 
inspector or other person authorized by the Administrator. All such 
products shall have been inspected in accordance with these regulations. 
The inspector shall have supervision over the use and handling of all 
material bearing any official identification.
    (c) Labels for products sold under Government contract. The 
inspector in the official plant may approve use of labels for containers 
of product sold under a contract specification to governmental agencies 
when such product is not offered for resale to the general public: 
Provided, That the contract specifications have been approved by the 
Administrator and include complete specific requirements with respect to 
labeling and are made available to the inspector.



Sec. 590.419  Reuse of containers bearing official identification 
prohibited.

    The reuse, by any person, of containers bearing official 
identification is prohibited unless such identification is applicable in 
all respects to product being packed therein. In such instances, the 
container and label may be used provided the packaging is accomplished 
under the supervision of an inspector and the container is in compliance 
with Sec. 590.504(k).

          Inspection, Reinspection, Condemnation, and Retention



Sec. 590.420  Inspection.

    (a) Continuous inspection shall be made, pursuant to these 
regulations, of the processing of egg products in each official plant 
processing egg products for commerce unless exempted under Sec. 
590.100. Inspections, certifications, or specification-type gradings, 
and other inspections which may be requested by the official plant and 
are in addition to the normal inspection requirements and functions for 
the processing, production, or certification of a wholesome egg product 
under this part, shall

[[Page 693]]

be made pursuant to the voluntary egg products inspection service (part 
55 of this chapter).
    (b) Any food manufacturing establishment or institution which uses 
any eggs that do not meet the requirements of Sec. 590.100(a) in the 
preparation of any articles for human food shall be deemed to be a plant 
processing egg products requiring continuous inspection under this part.
    (c) Any product which is prepared under inspection in an official 
plant shall be inspected in such plant as often as the inspector deems 
necessary in order to ascertain if the product is unadulterated, 
wholesome, properly labeled, and fit for human food at the time it 
leaves the plant. Upon any such inspection, if any product or portion 
thereof is found to be adulterated, unwholesome, or otherwise unfit for 
human food, such product or portion thereof shall be condemned and shall 
receive such treatment as provided in Sec. 590.422.



Sec. 590.422  Condemnation.

    Eggs and egg products found to be adulterated at official plants 
shall be condemned and, if no appeal be taken from such determination of 
condemnation, such articles shall be destroyed for human food purposes 
under the supervision of an inspector: Provided, That articles which may 
by reprocessing be made not adulterated need not be condemned and 
destroyed if so reprocessed under the supervision of an inspector and 
thereafter found to be not adulterated. If an appeal is requested, the 
eggs or egg products shall be appropriately marked and segregated 
pending completion of an appeal inspection. The appeal shall be at the 
cost of the appellant if the Administrator determines that the appeal is 
frivolous, as defined in Sec. 590.370.



Sec. 590.424  Reinspection.

    (a) No egg product may be brought into an official plant except as 
provided in Sec. 590.430(b) unless it has been prepared and handled in 
accordance with these regulations, and the container of such product is 
marked so as to identify the article as so inspected in accordance with 
this part.
    (b) All egg products shall be reinspected by an inspector at the 
time they are brought into the official plant. Upon reinspection, if any 
such product or portion thereof is found to be unsound, unwholesome, 
adulterated, or otherwise unfit for human food, such product or portion 
thereof, shall be condemned and shall receive such treatment as provided 
in Sec. 590.422, and shall, in the case of other products be disposed 
of according to applicable law.



Sec. 590.426  Retention.

    Retention tags or other devices and methods as may be approved by 
the Administrator shall be used for the identification and control of 
products which are not in compliance with the regulations or are held 
for further examination, and any equipment, utensils, rooms or 
compartments which are found to be unclean or otherwise in violation of 
the regulations. No product, equipment, utensil, room, or compartment 
shall be released for use until it has been made acceptable. Such 
identification shall not be removed by anyone other than an inspector.

           Entry of Material Into Official Egg Products Plants



Sec. 590.430  Limitation on entry of material.

    (a) The Administrator shall limit the entry of eggs and egg products 
and other materials into official plants under such conditions as he may 
prescribe to assure that allowing the entry of such articles will be 
consistent with the purposes of the Act and these regulations.
    (b) Inedible egg products may be brought into an official plant for 
storage and reshipment: Provided, they are handled in such a manner that 
adequate segregation and inventory controls are maintained at all times. 
Inedible egg products may be processed in official plants: Provided, 
That prior approval is obtained from the Administrator and under such 
conditions and time limitations as the Administrator may specify. The 
processing of inedible egg products shall be done under conditions which 
will not affect the processing of edible products, such as processing in 
separate areas, or at times

[[Page 694]]

when no edible product is being processed. All equipment and processing 
areas must be thoroughly cleaned and sanitized prior to processing any 
edible product.

[36 FR 9814, May 28, 1971, as amended at 40 FR 20059, May 8, 1975. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981]



Sec. 590.435  Wholesomeness and approval of materials.

    (a) Substances and ingredients used in the manufacture or 
preparation of any egg product capable of use as human food shall be 
clean, wholesome, and unadulterated.
    (b) The use of chemical additives in egg products shall be permitted 
only when they are approved by the Administrator. The Administrator may 
require, in addition to listing the ingredients, a declaration of the 
additive, and the purpose of its use.
    (c) Chemical additives to be used in the preparation of egg products 
will be approved only if they comply with the following criteria:
    (1) The additive shall be safe under the conditions of its intended 
use.
    (2) The additive shall not promote deception or cause the product to 
be otherwise adulterated or unwholesome. Scientific data acceptable to 
the Administrator showing that the additive meets the criteria specified 
in this paragraph (c) shall be submitted by the person interested in 
having the additive approved.
    (d) Containers and packing or packaging materials in which shell 
eggs are received into the official plant shall be free from odors and 
materials which could contaminate or adulterate the eggs or egg 
products.



Sec. 590.440  Processing ova.

    (a) Ova from slaughtered poultry may be brought into the official 
plant for processing: Provided, That the ova is from wholesome poultry 
inspected in a plant operating under the Poultry Products Inspection Act 
(21 U.S.C. 451 et seq.) and such product is harvested in a sanitary 
manner, properly handled, cooled, packaged and labeled: And provided 
further, That such product is wholesome and the containers of such 
product bear official identification which assures the provisions of 
this paragraph have been met.
    (b) The ova and products containing ova shall be processed, cooled, 
and pasteurized in the official plant in the same manner as liquid, 
frozen, or dried yolk products.
    (c) The labeling for all products containing ova shall be approved 
by the Administrator prior to use.

             Sanitary, Processing, and Facility Requirements



Sec. 590.500  Plant requirements.

    (a) The plant shall be free from objectionable odors, dust, and 
smokeladen air.
    (b) The premises shall be free from refuse, rubbish, waste, and 
other materials and conditions which constitute a source of odors or a 
harbor for insects, rodents, and other vermin.
    (c) The buildings shall be of sound construction and kept in good 
repair to prevent the entrance or harboring of vermin.
    (d) Rooms shall be kept free from refuse, rubbish, waste materials, 
odors, insects, rodents, and from any conditions which may constitute a 
source of odors or engender insects and rodents. Materials and equipment 
not currently needed shall be handled or stored in a manner so as not to 
constitute a sanitary hazard.
    (e) Doors and windows that open to the outside shall be protected 
against the entrance of flies and other insects. Doors and windows 
serving rooms where edible product is exposed shall be so designed and 
installed to prevent the entrance of dust and dirt. Doors leading into 
rooms where edible product is processed shall be of solid construction 
and such doors, other than freezer and cooler doors, shall be fitted 
with self-closing devices.
    (f) Doors and other openings which are accessible to rodents shall 
be of rodent-proof construction.
    (g) There shall be an efficient drainage and plumbing system for the 
plant and premises. Drains and gutters shall be properly installed with 
approved traps and vents. The sewage system shall have adequate slope 
and capacity to readily remove waste from the various processing 
operations. Floor

[[Page 695]]

drains shall be equipped with traps, and constructed so as to minimize 
clogging. In new or remodeled construction the drainage systems from 
toilets and laboratories shall not be connected with other drainage 
systems within the plant.
    (h) The water supply (both hot and cold) shall be ample, clean, and 
potable, with adequate pressure and facilities for its distribution 
throughout the plant or portion thereof utilized for egg processing and 
handling operations and protected against contamination and pollution. A 
water report, issued under the authority of a State or municipal health 
agency, certifying to the potability of the water supply shall be 
obtained by the applicant and furnished to the Administrator whenever 
such report is required by the Administrator.
    (i) The floors, walls, ceiling, partitions, posts, doors, and other 
parts of all structures shall be of such materials, construction, and 
finish to permit their ready and thorough cleaning. The floors and 
curbing shall be watertight.
    (j) Each room and each compartment in which any shell eggs or egg 
products are handled or processed shall be so designed, constructed, and 
maintained to insure processing and operating conditions of a clean and 
orderly character, free from objectionable odors and vapors, and 
maintained in a clean and sanitary condition.
    (k) Every precaution shall be taken to exclude dogs, cats, and 
vermin (including, but not being limited to, rodents and insects) from 
the plant, or portion thereof utilized in which shell eggs or egg 
products are handled or stored.
    (l)(1) There shall be a sufficient number of adequately lighted 
dressing rooms and toilet rooms, ample in size, conveniently located and 
separated from the rooms and compartments in which shell eggs or egg 
products are handled, processed, or stored. The dressing rooms and 
toilet rooms shall be separately ventilated, and shall meet all 
requirements as to sanitary construction and equipment.
    (2) The following formula shall serve as a basis for determining the 
toilet facilities required:

------------------------------------------------------------------------
                                                                 Toilet
                     Persons of same sex                         bowls
                                                                required
------------------------------------------------------------------------
1 to 15, inclusive...........................................          1
16 to 35, inclusive..........................................          2
36 to 55, inclusive..........................................      \1\ 3
56 to 80, inclusive..........................................      \1\ 4
For each additional 30 persons in excess of 80...............      \1\ 1
------------------------------------------------------------------------
\1\ Urinals may be substituted for toilet bowls but only to the extent
  of one-third of the total number of bowls stated.

    (m) Lavatory accommodations (including, but not being limited to, 
hot and cold running water, single service towels, and soap which does 
not impart an odor which interferes with accurate evaluation of the 
product) shall be placed at such locations in the plant to assure 
cleanliness of each person handling any shell eggs or egg products. The 
hand washing facilities in the processing areas shall be operated by 
other than hand operated controls and the drains shall be trapped and 
connected to the plumbing system.
    (n) Suitable facilities for cleaning and sanitizing utensils and 
equipment shall be provided at convenient locations throughout the 
plant.
    (o) Refuse rooms shall be provided for the accumulation and storage 
of shells, trash, and other refuse. They shall be separate rooms 
completely enclosed without doorways opening into breaking rooms or 
rooms where egg products or packaging materials are handled or stored 
and have concrete floors with approved drains, facilities for cleaning, 
and an approved exhaust system vented to the outside. Alternative 
systems of handling shells, trash, and other refuse may be approved by 
the Administrator when such systems adequately contain all refuse and 
provide equivalent sanitary methods for the handling and removal of 
refuse.

[36 FR 9814, May 28, 1971; 36 FR 10841, June 4, 1971, as amended at 40 
FR 20059, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, as 
amended at 45 FR 23641, Apr. 8, 1980. Redesignated at 46 FR 63203, Dec. 
31, 1981]



Sec. 590.502  Equipment and utensils; PCB-containing equipment.

    (a) Equipment and utensils used in processing shell eggs and egg 
products shall be of such design, material, and construction as will:
    (1) Enable the examination, segregation, and processing of such 
products in

[[Page 696]]

an efficient, clean, and satisfactory manner;
    (2) Permit easy access to all parts to insure thorough cleaning and 
sanitizing. So far as is practicable, all such equipment shall be made 
of metal or other impervious material which will not affect the product 
by chemical action or physical contact.
    (b) Except as authorized by the Administrator, in new or remodeled 
equipment and equipment installations, the equipment and installation 
shall comply with the applicable 3-A or E-3-A Sanitary Standards and 
accepted practices currently in effect for such equipment.
    (c) New or replacement equipment or machinery (including any 
replacement parts) brought onto the premises of any official plant shall 
not contain liquid polychlorinated biphenyls (PCBs) in concentrations 
above 50 parts per million by weight of the liquid medium. This 
provision applies to both food processing and nonfood processing 
equipment and machinery, and any replacement parts for such equipment 
and machinery. Totally enclosed capacitors containing less than 3 pounds 
of PCBs are exempted from this prohibition.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 45 FR 68919, Oct. 17, 1980. Redesignated at 46 FR 63203, 
Dec. 31, 1981, as amended at 60 FR 49170, Sept. 21, 1995]



Sec. 590.504  General operating procedures.

    (a) Operations involving processing, storing, and handling of shell 
eggs, ingredients, and egg products shall be strictly in accord with 
clean and sanitary methods and shall be conducted as rapidly as 
practicable. Pasteurization, heat treatment, stabilization, and other 
processes shall be in accord with this part and as approved by the 
Administrator. Processing methods and temperatures in all operations 
shall be such as will prevent a deterioration of the egg products.
    (b) Shell eggs and egg products processed in official plants shall 
be subjected to constant and continuous inspection throughout each and 
every processing operation. Any shell egg or egg product which was not 
processed in accordance with these regulations or is not fit for human 
food shall be removed and segregated.
    (c) All loss and inedible eggs or egg products shall be placed in a 
container clearly labeled ``inedible'' and containing a sufficient 
amount of approved denaturant or decharacterant, such as FD&C brown, 
blue, black, or green colors, meat and fish by-products, grain and 
milling by-products, or any other substance, as approved by the 
Administrator, that will accomplish the purposes of this section. Shell 
eggs shall be crushed and the substance shall be dispersed through the 
product in amounts sufficient to give the product a distinctive 
appearance or odor. Notwithstanding the foregoing, and upon permission 
of the Inspector, the applicant may hold inedible product in containers 
clearly labeled inedible which do not contain a denaturant if such 
inedible product is denatured or decharacterized prior to shipment from 
the official plant: Provided, That such product is properly packaged, 
labeled, segregated, and inventory controls are maintained. In addition, 
product shipped from the official plant for industrial use or animal 
food need not be denatured or decharacterized, provided, that such 
product is properly packaged, labeled, segregated, and inventory 
controls are maintained, and that such product is shipped under 
Government seal and certificate and received at the destination location 
by an inspector or grader as defined in this part.
    (d) The inspector may, prior to receipt of laboratory results for 
salmonella, or for other reasons such as labeling as to solids content, 
permit egg products to be shipped from the official plant when he has no 
reason to suspect noncompliance with any of the provisions of this part. 
However, such shipments shall be made under circumstances which will 
assure the return of the product to the plant for reprocessing, 
relabeling, or under such other conditions as the Administrator may 
determine to assure compliance with this part.
    (e) Pasteurizing, stabilizing, or drying operations shall start as 
soon as practicable after breaking to prevent deterioration of product, 
preferably

[[Page 697]]

within 72 hours from time of breaking for egg products other than whites 
which are to be desugared.
    (f) Each person who is to handle any exposed or unpacked egg 
products or any utensils or container which may come into contact with 
egg product, shall wash his hands and maintain them in a clean 
condition.
    (g) No product or material which creates an objectionable condition 
shall be processed, stored, or handled in any room, compartment, or 
place where any shell eggs or egg products are processed, stored or 
handled.
    (h) Only germicides, insecticides, rodenticides, detergents, or 
wetting agents or other similar compounds which will not deleteriously 
affect the eggs or egg products when used in an approved manner and 
which have been approved by the Administrator, may be used in an 
official plant. The identification, storage, and use of such compounds 
shall be in a manner approved by the Administrator.
    (i) Utensils and equipment which are contaminated during the course 
of processing any shell eggs or egg products shall be removed from use 
immediately and shall not be used again until cleaned and sanitized.
    (j) Any substance or ingredient added in the processing of any egg 
products shall be clean and fit for human food.
    (k) Packages or containers for egg products shall be of sanitary 
design and clean when being filled with any egg products; and all 
reasonable precautions shall be taken to avoid soiling or contaminating 
the surface of any package or container liner which is, or will be, in 
direct contact with such egg products. Only new containers or used 
containers that are clean, in sound condition and lined with suitable 
inner liners shall be used for packaging edible egg products. Fiber 
containers used without liners require the approval of the 
Administrator.
    (l) Egg products shall be inspected to determine the wholesomeness 
of the finished product.
    (m) Egg products shall be processed in such a manner as to insure 
the immediate removal of blood and meat spots, shell particles, and 
foreign materials.
    (n) Utensils and equipment, except drying units, powder conveyors, 
sifters, blenders, and mechanical powder coolers shall be clean and 
sanitized at the start of processing operations. Equipment and utensils 
shall be kept clean and sanitary during all processing operations.
    (o) Egg products prior to being released into consuming channels 
shall be pasteurized in accordance with Sec. 590.570 except that dried 
whites prepared from nonpasteurized liquid shall be heat treated in 
accordance with Sec. 590.575.
    (1) To assure adequate pasteurization, egg products shall be sampled 
and tested for the presence of salmonella. Sampling for the presence of 
salmonella shall be in accordance with Sec. 590.580 and product found 
to be salmonella positive shall be reprocessed, pasteurized, and 
analyzed for the presence of salmonella, or denatured.
    (2) Nonpasteurized or salmonella positive egg product may be shipped 
from an official plant only when it is to be pasteurized, repasteurized, 
or heat treated in another official plant. Shipments of products from 
one official plant to another for pasteurization, repasteurization, or 
heat treatment shall be in sealed cars or trucks with an accompanying 
certificate stating that the product is not pasteurized or is salmonella 
positive. If nonpasteurized or salmonella positive products are to be 
stored in other than the official plant facilities, the inspector at the 
consignee's and consignor's plants shall be given full knowledge of the 
disposition of the product, including warehouse inventory receipts, 
until such time as product is pasteurized, repasteurized, or heat 
treated. The containers of such nonpasteurized or salmonella positive 
product shall be marked with the identification mark shown in Figure 3 
of Sec. 590.415.
    (3) Notwithstanding the provision of paragraph (o)(2) of this 
section, nonpasteurized salted egg products containing 10 percent or 
more salt added may be shipped from an official plant directly to a 
manufacturer of acidic dressings only under the following provisions:
    (i) Before such shipment is made, the manufacturer of the acidic 
dressing

[[Page 698]]

shall apply in writing and receive permission from the Administrator to 
receive and use unpasteurized egg products. The applicant shall sign a 
written statement containing the specification for the treatment of the 
nonpasteurized egg product in a manner that will insure that viable 
salmonella microorganisms are destroyed, and such processing treatment 
shall be approved by the Administrator prior to use.
    (ii) Product shall be shipped under seal from the official plant, 
accompanied by an official USDA certificate stating that the product is 
nonpasteurized and for use in acidic dressings only.
    (iii) The applicant shall acknowledge receipt of each shipment by 
indicating on the reverse side of the USDA certificate. ``The quantity 
of nonpasteurized egg product stated on this certificate was received at 
----------,'' the blank being filled in with the name and address of the 
receiving company and the date and signature of the person completing 
the form. The certificate shall be returned to the USDA inspector at the 
origin plant.
    (iv) The acidic dressing manufacturer shall maintain processing 
records indicating the use of each shipment of unpasteurized salted 
product and the code lots of acidic dressing into which it was 
processed. Records of the pH and the acidity expressed as percent acetic 
acid of each code lot shall be maintained. The records shall also 
demonstrate that the acidic dressing was held 72 hours prior to 
shipment. These records shall be maintained for 2 years and shall be 
available for inspection by a representative of the Department.
    (v) Each container of salted egg product shipped from the official 
plant shall be labeled as required in Sec. 590.411, and shall bear the 
words ``Caution--this egg product has not been pasteurized or otherwise 
treated to destroy viable salmonella microorganisms,'' and shall bear 
the official identification shown in figure 4 of Sec. 590.415.
    (p) Air which is to come in contact with product or with product 
contact surfaces shall come from approved filtered outside air sources.
    (q) All liquid and solid waste material in the official plant shall 
be disposed of in a manner approved by the Administrator to prevent 
product contamination and in accordance with acceptable environmental 
protection practices.

[36 FR 9814, May 28, 1971, as amended at 37 FR 6658, Apr. 1, 1972; 40 FR 
20059, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, and 
further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 47 FR 
745, Jan. 7, 1982; 60 FR 49170, Sept. 21, 1995]



Sec. 590.506  Candling and transfer-room facilities and equipment.

    (a) The room shall be so constructed that it can be adequately 
darkened to assure accuracy in removal of inedible or loss eggs by 
candling. Equipment shall be arranged so as to facilitate cleaning and 
the removal of refuse and excess packing material.
    (b) The construction of the floor shall allow thorough cleaning. The 
floors shall be of water-resistant composition and provided with proper 
drainage.
    (c) An approved exhaust system shall be provided for the continuous 
removal directly to the outside of any steam, vapors, odors, or dust in 
the room. The room shall be maintained at reasonable working 
temperatures during operations.
    (d) Candling devices of an approved type shall be provided to enable 
candlers to detect loss, inedible, dirty eggs, and eggs other than 
chicken eggs.
    (e) Leaker trays shall be made of a material and of such design that 
is conducive to easy cleaning and sanitizing.
    (f) Containers made of a material and of such design that are 
conducive to easy cleaning shall be provided for inedible eggs. All such 
containers shall be conspicuously marked.
    (g) Containers made of a material and of such design that are 
conducive to easy cleaning shall be provided for trash unless clean, 
disposable containers are furnished daily.
    (h) Shell egg conveyors shall be constructed so that they can be 
thoroughly cleaned.

[36 FR 9814, May 28, 1971, as amended at 37 FR 6659, Apr. 1, 1972. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49170, Sept. 21, 1995]

[[Page 699]]



Sec. 590.508  Candling and transfer-room operations.

    (a) Candling and transfer rooms and equipment shall be kept clean, 
free from cobwebs, dust, objectionable odors, and excess packing 
materials.
    (b) Containers for trash and inedible eggs shall be removed from the 
candling rooms as often as necessary but at least once daily; and shall 
be cleaned and treated in such a manner as will prevent off odors or 
objectionable conditions in the plant.
    (c) Shell eggs shall be handled in a manner to minimize sweating 
prior to breaking.
    (d) Shell eggs with extensively damaged shells, unless prohibited 
under Sec. 590.510(d), shall be placed into leaker trays and shall be 
broken promptly.



Sec. 590.510  Classifications of shell eggs used in the processing of 
egg products.

    (a) The shell eggs shall be sorted and classified into the following 
categories in a manner approved by the National Supervisor:
    (1) Eggs listed in paragraph (d) of this section.
    (2) Dirty.
    (3) Leakers as described in paragraph (c)(2) of this section.
    (4) Eggs from other than chicken; duck, turkey, guinea, and goose 
eggs.
    (5) Other eggs--satisfactory for use as breaking stock.
    (b) Shell eggs having strong odors or eggs received in cases having 
strong odors shall be candled and broken separately to determine their 
acceptability.
    (c) Shell eggs, when presented for breaking, shall be of edible 
interior quality and the shell shall be sound and free of adhering dirt 
and foreign material, except that:
    (1) Checks and eggs with a portion of the shell missing may be used 
when the shell is free of adhering dirt and foreign material and the 
shell membranes are not ruptured.
    (2) Eggs with clean shells which are damaged in candling and/or 
transfer and have a portion of the shell and shell membranes missing may 
be used only when the yolk is unbroken and the contents of the egg are 
not exuding over the outside shell. Such eggs shall be placed in leaker 
trays and be broken promptly.
    (3) Eggs with meat or blood spots may be used if the spots are 
removed in an acceptable manner.
    (d) All loss or inedible eggs shall be placed in a designated 
container and be handled as required in Sec. 590.504(c). Inedible and 
loss eggs for the purpose of this section and Sec. 590.522 are defined 
to include black rots, white rots, mixed rots, green whites, eggs with 
diffused blood in the albumen or on the yolk, crusted yolks, stuck 
yolks, developed embryos at or beyond the blood ring state, moldy eggs, 
sour eggs, any eggs that are adulterated as such term is defined 
pursuant to this part, and any other filthy and decomposed eggs 
including the following:
    (1) Any egg with visible foreign matter other than removable blood 
and meat spots in the egg meat.
    (2) Any egg with a portion of the shell and shell membranes missing 
and with egg meat adhering to or in contact with the outside of the 
shell.
    (3) Any egg with dirt or foreign material adhering to the shell and 
with cracks in the shell and shell membranes.
    (4) Liquid egg recovered from shell egg containers and leaker trays.
    (5) Open leakers made in the washing operation.
    (6) Any egg which shows evidence that the contents are or have been 
exuding prior to transfer from the case.
    (e) Incubator reject eggs shall not be brought into the official 
plant.

[36 FR 9814, May 28, 1971, as amended at 40 FR 20059, May 8, 1975. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981]



Sec. 590.515  Egg cleaning operations.

    (a) The following requirements shall be met when washing shell eggs 
to be presented for breaking:
    (1) Shell egg cleaning equipment shall be kept in good repair and 
shall be cleaned after each day's use or more frequently if necessary.
    (2) The temperature of the wash water shall be maintained at 90 
[deg]F or higher, and shall be at least 20 [deg]F warmer than the 
temperature of the eggs to be washed. These temperatures

[[Page 700]]

shall be maintained throughout the cleaning cycle.
    (3) An approved cleaning compound shall be used in the wash water. 
(The use of metered equipment for dispensing the compound into solution 
is recommended.)
    (4) Wash water shall be changed approximately every 4 hours or more 
often if needed to maintain sanitary conditions and at the end of each 
shift. Remedial measures shall be taken to prevent excess foaming during 
the egg washing operation.
    (5) Replacement water shall be added continuously to the wash water 
of washers to maintain a continuous overflow. Rinse water and chlorine 
sanitizing rinse may be used as part of the replacement water. Iodine 
sanitizing rinse may not be used as part of the replacement water.
    (6) Waste water from the egg washing operation shall be piped 
directly to drains.
    (7) The washing operation shall be continuous and shall be completed 
as rapidly as possible. Eggs shall not be allowed to stand or soak in 
water. Immersion-type washers shall not be used.
    (8) Prewetting shell eggs prior to washing may be accomplished by 
spraying a continuous flow of water over the eggs in a manner which 
permits the water to drain away, or by other methods which may be 
approved by the Administrator.
    (b) Shell eggs shall not be washed in the breaking room or any room 
where edible products are processed.

[36 FR 9814, May 28, 1971, as amended at 40 FR 20059, May 8, 1975. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49170, Sept. 21, 1995]



Sec. 590.516  Sanitizing and drying of shell eggs prior to breaking.

    (a) Immediately prior to breaking, all shell eggs shall be spray 
rinsed with potable water containing an approved sanitizer of not less 
than 100 ppm nor more than 200 ppm of available chlorine or its 
equivalent. Alternative procedures may be approved by the Administrator 
in lieu of sanitizing shell eggs washed in the plant.
    (b) Shell eggs shall be sufficiently dry at time of breaking to 
prevent contamination or adulteration of the liquid egg product from 
free moisture on the shell.

[60 FR 49170, Sept. 21, 1995]



Sec. 590.520  Breaking room facilities.

    (a) The breaking room shall have at least 30 foot-candles of light 
on all working surfaces except that light intensity shall be at least 50 
foot-candles at breaking and inspection stations. Lights shall be 
protected with adequate safety devices.
    (b) The surface of the ceiling and walls shall be smooth and made of 
a water-resistant material.
    (c) The floor shall be of water-proof composition, reasonably free 
from cracks or rough surfaces, sloped for adequate drainage, and the 
intersections with walls and curbing shall be impervious to water.
    (d) Ventilation shall provide for:
    (1) A positive flow of outside filtered air through the room;
    (2) Air of suitable working temperature during operations.
    (e) There shall be provided adequate hand washing facilities which 
are easily accessible to all breaking personnel, an adequate supply of 
warm water, clean towels or other facilities for drying hands, odorless 
soap, and containers for used towels. Hand washing facilities shall be 
operated by other than hand operated controls.
    (f) Containers for packaging egg products are not acceptable as 
liquid egg buckets.
    (g) A suitable container conspicuously identified shall be provided 
for the disposal of rejected liquid.
    (h) Strainers, filters, or centrifugal clarifiers of approved 
construction shall be provided for the effective removal of shell 
particles and foreign material, unless specific approval is obtained 
from the National Supervisor for other mechanical devices.
    (i) A separate drawoff room with a filtered positive air ventilation 
system shall be provided for packaging liquid egg product, except 
product packaged

[[Page 701]]

by automatic, closed packaging systems.

[36 FR 9814, May 28, 1971, as amended at 37 FR 6659, Apr. 1, 1972. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981]



Sec. 590.522  Breaking room operations.

    (a) The breaking room shall be kept in a dust-free clean condition 
and free from flies, insects, and rodents. The floor shall be kept clean 
and reasonably dry during breaking operations and free of egg meat and 
shells.
    (b) All breaking room personnel shall wash their hands thoroughly 
with odorless soap and water each time they enter the breaking room and 
prior to receiving clean equipment after breaking an inedible egg.
    (c) Paper towels or tissues shall be used at breaking tables, and 
shall not be reused. Cloth towels are not permitted.
    (d) Breakers shall use a complete set of clean equipment when 
starting work and after lunch periods. All table equipment shall be 
rotated with clean equipment every 2\1/2\ hours.
    (e) Cups shall not be filled to overflowing.
    (f) Each shell egg shall be broken in a satisfactory and sanitary 
manner and inspected for wholesomeness by smelling the shell or the egg 
meat and by visual examination at the time of breaking. All egg meat 
shall be reexamined by a person qualified to perform such functions 
before being emptied into the tank or churn, except as otherwise 
approved by the National Supervisor.
    (g) Shell particles, meat and blood spots, and other foreign 
material accidentally falling into the cups or trays shall be removed 
with a spoon or other approved instrument.
    (h) Whenever an inedible egg is broken, the affected breaking 
equipment shall be cleaned and sanitized.
    (i) Inedible and loss eggs as defined in Sec. 590.510 apply to this 
section.
    (j) The contents of any cup or other liquid egg receptacle 
containing one or more inedible or loss eggs shall be rejected.
    (k) Contents of drip trays shall be emptied into a cup and smelled 
carefully before pouring into liquid egg bucket. Drip trays shall be 
emptied at least once for each 15 dozen eggs or every 15 minutes.
    (l) Edible leakers as defined in Sec. 590.510(c)(2) and checks 
which are liable to be smashed in the breaking operation shall be broken 
at a separate station by specially trained personnel.
    (m) Ingredients and additives used in, or for, processing egg 
products, shall be handled in a clean and sanitary manner.
    (n) Liquid egg containers shall not pass through the candling room.
    (o) Test kits shall be provided and used to determine the strength 
of the sanitizing solution. (See Sec. Sec. 590.515(a)(9) and 590.552.)
    (p) Leaker trays shall be washed and sanitized whenever they become 
soiled and at the end of each shift.
    (q) Shell egg containers whenever dirty shall be cleaned and 
drained; and shall be cleaned, sanitized, and drained at the end of each 
shift.
    (r) Belt-type shell egg conveyors shall be cleaned and sanitized 
approximately every 4 hours in addition to continuous cleaning during 
operation. When not in use, belts shall be raised to permit air drying.
    (s) Cups, knives, racks, separators, trays, spoons, liquid egg 
pails, and other breaking equipment, except for mechanical egg breaking 
equipment, shall be cleaned and sanitized at least every 2\1/2\ hours. 
This equipment shall be cleaned at the end of each shift and shall be 
clean and sanitized immediately prior to use.
    (t) Utensils and dismantled equipment shall be drained and air dried 
on approved self-draining metal racks and shall not be nested.
    (u) Dump tanks, drawoff tanks, and churns shall be cleaned 
approximately every 4 hours. All such equipment and all other liquid 
handling equipment, unless cleaned by acceptable cleaned in-place 
methods, shall be dismantled and cleaned after each shift. 
Pasteurization equipment shall be cleaned at the end of each day's use 
or more often if necessary. All such equipment shall be clean and shall 
be sanitized prior to placing in use.
    (v) Strainers, clarifiers, filtering and other devices used for 
removal of shell particles and other foreign material

[[Page 702]]

shall be cleaned and sanitized each time it is necessary to change such 
equipment, but at least once each 4 hours of operation.
    (w) Breaking room processing equipment shall not be stored on the 
floor.
    (x) Metal containers and lids for other than dried products shall be 
thoroughly washed, rinsed, sanitized, and drained immediately prior to 
filling. The foregoing sequence shall not be required if equally 
effective measures approved by the National Supervisor in writing are 
followed to assure clean and sanitary containers at the time of filling.
    (y) Liquid egg holding vats and containers (including tank trucks) 
used for transporting liquid eggs shall be cleaned after each use. Such 
equipment shall be clean and sanitized immediately prior to placing in 
use.
    (z) Tables, shell conveyors, and containers for inedible egg product 
shall be cleaned at the end of each shift.
    (aa) Mechanical egg breaking machines shall be operated at a rate to 
maintain complete control and accurately inspect and segregate each egg 
to insure the removal of all loss and inedible eggs. The machine shall 
be operated in a sanitary manner.
    (1) When an inedible egg is encountered on mechanical egg breaking 
equipment, the inedible egg and contaminated liquid shall be removed. 
The machine shall be cleaned and sanitized, or contaminated parts 
replaced with clean ones in the manner prescribed by the Administrator 
for the type of inedible egg encountered and the kind of egg breaking 
machine.
    (2) Systems for pumping egg liquid directly from egg breaking 
machines shall be of approved sanitary design and construction, and 
designed to minimize the entrance of shells into the system and be 
disconnected when inedible eggs are encountered. The pipelines of the 
pumping system shall be cleaned or flushed as often as needed to 
maintain them in a sanitary condition, and they shall be cleaned and 
sanitized at the end of each shift. Other pumping system equipment shall 
be cleaned and sanitized approximately every 4 hours or as often as 
needed to maintain it in a sanitary condition. All liquid egg pumped 
directly from egg breaking machines shall be reexamined, except as 
otherwise prescribed and approved by the Administrator.
    (3) Mechanical egg breaking equipment shall be clean and sanitized 
prior to use, and during operations the machines shall be cleaned and 
sanitized approximately every 4 hours or more often if needed to 
maintain them in a sanitary condition. This equipment shall be cleaned 
at the end of each shift.

[36 FR 9814, May 28, 1971, as amended at 37 FR 6659, Apr. 1, 1972; 40 FR 
20059, May 8, 1975; 40 FR 20941, May 14, 1975. Redesignated at 42 FR 
32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 
1981]



Sec. 590.530  Liquid egg cooling.

    (a) Liquid egg storage rooms, including surface coolers and holding 
tank rooms, shall be kept clean and free from objectionable odors and 
condensation. Surface coolers and liquid holding vats containing product 
shall be kept covered while in use. Liquid cooling units shall be of 
approved construction and have sufficient capacity to cool all liquid 
eggs to the temperature requirements specified in this section.
    (b) Compliance with temperature requirements applying to liquid eggs 
shall be considered as satisfactory only if the entire mass of the 
liquid meets the requirements.
    (c) The cooling and temperature requirements for liquid egg products 
shall be as specified in Table I of this section.

                                      Table I--Minimum Cooling and Temperature Requirements for Liquid Egg Products
                                        [Unpasterurized product temperature within 2 hours from time of breaking]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Liquid (other than
                                       Liquid (other than      salt product) to be                           Temperature within 2   Temperature within 3
              Product                  salt product) to be     held in excess of 8    Liquid salt product        hours after            hours after
                                      held 8 hours or less            hours                                     pasteurization         stabilization
--------------------------------------------------------------------------------------------------------------------------------------------------------
Whites (not to be stabilized)......  55 [deg]F. or lower...  45 [deg]F. or lower...  .....................  45 [deg]F. or lower..
Whites (to be stabilized)..........  70 [deg]F. or lower...  55 [deg]F. or lower...  .....................  55 [deg]F. or lower..  (\1\)

[[Page 703]]

 
All other product (except product    45 [deg]F. or lower...  40 [deg]F. or lower...  .....................  If to be held 8 hours  If to be held 8 hours
 with 10 percent or more salt                                                                                or less 45 [deg]F.     or less, 45 [deg]F.
 added).                                                                                                     or lower. If to be     or lower. If to be
                                                                                                             held in excess of 8    held in excess of 8
                                                                                                             hours, 40 [deg]F. or   hours, 40 [deg]F. or
                                                                                                             lower.                 lower.
Liquid egg product with 10 percent   ......................  ......................  If to be held 30       65 [deg]F. or
 or more salt added.                                                                  hours or less, 65      lower\2\.
                                                                                      [deg]F. or lower. If
                                                                                      to be held in excess
                                                                                      of 30 hours, 45
                                                                                      [deg]F. or lower.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Stabilized liquid whites shall be dried as soon as possible after removal of glucose. The storage of stabilized liquid whites shall be limited to
  that necessary to provide a continuous operation.
\2\ The cooling process shall be continued to assure that any salt product to be held in excess of 24 hours is cooled and maintained at 45 [deg]F. or
  lower.

    (d) Upon written request and under such conditions as may be 
prescribed by the National Supervisor, liquid cooling and holding 
temperatures not otherwise provided for in this section may be approved.
    (e) Agitators shall be operated in such a manner as will minimize 
foaming.
    (f) When ice is used as an emergency refrigerant by being placed 
directly into the egg meat, the source of the ice must be certified by 
the local or State board of health. Such liquid shall be dried. All ice 
shall be handled in a sanitary manner.
    (g) Previously frozen egg or egg product cannot be added to liquid 
product for the purpose of complying with liquid cooling requirements.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 47 
FR 745, Jan. 7, 1982; 60 FR 49170, Sept. 21, 1995]



Sec. 590.532  Liquid egg holding.

    (a) Tanks and vats used for holding liquid eggs shall be of approved 
construction, fitted with covers, and located in rooms maintained in a 
sanitary condition. Notwithstanding the foregoing, tanks designed for 
installation partially outside of a room or building are acceptable, 
providing all openings into the tanks terminate in the processing room.
    (b) Liquid egg holding tanks or vats shall be equipped with suitable 
thermometers and agitators.
    (c) Inlets to holding tanks or vats shall be such as to prevent 
excessive foaming.
    (d) Gaskets, if used, shall be of a sanitary type.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 45 FR 23641, Apr. 8, 1980. Redesignated at 46 FR 63203, 
Dec. 31, 1981]



Sec. 590.534  Freezing facilities.

    (a) Freezing rooms, either on or off the premises, shall be capable 
of freezing all liquid egg products in accordance with the freezing 
requirements as set forth in Sec. 590.536. Use of off-premise freezing 
facilities is permitted only when prior approval in writing from the 
National Supervisor is on file.
    (b) Adequate air circulation shall be provided in all freezing 
rooms.



Sec. 590.536  Freezing operations.

    (a) Freezing rooms shall be kept clean and free from objectionable 
odors.

[[Page 704]]

    (b) Requirements. (1) Nonpasteurized egg products which are to be 
frozen shall be solidly frozen or reduced to a temperature of 10 [deg]F 
or lower within 60 hours from time of breaking.
    (2) Pasteurized egg products which are to be frozen shall be solidly 
frozen or reduced to a temperature of 10 [deg]F or lower within 60 hours 
from time of pasteurization.
    (3) The temperature of the products not solidly frozen shall be 
taken at the center of the container to determine compliance with this 
section.
    (c) Containers shall be stacked so as to permit circulation of air 
around the containers.
    (d) The outside of liquid egg containers shall be clean and free 
from evidence of liquid egg.
    (e) Frozen egg products shall be examined by organoleptic 
examination after freezing to determine their fitness for human food. 
Any such products which are found to be unfit for human food shall be 
denatured and any official identification mark which appears on any 
container thereof shall be removed or completely obliterated and the 
containers identified as required in Sec. Sec. 590.840 and 590.860.



Sec. 590.538  Defrosting facilities.

    (a) Approved metal defrosting tanks or vats constructed so as to 
permit ready and thorough cleaning shall be provided.
    (b) Frozen egg crushers, when used, shall be of approved metal 
construction. The crushers shall permit ready and thorough cleaning and 
the bearings and housing shall be fabricated in such a manner as to 
prevent contamination of the egg products.
    (c) Service tables shall be of approved metal construction without 
open seams and the surfaces shall be smooth to allow thorough cleaning.



Sec. 590.539  Defrosting operations.

    (a) Frozen egg products which are to be defrosted shall be defrosted 
in a sanitary manner.
    (b) Each container of frozen eggs shall be checked for condition and 
odor just prior to being emptied into the crusher or receiving tank. 
Frozen eggs which have objectionable odors and are unfit for human food 
(e.g., sour, musty, fermented, or decomposed odors) shall be denatured.
    (c) Frozen whites to be used in the production of dried albumen may 
be defrosted at room temperature. All other whites shall be defrosted in 
accordance with paragraph (d) of this section.
    (d) Frozen whole eggs, whites and yolks, and yolks may be tempered 
or partially defrosted for not to exceed 48 hours at a room temperature 
no higher than 40 [deg]F. or not to exceed 24 hours at a room 
temperature above 40 [deg]F.: Provided, That no portion of the defrosted 
liquid shall exceed 50 [deg]F. while in or out of the container.
    (1) Frozen eggs packed in metal or plastic containers may be placed 
in running tap water (70 F[deg] or lower) without submersion to speed 
defrosting.
    (2) The defrosted liquid shall be held at 40 [deg]F. or less, except 
for product to be pasteurized or stabilized by glucose removal as 
provided in Sec. 590.530. Defrosted liquid shall not be held more than 
16 hours prior to processing or drying.
    (e) Sanitary methods shall be used in handling containers and 
removing egg product.
    (f) Crushers and other equipment used in defrosting operations shall 
be dismantled at the end of each shift and shall be washed, rinsed, and 
sanitized.
    (1) Where crushers are used intermittently, they shall be flushed 
after each use and again before being placed in use.
    (2) Floors and work tables shall be kept clean.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 43 FR 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, 
Dec. 31, 1981, as amended at 60 FR 49170, Sept. 21, 1995]



Sec. 590.540  Spray process drying facilities.

    (a) Driers shall be of a continuous discharge type and so 
constructed and equipped to prevent an excess accumulation of powder in 
the drier, bags, and powder conveyors.
    (b) Driers shall be of approved construction and materials, with 
welded seams, and the surfaces shall be smooth to allow for thorough 
cleaning.

[[Page 705]]

    (c) Driers shall be equipped with approved air intake filters.
    (d) Air shall be drawn into the drier from sources free from foul 
odors, dust, and dirt.
    (e) Indirect heat or the use of an approved premixing device or 
other approved devices for securing complete combustion in direct-fired 
units is required. A premix-type burner, if used, shall be equipped with 
approved air filters at blower intake.
    (f) High-pressure pump heads and lines shall be of stainless steel 
construction or equivalent which will allow for thorough cleaning.
    (g) Preheating units, if used, shall be of stainless steel 
construction, or equivalent which will allow thorough cleaning.
    (h) Powder conveying equipment shall be so constructed as will 
facilitate thorough cleaning.
    (i) Sifters shall be constructed of an approved metal or metal lined 
interior. The sifting screens and frames shall be of an approved metal 
construction. Sifters shall be so constructed that accumulations of 
large particles or lumps of dried eggs can be removed continuously while 
the sifters are in operation.

[36 FR 9814, May 28, 1971; 36 FR 10841, June 4, 1971. Redesignated at 42 
FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 
31, 1981]



Sec. 590.542  Spray process drying operations.

    (a) The drying room shall be kept in a clean condition and free of 
flies, insects, and rodents.
    (b) Low-pressure lines, high-pressure lines, high- and low-pressure 
pumps, homogenizers, and pasteurizers shall be cleaned by acceptable 
inplace cleaning methods or dismantled and cleaned after use or as 
necessary when operations have been interrupted.
    (1) Spray nozzles, orifices, cores, or whizzers shall be cleaned 
immediately after cessation of drying operations.
    (2) Equipment shall be sanitized within 2 hours prior to resuming 
operations.
    (c) Drying units, conveyors, sifters, and packaging systems shall be 
cleaned whenever wet powder is encountered or when other conditions 
occur which would adversely affect the product. The complete drying 
unit, including sifters, conveyors, and powder coolers shall be either 
wet washed or dry cleaned. A combination of wet washing and dry cleaning 
of the complete drying unit shall not be permitted unless that segment 
of the unit to be cleaned in a different manner is completely detached 
or disconnected from the balance of the drying unit.
    (1) Sifters and conveyors used for other than dried albumen shall be 
cleared of powder when such equipment is not to be used for a period of 
24 hours or longer.
    (2) Collector bags shall be cleaned as often as needed to maintain 
them in an acceptable clean condition.
    (d) Powder shall be sifted and the screen shall be replaced whenever 
torn or worn.
    (e) Accumulations of large particles or lumps of dried eggs shall be 
removed from the sifter screens continuously.
    (f) All openings into the drier around ports, augers, high-pressure 
lines, etc., shall be closed to the extent possible during the drying 
operation to prevent entrance of nonfiltered air.
    (g) Openings into the drying unit shall be closed when the drier is 
not in use, except when the drying unit has been completely emptied of 
powder and wet washed. This includes, but is not limited to, openings, 
for the air intake and exhaust systems, nozzle openings, ports, augers, 
etc.



Sec. 590.544  Spray process powder; definitions and requirements.

    (a) Definition of product:
    (1) Primary powder is that powder which is continuously removed from 
the primary or main drying chamber while the drying unit is in 
operation.
    (2) Secondary powder is that powder which is continuously and 
automatically removed from the secondary chamber and/or bag collector 
chamber while the drying unit is in operation.
    (3) Sweep-down powder is that powder which is recovered in the 
brush-down process from the primary or secondary chamber and conveyors.
    (4) Brush bag powder is that powder which is brushed from the 
collector bags.
    (b) Secondary powder shall be continuously discharged and mixed with

[[Page 706]]

the primary powder by methods approved by the Administrator.
    (c) Edible dried egg products, including edible ingredients which 
may be added to such dried products, may be dry-blended: Provided, That 
the blending is done in a room as provided in Sec. 590.548 or in a 
closed blending system and in accordance with clean, sanitary practices 
and such procedures as may be prescribed by the Administrator.
    (d) Any edible dried egg powder may be reconstituted, repasteurized, 
and redried when accomplished in a clean, sanitary manner and in 
accordance with such procedures as may be prescribed by the 
Administrator.
    (e) Edible dried egg powder obtained from the sweep down, 
screenings, brush bag (except for brush bag powder from albumen driers), 
and improperly dried or scorched powder shall be reconstituted, 
repasteurized, and redried.
    (f) Approximately the first and last 175 pounds of powder from the 
main driers for each continuous operation shall be checked for 
improperly dried or scorched powder.



Sec. 590.546  Albumen flake process drying facilities.

    (a) Drying facilities shall be constructed in such a manner as will 
allow thorough cleaning and be equipped with approved intake filters.
    (b) The intake air source shall be free from foul odors, dust, and 
dirt.
    (c) Premix-type burners, if used, shall be equipped with approved 
air filters at blower intake.
    (d) Fermentation tanks, drying pans, trays or belts, scrapers, 
curing racks, and equipment used for pulverizing pan dried albumen shall 
be constructed of approved materials in such a manner as will permit 
thorough cleaning.
    (e) Sifting screens shall be constructed of approved materials in 
such a manner as will permit thorough cleaning and be in accordance with 
the specification for the type of albumen produced.



Sec. 590.547  Albumen flake process drying operations.

    (a) The fermentation, drying, and curing rooms shall be kept in a 
dust-free clean condition and free of flies, insects, and rodents.
    (b) Drying units, racks, and trucks shall be kept in a clean and 
sanitary condition.
    (c) Drying pans, trays, belts, scrapers, or curing racks, if used, 
shall be kept in a clean condition.
    (d) Oils and waxes used in oiling drying pans or trays shall be of 
edible quality.
    (e) Equipment used for pulverizing or sifting dried albumen shall be 
kept in a clean condition.



Sec. 590.548  Drying, blending, packaging, and heat treatment rooms 
and facilities.

    (a) General. Processing rooms shall be maintained in a clean 
condition and free of flies, insects, and rodents. The drying, blending, 
and packaging rooms shall be well-lighted and have ceilings and walls of 
a tile surface, enamel paint, or other water-resistant material.
    (1) The floors shall be free from cracks or rough surfaces where 
water or dirt could accumulate.
    (2) The intersections of the walls and floors shall be impervious to 
water and the floor shall be sloped for adequate drainage.
    (3) Metal storage racks or cabinets shall be provided for storing of 
tools and accessories.
    (b) Dry blending of edible egg products, including adding edible dry 
ingredients, and/or packaging of spray-dried products shall be done in a 
room separate from other processing operations. Dry blending may also be 
done in other areas: Provided, That it is accomplished in an approved 
closed blending system.
    (1) Blending and packaging rooms for pasteurized products shall be 
provided with an adequate positive flow of approved outside filtered 
air.
    (2) Blending and packaging equipment and accessories which come into 
contact with the dried product shall be of an approved construction 
without open seams and of materials that can be kept clean and which 
will have no deleterious effect on the product. Service tables shall be 
of approved metal construction without open seams and surfaces shall be 
smooth to permit thorough cleaning.
    (3) Package liners shall be inserted in a sanitary manner, and 
equipment and

[[Page 707]]

supplies used in the operation shall be kept off the floor.
    (4) Utensils used in packaging dried eggs shall be kept clean at all 
times and whenever contaminated shall be cleaned and sanitized. When not 
in use, scoops, brushes, tampers, and other similar equipment shall be 
stored in sanitary cabinets or racks provided for this purpose.
    (5) Automatic container fillers shall be of a type that will 
accurately fill given quantities of product into the containers. Scales 
shall be provided to accurately check the weight of the filled 
containers. All equipment used in mechanically packaging dried egg 
products shall be vacuum cleaned daily.
    (c) The heat treatment room shall be of an approved construction and 
be maintained in a clean condition. The room or rooms shall be of 
sufficient size so that product to be heat treated can be so spaced to 
assure adequate heat and air circulation. The room shall have an 
adequate heat supply and a continuous air circulation system.



Sec. 590.549  Dried egg storage.

    Dried egg storage shall be sufficient to adequately handle the 
production of the plant and shall be kept clean, dry, and free from 
objectionable odors.



Sec. 590.550  Washing and sanitizing room or area facilities.

    (a) This room or area shall be well lighted, and of sufficient size 
to permit operators to properly wash and sanitize all equipment at the 
rate required by the size of the operation. Adequate exhaust shall be 
provided to assure the prompt removal of odors and vapors and the air 
flow shall be away from the breaking room. If the washing and sanitizing 
is not done in a separate room, it shall be in an area well segregated 
from the breaking areas and be well ventilated with air movement 
directed away from the breaking operations so that odors and vapors do 
not permeate the breaking areas.
    (b) Ceiling and walls shall have a surface of tile, enamel paint, or 
other water-resistant material.
    (c) Floors shall be adequately sloped for proper drainage, be free 
from cracks or rough surfaces where water and dirt could accumulate and 
the intersections with walls shall be impervious to water.



Sec. 590.552  Cleaning and sanitizing requirements.

    (a) Cleaning. (1) Equipment used in egg processing operations which 
comes in contact with liquid eggs or exposed edible products shall be 
cleaned to eliminate organic matter and inorganic residues. This may be 
accomplished by any sanitary means but it is preferable (unless high 
pressure cleaning is used) to flush soiled equipment with clean cool 
water, dismantle it when possible, wash by brushing with warm water 
containing a detergent and followed by rinsing with water. It is 
essential to have the equipment surfaces thoroughly clean if effective 
sanitizing is to be attained.
    (2) Equipment shall be cleaned with such frequency as is specified 
elsewhere under the sanitary requirements for the particular kind of 
operation and type of equipment involved.
    (3) C.I.P. (cleaned-in-place) shall be considered to be acceptable 
only if the methods and procedures used accomplish cleaning equivalent 
to that obtained by thorough manual washing and sanitizing of dismantled 
equipment. The Administrator shall determine the acceptability of C.I.P. 
cleaning procedures and may require bacteriological tests and periodic 
dismantling of equipment as a basis for such determination.
    (b) Sanitizing. (1) Sanitizing shall be accomplished by such methods 
as approved by the Administrator.
    (i) Chemicals and compounds used for sanitizing shall have approval 
by the Administrator prior to use.
    (ii) Sanitizing by use of hypochlorites or other approved sanitizing 
solutions shall be accomplished by subjecting the equipment surfaces to 
such sanitizing solution containing a maximum strength of 200 p.p.m. of 
available chlorine or its equivalent. These solutions shall be changed 
whenever the strength drops to 100 p.p.m. or less of available chlorine 
or its equivalent.
    (2) Shell eggs which have been sanitized and equipment which comes 
in contact with edible products shall be rinsed with clean water after 
sanitizing

[[Page 708]]

if other than hypochlorites are used as sanitizing agents unless 
otherwise approved by the Administrator.



Sec. 590.560  Health and hygiene of personnel.

    (a) Personnel facilities, including toilets, lavatories, lockers, 
and dressing rooms shall be adequate and meet State and local 
requirements for food processing plants.
    (b) Toilets and dressing rooms shall be kept clean and adequately 
ventilated to eliminate odors and kept adequately supplied with soap, 
towels, and tissues. Toilet rooms shall be ventilated to the outside of 
the building.
    (c) No person affected with any communicable disease in a 
transmissible stage or a carrier of such disease, or with boils, sores, 
infected wounds, or wearing cloth bandages on hands shall be permitted 
to come in contact with eggs in any form or with equipment used to 
process such eggs.
    (d) Workers coming into contact with liquid or dried eggs, 
containers, or equipment shall wear clean outer uniforms.
    (e) Plant personnel handling exposed edible product shall wash their 
hands before beginning work, and upon returning to work after leaving 
the work room.
    (f) Expectorating, or other unsanitary practices, shall not be 
permitted.
    (g) Use of tobacco in any form or the wearing of jewelry, nail 
polish, or perfumes shall not be permitted in any area where edible 
products are exposed.
    (h) Hair nets or caps shall be properly worn by all persons in 
breaking and packaging rooms.



Sec. 590.570  Pasteurization of liquid eggs.

    (a) Pasteurization facilities: The facilities for pasteurization of 
egg products shall be adequate and of approved construction so that all 
products will be processed as provided for in this section. 
Pasteurization equipment for liquid egg product shall include a holding 
tube, an automatic flow diversion valve, thermal controls, and recording 
devices to determine compliance for pasteurization as set forth in 
paragraph (b) of this section. The temperature of the heated liquid egg 
product shall be continuously and automatically recorded during the 
process.
    (b) Pasteurizing operations: Every particle of all products must be 
rapidly heated to the required temperature and held at that temperature 
for the required minimum holding time as set forth in this section. The 
temperatures and holding times listed in Table I of this section are 
minimum. The product may be heated to higher temperatures and held for 
longer periods of time. Pasteurization procedures shall assure complete 
pasteurization, and holding, packaging, facilities and operations shall 
be such as to prevent contamination of the product.

                Table I--Pasteurization Requirements \1\
------------------------------------------------------------------------
                                                 Minimum       Minimum
                                               temperature  holding time
             Liquid egg product               requirements  requirements
                                                ([deg]F.)     (Minutes)
------------------------------------------------------------------------
Albumen (without use of chemicals)..........          134           3.5
                                                      132           6.2
Whole egg...................................          140           3.5
Whole egg blends (less than 2 percent added           142           3.5
 nonegg ingredients)........................
                                                      140           6.2
Fortified whole egg and blends (24-38                 144           3.5
 percent egg solids, 2-12 percent added
 nonegg ingredients)........................
                                                      142           6.2
Salt whole egg (with 2 percent or more salt           146           3.5
 added).....................................
                                                      144           6.2
Sugar whole egg (2-12 percent sugar added)..          142           3.5
                                                      140           6.2
Plain yolk..................................          142           3.5
                                                      140           6.2
Sugar yolk (2 percent or more sugar added)..          146           3.5
                                                      144           6.2
Salt yolk (2-12 percent salt added).........          146           3.5
                                                      144           6.2
------------------------------------------------------------------------
\1\ Pasteurization of egg products not listed in this table shall be in
  accordance with paragraph (c) of this section.

    (c) Other methods of pasteurization may be approved by the 
Administrator when such treatments give equivalent effects to those 
specified in paragraph (b) of this section for those products or other 
products and results in a salmonella negative product.



Sec. 590.575  Heat treatment of dried whites.

    Heat treatment of dried whites is an approved method for 
pasteurization and the product shall be heated throughout for such times 
and at such

[[Page 709]]

temperatures as will result in salmonella negative product.
    (a) The product to be heat treated shall be held in the heat 
treatment room in closed containers and shall be spaced to assure 
adequate heat penetration and air circulation. Each container shall be 
identified as to type of product (spray or pan dried) and with the lot 
number or production code number.
    (b) The minimum requirements for heat treatment of spray or pan 
dried albumen shall be as follows:
    (1) Spray dried albumen shall be heated throughout to a temperature 
not less than 130 [deg]F and held continuously at such temperature not 
less than 7 days and until it is salmonella negative.
    (2) Pan dried albumen shall be heated throughout to a temperature of 
not less than 125 [deg]F and held continuously at such temperature not 
less than 5 days and until it is salmonella negative.
    (3) Methods of heat treatment of spray dried or pan dried albumen, 
other than listed in paragraphs (b) (1) and (2) of this section, may be 
approved by the Administrator upon receipt of satisfactory evidence that 
such methods will result in salmonella negative products.
    (c) Dried whites which have been heat treated in the dried form 
shall be sampled and analyzed for the presence of Salmonellae as 
required in Sec. 590.580.
    (d) Records shall be maintained for 1 year of the following:
    (1) Types of product;
    (2) Lot number;
    (3) Heat treatment room temperatures;
    (4) Product temperatures;
    (5) Length of time product is held in heat treatment room;
    (6) Results of all laboratory analyses made for the presence of 
Salmonellae.
    (e) Dried whites processed and tested in accordance with all of the 
applicable requirements specified in this section may be labeled 
``Pasteurized.''

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 47 
FR 745, Jan. 7, 1982; 60 FR 49169, Sept. 21, 1995; 60 FR 58199, Nov. 27, 
1995]

                               Laboratory



Sec. 590.580  Laboratory tests and analyses.

    The official plant, at their expense, shall make tests and analyses 
to determine compliance with the Act and the regulations.
    (a) Samples shall be drawn from liquid, frozen or dried egg products 
and analyzed for compliance with the standards of identity (if any) and 
with the product label.
    (b) To assure adequate pasteurization, pasteurized egg products and 
heat treated dried egg whites shall be sampled and analyzed for the 
presence of Salmonellae in accordance with such sequence, frequency, and 
approved laboratory methods as prescribed by the AMS Science Division 
Director. The samples of pasteurized egg products and heat treated dried 
egg whites shall be drawn from the final packaged form.
    (c) Results of all analyses and tests performed under paragraphs (a) 
and (b) of this section shall be provided to the inspector promptly upon 
receipt by the plant. If samples of pasteurized products or heat treated 
dried egg whites, in addition to those described in paragraphs (a) and 
(b) of this section, are analyzed for the presence of Salmonella, the 
plant shall immediately advise the inspector of any such samples which 
are determined to be Salmonella positive.
    (d) USDA will draw confirmation samples and submit them to a AMS 
Science Division laboratory at USDA's expense to determine the adequacy 
of the plant's tests and analyses.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 58 
FR 42413, Aug. 9, 1993; 60 FR 49170, Sept. 21, 1995; 60 FR 58199, Nov. 
27, 1995]

                      Exempted Egg Products Plants



Sec. 590.600  Application for exemption.

    An application for exemption from the continuous inspection 
requirements must be made in writing on

[[Page 710]]

forms approved by the Administrator and filed with the inspection 
service.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 47 
FR 745, Jan. 7, 1982]



Sec. 590.610  Criteria for exemption.

    Any plant processing egg products may qualify for exemption where:
    (a) The facility, operating procedures and practices, and sanitation 
meet the standards required for official egg products plants as are 
contained in Sec. Sec. 590.500 through 590.580, and such exempted 
plants shall thereafter be subject to other provisions applicable to 
official plants which shall include maintaining records such as 
pasteurization temperatures and holding times, laboratory records, egg 
products testing procedures, and making all such records available for 
review.
    (b) The eggs received or used in the manufacture of egg products 
contain no more restricted eggs than are allowed by the official 
standards for U.S. Consumer Grade B shell eggs.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 47 
FR 745, Jan. 7, 1982]



Sec. 590.620  Authority of applicant.

    Proof of authority of any person applying for exemption from 
continuous inspection may be required by the Administrator.



Sec. 590.630  Filing of application.

    An application for exemption shall be regarded as filed only when it 
has been filled in completely and signed by the applicant and has been 
received in the office of the inspection service.



Sec. 590.640  Application for exemption; approval.

    Any person desiring to process egg products pursuant to the 
exemption provision of the Act and these regulations must receive 
approval of such plant, facilities, and operating procedures as an 
exempted plant. An application for exemption shall be according to the 
following:
    (a) Initial survey. When an application for exemption of a plant has 
been filed, a Supervisory Egg Products Inspector will make a survey and 
inspection of the premises and plant to determine if the facilities, 
methods of operation, and eggs received or used therein are suitable and 
adequate in accordance with:
    (1) Section 590.610; and
    (2) Such other administrative instructions as may be issued, from 
time to time, by the Service and which are in effect at the time of the 
aforesaid survey and inspection.
    (b) Final survey and exemption approval. Upon notification by the 
applicant for exemption that all the criteria for exemption required in 
Sec. 590.610 are in effect and an initial survey has been performed, 
the applicant shall:
    (1) Submit drawings and specifications in accordance with the same 
requirements as official plants as specified in Sec. 590.146(b);
    (2) Submit labels for approval as specified in Sec. 590.680;
    (3) Request a final survey be made by a Supervisory Egg Products 
Inspector to determine if the plant is constructed and the facilities 
are installed in accordance with the approved drawings and these 
regulations.
    (c) The plant will be approved for exemption only when all the 
requirements of this section have been met.

[36 FR 9814, May 28, 1971; 36 FR 10841, June 4, 1971. Redesignated at 42 
FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 
31, 1981]



Sec. 590.650  Exempted plant registration number.

    Each plant processing egg products which receives the 
Administrator's approval for exemption shall be assigned an ``Exempted 
Registration Number'' at the time the exemption approval is provided.



Sec. 590.660  Inspection of exempted plants.

    Duly authorized representatives of the Administrator shall make such 
periodic inspections of exempted plants and records thereof as the 
Administrator may require to ascertain if any of the provisions of the 
Act or these regulations applicable to exempted plants have been 
violated. Such representatives shall be afforded access, at any 
reasonable time, to any plant or

[[Page 711]]

place of business subject to inspection under the provisions of the Act.



Sec. 590.670  Termination of exemption.

    The Administrator may suspend or terminate any exemption if the 
criteria for exemption required in Sec. 590.610 are not being met. In 
addition, if any violation has been committed, the applicable penalties 
provided in this part may be enforced as provided in the Act.



Sec. 590.680  Approval of labeling for egg products processed in exempted 
egg products processing plants.

    (a) The labels for egg products which are capable for use as human 
food shall be submitted to the Administrator for approval. The 
submission and approval shall be the same as for official plants as 
required in Sec. 590.411 except the labels or containers shall not bear 
official identification.
    (b) The label or container shall legibly and conspicuously bear the 
statement: ``Exempted--E.P.I.A. Registration No. ------.'' The 
registration number shall be that assigned to the exempted plant as 
provided in Sec. 590.650.

Identification of Restricted Eggs or Egg Products Not Intended for Human 
                               Consumption



Sec. 590.800  Identification of restricted eggs.

    The shipping container of restricted eggs shall be determined to be 
satisfactorily identified if such container bears the packer's name and 
address, the quality of the eggs in the container (e.g., dirties, 
checks, inedibles, or loss), or the statement ``Restricted Eggs--For 
Processing Only In An Official USDA Egg Products Plant,'' for checks or 
dirties, or ``Restricted Eggs--Not To Be Used As Human Food,'' for 
inedibles, loss, and incubator rejects, or ``Restricted Eggs--To Be 
Regraded'' for graded eggs which contain more restricted eggs than are 
allowed in the official standards for U.S. Consumer Grade B shell eggs. 
The size of the letters of the identification wording shall be as 
required in Sec. 590.860.

[40 FR 20060, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 
FR 49171, Sept. 21, 1995; 63 FR 69972, Dec. 17, 1998]



Sec. 590.840  Identification of inedible, unwholesome, or adulterated 
egg products.

    All inedible, unwholesome, or adulterated egg products shall be 
identified with the name and address of the processor, the words 
``Inedible Egg Products--Not To Be Used as Human Food.''



Sec. 590.860  Identification wording.

    The letters of the identification wording shall be legible and 
conspicuous.

[37 FR 6659, Apr. 1, 1972. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981]

                                 Imports



Sec. 590.900  Requirements for importation of egg products or restricted 
eggs into the United States.

    (a) Egg products and restricted eggs may be imported into the United 
States from any foreign country only in accordance with these 
regulations. The term United States means any State of the United 
States, the Commonwealth of Puerto Rico, the Virgin Islands of the 
United States, and the District of Columbia. The importation of any egg 
or egg product in violation of the regulations of this part is 
prohibited.
    (b) All such imported articles shall upon entry into the United 
States be deemed and treated as domestic articles and be subject to the 
other provisions of the Act, these regulations, and other Federal or 
State requirements.



Sec. 590.905  Importation of restricted eggs or eggs containing more 
restricted eggs than permitted in the official standards for U.S. 
Consumer Grade B.

    No containers of restricted egg(s) other than checks or dirties 
shall be imported into the United States. The shipping containers of 
such eggs shall be identified with the name, address, and country of 
origin of the exporter,

[[Page 712]]

and the date of pack and quality of the eggs (e.g., checks, or dirties) 
preceded by the word ``Imported'' or the statement ``Imported Restricted 
Eggs--For Processing Only In An Official USDA Plant,'' or ``Restricted 
Eggs--Not To Be Used As Human Food.'' Such identification shall be 
legible and conspicuous. Alternatively, for properly sealed and 
certified shipments of shell eggs imported for breaking at an official 
egg products plant, the shipping containers need not be labeled, 
provided that the shipment is segregated and controlled upon arrival at 
the destination breaking plant.

[36 FR 9814, May 28, 1971, as amended at 37 FR 6659, Apr. 1, 1972. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49171, Sept. 21, 1995; 
63 FR 69972, Dec. 17, 1998]



Sec. 590.910  Eligibility of foreign countries for importation of egg 
products into the United States.

    (a) Whenever it is determined by the Administrator that the system 
of egg products inspection maintained by any foreign country is such 
that the egg products produced in such country are processed, labeled, 
and packaged in accordance with, and otherwise comply with, the 
standards of the Act and these regulations including, but not limited to 
the same sanitary, processing, facility requirements, and continuous 
Government inspection as required in Sec. Sec. 590.500 through 590.580 
applicable to inspected articles produced within the United States, 
notice of that fact will be given by listing the name of such foreign 
country in paragraph (b) of this section. Thereafter, egg products from 
the countries so listed shall be eligible, subject to the provisions of 
this part and other applicable laws and regulations, for importation 
into the United States. Such products to be imported into the United 
States from these foreign countries must meet, to the extent applicable, 
the same standards and requirements that apply to comparable domestic 
products as set forth in these regulations. Egg products from foreign 
countries not listed herein are not eligible for importation into the 
United States, except as provided by Sec. 590.960. In determining if 
the inspection system of a foreign country is the equivalent of the 
system maintained by the United States, the Administrator shall review 
the inspection regulations of the foreign country and make a survey to 
determine the manner in which the inspection system is administered 
within the foreign country. The survey of the foreign inspection system 
may be expedited by payment by the interested Government agency in the 
foreign country of the travel expenses incurred in making the survey. 
After approval of the inspection system of a foreign country, the 
Administrator may, as often and to the extent deemed necessary, 
authorize representatives of the Department to review the system to 
determine that it is maintained in such a manner as to be the equivalent 
of the system maintained by the United States.
    (b) It has been determined that each of the following foreign 
countries maintain an egg products inspection system that is the 
equivalent of the system maintained by the United States: Canada, The 
Netherlands.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 42 FR 48327, Sept. 23, 1977. Redesignated at 46 FR 63203, 
Dec. 31, 1981, as amended at 52 FR 42426, Nov. 5, 1987]



Sec. 590.915  Foreign inspection certification required.

    (a) Except as provided in Sec. 590.960, each consignment of egg 
products, as defined in this part, shall be accompanied by a foreign egg 
products inspection certificate, which, unless otherwise approved by the 
Administrator, contains the following information:
    (1) Country exporting product;
    (2) City and date where issued;
    (3) Kind of product, number of containers, and weight;
    (4) Production date(s) of product;
    (5) Identification marks on containers;
    (6) Name and address of exporter;
    (7) Name, address, and plant number of processing plant;
    (8) Name and address of importer;
    (9) A certification that the egg products were produced under the 
approved

[[Page 713]]

regulations, requirements, and continuous Government inspection of the 
exporting country and;
    (10) Name (including signature) and official title of person 
authorized to issue inspection certificates for egg products exported to 
the United States.
    (b) [Reserved]

[36 FR 9814, May 28, 1971, as amended at 37 FR 6659, Apr. 1, 1972. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49171, Sept. 21, 1995; 
63 FR 45675, Aug. 27, 1998; 63 FR 69972, Dec. 17, 1998]



Sec. 590.920  Importer to make application for inspection of imported 
eggs and egg products.

    Each person importing any eggs or egg products shall make 
application for inspection to the Chief, Poultry Grading Branch, Poultry 
Division, Agricultural Marketing Service, U.S. Department of 
Agriculture, Washington, DC 20250, or to the Poultry Division, Poultry 
Grading Branch office at the port where the product is to be offered for 
importation. Application shall be made as long as possible prior to the 
arrival of each consignment of product, except in the case of product 
exempted from inspection by Sec. 590.960. Each application shall state 
the approximate date of product arrival in the United States, the name 
of the ship or other carrier, the country from which the product was 
shipped, the destination, the quantity and class of product, whether 
fresh, frozen, or dried, and the point of first arrival in the United 
States.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 43 FR 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, 
Dec. 31, 1981, as amended at 47 FR 46070, Oct. 15, 1982; 47 FR 54421, 
Dec. 3, 1982; 63 FR 69972, Dec. 17, 1998]



Sec. 590.925  Inspection of imported egg products.

    (a) Except as provided in Sec. 590.960, egg products offered for 
importation from any foreign country shall be subject to inspection in 
accordance with established inspection procedures, including the 
examination of the labeling information on the containers, by an 
inspector before the product shall be admitted into the United States. 
Importers will be advised of the point where inspection will be made, 
and in case of small shipments (less than carload lots), the importer 
may be required to move the product to the location of the nearest 
inspector.
    (b) Inspectors may take samples, without cost to the United States, 
of any product offered for importation which is subject to analysis or 
quality determination, except that samples shall not be taken of any 
products offered for importation under Sec. 590.960, unless there is 
reason for suspecting the presence therein of a substance in violation 
of that section.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 63 
FR 69972, Dec. 17, 1998]



Sec. 590.930  Imported egg products; retention in customs custody; 
delivery under bond; movement prior to inspection; sealing; handling; 
facilities, and assistance.

    (a) No egg products required by this part to be inspected shall be 
released from customs custody prior to required inspections, but such 
product may be delivered to the consignee, or his agent, prior to 
inspection if the consignee shall furnish a bond, in the form prescribed 
by the Secretary of the Treasury, conditioned that the product shall be 
returned, if demanded, to the collector of the port where the same is 
offered for clearance through customs.
    (b) Notwithstanding paragraph (a) of this section, no product 
required by this part to be inspected shall be moved prior to inspection 
from the port of arrival where first unloaded, and if arriving by water 
from the wharf where first unloaded at such port, to any place other 
than the place designated in accordance with this part as the place 
where the same shall be inspected; and no product shall be conveyed in 
any manner other than in compliance with this part.
    (c) Means of conveyance or packages in which any product is moved in 
accordance with this part, prior to inspection, from the port or wharf 
where first unloaded in the United States, shall be sealed with special 
import seals of the U.S. Department of Agriculture or otherwise 
identified as provided herein, unless already sealed

[[Page 714]]

with customs or consular seals in accordance with the customs 
regulations. Such special seals shall be affixed by an inspector or, if 
there is no inspector at such port, by a customs officer. In lieu of 
sealing packages, the carrier or importer may furnish and attach to each 
package of product a warning notice on bright yellow paper, not less 
than 5x8 inches in size, containing the following legend in black type 
of a conspicuous size:

                     (Name of Truck Line or Carrier)

                                 Notice

    This package of ---------- must be delivered intact to an inspector 
of the Poultry Division, U.S. Department of Agriculture.

                                 Warning

    Failure to comply with these instructions will result in penalty 
action being taken against the holder of the customs entry bond.
    If the product is found to be acceptable upon inspection, the 
product may be released to the consignee, or his agent, and this warning 
notice defaced.

    (d) No person shall affix, break, alter, deface, mutilate, remove, 
or destroy any special import seal of the U.S. Department of 
Agriculture, except customs officers or inspectors, or as provided in 
paragraph (f) of this section.
    (e) No product shall be removed from any means of conveyance or 
package sealed with a special import seal of the U.S. Department of 
Agriculture, except under the supervision of an inspector or a customs 
officer, or as provided in paragraph (f) of this section.
    (f) In case of a wreck or similar extraordinary emergency, the 
special import seal of the U.S. Department of Agriculture on a car, 
truck, or other means of conveyance may be broken by the carrier and, if 
necessary, the articles may be reloaded into another means of conveyance 
for transportation to destination. In all such cases, the carrier shall 
immediately report the facts by telegraph to the Chief of the Grading 
Branch.
    (g) The consignee or his agent shall provide such facilities and 
assistance as the inspector may require for the inspection and handling 
and marking of products offered for importation.

[36 FR 9814, May 28, 1971, as amended at 37 FR 6660, Apr. 1, 1972; 40 FR 
20060, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, as 
amended at 43 FR 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, Dec. 
31, 1981, as amended at 47 FR 46070, Oct. 15, 1982; 47 FR 54421, Dec. 3, 
1982; 63 FR 69972, Dec. 17, 1998]



Sec. 590.935  Means of conveyance and equipment used in handling egg 
products to be maintained in sanitary condition.

    Compartments of boats, railroad cars, and other means of conveyance 
transporting any product to the United States, and all chutes, 
platforms, racks, tables, tools, utensils, and all other devices used in 
moving and handling such product offered for importation, shall be 
maintained in a sanitary condition.



Sec. 590.940  Marking of egg products offered for importation.

    Egg products which, upon inspection, are found to be acceptable for 
importation into the United States, and are properly labeled and bear 
the inspection mark of the country of origin, need no further 
identification.

[40 FR 20060, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 
FR 49171, Sept. 21, 1995]



Sec. 590.945  Foreign egg products offered for importation; reporting 
of findings to customs; handling of products refused entry.

    (a) Inspectors shall report their findings to the collector of 
customs at the port where products are offered for entry, and shall 
request the collector to refuse entry to egg products which are marked 
or designated ``U.S. Refused Entry'' or otherwise are not in compliance 
with the regulations in this part. Unless such products are exported by 
the consignee within a time specified by the collector of customs 
(usually 30 days), the consignee shall cause the destruction of such 
products for human food purposes under the supervision of an inspector. 
If products are destroyed for human food purposes under the supervision 
of an inspector, he shall give prompt notice thereof to the District 
Director of Customs.

[[Page 715]]

    (b) Consignees shall, at their own expense, return immediately to 
the collector of customs, in means of conveyance or packages sealed by 
the U.S. Department of Agriculture, any egg products received by them 
under this part which in any respect do not comply with this part.
    (c) Except as provided in Sec. 590.930(a), no person shall remove 
or cause to be removed from any place designated as the place of 
inspection, any egg products which the regulations require to be marked 
in any way, unless the same has been clearly and legibly marked in 
compliance with this part.

[36 FR 9814, May 28, 1971, as amended at 37 FR 6660, Apr. 1, 1972. 
Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 
46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49171, Sept. 21, 1995; 
63 FR 69972, Dec. 17, 1998]



Sec. 590.950  Labeling of containers of eggs or egg products for 
importation.

    (a) Immediate containers of product offered for importation shall 
bear a label, printed in English, showing:
    (1) The name of product;
    (2) the name of the country of origin of the product, and for 
consumer packaged products, preceded by the words ``Product of,'' which 
statement shall appear immediately under the name of the product;
    (3) [Reserved]
    (4) For shell eggs, the words, ``Keep Refrigerated,'' or words of 
similar meaning;
    (5) for egg products, the word ``Ingredients'' followed by a list of 
the ingredients in order of descending proportions by weight;
    (6) the name and place of business of manufacturer, packer, or 
distributor, qualified by a phrase which reveals the connection that 
such person has with the product;
    (7) an accurate statement of the quantity;
    (8) for egg products, the inspection mark of the country of origin; 
and
    (9) The date of production and plant number of the plant at which 
the egg product was processed and/or packed.
    (b) For properly sealed and certified shipments of shell eggs 
imported for breaking at an official egg products plant, the immediate 
containers need not be labeled, provided that the shipment is segregated 
and controlled upon arrival at the destination breaking plant.
    (c) The labels shall not be false or misleading in any respect.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
as amended at 45 FR 23641, Apr. 8, 1980. Redesignated at 46 FR 63203, 
Dec. 31, 1981, as amended at 60 FR 49171, Sept. 21, 1995; 63 FR 45675, 
Aug. 27, 1998; 63 FR 69972, Dec. 17, 1998]



Sec. 590.955  Labeling of shipping containers of eggs or egg products 
for importation.

    (a) Shipping containers of foreign product which are shipped to the 
United States shall bear in a prominent and legible manner:
    (1) The common or usual name of the product;
    (2) The name of the country of origin;
    (3) The plant number of the plant in which the egg product was 
processed and/or packed;
    (4) The inspection mark of the country of origin;
    (5) [Reserved]
    (6) For shell eggs, the words ``Keep refrigerated'' or words of 
similar meaning.
    (b) Labeling on shipping containers examined at the time of 
inspection in the United States, if found to be false or misleading, 
shall be cause for the product to be refused entry.
    (c) [Reserved]
    (d) In the case of products which are not in compliance solely 
because of misbranding, such products may be brought into compliance 
with the regulations only under the supervision of an authorized 
representative of the Administrator.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 
FR 49171, Sept. 21, 1995; 63 FR 45675, Aug. 27, 1998; 63 FR 69972, Dec. 
17, 1998]



Sec. 590.956  Relabeling of imported egg products.

    (a) Egg products eligible for importation may be relabeled with an 
approved label under the supervision of an inspector at an official egg 
products plant or other location. The new label for such product shall 
indicate the country of origin except for products

[[Page 716]]

which are reprocessed (repasteurized, or in the case of dried products, 
dry blended with products produced in the United States) in an official 
egg products plant.
    (b) The label for relabeled products must state the name, address, 
and zip code of the distributor, qualified by an appropriate term such 
as ``packed for'', ``distributed by'' or ``distributors''.

[60 FR 49171, Sept. 21, 1995]



Sec. 590.960  Small importations for consignee's personal use, display, 
or laboratory analysis.

    Any egg products which are offered for importation, exclusively for 
the consignee's personal use, display, or laboratory analysis, and not 
for sale or distribution; which is sound, healthful, wholesome, and fit 
for human food; and which is not adulterated and does not contain any 
substance not permitted by the Act or regulations, may be admitted into 
the United States without a foreign inspection certificate. Such product 
is not required to be inspected upon arrival in the United States and 
may be shipped to the consignee without further restriction under this 
part: Provided, That the Department may, with respect to any specific 
importation, require that the consignee certify that such product is 
exclusively for the consignee's personal use, display, or laboratory 
analysis and not for sale or distribution. The amount of such product 
imported shall not exceed 30 pounds of liquid or frozen eggs, or 50 
pounds of dried egg products, unless otherwise authorized by the 
Administrator.

[37 FR 6660, Apr. 1, 1972. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 63 
FR 69972, Dec. 17, 1998]



Sec. 590.965  Returned U.S. inspected and marked products; not 
importations.

    Products which have been inspected by the United States Department 
of Agriculture and so marked, and which are returned from foreign 
countries are not importations within the meaning of this part. Such 
returned shipments shall be reported to the Administrator by letter.



Sec. 590.970  Charges for storage, cartage, and labor with respect 
to products imported contrary to the Act.

    All charges for storage, cartage, and labor with respect to any 
product which is imported contrary to this part shall be paid by the 
owner or consignee, and in default of such payment shall constitute a 
lien against such product and any other product thereafter imported 
under the Act by or for such owner or consignee.

[36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, 
and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 47 
FR 46071, Oct. 15, 1982; 47 FR 54421, Dec. 3, 1982]



PART 592_VOLUNTARY INSPECTION OF EGG PRODUCTS--Table of Contents




Sec.
592.1 Meaning of words.
592.2 Terms defined.
592.5 Designation of official certificates, memoranda, marks, other 
          identifications, and devices for purposes of the Agricultural 
          Marketing Act.

                             Administration

592.10 Authority.

                                 General

592.20 Kinds of services available.
592.22 Where service is offered.
592.24 Basis of service.

                         Performance of Services

592.70 Identification.
592.80 Political activity.
592.90 Authority and duties of inspection program personnel performing 
          service.
592.95 Facilities and equipment to be furnished for use of inspection 
          program personnel in performing service.
592.96 Schedule of operation of official plants.

                         Application for Service

592.100 Who may obtain service.
592.120 Authority of applicant.
592.130 How application for service may be made.
592.140 Application for inspection in official plants; approval.
592.150 When application may be rejected.
592.160 When application may be withdrawn.
592.170 Order of service.
592.180 Suspension of plant approval.

                            Denial of Service

592.200 Debarment.

[[Page 717]]

592.220 Other applicable regulations.
592.240 Report of violations.
592.260 Reuse of containers bearing official identification prohibited.

                    Identifying and Marking Products

592.300 Approval of official identification.
592.310 Form of official identification symbol and inspection mark.
592.320 Products that may bear the inspection mark.
592.330 Unauthorized use or disposition of approved labels.
592.340 Supervision of marking and packaging.
592.350 Accessibility of product.
592.360 Certificates.
592.370 Certificate issuance.
592.380 Disposition of certificates.
592.390 Advance information.

                                 Appeals

592.400 Who may request an appeal inspection or review of an inspection 
          program employee's decision.
592.410 Where to file an appeal.
592.420 How to file an appeal.
592.430 When an application for an appeal inspection may be refused.
592.440 Who shall perform the appeal.
592.450 Procedures for selecting appeal samples.
592.460 Appeal certificates.

                            Fees and Charges

592.500 Payment of fees and charges.
592.510 Base Time Rate.
592.520 Overtime Inspection Service.
592.530 Holiday Inspection Service.

                  Sanitary and Processing Requirements

592.600 General.
592.650 Inspection.

    Authority: 7 U.S.C. 1621-1627.

    Source: 69 FR 1648, Jan. 12, 2004, unless otherwise noted.

                               Definitions



Sec. 592.1  Meaning of words.

    Under the regulations in this part words in the singular shall be 
deemed to import the plural and vice versa, as the case may demand.



Sec. 592.2  Terms defined.

    For the purpose of the regulations in this part, unless the context 
otherwise requires, the following terms shall be construed, 
respectively:
    Act means the applicable provisions of the Agricultural Marketing 
Act of 1946 (60 Stat. 1087; 7 U.S.C. 1621 et seq.), or any other Act of 
Congress conferring like authority.
    Administrator means the Administrator of the Food Safety and 
Inspection Service (FSIS) of the Department or any other officer or 
employee of the Department to whom there has been delegated, or to whom 
there may be delegated the authority to act in the Administrator's 
stead.
    Applicant means any interested party who requests any inspection 
service, or appeal inspection, with respect to any product.
    Class means any subdivision of a product based on essential physical 
characteristics that differentiate between major groups of the same 
kind, species, or method of processing.
    Condition means any condition (including, but not being limited to, 
the state of preservation, cleanliness, soundness, wholesomeness, or 
fitness for human food) of any product which affects its 
merchantability; or any condition, including, but not being limited to, 
the processing, or packaging which affects such product.
    Department means the United States Department of Agriculture.
    District Manager means the manager in charge of a district, which is 
a designated geographical area.
    Eggs of Current Production means shell eggs that have moved through 
the usual marketing channels since the date of lay and are not in excess 
of 60 days old.
    Holiday or Legal holiday means the legal public holidays specified 
by the Congress in paragraph (a) of section 6103, Title 5, of the United 
States Code.
    Inspection means the act by inspection program personnel of:
    (1) Determining, according to these regulations, the class, quality, 
quantity, or condition of any product by examining each unit thereof or 
a representative sample drawn by inspection program personnel;
    (2) Issuing a certificate; or
    (3) Identifying, when requested by the applicant, any product by 
means of official identification pursuant to the Act and this part.
    Inspection certificate or certificate means a statement, either 
written or printed, issued by inspection program personnel pursuant to 
the Act and this

[[Page 718]]

part, relative to the class, quality, quantity, and condition of 
products.
    Inspection program personnel (employee) means employees of the 
Department authorized by the Secretary to investigate and certify, in 
accordance with the Act and this part, to shippers of products and other 
interested parties the class, quality, quantity, and condition of such 
products.
    Interested party means any person financially interested in a 
transaction involving any inspection or appeal inspection of any 
product.
    Official plant means any plant in which the facilities and methods 
of operation therein have been found by the Administrator to be suitable 
and adequate for inspection in accordance with this part and in which 
such service is carried on.
    Person means any individual, partnership, association, business 
trust, corporation, or any organized group of persons, whether 
incorporated or not.
    Product or products means eggs (whether liquid, frozen, or dried), 
egg products, and any food product that is prepared or manufactured and 
contains eggs as an ingredient.
    Program employee means any person employed by the Department or any 
cooperating agency who is authorized by the Secretary to do any work or 
perform any duty in connection with the program.
    Quality means the inherent properties of any product that determine 
its relative degree of excellence.
    Regulations mean the provisions in this part.
    Sampling means the act of taking samples of any product for 
inspection.
    Secretary means the Secretary of the Department or any other officer 
or employee of the Department to whom there has heretofore been 
delegated, or to whom there may hereafter be delegated, the authority to 
act in the Secretary's stead.
    Service means: (1) Any inspection, in accordance with the 
Agriculture Marketing Act and the regulations in this part, of any 
product,
    (2) Supervision, in any official plant, of the processing, packaging 
and identification, or
    (3) Any appeal inspection of any previously inspected product.
    Shell eggs mean the shell eggs of the domesticated chicken, turkey, 
duck, goose, and guinea.



Sec. 592.5  Designation of official certificates, memoranda, marks, 
other identifications, and devices for purposes of the Agricultural 
Marketing Act.

    Subsection 203(h) of the Agricultural Marketing Act of 1946, as 
amended by Public Law 272, 84th Congress, provides criminal penalties 
for various specified offenses relating to official certificates, 
memoranda, marks or other identifications, and devices for making such 
marks or identifications, issued or authorized under section 203 of said 
Act, and certain misrepresentations concerning the inspection of 
agricultural products under said section. For the purposes of said 
subsection and the provisions in this part, the terms listed below shall 
have the respective meanings specified:
    (a) Official certificate means any form of certification, either 
written or printed, used under this part to certify with respect to the 
sampling, inspection, class, quality, quantity, or condition of products 
(including the compliance of products with applicable specifications).
    (b) Official memorandum means any initial record of findings made by 
an authorized person in the process of inspecting, or sampling pursuant 
to this part, any processing or plant-operation report made by an 
authorized person in connection with inspecting, or sampling under this 
part and any report made by an authorized person of services performed 
pursuant to this part.
    (c) Official mark means the inspection mark, and any other mark or 
symbol formulated pursuant to the regulations in this part, stating that 
the product was inspected, or for the purpose of maintaining the 
identity of the product.
    (d) Official identification means any United States (U.S.) standard 
designation of class, quality, quantity, or condition specified in this 
part or any symbol, stamp, label, or seal indicating that the product 
has been officially inspected or indicating the class, quality, 
quantity, or condition of the product approved by the Administrator and 
authorized to be affixed to any product,

[[Page 719]]

or affixed to or printed on the packaging material of any product.
    (e) Official device means a printed label, or other method as 
approved by the Secretary for the purpose of applying any official mark 
or other identification to any product of the packaging material 
thereof.

                             Administration



Sec. 592.10  Authority.

    The Administrator shall perform, for and under the supervision of 
the Secretary, such duties as the Secretary may require in the 
enforcement or administration of the provisions of the Act and this 
part. The Administrator is authorized to waive for a limited period any 
particular provisions of the regulations in this part to permit 
experimentation so that new procedures, equipment, and processing 
techniques may be tested to facilitate definite improvements and at the 
same time to determine full compliance with the spirit and intent of the 
regulations in this part. The Food Safety Inspection Service and its 
officers and employees shall not be liable in damages through acts of 
commission or omission in the administration of this part.

                                 General



Sec. 592.20  Kinds of services available.

    The regulations in this part provide for the following kinds of 
services:
    (a) Inspection of the processing in official plants of products 
containing eggs;
    (b) Sampling of products; and
    (c) Quantity and condition inspection of products.



Sec. 592.22  Where service is offered.

    Any product may be inspected wherever inspection program personnel 
are available and the facilities and the conditions are satisfactory for 
the conduct of the service.



Sec. 592.24  Basis of service.

    (a) Products shall be inspected in accordance with such standards, 
methods, and instructions as may be issued or approved by the 
Administrator. All service shall be subject to supervision at all times 
by the applicable FSIS designated supervisor. Whenever the supervisor of 
an inspection program person has evidence that such inspection program 
employee incorrectly inspected a product, such supervisor shall take 
such action as is necessary to correct the inspection and to cause any 
improper official identification that appears on the product or 
containers thereof to be corrected prior to shipment of the product from 
the place of the initial inspection.
    (b) Whenever service is performed on a sample basis, such sample 
shall be drawn in accordance with the instructions as issued by the 
Administrator.

                         Performance of Services



Sec. 592.70  Identification.

    All inspection program personnel and supervisors shall have in their 
possession at all times while on duty and present upon request the means 
of identification furnished by the Department to such person.



Sec. 592.80  Political activity.

    All inspection program personnel are forbidden during the period of 
their respective appointments, to take an active part in political 
management or in political campaigns. Political activity in city, 
county, State, or national elections, whether primary or regular, or in 
behalf of any party or candidate is prohibited, except as authorized by 
law or regulation of the Department. This applies to all appointees, 
including, but not being limited to, temporary and cooperative employees 
and employees on leave of absence with or without pay. Willful violation 
of this section will constitute grounds for dismissal.



Sec. 592.90  Authority and duties of inspection program personnel 
performing service.

    (a) Inspection program personnel are authorized:
    (1) To make such observations and inspections as they deem necessary 
to enable them to certify that products have been prepared, processed, 
stored, and otherwise handled in conformity with the regulations in this 
part;

[[Page 720]]

    (2) To supervise the marking of packages containing products that 
are eligible to be identified with official identification;
    (3) To retain in their custody, or under their supervision, labels 
with official identification, marking devices, samples, certificates, 
seals, and reports of inspection program personnel;
    (4) To deface or remove, or cause to be defaced or removed under 
their personal supervision, any official identification from any package 
containing products whenever the program employee determines that such 
products were not processed in accordance with the regulations in this 
part or are not fit for human food;
    (5) To issue a certificate upon request on any product processed in 
the official plant; and
    (6) To use retention tags or other devices and methods as may be 
approved by the Administrator for the identification and control of 
products that are not in compliance with the regulations in this part or 
are held for further examination, and any equipment, utensils, rooms or 
compartments that are found to be unclean or otherwise in violation of 
any of the regulations in this part. No product, equipment, utensil, 
room, or compartment shall be released for use until it has been made 
acceptable. Such identification shall not be removed by anyone other 
than inspection program personnel.
    (b) Inspection program personnel shall prepare such reports and 
records as may be prescribed by the Administrator.



Sec. 592.95  Facilities and equipment to be furnished for use of 
inspection program personnel in performing service.

    (a) Facilities and equipment for proper sampling, weighing, 
examination of products, and monitoring processing procedures shall be 
furnished by the official plant for use by inspection program personnel. 
Such facilities and equipment shall include but not be limited to a room 
or area suitable for sampling product and stationary or adequately 
secured storage box or cage (capable of being locked only by inspection 
program personnel) for holding official samples.
    (b) Acceptable furnished office space and equipment, including but 
not being limited to, a desk, lockers or cabinets (equipped with a 
satisfactory locking device) suitable for the protection and storage of 
supplies, and with facilities for inspection program personnel to change 
clothing.



Sec. 592.96  Schedule of operation of official plants.

    Inspection operating schedules for services performed pursuant to 
this part shall be requested in writing and approved by the appropriate 
District Office. Normal operating schedules for a full-week consist of a 
continuous 8-hour period per day (excluding but not to exceed 1 hour for 
lunch), 5 consecutive days per week, within the administrative workweek, 
Sunday through Saturday, for each shift required. Less than 8-hour 
schedules may be requested and will be approved if inspection program 
personnel are available. Clock hours of daily operations need not be 
specified in the request, although as a condition of continued approval, 
the hours of operation shall consist of a continuous 10-hour period per 
day (excluding but not to exceed 1 hour for lunch), 4 consecutive days 
per week, within the administrative workweek, Sunday through Saturday 
for each full shift required. Inspection program personnel are to be 
given reasonable advance notice by management of any change in the hours 
the inspection service is requested.

                         Application for Service



Sec. 592.100  Who may obtain service.

    (a) An application for service may be made by any interested person, 
including, but not being limited to, the United States, any State, 
county, municipality, or common carrier, and any authorized agent of the 
foregoing.
    (b) Where service is offered: Any product may be inspected, wherever 
an inspection program employee is available and the facilities and the 
conditions are satisfactory for the conduct of the service.
    (c) The applicant must have a tax identification number for billing 
purposes.

[[Page 721]]



Sec. 592.120  Authority of applicant.

    Proof of the authority of any person applying for any service may be 
required at the discretion of the Administrator.



Sec. 592.130  How application for service may be made.

    (a) On a fee basis. An application for service may be made with any 
inspection program personnel at or nearest the place where the service 
is desired. Such application for service may be made orally (in person 
or by telephone), in writing or by transmission. If an application for 
inspection service is made orally, the inspection program personnel with 
whom such application is made, or the Administrator, may require that 
the application be confirmed in writing.
    (b) Form of application. Each application for inspection of a 
specified lot of any product shall include such information as may be 
required by the Administrator in regard to the product and the premises 
where such product is to be inspected.



Sec. 592.140  Application for inspection in official plants; approval.

    Any person desiring to process products under inspection service 
must receive approval of such plant and facilities as an official plant 
prior to the installation of such service. The initial survey, drawings, 
and specifications to be submitted, changes and revisions in the 
official plant, and final survey and procedure for plant approval shall 
be in accordance with and conform to the applicable provisions of Part 
590 of this chapter.



Sec. 592.150  When an application may be rejected.

    (a) Any application for service may be rejected by the 
Administrator:
    (1) Whenever the applicant fails to meet the requirements of the 
regulations in this part prescribing the conditions under which the 
service is made available;
    (2) Whenever the product is owned by or located on the premises of a 
person currently denied the benefits of the Act;
    (3) Where any individual holding office or a responsible position 
with or having a substantial financial interest or share in the 
applicant is currently denied the benefits of the Act or was responsible 
in whole or in part for the current denial of the benefits of the Act to 
any person;
    (4) Where the Administrator determines that the application is an 
attempt on the part of a person currently denied the benefits of the Act 
to obtain service;
    (5) Whenever the applicant, after an initial survey has been made in 
accordance with Part 590, fails to bring the plant, facilities, and 
operating procedures into compliance with the regulations in this part 
within a reasonable period of time;
    (6) Notwithstanding any prior approval whenever, before inauguration 
of service, the applicant fails to fulfill commitments concerning the 
inauguration of the service;
    (7) When it appears that to perform the services specified in this 
part would not be to the best interests of the public welfare or of the 
Government; or
    (8) When it appears to the Administrator that prior commitments of 
the Department necessitate rejection of the application.
    (b) Each such applicant shall be promptly notified by registered 
mail of the reasons for the rejection. A written petition for 
reconsideration of such rejection may be filed by the applicant with the 
Administrator if postmarked or delivered within 10 days after receipt of 
notice of the rejection. Such petition shall state specifically the 
errors alleged to have been made by the Administrator in rejecting the 
application. Within 20 days following the receipt of such a petition for 
reconsideration, the Administrator shall approve the application or 
notify the applicant by registered mail of the reasons for the rejection 
thereof.



Sec. 592.160  When an application may be withdrawn.

    An application for service may be withdrawn by the applicant at any 
time before the service is performed upon payment, by the applicant, of 
all expenses incurred by the Agency in connection with such application.

[[Page 722]]



Sec. 592.170  Order of service.

    Service shall be performed, insofar as practicable, in the order in 
which applications therefor are made except that precedence may be given 
to any application for an appeal.



Sec. 592.180  Suspension of plant approval.

    (a) Any plant approval pursuant to the regulations in this part may 
be suspended for:
    (1) Failure to maintain plant and equipment in a satisfactory state 
of repairs;
    (2) The use of operating procedures that are not in accordance with 
the regulations in this part; or
    (3) Alterations of buildings, facilities, or equipment that cannot 
be approved in accordance with the regulations in this part.
    (b) During such period of suspension, inspection service shall not 
be rendered. However, the other provisions of the regulations in this 
part pertaining to providing service will remain in effect unless 
service is terminated in accordance with the terms thereof. If the plant 
facilities or methods of operation are not brought into compliance 
within a reasonable period of time to be specified by the Administrator, 
the application and service shall be terminated. Upon termination of 
service in an official plant pursuant to the regulations in this part, 
the plant approval shall also become terminated, and all labels, seals, 
tags, or packaging material bearing official identification shall, under 
the supervision of a person designated by the Administrator, either be 
destroyed, or if to be used at another location, modified in a manner 
acceptable to the Agency.

                            Denial of Service



Sec. 592.200  Debarment.

    (a) The following acts or practices or the causing thereof may be 
deemed sufficient cause for the debarment by the Administrator of any 
person, including any agents, officers, subsidiaries, or affiliates of 
such person, from any or all benefits of the Act for a specified period.
    (1) Misrepresentation, or deceptive or fraudulent act or practice. 
Any willful misrepresentation or any deceptive or fraudulent act or 
practice found to be made or committed by any person in connection with:
    (i) The making or filing of an application for any service or 
appeal;
    (ii) The making of the product accessible for sampling or 
inspection;
    (iii) The making, issuing, or using, or attempting to issue or use, 
any certificate, symbol, stamp, label, seal, or identification 
authorized pursuant to the regulations in this part;
    (iv) The use of the terms ``United States,'' ``U.S.,'' ``U.S. 
Inspected,'' ``Government Inspected,'' or terms of similar import in the 
labeling or advertising of any product;
    (v) The use of any official stamp, symbol, label, seal, or 
identification in the labeling or advertising of any product.
    (2) Use of facsimile forms. Using or attempting to use a form that 
simulates in whole or in part any certificate, symbol, stamp, label, 
seal, or identification authorized to be issued or used under the 
regulations in this part.
    (3) Willful violation of the regulations. Any willful violation of 
the regulations in this part or of the Act.
    (4) Interfering with inspection program personnel or program 
employee of the Agency. Any interference with or obstruction or any 
attempted interference or obstruction of or assault upon any inspection 
program personnel or program employee of the Agency in the performance 
of their duties. The giving or offering, directly or indirectly, of any 
money, loan, gift, or anything of value to a program employee of the 
Agency, or the making or offering of any contribution to or in any way 
supplementing the salary, compensation or expenses of a program employee 
of the Agency, or the offering or entering into a private contract or 
agreement with a program employee of the Agency for any services to be 
rendered while employed by the Agency.
    (5) Miscellaneous. The existence of any of the conditions set forth 
in Sec. 592.150 constituting the basis for the rejection of an 
application for inspection service.



Sec. 592.220  Other applicable regulations.

    Compliance with the regulations in this part shall not excuse 
failure to

[[Page 723]]

comply with any other Federal or any State or municipal applicable laws 
or regulations.



Sec. 592.240  Report of violations.

    Each inspection program employee shall report, in the manner 
prescribed by the Administrator, all violations and noncompliance under 
the Act and this part of which such inspection program employee has 
knowledge.



Sec. 592.260  Reuse of containers bearing official identification 
prohibited.

    The reuse, by any person, of containers bearing official 
identification is prohibited unless such identification is applicable in 
all respects to product being packed therein. In such instances, the 
container and label may be used provided the packaging is accomplished 
under the supervision of inspection program personnel or program 
employee, and the container is in clean, sound condition and lined with 
a suitable inner liner.

                    Identifying and Marking Products



Sec. 592.300  Approval of official identification.

    Labeling procedures, required information on labels, and method of 
label approval, shall be in accordance with and conform to the 
applicable provisions of part 590 of this chapter.



Sec. 592.310  Form of official identification symbol and inspection mark.

    (a) The shield set forth in Figure 1, containing the letters 
``USDA,'' shall be the official identification symbol for the purposes 
of this part and when used, imitated, or simulated in any manner in 
connection with a product shall be deemed to constitute a representation 
that the product has been officially inspected for the purpose of Sec. 
592.5.
[GRAPHIC] [TIFF OMITTED] TR12JA04.049

    (b) The inspection marks that are permitted to be used on products 
shall be contained within the outline of a shield and with the wording 
and design set forth in Figure 2 of this section, except the plant 
number may be followed by the letter ``G'' in lieu of the word 
``plant.'' Alternatively, it may be omitted from the official shield if 
applied on the container's principal display panel or other prominent 
location and preceded by the word ``Plant'' or followed by the letter 
``G.''
[GRAPHIC] [TIFF OMITTED] TR12JA04.050



Sec. 592.320  Products that may bear the inspection mark.

    Products that are permitted to bear the inspection mark shall be 
processed in an official plant from edible shell eggs or other edible 
egg products eligible to bear the inspection mark and may contain other 
edible ingredients. The official mark, when used, shall be printed or 
lithographed and applied as a part of the principal display panel of

[[Page 724]]

the container, but shall not be applied to a detachable cover.



Sec. 592.330  Unauthorized use or disposition of approved labels.

    (a) Containers or labels that bear official identification approved 
for use pursuant to Sec. 592.300 shall be used only for the purpose for 
which approved. Any unauthorized use or disposition of approved 
containers or labels that bear any official identification may result in 
cancellation of the approval and denial of the use of containers or 
labels bearing official identification or denial of the benefits of the 
Act pursuant to the provisions of Sec. 592.200;
    (b) The use of simulations or imitations of any official 
identification by any person is prohibited;
    (c) Upon termination of inspection service in an official plant 
pursuant to the regulations in this part, all labels or packaging 
material bearing official identification to be used to identify product 
packed by the plant shall either be destroyed, or have the official 
identification completely obliterated under the supervision of a USDA 
representative, or, if to be used at another location, modified in a 
manner acceptable to the Agency.



Sec. 592.340  Supervision of marking and packaging.

    (a) Evidence of label approval. Inspection program personnel shall 
authorize the use of official identification on any inspected product 
when they have evidence that such official identification or packaging 
material bearing such official identification has been approved in 
accordance with the provisions of Sec. 592.300.
    (b) Affixing of official identification. No official identification 
may be affixed to or placed on or caused to be affixed to or placed on 
any product or container thereof except by an inspection program 
employee or under the supervision of an inspection program employee or 
other person authorized by the Administrator. All such products shall 
have been inspected in accordance with the regulations in this part. 
Inspection program personnel shall have supervision over the use and 
handling of all material bearing any official identification.
    (c) Labels for products sold under Government contract. Inspectors-
in-charge may approve labels for containers of product sold under a 
contract specification to governmental agencies when such product is not 
offered for resale to the general public: Provided, that the contract 
specifications include complete specific requirements with respect to 
labeling, and are made available to inspection program personnel.



Sec. 592.350  Accessibility of product.

    Each product for which service is requested shall be so placed as to 
disclose fully its class, quality, quantity, and condition as the 
circumstances may warrant.



Sec. 592.360  Certificates.

    Certificates (including appeal certificates) shall be issued on 
forms approved by the Administrator.



Sec. 592.370  Certificate issuance.

    When performing inspection service at locations other than an 
official establishment, inspection program personnel shall issue a 
certificate covering each product inspected. An applicant may request 
issuance of a certificate for each production lot inspected.



Sec. 592.380  Disposition of certificates.

    The original and a copy of each certificate issued pursuant to Sec. 
592.370, and not to exceed two additional copies thereof if requested by 
the applicant prior to issuance, shall, immediately upon issuance, be 
delivered or mailed to the applicant or designee. Other copies shall be 
filed and retained in accordance with the disposition schedule for 
inspection program records.



Sec. 592.390  Advance information.

    Upon request of an applicant, all or part of the contents of any 
certificate issued to such applicant may be telephoned or transmitted to 
the applicant or designee, at the applicant's expense.

[[Page 725]]

                                 Appeals



Sec. 592.400  Who may request an appeal inspection or review of an 
inspection program employee's decision.

    An appeal inspection may be requested by any interested party who is 
dissatisfied with the determination by an inspection program employee of 
the class, quality, quantity, or condition of any product, as evidenced 
by the USDA inspection mark and accompanying label, or as stated on a 
certificate and a review may be requested by the operator of an official 
plant with respect to an inspection program personnel decision or on any 
other matter related to inspection in the official plant.



Sec. 592.410  Where to file an appeal.

    (a) Appeal of inspection program personnel decision in an official 
plant. Any interested party who is not satisfied with the determination 
of the class, quality, quantity, or condition of product that was 
inspected by inspection program personnel in an official plant and has 
not left such plant, and the operator of any official plant who is not 
satisfied with a decision by inspection program personnel on any other 
matter relating to inspection in such plant, may request an appeal 
inspection or review of the decision by the inspection program employee 
by filing such request with the inspection program employee's immediate 
supervisor.
    (b) All other appeal requests. Any interested party who is not 
satisfied with the determination of the class, quality, quantity, or 
condition of product that has left the official plant where it was 
inspected or inspected other than in an official plant may request an 
appeal inspection by filing such request with the District Manager in 
the district where the product is located.



Sec. 592.420  How to file an appeal.

    The request for an appeal inspection or review of an inspection 
program employee's decision may be made orally or in writing. If made 
orally, written confirmation may be required. The applicant shall 
clearly state the identity of the product, the decision which is 
questioned, and the reasons for requesting the appeal service. If such 
appeal request is based on the results stated on an official 
certificate, the original and all copies of the certificate available at 
the appeal inspection site shall be provided to the appeal inspection 
program employee assigned to make the appeal inspection.



Sec. 592.430  When an application for an appeal inspection may be refused.

    When it appears to the official with whom an appeal request is filed 
that the reasons given in the request are frivolous or not substantial, 
class, quality, quantity, or that the condition of the product has 
undergone a material change since the original inspection, or that the 
original lot has changed in some manner, or the Act or the regulations 
in this part have not been complied with, the applicant's request for 
the appeal inspection may be refused. In such case, the applicant shall 
be promptly notified of the reason(s) for refusal.



Sec. 592.440  Who shall perform the appeal.

    (a) An appeal inspection or review of a decision requested under 
Sec. 592.410(a) shall be made by the inspection program employee's 
immediate supervisor or by an inspection program employee assigned by 
the immediate supervisor other than the inspection program employee 
whose inspection or decision is being appealed.
    (b) Appeal inspections requested under Sec. 592.410(b) shall be 
performed by an inspection program employee other than the inspection 
program employee who originally inspected the product.
    (c) Whenever practical, an appeal inspection shall be conducted 
jointly by two inspection program employees. The assignment of the 
inspection program personnel who will make the appeal inspection under 
Sec. 592.410(b) shall be made by the District Manager.



Sec. 592.450  Procedures for selecting appeal samples.

    (a) Prohibition on movement of product. Products shall not have been 
moved from the place where the inspection being appealed was performed 
and must have been maintained under adequate refrigeration, when 
applicable.

[[Page 726]]

    (b) Laboratory analyses. The appeal sample shall consist of product 
taken from the original sample containers plus an equal number of 
containers selected at random. When the original sample containers 
cannot be located, the appeal sample shall consist of product taken at 
random from double the number of original sample containers.
    (c) Condition inspection. The appeal sample shall consist of product 
taken from the original sample containers plus an equal number of 
containers selected at random. A condition appeal cannot be made unless 
all originally sampled containers are available.



Sec. 592.460  Appeal certificates.

    Immediately after an appeal inspection is completed, an appeal 
certificate shall be issued to show that the original inspection was 
sustained or was not sustained. Such certificate shall supersede any 
previously issued certificate for the product involved and shall clearly 
identify the number and date of the superseded certificate. The issuance 
of the appeal certificate may be withheld until any previously issued 
certificate and all copies have been returned when such action is deemed 
necessary to protect the interest of the Government. When the appeal 
inspection program employee assigns a different class to the lot or 
determines that a net weight shortage exists, the lot shall be retained 
pending correction of the labeling or approval of the product 
disposition by the District Office.

                            Fees and Charges



Sec. 592.500  Payment of fees and charges.

    (a) Fees and charges for voluntary base time rate, overtime 
inspection service, and holiday inspection service shall be paid by the 
interested party making the application for such service, in accordance 
with the applicable provisions of this section and Sec. 592.510 through 
Sec. 592.530, both inclusive. If so required by the Inspection program 
personnel, such fees and charges shall be paid in advance.
    (b) Fees and charges for any service shall, unless otherwise 
required pursuant to paragraph (c) of this section, be paid by check, 
draft, or money order payable to the Food Safety Inspection Service and 
remitted promptly to FSIS.
    (c) Fees and charges for any service under a cooperative agreement 
with any State or person shall be paid in accordance with the terms of 
such cooperative agreement.



Sec. 592.510  Base time rate.

    The base time rate for voluntary inspection services of egg products 
is $43.64 per hour per program employee.



Sec. 592.520  Overtime inspection service.

    When operations in an official plant require the services of 
inspection personnel beyond their regularly assigned tour of duty on any 
day or on a day outside the established schedule, such services are 
considered as overtime work. The official plant must give reasonable 
advance notice to the inspection program personnel of any overtime 
service necessary and must pay the Agency for such overtime at an hourly 
rate of $50.04.



Sec. 592.530  Holiday inspection service.

    When an official plant requires inspection service on a holiday or a 
day designated in lieu of a holiday, such service is considered holiday 
work. The official plant must, in advance of such holiday work, request 
the inspector in charge to furnish inspection service during such period 
and must pay the Agency for such holiday work at an hourly rate of 
$50.04.

                  Sanitary and Processing Requirements



Sec. 592.600  General.

    Except as otherwise approved by the Administrator, the sanitary, 
processing, and facility requirements, as applicable, shall be the same 
for the product processed under this part as for egg products processed 
under part 590 of this chapter.



Sec. 592.650  Inspection.

    Examinations of the ingredients, processing, and the product shall 
be made to ensure the production of a wholesome, unadulterated, and 
properly labeled product. Such examinations include, but are not being 
limited to:

[[Page 727]]

    (a) Sanitation checks of plant premises, facilities, equipment, and 
processing operations.
    (b) Checks on ingredients and additives used in products to ensure 
that they are not adulterated, are fit for use as human food, and are 
stored, handled, and used in a sanitary manner.
    (c) Examination of the eggs or egg products used in the products to 
ensure they are wholesome, not adulterated, and comply with the 
temperature, pasteurization, or other applicable requirements.
    (d) Inspection during the processing and production of the product 
to determine compliance with any applicable standard or specification 
for such product.
    (e) Examination during processing of the product to ensure 
compliance with approved formulas and labeling.
    (f) Test weighing and organoleptic examinations of finished product.


[[Page 729]]



                              FINDING AIDS




  --------------------------------------------------------------------

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Material Approved for Incorporation by Reference
  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 731]]

            Material Approved for Incorporation by Reference

                     (Revised as of January 1, 2006)

  The Director of the Federal Register has approved under 5 U.S.C. 
552(a) and 1 CFR Part 51 the incorporation by reference of the following 
publications. This list contains only those incorporations by reference 
effective as of the revision date of this volume. Incorporations by 
reference found within a regulation are effective upon the effective 
date of that regulation. For more information on incorporation by 
reference, see the preliminary pages of this volume.


9 CFR (PARTS 200-299)

GRAIN INSPECTION, PACKERS AND STOCKYARDS ADMINISTRATION, (PACKERS AND 
STOCKYARDS PROGRAMS), DEPARTMENT OF AGRICULTURE
                                                                   9 CFR


National Institute of Standards and Technology (formerly National Bureau 
of Standards), Department of Commerce, Washington, DC 20234

National Institute of Standards and Technology                    201.71
  Handbook 44, Specifications, Tolerances, and 
  other Technical Requirements for Weighing and 
  Measuring Devices, 1996 edition.


9 CFR (PARTS 300-399)

FOOD SAFETY AND INSPECTION SERVICE, MEAT AND POULTRY INSPECTION, 
DEPARTMENT OF AGRICULTURE
                                                                   9 CFR


Agriculture Department

  Food Safety and Inspection Service, Meat and 
  Poultry Inspection Program, 14th and 
  Independence Ave., SW., Washington, DC 20250
USDA Handbook 74, ``Energy Value of Foods. Basis         317.309(c)(1), 
  and Derivation'' (Slightly Revised 1973), A. L.               (c)(6); 
  Merrill and B. K. Watt.                          381.409(c)(1), (c)(6)
Diagram 1 of the Meat Denaturing Guide (MP Form                   325.13
  91).
  Copies of MP Form 91 may also be obtained 
    without charge, by writing to the Food Safety 
    and Inspection Service, USDA, Compliance 
    Program, Evaluation and Enforcement Division, 
    Washington, DC 20250


Association of Official Analytical Chemists International

  1111 N. 19th St., Suite 210, Arlington, VA 22209
Official Methods of Analysis of the Association of                 319.5
  Official Analytical Chemists, 1984, 14th Ed..
  AOAC sections incorporated: 24.005; 24.006; 
    24.007; 24.008; 24.027; 43.212; 43.213; 
    43.214; 43.215; 43.216
Official Methods of Analysis of the Association of                 319.5
  Official Analytical Chemists, 2nd Supplement to 
  13th Ed..
AOAC sections incorporated: 24.001-24.071.........                318.19
AOAC sections incorporated: 24.B01; 24.B02; 24.B03                318.19
AOAC sections incorporated: 16.206................               319.700

[[Page 732]]

Official Methods of Analysis of the AOAC                    317.309(h); 
  International 15th Ed., 1990.                    318.10(c); 381.21(a), 
                                                         (b); 319.5(c); 
                                                            319.700(a); 
                                                       381.153(a), (b); 
                                                              381.409(h)
Official Methods of Analysis of the Association of           319.5(e)(2)
  Official Analytical Chemists (AOAC 
  International) 16th Ed., 1995: Sec. Sec. 
  960.33, 976.21, 928.08 (Chapter 39), 940.33 
  (Chapter 45).


Food and Agriculture Organization of the United Nations/World Health 
Organization

  Copies available from: Product Assessment 
  Division, Regulatory Programs, USDA, Room 329, 
  West End Court Building, 1255 22nd Street, N.W., 
  Washington, DC 20037
Sections 5.4.1, 7.2.1 and 8 of ``Protein Quality     317.309(c)(7)(ii); 
  Evaluation, Report of the Joint FAO/WHO Expert       381.409(c)(7)(ii)
  Consultation on Protein Quality Evaluation,'' 
  Rome 1990.


National Institute of Standards and Technology

  Copies of NIST Handbooks are available from the 
  Superintendent of Documents, U.S. Government 
  Printing Office, P.O. Box 371954, Pittsburgh, PA 
  15250-7954, Telephone: 1-866-512-1800; 202-512-
  1800 if in Washington DC metropolitan area.
Handbook 44 Specifications, Tolerances, and Other            317.20(a); 
  Technical Requirements for Weighing and                    381.121c(a)
  Measuring Devices, 1999 Edition.
Handbook 133 Checking the Net Contents of Packaged           317.19(a); 
  Goods, Third Edition, September 1988, and                  381.121b(a)
  Supplements 1, 2, 3, and 4 dated September 1990, 
  October 1991, October 1992, and October 1994.


U.S. Government Printing Office

  Superintendent of Documents, P.O. Box 371954, 
  Pittsburgh, PA 15250-7954; 1-866-512-1800; 202-
  512-1800 if in Washington DC metropolitan area.
Food Service Sanitation Manual (1976                 303.1(e); 381.10(e)
  Recommendations, DHEW Publication No. (FDA) 78-
  2081, except for the following sections 
  contained in Part IV of the Manual: 1-102(z), 2-
  102(a) and (b), 2-302(d), 2-403(a), 2-403(c), 2-
  404, 2-405, 2-407, 2-502 through 2-506, 2-508, 
  2-509, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 
  5-202(c), and 5-203.

[[Page 733]]



                    Table of CFR Titles and Chapters




                     (Revised as of January 1, 2006)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
        IV  Miscellaneous Agencies (Parts 400--500)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 100-199)
        II  Office of Management and Budget Circulars and Guidance 
                (200-299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements [Reserved]


                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--99)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Part 2100)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)

[[Page 734]]

        XV  Office of Administration, Executive Office of the 
                President (Parts 2500--2599)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Part 3201)
     XXIII  Department of Energy (Part 3301)
      XXIV  Federal Energy Regulatory Commission (Part 3401)
       XXV  Department of the Interior (Part 3501)
      XXVI  Department of Defense (Part 3601)
    XXVIII  Department of Justice (Part 3801)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  Overseas Private Investment Corporation (Part 4301)
      XXXV  Office of Personnel Management (Part 4501)
        XL  Interstate Commerce Commission (Part 5001)
       XLI  Commodity Futures Trading Commission (Part 5101)
      XLII  Department of Labor (Part 5201)
     XLIII  National Science Foundation (Part 5301)
       XLV  Department of Health and Human Services (Part 5501)
      XLVI  Postal Rate Commission (Part 5601)
     XLVII  Federal Trade Commission (Part 5701)
    XLVIII  Nuclear Regulatory Commission (Part 5801)
         L  Department of Transportation (Part 6001)
       LII  Export-Import Bank of the United States (Part 6201)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Part 6401)
        LV  National Endowment for the Arts (Part 6501)
       LVI  National Endowment for the Humanities (Part 6601)
      LVII  General Services Administration (Part 6701)
     LVIII  Board of Governors of the Federal Reserve System (Part 
                6801)
       LIX  National Aeronautics and Space Administration (Part 
                6901)
        LX  United States Postal Service (Part 7001)
       LXI  National Labor Relations Board (Part 7101)
      LXII  Equal Employment Opportunity Commission (Part 7201)
     LXIII  Inter-American Foundation (Part 7301)
       LXV  Department of Housing and Urban Development (Part 
                7501)
      LXVI  National Archives and Records Administration (Part 
                7601)
     LXVII  Institute of Museum and Library Services (Part 7701)
      LXIX  Tennessee Valley Authority (Part 7901)
      LXXI  Consumer Product Safety Commission (Part 8101)
    LXXIII  Department of Agriculture (Part 8301)
     LXXIV  Federal Mine Safety and Health Review Commission (Part 
                8401)
     LXXVI  Federal Retirement Thrift Investment Board (Part 8601)

[[Page 735]]

    LXXVII  Office of Management and Budget (Part 8701)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Part 
                9701)
      XCIX  Department of Defense Human Resources Management and 
                Labor Relations Systems (Department of Defense--
                Office of Personnel Management) (Part 9901)

                      Title 6--Homeland Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 0--99)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Grain Inspection, Packers and Stockyards 
                Administration (Federal Grain Inspection Service), 
                Department of Agriculture (Parts 800--899)
        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  Rural Telephone Bank, Department of Agriculture (Parts 
                1600--1699)
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)

[[Page 736]]

     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  Local Television Loan Guarantee Board (Parts 2200--
                2299)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  Cooperative State Research, Education, and Extension 
                Service, Department of Agriculture (Parts 3400--
                3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Immigration and 
                Naturalization) (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Grain Inspection, Packers and Stockyards 
                Administration (Packers and Stockyards Programs), 
                Department of Agriculture (Parts 200--299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

[[Page 737]]

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1303--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Part 1800)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  Office of Thrift Supervision, Department of the 
                Treasury (Parts 500--599)
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  Federal Housing Finance Board (Parts 900--999)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board, Department of 
                Commerce (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board, 
                Department of Commerce (Parts 500--599)

[[Page 738]]

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--499)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)
      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  Technology Administration, Department of Commerce 
                (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399)

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

[[Page 739]]

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  Bureau of Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Bureau of Immigration and Customs Enforcement, 
                Department of Homeland Security (Parts 400--599)

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Employment Standards Administration, Department of 
                Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training, Department of Labor 
                (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

[[Page 740]]

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  Broadcasting Board of Governors (Parts 500--599)
       VII  Overseas Private Investment Corporation (Parts 700--
                799)
        IX  Foreign Service Grievance Board Regulations (Parts 
                900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)

[[Page 741]]

        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--799)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900)
        VI  Office of the Assistant Secretary-Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Part 1200)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--899)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)

[[Page 742]]

        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--699)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)
        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

[[Page 743]]

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Minerals Management Service, Department of the 
                Interior (Parts 200--299)
       III  Board of Surface Mining and Reclamation Appeals, 
                Department of the Interior (Parts 300--399)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance
         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of International Investment, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)

[[Page 744]]

    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army (Parts 
                200--399)
        IV  Saint Lawrence Seaway Development Corporation, 
                Department of Transportation (Parts 400--499)

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Vocational and Adult Education, Department 
                of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599)
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
        XI  National Institute for Literacy (Parts 1100--1199)
            Subtitle C--Regulations Relating to Education
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Part 1501)

[[Page 745]]

       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  Copyright Office, Library of Congress (Parts 200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                301--399)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--499)
         V  Under Secretary for Technology, Department of Commerce 
                (Parts 500--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--99)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Rate Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)

          Title 41--Public Contracts and Property Management

            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)

[[Page 746]]

       105  General Services Administration (Parts 105-1--105-999)
       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System
       201  Federal Information Resources Management Regulation 
                (Parts 201-1--201-99) [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--499)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 200--499)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10010)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

[[Page 747]]

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Office of Human Development Services, Department of 
                Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission on Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Part 2301)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)

[[Page 748]]

        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  United States Agency for International Development 
                (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management, Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees' 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        35  [Reserved]
        44  Federal Emergency Management Agency (Parts 4400--4499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)

[[Page 749]]

        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399)
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  General Services Administration Board of Contract 
                Appeals (Parts 6100--6199)
        63  Department of Transportation Board of Contract Appeals 
                (Parts 6300--6399)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board, Department of 
                Transportation (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499)
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)

[[Page 750]]

        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

                      CFR Index and Finding Aids

            Subject/Agency Index
            List of Agency Prepared Indexes
            Parallel Tables of Statutory Authorities and Rules
            List of CFR Titles, Chapters, Subchapters, and Parts
            Alphabetical List of Agencies Appearing in the CFR

[[Page 751]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of January 1, 2006)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Committee of the Federal Register  1, I
Advanced Research Projects Agency                 32, I
Advisory Council on Historic Preservation         36, VIII
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development, United      22, II
     States
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department                            5, LXXIII
  Agricultural Marketing Service                  7, I, IX, X, XI
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Cooperative State Research, Education, and      7, XXXIV
       Extension Service
  Economic Research Service                       7, XXXVII
  Energy, Office of                               7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Grain Inspection, Packers and Stockyards        7, VIII; 9, II
       Administration
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Telephone Bank                            7, XVI
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force Department                              32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX

[[Page 752]]

Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI
Army Department                                   32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Benefits Review Board                             20, VII
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase From People Who Are
Broadcasting Board of Governors                   22, V
  Federal Acquisition Regulation                  48, 19
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X
Civil Rights, Commission on                       45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce Department                               44, IV
  Census Bureau                                   15, I
  Economic Affairs, Under Secretary               37, V
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Fishery Conservation and Management             50, VI
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II
  National Marine Fisheries Service               50, II, IV, VI
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Telecommunications and Information     15, XXIII; 47, III
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Productivity, Technology and Innovation,        37, IV
       Assistant Secretary for
  Secretary of Commerce, Office of                15, Subtitle A
  Technology, Under Secretary for                 37, V
  Technology Administration                       15, XI
  Technology Policy, Assistant Secretary for      37, IV
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Product Safety Commission                5, LXXI; 16, II
Cooperative State Research, Education, and        7, XXXIV
     Extension Service
Copyright Office                                  37, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Court Services and Offender Supervision Agency    28, VIII
     for the District of Columbia
Customs and Border Protection Bureau              19, I
Defense Acquisition Regulations System            48, 2
Defense Contract Audit Agency                     32, I

[[Page 753]]

Defense Department                                5, XXVI; 32, Subtitle A; 
                                                  40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III, 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 1
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
District of Columbia, Court Services and          28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Under Secretary                 37, V
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
  Vocational and Adult Education, Office of       34, IV
Educational Research and Improvement, Office of   34, VII
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             5, XXIII; 10, II, III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   5, LIV; 40, I, IV, VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Administration, Office of                       5, XV
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                5, III, LXXVII; 14, VI; 
                                                  48, 99
  National Drug Control Policy, Office of         21, III

[[Page 754]]

  National Security Council                       32, XXI; 47, 2
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export-Import Bank of the United States           5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       11, I
Federal Emergency Management Agency               44, I
  Federal Acquisition Regulation                  48, 44
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Board                     12, IX
Federal Labor Relations Authority, and General    5, XIV; 22, XIV
     Counsel of the Federal Labor Relations 
     Authority
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Fine Arts, Commission on                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Fishery Conservation and Management               50, VI
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105

[[Page 755]]

  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          5, XLV; 45, Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Human Development Services, Office of           45, XIII
  Indian Health Service                           25, V; 42, I
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  6, I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection Bureau            19, I
  Federal Emergency Management Agency             44, I
  Immigration and Customs Enforcement Bureau      19, IV
  Immigration and Naturalization                  8, I
  Transportation Security Administration          49, XII
Housing and Urban Development, Department of      5, LXV; 24, Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Human Development Services, Office of             45, XIII
Immigration and Customs Enforcement Bureau        19, IV
Immigration and Naturalization                    8, I
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V; 42, I
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII

[[Page 756]]

Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior Department
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  Minerals Management Service                     30, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Reclamation, Bureau of                          43, I
  Secretary of the Interior, Office of            43, Subtitle A
  Surface Mining and Reclamation Appeals, Board   30, III
       of
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Fishing and Related Activities      50, III
International Investment, Office of               31, VIII
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice Department                                5, XXVIII; 28, I, XI; 40, 
                                                  IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Offices of Independent Counsel                  28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department                                  5, XLII
  Benefits Review Board                           20, VII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Employment Standards Administration             20, VI
  Federal Acquisition Regulation                  48, 29
  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I

[[Page 757]]

  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Library of Congress                               36, VII
  Copyright Office                                37, II
  Copyright Royalty Board                         37, III
Local Television Loan Guarantee Board             7, XX
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II
Micronesian Status Negotiations, Office for       32, XXVII
Mine Safety and Health Administration             30, I
Minerals Management Service                       30, II
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
National Aeronautics and Space Administration     5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   45, XII, XXV
National Archives and Records Administration      5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Bureau of Standards                      15, II
National Capital Planning Commission              1, IV
National Commission for Employment Policy         1, IV
National Commission on Libraries and Information  45, XVII
     Science
National Council on Disability                    34, XII
National Counterintelligence Center               32, XVIII
National Credit Union Administration              12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           21, III
National Foundation on the Arts and the           45, XI
     Humanities
National Highway Traffic Safety Administration    23, II, III; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute for Literacy                   34, XI
National Institute of Standards and Technology    15, II
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV, VI
National Mediation Board                          29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI
National Security Council and Office of Science   47, II
     and Technology Policy
National Telecommunications and Information       15, XXIII; 47, III
     Administration
National Transportation Safety Board              49, VIII
National Weather Service                          15, IX
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV

[[Page 758]]

Navy Department                                   32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Offices of Independent Counsel                    28, VI
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Overseas Private Investment Corporation           5, XXXIII; 22, VII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Rate Commission                            5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Procurement and Property Management, Office of    7, XXXII
Productivity, Technology and Innovation,          37, IV
     Assistant Secretary
Public Contracts, Department of Labor             41, 50
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Regional Action Planning Commissions              13, V
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII
Saint Lawrence Seaway Development Corporation     33, IV
Science and Technology Policy, Office of          32, XXIV
Science and Technology Policy, Office of, and     47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                17, II
Selective Service System                          32, XVI
Small Business Administration                     13, I
Smithsonian Institution                           36, V
Social Security Administration                    20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State Department                                  22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining and Reclamation Appeals, Board of  30, III
Surface Mining Reclamation and Enforcement,       30, VII
   Office of
[[Page 759]]

Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Technology Administration                         15, XI
Technology Policy, Assistant Secretary for        37, IV
Technology, Under Secretary for                   37, V
Tennessee Valley Authority                        5, LXIX; 18, XIII
Thrift Supervision Office, Department of the      12, V
     Treasury
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     5, L
  Commercial Space Transportation                 14, III
  Contract Appeals, Board of                      48, 63
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Surface Transportation Board                    49, X
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury Department                               5, XXI; 12, XV; 17, IV; 
                                                  31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection Bureau            19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Law Enforcement Training Center         31, VII
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  International Investment, Office of             31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
  Thrift Supervision, Office of                   12, V
Truman, Harry S. Scholarship Foundation           45, XVIII
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Vocational and Adult Education, Office of         34, IV
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I
World Agricultural Outlook Board                  7, XXXVIII

[[Page 761]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations that were 
made by documents published in the Federal Register since January 1, 
2001, are enumerated in the following list. Entries indicate the nature 
of the changes effected. Page numbers refer to Federal Register pages. 
The user should consult the entries for chapters and parts as well as 
sections for revisions.
For the period before January 1, 2001, see the ``List of CFR Sections 
Affected, 1949-1963, 1964-1972, 1973-1985, and 1986-2000'' published in 
11 separate volumes.

                                  2001

9 CFR
                                                                   66 FR
                                                                    Page
Chapter III
317.8 (b)(37) and (38) added.......................................40845
    (b)(39) added..................................................54915
317.21 (b) revised.................................................52486
319.15 (d) revised.................................................54916
319.81 Amended.....................................................54916
319.104 (d) revised................................................54916
319.140 Amended....................................................54916
319.143 Amended....................................................54916
319.180 (e) revised................................................54916
331.2 Table amended.................................................2207
331.6 Table amended.................................................2207
362 Authority citation revised..............................21637, 22905
362.1 Revised; interim......................................21637, 22905
362.2 Revised; interim......................................21637, 22905
381.1 (b) amended; eff. 1-9-02......................................1770
    (b) corrected..................................................19714
    (b) amended; interim....................................21637, 22905
381.36 (b) amended; interim.................................21637, 22905
381.65 Revised; eff. 1-9-02.........................................1771
    (e) correctly revised; (f) correctly added.....................19714
381.66 (a), (c) and (d) revised; (f)(6) removed; eff. 1-9-02........1771
    (c)(1) corrected...............................................19714
    (b) heading, (c) heading and (d)(1) revised; interim....21637, 22905
381.67 Introductory text revised; table amended; interim....21637, 22906
381.70 Existing text designated as (a); (b) added; interim........21638, 
                                                                   22906
381.71 Existing text designated as (a); (b) through (f) added; 
        interim.............................................21638, 22906
381.72 Revised; interim.....................................21638, 22906
381.76 (b)(1) introductory text revised; interim............21638, 22906
381.96 Revised; interim.....................................21638, 22906
381.117 (f) and (g) added..........................................40845
381.121d (b) revised...............................................52486
381.129 (e) added..................................................54916
381.159 (a) revised................................................54916
381.221 Table amended...............................................2207
381.224 Table amended...............................................2207
441 Added; eff. 1-9-02..............................................1771

                                  2002

9 CFR
                                                                   67 FR
                                                                    Page
Chapter III
317.8 Regulation at 66 FR 54915 eff. date confirmed................11413
319.15 Regulation at 66 FR 54916 eff. date confirmed...............11413
319.81 Regulation at 66 FR 54916 eff. date confirmed...............11413
319.104 Regulation at 66 FR 54916 eff. date confirmed..............11413
319.140 Regulation at 66 FR 54916 eff. date confirmed..............11413
319.143 Regulation at 66 FR 54916 eff. date confirmed..............11413
319.180 Regulation at 66 FR 54916 eff. date confirmed..............11413
331.2 Table amended................................................61768
331.6 Table amended................................................61768
362 Regulation at 66 FR 22905 confirmed............................13258
362.1 Regulation at 66 FR 22905 confirmed..........................13258

[[Page 762]]

362.2 Regulation at 66 FR 22905 confirmed..........................13258
381.1 Regulation at 66 FR 22905 confirmed..........................13258
    (b) amended....................................................13258
381.36 Regulation at 66 FR 22905 confirmed.........................13258
381.66 Regulation at 66 FR 22905 confirmed.........................13258
381.67 Regulation at 66 FR 22905 confirmed.........................13258
381.70 Regulation at 66 FR 22906 confirmed.........................13258
381.71 Regulation at 66 FR 22906 confirmed.........................13258
    (b) revised....................................................13258
381.72 Regulation at 66 FR 22906 confirmed.........................13258
381.76 Regulation at 66 FR 22906 confirmed.........................13258
381.94 (a)(2)(ii), (iii)(B), (v)(A), (5)(i) Table 1 and (b)(1) 
        Table 2 revised............................................13258
381.96 Regulation at 66 FR 22906 confirmed.........................13258
381.129 Regulation at 66 FR 54916 eff. date confirmed..............11413
381.159 Regulation at 66 FR 54916 eff. date confirmed..............11413
381.221 Table amended..............................................61768
381.224 Table amended..............................................61768
390.9 Added........................................................20013
391.2 Revised.......................................................3430
391.3 Revised.......................................................3430
391.4 Revised.......................................................3430
417 Policy statement...............................................62325
441 Stayed; eff. 1-9-02 through 1-9-03..............................1277
590.1--590.970 (Subchapter I) Heading revised.......................3430
590.126 Revised.....................................................3430
590.128 (a) revised.................................................3430
592 Added...........................................................3430

                                  2003

9 CFR
                                                                   68 FR
                                                                    Page
Chapter II
206 Added..........................................................47826
Chapter III
317.8 (b)(40) added................................................44870
317.363 (b)(3) introductory text and (i) amended; interim............463
319.1 Existing text designated as (a); new (b) added...............22578
    Regulation at 68 FR 22578 confirmed............................62228
319.600 Removed....................................................44870
320 Policy statement...............................................37730
381 Policy statement...............................................37730
381.129 (f) added..................................................44870
381.155 (b) added..................................................22578
    Regulation at 68 FR 22578 confirmed............................62228
381.196 (b) amended................................................37071
    Regulation at 68 FR 37071 confirmed............................63983
381.463 (b)(3) introductory text and (i) amended; interim............463
391.2 Revised......................................................37956
391.3 Revised......................................................37956
391.4 Revised......................................................37956
430 Added; interim.................................................34224
    Workshops......................................................50687
590.126 Revised....................................................37957
590.128 (a) revised................................................37957
592.2 Revised......................................................37957
592.3 Revised......................................................37957
592.4 Revised......................................................37957

                                  2004

9 CFR
                                                                   69 FR
                                                                    Page
Title 9 Nomenclature change........................................18803
Chapter III
300.1 Amended........................................................253
300.2 (a) revised....................................................253
300.3 (a), (b) introductory text, (1) and (c)(1) table amended; 
        (b)(2) removed...............................................253
300.4 Added..........................................................253
300.6 (b) added......................................................254
301 Heading and authority citation revised...........................254
301.1 Revised........................................................254
301.2 Amended........................................................254
    Amended; interim................................................1884
    Regulation at 69 FR 1884 comment period extended...............18245
306 Authority citation revised.......................................254
306.1 Revised........................................................254
306.2 Revised........................................................254
306.3 Amended........................................................254
309.2 (b) revised; interim..........................................1873
    Regulation at 69 FR 1873 comment period extended...............18245
309.3 (e) added; interim............................................1873
    Regulation at 69 FR 1873 comment period extended...............18245
310.13 (a)(2)(iv)(C) amended; interim...............................1891

[[Page 763]]

    Regulation at 69 FR 1891 comment period extended...............18245
310.22 Added; interim...............................................1873
    Regulation at 69 FR 1873 comment period extended...............18245
311.27 Amended; interim.............................................1874
    Regulation at 69 FR 1873 comment period extended...............18245
313.15 (b)(2) heading revised; (b)(2) existing text redesignated 
        as (b)(2)(i); (b)(2)(ii) added; interim.....................1891
    Regulation at 69 FR 1891 comment period extended...............18245
317 Compliance notification.................................28042, 74405
317.309 (b)(7)(iv) amended; (b)(12) revised........................58801
317.313 (l) revised; (m) added.....................................58801
317.354 (b)(1) introductory text, (2) introductory text, (c)(1) 
        introductory text, (2) introductory text, (d)(1), (e)(1) 
        introductory text, (e)(2) introductory text and (ii)(B) 
        amended....................................................58802
317.356 (b) introductory text, (c)(3), (d)(1) introductory text 
        and (2)(i) amended.........................................58802
317.360 (b)(2) introductory text, (3) introductory text, (4) 
        introductory text, (5) introductory text, (c)(1)(i), (4) 
        introductory text and (5) introductory text amended........58802
317.361 (b)(1)(i), (2) introductory text, (3) introductory text, 
        (4) introductory text, (5) introductory text, (6) 
        introductory text and (7) introductory text amended........58802
317.362 (b)(1)(i), (2) introductory text, (3) introductory text, 
        (4) introductory text, (5) introductory text, (c)(1)(i), 
        (2) introductory text, (3) introductory text, (4) 
        introductory text, (5) introductory text, (d)(1)(i), 
        (iii), (2) introductory text, (3), (4) introductory text, 
        (5), (e)(1) introductory text and (2) introductory text 
        amended....................................................58802
317.363 (b)(2)(i) introductory text, (3)(i) introductory text, 
        (4)(i) and (ii) amended....................................58802
318 Authority citation revised.................................254, 1874
318.6 (b)(1), (4) and (8) amended; interim..........................1874
    Regulation at 69 FR 1874 comment period extended...............18245
318.21 (b)(1), (3)(i), (vi), (xi), (c)(1), (3)(vi) and (xi) 
        amended......................................................254
318.24 Revised; interim.............................................1884
    Regulation at 69 FR 1884 comment period extended...............18245
319 Authority citation revised.....................................34916
319.5 (b) added; interim............................................1874
    Regulation at 69 FR 1874 comment period extended...............18245
319.312 Revised....................................................34916
320 Authority citation revised.......................................254
    Policy statement...............................................21047
320.1 (b)(10) amended; interim......................................1885
    Regulation at 69 FR 1885 comment period extended...............18245
320.4 Revised........................................................254
320.5 (a) amended....................................................254
381 Authority citation revised.......................................254
    Policy statement...............................................21047
    Compliance notification.................................28042, 74405
381.1 (b) amended....................................................255
381.3 (a) removed....................................................255
381.32 Revised.......................................................255
381.33 Amended.......................................................255
381.153 (b)(1), (3)(i), (vi), (xi), (c)(1), (3)(vi) and (xi) 
        amended......................................................255
381.178 Revised......................................................255
381.179 (a) amended..................................................255
381.409 (b)(7)(iv) amended; (b)(12) revised........................58802
381.413 (l) revised; (m) added.....................................58802
381.454 (b)(1) introductory text, (2) introductory text, (c)(1), 
        (2) introductory text, (d)(1), (e)(1) introductory text, 
        (2) introductory text and (ii)(B) amended..................58803
381.456 (b) introductory text, (c)(3), (d)(1) introductory text 
        and (2)(i) amended.........................................58803
381.460 (b)(2) introductory text, (3) introductory text, (4) 
        introductory text, (5) introductory text, (c)(1)(i), (4) 
        introductory text and (5) introductory text amended........58803

[[Page 764]]

381.461 (b)(1)(i), (2) introductory text, (3) introductory text, 
        (4) introductory text, (5) introductory text, (6) 
        introductory text and (7) introductory text amended........58803
381.462 (b)(2) introductory text, (3) introductory text, (4) 
        introductory text, (5) introductory text, (c)(2) 
        introductory text, (3) introductory text, (4) introductory 
        text, (d)(1)(i) introductory text, (iii) introductory 
        text, (2) introductory text, (3) introductory text, (4) 
        introductory text, (5) introductory text, (e)(1) 
        introductory text and (2) introductory text amended........58803
381.463 (b)(2)(i) introductory text, (3)(i), (4)(i) and (ii) 
        amended....................................................58803
430 Regulation at 68 FR 34224 comment period extended..............70051
    Policy statement...............................................70051
592 Revised.........................................................1648

                                  2005

9 CFR
                                                                   70 FR
                                                                    Page
Chapter III
310.22 (a)(3) amended, (a)(3)(i) and (ii) added....................53050
318.6 (b)(1) and (8) revised; interim..............................53050
319.10 Added; eff. 1-1-08..........................................33818
320 Policy statement...............................................21047
327.2 (b) amended.....................................6556, 57726, 70035
381 Policy statement...............................................21047
381.172 Added; eff. 1-1-08.........................................33818
381.221 Table amended..............................................35166
381.224 Table amended..............................................35166
417 Policy statement...............................................30331


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