[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2021 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

                                                   Title 21

                                                Food and Drugs

                                           ________________________

                                                Parts 100 to 169

                                            Revised as of April 1, 2021

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2021
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

[[Page ii]]

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                            Table of Contents



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

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services (Continued)                   3
  Finding Aids:
      Table of CFR Titles and Chapters........................     739
      Alphabetical List of Agencies Appearing in the CFR......     759
      List of CFR Sections Affected...........................     769

[[Page iv]]





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

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 100.1 refers 
                       to title 21, part 100, 
                       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

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, April 1, 2021), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

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Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
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instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

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 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
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PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
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the Code prior to the LSA listings at the end of the volume, consult 
previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not dropped in error.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
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if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    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.
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CFR INDEXES AND TABULAR GUIDES

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    An index to the text of ``Title 3--The President'' is carried within 
that volume.

[[Page vii]]

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This index is based on a consolidation of the ``Contents'' entries in 
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the revision dates of the 50 CFR titles.

REPUBLICATION OF MATERIAL

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in the Code of Federal Regulations.

INQUIRIES

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or write to the Director, Office of the Federal Register, National 
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Connect to NARA's website at www.archives.gov/federal-register.
    The e-CFR is a regularly updated, unofficial editorial compilation 
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available at www.ecfr.gov.

    Oliver A. Potts,
    Director,
    Office of the Federal Register
    April 1, 2021







[[Page ix]]



                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299, and 1300 to end. 
The first eight volumes, containing parts 1-1299, comprise Chapter I--
Food and Drug Administration, Department of Health and Human Services. 
The ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2021.

    For this volume, Gabrielle E. Burns was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

[[Page 1]]



                        TITLE 21--FOOD AND DRUGS




                  (This book contains parts 100 to 169)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Food and Drug Administration, Department of 
  Health and Human Services (Continued).....................         100

[[Page 3]]



CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)




                           (Parts 100 to 169)

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


  Editorial Note: Nomenclature changes to chapter I appear at 59 FR 
14366, Mar. 28, 1994, 59 FR 24879, May 9, 1994, 68 FR 13717, Mar. 24, 
2004, 69 FR 18803, Apr. 9, 2004, 70 FR 40880, July 15, 2005, and 70 FR 
67650, Nov. 8, 2005.

                SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
Part                                                                Page
100             General.....................................           5
101             Food labeling...............................          10
102             Common or usual name for nonstandardized 
                    foods...................................         199
104             Nutritional quality guidelines for foods....         206
105             Foods for special dietary use...............         210
106             Infant formula requirements pertaining to 
                    current good manufacturing practice, 
                    quality control procedures, quality 
                    factors, records and reports, and 
                    notifications...........................         212
107             Infant formula..............................         239
108             Emergency permit control....................         249
109             Unavoidable contaminants in food for human 
                    consumption and food-packaging material.         259
110             Current good manufacturing practice in 
                    manufacturing, packing, or holding human 
                    food....................................         265
111             Current good manufacturing practice in 
                    manufacturing, packaging, labeling, or 
                    holding operations for dietary 
                    supplements.............................         275
112             Standards for the growing, harvesting, 
                    packing, and holding of produce for 
                    human consumption.......................         305
113             Thermally processed low-acid foods packaged 
                    in hermetically sealed containers.......         343
114             Acidified foods.............................         377
115             Shell eggs..................................         383

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117             Current good manufacturing practice, hazard 
                    analysis, and risk-based preventive 
                    controls for human food.................         386
118             Production, storage, and transportation of 
                    shell eggs..............................         426
119             Dietary supplements that present a 
                    significant or unreasonable risk........         437
120             Hazard Analysis and Critical Control Point 
                    (HACCP) systems.........................         437
121             Mitigation strategies to protect food 
                    against intentional adulteration........         446
123             Fish and fishery products...................         454
129             Processing and bottling of bottled drinking 
                    water...................................         462
130             Food standards: General.....................         467
131             Milk and cream..............................         474
133             Cheeses and related cheese products.........         493
135             Frozen desserts.............................         545
136             Bakery products.............................         552
137             Cereal flours and related products..........         556
139             Macaroni and noodle products................         571
145             Canned fruits...............................         581
146             Canned fruit juices.........................         622
150             Fruit butters, jellies, preserves, and 
                    related products........................         636
152             Fruit pies..................................         641
155             Canned vegetables...........................         643
156             Vegetable juices............................         665
158             Frozen vegetables...........................         668
160             Eggs and egg products.......................         671
161             Fish and shellfish..........................         676
163             Cacao products..............................         693
164             Tree nut and peanut products................         701
165             Beverages...................................         704
166             Margarine...................................         724
168             Sweeteners and table sirups.................         726
169             Food dressings and flavorings...............         731

[[Page 5]]



                 SUBCHAPTER B_FOOD FOR HUMAN CONSUMPTION





PART 100_GENERAL--Table of Contents



                 Subpart A_State and Local Requirements

Sec.
100.1 Petitions requesting exemption from preemption for State or local 
          requirements.
100.2 State enforcement of Federal regulations.

Subparts B-E [Reserved]

          Subpart F_Misbranding for Reasons Other Than Labeling

100.100 Misleading containers.

         Subpart G_Specific Administrative Rulings and Decisions

100.155 Salt and iodized salt.

    Authority: 21 U.S.C. 321, 331, 337, 342, 343, 348, 371.

    Source: 42 FR 14306, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 100 appear at 81 FR 
49895, July 29, 2016.



                 Subpart A_State and Local Requirements



Sec. 100.1  Petitions requesting exemption from preemption for State
or local requirements.

    (a) Scope and purpose. (1) This subpart applies to the submission 
and consideration of petitions under section 403A(b) of the Federal 
Food, Drug, and Cosmetic Act (the act), by a State or a political 
subdivision of a State, requesting exemption of a State requirement from 
preemption under section 403A(a) of the act.
    (2) Section 403A(b) of the act provides that where a State 
requirement has been preempted under section 403A(a) of the act, the 
State may petition the agency for an exemption. The agency may grant the 
exemption, under such conditions as it may prescribe by regulation, if 
the agency finds that the State requirement will not cause any food to 
be in violation of any applicable requirement under Federal law, will 
not unduly burden interstate commerce, and is designed to address a 
particular need for information that is not met by the preemptive 
Federal requirement.
    (b) Definitions. (1) Act means the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321 et seq.).
    (2) Agency means the Food and Drug Administration.
    (3) Commissioner means the Commissioner of Food and Drugs.
    (4) State means a State as defined in section 201(a)(1) of the act 
(which includes a territory of the United States, the District of 
Columbia, and Puerto Rico) or any political subdivision of a State 
having authority to issue food standards and food labeling regulations 
having force of law.
    (5) State requirement means any statute, standard, regulation, or 
other requirement that is issued by a State.
    (c) Prerequisites for petitions for exemption from preemption. The 
Food and Drug Administration will consider a petition for exemption from 
preemption on its merits only if the petition demonstrates that:
    (1) The State requirement was enacted or was issued as a final rule 
by an authorized official of the State and is in effect or would be in 
effect but for the provisions of section 403A of the act.
    (2) The State requirement is subject to preemption under section 
403A(a) of the act because of a statutory provision listed in that 
section or because of a Federal standard or other Federal regulation 
that is in effect, or that has been published as a final rule with a 
designated effective date, and that was issued under the authority of a 
statutory provision listed in that section. For the purposes of this 
subpart, all petitions seeking exemption from preemption under section 
403A(a)(3) through (a)(5) of the act submitted before May 8, 1992, will 
be considered timely even though the applicable statutory provisions or 
regulations are not yet in effect.
    (3) The petitioner is an official of a State having authority to act 
for, or on behalf of, the Government in applying for an exemption of 
State requirements from preemption.

[[Page 6]]

    (4) The State requirement is subject to preemption under section 
403A(a) of the act because it is not identical to the requirement of the 
preemptive Federal statutory provision or regulation including a 
standard of identity, quality, and fill. ``Not identical to'' does not 
refer to the specific words in the requirement but instead means that 
the State requirement directly or indirectly imposes obligations or 
contains provisions concerning the composition or labeling of food, or 
concerning a food container, that:
    (i) Are not imposed by or contained in the applicable provision 
(including any implementing regulation) of section 401 or 403 of the 
act; or
    (ii) Differ from those specifically imposed by or contained in the 
applicable provision (including any implementing regulation) of section 
401 or 403 of the act.
    (d) Form of petition. (1) All information included in the petition 
should meet the general requirements of Sec. 10.20(c) of this chapter.
    (2) An original and one copy of the petition shall be submitted, or 
the petitioner may submit an original and a computer readable disk 
containing the petition. Contents of the disk should be in a standard 
format, such as ASCII format. (Petitioners interested in submitting a 
disk should contact the Center for Food Safety and Applied Nutrition for 
details.)
    (3) Petitions for exemption from preemption for a State requirement 
shall be submitted to the Division of Dockets Management in the 
following form:

(Date) ________
Division of Dockets Management,
Food and Drug Administration,
Department of Health and Human Services,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

   Petition Requesting Exemption from Preemption for State Requirement

    The undersigned submits this petition under section 403A(b)of the 
Federal Food, Drug, and Cosmetic Act to request that the Food and Drug 
Administration exempt a State requirement from preemption.
    The undersigned has authority to act for, or on behalf of, the 
(identify State or political subdivision of the State) because (document 
petitioner's authority to submit petition on behalf of the State).

                           A. Action Requested

    1. Identify and give the exact wording of the State requirement and 
give date it was enacted or issued in final form.
    2. Identify the specific standard or regulation that is believed to 
preempt the State requirement and the section and paragraph of the act 
that the standard or regulation implements.

                  B. Documentation of State Requirement

    Provide a copy of the State requirement that is the subject of the 
application. Where available, the application should also include copies 
of any legislative history or background materials used in issuing the 
requirement, including hearing reports or studies concerning the 
development or consideration of the requirement.

                         C. Statement of Grounds

    A petition for an exemption from preemption should contain the 
following:
    1. An explanation of the State requirement and its rationale, and a 
comparison of State and Federal requirements to show differences.
    2. An explanation of why compliance with the State requirement would 
not cause a food to be in violation of any applicable requirement under 
Federal law.
    3. Information on the effect that granting the State petition will 
have on interstate commerce. The petition should contain information on 
economic feasibility, i.e., whether the State and Federal requirements 
have significantly different effects on the production and distribution 
of the food product; comparison of the costs of compliance as shown by 
data or information on the actual or anticipated effect of the State and 
Federal requirements on the sale and price of the food product in 
interstate commerce; and the effect of the State requirement on the 
availability of the food product to consumers. To the extent possible, 
the petition should include information showing that it is practical and 
feasible for producers of food products to comply with the State 
requirement. Such information may be submitted in the form of statements 
from affected persons indicating their ability to comply.
    4. Identification of a particular need for information that the 
State requirement is designed to meet, which need is not met by Federal 
law. The petition should describe the conditions that require the State 
to petition for an exemption, the information need that the State 
requirement fulfills, the inadequacy of the Federal requirement in 
addressing this need, and the geographical area or political subdivision 
in which such need exists.

[[Page 7]]

                         D. Environmental Impact

    The petition shall contain a claim for categorical exclusion under 
21 CFR 25.24 or an environmental assessment under 21 CFR 25.31.

                             E. Notification

    Provide name and address of person, branch, department, or other 
instrumentality of the State government that should be notified of the 
Commissioner's action concerning the petition.

                            F. Certification

    The undersigned certifies, that, to the best knowledge and belief of 
the undersigned, this petition includes all information and views on 
which the petition relies.
(Signature) ____________
(Name of petitioner) ________
(Mailing address) _________
(Telephone number) ________
    (Information collection requirements in this section were approved 
by the Office of Management and Budget (OMB) and assigned OMB number 
0910-0277)

    (e) Submission of petition for exemption; public disclosure. The 
availability for public disclosure of a petition for exemption will be 
governed by the rules specified in Sec. 10.20(j) of this chapter.
    (f) Agency consideration of petitions. (1) Unless otherwise 
specified in this section, all relevant provisions and requirements of 
subpart B of part 10 of this chapter, are applicable to State petitions 
requesting exemption from Federal preemption under section 403A(b) of 
the act.
    (2) If a petition does not meet the prerequisite requirements of 
paragraph (c) of this section, the agency will issue a letter to the 
petitioner denying the petition and stating in what respect the petition 
does not meet these requirements.
    (3) If a petition appears to meet the prerequisite requirements in 
paragraph (c) of this section, it will be filed by the Division of 
Dockets Management, stamped with the date of filing, and assigned a 
docket number. The docket number identifies the file established by the 
Division of Dockets Management for all submissions relating to the 
petition, as provided in this part. Subsequent submissions relating to 
the matter must refer to the docket number and will be filed in the 
docket file. The Division of Dockets Management will promptly notify the 
petitioner in writing of the filing and docket number of a petition.
    (4) Any interested person may submit written comments to the 
Division of Dockets Management on a filed petition as provided in Sec. 
10.30(d) of this chapter.
    (5) Within 90 days of the date of filing the agency will furnish a 
response to the petitioner. The response will either:
    (i) State that the agency has tentatively determined that the 
petition merits the granting of an exemption, and that it intends to 
publish in the Federal Register a proposal to grant the exemption 
through rulemaking;
    (ii) Deny the petition and state the reasons for such denial; or
    (iii) Provide a tentative response indicating why the agency has 
been unable to reach a decision on the petition, e.g., because of other 
agency priorities or a need for additional information.
    (g) If a State submitted a petition for exemption of a State 
requirement from preemption under section 403A(a)(3) through (a)(5) of 
the act before May 8, 1992, that State requirement will not be subject 
to preemption until:
    (1) November 8, 1992; or
    (2) Action on the petition, whichever occurs later.

[58 FR 2468, Jan. 6, 1993]



Sec. 100.2  State enforcement of Federal regulations.

    (a) Under section 307 of the Federal Food, Drug, and Cosmetic Act 
(the act), a State may bring, in its own name and within its own 
jurisdiction, proceedings for the civil enforcement, or to restrain 
violations, of sections 401, 403(b), 403(c), 403(d), 403(e), 403(f), 
403(g), 403(h), 403(i), 403(k), 403(q), or 403(r) of the act if the food 
that is the subject of the proceedings is located in the State.
    (b) No proceeding may be commenced by a State under paragraph (a) of 
this section:
    (1) Before 30 days after the State has given notice to the Food and 
Drug Administration (FDA) that the State intends to bring such 
proceeding.
    (2) Before 90 days after the State has given notice to FDA of such 
intent if

[[Page 8]]

FDA has, within such 30 days, commenced an informal or formal 
enforcement action pertaining to the food which would be the subject of 
such proceeding.
    (3) If FDA is diligently prosecuting a proceeding in court 
pertaining to such food, has settled such proceeding, or has settled the 
informal or formal enforcement action pertaining to such food.
    (c) A State may intervene as a matter of right, in any court 
proceeding described in paragraph (b)(3) of this section.
    (d) The notification that a State submits in accordance with 
paragraph (b) of this section should include the following information 
and be submitted in the following recommended format:

(Date) ________
Name of State agency ______
Post office address ______
Street address ______
City, State, and ZIP code ______
Name of product(s) covered by the notification ______
Reporting official, title, and telephone no. ______
FAX No. ______
Agency contact (if different from reporting official), title, and 
telephone no. ______

Director,
Division of Enforcement (HFS-605),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5001 Campus Dr.,
College Park, MD 20740.

To Whom It May Concern:
    The undersigned, ___, submits this letter of notification pursuant 
to section 307(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 337(b)(1)) with respect to ____. (name of products covered by 
the notification and the enforcement action that is to be initiated)
Attached hereto, and constituting a part of this letter of notification 
are the following:
    A. The name of the product.
    B. The type and size of each product container.
    C. Copy of the label and labeling of the product.
    D. Manufacturing code (if applicable).
    E. Name and address of firm believed to be responsible for 
violations.
    F. Name and address of parent firm (if known).
    G. Reason for the anticipated State enforcement action (list 
specific violations, including sections of the law violated).
    H. Name of firm against which action is anticipated (if applicable).
    I. Type of enforcement action.
    Yours very truly,
Reporting Agency
By ______
(Indicate authority)

    (e) The letter of notification should be signed by a State official 
authorized by the State to institute the contemplated enforcement 
actions.
    (f) The letter of notification should be sent to the Division of 
Enforcement (HFS-605), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
FAX number 202-205-4642.
    (g) FDA will notify the State of the date in which its letter of 
notification was received by FDA, Center for Food Safety and Applied 
Nutrition, Division of Enforcement (HFS-605) (within 2 working days 
after date of receipt). This date will be the date of notification for 
the purposes of paragraph (b) of this section.
    (h) The Director, Division of Enforcement, Office of Field Programs, 
Center for Food Safety and Applied Nutrition, FDA, will respond to the 
State's notification within 30 days of the date of notification by 
advising:
    (1) Whether FDA has commenced an informal or formal enforcement 
action pertaining to the food that is the subject of the notification; 
or
    (2) Whether FDA is prosecuting a proceeding in court pertaining to 
such food, has settled such proceeding, or has settled informal or 
formal enforcement action pertaining to such food.
    (i) Information contained in State notification letters shall be 
exempt from public disclosure to the same extent to which such 
information would be so exempt pursuant to Sec. Sec. 20.61, 20.64, and 
20.88 of this chapter.
    (j) Definitions. (1) Informal enforcement actions include warning 
letters, recalls, detentions, or other administrative enforcement 
actions that pertain to the food in question.
    (2) Formal enforcement actions include seizures, injunctions, or 
other civil judicial enforcement actions that pertain to the food in 
question. (Information collection requirements in this section

[[Page 9]]

were approved by the Office of Management and Budget (OMB) and assigned 
OMB control number 0910-0275.)

[58 FR 2460, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 66 
FR 56035, Nov. 6, 2001]

Subparts B-E [Reserved]



          Subpart F_Misbranding for Reasons Other Than Labeling



Sec. 100.100  Misleading containers.

    In accordance with section 403(d) of the act, a food shall be deemed 
to be misbranded if its container is so made, formed, or filled as to be 
misleading.
    (a) A container that does not allow the consumer to fully view its 
contents shall be considered to be filled as to be misleading if it 
contains nonfunctional slack-fill. Slack-fill is the difference between 
the actual capacity of a container and the volume of product contained 
therein. Nonfunctional slack-fill is the empty space in a package that 
is filled to less than its capacity for reasons other than:
    (1) Protection of the contents of the package;
    (2) The requirements of the machines used for enclosing the contents 
in such package;
    (3) Unavoidable product settling during shipping and handling;
    (4) The need for the package to perform a specific function (e.g., 
where packaging plays a role in the preparation or consumption of a 
food), where such function is inherent to the nature of the food and is 
clearly communicated to consumers;
    (5) The fact that the product consists of a food packaged in a 
reusable container where the container is part of the presentation of 
the food and has value which is both significant in proportion to the 
value of the product and independent of its function to hold the food, 
e.g., a gift product consisting of a food or foods combined with a 
container that is intended for further use after the food is consumed; 
or durable commemorative or promotional packages; or
    (6) Inability to increase level of fill or to further reduce the 
size of the package (e.g., where some minimum package size is necessary 
to accommodate required food labeling (excluding any vignettes or other 
nonmandatory designs or label information), discourage pilfering, 
facilitate handling, or accommodate tamper-resistant devices).
    (b) [Reserved]

[59 FR 537, Jan. 5, 1994]



         Subpart G_Specific Administrative Rulings and Decisions



Sec. 100.155  Salt and iodized salt.

    (a) For the purposes of this section, the term iodized salt or 
iodized table salt is designated as the name of salt for human food use 
to which iodide has been added in the form of cuprous iodide or 
potassium iodide permitted by Sec. Sec. 184.1265 and 184.1634 of this 
chapter. In the labeling of such products, all words in the name shall 
be equal in prominence and type size. The statement ``This salt supplies 
iodide, a necessary nutrient'' shall appear on the label immediately 
following the name and shall be in letters which are not less in height 
than those required for the declaration of the net quantity of contents 
as specified in Sec. 101.7 of this chapter.
    (b) Salt or table salt for human food use to which iodide has not 
been added shall bear the statement, ``This salt does not supply iodide, 
a necessary nutrient.'' This statement shall appear immediately 
following the name of the food and shall be in letters which are not 
less in height than those required for the declaration of the net 
quantity of contents as specified in Sec. 101.7 of this chapter.
    (c) Salt, table salt, iodized salt, or iodized table salt to which 
anticaking agents have been added may bear in addition to the ingredient 
statement designating the anticaking agent(s), a label statement 
describing the characteristics imparted by such agent(s) (for example, 
``free flowing''), providing such statement does not appear with greater 
prominence or in type size larger than the statements which immediately 
follow the name of the food as required by paragraphs (a) and (b) of 
this section.
    (d) Individual serving-sized packages containing less than \1/2\ 
ounce and packages containing more than 2\1/2\ pounds

[[Page 10]]

of a food described in this section shall be exempt from declaration of 
the statements which paragraphs (a) and (b) of this section require 
immediately following the name of the food. Such exemption shall not 
apply to the outer container or wrapper of a multiunit retail package.
    (e) All salt, table salt, iodized salt, or iodized table salt in 
packages intended for retail sale shipped in interstate commerce 18 
months after the date of publication of this statement of policy in the 
Federal Register, shall be labeled as prescribed by this section; and if 
not so labeled, the Food and Drug Administration will regard them as 
misbranded within the meaning of sections 403 (a) and (f) of the Federal 
Food, Drug, and Cosmetic Act.

[42 FR 14306, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983; 
49 FR 24119, June 12, 1984; 81 FR 59131, Aug. 29, 2016]



PART 101_FOOD LABELING--Table of Contents



                      Subpart A_General Provisions

Sec.
101.1 Principal display panel of package form food.
101.2 Information panel of package form food.
101.3 Identity labeling of food in packaged form.
101.4 Food; designation of ingredients.
101.5 Food; name and place of business of manufacturer, packer, or 
          distributor.
101.7 Declaration of net quantity of contents.
101.8 Vending machines.
101.9 Nutrition labeling of food.
101.10 Nutrition labeling of restaurant foods whose labels or labeling 
          bear nutrient content claims or health claims.
101.11 Nutrition labeling of standard menu items in covered 
          establishments.
101.12 Reference amounts customarily consumed per eating occasion.
101.13 Nutrient content claims--general principles.
101.14 Health claims: general requirements.
101.15 Food; prominence of required statements.
101.17 Food labeling warning, notice, and safe handling statements.
101.18 Misbranding of food.

              Subpart B_Specific Food Labeling Requirements

101.22 Foods; labeling of spices, flavorings, colorings and chemical 
          preservatives.
101.30 Percentage juice declaration for foods purporting to be beverages 
          that contain fruit or vegetable juice.

    Subpart C_Specific Nutrition Labeling Requirements and Guidelines

101.36 Nutrition labeling of dietary supplements.
101.42 Nutrition labeling of raw fruit, vegetables, and fish.
101.43 Substantial compliance of food retailers with the guidelines for 
          the voluntary nutrition labeling of raw fruit, vegetables, and 
          fish.
101.44 Identification of the 20 most frequently consumed raw fruit, 
          vegetables, and fish in the United States.
101.45 Guidelines for the voluntary nutrition labeling of raw fruit, 
          vegetables, and fish.

       Subpart D_Specific Requirements for Nutrient Content Claims

101.54 Nutrient content claims for ``good source,'' ``high,'' ``more,'' 
          and ``high potency.''
101.56 Nutrient content claims for ``light'' or ``lite.''
101.60 Nutrient content claims for the calorie content of foods.
101.61 Nutrient content claims for the sodium content of foods.
101.62 Nutrient content claims for fat, fatty acid, and cholesterol 
          content of foods.
101.65 Implied nutrient content claims and related label statements.
101.67 Use of nutrient content claims for butter.
101.69 Petitions for nutrient content claims.

            Subpart E_Specific Requirements for Health Claims

101.70 Petitions for health claims.
101.71 Health claims: claims not authorized.
101.72 Health claims: calcium, vitamin D, and osteoporosis.
101.73 Health claims: dietary lipids and cancer.
101.74 Health claims: sodium and hypertension.
101.75 Health claims: dietary saturated fat and cholesterol and risk of 
          coronary heart disease.
101.76 Health claims: fiber-containing grain products, fruits, and 
          vegetables and cancer.
101.77 Health claims: fruits, vegetables, and grain products that 
          contain fiber, particularly soluble fiber, and risk of 
          coronary heart disease.
101.78 Health claims: fruits and vegetables and cancer.
101.79 Health claims: Folate and neural tube defects.

[[Page 11]]

101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and 
          dental caries.
101.81 Health claims: Soluble fiber from certain foods and risk of 
          coronary heart disease (CHD).
101.82 Health claims: Soy protein and risk of coronary heart disease 
          (CHD).
101.83 Health claims: plant sterol/stanol esters and risk of coronary 
          heart disease (CHD).

Subpart F_Specific Requirements for Descriptive Claims That Are Neither 
                Nutrient Content Claims nor Health Claims

101.91 Gluten-free labeling of food.
101.93 Certain types of statements for dietary supplements.
101.95 ``Fresh,'' ``freshly frozen,'' ``fresh frozen,'' ``frozen 
          fresh.''

          Subpart G_Exemptions From Food Labeling Requirements

101.100 Food; exemptions from labeling.
101.108 Temporary exemptions for purposes of conducting authorized food 
          labeling experiments.

Appendix A to Part 101--Monier-Williams Procedure (With Modifications) 
          for Sulfites in Food, Center for Food Safety and Applied 
          Nutrition, Food and Drug Administration (November 1985)
Appendix B to Part 101--Graphic Enhancements Used by the FDA
Appendix C to Part 101--Nutrition Facts for Raw Fruits and Vegetables
Appendix D to Part 101--Nutrition Facts for Cooked Fish

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 
348, 371; 42 U.S.C. 243, 264, 271.

    Source: 42 FR 14308, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 101 appear at 63 FR 
14035, Mar. 24, 1998, 66 FR 17358, Mar. 30, 2001, 66 FR 56035, Nov. 6, 
2001, and 81 FR 49895, July 29, 2016.



                      Subpart A_General Provisions



Sec. 101.1  Principal display panel of package form food.

    The term principal display panel as it applies to food in package 
form and as used in this part, means the part of a label that is most 
likely to be displayed, presented, shown, or examined under customary 
conditions of display for retail sale. The principal display panel shall 
be large enough to accommodate all the mandatory label information 
required to be placed thereon by this part with clarity and 
conspicuousness and without obscuring design, 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. For the purpose of obtaining uniform 
type size in declaring the quantity of contents for all packages of 
substantially the same size, the term area of the principal display 
panel means the area of the side or surface that bears the principal 
display panel, which area shall be:
    (a) In the case of a rectangular package where one entire side 
properly can be considered to be the principal display panel side, the 
product of the height times the width of that side;
    (b) In the case of a cylindrical or nearly cylindrical container, 40 
percent of the product of the height of the container times the 
circumference;
    (c) In the case of any otherwise shaped container, 40 percent of the 
total surface of the container: Provided, however, That where such 
container presents an obvious ``principal display panel'' such as the 
top of a triangular or circular package of cheese, the area shall 
consist of the entire top surface. 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. In the case 
of cylindrical or nearly cylindrical containers, information required by 
this part to appear on the principal display panel shall appear within 
that 40 percent of the circumference which is most likely to be 
displayed, presented, shown, or examined under customary conditions of 
display for retail sale.



Sec. 101.2  Information panel of package form food.

    (a) The term information panel as it applies to packaged food means 
that part of the label immediately contiguous and to the right of the 
principal display panel as observed by an individual facing the 
principal display panel with the following exceptions:
    (1) If the part of the label immediately contiguous and to the right 
of

[[Page 12]]

the principal display panel is too small to accommodate the necessary 
information or is otherwise unusable label space, e.g., folded flaps or 
can ends, the panel immediately contiguous and to the right of this part 
of the label may be used.
    (2) If the package has one or more alternate principal display 
panels, the information panel is immediately contiguous and to the right 
of any principal display panel.
    (3) 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.
    (b) All information required to appear on the label of any package 
of food under Sec. Sec. 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 
101.36, subpart D of part 101, and part 105 of this chapter shall appear 
either on the principal display panel or on the information panel, 
unless otherwise specified by regulations in this chapter.
    (c) All information appearing on the principal display panel or the 
information panel pursuant to this section shall appear prominently and 
conspicuously, but in no case may the letters and/or numbers be less 
than one-sixteenth inch in height unless an exemption pursuant to 
paragraph (f) of this section is established. The requirements for 
conspicuousness and legibility shall include the specifications of 
Sec. Sec. 101.7(h)(1) and (2) and 101.15.
    (1)(i) Soft drinks packaged in bottles manufactured before October 
31, 1975 shall be exempt from the requirements prescribed by this 
section to the extent that information which is blown, lithographed, or 
formed onto the surface of the bottle is exempt from the size and 
placement requirements of this section.
    (ii) Soft drinks packaged in bottles shall be exempt from the size 
and placement requirements prescribed by this section if all of the 
following conditions are met:
    (A) If the soft drink is packaged in a bottle bearing a paper, 
plastic foam jacket, or foil label, or is packaged in a nonreusable 
bottle bearing a label lithographed onto the surface of the bottle or is 
packaged in metal cans, the product shall not be exempt from any 
requirement of this section other than the exemptions created by Sec. 
1.24(a)(5) (ii) and (v) of this chapter and the label shall bear all 
required information in the specified minimum type size, except the 
label will not be required to bear the information required by Sec. 
101.5 if this information appears on the bottle closure or on the lid of 
the can in a type size not less than one-sixteenth inch in height, or if 
embossed on the lid of the can in a type size not less than one-eighth 
inch in height.
    (B) If the soft drink is packaged in a bottle which does not bear a 
paper, plastic foam jacket or foil label, or is packaged in a reusable 
bottle bearing a label lithographed onto the surface of the bottle:
    (1) Neither the bottle nor the closure is required to bear nutrition 
labeling in compliance with Sec. 101.9, except that any multiunit 
retail package in which it is contained shall bear nutrition labeling if 
required by Sec. 101.9; and any vending machine in which it is 
contained shall bear nutrition labeling if nutrition labeling is not 
present on the bottle or closure, if required by Sec. 101.9.
    (2) All other information pursuant to this section shall appear on 
the top of the bottle closure prominently and conspicuously in letters 
and/or numbers no less than one thirty-second inch in height, except 
that if the information required by Sec. 101.5 is placed on the side of 
the closure in accordance with Sec. 1.24(a)(5)(ii) of this chapter, 
such information shall appear in letters and/or numbers no less than 
one-sixteenth inch in height.
    (3) Upon the petition of any interested person demonstrating that 
the bottle closure is too small to accommodate this information, the 
Commissioner may by regulation establish an alternative method of 
disseminating such information. Information appearing on the closure 
shall appear in the following priority:
    (i) The statement of ingredients.
    (ii) The name and address of the manufacturer, packer, or 
distributor.
    (iii) The statement of identity.
    (2) Individual serving-size packages of food served with meals in 
restaurants, institutions, and on board passenger carriers, and not 
intended

[[Page 13]]

for sale at retail, are exempt from type-size requirements of this 
paragraph, provided:
    (i) The package has a total area of 3 square inches or less 
available to bear labeling;
    (ii) There is insufficient area on the package available to print 
all required information in a type size of \1/16\ inch in height;
    (iii) The information required by paragraph (b) of this section 
appears on the label in accordance with the provisions of this 
paragraph, except that the type size is not less than \1/32\ inch in 
height.
    (d)(1) Except as provided by Sec. Sec. 101.9(j)(13) and (j)(17) and 
101.36(i)(2) and (i)(5), all information required to appear on the 
principal display panel or on the information panel under this section 
shall appear on the same panel unless there is insufficient space. In 
determining the sufficiency of the available space, except as provided 
by Sec. Sec. 101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and 
other nonmandatory label information shall not be considered. If there 
is insufficient space for all of this information to appear on a single 
panel, it may be divided between these two panels, except that the 
information required under any given section or part shall all appear on 
the same panel. A food whose label is required to bear the ingredient 
statement on the principal display panel may bear all other information 
specified in paragraph (b) of this section on the information panel.
    (2) Any food, not otherwise exempted in this section, if packaged in 
a container consisting of a separate lid and body, and bearing nutrition 
labeling pursuant to Sec. 101.9, and if the lid qualifies for and is 
designed to serve as a principal display panel, shall be exempt from the 
placement requirements of this section in the following respects:
    (i) The name and place of business information required by Sec. 
101.5 shall not be required on the body of the container if this 
information appears on the lid in accordance with this section.
    (ii) The nutrition information required by Sec. 101.9 shall not be 
required on the lid if this information appears on the container body in 
accordance with this section.
    (iii) The statement of ingredients required by Sec. 101.4 shall not 
be required on the lid if this information appears on the container body 
in accordance with this section. Further, the statement of ingredients 
is not required on the container body if this information appears on the 
lid in accordance with this section.
    (e) All information appearing on the information panel pursuant to 
this section shall appear in one place without other intervening 
material.
    (f) If the label of any package of food is too small to accommodate 
all of the information required by Sec. Sec. 101.4, 101.5, 101.8, 
101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of 
this chapter, the Commissioner may establish by regulation an acceptable 
alternative method of disseminating such information to the public, 
e.g., a type size smaller than one-sixteenth inch in height, or labeling 
attached to or inserted in the package or available at the point of 
purchase. A petition requesting such a regulation, as an amendment to 
this paragraph, shall be submitted under part 10 of this chapter.

[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006, 
Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5, 1988; 58 
FR 44030, Aug. 18, 1993; 60 FR 17205, Apr. 5, 1995; 62 FR 43074, Aug. 
12, 1997; 62 FR 49847, Sept. 23, 1997; 63 FR 14817, Mar. 27, 1998; 81 FR 
59131, Aug. 29, 2016]



Sec. 101.3  Identity labeling of food in packaged form.

    (a) The principal display panel of a food in package form shall bear 
as one of its principal features a statement of the identity of the 
commodity.
    (b) Such statement of identity shall be in terms of:
    (1) The name now or hereafter specified in or required by any 
applicable Federal law or regulation; or, in the absence thereof,
    (2) The common or usual name of the food; or, in the absence 
thereof,
    (3) An appropriately descriptive term, or when the nature of the 
food is obvious, a fanciful name commonly used by the public for such 
food.

[[Page 14]]

    (c) Where a food is marketed in various optional forms (whole, 
slices, diced, etc.), the particular form shall be considered to be a 
necessary part of the statement of identity and shall be declared in 
letters of a type size bearing a reasonable relation to the size of the 
letters forming the other components of the statement of identity; 
except that if the optional form is visible through the container or is 
depicted by an appropriate vignette, the particular form need not be 
included in the statement. This specification does not affect the 
required declarations of identity under definitions and standards for 
foods promulgated pursuant to section 401 of the act.
    (d) This statement of identity shall be presented in bold type on 
the principal display panel, shall be in a size reasonably related to 
the most prominent printed matter on such panel, and shall be in lines 
generally parallel to the base on which the package rests as it is 
designed to be displayed.
    (e) Under the provisions of section 403(c) of the Federal Food, 
Drug, and Cosmetic Act, a food shall be deemed to be misbranded 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.
    (1) A food shall be deemed to be an imitation and thus subject to 
the requirements of section 403(c) of the act if it is a substitute for 
and resembles another food but is nutritionally inferior to that food.
    (2) A food that is a substitute for and resembles another food shall 
not be deemed to be an imitation provided it meets each of the following 
requirements:
    (i) It is not nutritionally inferior to the food for which it 
substitutes and which it resembles.
    (ii) Its label bears a common or usual name that complies with the 
provisions of Sec. 102.5 of this chapter and that is not false or 
misleading, or in the absence of an existing common or usual name, an 
appropriately descriptive term that is not false or misleading. The 
label may, in addition, bear a fanciful name which is not false or 
misleading.
    (3) A food for which a common or usual name is established by 
regulation (e.g., in a standard of identity pursuant to section 401 of 
the act, in a common or usual name regulation pursuant to part 102 of 
this chapter, or in a regulation establishing a nutritional quality 
guideline pursuant to part 104 of this chapter), and which complies with 
all of the applicable requirements of such regulation(s), shall not be 
deemed to be an imitation.
    (4) Nutritional inferiority includes:
    (i) Any reduction in the content of an essential nutrient that is 
present in a measurable amount, but does not include a reduction in the 
caloric or fat content provided the food is labeled pursuant to the 
provisions of Sec. 101.9, and provided the labeling with respect to any 
reduction in caloric content complies with the provisions applicable to 
caloric content in part 105 of this chapter.
    (ii) For the purpose of this section, a measurable amount of an 
essential nutrient in a food shall be considered to be 2 percent or more 
of the Daily Reference Value (DRV) of protein listed under Sec. 
101.9(c)(7)(iii) and of potassium listed under Sec. 101.9(c)(9) per 
reference amount customarily consumed and 2 percent or more of the 
Reference Daily Intake (RDI) of any vitamin or mineral listed under 
Sec. 101.9(c)(8)(iv) per reference amount customarily consumed, except 
that selenium, molybdenum, chromium, and chloride need not be 
considered.
    (iii) If the Commissioner concludes that a food is a substitute for 
and resembles another food but is inferior to the food imitated for 
reasons other than those set forth in this paragraph, he may propose 
appropriate revisions to this regulation or he may propose a separate 
regulation governing the particular food.
    (f) A label may be required to bear the percentage(s) of a 
characterizing ingredient(s) or information concerning the presence or 
absence of an ingredient(s) or the need to add an ingredient(s) as part 
of the common or usual name of the food pursuant to subpart B of part 
102 of this chapter.
    (g) Dietary supplements shall be identified by the term ``dietary 
supplement'' as a part of the statement of

[[Page 15]]

identity, except that the word ``dietary'' may be deleted and replaced 
by the name of the dietary ingredients in the product (e.g., calcium 
supplement) or an appropriately descriptive term indicating the type of 
dietary ingredients that are in the product (e.g., herbal supplement 
with vitamins).

[42 FR 14308, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983; 
58 FR 2227, Jan. 6, 1993; 60 FR 67174, Dec. 28, 1995; 62 FR 49847, Sept. 
23, 1997]



Sec. 101.4  Food; designation of ingredients.

    (a)(1) Ingredients required to be declared on the label or labeling 
of a food, including foods that comply with standards of identity, 
except those ingredients exempted by Sec. 101.100, shall be listed by 
common or usual name in descending order of predominance by weight on 
either the principal display panel or the information panel in 
accordance with the provisions of Sec. 101.2, except that ingredients 
in dietary supplements that are listed in the nutrition label in 
accordance with Sec. 101.36 need not be repeated in the ingredient 
list. Paragraph (g) of this section describes the ingredient list on 
dietary supplement products.
    (2) The descending order of predominance requirements of paragraph 
(a)(1) of this section do not apply to ingredients present in amounts of 
2 percent or less by weight when a listing of these ingredients is 
placed at the end of the ingredient statement following an appropriate 
quantifying statement, e.g., ``Contains _ percent or less of ___'' or 
``Less than _ percent of ___.'' The blank percentage within the 
quantifying statement shall be filled in with a threshold level of 2 
percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as 
appropriate. No ingredient to which the quantifying phrase applies may 
be present in an amount greater than the stated threshold.
    (b) The name of an ingredient shall be a specific name and not a 
collective (generic) name, except that:
    (1) Spices, flavorings, colorings and chemical preservatives shall 
be declared according to the provisions of Sec. 101.22.
    (2) An ingredient which itself contains two or more ingredients and 
which has an established common or usual name, conforms to a standard 
established pursuant to the Meat Inspection or Poultry Products 
Inspection Acts by the U.S. Department of Agriculture, or conforms to a 
definition and standard of identity established pursuant to section 401 
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the 
statement of ingredients on the label of such food by either of the 
following alternatives:
    (i) By declaring the established common or usual name of the 
ingredient followed by a parenthetical listing of all ingredients 
contained therein in descending order of predominance except that, if 
the ingredient is a food subject to a definition and standard of 
identity established in subchapter B of this chapter that has specific 
labeling provisions for optional ingredients, optional ingredients may 
be declared within the parenthetical listing in accordance with those 
provisions.
    (ii) By incorporating into the statement of ingredients in 
descending order of predominance in the finished food, the common or 
usual name of every component of the ingredient without listing the 
ingredient itself.
    (3) Skim milk, concentrated skim milk, reconstituted skim milk, and 
nonfat dry milk may be declared as ``skim milk'' or ``nonfat milk''.
    (4) Milk, concentrated milk, reconstituted milk, and dry whole milk 
may be declared as ``milk''.
    (5) Bacterial cultures may be declared by the word ``cultured'' 
followed by the name of the substrate, e.g., ``made from cultured skim 
milk or cultured buttermilk''.
    (6) Sweetcream buttermilk, concentrated sweetcream buttermilk, 
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may 
be declared as ``buttermilk''.
    (7) Whey, concentrated whey, reconstituted whey, and dried whey may 
be declared as ``whey''.
    (8) Cream, reconstituted cream, dried cream, and plastic cream 
(sometimes known as concentrated milk fat) may be declared as ``cream''.
    (9) Butteroil and anhydrous butterfat may be declared as 
``butterfat''.

[[Page 16]]

    (10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may 
be declared as ``eggs''.
    (11) Dried egg whites, frozen egg whites, and liquid egg whites may 
be declared as ``egg whites''.
    (12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be 
declared as ``egg yolks''.
    (13) [Reserved]
    (14) Each individual fat and/or oil ingredient of a food intended 
for human consumption shall be declared by its specific common or usual 
name (e.g., ``beef fat'', ``cottonseed oil'') in its order of 
predominance in the food except that blends of fats and/or oils may be 
designated in their order of predominance in the foods as ``___ 
shortening'' or ``blend of ___ oils'', the blank to be filled in with 
the word ``vegetable'', ``animal'', ``marine'', with or without the 
terms ``fat'' or ``oils'', or combination of these, whichever is 
applicable if, immediately following the term, the common or usual name 
of each individual vegetable, animal, or marine fat or oil is given in 
parentheses, e.g., ``vegetable oil shortening (soybean and cottonseed 
oil)''. For products that are blends of fats and/or oils and for foods 
in which fats and/or oils constitute the predominant ingredient, i.e., 
in which the combined weight of all fat and/or oil ingredients equals or 
exceeds the weight of the most predominant ingredient that is not a fat 
or oil, the listing of the common or usual names of such fats and/or 
oils in parentheses shall be in descending order of predominance. In all 
other foods in which a blend of fats and/or oils is used as an 
ingredient, the listing of the common or usual names in parentheses need 
not be in descending order of predominance if the manufacturer, because 
of the use of varying mixtures, is unable to adhere to a constant 
pattern of fats and/or oils in the product. If the fat or oil is 
completely hydrogenated, the name shall include the term hydrogenated, 
or if partially hydrogenated, the name shall include the term partially 
hydrogenated. If each fat and/or oil in a blend or the blend is 
completely hydrogenated, the term ``hydrogenated'' may precede the 
term(s) describing the blend, e.g., ``hydrogenated vegetable oil 
(soybean, cottonseed, and palm oils)'', rather than preceding the name 
of each individual fat and/or oil; if the blend of fats and/or oils is 
partially hydrogenated, the term ``partially hydrogenated'' may be used 
in the same manner. Fat and/or oil ingredients not present in the 
product may be listed if they may sometimes be used in the product. Such 
ingredients shall be identified by words indicating that they may not be 
present, such as ``or'', ``and/or'', ``contains one or more of the 
following:'', e.g., ``vegetable oil shortening (contains one or more of 
the following: cottonseed oil, palm oil, soybean oil)''. No fat or oil 
ingredient shall be listed unless actually present if the fats and/or 
oils constitute the predominant ingredient of the product, as defined in 
this paragraph (b)(14).
    (15) When all the ingredients of a wheat flour are declared in an 
ingredient statement, the principal ingredient of the flour shall be 
declared by the name(s) specified in Sec. Sec. 137.105, 137.200, 
137.220 and 137.225 of this chapter, i.e., the first ingredient 
designated in the ingredient list of flour, or bromated flour, or 
enriched flour, or self-rising flour is ``flour'', ``white flour'', 
``wheat flour'', or ``plain flour''; the first ingredient designated in 
the ingredient list of durum flour is ``durum flour''; the first 
ingredient designated in the ingredient list of whole wheat flour, or 
bromated whole wheat flour is ``whole wheat flour'', ``graham flour'', 
or ``entire wheat flour''; and the first ingredient designated in the 
ingredient list of whole durum wheat flour is ``whole durum wheat 
flour''.
    (16) Ingredients that act as leavening agents in food may be 
declared in the ingredient statement by stating the specific common or 
usual name of each individual leavening agent in parentheses following 
the collective name ``leavening'', e.g., ``leavening (baking soda, 
monocalcium phosphate, and calcium carbonate)''. The listing of the 
common or usual name of each individual leavening agent in parentheses 
shall be in descending order of predominance: Except, That if the 
manufacturer is unable to adhere to a constant pattern of leavening 
agents in the product, the listing of individual

[[Page 17]]

leavening agents need not be in descending order of predominance. 
Leavening agents not present in the product may be listed if they are 
sometimes used in the product. Such ingredients shall be identified by 
words indicating that they may not be present, such as ``or'', ``and/
or'', ``contains one or more of the following:''.
    (17) Ingredients that act as yeast nutrients in foods may be 
declared in the ingredient statement by stating the specific common or 
usual name of each individual yeast nutrient in parentheses following 
the collective name ``yeast nutrients'', e.g., ``yeast nutrients 
(calcium sulfate and ammonium phosphate)''. The listing of the common or 
usual name of each individual yeast nutrient in parentheses shall be in 
descending order of predominance: Except, That if the manufacturer is 
unable to adhere to a constant pattern of yeast nutrients in the 
product, the listing of the common or usual names of individual yeast 
nutrients need not be in descending order of predominance. Yeast 
nutrients not present in the product may be listed if they are sometimes 
used in the product. Such ingredients shall be identified by words 
indicating that they may not be present, such as ``or'', ``and/or'', or 
``contains one or more of the following:''.
    (18) Ingredients that act as dough conditioners may be declared in 
the ingredient statement by stating the specific common or usual name of 
each individual dough conditioner in parentheses following the 
collective name ``dough conditioner'', e.g., ``dough conditioners (L-
cysteine, ammonium sulfate)''. The listing of the common or usual name 
of each dough conditioner in parentheses shall be in descending order of 
predominance: Except, That if the manufacturer is unable to adhere to a 
constant pattern of dough conditioners in the product, the listing of 
the common or usual names of individual dough conditioners need not be 
in descending order of predominance. Dough conditioners not present in 
the product may be listed if they are sometimes used in the product. 
Such ingredients shall be identified by words indicating that they may 
not be present, such as ``or'', ``and/or'', or ``contains one or more of 
the following:''.
    (19) Ingredients that act as firming agents in food (e.g., salts of 
calcium and other safe and suitable salts in canned vegetables) may be 
declared in the ingredient statement, in order of predominance 
appropriate for the total of all firming agents in the food, by stating 
the specific common or usual name of each individual firming agent in 
descending order of predominance in parentheses following the collective 
name ``firming agents''. If the manufacturer is unable to adhere to a 
constant pattern of firming agents in the food, the listing of the 
individual firming agents need not be in descending order of 
predominance. Firming agents not present in the product may be listed if 
they are sometimes used in the product. Such ingredients shall be 
identified by words indicating that they may not be present, such as 
``or'', ``and/or'', ``contains one or more of the following:''.
    (20) For purposes of ingredient labeling, the term sugar shall refer 
to sucrose, which is obtained from sugar cane or sugar beets in 
accordance with the provisions of Sec. 184.1854 of this chapter.
    (21) [Reserved]
    (22) Wax and resin ingredients on fresh produce when such produce is 
held for retail sale, or when held for other than retail sale by packers 
or repackers shall be declared collectively by the phrase ``coated with 
food-grade animal-based wax, to maintain freshness'' or the phrase 
``coated with food-grade vegetable-, petroleum-, beeswax-, and/or 
shellac-based wax or resin, to maintain freshness'' as appropriate. The 
terms ``food-grade'' and ``to maintain freshness'' are optional. The 
term lac-resin may be substituted for the term shellac.
    (23) When processed seafood products contain fish protein 
ingredients consisting primarily of the myofibrillar protein fraction 
from one or more fish species and the manufacturer is unable to adhere 
to a constant pattern of fish species in the fish protein ingredient, 
because of seasonal or other limitations of species availability, the 
common or usual name of each individual fish species need not be listed 
in descending order of predominance. Fish species not present in the 
fish protein

[[Page 18]]

ingredient may be listed if they are sometimes used in the product. Such 
ingredients must be identified by words indicating that they may not be 
present, such as ``or'', ``and/or'', or ``contains one or more of the 
following:'' Fish protein ingredients may be declared in the ingredient 
statement by stating the specific common or usual name of each fish 
species that may be present in parentheses following the collective name 
``fish protein'', e.g., ``fish protein (contains one or more of the 
following: Pollock, cod, and/or pacific whiting)''.
    (c) When water is added to reconstitute, completely or partially, an 
ingredient permitted by paragraph (b) of this section to be declared by 
a class name, the position of the ingredient class name in the 
ingredient statement shall be determined by the weight of the 
unreconstituted ingredient plus the weight of the quantity of water 
added to reconstitute that ingredient, up to the amount of water needed 
to reconstitute the ingredient to single strength. Any water added in 
excess of the amount of water needed to reconstitute the ingredient to 
single strength shall be declared as ``water'' in the ingredient 
statement.
    (d) When foods characterized on the label as ``nondairy'' contain a 
caseinate ingredient, the caseinate ingredient shall be followed by a 
parenthetical statement identifying its source. For example, if the 
manufacturer uses the term ``nondairy'' on a creamer that contains 
sodium caseinate, it shall include a parenthetical term such as ``a milk 
derivative'' after the listing of sodium caseinate in the ingredient 
list.
    (e) If the percentage of an ingredient is included in the statement 
of ingredients, it shall be shown in parentheses following the name of 
the ingredient and expressed in terms of percent by weight. Percentage 
declarations shall be expressed to the nearest 1 percent, except that 
where ingredients are present at levels of 2 percent or less, they may 
be grouped together and expressed in accordance with the quantifying 
guidance set forth in paragraph (a)(2) of this section.
    (f) Except as provided in Sec. 101.100, ingredients that must be 
declared on labeling because there is no label for the food, including 
foods that comply with standards of identity, shall be listed 
prominently and conspicuously by common or usual name in the manner 
prescribed by paragraph (b) of this section.
    (g) When present, the ingredient list on dietary supplement products 
shall be located immediately below the nutrition label, or, if there is 
insufficient space below the nutrition label, immediately contiguous and 
to the right of the nutrition label and shall be preceded by the word 
``Ingredients,'' unless some ingredients (i.e., sources) are identified 
within the nutrition label in accordance with Sec. 101.36(d), in which 
case the ingredients listed outside the nutrition label shall be in a 
list preceded by the words ``Other ingredients.'' Ingredients in dietary 
supplements that are not dietary ingredients or that do not contain 
dietary ingredients, such as excipients, fillers, artificial colors, 
artificial sweeteners, flavors, or binders, shall be included in the 
ingredient list.
    (h) The common or usual name of ingredients of dietary supplements 
that are botanicals (including fungi and algae) shall be consistent with 
the names standardized in Herbs of Commerce, 1992 edition, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from the American Herbal Products 
Association, 8484 Georgia Ave., suite 370, Silver Spring, MD 20910, 301-
588-1171, FAX 301-588-1174, e-mail: [email protected], or may be examined at 
the Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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. The listing of these names on the label 
shall be followed by statements of:
    (1) The part of the plant (e.g., root, leaves) from which the 
dietary ingredient is derived (e.g., ``Garlic bulb'' or ``Garlic 
(bulb)''), except that this designation is not required for algae. The 
name of the part of the plant shall be

[[Page 19]]

expressed in English (e.g., ``flower'' rather than ``flos'');
    (2) The Latin binomial name of the plant, in parentheses, except 
that this name is not required when it is available in the reference 
entitled: Herbs of Commerce for the common or usual name listed on the 
label, and, when required, the Latin binomial name may be listed before 
the part of the plant. Any name in Latin form shall be in accordance 
with internationally accepted rules on nomenclature, such as those found 
in the International Code of Botanical Nomenclature and shall include 
the designation of the author or authors who published the Latin name, 
when a positive identification cannot be made in its absence. The 
International Code of Botanical Nomenclature (Tokyo Code), 1994 edition, 
a publication of the International Association for Plant Taxonomy, is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of the International Code of Botanical Nomenclature may 
be obtained from Koeltz Scientific Books, D-61453 Konigstein, Germany, 
and University Bookstore, Southern Illinois University, Carbondale, IL 
62901-4422, 618-536-3321, FAX 618-453-5207, or may be examined at the 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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) On labels of single-ingredient dietary supplements that do not 
include an ingredient list, the identification of the Latin binomial 
name, when needed, and the part of the plant may be prominently placed 
on the principal display panel or information panel, or included in the 
nutrition label.

[42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978; 
43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, Apr. 
25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR 49847, Sept. 23, 1997; 62 FR 
64634, Dec. 8, 1997; 64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar. 30, 
2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 81 FR 
5590, Feb. 3, 2016]



Sec. 101.5  Food; name and place of business of manufacturer, packer,
or distributor.

    (a) The label of a food in packaged form shall specify conspicuously 
the name and place of business of the manufacturer, packer, or 
distributor.
    (b) The requirement for declaration of the name of the manufacturer, 
packer, or distributor shall be deemed to be satisfied, in the case of a 
corporation, only by the actual corporate name, which may be preceded or 
followed by the name of the particular division of the corporation. In 
the case of an individual, partnership, or association, the name under 
which the business is conducted shall be used.
    (c) Where the food is not manufactured by the person whose name 
appears on the label, the name shall be qualified by a phrase that 
reveals the connection such person has with such food; such as 
``Manufactured for ___'', ``Distributed by ___'', or any other wording 
that expresses the facts.
    (d) The statement of the place of business shall include the street 
address, city, State, and ZIP code; however, the street address may be 
omitted if it is shown in a current city directory or telephone 
directory. The requirement for inclusion of the ZIP code shall apply 
only to consumer commodity labels developed or revised after the 
effective date of this section. In the case of nonconsumer packages, the 
ZIP code shall appear either on the label or the labeling (including 
invoice).
    (e) If a person manufactures, packs, or distributes a food at a 
place other than his principal place of business, the label may state 
the principal place of business in lieu of the actual place where such 
food was manufactured or packed or is to be distributed, unless such 
statement would be misleading.



Sec. 101.7  Declaration of net quantity of contents.

    (a) The principal display panel of a food in package form shall bear 
a declaration of the net quantity of contents. This shall be expressed 
in the terms of weight, measure, numerical count, or a combination of 
numerical count and weight or measure. The statement shall be in terms 
of fluid

[[Page 20]]

measure if the food is liquid, or in terms of weight if the food is 
solid, semisolid, or viscous, or a mixture of solid and liquid; except 
that such statement may be in terms of dry measure if the food is a 
fresh fruit, fresh vegetable, or other dry commodity that is customarily 
sold by dry measure. If there is a firmly established general consumer 
usage and trade custom of declaring the contents of a liquid by weight, 
or a solid, semisolid, or viscous product by fluid measure, it may be 
used. Whenever the Commissioner determines that an existing practice of 
declaring net quantity of contents by weight, measure, numerical count, 
or a combination in the case of a specific packaged food does not 
facilitate value comparisons by consumers and offers opportunity for 
consumer confusion, he will by regulation designate the appropriate term 
or terms to be used for such commodity.
    (b)(1) Statements of weight shall be in terms of avoirdupois pound 
and ounce.
    (2) Statements of fluid measure shall be in terms of the U.S. gallon 
of 231 cubic inches and quart, pint, and fluid ounce subdivisions 
thereof, and shall:
    (i) In the case of frozen food that is sold and consumed in a frozen 
state, express the volume at the frozen temperature.
    (ii) In the case of refrigerated food that is sold in the 
refrigerated state, express the volume at 40 [deg]F (4 [deg]C).
    (iii) In the case of other foods, express the volume at 68 [deg]F 
(20 [deg]C).
    (3) Statements of dry measure shall be in terms of the U.S. bushel 
of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions 
thereof.
    (c) When the declaration of quantity of contents by numerical count 
does not give adequate information as to the quantity of food in the 
package, it shall be combined with such statement of weight, measure, or 
size of the individual units of the foods as will provide such 
information.
    (d) The declaration may contain common or decimal fractions. A 
common fraction shall be in terms of halves, quarters, eighths, 
sixteenths, or thirty-seconds; except that if there exists a firmly 
established general consumer usage and trade custom of employing 
different common fractions in the net quantity declaration of a 
particular commodity, they may be employed. A common fraction shall be 
reduced to its lowest terms; a decimal fraction shall not be carried out 
to more than two places. A statement that includes small fractions of an 
ounce shall be deemed to permit smaller variations than one which does 
not include such fractions.
    (e) The declaration shall be located on the principal display panel 
of the label, and with respect to packages bearing alternate principal 
panels it shall be duplicated on each principal display panel.
    (f) The declaration shall appear as a distinct item on the principal 
display panel, shall be separated (by at least a space equal to the 
height of the lettering used in the declaration) from other printed 
label information appearing above or below the declaration and (by at 
least a space 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 declaration. It 
shall not include any term qualifying a unit of weight, measure, or 
count (such as ``jumbo quart'' and ``full gallon'') that tends to 
exaggerate the amount of the food in the container. It shall be placed 
on the principal display panel within the bottom 30 percent of the area 
of the label panel in lines generally parallel to the base on which the 
package rests as it is designed to be displayed: 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 declaration of net quantity 
of contents meets the other requirements of this part.
    (g) The declaration shall accurately reveal the quantity of food in 
the package exclusive of wrappers and other material packed therewith: 
Provided, That in the case of foods packed in containers designed to 
deliver the food under pressure, the declaration shall state the net 
quantity of the contents that will be expelled when the instructions for 
use as shown on the container

[[Page 21]]

are followed. The propellant is included in the net quantity 
declaration.
    (h) The declaration shall appear in conspicuous and easily legible 
boldface print or type in distinct contrast (by typography, layout, 
color, embossing, or molding) to other matter on the package; except 
that a declaration of net quantity blown, embossed, or molded on a glass 
or plastic surface is permissible when all label information is so 
formed on the surface. Requirements of conspicuousness and legibility 
shall include the specifications that:
    (1) The ratio of height to width (of the letter) shall not exceed a 
differential of 3 units to 1 unit (no more than 3 times as high as it is 
wide).
    (2) Letter 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.
    (3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
    (i) The declaration shall be in letters and numerals in a 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:
    (1) 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.
    (2) 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.
    (3) 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.
    (4) Not less than one-fourth inch in height on packages the 
principal display panel of which has an area of more than 100 square 
inches, except not less than \1/2\ inch in height if the area is more 
than 400 square inches.


Where the declaration is blown, embossed, or molded on a glass or 
plastic surface rather than by printing, typing, or coloring, the 
lettering sizes specified in paragraphs (h)(1) through (4) of this 
section shall be increased by one-sixteenth of an inch.
    (j) On packages containing less than 4 pounds or 1 gallon and 
labeled in terms of weight or fluid measure:
    (1) The declaration shall be expressed both in ounces, with 
identification by weight or by liquid measure and, if applicable (1 
pound or 1 pint or more) followed in parentheses by a declaration in 
pounds for weight units, with any remainder in terms of ounces or common 
or decimal fractions of the pound (see examples set forth in paragraphs 
(m) (1) and (2) of this section), or in the case of liquid measure, in 
the largest whole units (quarts, quarts and pints, or pints, as 
appropriate) with any remainder in terms of fluid ounces or common or 
decimal fractions of the pint or quart (see examples in paragraphs (m) 
(3) and (4) of this section).
    (2) If the net quantity of contents declaration appears on a random 
package, that is a package which is one of a lot, shipment, or delivery 
of packages of the same consumer commodity with varying weights and with 
no fixed weight pattern, it may, when the net weight exceeds 1 pound, be 
expressed in terms of pounds and decimal fractions of the pound carried 
out to not more than two decimal places. When the net weight does not 
exceed 1 pound, the declaration on the random package may be in decimal 
fractions of the pound in lieu of ounces (see example in paragraph 
(m)(5) of this section).
    (3) The declaration may appear in more than one line. The term ``net 
weight'' shall be used when stating the net quantity of contents in 
terms of weight. Use of the terms ``net'' or ``net contents'' in terms 
of fluid measure or numerical count is optional. It is sufficient to 
distinguish avoirdupois ounce from fluid ounce through association of 
terms; for example, ``Net wt. 6 oz'' or ``6 oz Net wt.'' and ``6 fl oz'' 
or ``Net contents 6 fl oz''.
    (k) On packages containing 4 pounds or 1 gallon or more and labeled 
in terms of weight or fluid measure, the declaration shall be expressed 
in pounds for weight units with any remainder in terms of ounces or 
common or decimal fraction of the pound, or in the case of fluid 
measure, it shall be

[[Page 22]]

expressed in the largest whole unit (gallons followed by common or 
decimal fraction of a gallon or by the next smaller whole unit or units 
(quarts, or quarts and pints)) with any remainder in terms of fluid 
ounces or common or decimal fractions of the pint or quart (see 
paragraph (m)(6) of this section).
    (l) [Reserved]
    (m) Examples:
    (1) A declaration of 1\1/2\ pounds 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 lb)''.
    (2) A declaration of three-fourths pound avoirdupois weight shall be 
expressed as ``Net Wt. 12 oz''.
    (3) A declaration of 1 quart liquid measure shall be expressed as 
``Net 32 fl oz (1 qt)''.
    (4) A declaration of 1\3/4\ quarts liquid measure shall be expressed 
as ``Net contents 56 fluid ounces (1 quart 1\1/2\ pints)'' or as ``Net 
56 fluid oz (1 qt 1 pt 8 oz)'', but not in terms of quart and ounce such 
as ``Net 56 fluid oz (1 quart 24 ounces)''.
    (5) On a random package, declaration of three-fourths pound 
avoirdupois may be expressed as ``Net Wt. .75 lb''.
    (6) A declaration of 2\1/2\ gallons liquid measure shall be 
expressed as ``Net contents 2\1/2\ gallons,'' ``Net contents 2.5 
gallons,'' or ``Net contents 2 gallons 2 quarts'' and not as ``2 gallons 
4 pints''.
    (n) For quantities, the following abbreviations and none other may 
be employed (periods and plural forms are optional):

weight wt
ounce oz
pound lb
gallon gal
pint pt
quart qt
fluid fl

    (o) Nothing in this section shall prohibit supplemental statements 
at locations other than the principal display panel(s) describing in 
nondeceptive terms the net quantity of contents; Provided, that such 
supplemental statements of net quantity of contents shall not include 
any term qualifying a unit of weight, measure, or count that tends to 
exaggerate the amount of the food contained in the package; for example, 
``jumbo quart'' and ``full gallon''. Dual or combination declarations of 
net quantity of contents as provided for in paragraphs (a), (c), and (j) 
of this section (for example, a combination of net weight plus numerical 
count, net contents plus dilution directions of a concentrate, etc.) are 
not regarded as supplemental net quantity statements and may be located 
on the principal display panel.
    (p) A separate statement of the net quantity of contents in terms of 
the metric system is not regarded as a supplemental statement and an 
accurate statement of the net quantity of contents in terms of the 
metric system of weight or measure may also appear on the principal 
display panel or on other panels.
    (q) The declaration of net quantity of contents shall express an 
accurate statement of the quantity of contents of the package. 
Reasonable variations caused by loss or gain of moisture during the 
course of good distribution practice or by unavoidable deviations in 
good manufacturing practice will be recognized. Variations from stated 
quantity of contents shall not be unreasonably large.
    (r) The declaration of net quantity of contents on pickles and 
pickle products, including relishes but excluding one or two whole 
pickles in clear plastic bags which may be declared by count, shall be 
expressed in terms of the U.S. gallon of 231 cubic inches and quart, 
pint, and fluid ounce subdivisions thereof.
    (s) 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 required by paragraph (j)(1) of this section. A 
multiunit retail package may thus be properly labeled: ``6-16 oz 
bottles--(96 fl oz)'' or ``3-16 oz cans--(net wt. 48 oz)''. For the 
purposes of this section, ``multiunit retail package'' means a package 
containing two or more individually packaged units of the identical 
commodity and in the same quantity, intended to be sold as part of the 
multiunit retail package

[[Page 23]]

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 or prevent examination 
of the labeling on each of the individual units are not subject to this 
paragraph if the labeling of each individual unit complies with the 
requirements of paragraphs (f) and (i) of this section. The provisions 
of this section do not apply to that butter or margarine covered by the 
exemptions in Sec. 1.24(a) (10) and (11) of this chapter.
    (t) Where the declaration of net quantity of contents is in terms of 
net weight and/or drained weight or volume and does not accurately 
reflect the actual quantity of the contents or the product falls below 
the applicable standard of fill of container because of equipment 
malfunction or otherwise unintentional product variation, and the label 
conforms in all other respects to the requirements of this chapter 
(except the requirement that food falling below the applicable standard 
of fill of container shall bear the general statement of substandard 
fill specified in Sec. 130.14(b) of this chapter), the mislabeled food 
product, including any food product that fails to bear the general 
statement of substandard fill specified in Sec. 130.14(b) of this 
chapter, may be sold by the manufacturer or processor directly to 
institutions operated by Federal, State or local governments (schools, 
prisons, hospitals, etc.): Provided, That:
    (1) The purchaser shall sign a statement at the time of sale stating 
that he is aware that the product is mislabeled to include 
acknowledgment of the nature and extent of the mislabeling, (e.g., 
``Actual net weight may be as low as _% below labeled quantity'') and 
that any subsequent distribution by him of said product except for his 
own institutional use is unlawful. This statement shall be kept on file 
at the principal place of business of the manufacturer or processor for 
2 years subsequent to the date of shipment of the product and shall be 
available to the Food and Drug Administration upon request.
    (2) The product shall be labeled on the outside of its shipping 
container with the statement(s):
    (i) When the variation concerns net weight and/or drained weight or 
volume, ``Product Mislabeled. Actual net weight (drained weight or 
volume where appropriate) may be as low as _% below labeled quantity. 
This Product Not for Retail Distribution'', the blank to be filled in 
with the maximum percentage variance between the labeled and actual 
weight or volume of contents of the individual packages in the shipping 
container, and
    (ii) When the variation is in regard to a fill of container 
standard, ``Product Mislabeled. Actual fill may be as low as _% below 
standard of fill. This Product Not for Retail Distribution''.
    (3) The statements required by paragraphs (t)(2) (i) and (ii) of 
this section, which may be consolidated where appropriate, shall appear 
prominently and conspicuously as compared to other printed matter on the 
shipping container and in boldface print or type on a clear, contrasting 
background in order to render them likely to be read and understood by 
the purchaser under ordinary conditions of purchase.

[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977. 
Redesignated at 81 FR 59131, Aug. 29, 2016]



Sec. 101.8  Vending machines.

    (a) Definitions. The definitions of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this section. In addition, for the purposes of this section:
    Authorized official of a vending machine operator means an owner, 
operator, agent in charge, or any other person authorized by a vending 
machine operator who is not otherwise subject to section 
403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343(q)(5)(H)(viii)), to register the vending machine operator 
with the Food and Drug Administration (``FDA'') for purposes of 
paragraph (d) of this section.
    Vending machine means a self-service machine that, upon insertion of 
a coin, paper currency, token, card, or key, or by optional manual 
operation, dispenses servings of food in bulk or in

[[Page 24]]

packages, or prepared by the machine, without the necessity of 
replenishing the machine between each vending operation.
    Vending machine operator means a person(s) or entity that controls 
or directs the function of the vending machine, including deciding which 
articles of food are sold from the machine or the placement of the 
articles of food within the vending machine, and is compensated for the 
control or direction of the function of the vending machine.
    (b) Articles of food not covered. Articles of food sold from a 
vending machine are not covered vending machine food if:
    (1) The prospective purchaser can view:
    (i) The calories, serving size, and servings per container listed in 
the Nutrition Facts label on the vending machine food without any 
obstruction. The Nutrition Facts label must be in the format required in 
Sec. 101.9(c) and (d). The Nutrition Facts label must be in a size that 
permits the prospective purchaser to be able to easily read the 
nutrition information contained in the Nutrition Facts label on the 
article of food in the vending machine. Smaller formats allowed for 
Nutrition Facts for certain food labeling under FDA regulation at Sec. 
101.9 are not considered to be a size that a prospective purchaser is 
able to easily read; or
    (ii) The calories, serving size, and servings per container listed 
in a reproduction of the Nutrition Facts label on the vending machine 
food, provided that the reproduction is a reproduction of an actual 
Nutrition Facts label that complies with Sec. 101.9 for a vending 
machine food, is presented in a size that permits the prospective 
purchaser to be able to easily read the nutrition information, and the 
calories, serving size, and servings per container are displayed by the 
vending machine before the prospective purchaser makes his or her 
purchase; or
    (2) The prospective purchaser can otherwise view visible nutrition 
information, including, at a minimum, the total number of calories for 
the article of food as sold at the point of purchase. This visible 
nutrition information must appear on the food label itself. The visible 
nutrition information must be clear and conspicuous and able to be 
easily read on the article of food while in the vending machine, in a 
type size at least 150 percent of the size required by Sec. 101.7(i) 
for the net quantity of contents declaration on the front of the 
package, and with sufficient color and contrasting background to other 
print on the label to permit the prospective purchaser to clearly 
distinguish the information.
    (c) Requirements for calorie labeling for certain food sold from 
vending machines--(1) Applicability; covered vending machine food. For 
the purposes of this section, the term ``covered vending machine food'' 
means an article of food that is:
    (i) Sold from a vending machine that does not permit the prospective 
purchaser to examine the Nutrition Facts label prior to purchase as 
provided in paragraph (b)(1) of this section or otherwise provide 
visible nutrition information at the point of purchase as provided in 
paragraph (b)(2) of this section; and
    (ii) Sold from a vending machine that:
    (A) Is operated by a person engaged in the business of owning or 
operating 20 or more vending machines; or
    (B) Is operated by a vending machine operator that has voluntarily 
elected to be subject to the requirements of this section by registering 
with FDA under paragraph (d) of this section.
    (2) Calorie declaration. (i) The number of calories for a covered 
vending machine food must be declared in the following manner:
    (A) 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.
    (B) The term ``Calories'' or ``Cal'' must appear adjacent to the 
caloric content value for each food in the vending machine.
    (C) The calorie declaration for a packaged food must include the 
total calories present in the packaged food, regardless of whether the 
packaged food contains a single serving or multiple servings. The 
vending machine

[[Page 25]]

operator may voluntarily disclose calories per serving in addition to 
the total calories for the food.
    (D) If a covered vending machine food is one where the prospective 
purchaser selects among options to produce a final vended product (e.g., 
vended coffee, hot chocolate or tea with options for added sugar, sugar 
substitute, milk, and cream), calories must be declared per option or 
for the final vended products.
    (ii) Calorie declarations for covered vending machine food must be 
clear and conspicuous and placed prominently in the following manner:
    (A) The calorie declarations may be placed on a sign in close 
proximity to the article of food or selection button, i.e., in, on, or 
adjacent to the vending machine, but not necessarily attached to the 
vending machine, so long as the calorie declaration is visible at the 
same time as the food, its name, price, selection button, or selection 
number is visible. The sign must give calorie declarations for those 
articles of food that are sold from that particular vending machine.
    (B) When the calorie declaration is in or on the vending machine, 
the calorie declaration must be in a type size no smaller than the name 
of the food on the machine (not the label), selection number, or price 
of the food as displayed on the vending machine, whichever is smallest, 
with the same prominence, i.e., the same color, or in a color at least 
as conspicuous, as the color of the name, if applicable, or price of the 
food or selection number, and the same contrasting background, or a 
background at least as contrasting as the background used for the item 
it is in closest proximity to, i.e., name, selection number, or price of 
the food item as displayed on the machine.
    (C) When the calorie declaration is on a sign adjacent to the 
vending machine, the calorie declaration must be in a type size large 
enough to render it likely to be read and understood by the prospective 
purchaser under customary conditions of purchase and use, and in a type 
that is all black or one color on a white or other neutral background 
that contrasts with the type color.
    (D) Where the vending machine only displays a picture or other 
representation or name of the food item, the calorie declaration must be 
in close proximity to the picture or other representation or name, or in 
close proximity to the selection button.
    (E) For electronic vending machines (e.g., machines with digital or 
electronic or liquid crystal display (LCD) displays), the calorie 
declaration must be displayed before the prospective purchaser makes his 
or her purchase.
    (F) For vending machines with few choices, e.g., popcorn, the 
calorie declaration may appear on the face of the machine so long as the 
declaration is prominent, not crowded by other labeling on the machine, 
and the type size is no smaller than the name of the food on the machine 
(not the label), selection number, or price of the food as displayed on 
the vending machine, whichever is smallest.
    (d) Voluntary provision of calorie labeling for foods sold from 
vending machines--(1) Applicability. A vending machine operator that is 
not subject to the requirements of section 403(q)(5)(H)(viii) of the 
Federal Food, Drug, and Cosmetic Act may, through its authorized 
official, voluntarily register with FDA to be subject to the 
requirements established in paragraph (c)(2) of this section. An 
authorized official of a vending machine operator that voluntarily 
registers cannot be subject to any State or local nutrition labeling 
requirements that are not identical to the requirements in 403(q)(5)(H) 
of the Federal Food, Drug, and Cosmetic Act.
    (2) Who may register? A vending machine operator that is not 
otherwise subject to the requirements of section 403(q)(5)(H) of the 
Federal Food, Drug, and Cosmetic Act may register with FDA.
    (3) What information is required? The vending machine operator must 
provide FDA with the following information:
    (i) The contact information (including name, address, phone number, 
email address), for the vending machine operator;
    (ii) The address of the location of each vending machine owned or 
operated by the vending machine operator that is being registered;

[[Page 26]]

    (iii) Preferred mailing address (if different from the vending 
machine operator address), for purposes of receiving correspondence; and
    (iv) Certification that the information submitted is true and 
accurate, that the person or firm submitting it is authorized to do so, 
and that each registered vending machine will be subject to the 
requirements of this section.
    (v) Information should be submitted by email by typing complete 
information into the portable document format (PDF) form, saving it on 
the registrant's computer, and sending it by email to 
[email protected]. If email is not available, the 
registrant can either fill in the PDF form and print it out (or print 
out the blank PDF and fill in the information by hand or typewriter), 
and either fax the completed form to 301-436-2804 or mail it to FDA, 
CFSAN Menu and Vending Machine Labeling Registration, White Oak Building 
22, rm. 0209, 10903 New Hampshire Ave., Silver Spring, MD 20993.
    (vi) Authorized officials of a vending machine operator who elect to 
be subject to the Federal requirements can register by visiting http://
www.fda.gov/food/ingredientspackaginglabeling/ labelingnutrition/
ucm217762.htm. FDA has created a form that contains fields requesting 
the information in paragraph (d) of this section and made the form 
available at this Web site. Registrants must use this form to ensure 
that complete information is submitted.
    (vii) To keep the establishment's registration active, the 
authorized official of the vending machine operator must register every 
other year within 60 days prior to the expiration of the vending machine 
operator's current registration with FDA. Registration will 
automatically expire if not renewed.
    (e) Vending machine operator contact information. (1) A vending 
machine operator that is subject to section 403(q)(5)(H)(viii) of the 
Federal Food, Drug, and Cosmetic Act or a vending machine operator that 
voluntarily registers to be subject to the requirements under paragraph 
(d) of this section must provide its contact information for vending 
machines selling covered vending machine food. The contact information 
must list the vending machine operator's name, telephone number, and 
mailing address or email address.
    (2) The contact information must be readable and may be placed on 
the face of the vending machine, or otherwise must be placed with the 
calorie declarations as described in paragraph (c)(2)(ii) of this 
section (i.e., on the sign in, on, or adjacent to the vending machine).
    (f) Signatures. Signatures obtained under paragraph (d) of this 
section that meet the definition of electronic signatures in Sec. 
11.3(b)(7) of this chapter are exempt from the requirements of part 11 
of this chapter.

[79 FR 71291, Dec. 1, 2014, as amended at 84 FR 57610, Oct. 28, 2019]



Sec. 101.9  Nutrition labeling of food.

    (a) Nutrition information relating to food shall be provided for all 
products intended for human consumption and offered for sale unless an 
exemption is provided for the product in paragraph (j) of this section.
    (1) When food is in package form, the required nutrition labeling 
information shall appear on the label in the format specified in this 
section.
    (2) When food is not in package form, the required nutrition 
labeling information shall be displayed clearly at the point of purchase 
(e.g., on a counter card, sign, tag affixed to the product, or some 
other appropriate device). Alternatively, the required information may 
be placed in a booklet, looseleaf binder, or other appropriate format 
that is available at the point of purchase.
    (3) Solicitation of requests for nutrition information by a 
statement ``For nutrition information write to ___________ '' on the 
label or in the labeling or advertising for a food, or providing such 
information in a direct written reply to a solicited or unsolicited 
request, does not subject the label or the labeling of a food exempted 
under paragraph (j) of this section to the requirements of this section 
if the reply to the request conforms to the requirements of this 
section.

[[Page 27]]

    (4) If any vitamin or mineral is added to a food so that a single 
serving provides 50 percent or more of the Reference Daily Intake (RDI) 
for the age group for which the product is intended, as specified in 
paragraph (c)(8)(iv) of this section, of any one of the added vitamins 
or minerals, unless such addition is permitted or required in other 
regulations, e.g., a standard of identity or nutritional quality 
guideline, or is otherwise exempted by the Commissioner, the food shall 
be considered a food for special dietary use within the meaning of Sec. 
105.3(a)(1)(iii) of this chapter.
    (b) Except as provided in Sec. 101.9(h)(3), all nutrient and food 
component quantities shall be declared in relation to a serving as 
defined in this section.
    (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 food. When the food 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)(3), (b)(4), and (b)(6) 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 * 
* * *'' (reference amounts) that appear in Sec. 101.12(b) using the 
procedures described below. 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. 
101.12(b) shall be used for purposes of evaluating whether weight-
control products that are available only through a weight-control 
program qualify for nutrient content claims or health claims.
    (i) For products in discrete units (e.g., muffins, sliced products, 
such as sliced bread, or individually packaged products within a 
multiserving 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., pancakes and syrup), the serving size shall be declared as 
follows:
    (A) 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;
    (B) 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;
    (C) If a unit weighs 67 percent or more, but less than 200 percent 
of the reference amount, the serving size shall be one unit;
    (D) If a unit weighs at least 200 percent and up to and including 
300 percent of the applicable reference amount, the serving size shall 
be the amount that approximates the reference amount. In addition to 
providing a column within the Nutrition Facts label that lists the 
quantitative amounts and percent Daily Values per serving size, the 
manufacturer shall provide a column within the Nutrition Facts label 
that lists the quantitative amounts and percent Daily Values per 
individual unit. The first column would be based on the serving size for 
the product and the second column would be based on the individual unit. 
The exemptions in paragraphs (b)(12)(i)(A), (B), and (C) of this section 
apply to this provision.
    (E) The serving size for maraschino cherries shall be expressed as 1 
cherry with the parenthetical metric measure equal to the average weight 
of a medium size cherry.
    (F) The serving size for products that naturally vary in size (e.g., 
pickles, shellfish, whole fish, and fillet of fish)

[[Page 28]]

may be the amount in ounces that most closely approximates the reference 
amount for the product category. Manufacturers shall adhere to the 
requirements in paragraph (b)(5)(vi) of this section for expressing the 
serving size in ounces.
    (G) 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., pancakes and syrup), 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 determined in Sec. 101.12(f).
    (H) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in Sec. 101.9 (that is, are 
labeled appropriately for individual sale as single-serving containers), 
the serving size shall be 1 unit.
    (ii) For products in large discrete units that are usually divided 
for consumption (e.g., cake, pie, pizza, melon, cabbage), 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., 
cake mix, 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 (e.g., prepared cake packaged with a can 
of frosting), the serving size shall be the fractional slice of the 
ready-to-eat product (e.g., \1/12\ cake, \1/8\ pie, \1/4\ pizza, \1/4\ 
melon, \1/6\ cabbage) that most closely approximates the reference 
amount for the product category, and may be the fraction of the package 
used to make the reference amount for the unprepared product determined 
in Sec. 101.12(c) or the fraction of the large discrete unit 
represented as the main ingredient plus proportioned minor ingredients 
used to make the reference amount for the combined product determined in 
Sec. 101.12(f). 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.
    (iii) For nondiscrete bulk products (e.g., breakfast cereal, flour, 
sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese 
kits), 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., peanut butter and jelly), 
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. 101.12(f).
    (3) The serving size for meal products and main dish products as 
defined in Sec. 101.13 (l) and (m) that comes in single-serving 
containers as defined in paragraph (b)(6) of this section shall be the 
entire content (edible portion only) of the package. Serving size for 
meal products and main dish products in multiserving containers shall be 
based on the reference amount applicable to the product in Sec. 
101.12(b) if the product is listed in Sec. 101.12(b). Serving size for 
meal products and main dish products in multiserving containers that are 
not listed in Sec. 101.12(b) shall be based on the reference amount 
according to Sec. 101.12(f).
    (4) A variety pack, such as a package containing several varieties 
of single-serving units as defined in paragraph (b)(2)(i) of this 
section, and a product having two or more compartments with each 
compartment containing a different food, shall provide nutrition 
information for each variety or food per serving size that is derived 
from the reference amount in Sec. 101.12(b) applicable for each variety 
or food and the procedures to convert the reference amount to serving 
size in paragraph (b)(2) of this section.
    (5) 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), fluid ounce (fl oz), or other 
common household equipment used to package food products (e.g., jar,

[[Page 29]]

tray). In expressing serving size in household measures, except as 
specified in paragraphs (b)(5)(iv), (b)(5)(v), (b)(5)(vi), and 
(b)(5)(vii) of this section, the following rules shall be used:
    (i) Cups, tablespoons, or teaspoons shall be used wherever possible 
and appropriate except for beverages. For beverages, a manufacturer may 
use fluid ounces. Cups shall be expressed in 1/4- or 1/3-cup increments. 
Tablespoons shall be expressed as 1, 1 1/3, 1 1/2, 1 2/3, 2, or 3 
tablespoons. Teaspoons shall be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 
teaspoons.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If paragraphs (b)(5)(i) and (b)(5)(ii) of this section are not 
applicable, ounces may be used with an appropriate visual unit of 
measure such as a dimension of a piece, e.g., 1 oz (28 g/about \1/2\ 
pickle). Ounce measurements shall be expressed in 0.5 oz increments most 
closely approximating the reference amount.
    (iv) A description of the individual container or package shall be 
used for single serving containers and for individually packaged 
products within multiserving containers (e.g., can, box, package). A 
description of the individual unit shall be used for other products in 
discrete units (e.g., piece, slice, cracker, bar).
    (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., cake mix, pizza kit), the fraction or portion of the 
package may be used.
    (vi) Ounces with an appropriate visual unit of measure, as described 
in paragraph (b)(5)(iii) of this section, may be used for products that 
naturally vary in size as provided for in paragraph (b)(2)(i)(F) of this 
section.
    (vii) As provided for in Sec. 101.9(h)(1), for products that 
consist of two or more distinct ingredients or components packaged and 
presented to be consumed together (e.g. dry macaroni and cheese mix, 
cake and muffin mixes with separate ingredient packages, pancakes and 
syrup), 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)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this 
section, or alternatively in ounces with an appropriate visual unit of 
measure, as described in paragraph (b)(5)(iii) of this section (e.g., 
declared as separate components: ``3 oz dry macaroni (84 g/about \2/3\ 
cup)'' and ``1 oz dry cheese mix (28 g/about 2 tbsp);'' declared as a 
composite value: ``4 oz (112 g/about \2/3\ cup macaroni and 2 tbsp dry 
cheese mix)'').
    (viii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, 1 fl oz 
means 30 mL, and 1 oz in weight means 28 g.
    (ix) When a serving size, determined from the reference amount in 
Sec. 101.12(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.
    (6) A product that is packaged and sold individually that contains 
less than 200 percent of the applicable reference amount must be 
considered to be a single-serving container, and the entire content of 
the product must be labeled as one serving. In addition to providing a 
column within the Nutrition Facts label that lists the quantitative 
amounts and percent Daily Values per serving, for a product that is 
packaged and sold individually that contains more than 150 percent and 
less than 200 percent of the applicable reference amount, the Nutrition 
Facts label may voluntarily provide, to the left of the column that 
provides nutrition information per container (i.e., per serving), an 
additional column that lists the quantitative amounts and percent Daily 
Values per common household measure that most closely approximates the 
reference amount.
    (7) 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)(6) 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

[[Page 30]]

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 Sec. 101.9(b)(9). 
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 and fluid 
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 bread. 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, oz for ounce, and fl oz for 
fluid ounce.
    (v) For products that only require the addition of water or another 
ingredient that contains insignificant amounts of nutrients in the 
amount added and that are prepared in such a way that there are no 
significant changes to the nutrient profile, the amount of the finished 
product may be declared in parentheses at the end of the serving size 
declaration (e.g., \1/2\ cup (120 mL) concentrated soup (makes 1 cup 
prepared)).
    (vi) To promote uniformity in label serving sizes in household 
measures declared by different manufacturers, FDA has provided a 
guidance document entitled, ``Guidelines for Determining the Gram Weight 
of the Household Measure.'' The guidance document can be obtained from 
the Office of Nutritional Products, Labeling and Dietary Supplements 
(HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740.
    (8) 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., maraschino cherries, pickles), the 
manufacturer may state the typical number of servings per container 
(e.g., usually 5 servings).
    (iii) For random weight products, manufacturers may declare 
``varied'' for the number of servings per container provided the 
nutrition information is based on the reference amount expressed in the 
appropriate household measure based on the hierarchy described in 
paragraph (b)(5) of this section. Random weight products are foods such 
as cheeses that are sold as random weights that vary in size, such that 
the net contents for different containers would vary. The manufacturer 
may provide the typical number of servings in parentheses following the 
``varied'' statement.
    (iv) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in Sec. 101.9 (that is, 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 
multiserving units, the number of servings shall be determined by 
multiplying the number

[[Page 31]]

of individual multiserving units in the total package by the number of 
servings in each individual unit.
    (9) The declaration of nutrient and food component content shall be 
on the basis of food as packaged or purchased with the exception of raw 
fish covered under Sec. 101.42 (see 101.44), packaged single-ingredient 
products that consist of fish or game meat as provided for in paragraph 
(j)(11) of this section, and of foods that are packed or canned in 
water, brine, or oil but whose liquid packing medium is not customarily 
consumed (e.g., canned fish, maraschino cherries, pickled fruits, and 
pickled vegetables). Declaration of nutrient and food component content 
of raw fish shall follow the provisions in Sec. 101.45. Declaration of 
the nutrient and food component content of foods that are packed in 
liquid which is not customarily consumed shall be based on the drained 
solids.
    (10) Another column of figures may be used to declare the nutrient 
and food component information:
    (i) Per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as 
packaged or purchased;
    (ii) Per one unit if the serving size of a product in discrete units 
is more than 1 unit.
    (iii) Per cup popped for popcorn in a multiserving container.
    (11) If a product is promoted on the label, labeling, or advertising 
for a use that differs in quantity by twofold or greater from the use 
upon which the reference amount in Sec. 101.12(b) was based (e.g., 
liquid cream substitutes promoted for use with breakfast cereals), the 
manufacturer shall provide a second column of nutrition information 
based on the amount customarily consumed in the promoted use, in 
addition to the nutrition information per serving derived from the 
reference amount in Sec. 101.12(b), except that nondiscrete bulk 
products that are used primarily as ingredients (e.g., flour, 
sweeteners, shortenings, oils), or traditionally used for multipurposes 
(e.g., eggs, butter, margarine), and multipurpose baking mixes are 
exempt from this requirement.
    (12)(i) Products that are packaged and sold individually and that 
contain at least 200 percent and up to and including 300 percent of the 
applicable reference amount must provide an additional column within the 
Nutrition Facts label that lists the quantitative amounts and percent 
Daily Values for the entire package, as well as a column listing the 
quantitative amounts and percent Daily Values for a serving that is less 
than the entire package (i.e., the serving size derived from the 
reference amount). The first column would be based on the serving size 
for the product and the second column would be based on the entire 
contents of the package.
    (A) This provision does not apply to products that meet the 
requirements to use the tabular format in paragraph (j)(13)(ii)(A)(1) of 
this section or to products that meet the requirements to use the linear 
format in paragraph (j)(13)(ii)(A)(2) of this section.
    (B) This provision does not apply to raw fruits, vegetables, and 
seafood for which voluntary nutrition labeling is provided in the 
product labeling or advertising or when claims are made about the 
product.
    (C) This provision does not apply to products that require further 
preparation and provide an additional column of nutrition information 
under paragraph (e) of this section, to products that are commonly 
consumed in combination with another food and provide an additional 
column of nutrition information under paragraph (e) of this section, to 
products that provide an additional column of nutrition information for 
two or more groups for which RDIs are established (e.g., both infants 
and children less than 4 years of age), to popcorn products that provide 
an additional column of nutrition information per 1 cup popped popcorn, 
or to varied-weight products covered under paragraph (b)(8)(iii) of this 
section.
    (ii) When a nutrient content claim or health claim is made on the 
label of a product that uses a dual column as required in paragraph 
(b)(2)(i)(D) or (b)(12)(i) of this section, the claim must be followed 
by a statement that sets forth the basis on which the claim is made, 
except that the statement is not required for products when the nutrient 
that is the subject of the claim meets the criteria for the claim based

[[Page 32]]

on the reference amount for the product and the entire container or the 
unit amount. When a nutrient content claim is made, the statement must 
express that the claim refers to the amount of the nutrient per serving 
(e.g., ``good source of calcium per serving'' or ``per X [insert 
unit]_serving'') or per reference amount (e.g., ``good source of calcium 
per [insert reference amount (e.g., per 8 ounces)]), as required based 
on Sec. 101.12(g). When a health claim is made, the statement shall be 
``A serving of _ounces of this product conforms to such a diet.''
    (c) The declaration of nutrition information on the label and in 
labeling of a food 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 paragraphs (f) or (j) of this section, 
nutrient information shall be presented using the nutrient names 
specified and in the following order in the formats specified in 
paragraphs (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 parentheses 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, USDA Handbook No. 74 (slightly revised, 1973),
    (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 Handbook No. 74 (slightly revised, 1973) pp. 9-11;
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate (less the amount of non-digestible 
carbohydrates and sugar alcohols), and total fat, respectively, as 
described in USDA Handbook No. 74 (slightly revised, 1973) pp. 9-11. A 
general factor of 2 calories per gram for soluble non-digestible 
carbohydrates shall be used. The general factors for caloric value of 
sugar alcohols provided in paragraph (c)(1)(i)(F) of this section shall 
be used;
    (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 this chapter, or by other means, as 
appropriate;
    (E) Using bomb calorimetry data subtracting 1.25 calories per gram 
protein to correct for incomplete digestibility, as described in USDA 
Handbook No. 74 (slightly revised, 1973) p. 10; or
    (F) Using the following general factors for caloric value of sugar 
alcohols: Isomalt--2.0 calories per gram, lactitol--2.0 calories per 
gram, xylitol--2.4 calories per gram, maltitol--2.1 calories per gram, 
sorbitol--2.6 calories per gram, hydrogenated starch hydrolysates--3.0 
calories per gram, mannitol--1.6 calories per gram, and erythritol--0 
calories per gram.
    (ii) ``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 in a 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 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 in a serving defined as total

[[Page 33]]

lipid fatty acids and expressed as triglycerides where fatty acids are 
aliphatic carboxylic acids consisting of a chain of alkyl groups and 
characterized by a terminal carboxyl group. 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 in a 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 in a serving if no claims are 
made about fat, fatty acid, or cholesterol content, and if ``calories 
from saturated fat'' is not declared. Except as provided for in 
paragraph (f) of this section, if a statement of the saturated fat 
content is not required and, as a result, not declared, the statement 
``Not a significant source of saturated fat'' shall be placed at the 
bottom of the table of nutrient values. Saturated fat content shall be 
indented and expressed as grams per serving to the nearest 0.5 gram (\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.
    (ii) ``Trans fat'' or ``Trans'': A statement of the number of grams 
of trans fat in a serving, defined as the sum of all unsaturated fatty 
acids that contain one or more isolated (i.e., nonconjugated) double 
bonds in a trans configuration, except that label declaration of trans 
fat content information is not required for products that contain less 
than 0.5 gram of total fat in a serving if no claims are made about fat, 
fatty acid or cholesterol content. The word ``trans'' may be italicized 
to indicate its Latin origin. Trans 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, when declared, shall 
be expressed as zero. Except as provided for in paragraph (f) of this 
section, if a statement of the trans fat content is not required and, as 
a result, not declared, the statement ``Not a significant source of 
trans fat'' shall be placed at the bottom of the table of nutrient 
values.
    (iii) ``Polyunsaturated fat'' or ``Poly-unsaturated'' (VOLUNTARY): A 
statement of the number of grams of polyunsaturated fat in a 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 food other than one that meets the 
criteria in Sec. 101.62(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.
    (iv) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A 
statement of the number of grams of monounsaturated fat in a 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 food 
other than one that meets the criteria in Sec. 101.62(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 in a 
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 cholesterol in a 
serving and make no claim about fat, fatty acids, or cholesterol 
content,

[[Page 34]]

or such products may state the cholesterol content as zero. Except as 
provided for in paragraph (f) of this section, if cholesterol content is 
not required and, as a result, not declared, the statement ``Not a 
significant source of cholesterol'' shall be placed at the bottom of the 
table of nutrient values in the same type size. If the food 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 in 
a specified serving of food 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) ``Fluoride'' (VOLUNTARY): A statement of the number of 
milligrams of fluoride in a specified serving of food may be declared 
voluntarily, except that when a claim is made about fluoride content, 
label declaration shall be required. Fluoride content shall be expressed 
as zero when the serving contains less than 0.1 milligrams of fluoride, 
to the nearest 0.1-milligram increment when the serving contains less 
than or equal to 0.8 milligrams of fluoride, and the nearest 0.2 
milligram-increment when a serving contains more than 0.8 milligrams of 
fluoride. Bottled water that bears a statement about added fluoride, as 
permitted by Sec. 101.13(q)(8), must bear nutrition labeling that 
complies with requirements for the simplified format in paragraph (f) of 
this section.
    (6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement 
of the number of grams of total carbohydrate in a 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 food. This 
calculation method is described in A. L. Merrill and B. K. Watt, 
``Energy Value of Foods--Basis and Derivation,'' USDA Handbook 74 
(slightly revised 1973) pp. 2 and 3, 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).
    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber in a 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. Dietary fiber is defined as non-digestible soluble and 
insoluble carbohydrates (with 3 or more monomeric units), and lignin 
that are intrinsic and intact in plants; isolated or synthetic non-
digestible carbohydrates (with 3 or more monomeric units) determined by 
FDA to have physiological effects that are beneficial to human health. 
Except as provided for in paragraph (f) of this section, if dietary 
fiber content is not required, and as a result not declared, the 
statement ``Not a significant source of dietary fiber'' shall be placed 
at the bottom of the table of nutrient values in the same type size. The 
following isolated or synthetic nondigestible carbohydrate(s) have been 
determined by FDA to have physiological effects that are beneficial to 
human health and, therefore, shall be included in the calculation of the 
amount of dietary fiber: [beta]-glucan soluble fiber (as described in 
Sec. 101.81(c)(2)(ii)(A)), psyllium husk (as described in Sec. 
101.81(c)(2)(ii)(B)(1)), cellulose, guar gum, pectin, locust bean gum, 
and hydroxypropylmethylcellulose. The manufacturer must make and keep 
records in accordance with paragraphs (g)(10) and (11) of this section 
to verify the declared amount of dietary fiber in the label and labeling 
of food when a mixture of dietary fiber, and added nondigestible 
carbohydrate(s) that does not meet the definition of dietary fiber, is 
present in the food.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber in a serving may

[[Page 35]]

be declared voluntarily except that when a claim is made on the label or 
in labeling about soluble fiber, label declaration shall be required. 
Soluble fiber must meet the definition of dietary fiber in this 
paragraph (c)(6)(i). The manufacturer must make and keep records in 
accordance with paragraphs (g)(10) and (11) of this section to verify 
the declared amount of soluble fiber in the label and labeling of food 
when a mixture of soluble fiber and added non-digestible carbohydrate(s) 
that does not meet the definition of dietary fiber is present in the 
food. 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 in a serving may be declared 
voluntarily except that when a claim is made on the label or in labeling 
about insoluble fiber, label declaration shall be required. Insoluble 
fiber must meet the definition of dietary fiber in this paragraph 
(c)(6)(i). The manufacturer must make and keep records in accordance 
with paragraphs (g)(10) and (11) of this section to verify the declared 
amount of insoluble fiber in the label and labeling of food when a 
mixture of insoluble and added non-digestible carbohydrate(s) that does 
not meet the definition of dietary fiber is present in the food. 
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) ``Total Sugars'': A statement of the number of grams of sugars 
in a serving, except that the label declaration of sugars content is not 
required for products that contain less than 1 gram of sugars in a 
serving if no claims are made about sweeteners, sugars, or sugar alcohol 
content. Except as provided for in paragraph (f) of this section, if a 
statement of the total sugars content is not required and, as a result, 
not declared, the statement ``Not a significant source of total sugars'' 
shall be placed at the bottom of the table of nutrient values in the 
same type size. Total sugars shall be defined as the sum of all free 
mono- and disaccharides (such as glucose, fructose, lactose, and 
sucrose). Total 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) ``Added Sugars'': A statement of the number of grams of added 
sugars in a serving, except that label declaration of added sugars 
content is not required for products that contain less than 1 gram of 
added sugars in a serving if no claims are made about sweeteners, 
sugars, added sugars, or sugar alcohol content. Except as provided for 
in paragraph (f) of this section, if a statement of the added sugars 
content is not required and, as a result, not declared, the statement 
``Not a significant source of added sugars'' shall be placed at the 
bottom of the table of nutrient values in the same type size. Added 
sugars are either added during the processing of foods, or are packaged 
as such, and include sugars (free, mono and disaccharides), sugars from 
syrups and honey, and sugars from concentrated fruit or vegetable juices 
that are in excess of what would be expected from the same volume of 100 
percent fruit or vegetable juice of the same type, except that fruit or 
vegetable juice concentrated from 100 percent juices sold to consumers, 
fruit or vegetable juice concentrates used towards the total juice 
percentage label declaration under Sec. 101.30 or for Brix 
standardization under Sec. 102.33(g)(2) of this chapter, fruit juice 
concentrates which are used to formulate the fruit component of jellies, 
jams, or preserves in accordance with the standard of identities set 
forth in Sec. Sec. 150.140 and 150.160 of this chapter, or the fruit 
component of fruit spreads shall not be labeled as added sugars. Added 
sugars content

[[Page 36]]

shall be indented under Total Sugars and shall be prefaced with the word 
``Includes'' followed by the amount (in grams) ``Added Sugars'' 
(``Includes `X' g Added Sugars''). It shall be 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 a mixture of naturally occurring and 
added sugars is present in the food, and for specific foods containing 
added sugars, alone or in combination with naturally occurring sugars, 
where the added sugars are subject to fermentation and/or non-enzymatic 
browning, the manufacturer must make and keep records in accordance with 
paragraphs (g)(10) and (11) of this section to verify the declared 
amount of added sugars in the label and labeling of food.
    (iv) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols in a 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 total sugars, or added sugars when sugar alcohols 
are present in the food, 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 food may be 
used in the nutrition label provided that only one sugar alcohol is 
present in the food. 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.
    (7) ``Protein'': A statement of the number of grams of protein in a 
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 foods 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 food 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 a Percent of Daily Value. When the protein 
quality in a food as measured by the Protein Efficiency Ratio (PER) is 
less than 40 percent of the reference standard (casein) for a food 
represented or purported to be specifically for infants through 12 
months, 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 6.25 times the nitrogen 
content of the food as determined by the appropriate method of analysis 
as given in the ``Official Methods of Analysis of the AOAC 
International,'' except when official AOAC procedures described in this 
paragraph (c)(7) require a specific factor other than 6.25, that 
specific factor shall be used.
    (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

[[Page 37]]

is represented or purported to be specifically for infants through 12 
months or children 1 through 3 years of age. When such a declaration is 
provided, it should 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 food is 
represented or purported to be specifically for infants through 12 
months and the protein quality value is less than 40 percent of the 
reference standard.
    (ii) The ``corrected amount of protein (gram) per serving'' for 
foods represented or purported for adults and children 1 or more years 
of age is equal to the actual amount of protein (gram) 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 8.00 in ``Report of the 
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,'' 
except that when official AOAC procedures described in paragraph (c)(7) 
of this section require a specific factor other than 6.25, that specific 
factor shall be used. For foods represented or purported to be 
specifically for infants through 12 months, 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 food 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, a value of 11 grams of protein shall be the RDI 
for infants through 12 months, a value of 13 grams shall be the DRV for 
children 1 through 3 years of age, and a value of 71 grams of protein 
shall be the RDI for pregnant women and lactating women.
    (8) ``Vitamins and minerals'': The requirements related to including 
a statement of the amount per serving of vitamins and minerals are 
described in this paragraph (c)(8).
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d), (e), and (f) of this section, foods 
represented or purported to be specifically for infants through 12 
months, children 1 through 3 years, pregnant women, and lactating women 
shall use the RDIs that are specified for the intended group. For foods 
represented or purported to be specifically for both infants through 12 
months of age and children 1 through 3 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 
through 12 months of age and children 1 through 3 years of age. 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. The percent Daily Value based on the RDI values for pregnant 
women and lactating women shall be declared on food represented or 
purported to be specifically for pregnant women and lactating women. All 
other foods shall use the RDI for adults and children 4 or more years of 
age.
    (ii) The declaration of vitamins and minerals as a quantitative 
amount by weight and percent of the RDI shall include vitamin D, 
calcium, iron, and potassium in that order, for infants through 12 
months, children 1 through 3 years of age, pregnant women, lactating 
women, and adults and children 4 or more years of age, except 
quantitative weights for these vitamins and minerals are not required 
for labels described in paragraph (j)(13) of this section. The 
declaration of folic acid shall be included as a quantitative amount by 
weight when added as a nutrient supplement or a claim is made about the 
nutrient. The declaration of vitamins and minerals in a food, as a 
quantitative amount by weight and percent of the RDI, may include any of 
the other vitamins and minerals listed in paragraph (c)(8)(iv) of this 
section. The declaration of vitamins and minerals shall include any of 
the other vitamins and minerals listed in paragraph (c)(8)(iv) of this 
section as a statement

[[Page 38]]

of the amount per serving of the vitamins and minerals as described in 
this paragraph (c)(8)(ii), calculated as a percent of the RDI and 
expressed as a percent of the Daily Value, when they are added as a 
nutrient supplement, or when a claim is made about them, unless 
otherwise stated as quantitative amount by weight and percent of the 
Daily Value. Other vitamins and minerals need not be declared if neither 
the nutrient nor the component is otherwise referred to on the label or 
the 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 food; or
    (B) Included in a food solely for technological purposes and 
declared only in the ingredient 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. Quantitative amounts and percentages 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)'' or ``Contains <2 
percent of the Daily Value of this (these) nutrient (nutrients).'' 
Alternatively, except as provided for in paragraph (f) of this section, 
if vitamin D, calcium, iron, or potassium 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. Either statement shall be in the same type size as 
nutrients that are indented. The quantitative amounts of vitamins and 
minerals, excluding sodium, shall be the amount of the vitamin or 
mineral included in one serving of the product, using the units of 
measurement and the levels of significance given in paragraph (c)(8)(iv) 
of this section, except that zeros following decimal points may be 
dropped, and additional levels of significance may be used when the 
number of decimal places indicated is not sufficient to express lower 
amounts (e.g., the RDI for zinc is given in whole milligrams, but the 
quantitative amount may be declared in tenths of a milligram).
    (iv) The following RDIs, nomenclature, and units of measure are 
established for the following vitamins and minerals which are essential 
in human nutrition:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        RDI
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Adults and
                                                                                           children = 4      through 12       through 3     and lactating
                                                                                               years          months           years           women
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin D......................................  Micrograms (mcg) \2\...................              20              10              15              15
Calcium........................................  Milligrams (mg)........................           1,300             260             700           1,300
Iron...........................................  Milligrams (mg)........................              18              11               7              27
Potassium......................................  Milligrams (mg)........................           4,700             700           3,000           5,100
Vitamin A......................................  Micrograms RAE \3\ (mcg)...............             900             500             300           1,300
Vitamin C......................................  Milligrams (mg)........................              90              50              15             120
Vitamin E......................................  Milligrams (mg) \4\....................              15               5               6              19
Vitamin K......................................  Micrograms (mcg).......................             120             2.5              30              90
Thiamin........................................  Milligrams (mg)........................             1.2             0.3             0.5             1.4
Riboflavin.....................................  Milligrams (mg)........................             1.3             0.4             0.5             1.6
Niacin.........................................  Milligrams NE \5\ (mg).................              16               4               6              18
Vitamin B6.....................................  Milligrams (mg)........................             1.7             0.3             0.5             2.0
Folate \6\.....................................  Micrograms DFE \7\ (mcg)...............             400              80             150             600

[[Page 39]]

 
Vitamin B12....................................  Micrograms (mcg).......................             2.4             0.5             0.9             2.8
Biotin.........................................  Micrograms (mcg).......................              30               6               8              35
Pantothenic acid...............................  Milligrams (mg)........................               5             1.8               2               7
Phosphorus.....................................  Milligrams (mg)........................           1,250             275             460           1,250
Iodine.........................................  Micrograms (mcg).......................             150             130              90             290
Magnesium......................................  Milligrams (mg)........................             420              75              80             400
Zinc...........................................  Milligrams (mg)........................              11               3               3              13
Selenium.......................................  Micrograms (mcg).......................              55              20              20              70
Copper.........................................  Milligrams (mg)........................             0.9             0.2             0.3             1.3
Manganese......................................  Milligrams (mg)........................             2.3             0.6             1.2             2.6
Chromium.......................................  Micrograms (mcg).......................              35             5.5              11              45
Molybdenum.....................................  Micrograms (mcg).......................              45               3              17              50
Chloride.......................................  Milligrams (mg)........................           2,300             570           1,500           2,300
Choline........................................  Milligrams (mg)........................             550             150             200             550
Protein........................................  Grams (g)..............................             N/A              11             N/A          \8\ 71
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ RDIs are based on dietary reference intake recommendations for infants through 12 months of age.
\2\ The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition to the mandatory declaration in mcg. Any
  declaration of the amount of vitamin D in IU must appear in parentheses after the declaration of the amount of vitamin D in mcg.
\3\ RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 microgram supplemental [beta]-carotene, 12 micrograms dietary [beta]-
  carotene, or 24 micrograms dietary [alpha]-carotene, or dietary 24 micrograms dietary [beta]-cryptoxanthin.
\4\ 1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all rac-[alpha]-tocopherol.
\5\ NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan.
\6\ ``Folate'' and ``Folic Acid'' must be used for purposes of declaration in the labeling of conventional foods and dietary supplements. The
  declaration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement), and
  percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is made
  about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid.
\7\ DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally occurring folate = 0.6 mcg folic acid.
\8\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating women.

    (v) The following synonyms may be added in parentheses immediately 
following the name of the nutrient or dietary component:

Calories--Energy
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2

    (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 DV of 
vitamin A in the food (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.
    (vii) When the amount of folate is declared in the labeling of a 
conventional food or a dietary supplement, the nutrient name ``folate'' 
shall be listed for products containing folate (natural folate, and/or 
synthetic folate as a component of dietary supplement, such as calcium 
salt of L-5-MTHF), folic acid, or a mixture of folate and folic acid. 
The name of the synthetic form of the nutrient ``folic acid'', when 
added or a claim is made about the nutrient, shall be included in 
parentheses after this declaration with the amount of folic acid. The 
declaration must be folate in mcg DFE (when expressed as a quantitative 
amount by weight in a conventional food or a dietary supplement) and the 
percent DV based on folate in mcg DFE, or for conventional food, may be 
expressed as folate and the percent DV based on folate in mcg DFE. When 
declared, folic acid must be in parentheses, mcg of folic acid as shown 
in paragraph (d)(12) of this section in the display that illustrates 
voluntary declaration of nutrition information.

[[Page 40]]

    (9) The following DRVs, nomenclature, and units of measure are 
established for the following food components:

----------------------------------------------------------------------------------------------------------------
                                                    Adults and
                                                   children =4      through 12       through 3     and lactating
                                                       years          months           years           women
----------------------------------------------------------------------------------------------------------------
Fat...........................  Grams (g).......          \1\ 78              30          \2\ 39          \1\ 78
Saturated fat.................  Grams (g).......          \1\ 20             N/A          \2\ 10          \1\ 20
Cholesterol...................  Milligrams (mg).             300             N/A             300             300
Total carbohydrate............  Grams (g).......         \1\ 275              95         \2\ 150         \1\ 275
Sodium........................  Milligrams (mg).           2,300             N/A           1,500           2,300
Dietary Fiber.................  Grams (g).......          \1\ 28             N/A          \2\ 14          \1\ 28
Protein.......................  Grams (g).......          \1\ 50             N/A          \2\ 13             N/A
Added Sugars..................  Grams (g).......          \1\ 50             N/A          \2\ 25          \1\ 50
----------------------------------------------------------------------------------------------------------------
\1\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  for pregnant women and lactating women
\2\ Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on foods in the following format, as shown in 
paragraph (d)(12) of this section, except on foods where the tabular 
display is permitted as provided for in paragraph (d)(11) of this 
section, on which dual columns of nutrition information are declared as 
provided for in paragraph (e) of this section, on those food products on 
which the simplified format is required to be used as provided for in 
paragraph (f) of this section, on foods for infants through 12 months of 
age and children 1 through 3 years of age as provided for in paragraph 
(j)(5) of this section, and on foods in small or intermediate-sized 
packages as provided for in paragraph (j)(13) of this section. In the 
interest of uniformity of presentation, FDA strongly recommends that the 
nutrition information be presented using the graphic specifications set 
forth in appendix B to part 101.
    (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) Except as provided for in paragraph (c)(2)(ii) of this section, 
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 as 
shown in paragraph (d)(12), and
    (D) Letters should never touch.
    (iii) Information required in paragraphs (d)(7) and (8) of this 
section shall be in type size no smaller than 8 point. Information 
required in paragraph (d)(5) of this section for the ``Calories'' 
declaration shall be highlighted in bold or extra bold and shall be in a 
type size no smaller than 16 point except the type size for this 
information required in the tabular displays as shown in paragraphs 
(d)(11), (e)(6)(ii), and (j)(13)(ii)(A)(1) of this section and the 
linear display for small packages as shown in paragraph 
(j)(13)(ii)(A)(2) of this section shall be in a type size no smaller 
than 10 point. The numeric amount for the information required in 
paragraph (d)(5) of this section shall also be highlighted in bold or 
extra bold type and shall be in a type size no smaller than 22 point, 
except the type size for this information required for the tabular 
display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of 
this section, and for the linear display for small packages as shown in 
paragraph (j)(13)(ii)(A)(2) of this section no smaller than 14 point. 
The information required in paragraphs (d)(4), (6), and (9) of this 
section shall be in a type size no smaller than 6 point. When provided, 
the information described in paragraph (d)(10) of this section shall be 
in a type size no smaller than 6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(3)(ii), (d)(4), 
and (d)(6) of this section (i.e., ``Nutrition Facts,'' ``Serving size,'' 
``Amount per serving,''

[[Page 41]]

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,'' ``Total 
Carbohydrate'' and ``Protein''), and the percentage amounts required by 
paragraph (d)(7)(ii) of this section shall be highlighted in 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 ``Nutrition Facts'' from the servings per container statement 
required in paragraph (d)(3)(i) of this section and shall separate each 
nutrient and its corresponding percent Daily Value required in 
paragraphs (d)(7)(i) and (ii) of this section from the nutrient and 
percent Daily Value above and below it, as shown in paragraph (d)(12) of 
this section and in Appendix B to Part 101.
    (2) The information shall be presented under the identifying heading 
of ``Nutrition Facts'' which shall be set in a type size no smaller than 
all other print size in the nutrition label except for the numerical 
information for ``Calories'' required in paragraph (d)(5) of this 
section, and except for labels presented according to the format 
provided for in paragraphs (d)(11), (d)(13)(ii), (e)(6)(ii), 
(j)(13)(ii)(A)(1), and (j)(13)(ii)(A)(2) of this section, unless 
impractical, shall be set the full width of the information provided 
under paragraph (d)(7) of this section, as shown in paragraph (d)(12) of 
this section.
    (3) Information on servings per container and serving size shall 
immediately follow the heading as shown in paragraph (d)(12) of this 
section. Such information shall include:
    (i) ``__ 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)(6) of this section or on other 
food containers when this information is stated in the net quantity of 
contents declaration. The information required in this paragraph shall 
be located immediately after the ``Nutrition Facts'' heading and shall 
be in a type size no smaller than 10 point, except the type size for 
this information shall be no smaller than 9 point in the tabular display 
for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this 
section and the linear display for small packages as shown in paragraph 
(j)(13)(ii)(A)(2) of this section. For the linear display for small 
packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, the 
actual number of servings may be listed after the servings per container 
declaration.
    (ii) ``Serving size'': A statement of the serving size as specified 
in paragraph (b)(7) of this section which shall immediately follow the 
``__servings per container'' declaration. The information required in 
this paragraph shall be highlighted in bold or extra bold and be in a 
type size no smaller than 10 point, except the type size shall be no 
smaller than 9 point for this information in the tabular displays as 
shown in paragraphs (d)(11) and (e)(6)(ii) of this section, the tabular 
display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of 
this section, and the linear display for small packages as shown in 
paragraph (j)(13)(ii)(A)(2) of this section. The serving size amount 
must be right justified if adequate space is available. If the ``Serving 
size'' declaration does not fit in the allocated space a type size of no 
smaller than 8 point may be used on packages of any size.
    (4) A subheading ``Amount per serving'' shall be separated from the 
serving size information by a bar as shown in paragraph (d)(12) of this 
section, except this information is not required for the dual column 
formats shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of this 
section.
    (5) Information on calories shall immediately follow the subheading 
``Amount per serving'' and shall be declared in one line. If ``Calories 
from saturated fat'' is declared, it shall be indented under 
``Calories'' and shall be in a type size no smaller than 8 point.
    (6) The column heading ``% Daily Value,'' followed by an asterisk 
(e.g., ``% Daily Value*''), shall be separated from information on 
calories by a bar as shown in paragraph (d)(12) of this section. The 
position of this column

[[Page 42]]

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 (j)(13)(ii)(A)(2) of this 
section, 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 for folic acid in conventional 
food and voluntarily declared vitamins and minerals expressed as a 
statement of the amount per serving calculated as a percent of the RDI 
and expressed as a percent Daily Value, 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, ``mg'' for milligrams, or ``mcg'' for micrograms as shown in 
paragraph (d)(12) of this section. The symbol ``<'' may be used in place 
of ``less than.''
    (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 (except sodium) 
shall be separated from information on other nutrients by a bar and may 
be arrayed vertically as shown in paragraph (d)(12) of this section 
(e.g., Vitamin D 2 mcg 10%, Calcium 260 mg 20%, Iron 8 mg 45%, Potassium 
235 mg 6%) or may be listed horizontally. When listed horizontally in 
two columns, vitamin D and calcium should be listed on the first line 
and iron and potassium should be listed on the second line, as shown in 
paragraph (d)(12) of this section in the side-by-side display. When more 
than four vitamins and minerals are declared voluntarily as shown in 
paragraph (d)(12) of this section in the label which illustrates the 
mandatory plus voluntary provisions of paragraph (d) of this section, 
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 the list by a 
bar, except that the footnote may be omitted from foods that can use the 
terms ``calorie free,'' ``free of calories,'' ``without calories,'' 
``trivial source of calories,'' ``negligible source of calories,'' or 
``dietary insignificant source of calories'' on the label or in the 
labeling of foods as defined in Sec. 101.60(b). The first sentence of 
the footnote: ``The % Daily Value tells you how much a nutrient in a 
serving of food contributes to a daily diet'' may be used on foods that 
can use the terms ``calorie free,'' ``free of calories,'' ``without 
calories,'' ``trivial source of calories,'' ``negligible source of 
calories,'' or ``dietary insignificant source of calories'' on the label 
or in the labeling of foods as defined in Sec. 101.60(b). The footnote 
shall state: ``*The % Daily Value tells you how much a nutrient in a 
serving of food contributes to a daily diet. 2,000 calories a day is 
used for general nutrition advice.'' If the food product is represented 
or purported to be for children 1 through 3 years of age, the second 
sentence of the footnote shall substitute ``1,000 calories'' for ``2,000 
calories.''
    (10) Caloric conversion information on a per gram basis for fat, 
carbohydrate, and protein may be presented beneath the information 
required in

[[Page 43]]

paragraph (d)(9) of this section, separated from that information by a 
hairline. This information may be presented horizontally as shown in 
paragraph (d)(12) of this section (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 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 potassium 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 nutrients and 
the percent DV 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 in) to accommodate the required components of the 
nutrition label up to and including the mandatory declaration of 
potassium, the nutrition label may be presented in a tabular display as 
shown in the following sample label.
[GRAPHIC] [TIFF OMITTED] TR27MY16.000

    (12) The following sample labels illustrate the mandatory provisions 
and mandatory plus voluntary provisions of paragraph (d) of this section 
and the side-by-side display.

[[Page 44]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.001


[[Page 45]]


[GRAPHIC] [TIFF OMITTED] TR27MY16.002


[[Page 46]]


[GRAPHIC] [TIFF OMITTED] TR27MY16.003

    (13)(i) Nutrition labels on the outer label of packages of products 
that contain two or more separately packaged foods that are intended to 
be eaten individually (e.g., variety packs of cereals or snack foods) or 
of packages that are used interchangeably for the same type of food 
(e.g., round ice cream containers) may use an aggregate display.
    (ii) Aggregate displays shall comply with the format requirements of 
paragraph (d) of this section to the maximum extent possible, except 
that the identity of each food shall be specified immediately to the 
right of the ``Nutrition Facts'' heading, and both the quantitative 
amount by weight (i.e., g/mg/mcg amounts) and the percent Daily Value 
for each nutrient shall be listed in separate columns under the name of 
each food. The following sample label illustrates an aggregate display.

[[Page 47]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.004

    (14) In accordance with Sec. 101.15(c)(2), when nutrition labeling 
must appear 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 food (e.g., both ``as purchased'' and ``as prepared'') or for 
common combinations of food as provided for in paragraph (h)(4) of this 
section, for different units (e.g., slices of bread or per 100 grams) as 
provided for in paragraph (b) of this section, or for two or more groups 
for which RDIs are established (e.g., both infants through 12 months of 
age and children 1 through 3 years of age) as shown in paragraph (e)(5) 
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 serving size information there shall be two or 
more column headings accurately describing the amount per serving size 
of the form of the same food (e.g., ``Per \1/4\ cup mix'' and ``Per 
prepared portion''), the combinations of food, the units, or the RDI 
groups that are being declared as shown in paragraph (e)(5) of this 
section.
    (2) The quantitative information by weight as required in paragraph 
(d)(7)(i) and the information required in paragraph (d)(7)(ii) of this 
section shall be presented for the form of the product as packaged and 
for any other form of the product (e.g., ``as prepared'' or combined 
with another ingredient as shown in paragraph (e)(5) of this section).
    (3) When the dual labeling is presented for two or more forms of the

[[Page 48]]

same food, for combinations of food, for different units, or for two or 
more groups for which RDIs are established, the quantitative information 
by weight and the percent Daily Value shall be presented in two columns 
and the columns shall be separated by vertical lines as shown in 
paragraph (e)(5) of this section.
    (4) Nutrient information for vitamins and minerals (except sodium) 
shall be separated from information on other nutrients by a bar and 
shall be arrayed vertically in the following order: Vitamin D, calcium, 
iron, potassium as shown in paragraph (e)(5) of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:
[GRAPHIC] [TIFF OMITTED] TR21DE18.010

    (6) When dual labeling is presented for a food on a per serving 
basis and per container basis as required in paragraph (b)(12)(i) of 
this section or on a per serving basis and per unit basis as required in 
paragraph (b)(2)(i)(D) of

[[Page 49]]

this section, the quantitative information by weight as required in 
paragraph (d)(7)(i) and the percent Daily Value as required in paragraph 
(d)(7)(ii) shall be presented in two columns, and the columns shall be 
separated by vertical lines as shown in the displays in paragraph 
(e)(6)(i) of this section.
    (i) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed vertically in the following order: Vitamin D, calcium, iron, and 
potassium as shown in the following sample labels.
[GRAPHIC] [TIFF OMITTED] TR21DE18.011


[[Page 50]]


[GRAPHIC] [TIFF OMITTED] TR21DE18.012

    (ii) The following sample label illustrates the provisions of 
paragraphs (b)(2)(i)(D) and (b)(12)(i) of this section for labels that 
use the tabular display.
[GRAPHIC] [TIFF OMITTED] TR21DE18.013


[[Page 51]]


    (f) The declaration of nutrition information may be presented in the 
simplified format set forth herein when a food product contains 
insignificant amounts of eight or more of the following: Calories, total 
fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, 
dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, 
iron, and potassium; except that for foods intended for infants through 
12 months of age and children 1 through 3 years of age to which 
paragraph (j)(5)(i) of this section applies, nutrition information may 
be presented in the simplified format when a food product contains 
insignificant amounts of six or more of the following: Calories, total 
fat, sodium, total carbohydrate, dietary fiber, total sugars, added 
sugars, protein, vitamin D, calcium, iron, and potassium.
    (1) An ``insignificant amount'' shall be defined as that amount that 
allows a declaration of zero in nutrition labeling, except that for 
total carbohydrate, dietary fiber, and protein, it shall be an amount 
that allows a declaration of ``less than 1 gram.''
    (2) The simplified format shall include information on the following 
nutrients:
    (i) Total calories, total fat, total carbohydrate, protein, and 
sodium;
    (ii) Any other nutrients identified in paragraph (f) of this section 
that are present in the food in more than insignificant amounts; and
    (iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of 
this section when they are required to be added as a nutrient supplement 
to foods for which a standard of identity exists.
    (iv) Any vitamins or minerals listed in paragraph (c)(8)(iv) of this 
section voluntarily added to the food as nutrient supplements.
    (3) Other nutrients that are naturally present in the food in more 
than insignificant amounts may be voluntarily declared as part of the 
simplified format.
    (4) If any nutrients are declared as provided in paragraphs 
(f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the 
simplified format or if any nutrition claims are made on the label or in 
labeling, the statement ``Not a significant source of ____'' (with the 
blank filled in with the name(s) of any nutrient(s) identified in 
paragraph (f) of this section that are present in insignificant amounts) 
shall be included at the bottom of the nutrition label.
[GRAPHIC] [TIFF OMITTED] TR27MY16.008


[[Page 52]]


    (5) Except as provided for in paragraphs (j)(5) and (j)(13) of this 
section, 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, and an asterisk shall be placed at the 
bottom of the label followed by the statement ``% DV = % Daily Value'' 
when ``Daily Value'' is not spelled out in the heading, as shown in 
paragraph (f)(4).
    (g) Compliance with this section shall be determined as follows:
    (1) A collection of primary containers or units of the same size, 
type, and style produced under conditions as nearly uniform as possible, 
designated by a common container code or marking, or in the absence of 
any common container code or marking, a day's production, constitutes a 
``lot.''
    (2) The sample for nutrient analysis shall consist of a composite of 
12 subsamples (consumer units), taken 1 from each of 12 different 
randomly chosen shipping cases, to be representative of a lot. Unless a 
particular method of analysis is specified in paragraph (c) of this 
section, composites shall be analyzed by appropriate methods as given in 
the ``Official Methods of Analysis of the AOAC International,'' or, if 
no AOAC method is available or appropriate, by other reliable and 
appropriate analytical procedures.
    (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. When a 
nutrient is naturally occurring (indigenous) in a food or an ingredient 
that is added to a food, the total amount of such nutrient in the final 
food product is subject to class II requirements, except that when an 
exogenous source of the nutrient is also added to the final food 
product, the total amount of the nutrient in the final food product 
(indigenous and exogenous) is subject to class I requirements.
    (4) A food with a label declaration of a vitamin, mineral, protein, 
total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, 
polyunsaturated or monounsaturated fat shall be deemed to be misbranded 
under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) unless it meets the following requirements:
    (i) When a vitamin, mineral, protein, or dietary fiber meets the 
definition of a Class I nutrient, the nutrient content of the composite 
must be formulated to be at least equal to the value for that nutrient 
declared on the label.
    (ii) When a vitamin, mineral, protein, total carbohydrate, 
polyunsaturated or monounsaturated fat, or dietary fiber meets the 
definition of a Class II nutrient, the nutrient content of the composite 
must be 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 that falls below this level by a 
factor less than the variability generally recognized for the analytical 
method used in that food at the level involved.
    (5) A food with a label declaration of calories, total sugars, added 
sugars (when the only source of sugars in the food is added sugars), 
total fat, saturated fat, trans fat, cholesterol, or sodium shall be 
deemed to be misbranded under section 403(a) of the act 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 
that falls above this level by a factor less than the variability 
generally recognized for the analytical method used in that food at the 
level involved.
    (6) Reasonable excesses of vitamins, minerals, protein, total 
carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugar 
alcohols, polyunsaturated or monounsaturated fat over labeled amounts 
are acceptable within current good manufacturing practice. Reasonable 
deficiencies of calories, total sugars, added sugars, total fat, 
saturated fat, trans fat, cholesterol, or sodium under labeled amounts 
are acceptable within current good manufacturing practice.
    (7) Compliance will be based on the metric measure specified in the 
label statement of serving size.

[[Page 53]]

    (8) Alternatively, compliance with the provisions set forth in 
paragraphs (g)(1) through (6) of this section may be provided by use of 
an FDA approved database that has been computed following FDA guideline 
procedures and where food samples have been handled in accordance with 
current good manufacturing practice to prevent nutrition loss. FDA 
approval of a database shall not be considered granted until the Center 
for Food Safety and Applied Nutrition has agreed to all aspects of the 
database in writing. The approval will be granted where a clear need is 
presented (e.g., raw produce and seafood). Approvals will be in effect 
for a limited time, e.g., 10 years, and will be eligible for renewal in 
the absence of significant changes in agricultural or industry 
practices. Approval requests shall be submitted in accordance with the 
provisions of Sec. 10.30 of this chapter. Guidance in the use of 
databases may be found in the ``FDA Nutrition Labeling Manual--A Guide 
for Developing and Using Data Bases,'' available from the Office of 
Nutrition and Food Labeling (HFS-800), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740 or by going to http://www.fda.gov.
    (9) When it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of this section (e.g., to develop adequate nutrient 
profiles to comply with the requirements of paragraph (c) of this 
section), FDA may permit alternative means of compliance or additional 
exemptions to deal with the situation. Firms in need of such special 
allowances shall make their request in writing to the Center for Food 
Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740.
    (10) The manufacturer must make and keep written records (e.g., 
analyses of databases, recipes, formulations, information from recipes 
or formulations, or batch records) to verify the declared amount of that 
nutrient on the Nutrition Facts label as follows:
    (i) When a mixture of dietary fiber, and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber, is 
present in the food, a manufacturer must make and keep written records 
of the amount of non-digestible carbohydrate(s) added to the food that 
does not meet the definition of dietary fiber.
    (ii) When a mixture of soluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food, a manufacturer must make and keep written records 
necessary to verify the amount of the non-digestible carbohydrate(s) 
added to the food that does not meet the definition of dietary fiber.
    (iii) When a mixture of insoluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food, a manufacturer must make and keep written records 
necessary to verify the amount of the non-digestible carbohydrate(s) 
added to the food that does not meet the definition of dietary fiber.
    (iv) When a mixture of naturally occurring and added sugars is 
present in the food, a manufacturer must make and keep written records 
of the amount of added sugars added to the food during the processing of 
the food, and if packaged as a separate ingredient, as packaged (whether 
as part of a package containing one or more ingredients or packaged as a 
single ingredient).
    (v) When the amount of sugars added to food products is reduced 
through non-enzymatic browning and/or fermentation, manufacturers must:
    (A) Make and keep records of all relevant scientific data and 
information relied upon by the manufacturer that demonstrates the amount 
of added sugars in the food after non-enzymatic browning and/or 
fermentation and a narrative explaining why the data and information are 
sufficient to demonstrate the amount of added sugars declared in the 
finished food, provided the data and information used is specific to the 
type of food that is subject to non-enzymatic browning and/or 
fermentation; or
    (B) Make and keep records of the amount of added sugars added to the 
food before and during the processing of the food, and if packaged as a 
separate ingredient, as packaged (whether

[[Page 54]]

as part of a package containing one or more ingredients or packaged as a 
single ingredient) and in no event shall the amount of added sugars 
declared exceed the amount of total sugars on the label; or
    (C) Submit a petition, under 21 CFR 10.30, to request an alternative 
means of compliance. The petition must provide scientific data or other 
information for why the amount of added sugars in a serving of the 
product is likely to have a significant reduction in added sugars 
compared to the amount added prior to non-enzymatic browning and/or 
fermentation. A significant reduction would be where reduction in added 
sugars after non-enzymatic browning and/or fermentation may be 
significant enough to impact the label declaration for added sugars by 
an amount that exceeds the reasonable deficiency acceptable within good 
manufacturing practice under paragraph (g)(6) of this section. In 
addition, the scientific data or other information must include the 
reason that the manufacturer is unable to determine a reasonable 
approximation of the amount of added sugars in a serving of their 
finished product and a description of the process that they used to come 
to that conclusion.
    (vi) When a mixture of all rac-[alpha]-tocopherol and RRR-[alpha]-
tocopherol is present in a food, manufacturers must make and keep 
written records of the amount of all rac-[alpha]-tocopherol added to the 
food and RRR-[alpha]-tocopherol in the finished food.
    (vii) When a mixture of folate and folic acid is present in a food, 
manufacturers must make and keep written records of the amount of 
synthetic folate and/or folic acid added to the food and the amount of 
naturally-occurring folate in the finished food.
    (11) Records necessary to verify certain nutrient declarations that 
are specified in paragraph (g)(10) of this section must be kept for a 
period of at least 2 years after introduction or delivery for 
introduction of the food into interstate commerce. Such records must be 
provided to FDA upon request, during an inspection, for official review 
and photocopying or other means of reproduction. Records required to 
verify information on the label may be kept either as original records, 
true copies (such as photocopies, pictures, scanned copies, microfilm, 
microfiche, or other accurate reproductions of the original records), or 
electronic records which must be kept in accordance with part 11 of this 
chapter. These records must be accurate, indelible, and legible.
    Failure to make and keep the records or provide the records to 
appropriate regulatory authorities, as required by this paragraph 
(g)(11), would result in the food being misbranded under section 
403(a)(1) of the act.
    (h) Products with separately packaged ingredients or foods, with 
assortments of food, or to which other ingredients are added by the user 
may be labeled as follows:
    (1) If a product consists of two or more separately packaged 
ingredients enclosed in an outer container or of assortments of the same 
type of food (e.g., assorted nuts or candy mixtures) in the same retail 
package, nutrition labeling shall be located on the outer container or 
retail package (as the case may be) to provide information for the 
consumer at the point of purchase. However, when two or more food 
products are simply combined together in such a manner that no outer 
container is used, or no outer label is available, each product shall 
have its own nutrition information, e.g., two boxes taped together or 
two cans combined in a clear plastic overwrap. When separately packaged 
ingredients or assortments of the same type of food are intended to be 
eaten at the same time, the nutrition information may be specified per 
serving for each component or as a composite value.
    (2) If a product consists of two or more separately packaged foods 
that are intended to be eaten individually and that are enclosed in an 
outer container (e.g., variety packs of cereals or snack foods), the 
nutrition information shall:
    (i) Be specified per serving for each food in a location that is 
clearly visible to the consumer at the point of purchase; and
    (ii) Be presented in separate nutrition labels or in one aggregate 
nutrition label with separate columns for the quantitative amount by 
weight and the percent Daily Value for each food.

[[Page 55]]

    (3) If a package contains a variety of foods, or an assortment of 
foods, and is in a form intended to be used as a gift, the nutrition 
labeling shall be in the form required by paragraphs (a) through (f) of 
this section, but it may be modified as follows:
    (i) Nutrition information may be presented on the label of the outer 
package or in labeling within or attached to the outer package.
    (ii) In the absence of a reference amount customarily consumed in 
Sec. 101.12(b) that is appropriate for the variety or assortment of 
foods in a gift package, the following may be used as the standard 
serving size for purposes of nutrition labeling of foods subject to this 
paragraph: 1 ounce for solid foods; 2 fluid ounces for nonbeverage 
liquids (e.g., syrups); 8 ounces for beverages that consist of milk and 
fruit juices, nectars and fruit drinks; and 12 fluid ounces for other 
beverages. However, the reference amounts customarily consumed in Sec. 
101.12(b) shall be used for purposes of evaluating whether individual 
foods in a gift package qualify for nutrient content claims or health 
claims.
    (iii) The number of servings per container may be stated as 
``varied.''
    (iv) Nutrition information may be provided per serving for 
individual foods in the package, or, alternatively, as a composite per 
serving for reasonable categories of foods in the package having similar 
dietary uses and similar significant nutritional characteristics. 
Reasonable categories of foods may be used only if accepted by FDA. In 
determining whether a proposed category is reasonable, FDA will consider 
whether the values of the characterizing nutrients in the foods proposed 
to be in the category meet the compliance criteria set forth in 
paragraphs (g)(3) through (6) of this section. Proposals for such 
categories may be submitted in writing to the Office of Nutrition and 
Food Labeling (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.
    (v) If a food subject to paragraph (j)(13) of this section because 
of its small size is contained in a gift package, the food need not be 
included in the determination of nutrition information under paragraph 
(h) of this section if it is not specifically listed in a promotional 
catalogue as being present in the gift package, and:
    (A) It is used in small quantities primarily to enhance the 
appearance of the gift package; or
    (B) It is included in the gift package as a free gift or promotional 
item.
    (4) If a food 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 nutrition information on the basis of the food as 
consumed in the format required in paragraph (e) of this section; e.g., 
a dry ready-to-eat cereal may be described with the percent Daily Value 
and the quantitative amounts for the cereal as sold (e.g., per ounce), 
and the percent Daily Value and the quantitative amounts for the cereal 
and milk as suggested in the label (e.g., per ounce of cereal and \1/
2\cup of vitamin D fortified skim milk); and a cake mix may be labeled 
with the percent Daily Value and the quantitative amounts for the dry 
mix (per serving) and the percent Daily Value and the quantitative 
amounts for the serving of the final cake when prepared, as shown in 
paragraph (e)(5) of this section: 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.
    (i) Except as provided in paragraphs (j)(13) and (j)(17) of this 
section, the location of nutrition information on a label shall be in 
compliance with Sec. 101.2.
    (j) The following foods are exempt from this section or are subject 
to special labeling requirements:
    (1)(i) Food offered for sale by a person who makes direct sales to 
consumers (e.g., a retailer) who has annual gross sales made or business 
done in sales to consumers that is not more than $500,000 or has annual 
gross sales made or business done in sales of food to consumers of not 
more than $50,000, Provided, That the food bears no nutrition claims or 
other nutrition information

[[Page 56]]

in any context on the label or in labeling or advertising. Claims or 
other nutrition information subject the food to the provisions of this 
section, Sec. 101.10, or Sec. 101.11, as applicable.
    (ii) For purposes of this paragraph, calculation of the amount of 
sales shall be based on the most recent 2-year average of business 
activity. Where firms have been in business less than 2 years, 
reasonable estimates must indicate that annual sales will not exceed the 
amounts specified. For foreign firms that ship foods into the United 
States, the business activities to be included shall be the total amount 
of food sales, as well as other sales to consumers, by the firm in the 
United States.
    (2) Except as provided in Sec. 101.11, food products that are:
    (i) Served in restaurants, Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section;
    (ii) Served in other establishments in which food is served for 
immediate human consumption (e.g., institutional food service 
establishments, such as schools, hospitals, and cafeterias; 
transportation carriers, such as trains and airplanes; bakeries, 
delicatessens, and retail confectionery stores where there are 
facilities for immediate consumption on the premises; food service 
vendors, such as lunch wagons, ice cream shops, mall cookie counters, 
vending machines, and sidewalk carts where foods are generally consumed 
immediately where purchased or while the consumer is walking away, 
including similar foods sold from convenience stores; and food delivery 
systems or establishments where ready-to-eat foods are delivered to 
homes or offices), Provided, That the food bears no nutrition claims or 
other nutrition information in any context on the label or in labeling 
or advertising, except as provided in Sec. 101.8(c). Claims or other 
nutrition information, except as provided in Sec. 101.8(c), subject the 
food to the provisions of this section;
    (iii) Sold only in such facilities, Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section;
    (iv) Used only in such facilities and not served to the consumer in 
the package in which they are received (e.g., foods that are not 
packaged in individual serving containers); or
    (v) Sold by a distributor who principally sells food to such 
facilities: Provided, That:
    (A) This exemption shall not be available for those foods that are 
manufactured, processed, or repackaged by that distributor for sale to 
any persons other than restaurants or other establishments that serve 
food for immediate human consumption, and
    (B) The manufacturer of such products is responsible for providing 
the nutrition information on the products if there is a reasonable 
possibility that the product will be purchased directly by consumers.
    (3) Except as provided in Sec. 101.11, food products that are:
    (i) Of the type of food described in paragraphs (j)(2)(i) and 
(j)(2)(ii) of this section,
    (ii) Ready for human consumption,
    (iii) Offered for sale to consumers but not for immediate human 
consumption,
    (iv) Processed and prepared primarily in a retail establishment, and
    (v) Not offered for sale outside of that establishment (e.g., ready-
to-eat foods that are processed and prepared on-site and sold by 
independent delicatessens, bakeries, or retail confectionery stores 
where there are no facilities for immediate human consumption; by in-
store delicatessen, bakery, or candy departments; or at self-service 
food bars such as salad bars), Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section.
    (4) Except as provided in Sec. 101.11, foods that contain 
insignificant amounts of all of the nutrients and food components 
required to be included in the declaration of nutrition information 
under paragraph (c) of this section, Provided, That the food bears no 
nutrition claims or other nutrition

[[Page 57]]

information in any context on the label or in labeling or advertising. 
Claims or other nutrition information, except as provided in Sec. 
101.8(c), subject the food to the provisions of this section. An 
insignificant amount of a nutrient or food component shall be that 
amount that allows a declaration of zero in nutrition labeling, except 
that for total carbohydrate, dietary fiber, and protein, it shall be an 
amount that allows a declaration of ``less than 1 gram.'' Examples of 
foods that are exempt under this paragraph include coffee beans (whole 
or ground), tea leaves, plain unsweetened instant coffee and tea, 
condiment-type dehydrated vegetables, flavor extracts, and food colors.
    (5)(i) Foods, other than infant formula, represented or purported to 
be specifically for infants through 12 months of age and children 1 
through 3 years of age shall bear nutrition labeling. The nutrients 
declared for infants through 12 months of age and children 1 through 3 
years of age shall include calories, total fat, saturated fat, trans 
fat, cholesterol, sodium, total carbohydrates, dietary fiber, total 
sugars, added sugars, protein, and the following vitamins and minerals: 
Vitamin D, calcium, iron, and potassium.
    (ii) Foods, other than infant formula, represented or purported to 
be specifically for infants through 12 months of age shall bear 
nutrition labeling, except that:
    (A) Such labeling shall not declare a percent Daily Value for 
saturated fat, trans fat, cholesterol, sodium, dietary fiber, total 
sugars, or added sugars and shall not include a footnote.
    (B) The following sample label illustrates the provisions of 
paragraph (j)(5)(ii) of this section.
[GRAPHIC] [TIFF OMITTED] TR27MY16.009

    (C)-(E) [Reserved]
    (iii) Foods, other than infant formula, represented or purported to 
be specifically for children 1 through 3 years of age shall include a 
footnote that states: ``*The % Daily Value tells you how much a nutrient 
in a serving of food contributes to a daily diet. 1,000 calories a day 
is used for general nutrition advice.''

[[Page 58]]

    (A) The following sample label illustrates the provisions of 
paragraph (j)(5)(iii) of this section.
[GRAPHIC] [TIFF OMITTED] TR27MY16.010

    (B) [Reserved]
    (6) Dietary supplements, except that such foods shall be labeled in 
compliance with Sec. 101.36.
    (7) Infant formula subject to section 412 of the act, as amended, 
except that such foods shall be labeled in compliance with part 107 of 
this chapter.
    (8) Medical foods as defined in section 5(b) of the Orphan Drug Act 
(21 U.S.C. 360ee(b)(3)). A medical food is a food which is formulated to 
be consumed or administered enterally under the supervision of a 
physician and which is intended for the specific dietary management of a 
disease or condition for which distinctive nutritional requirements, 
based on recognized scientific principles, are established by medical 
evaluation. A food is subject to this exemption only if:
    (i) It is a specially formulated and processed product (as opposed 
to a naturally occurring foodstuff used in its natural state) for the 
partial or exclusive feeding of a patient by means of oral intake or 
enteral feeding by tube;
    (ii) It is intended for the dietary management of a patient who, 
because of therapeutic or chronic medical needs, has limited or impaired 
capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or 
certain nutrients, or who has other special medically determined 
nutrient requirements, the dietary management of which cannot be 
achieved by the modification of the normal diet alone;
    (iii) It provides nutritional support specifically modified for the 
management of the unique nutrient needs that result from the specific 
disease or condition, as determined by medical evaluation;
    (iv) It is intended to be used under medical supervision; and
    (v) It is intended only for a patient receiving active and ongoing 
medical

[[Page 59]]

supervision wherein the patient requires medical care on a recurring 
basis for, among other things, instructions on the use of the medical 
food.
    (9) Food products shipped in bulk form that are not for distribution 
to consumers in such form and that are for use solely in the manufacture 
of other foods or that are to be processed, labeled, or repacked at a 
site other than where originally processed or packed.
    (10) Raw fruits, vegetables, and fish subject to section 403(q)(4) 
of the act, except that the labeling of such foods should adhere to 
guidelines in Sec. 101.45. This exemption is contingent on the food 
bearing no nutrition claims or other nutrition information in any 
context on the label or in labeling or advertising. Claims or other 
nutrition information subject the food to nutrition labeling in 
accordance with Sec. 101.45. The term fish includes freshwater or 
marine fin fish, crustaceans, and mollusks, including shellfish, 
amphibians, and other forms of aquatic animal life.
    (11) Packaged single-ingredient products that consist of fish or 
game meat (i.e., animal products not covered under the Federal Meat 
Inspection Act or the Poultry Products Inspection Act, such as flesh 
products from deer, bison, rabbit, quail, wild turkey, or ostrich) 
subject to this section may provide required nutrition information for a 
3-ounce cooked edible portion (i.e., on an ``as prepared'' basis), 
except that:
    (i) Such products that make claims that are based on values as 
packaged must provide nutrition information on an as packaged basis, and
    (ii) Nutrition information is not required for custom processed fish 
or game meats.
    (12) Game meats (i.e., animal products not covered under the Federal 
Meat Inspection Act or the Poultry Products Inspection Act, such as 
flesh products from deer, bison, rabbit, quail, wild turkey, or ostrich) 
may provide required nutrition information on labeling in accordance 
with the provisions of paragraph (a)(2) of this section.
    (13)(i) Foods in small packages that have a total surface area 
available to bear labeling of less than 12 square inches, Provided, That 
the labels for these foods bear no nutrition claims or other nutrition 
information in any context on the label or in labeling or advertising, 
except as provided in Sec. 101.8(c). Claims or other nutrition 
information, except as provided in Sec. 101.8(c), subject the food to 
the provisions of this section.
    (A) 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'').
    (B) When such products bear nutrition labeling, either voluntarily 
or because nutrition claims or other nutrition information is provided, 
all required information shall be in type size no smaller than 6 point 
or all upper-case type of 1-16 inches minimum height, except that 
individual serving-size packages of food served with meals in 
restaurants, institutions, and on board passenger carriers, and not 
intended for sale at retail, may comply with Sec. 101.2(c)(2).
    (ii) 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) and (i) of this section by one or more of the 
following means:
    (A) Presenting the required nutrition information in a tabular or, 
as provided below, 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 label will not accommodate a 
tabular display.
    (1) The following sample label illustrates the tabular display for 
small packages.

[[Page 60]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.011

    (2) The following sample label illustrates the linear display.
    [GRAPHIC] [TIFF OMITTED] TR27MY16.012
    
    (B) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
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. This abbreviation can also be used on 
    dual-column displays as shown in paragraphs (e)(5), (e)(6)(i), and 
    (e)(6)(ii).
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Vitamin--Vit
Potassium--Potas
Includes--Incl. This abbreviation can also be used on dual-column 
    displays as shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of 
    this section.

    (C) Presenting the required nutrition information on any label 
panel.
    (14) Shell eggs packaged in a carton that has a top lid designed to 
conform to the shape of the eggs are exempt from outer carton label 
requirements where the required nutrition information is clearly 
presented immediately beneath the carton lid or in an insert that can be 
clearly seen when the carton is opened.
    (15) The unit containers in a multiunit retail food package where:
    (i) The multiunit retail food package labeling contains all 
nutrition information in accordance with the requirements of this 
section;
    (ii) The unit containers are securely enclosed within and not 
intended to be separated from the retail package under conditions of 
retail sale; and
    (iii) Each unit container is labeled with the statement ``This Unit 
Not Labeled For Retail Sale'' in type size not less than 1/16-inch in 
height, except that this statement shall not be required when the inner 
unit containers bear no labeling at all. The word ``individual'' may be 
used in lieu of or immediately preceding the word ``Retail'' in the 
statement.
    (16) Food products sold from bulk containers: Provided, That 
nutrition information required by this section be

[[Page 61]]

displayed to consumers either on the labeling of the bulk container 
plainly in view or in accordance with the provisions of paragraph (a)(2) 
of this section.
    (17) Foods 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 label. The space 
needed for vignettes, designs, and other nonmandatory label information 
on the principal display panel may be considered in determining the 
sufficiency of available space on the principal display panel for the 
placement of the nutrition label. Nonmandatory label information on the 
information panel shall not be considered in determining the sufficiency 
of available space for the placement of the nutrition label.
    (18) Food products that are low-volume (that is, they meet the 
requirements for units sold in paragraphs (j)(18)(i) or (j)(18)(ii) of 
this section); that, except as provided in paragraph (j)(18)(iv) of this 
section, are the subject of a claim for an exemption that provides the 
information required under paragraph (j)(18)(iv) of this section, that 
is filed before the beginning of the time period for which the exemption 
is claimed, and that is filed by a person, whether it is the 
manufacturer, packer, or distributor, that qualifies to claim the 
exemption under the requirements for average full-time equivalent 
employees in paragraphs (j)(18)(i) or (j)(18)(ii) of this section; and 
whose labels, labeling, and advertising do not provide nutrition 
information or make a nutrient content or health claim.
    (i) For food products first introduced into interstate commerce 
before May 8, 1994, the product shall be exempt for the period:
    (A) Between May 8, 1995, and May 7, 1996, if, for the period between 
May 8, 1994, and May 7, 1995, the person claiming the exemption employed 
fewer than an average of 300 full-time equivalent employees and fewer 
than 400,000 units of that product were sold in the United States; and
    (B) Between May 8, 1996, and May 7, 1997, if for the period between 
May 8, 1995, and May 7, 1996, the person claiming the exemption employed 
fewer than an average of 200 full-time equivalent employees and fewer 
than 200,000 units of that product were sold in the United States.
    (ii) For all other food products, the product shall be eligible for 
an exemption for any 12-month period if, for the preceding 12 months, 
the person claiming the exemption employed fewer than an average of 100 
full-time equivalent employees and fewer than 100,000 units of that 
product were sold in the United States, or in the case of a food product 
that was not sold in the 12-month period preceding the period for which 
exemption is claimed, fewer than 100,000 units of such product are 
reasonably anticipated to be sold in the United States during the period 
for which exemption is claimed.
    (iii) If a person claims an exemption under paragraphs (j)(18)(i) or 
(j)(18)(ii) of this section for a food product and then, during the 
period of such exemption, the number of full-time equivalent employees 
of such person exceeds the appropriate number, or the number of food 
products sold in the United States exceeds the appropriate number, or, 
if at the end of the period of such exemption, the food product no 
longer qualifies for an exemption under the provisions of paragraphs 
(j)(18)(i) or (j)(18)(ii) of this section, such person shall have 18 
months from the date that the product was no longer qualified as a low-
volume product of a small business to comply with this section.
    (iv) A notice shall be filed with the Office of Nutrition and Food 
Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740 and 
contain the following information, except that if the person is not an 
importer and has fewer than 10 full-time equivalent employees, that 
person does not have to file a notice for any food product with annual 
sales of fewer than 10,000 total units:

[[Page 62]]

    (A) Name and address of person requesting exemption. This should 
include a telephone number or FAX number that can be used to contact the 
person along with the name of a specific contact;
    (B) Names of the food products (including the various brand names) 
for which exemption is claimed;
    (C) Name and address of the manufacturer, distributor, or importer 
of the food product for which an exemption is claimed, if different than 
the person that is claiming the exemption;
    (D) The number of full-time equivalent employees. Provide the 
average number of full-time equivalent individuals employed by the 
person and its affiliates for the 12 months preceding the period for 
which a small business exemption is claimed for a product. The average 
number of full-time equivalent employees is to be determined by dividing 
the total number of hours of salary or wages paid to employees of the 
person and its affiliates by the number of hours of work in a year, 
2,080 hours (i.e., 40 hours x 52 weeks);
    (E) Approximate total number of units of the food product sold by 
the person in the United States in the 12-month period preceding that 
for which a small business exemption is claimed. Provide the approximate 
total number of units sold, or expected to be sold, in a 12-month period 
for each product for which an exemption is claimed. For products that 
have been in production for 1 year or more prior to the period for which 
exemption is claimed, the 12-month period is the period immediately 
preceding the period for which an exemption is claimed. For other 
products, the 12-month period is the period for which an exemption is 
claimed; and
    (F) The notice shall be signed by a responsible individual for the 
person who can certify the accuracy of the information presented in the 
notice. The individual shall certify that the information contained in 
the notice is a complete and accurate statement of the average number of 
full-time equivalent employees of this person and its affiliates and of 
the number of units of the product for which an exemption is claimed 
sold by the person. The individual shall also state that should the 
average number of full-time equivalent employees or the number of units 
of food products sold in the United States by the person exceed the 
applicable numbers for the time period for which exemption is claimed, 
the person will notify FDA of that fact and the date on which the number 
of employees or the number of products sold exceeded the standard.
    (v) FDA may by regulation lower the employee or units of food 
products requirements of paragraph (j)(18)(ii) of this section for any 
food product first introduced into interstate commerce after May 8, 
2002, if the agency determines that the cost of compliance with such 
lower requirement will not place an undue burden on persons subject to 
it.
    (vi) For the purposes of this paragraph, the following definitions 
apply:
    (A) Unit means the packaging or, if there is no packaging, the form 
in which a food product is offered for sale to consumers.
    (B) Food product means food in any sized package which is 
manufactured by a single manufacturer or which bears the same brand 
name, which bears the same statement of identity, and which has similar 
preparation methods.
    (C) Person means all domestic and foreign affiliates, as defined in 
13 CFR 121.401, of the corporation, in the case of a corporation, and 
all affiliates, as defined in 13 CFR 121.401, of a firm or other entity, 
when referring to a firm or other entity that is not a corporation.
    (D) Full-time equivalent employee means all individuals employed by 
the person claiming the exemption. This number shall be determined by 
dividing the total number of hours of salary or wages paid directly to 
employees of the person and of all of its affiliates by the number of 
hours of work in a year, 2,080 hours (i.e., 40 hours x 52 weeks).
    (k) A food labeled under the provisions of this section shall be 
deemed to be misbranded under sections 201(n) and 403(a) of the act if 
its label or labeling represents, suggests, or implies:
    (1) That the food, because of the presence or absence of certain 
dietary properties, is adequate or effective in the

[[Page 63]]

prevention, cure, mitigation, or treatment of any disease or symptom. 
Information about the relationship of a dietary property to a disease or 
health-related condition may only be provided in conformance with the 
requirements of Sec. 101.14 and part 101, subpart E.
    (2) That the lack of optimum nutritive quality of a food, by reason 
of the soil on which that food was grown, is or may be responsible for 
an inadequacy or deficiency in the quality of the daily diet.
    (3) That the storage, transportation, processing, or cooking of a 
food is or may be responsible for an inadequacy or deficiency in the 
quality of the daily diet.
    (4) That a natural vitamin in a food is superior to an added or 
synthetic vitamin.
    (l) The standards required in this section are incorporated by 
reference into this section with the approval of the Director of the 
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved 
material is available for inspection at the Office of Nutrition and Food 
Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2404 and is available from the sources indicated below. 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.
    (1) AOAC Reseller. Techstreet, 6300 Interfirst Dr., Ann Arbor, MI 
48108, Toll free in United States: 1-800-699-9277, Outside United 
States: 1-734-780-8000, Fax: 1-734-780-2046, www.techstreet.com, 
[email protected]. FDA does not endorse any 
particular reseller and notes that other resellers also may have the 
reference for sale. Consult FDA at 240-402-2404 for more information on 
additional resellers.
    (i) ``Official Methods of Analysis of the AOAC INTERNATIONAL,'' 19th 
Edition, Volumes 1 and 2, 2012.
    (ii) [Reserved]
    (2) Food and Agriculture Organization of the United Nations/World 
Health Organization (FAO/WHO), Publications Division, Viale delle Terme 
di Caracalla, 00100 Rome, Italy
    (i) FAO Food and Nutrition Paper 51,''Report of the Joint FAO/WHO 
Expert Consultation on Protein Quality Evaluation,'' Rome, 1991. http://
apps.who.int/iris/bitstream/ 10665/38133/1/9251030979_eng.pdf.
    (ii) [Reserved]
    (3) United States Department of Agriculture (USDA), Agricultural 
Research Service, Washington, DC, Nutrient Data Laboratory, Bldg. 005 
Room 105 BARC-West, Beltsville, MD 20705, 301-504-0630. http://
www.ars.usda.gov/News/docs.htm?docid=9447.
    (i) USDA Handbook No. 74, Energy Value of Foods--basis and 
derivation, by A. L. Merrill and B. K. Watt, (slightly revised, 1973) 
http://www.ars.usda.gov/SP2UserFiles/ Place/80400525/Data/Classics/
ah74.pdf.
    (ii) [Reserved]

[58 FR 2175, Jan. 6, 1993]

    Editorial Note: For Federal Register citations affecting Sec. 
101.9, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 101.10  Nutrition labeling of restaurant foods whose labels
or labeling bear nutrient content claims or health claims.

    Nutrition labeling in accordance with Sec. 101.9 shall be provided 
upon request for any restaurant food or meal for which a nutrient 
content claim (as defined in Sec. 101.13 or in subpart D of this part) 
or a health claim (as defined in Sec. 101.14 and permitted by a 
regulation in subpart E of this part) is made, except that information 
on the nutrient amounts that are the basis for the claim (e.g., ``low 
fat, this meal provides less than 10 grams of fat'') may serve as the 
functional equivalent of complete nutrition information as described in 
Sec. 101.9. For the purposes of this section, restaurant food includes 
two categories of food. It includes food which is served in restaurants 
or other establishments in which food is served for immediate human 
consumption or which is sold for sale or use in such establishments. It 
also includes food which is processed and prepared primarily in a retail 
establishment, which

[[Page 64]]

is ready for human consumption, which is of the type described in the 
previous sentence, and which is offered for sale to consumers but not 
for immediate human consumption in such establishment and which is not 
offered for sale outside such establishment. For standard menu items 
that are offered for sale in covered establishments (as defined in Sec. 
101.11(a)), the information in the written nutrition information 
required by Sec. 101.11(b)(2)(ii)(A) will serve to meet the 
requirements of this section. Nutrient levels may be determined by 
nutrient databases, cookbooks, or analyses or by other reasonable bases 
that provide assurance that the food or meal meets the nutrient 
requirements for the claim. Presentation of nutrition labeling may be in 
various forms, including those provided in Sec. 101.45 and other 
reasonable means.

[79 FR 71253, Dec. 1, 2014]



Sec. 101.11  Nutrition labeling of standard menu items in covered
establishments.

    (a) Definitions. The definitions of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this section. In addition, for purposes of this section:
    Authorized official of a restaurant or similar retail food 
establishment means the owner, operator, agent in charge, or other 
person authorized by the owner, operator, or agent in charge to register 
the restaurant or similar retail food establishment, which is not 
otherwise subject to section 403(q)(5)(H) of the Federal Food, Drug, and 
Cosmetic Act, with FDA for the purposes of paragraph (d) of this 
section.
    Combination meal means a standard menu item that consists of more 
than one food item, for example a meal that includes a sandwich, a side 
dish, and a drink. A combination meal may be represented on the menu or 
menu board in narrative form, numerically, or pictorially. Some 
combination meals may include a variable menu item or be a variable menu 
item as defined in this paragraph where the components may vary. For 
example, the side dish may vary among several options (e.g., fries, 
salad, or onion rings) or the drinks may vary (e.g., soft drinks, milk, 
or juice) and the customer selects which of these items will be included 
in the meal.
    Covered establishment means a restaurant or similar retail food 
establishment that is a part of a chain with 20 or more locations doing 
business under the same name (regardless of the type of ownership, e.g., 
individual franchises) and offering for sale substantially the same menu 
items, as well as a restaurant or similar retail food establishment that 
is registered to be covered under paragraph (d) of this section.
    Custom order means a food order that is prepared in a specific 
manner based on an individual customer's request, which requires the 
covered establishment to deviate from its usual preparation of a 
standard menu item, e.g., a club sandwich without the bacon if the 
establishment usually includes bacon in its club sandwich.
    Daily special means a menu item that is prepared and offered for 
sale on a particular day, that is not routinely listed on a menu or menu 
board or offered by the covered establishment, and that is promoted by 
the covered establishment as a special menu item for that particular 
day.
    Doing business under the same name means sharing the same name. The 
term ``name'' refers to either:
    (i) The name of the establishment presented to the public; or
    (ii) If there is no name of the establishment presented to the 
public (e.g., an establishment with the generic descriptor ``concession 
stand''), the name of the parent entity of the establishment. When the 
term ``name'' refers to the name of the establishment presented to the 
public under paragraph (i) of this definition, the term ``same'' 
includes names that are slight variations of each other, for example, 
due to the region, location, or size (e.g., ``New York Ave. Burgers'' 
and ``Pennsylvania Ave. Burgers'' or ``ABC'' and ``ABC Express'').
    Food on display means restaurant-type food that is visible to the 
customer before the customer makes a selection, so long as there is not 
an ordinary expectation of further preparation by the consumer before 
consumption.

[[Page 65]]

    Food that is part of a customary market test means food that appears 
on a menu or menu board for less than 90 consecutive days in order to 
test consumer acceptance of the product.
    Location means a fixed position or site.
    Menu or menu board means the primary writing of the covered 
establishment from which a customer makes an order selection, including, 
but not limited to, breakfast, lunch, and dinner menus; dessert menus; 
beverage menus; children's menus; other specialty menus; electronic 
menus; and menus on the Internet. Determining whether a writing is or is 
part of the primary writing of the covered establishment from which a 
customer makes an order selection depends on a number of factors, 
including whether the writing lists the name of a standard menu item (or 
an image depicting the standard menu item) and the price of the standard 
menu item, and whether the writing can be used by a customer to make an 
order selection at the time the customer is viewing the writing. The 
menus may be in different forms, e.g., booklets, pamphlets, or single 
sheets of paper. Menu boards include those inside a covered 
establishment as well as drive-through menu boards at covered 
establishments.
    Offering for sale substantially the same menu items means offering 
for sale a significant proportion of menu items that use the same 
general recipe and are prepared in substantially the same way with 
substantially the same food components, even if the name of the menu 
item varies, (e.g., ``Bay View Crab Cake'' and ``Ocean View Crab 
Cake''). ``Menu items'' in this definition refers to food items that are 
listed on a menu or menu board or that are offered as self-service food 
or food on display. Restaurants and similar retail food establishments 
that are part of a chain can still be offering for sale substantially 
the same menu items if the availability of some menu items varies within 
the chain. Having the same name may indicate, but does not necessarily 
guarantee, that menu items are substantially the same.
    Restaurant or similar retail food establishment means a retail 
establishment that offers for sale restaurant-type food, except if it is 
a school as defined by 7 CFR 210.2 or 220.2.
    Restaurant-type food means food that is:
    (i) Usually eaten on the premises, while walking away, or soon after 
arriving at another location; and
    (ii) Either:
    (A) Served in restaurants or other establishments in which food is 
served for immediate human consumption or which is sold for sale or use 
in such establishments; or
    (B) Processed and prepared primarily in a retail establishment, 
ready for human consumption, of the type described in paragraph (ii)(A) 
of this definition, and offered for sale to consumers but not for 
immediate human consumption in such establishment and which is not 
offered for sale outside such establishment.
    Self-service food means restaurant-type food that is available at a 
salad bar, buffet line, cafeteria line, or similar self-service facility 
and that is served by the customers themselves. Self-service food also 
includes self-service beverages.
    Standard menu item means a restaurant-type food that is routinely 
included on a menu or menu board or routinely offered as a self-service 
food or food on display.
    Temporary menu item means a food that appears on a menu or menu 
board for less than a total of 60 days per calendar year. The 60 days 
includes the total of consecutive and non-consecutive days the item 
appears on the menu.
    Variable menu item means a standard menu item that comes in 
different flavors, varieties, or combinations, and is listed as a single 
menu item.
    (b) Requirements for nutrition labeling for food sold in covered 
establishments--(1) Applicability. (i) The labeling requirements in this 
paragraph (b) apply to standard menu items offered for sale in covered 
establishments.
    (ii)(A) The labeling requirements in this paragraph (b) do not apply 
to foods that are not standard menu items, including:
    (1) Items such as condiments that are for general use, including 
those placed on the table or on or behind the counter; daily specials; 
temporary

[[Page 66]]

menu items; custom orders; food that is part of a customary market test; 
and
    (2) Self-service food and food on display that is offered for sale 
for less than a total of 60 days per calendar year or fewer than 90 
consecutive days in order to test consumer acceptance.
    (B) The labeling requirements of paragraph (b)(2)(iii) of this 
section do not apply to alcoholic beverages that are foods on display 
and are not self-service foods.
    (2) Nutrition information. (i) Except as provided by paragraph 
(b)(2)(i)(A)(8) of this section, the following must be provided on menus 
and menu boards:
    (A) The number of calories contained in each standard menu item 
listed on the menu or menu board, as usually prepared and offered for 
sale. In the case of multiple-serving standard menu items, this means 
the calories declared must be for the whole menu item listed on the menu 
or menu board as usually prepared and offered for sale (e.g., ``pizza 
pie: 1600 cal''); or per discrete serving unit as long as the discrete 
serving unit (e.g., pizza slice) and total number of discrete serving 
units contained in the menu item are declared on the menu or menu board, 
and the menu item is usually prepared and offered for sale divided in 
discrete serving units (e.g., ``pizza pie: 200 cal/slice, 8 slices''). 
The calories must be declared in the following manner:
    (1) The number of calories must be listed adjacent to the name or 
the price of the associated standard menu item, in a type size no 
smaller than the type size of the name or the price of the associated 
standard menu item, whichever is smaller, in the same color, or a color 
at least as conspicuous as that used for the name of the associated 
standard menu item, and with the same contrasting background or a 
background at least as contrasting as that used for the name of the 
associated standard menu item.
    (2) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increment above 50 calories, 
except that amounts less than 5 calories may be expressed as zero.
    (3) The term ``Calories'' or ``Cal'' must appear as a heading above 
a column listing the number of calories for each standard menu item or 
adjacent to the number of calories for each standard menu item. If the 
term ``Calories'' or ``Cal'' appears as a heading above a column of 
calorie declarations, the term must be in a type size no smaller than 
the smallest type size of the name or price of any menu item on that 
menu or menu board in the same color or a color at least as conspicuous 
as that used for that name or price and in the same contrasting 
background or a background at least as contrasting as that used for that 
name or price. If the term ``Calories'' or ``Cal'' appears adjacent to 
the number of calories for the standard menu item, the term ``Calories'' 
or ``Cal'' must appear in the same type size and in the same color and 
contrasting background as the number of calories.
    (4) Additional requirements that apply to each individual variable 
menu item:
    (i) When the menu or menu board lists flavors or varieties of an 
entire individual variable menu item (such as soft drinks, ice cream, 
doughnuts, dips, and chicken that can be grilled or fried), the calories 
must be declared separately for each listed flavor or variety. Where 
flavors or varieties have the same calorie amounts (after rounding in 
accordance with paragraph (b)(2)(i)(A)(2) of this section), the calorie 
declaration for such flavors or varieties can be listed as a single 
calorie declaration adjacent to the flavors or varieties, provided that 
the calorie declaration specifies that the calorie amount listed 
represents the calorie amounts for each individual flavor or variety.
    (ii) When the menu or menu board does not list flavors or varieties 
for an entire individual variable menu item, and only includes a general 
description of the variable menu item (e.g., ``soft drinks''), the 
calories must be declared for each option with a slash between the two 
calorie declarations where only two options are available (e.g., ``150/
250 calories'') or as a range in accordance with the requirements of 
paragraph (b)(2)(i)(A)(7) of this section where more than two options 
are available (e.g., ``100-250 calories'').
    (iii) When the menu or menu board describes flavors or varieties for 
only

[[Page 67]]

part of an individual variable menu item (such as different types of 
cheese offered in a grilled cheese sandwich (e.g., ``Grilled Cheese 
(Cheddar or Swiss)''), the calories must be declared for each option 
with a slash between the two calorie declarations where only two options 
are available (e.g., ``450/500 calories'') or as a range in accordance 
with the requirements of paragraph (b)(2)(i)(A)(7) of this section where 
more than two options are available (e.g., ``450-550 calories'').
    (5) Additional requirements that apply to a variable menu item that 
is offered for sale with the option of adding toppings listed on the 
menu or menu board. When the menu or menu board lists toppings that can 
be added to a menu item (such as pizza or ice cream):
    (i) The calories must be declared for the basic preparation of the 
menu item as listed (e.g., ``small pizza pie,'' ``single scoop ice 
cream'').
    (ii) The calories must be separately declared for each topping 
listed on the menu or menu board (e.g., pepperoni, sausage, green 
peppers, onions on pizza; fudge, almonds, sprinkles on ice cream), 
specifying that the calories are added to the calories contained in the 
basic preparation of the menu item. Where toppings have the same calorie 
amounts (after rounding in accordance with paragraph (b)(2)(i)(A)(2) of 
this section), the calorie declaration for such toppings can be listed 
as a single calorie declaration adjacent to the toppings, provided that 
the calorie declaration specifies that the calorie amount listed 
represents the calorie amount for each individual topping.
    (iii) The calories for the basic preparation of the menu item must 
be declared for each size of the menu item. The calories for each 
topping listed on the menu or menu board must be declared for each size 
of the menu item, or declared using a slash between the two calorie 
declarations for each topping where only two sizes of the menu item are 
available (e.g., ``adds 150/250 cal'') or as a range for each topping in 
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this 
section where more than two sizes of the menu item are available (e.g., 
``adds 100-250 cal''). If a slash between two calorie declarations or a 
range of calorie declarations is used, the menu or menu board must 
indicate that the variation in calories for each topping arises from the 
size of the menu item to which the toppings are added.
    (iv) If the amount of the topping included on the basic preparation 
of the menu item decreases based on the total number of toppings ordered 
for the menu item (such as is sometimes the case with pizza toppings), 
the calories for each topping must be declared as single values 
representing the calories for each topping when added to a one-topping 
menu item, specifying that the calorie declaration is for the topping 
when added to a one-topping menu item.
    (6) Additional requirements that apply to a combination meal. Except 
as provided in paragraph (b)(2)(i)(A)(6)(iv) of this section:
    (i) When the menu or menu board lists two options for menu items in 
a combination meal (e.g., a sandwich with a side salad or chips), the 
calories must be declared for each option with a slash between the two 
calorie declarations (e.g., ``350/450 calories'').
    (ii) When the menu or menu board lists three or more options for 
menu items in a combination meal (e.g., a sandwich with chips, a side 
salad, or fruit), the calories must be declared as a range in accordance 
with the requirements of paragraph (b)(2)(i)(A)(7) of this section 
(e.g., ``350-500 calories'').
    (iii) When the menu or menu board includes a choice to increase or 
decrease the size of a combination meal, the calorie difference must be 
declared for the increased or decreased size with a slash between two 
calorie declarations (e.g., ``Adds 100/150 calories,'' ``Subtracts 100/
150 calories'') if the menu or menu board lists two options for menu 
items in the combination meal, or as a range in accordance with the 
requirements of paragraph (b)(2)(i)(A)(7) of this section (e.g., ``Adds 
100-250 calories,'' ``Subtracts 100-250 calories'') if the menu or menu 
board lists three or more options for menu items in the combination 
meal.
    (iv) Where the menu or menu board describes an opportunity for a 
consumer to combine standard menu items for a special price 
(e.g.,''Combine Any

[[Page 68]]

Sandwich with Any Soup or Any Salad for $8.99''), and the calories for 
each standard menu item, including each size option as described in 
paragraph (b)(2)(i)(A)(6)(iii) of this section if applicable, available 
for the consumer to combine are declared elsewhere on the menu or menu 
board, the requirements of paragraphs (b)(2)(i)(A)(6)(i), (ii), and 
(iii) of this section do not apply.
    (7) Additional format requirements for declaring calories for an 
individual variable menu item, a combination meal, and toppings as a 
range, if applicable. Calories declared as a range must be in the format 
``xx-yy,'' where ``xx'' is the caloric content of the lowest calorie 
variety, flavor, or combination, and ``yy'' is the caloric content of 
the highest calorie variety, flavor, or combination.
    (8) Exception for a variable menu item that has no clearly 
identifiable upper bound to the range of calories: If the variable menu 
item appears on the menu or menu board and is a self-service food or 
food on display, and there is no clearly identifiable upper bound to the 
range, e.g., all-you-can-eat buffet, then the menu or menu board must 
include a statement, adjacent to the name or price of the item, 
referring customers to the self-service facility for calorie 
information, e.g., ``See buffet for calorie declarations.'' This 
statement must appear in a type size no smaller than the type size of 
the name or price of the variable menu item, whichever is smaller, and 
in the same color or a color at least as conspicuous as that used for 
that name or price, with the same contrasting background or a background 
at least as contrasting as that used for that name or price.
    (9) Additional requirements that apply to beverages that are not 
self-service. For beverages that are not self-service, calories must be 
declared based on the full volume of the cup served without ice, unless 
the covered establishment ordinarily dispenses and offers for sale a 
standard beverage fill (i.e., a fixed amount that is less than the full 
volume of the cup per cup size) or dispenses a standard ice fill (i.e., 
a fixed amount of ice per cup size). If the covered establishment 
ordinarily dispenses and offers for sale a standard beverage fill or 
dispenses a standard ice fill, the covered establishment must declare 
calories based on such standard beverage fill or standard ice fill.
    (B) The following statement designed to enable consumers to 
understand, in the context of a total daily diet, the significance of 
the calorie information provided on menus and menu boards: ``2,000 
calories a day is used for general nutrition advice, but calorie needs 
vary.'' For menus and menu boards targeted to children, the following 
options may be used as a substitute for or in addition to the succinct 
statement: ``1,200 to 1,400 calories a day is used for general nutrition 
advice for children ages 4 to 8 years, but calorie needs vary.'' or 
``1,200 to 1,400 calories a day is used for general nutrition advice for 
children ages 4 to 8 years and 1,400 to 2,000 calories a day for 
children ages 9 to 13 years, but calorie needs vary.''
    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest type size 
of any calorie declaration appearing on the same menu or menu board and 
in the same color or in a color at least as conspicuous as that used for 
the calorie declarations and with the same contrasting background or a 
background at least as contrasting as that used for the calorie 
declarations.
    (2) For menus, this statement must appear on the bottom of each page 
of the menu. On menu pages that also bear the statement required by 
paragraph (b)(2)(i)(C) of this section, this statement must appear 
immediately above, below, or beside the statement required by paragraph 
(b)(2)(i)(C) of this section.
    (3) For menu boards, this statement must appear on the bottom of the 
menu board, immediately above, below, or beside the statement required 
by paragraph (b)(2)(i)(C) of this section.
    (C) The following statement regarding the availability of the 
additional written nutrition information required in paragraph 
(b)(2)(ii) of this section must be on all forms of the menu or menu 
board: ``Additional nutrition information available upon request.''

[[Page 69]]

    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest type size 
of any calorie declaration appearing on the same menu or menu board and 
in the same color or in a color at least as conspicuous as that used for 
the caloric declarations, and with the same contrasting background or a 
background at least as contrasting as that used for the caloric 
declarations.
    (2) For menus, the statement must appear on the bottom of the first 
page with menu items immediately above, below, or beside the succinct 
statement required by paragraph (b)(2)(i)(B) of this section.
    (3) For menu boards, the statement must appear on the bottom of the 
menu board immediately above, below, or beside the succinct statement 
required by paragraph (b)(2)(i)(B) of this section.
    (ii) The following nutrition information for a standard menu item 
must be available in written form on the premises of the covered 
establishment and provided to the customer upon request. This nutrition 
information must be presented in the order listed and using the 
measurements listed, except as provided in paragraph (b)(2)(ii)(B) of 
this section. Rounding of these nutrients must be in compliance with 
Sec. 101.9(c). The information must be presented in a clear and 
conspicuous manner, including using a color, type size, and contrasting 
background that render the information likely to be read and understood 
by the ordinary individual under customary conditions of purchase and 
use. Covered establishments may use the abbreviations allowed for 
Nutrition Facts for certain packaged foods in Sec. 101.9(j)(13)(ii)(B):
    (A)(1) Total calories (cal);
    (2) Calories from fat (fat cal);
    (3) Total fat (g);
    (4) Saturated fat (g);
    (5) Trans fat (g);
    (6) Cholesterol (mg);
    (7) Sodium (mg);
    (8) Total carbohydrate (g);
    (9) Dietary fiber (g);
    (10) Sugars (g); and
    (11) Protein (g).
    (B) If a standard menu item contains insignificant amounts of all 
the nutrients required to be disclosed in paragraph (b)(2)(ii)(A) of 
this section, the establishment is not required to include nutrition 
information regarding the standard menu item in the written form. 
However, if the covered establishment makes a nutrient content claim or 
health claim, the establishment is required to provide nutrition 
information on the nutrient that is the subject of the claim in 
accordance with Sec. 101.10. For standard menu items that contain 
insignificant amounts of six or more of the required nutrients, the 
declaration of nutrition information required by paragraph (b)(2)(ii)(A) 
of this section may be presented in a simplified format.
    (1) An insignificant amount is defined as that amount that allows a 
declaration of zero in nutrition labeling, except that for total 
carbohydrates, dietary fiber, and protein, it must be an amount that 
allows a declaration of ``less than one gram.''
    (2) The simplified format must include information, in a column, 
list, or table, on the following nutrients:
    (i) Total calories, total fat, total carbohydrates, protein, and 
sodium; and
    (ii) Calories from fat, and any other nutrients identified in 
paragraph (b)(2)(ii)(A) of this section that are present in more than 
insignificant amounts.
    (3) If the simplified format is used, the statement ``Not a 
significant source of __'' (with the blank filled in with the names of 
the nutrients required to be declared in the written nutrient 
information and calories from fat that are present in insignificant 
amounts) must be included at the bottom of the list of nutrients.
    (C) For variable menu items, the nutrition information listed in 
paragraph (b)(2)(ii)(A) of this section must be declared as follows for 
each size offered for sale:
    (1) The nutrition information required in paragraph (b)(2)(ii)(A) of 
this section must be declared for the basic preparation of the item and, 
separately, for each topping, flavor, or variable component.
    (2) Additional format requirements for toppings if the amount of the 
topping included on the basic preparation of the menu item decreases 
based on

[[Page 70]]

the total number of toppings ordered for the menu item (such as is 
sometimes the case with pizza toppings). The nutrients for such topping 
must be declared as single values representing the nutrients for each 
topping when added to a one-topping menu item, specifying that the 
nutrient declaration is for the topping when added to a one-topping menu 
item.
    (3) If the calories and other nutrients are the same for different 
flavors, varieties, and variable components of the combination meal, 
each variety, flavor, and variable component of the combination meal is 
not required to be listed separately. All items that have the same 
nutrient values could be listed together with the nutrient values listed 
only once.
    (D) The written nutrition information required in paragraph 
(b)(2)(ii)(A) of this section may be provided on a counter card, sign, 
poster, handout, booklet, loose leaf binder, or electronic device such 
as a computer, or in a menu, or in any other form that similarly permits 
the written declaration of the required nutrient content information for 
all standard menu items. If the written nutrition information is not in 
a form that can be given to the customer upon request, it must be 
readily available in a manner and location on the premises that allows 
the customer/consumer to review the written nutrition information upon 
request.
    (iii) The following must be provided for a standard menu item that 
is self-service or on display.
    (A) Calories per displayed food item (e.g., a bagel, a slice of 
pizza, or a muffin), or if the food is not offered for sale in a 
discrete unit, calories per serving (e.g., scoop, cup), and the serving 
or discrete unit used to determine the calorie content (e.g., ``per 
scoop'' or ``per muffin'') on either: A sign adjacent to and clearly 
associated with the corresponding food; (e.g., ``150 calories per 
scoop); a sign attached to a sneeze guard with the calorie declaration 
and the serving or unit used to determine the calorie content above each 
specific food so that the consumer can clearly associate the calorie 
declaration with the food, except that if it is not clear to which food 
the calorie declaration and serving or unit refers, then the sign must 
also include the name of the food, e.g., ``Broccoli and cheese 
casserole--200 calories per scoop''; or a single sign or placard listing 
the calorie declaration for several food items along with the names of 
the food items, so long as the sign or placard is located where a 
consumer can view the name, calorie declaration, and serving or unit of 
a particular item while selecting that item.
    (1) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per 
displayed food item''; means per each discrete unit offered for sale, 
for example, a bagel, a slice of pizza, or a muffin.
    (2) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per 
serving'' means, for each food:
    (i) Per serving instrument used to dispense the food offered for 
sale, provided that the serving instrument dispenses a uniform amount of 
the food (e.g., a scoop or ladle);
    (ii) If a serving instrument that dispenses a uniform amount of food 
is not used to dispense the food, per each common household measure 
(e.g., cup or tablespoon) offered for sale or per unit of weight offered 
for sale, e.g., per quarter pound or per 4 ounces; or
    (iii) Per total number of fluid ounces in the cup in which a self-
service beverage is served and, if applicable, the description of the 
cup size (e.g., ``140 calories per 12 fluid ounces (small)'').
    (3) The calories must be declared in the following manner:
    (i) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increment above 50 calories 
except that amounts less than 5 calories may be expressed as zero.
    (ii) If the calorie declaration is provided on a sign with the 
food's name, price, or both, the calorie declaration, accompanied by the 
term ``Calories'' or ``Cal'' and the amount of the serving or displayed 
food item on which the calories declaration is based must be in a type 
size no smaller than the type size of the name or price of the menu item 
whichever is smaller, in the same color, or a color that is at least as 
conspicuous as that used for that name or

[[Page 71]]

price, using the same contrasting background or a background at least as 
contrasting as that used for that name or price. If the calorie 
declaration is provided on a sign that does not include the food's name, 
price, or both, the calorie declaration, accompanied by the term 
``Calories'' or ``Cal'' and the amount of the serving or displayed food 
item on which the calorie declaration is based must be clear and 
conspicuous.
    (iii) For self-service beverages, calorie declarations must be 
accompanied by the term ``fluid ounces'' and, if applicable, the 
description of the cup size (e.g., ``small,'' ``medium'').
    (B) For food that is self-service or on display and is identified by 
an individual sign adjacent to the food itself where such sign meets the 
definition of a menu or menu board under paragraph (a) of this section, 
the statement required by paragraph (b)(2)(i)(B) of this section and the 
statement required by paragraph (b)(2)(i)(C) of this section. These two 
statements may appear on the sign adjacent to the food itself; on a 
separate, larger sign, in close proximity to the food that can be easily 
read as the consumer is making order selections; or on a large menu 
board that can be easily read as the consumer is viewing the food.
    (C) The nutrition information in written form required by paragraph 
(b)(2)(ii) of this section, except for packaged food insofar as it bears 
nutrition labeling information required by and in accordance with 
paragraph (b)(2)(ii) of this section and the packaged food, including 
its label, can be examined by a consumer before purchasing the food.
    (c) Determination of nutrient content. (1) A covered establishment 
must have a reasonable basis for its nutrient declarations. Nutrient 
values may be determined by using nutrient databases (with or without 
computer software programs), cookbooks, laboratory analyses, or other 
reasonable means, including the use of Nutrition Facts on labels on 
packaged foods that comply with the nutrition labeling requirements of 
section 403(q)(1) of the Federal Food, Drug, and Cosmetic Act and Sec. 
101.9, FDA nutrient values for raw fruits and vegetables in Appendix C 
of this part, or FDA nutrient values for cooked fish in Appendix D of 
this part.
    (2) Nutrient declarations for standard menu items must be accurate 
and consistent with the specific basis used to determine nutrient 
values. A covered establishment must take reasonable steps to ensure 
that the method of preparation (e.g., types and amounts of ingredients, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were determined.
    (3) A covered establishment must provide to FDA, within a reasonable 
period of time upon request, information substantiating nutrient values 
including the method and data used to derive these nutrient values. This 
information must include the following:
    (i) For nutrient databases:
    (A) The name and version (including the date of the version) of the 
database, and, as applicable, the name of the applicable software 
company and any Web site address for the database. The name and version 
of a database would include the name and version of the computer 
software, if applicable;
    (B) The recipe or formula used as a basis for the nutrient 
declarations;
    (C)(1) Information on:
    (i) The amount of each nutrient that the specified amount of each 
ingredient identified in the recipe contributes to the menu item; and
    (ii) How the database was used including calculations or operations 
(e.g., worksheets or computer printouts) to determine the nutrient 
values for the standard menu items;
    (2) If the information in paragraph (c)(3)(i)(C)(1) of this section 
is not available, certification attesting that the database will provide 
accurate results when used appropriately and that the database was used 
in accordance with its instructions;
    (D) A detailed listing (e.g., printout) of the nutrient values 
determined for each standard menu item.
    (E) Any other information pertinent to the final nutrient values of 
the standard menu item (e.g., information about what might cause slight 
variations in the nutrient profile such as moisture variations);

[[Page 72]]

    (F) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (G) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were determined.
    (ii) For published cookbooks that contain nutritional information 
for recipes in the cookbook:
    (A) The name, author, and publisher of the cookbook used;
    (B) If available, information provided by the cookbook or from the 
author or publisher about how the nutrition information for the recipes 
was obtained;
    (C) A copy of the recipe used to prepare the standard menu item and 
a copy of the nutrition information for that standard menu item as 
provided by the cookbook; and
    (D) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were determined. 
(Recipes may be divided as necessary to accommodate differences in the 
portion size derived from the recipe and that are served as the standard 
menu item but no changes may be made to the proportion of ingredients 
used.)
    (iii) For laboratory analyses:
    (A) A copy of the recipe for the standard menu item used for the 
nutrient analysis;
    (B) The name and address of the laboratory performing the analysis;
    (C) Copies of analytical worksheets, including the analytical 
method, used to determine and verify nutrition information;
    (D) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were determined.
    (iv) For nutrition information provided by other reasonable means:
    (A) A detailed description of the means used to determine the 
nutrition information;
    (B) A recipe or formula used as a basis for the nutrient 
determination;
    (C) Any data derived in determining the nutrient values for the 
standard menu item, e.g., nutrition information about the ingredients 
used with the source of the nutrient information;
    (D) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were determined.
    (d) Voluntary registration to be subject to the menu labeling 
requirements--(1) Applicability. A restaurant or similar retail food 
establishment that is not part of a chain with 20 or more locations 
doing business under the same

[[Page 73]]

name and offering for sale substantially the same menu items may 
voluntarily register to be subject to the requirements established in 
this section. Restaurants and similar retail food establishments that 
voluntarily register will no longer be subject to non-identical State or 
local nutrition labeling requirements.
    (2) Who may register? The authorized official of a restaurant or 
similar retail food establishment as defined in paragraph (a) of this 
section, which is not otherwise subject to paragraph (b) of this 
section, may register with FDA.
    (3) What information is required? Authorized officials for 
restaurants and similar retail food establishments must provide FDA with 
the following information on Form FDA 3757:
    (i) The contact information (including name, address, phone number, 
and email address) for the authorized official;
    (ii) The contact information (including name, address, phone number, 
and email address) of each restaurant or similar retail food 
establishment being registered, as well as the name and contact 
information for an official onsite, such as the owner or manager, for 
each specific restaurant or similar retail food establishment;
    (iii) All trade names the restaurant or similar retail food 
establishment uses;
    (iv) Preferred mailing address (if different from location address 
for each establishment) for purposes of receiving correspondence; and
    (v) Certification that the information submitted is true and 
accurate, that the person submitting it is authorized to do so, and that 
each registered restaurant or similar retail food establishment will be 
subject to the requirements of section 403(q)(5)(H) of the Federal Food, 
Drug, and Cosmetic Act and this section.
    (4) How to register. Authorized officials of restaurants and similar 
retail food establishments who elect to be subject to requirements in 
section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act can 
register by visiting http://www.fda.gov/food/
ingredientspackaginglabeling/ labelingnutrition/ucm217762.htm. FDA has 
created a form (Form 3757) that contains fields requesting the 
information in paragraph (d)(3) of this section and made the form 
available at this Web site. Registrants must use this form to ensure 
that complete information is submitted.
    (i) Information should be submitted by email by typing complete 
information into the form (PDF), saving it on the registrant's computer, 
and sending it by email to [email protected].
    (ii) If email is not available, the registrant can either fill in 
the form (PDF) and print it out (or print out the blank PDF and fill in 
the information by hand or typewriter), and either fax the completed 
form to 301-436-2804 or mail it to FDA, CFSAN Menu and Vending Machine 
Registration, White Oak Building 22, Rm. 0209, 10903 New Hampshire Ave., 
Silver Spring, MD 20993.
    (5) When to renew the registration. To keep the establishment's 
registration active, the authorized official of the restaurant or 
similar retail food establishment must register every other year within 
60 days prior to the expiration of the establishment's current 
registration with FDA. Registration will automatically expire if not 
renewed.
    (e) Signatures. Signatures obtained under paragraph (d) of this 
section that meet the definition of electronic signatures in Sec. 
11.3(b)(7) of this chapter are exempt from the requirements of part 11 
of this chapter.
    (f) Misbranding. A standard menu item offered for sale in a covered 
establishment shall be deemed misbranded under sections 201(n), 403(a), 
403(f) and/or 403(q) of the Federal Food, Drug, and Cosmetic Act if its 
label or labeling is not in conformity with paragraph (b) or (c) of this 
section.

[79 FR 71253, Dec. 1, 2014]



Sec. 101.12  Reference amounts customarily consumed per eating
occasion.

    (a) The general principles and factors that the Food and Drug 
Administration (FDA) considered in arriving at the reference amounts 
customarily consumed per eating occasion (reference amounts) which are 
set forth in paragraph (b) of this section, are that:
    (1) FDA calculated the reference amounts for persons 4 years of age 
or

[[Page 74]]

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) FDA calculated the reference amounts 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 food 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, FDA considered the mean, median, and mode of the consumed 
amount per eating occasion.
    (5) When survey data were insufficient, FDA 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.
    (7) The reference amount is based on the major intended use of the 
food (e.g., milk as a beverage and not as an addition to cereal).
    (8) The reference amounts for products that are consumed as an 
ingredient of other foods, but that may also be consumed in the form in 
which they are purchased (e.g., butter), are based on use in the form 
purchased.
    (9) FDA sought to ensure that foods that have similar dietary usage, 
product characteristics, and customarily consumed amounts have a uniform 
reference amount.
    (b) The following reference amounts shall be used as the basis for 
determining serving sizes for specific products:

  Table 1--Reference Amounts Customarily Consumed per Eating Occasion:
  Foods for Infants and Young Children 1 Through 3 Years of Age \1\ \2\
                                   \3\
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference amount           \4\
------------------------------------------------------------------------
Cereals, dry instant............  15 g..............  _ cup (_ g)
Cereals, prepared, ready-to-      110 g.............  _ cup(s) (_ g)
 serve.
Other cereal and grain products,  7 g for infants     _ cup(s) (_ g) for
 dry ready-to-eat, e.g., ready-    and 20 g for        ready-to-eat
 to-eat cereals, cookies,          young children (1   cereals; piece(s)
 teething biscuits, and toasts.    through 3 years     (_ g) for others
                                   of age) for ready-
                                   to-eat cereals; 7
                                   g for all others.
Dinners, deserts, fruits,         15 g..............  _ tbsp(s) (_ g); _
 vegetables or soups, dry mix.                         cup(s) (_ g)
Dinners, desserts, fruits,        110 g.............  _ cup(s) (_ g);
 vegetables or soups, ready-to-                        cup(s) (_ mL)
 serve, junior type.
Dinners, desserts, fruits,        110 g.............  _ cup(s) (_ g);
 vegetables or soups, ready-to-                        cup(s) (_ mL)
 serve, strained type.

[[Page 75]]

 
Dinners, stews or soups for       170 g.............  _ cup(s) (_ g);
 young children, ready-to-serve.                       cup(s) (_ mL)
Fruits for young children, ready- 125 g.............  _ cup(s) (_ g)
 to-serve.
Vegetables for young children,    70 g..............  _ cup(s) (_ g)
 ready-to-serve.
Eggs/egg yolks, ready-to serve..  55 g..............  _ cup(s) (_ g)
Juices all varieties............  120 mL............  4 fl oz (120 mL)
------------------------------------------------------------------------
\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. We further considered data from the
  National Health and Nutrition Examination Survey, 2003-2004, 2005-
  2006, and 2007-2008 conducted by the Centers for Disease Control and
  Prevention, in the U.S. Department of Health and Human Services.
\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 (e.g., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  mixes, concentrates, dough, batter, fresh and frozen pasta) is the
  amount required to make the reference amount of the prepared form.
  Prepared means prepared for consumption (e.g., cooked).
\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 in 21 CFR 101.9(b).
\4\ The label statements are meant to provide examples of serving size
  statements that may be used on the label, but the specific wording may
  be changed as appropriate for individual products. The term ``piece''
  is used as a generic description of a discrete unit. Manufacturers
  should use the description of a unit that is most appropriate for the
  specific product (e.g., sandwich for sandwiches, cookie for cookies,
  and bar for frozen novelties).


  Table 2--Reference Amounts Customarily Consumed Per Eating Occasion:
                     General Food Supply \1\ \2\ \3\
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference amount           \4\
------------------------------------------------------------------------
Bakery Products:
    Bagels, toaster pastries,     110 g.............  _ piece(s) (_ g)
     muffins (excluding English
     muffins).
    Biscuits, croissants,         55 g..............  _ piece(s) (_ g)
     tortillas, soft bread
     sticks, soft pretzels, corn
     bread, hush puppies,
     scones, crumpets, English
     muffins.
    Breads (excluding sweet       50 g..............  _ piece(s) (_ g)
     quick type), rolls.                               for sliced bread
                                                       and distinct
                                                       pieces (e.g.,
                                                       rolls); 2 oz (56
                                                       g/_ inch slice)
                                                       for unsliced
                                                       bread
    Bread sticks--see crackers..
    Toaster pastries--see
     bagels, toaster pastries,
     muffins (excluding English
     muffins).
    Brownies....................  40 g..............  _ piece(s) (_ g)
                                                       for distinct
                                                       pieces;
                                                       fractional slice
                                                       (_ g) for bulk

[[Page 76]]

 
    Cakes, heavyweight (cheese    125 g.............  _ piece(s) (_ g)
     cake; pineapple upside-down                       for distinct
     cake; fruit, nut, and                             pieces (e.g.,
     vegetable cakes with more                         sliced or
     than or equal to 35 percent                       individually
     of the finished weight as                         packaged
     fruit, nuts, or vegetables                        products); _
     or any of these                                   fractional slice
     combinations) \5\.                                (_ g) for large
                                                       discrete units
    Cakes, mediumweight           80 g..............  _ piece(s) (_ g)
     (chemically leavened cake                         for distinct
     with or without icing or                          pieces (e.g.,
     filling except those                              cupcake); _
     classified as light weight                        fractional slice
     cake; fruit, nut, and                             (_ g) for large
     vegetable cake with less                          discrete units
     than 35 percent of the
     finished weight as fruit,
     nuts, or vegetables or any
     of these combinations;
     light weight cake with
     icing; Boston cream pie;
     cupcake; eclair; cream
     puff) \6\.
    Cakes, lightweight (angel     55 g..............  _ piece(s) (_ g)
     food, chiffon, or sponge                          for distinct
     cake without icing or                             pieces (e.g.,
     filling) \7\.                                     sliced or
                                                       individually
                                                       packaged
                                                       products); _
                                                       fractional slice
                                                       (_ g) for large
                                                       discrete units
    Coffee cakes, crumb cakes,    55 g..............  _ piece(s) (_ g)
     doughnuts, Danish, sweet                          for sliced bread
     rolls, sweet quick type                           and distinct
     breads.                                           pieces (e.g.,
                                                       doughnut); 2 oz
                                                       (56 g/visual unit
                                                       of measure) for
                                                       bulk products
                                                       (e.g., unsliced
                                                       bread)
    Cookies.....................  30 g..............  _ piece(s) (_ g)
    Crackers that are usually     15 g..............  _ piece(s) (_ g)
     not used as snack, melba
     toast, hard bread sticks,
     ice cream cones \8\.
    Crackers that are usually     30 g..............  _ piece(s) (_ g)
     used as snacks.
    Croutons....................  7 g...............  _ tbsp(s) (_ g); _
                                                       cup(s) (_ g); _
                                                       piece(s) (_ g)
                                                       for large pieces
    Eggroll, dumpling, wonton,    20 g..............  _ sheet (_ g);
     or potsticker wrappers.                           wrapper (_ g)
    French toast, crepes,         110 g prepaed for   _ piece(s) (_ g);
     pancakes, variety mixes.      French toast,       _ cup(s) (_ g)
                                   crepes, and         for dry mix
                                   pancakes; 40 g
                                   dry mix for
                                   variety mixes.
    Grain-based bars with or      40 g..............  _ piece(s) (_ g)
     without filling or coating,
     e.g., breakfast bars,
     granola bars, rice cereal
     bars.
    Ice cream cones--see
     crackers.

[[Page 77]]

 
    Pies, cobblers, fruit         125 g.............  _ piece(s) (_ g)
     crisps, turnovers, other                          for distinct
     pastries.                                         pieces; _
                                                       fractional slice
                                                       (_ g) for large
                                                       discrete units
    Pie crust, pie shells,        the allowable       _ fractional
     pastry sheets, (e.g.,         declaration         slice(s) (_ g)
     phyllo, puff pastry sheets).  closest to an 8     for large
                                   square inch         discrete units; _
                                   surface area.       shells (_ g); _
                                                       fractional _
                                                       sheet(s) (_ g)
                                                       for distinct
                                                       pieces (e.g.,
                                                       Pastry sheet).
    Pizza crust.................  55 g..............  _ fractional slice
                                                       (_ g)
    Taco shells, hard...........  30 g..............  _ shell(s) (_ g)
    Waffles.....................  85 g..............  _ piece(s) (_ g)
Beverages:
    Carbonated and noncarbonated  360 mL............  12 fl oz (360 mL)
     beverages, wine coolers,
     water.
    Coffee or tea, flavored and   360 mL prepared...  12 fl oz (360 mL)
     sweetened.
Cereals and Other Grain
 Products:
    Breakfast cereals (hot        1 cup prepared; 40  _ cup(s) (_ g)
     cereal type), hominy grits.   g plain dry
                                   cereal; 55 g
                                   flavored,
                                   sweetened cereal.
    Breakfast cereals, ready-to-  15 g..............  _ cup(s) (_ g)
     eat, weighing less than 20
     g per cup, e.g., plain
     puffed cereal grains.
    Breakfast cereals, ready-to-  40 g..............  _ cup(s) (_ g)
     eat, weighing 20 g or more
     but less than 43 g per cup;
     high fiber cereals
     containing 28 g or more of
     fiber per 100 g.
    Breakfast cereals, ready-to-  60 g..............  _ piece(s) (_ g)
     eat, weighing 43 g or more                        for large
     per cup; biscuit types.                           distinct pieces
                                                       (e.g., biscuit
                                                       type); _ cup(s)
                                                       (_ g) for all
                                                       others
    Bran or wheat germ..........  15 g..............  _ tbsp(s) (_ g); _
                                                       cup(s) (_ g)
    Flours or cornmeal..........  30 g..............  _ tbsp(s) (_ g); _
                                                       cup(s) (_ g)
    Grains, e.g., rice, barley,   140 g prepared; 45  _ cup(s) (_ g)
     plain.                        g dry.
    Pastas, plain...............  140 g prepared; 55  _ cup(s) (_ g); _
                                   g dry.              piece(s) (_ g)
                                                       for large pieces
                                                       (e.g., large
                                                       shells or lasagna
                                                       noodles) or 2 oz
                                                       (56 g/visual unit
                                                       of measure) for
                                                       dry bulk products
                                                       (e.g., spaghetti)
    Pastas, dry, ready-to-eat,    25 g..............  _ cup(s) (_ g)
     e.g., fried canned chow
     mein noodles.
    Starches, e.g., cornstarch,   10 g..............  _ tbsp (_ g)
     potato starch, tapioca, etc.
    Stuffing....................  100 g.............  _ cup(s) (_ g)
Dairy Products and Substitutes:
    Cheese, cottage.............  110 g.............  _ cup (_ g)

[[Page 78]]

 
    Cheese used primarily as      55 g..............  _ cup (_ g)
     ingredients, e.g., dry
     cottage cheese, ricotta
     cheese.
    Cheese, grated hard, e.g.,    5 g...............  _ tbsp (_ g)
     Parmesan, Romano.
    Cheese, all others except     30 g..............  _ piece(s) (_ g)
     those listed as separate                          for distinct
     categories--includes cream                        pieces; _ tbsp(s)
     cheese and cheese spread.                         (_ g) for cream
                                                       cheese and cheese
                                                       spread; 1 oz (28
                                                       g/visual unit of
                                                       measure) for bulk
    Cheese sauce--see sauce
     category.
    Cream or cream substitutes,   15 mL.............  1 tbsp (15 mL)
     fluid.
    Cream or cream substitutes,   2 g...............  _ tsp (_ g)
     powder.
    Cream, half & half..........  30 mL.............  2 tbsp (30 mL)
    Eggnog......................  120 mL............  \1/2\ cup (120
                                                       mL); 4 fl oz (120
                                                       mL)
    Milk, condensed, undiluted..  30 mL.............  2 tbsp (30 mL)
    Milk, evaporated, undiluted.  30 mL.............  2 tbsp (30 mL)
    Milk, milk-substitute         240 mL............  1 cup (240 mL); 8
     beverages, milk-based                             fl oz (240 mL)
     drinks, e.g., instant
     breakfast, meal
     replacement, cocoa, soy
     beverage.
    Shakes or shake substitutes,  240 mL............  1 cup (240 mL); 8
     e.g., dairy shake mixes,                          fl oz (240 mL)
     fruit frost mixes.
    Sour cream..................  30 g..............  _ tbsp (_ g)
    Yogurt......................  170 g.............  _ cup (_ g)
Desserts:
    Ice cream, frozen yogurt,     \2/3\ cup--         \2/3\ cup (_ g), _
     sherbet, frozen flavored      includes the        piece(s) (_ g)
     and sweetened ice and pops,   volume for          for individually
     frozen fruit juices: all      coatings and        wrapped or
     types bulk and novelties      wafers.             packaged products
     (e.g., bars, sandwiches,
     cones, cups).
    Sundae......................  1 cup.............  1 cup (_ g)
    Custards, gelatin, or         \1/2\ cup           _ piece(s) (_ g)
     pudding.                      prepared; amount    for distinct unit
                                   to make \1/2\ cup   (e.g.,
                                   prepared when dry.  individually
                                                       packaged
                                                       products); \1/2\
                                                       cup (_ g) for
                                                       bulk
Dessert Toppings and Fillings:
    Cake frostings or icings....  2 tbsp............  _ tbsp(s) (_ g)
    Other dessert toppings,       2 tbsp............  2 tbsp (_ g); 2
     e.g., fruits, syrups,                             tbsp (30 mL)
     spreads, marshmallow cream,
     nuts, dairy and non-dairy
     whipped toppings.
    Pie fillings................  85 g..............  _ cup(s) (_ g)
Egg and Egg Substitutes:
    Egg mixtures, e.g., egg foo   110 g.............  _ piece(s) (_ g)
     young, scrambled eggs,                            for discrete
     omelets.                                          pieces; _ cup(s)
                                                       (_ g)

[[Page 79]]

 
    Eggs (all sizes) \8\........  50 g..............  1 large, medium,
                                                       etc. (_ g)
    Egg whites, sugared eggs,     An amount to make   _ cup(s) (_ g); _
     sugared egg yolks, and egg    1 large (50 g)      cup(s) (_ mL)
     substitutes (fresh, frozen,   egg.
     dried).
Fats and Oils:
    Butter, margarine, oil,       1 tbsp............  1 tbsp (_ g); 1
     shortening.                                       tbsp (15 mL)
    Butter replacement, powder..  2 g...............  _ tsp(s) (_ g)
    Dressings for salads........  30 g..............  _ tbsp (_ g); _
                                                       tbsp (_ mL)
    Mayonnaise, sandwich          15 g..............  _ tbsp (_ g)
     spreads, mayonnaise-type
     dressings.
    Spray types.................  0.25 g............  About _ seconds
                                                       spray (_ g)
Fish, Shellfish, Game Meats,\9\
 and Meat or Poultry
 Substitutes:
    Bacon substitutes, canned     15 g..............  _ piece(s) (_ g)
     anchovies,\10\ anchovy                            for discrete
     pastes, caviar.                                   pieces; _ tbsp(s)
                                                       (_ g) for others
    Dried, e.g., jerky..........  30 g..............  _ piece(s) (_ g)
    Entrees with sauce, e.g.,     140 g cooked......  _ cup(s) (_ g); 5
     fish with cream sauce,                            oz (140 g/visual
     shrimp with lobster sauce.                        unit of measure)
                                                       if not measurable
                                                       by cup
    Entrees without sauce, e.g.,  85 g cooked; 110 g  _ piece(s) (_ g)
     plain or fried fish and       uncooked \11\.      for discrete
     shellfish, fish and                               pieces; _ cup(s)
     shellfish cake.                                   (_ g); _ oz (_ g/
                                                       visual unit of
                                                       measure) if not
                                                       measurable by cup
                                                       \12\
    Fish, shellfish, or game      85 g..............  _ piece(s) (_ g)
     meat \9\, canned \10\.                            for discrete
                                                       pieces; _ cup(s)
                                                       (_ g); 3 oz (85 g/
                                                       _ cup) for
                                                       products that are
                                                       difficult to
                                                       measure the g
                                                       weight of cup
                                                       measure (e.g.,
                                                       tuna); 3 oz (85 g/
                                                       _ pieces) for
                                                       products that
                                                       naturally vary in
                                                       size (e.g.,
                                                       sardines)
    Substitute for luncheon       55 g..............  _ piece(s) (_ g)
     meat, meat spreads,                               for distinct
     Canadian bacon, sausages,                         pieces (e.g.,
     frankfurters, and seafood.                        slices, links); _
                                                       cup(s) (_ g); 2
                                                       oz (56 g/visual
                                                       unit of measure)
                                                       for nondiscrete
                                                       bulk product
    Smoked or pickled fish,\10\   55 g..............  _ piece(s) (_ g)
     shellfish, or game meat                           for distinct
     \9\; fish or shellfish                            pieces (e.g.,
     spread.                                           slices, links) or
                                                       _ cup(s) (_ g); 2
                                                       oz (56 g/visual
                                                       unit of measure)
                                                       for nondiscrete
                                                       bulk product
    Substitutes for bacon bits--
     see Miscellaneous.
Fruits and Fruit Juices:
    Candied or pickled \10\.....  30 g..............  _ piece(s) (_ g)
    Dehydrated fruits--see snack
     category.
    Dried.......................  40 g..............  _ piece(s) (_ g)
                                                       for large pieces
                                                       (e.g., dates,
                                                       figs, prunes); _
                                                       cup(s) (_ g) for
                                                       small pieces
                                                       (e.g., raisins)

[[Page 80]]

 
    Fruits for garnish or         4 g...............  1 cherry (_ g); _
     flavor, e.g., maraschino                          piece(s) (_ g)
     cherries \10\.
    Fruit relishes, e.g.,         70 g..............  _ cup(s) (_ g)
     cranberry sauce, cranberry
     relish.
    Fruits used primarily as      50 g..............  See footnote \12\
     ingredients, avocado.
    Fruits used primarily as      50 g..............  _ piece(s) (_ g)
     ingredients, others                               for large fruits;
     (cranberries, lemon, lime).                       _ cup(s) (_ g)
                                                       for small fruits
                                                       measurable by
                                                       cup\12\
    Watermelon..................  280 g.............  See footnote \12\
    All other fruits (except      140 g.............  _ piece(s) (_ g)
     those listed as separate                          for large pieces
     categories), fresh, canned                        (e.g.,
     or frozen.                                        strawberries,
                                                       prunes, apricots,
                                                       etc.); _ cup(s)
                                                       (_ g) for small
                                                       pieces (e.g.,
                                                       blueberries,
                                                       raspberries,
                                                       etc.) \12\
    Juices, nectars, fruit        240 mL............  8 fl oz (240 mL)
     drinks.
    Juices used as ingredients,   5 mL..............  1 tsp (5 mL)
     e.g., lemon juice, lime
     juice.
Legumes:
    Tofu,\10\ tempeh............  85 g..............  _ piece(s) (_ g)
                                                       for discrete
                                                       pieces; 3 oz (84
                                                       g/visual unit of
                                                       measure) for bulk
                                                       products
    Beans, plain or in sauce....  130 g for beans in  _ cup (_ g)
                                   sauce or canned
                                   in liquid and
                                   refried beans
                                   prepared; 90 g
                                   for others
                                   prepared; 35 g
                                   dry.
Miscellaneous:
    Baking powder, baking soda,   0.6 g.............  _ tsp (_ g)
     pectin.
    Baking decorations, e.g.,     1 tsp or 4 g if     _ piece(s) (_ g)
     colored sugars and            not measurable by   for discrete
     sprinkles for cookies, cake   teaspoon.           pieces; 1 tsp (_
     decorations.                                      g)
    Batter mixes, bread crumbs..  30 g..............  _ tbsp(s) (_ g); _
                                                       cup(s) (_ g)
    Chewing gum \8\.............  3 g...............  _ piece(s) (_ g)
    Cocoa powder, carob powder,   1 tbsp............  1 tbsp (_ g)
     unsweetened.
    Cooking wine................  30 mL.............  2 tbsp (30 mL)
    Dietary supplements.........  The maximum amount  _ tablet(s), _
                                   recommended, as     capsules(s), _
                                   appropriate, on     packet(s), _
                                   the label for       tsp(s) (_ g),
                                   consumption per     etc.
                                   eating occasion
                                   or, in the
                                   absence of
                                   recommendations,
                                   1 unit, e.g.,
                                   tablet, capsule,
                                   packet,
                                   teaspoonful, etc.
    Meat, poultry, and fish       Amount to make one  _ tsp(s) (_ g); _
     coating mixes, dry;           reference amount    tbsp(s) (_ g)
     seasoning mixes, dry, e.g.,   of final dish.
     chili seasoning mixes,
     pasta salad seasoning mixes.

[[Page 81]]

 
    Milk, milk substitute, and    Amount to make 240  _ fl oz (_ mL); _
     fruit juice concentrates      mL drink (without   tsp (_  g); tbsp
     (without alcohol) (e.g.,      ice).               (_ g)
     drink mixers, frozen fruit
     juice concentrate,
     sweetened cocoa powder).
    Drink mixes (without          Amount to make 360  _ fl oz (_ mL); _
     alcohol): All other types     mL drink (without   tsp (_ g); _ tbsp
     (e.g., flavored syrups and    ice).               (_ g)
     powdered drink mixes).
    Salad and potato toppers,     7 g...............  _ tbsp(s) (_ g)
     e.g., salad crunchies,
     salad crispins, substitutes
     for bacon bits.
    Salt, salt substitutes,       \1/4\ tsp.........  \1/4\ tsp (_ g); _
     seasoning salts (e.g.,                            piece(s) (_ g)
     garlic salt).                                     for discrete
                                                       pieces (e.g.,
                                                       individually
                                                       packaged
                                                       products)
    Seasoning oils and seasoning  1 tbsp............  1 tbsp (_ g)
     sauces (e.g., coconut
     concentrate, sesame oil,
     almond oil, chili oil,
     coconut oil, walnut oil).
    Seasoning pastes (e.g.,       1 tsp.............  1 tsp (_ g)
     garlic paste, ginger paste,
     curry paste, chili paste,
     miso paste), fresh or
     frozen.
    Spices, herbs (other than     \1/4\ tsp or 0.5 g  \1/4\ tsp (_ g); _
     dietary supplements).         if not measurable   piece(s) (_ g) if
                                   by teaspoon.        not measurable by
                                                       teaspoons (e.g.,
                                                       bay leaf)
Mixed Dishes:
    Appetizers, hors d'oeuvres,   85 g, add 35 g for  _ piece(s) (_ g)
     mini mixed dishes, e.g.,      products with
     mini bagel pizzas, breaded    gravy or sauce
     mozzarella sticks, egg        topping.
     rolls, dumplings,
     potstickers, wontons, mini
     quesadillas, mini quiches,
     mini sandwiches, mini pizza
     rolls, potato skins.
    Measurable with cup, e.g.,    1 cup.............  1 cup (_ g)
     casseroles, hash, macaroni
     and cheese, pot pies,
     spaghetti with sauce,
     stews, etc.
    Not measurable with cup,      140 g, add 55 g     _ piece(s) (_ g)
     e.g., burritos, enchiladas,   for products with   for discrete
     pizza, pizza rolls, quiche,   gravy or sauce      pieces; _
     all types of sandwiches.      topping, e.g.,      fractional slice
                                   enchilada with      (_ g) for large
                                   cheese sauce,       discrete units
                                   crepe with white
                                   sauce \13\.
Nuts and Seeds:

[[Page 82]]

 
    Nuts, seeds and mixtures,     30 g..............  _ piece(s) (_ g)
     all types: Sliced, chopped,                       for large pieces
     slivered, and whole.                              (e.g., unshelled
                                                       nuts); _ tbsp(s)
                                                       (_ g); _ cup(s)
                                                       (_ g) for small
                                                       pieces (e.g.,
                                                       peanuts,
                                                       sunflower seeds)
    Nut and seed butters,         2 tbsp............  2 tbsp (_ g)
     pastes, or creams.
    Coconut, nut and seed flours  15 g..............  _ tbsp(s) (_ g); _
                                                       cup (_ g)
Potatoes and Sweet Potatoes/
 Yams:
    French fries, hash browns,    70 g prepared; 85   _ piece(s) (_ g)
     skins, or pancakes.           g for frozen        for large
                                   unprepared French   distinct pieces
                                   fries.              (e.g., patties,
                                                       skins); 2.5 oz
                                                       (70 g/_ pieces)
                                                       for prepared
                                                       fries; 3 oz (84 g/
                                                       _ pieces) for
                                                       unprepared fries
    Mashed, candied, stuffed or   140 g.............  _ piece(s) (_ g)
     with sauce.                                       for discrete
                                                       pieces (e.g.,
                                                       stuffed potato);
                                                       _ cup(s) (_ g)
    Plain, fresh, canned, or      110 g for fresh or  _ piece(s) (_ g)
     frozen.                       frozen; 125 g for   for discrete
                                   vacuum packed;      pieces; _ cup(s)
                                   160 g for canned    (_ g) for sliced
                                   in liquid.          or chopped
                                                       products
Salads:
    Gelatin salad...............  120 g.............  _ cup (_ g)
    Pasta or potato salad.......  140 g.............  _ cup(s) (_ g)
    All other salads, e.g., egg,  100 g.............  _ cup(s) (_ g)
     fish, shellfish, bean,
     fruit, or vegetable salads.
Sauces, Dips, Gravies, and
 Condiments:
    Barbecue sauce, hollandaise   2 tbsp............  2 tbsp (_ g); 2
     sauce, tartar sauce, tomato                       tbsp (30 mL)
     chili sauce, other sauces
     for dipping (e.g., mustard
     sauce, sweet and sour
     sauce), all dips (e.g.,
     bean dips, dairy-based
     dips, salsa).
    Major main entree sauces,     125 g.............  _ cup (_ g); _ cup
     e.g., spaghetti sauce.                            (_ mL)
    Minor main entree sauces      \1/4\ cup.........  \1/4\ cup (_ g);
     (e.g., pizza sauce, pesto                         \1/4\ cup (60 mL)
     sauce, Alfredo sauce),
     other sauces used as
     toppings (e.g., gravy,
     white sauce, cheese sauce),
     cocktail sauce.
    Major condiments, e.g.,       1 tbsp............  1 tbsp (_ g); 1
     catsup, steak sauce, soy                          tbsp (15 mL)
     sauce, vinegar, teriyaki
     sauce, marinades.
    Minor condiments, e.g.,       1 tsp.............  1 tsp (_ g); 1 tsp
     horseradish, hot sauces,                          (5 mL)
     mustards, Worcestershire
     sauce.
Snacks:

[[Page 83]]

 
    All varieties, chips,         30 g..............  _ cup (_ g) for
     pretzels, popcorn, extruded                       small pieces
     snacks, fruit and vegetable-                      (e.g., popcorn);
     based snacks (e.g., fruit                         _ piece(s) (_ g)
     chips), grain-based snack                         for large pieces
     mixes.                                            (e.g., large
                                                       pretzels; pressed
                                                       dried fruit
                                                       sheet); 1 oz (28g/
                                                       visual unit of
                                                       measure) for bulk
                                                       products (e.g.,
                                                       potato chips)
Soups:
    All varieties...............  245 g.............  _ cup (_ g); _ cup
                                                       (_ mL)
    Dry soup mixes, bouillon....  Amount to make 245  _ cup (_ g); _ cup
                                   g.                  (_ mL)
Sugars and Sweets:
    Baking candies (e.g., chips)  15 g..............  _ piece(s) (_ g)
                                                       for large pieces;
                                                       _ tbsp(s) (_ g)
                                                       for small pieces;
                                                       \1/2\ oz (14 g/
                                                       visual unit of
                                                       measure) for bulk
                                                       products
    After-dinner confectioneries  10 g..............  _ piece(s) (_ g)
    Hard candies, breath mints    2 g...............  _ piece(s) (_ g)
     \8\.
    Hard candies, roll-type,      5 g...............  _ piece(s) (_ g)
     mini-size in dispenser
     packages.
    Hard candies, others;         15 mL for liquid    _ piece(s) (_ g)
     powdered candies, liquid      candies; 15 g for   for large pieces;
     candies.                      all others.         _ tbsp(s) (_ g)
                                                       for ``mini-size''
                                                       candies
                                                       measurable by
                                                       tablespoon; _
                                                       straw(s) (_ g)
                                                       for powdered
                                                       candies; _ wax
                                                       bottle(s) (_ mL)
                                                       for liquid
                                                       candies; \1/2\ oz
                                                       (14 g/visual unit
                                                       of measure) for
                                                       bulk products
    All other candies...........  30 g..............  _ piece(s) (_ g);
                                                       1 oz (30 g/visual
                                                       unit of measure)
                                                       for bulk products
    Confectioner's sugar........  30 g..............  _ cup (_ g)
    Honey, jams, jellies, fruit   1 tbsp............  1 tbsp (_ g); 1
     butter, molasses, fruit                           tbsp (15 mL)
     pastes, fruit chutneys.
    Marshmallows................  30 g..............  _ cup(s) (_ g) for
                                                       small pieces; _
                                                       piece(s) (_ g)
                                                       for large pieces
    Sugar.......................  8 g...............  _ tsp (_ g); _
                                                       piece(s) (_ g)
                                                       for discrete
                                                       pieces (e.g.,
                                                       sugar cubes,
                                                       individually
                                                       packaged
                                                       products)
    Sugar substitutes...........  An amount           _ tsp(s) (_ g) for
                                   equivalent to one   solids; _ drop(s)
                                   reference amount    (_ g) for liquid;
                                   for sugar in        _ piece(s) (_ g)
                                   sweetness.          (e.g.,
                                                       individually
                                                       packaged
                                                       products)
    Syrups......................  30 mL for all       2 tbsp (30 mL)
                                   syrups.
Vegetables:
    Dried vegetables, dried       5 g, add 5 g for    _ piece(s); \1/3\
     tomatoes, sun-dried           products packaged   cup (_ g)
     tomatoes, dried mushrooms,    in oil.
     dried seaweed.
    Dried seaweed sheets........  3 g...............  _ piece(s) (_ g);
                                                       _ cup(s) (_ g)

[[Page 84]]

 
    Vegetables primarily used     4 g...............  _ piece(s) (_ g);
     for garnish or flavor                             _ tbsp(s) (_ g)
     (e.g., pimento,\10\                               for chopped
     parsley, fresh or dried).                         products
    Fresh or canned chili         30 g..............  _ piece(s) (_ g)
     peppers, jalapeno peppers,                        \12\; _ tbsp(s)
     other hot peppers, green                          (_ g); _ cup(s)
     onion.                                            (_ g) for sliced
                                                       or chopped
                                                       products
    All other vegetables without  85 g for fresh or   _ piece(s) (_ g)
     sauce: Fresh, canned, or      frozen; 95 g for    for large pieces
     frozen.                       vacuum packed;      (e.g., Brussels
                                   130 g for canned    sprouts); _
                                   in liquid, cream-   cup(s) (_ g) for
                                   style corn,         small pieces
                                   canned or stewed    (e.g., cut corn,
                                   tomatoes,           green peas); 3 oz
                                   pumpkin, or         (84 g/visual unit
                                   winter squash.      of measure) if
                                                       not measurable by
                                                       cup
    All other vegetables with     110 g.............  _ piece(s) (_ g)
     sauce: Fresh, canned, or                          for large pieces
     frozen.                                           (e.g., Brussels
                                                       sprouts); _
                                                       cup(s) (_ g) for
                                                       small pieces
                                                       (e.g., cut corn,
                                                       green peas); 4 oz
                                                       (112 g/visual
                                                       unit of measure)
                                                       if not measurable
                                                       by cup
    Vegetable juice.............  240 mL............  8 fl oz (240 mL)
    Olives \10\.................  15 g..............  _ piece(s) (_ g);
                                                       _ tbsp(s) (_ g)
                                                       for sliced
                                                       products
    Pickles and pickled           30 g..............  1 oz (28 g/visual
     vegetables, all types \10\.                       unit of measure)
    Pickle relishes.............  15 g..............  _ tbsp (_ g)
    Sprouts, all types: Fresh or  1/4 cup...........  \1/4\ cup (_ g)
     canned.
    Vegetable pastes, e.g.,       30 g..............  _ tbsp (_ g)
     tomato paste.
    Vegetable sauces or purees,   60 g..............  _ cup (_ g); _ cup
     e.g., tomato sauce, tomato                        (_ mL)
     puree.
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) 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 and updated
  with data from the National Health and Nutrition Examination Survey,
  2003-2004, 2005-2006 and 2007-2008 conducted by the Centers for
  Diseases Control and Prevention, in the Department of Health and Human
  Services.
\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 (e.g., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  mixes, concentrates, dough, batter, fresh and frozen pasta) is the
  amount required to make the reference amount of the prepared form.
  Prepared means prepared for consumption (e.g., cooked).
\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 in 21 CFR 101.9(b).
\4\ The label statements are meant to provide examples of serving size
  statements that may be used on the label, but the specific wording may
  be changed as appropriate for individual products. The term ``piece''
  is used as a generic description of a discrete unit. Manufacturers
  should use the description of a unit that is most appropriate for the
  specific product (e.g., sandwich for sandwiches, cookie for cookies,
  and bar for ice cream bars). The guidance provided is for the label
  statement of products in ready-to-serve or almost ready-to-serve form.
  The guidance does not apply to the products which require further
  preparation for consumption (e.g., dry mixes, concentrates) unless
  specifically stated in the product category, reference amount, or
  label statement column that it is for these forms of the product. For
  products that require further preparation, manufacturers must
  determine the label statement following the rules in Sec. 101.9(b)
  using the reference amount determined according to Sec. 101.12(c).

[[Page 85]]

 
\5\ Includes cakes that weigh 10 g or more per cubic inch. The serving
  size for fruitcake is 1 \1/2\ ounces.
\6\ Includes cakes that weigh 4 g or more per cubic inch but less than
  10 g per cubic inch.
\7\ Includes cakes that weigh less than 4 g per cubic inch.
\8\ Label serving size for ice cream cones, eggs, and breath mints of
  all sizes will be 1 unit. Label serving size of all chewing gums that
  weigh more than the reference amount that can reasonably be consumed
  at a single-eating occasion will be 1 unit.
\9\ Animal products not covered under the Federal Meat Inspection Act or
  the Poultry Products Inspection Act, such as flesh products from deer,
  bison, rabbit, quail, wild turkey, geese, ostrich, etc.
\10\ 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 (e.g., canned chopped clam in juice).
\11\ The reference amount for the uncooked form does not apply to raw
  fish in Sec. 101.45 or to single-ingredient products that consist of
  fish or game meat as provided for in Sec. 101.9(j)(11).
\12\ For raw fruit, vegetables, and fish, manufacturers should follow
  the label statement for the serving size specified in Appendices C and
  D to part 101 (21 CFR part 101) Code of Federal Regulations.
\13\ Pizza sauce is part of the pizza and is not considered to be sauce
  topping.

    (c) 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, but not the unprepared form, then the reference amount for the 
unprepared product must 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.
    (d) The reference amount for an imitation or substitute food or 
altered food, such as a ``low calorie'' version, shall be the same as 
for the food for which it is offered as a substitute.
    (e) If a food is modified by incorporating air (aerated), and 
thereby the density of the food is lowered by 25 percent or more in 
weight than that of an appropriate reference regular food as described 
in Sec. 101.13(j)(1)(ii)(A), and the reference amount of the regular 
food is in grams, the manufacturer may determine the reference amount of 
the aerated food by adjusting for the difference in density of the 
aerated food relative to the density of the appropriate reference food 
provided that the manufacturer will show FDA detailed protocol and 
records of all data that were used to determine the density-adjusted 
reference amount for the aerated food. The reference amount for the 
aerated food shall be rounded to the nearest 5-g increment. Such 
products shall bear a descriptive term indicating that extra air has 
been incorporated (e.g., whipped, aerated). The density-adjusted 
reference amounts described in paragraph (b) of this section may not be 
used for cakes except for cheese cake. The differences in the densities 
of different types of cakes having different degrees of air 
incorporation have already been taken into consideration in determining 
the reference amounts for cakes in Sec. 101.12(b). In determining the 
difference in density of the aerated and the regular food, the 
manufacturer shall adhere to the following:
    (1) The regular and the aerated product must be the same in size, 
shape, and volume. To compare the densities of products having nonsmooth 
surfaces (e.g., waffles), manufacturers shall use a device or method 
that ensures that the volumes of the regular and the aerated products 
are the same.
    (2) Sample selections for the density measurements shall be done in 
accordance with the provisions in Sec. 101.9(g).
    (3) Density measurements of the regular and the aerated products 
shall be conducted by the same trained operator using the same 
methodology (e.g., the same equipment, procedures, and techniques) under 
the same conditions.
    (4) Density measurements shall be replicated a sufficient number of 
times to ensure that the average of the measurements is representative 
of the true differences in the densities of the regular and the 
``aerated'' products.
    (f) 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

[[Page 86]]

that consist of two or more foods packaged and presented to be consumed 
together (e.g., peanut putter and jelly, cracker and cheese pack, 
pancakes and syrup, cake and frosting), the reference amount for the 
combined product shall be determined using the following rules:
    (1) The reference amount for the combined product must be the 
reference amount, as established in paragraph (b) of this section, for 
the ingredient that is represented as the main ingredient (e.g., peanut 
butter, pancakes, cake) plus proportioned amounts of all minor 
ingredients.
    (2) If the reference amounts are in compatible units, the weights or 
volumes must be summed (e.g., the reference amount for equal volumes of 
peanut butter and jelly for which peanut butter is represented as the 
main ingredient would be 4 tablespoons (tbsp) (2 tbsp peanut butter plus 
2 tbsp jelly)). If the reference amounts are in incompatible units, all 
amounts must be converted to weights and summed, e.g., the reference 
amount for pancakes and syrup would be 110 g (the reference amount for 
pancakes) plus the weight of the proportioned amount of syrup.
    (g) The reference amounts set forth in paragraphs (b) through (f) of 
this section shall be used in determining whether a product meets the 
criteria for nutrient content claims, such as ``low calorie,'' and for 
health 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 parenthesis, by the amount in 
common household measure if the reference amount is expressed in 
measures other than common household measures (e.g., for a beverage, 
``Very low sodium, 35 mg or less per 240 mL (8 fl oz)'').
    (h) The Commissioner of Food and Drugs, either on his or her own 
initiative or in response to a petition submitted pursuant to part 10 of 
this chapter, may issue a proposal to establish or amend a reference 
amount in paragraph (b) of this section. A petition to establish or 
amend a reference amount shall include:
    (1) Objective of the petition;
    (2) A description of the product;
    (3) A complete sample product label including nutrition label, using 
the format established by regulation;
    (4) A description of the form (e.g., dry mix, frozen dough) in which 
the product will be marketed;
    (5) The intended dietary uses of the product with the major use 
identified (e.g., milk as a beverage and chips as a snack);
    (6) 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;
    (7) The population group for which the product will be offered for 
use (e.g., infants, children under 4 years of age);
    (8) 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);
    (9) The suggested reference amount (the amount of edible portion of 
food as consumed, excluding bone, seed, shell, 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.
    (10) The suggested reference amount shall be expressed in metric 
units. Reference amounts for fluids shall be expressed in milliliters. 
Reference amounts for other 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 frozen desserts.

[[Page 87]]

    (i) In expressing the reference amounts in milliliters, the 
following rules shall be followed:
    (A) For volumes greater than 30 milliliters (mL), the volume shall 
be expressed in multiples of 30 mL.
    (B) For volumes less than 30 mL, the volume shall be expressed in 
milliliters equivalent to a whole number of teaspoons or 1 tbsp, i.e., 
5, 10, or 15 mL.
    (ii) In expressing the reference amounts in grams, the following 
general rules shall be followed:
    (A) For quantities greater than 10 g, the quantity shall be 
expressed in the nearest 5-g increment.
    (B) For quantities less than 10 g, exact gram weights shall be used.
    (11) A petition to create a new subcategory of food with its own 
reference amount shall include the following additional information:
    (i) 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 petitioned product and for 
other products in the category, excluding the petitioned product. All 
data must be derived from the same survey data.
    (ii) Documentation supporting the difference in dietary usage and 
product characteristics that affect the consumption size that 
distinguishes the petitioned product from the rest of the products in 
the category.
    (12) A claim for categorical exclusion under Sec. 25.30 or Sec. 
25.32 of this chapter or an environmental assessment under Sec. 25.40 
of this chapter, and
    (13) In conducting research to collect or process food consumption 
data in support of the petition, the following general guidelines should 
be followed.
    (i) Sampled population selected should be representative of the 
demographic and socioeconomic characteristics of the target population 
group for which the food is intended.
    (ii) Sample size (i.e., number of eaters) should be large enough to 
give reliable estimates for customarily consumed amounts.
    (iii) 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.
    (iv) The methodology used to collect or process data should be fully 
documented and should include: study design, sampling procedures, 
materials used (e.g., questionnaire, and 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.
    (14) A statement concerning the feasibility of convening 
associations, corporations, consumers, and other interested parties to 
engage in negotiated rulemaking to develop a proposed rule consistent 
with the Negotiated Rulemaking Act (5 U.S.C. 561).

[58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. 15, 1993, as amended at 
59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994; 62 FR 40598, July 
29, 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 64 FR 
12890, Mar. 16, 1999; 66 FR 56035, Nov. 6, 2001; 81 FR 34041, May 27, 
2016]



Sec. 101.13  Nutrient content claims--general principles.

    (a) This section and the regulations in subpart D of this part apply 
to foods that are intended for human consumption and that are offered 
for sale, including conventional foods and dietary supplements.
    (b) A claim that expressly or implicitly characterizes the level of 
a nutrient of the type required to be in nutrition labeling under Sec. 
101.9 or under Sec. 101.36 (that is, a nutrient content claim) may not 
be made on the label or in labeling of foods unless the claim is made in 
accordance with this regulation and with the applicable regulations in 
subpart D of this part or in part 105 or part 107 of this chapter.
    (1) An expressed nutrient content claim is any direct statement 
about the level (or range) of a nutrient in the food, e.g., ``low 
sodium'' or ``contains 100 calories.''
    (2) An implied nutrient content claim is any claim that:
    (i) Describes the food or an ingredient therein in a manner that 
suggests that a nutrient is absent or

[[Page 88]]

present in a certain amount (e.g., ``high in oat bran''); or
    (ii) Suggests that the food, 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 food intended specifically for use by infants and children less than 
2 years of age unless the claim is specifically provided for in parts 
101, 105, or 107 of this chapter.
    (4) Reasonable variations in the spelling of the terms defined in 
part 101 and their synonyms are permitted provided these variations are 
not misleading (e.g., ``hi'' or ``lo'').
    (5) For dietary supplements, claims for calories, fat, saturated 
fat, and cholesterol may not be made on products that meet the criteria 
in Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie'' 
claims, except, in the case of calorie claims, when an equivalent amount 
of a similar dietary supplement (e.g., another protein supplement) that 
the labeled food resembles and for which it substitutes, normally 
exceeds the definition for ``low calorie'' in Sec. 101.60(b)(2).
    (c) Information that is required or permitted by Sec. 101.9 or 
Sec. 101.36, as applicable, 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'' food is one that may be used interchangeably 
with another food 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 food, the food 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. 101.7(i) 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 shall be no less than one-half the size of 
the claim but no smaller than one-sixteenth of an inch, unless the 
package complies with Sec. 101.2(c)(5), in which case the disclaimer 
may be in type of not less than one thirty-second of an inch.
    (e)(1) Because the use of a ``free'' or ``low'' claim before the 
name of a food implies that the food differs from other foods of the 
same type by virtue of its having a lower amount of the nutrient, only 
foods that have been specially processed, altered, formulated, or 
reformulated so as to lower the amount of the nutrient in the food, 
remove the nutrient from the food, or not include the nutrient in the 
food, may bear such a claim (e.g., ``low sodium potato chips'').
    (2) Any claim for the absence of a nutrient in a food, or that a 
food is low in a nutrient when the food has not been specially 
processed, altered, formulated, or reformulated to qualify for that 
claim shall indicate that the food inherently meets the criteria and 
shall clearly refer to all foods of that type and not merely to the 
particular brand to which the labeling attaches (e.g., ``corn oil, a 
sodium-free food'').
    (f) A nutrient content claim shall be in type size no larger than 
two times the statement of identity and shall not be unduly prominent in 
type style compared to the statement of identity.
    (g) [Reserved]
    (h)(1) If a food, except a meal product as defined in Sec. 
101.13(l), a main dish product as defined in Sec. 101.13(m), or food 
intended specifically for use by infants and children less than 2 years 
of age, contains more than 13.0 g of fat, 4.0 g of saturated fat, 60 
milligrams (mg) of cholesterol, or 480 mg of sodium per

[[Page 89]]

reference amount customarily consumed, per labeled serving, or, for a 
food with a reference amount customarily consumed of 30 g or less or 2 
tablespoons or less, per 50 g (for dehydrated foods that must be 
reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec. 101.9(f)(1), of 
all nutrients per reference amount customarily consumed, the per 50 g 
criterion refers to the ``as prepared'' form), then that food must bear 
a statement disclosing that the nutrient exceeding the specified level 
is present in the food as follows: ``See nutrition information for __ 
content'' with the blank filled in with the identity of the nutrient 
exceeding the specified level, e.g., ``See nutrition information for fat 
content.''
    (2) If a food is a meal product as defined in Sec. 101.13(l), and 
contains more than 26 g of fat, 8.0 g of saturated fat, 120 mg of 
cholesterol, or 960 mg of sodium per labeled serving, then that food 
must disclose, in accordance with the requirements as provided in 
paragraph (h)(1) of this section, that the nutrient exceeding the 
specified level is present in the food.
    (3) If a food is a main dish product as defined in Sec. 101.13(m), 
and contains more than 19.5 g of fat, 6.0 g of saturated fat, 90 mg of 
cholesterol, or 720 mg of sodium per labeled serving, then that food 
must disclose, in accordance with the requirements as provided in 
paragraph (h)(1) of this section, that the nutrient exceeding the 
specified level is present in the food.
    (4)(i) The disclosure statement ``See nutrition information for __ 
content'' shall be in easily legible boldface print or type, in distinct 
contrast to other printed or graphic matter, and in a size no less than 
that required by Sec. 101.7(i) 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 disclosure statement shall be no less than one-half the size of the 
claim but no smaller than one-sixteenth of an inch, unless the package 
complies with Sec. 101.2(c)(2), in which case the disclosure statement 
may be in type of not less than one thirty-second of an inch.
    (ii) The disclosure statement shall be immediately adjacent to the 
nutrient content claim and may have no intervening material other than, 
if applicable, other information in the statement of identity or any 
other information that is required to be presented with the claim under 
this section (e.g., see paragraph (j)(2) of this section) or under a 
regulation in subpart D of this part (e.g., see Sec. Sec. 101.54 and 
101.62). If the nutrient content claim appears on more than one panel of 
the label, the disclosure statement shall be adjacent to the claim on 
each panel except for the panel that bears the nutrition information 
where it may be omitted.
    (iii) If a single panel of a food label or labeling contains 
multiple nutrient content claims or a single claim repeated several 
times, a single disclosure statement may be made. The statement shall be 
adjacent to the claim that is printed in the largest type on that panel.
    (i) Except as provided in Sec. 101.9 or Sec. 101.36, as 
applicable, 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 food implicitly characterizes 
the level of the nutrient in the food and is consistent with a 
definition for a claim, as provided in subpart D of this part, for the 
nutrient that the label addresses. Such a claim might be, ``less than 3 
g of fat per serving;''
    (2) The use of the statement on the food implicitly characterizes 
the level of the nutrient in the food and is not consistent with such a 
definition, but the label carries a disclaimer adjacent to the statement 
that the food is not ``low'' in or a ``good source'' of the nutrient, 
such as ``only 200 mg sodium per serving, not a low sodium food.'' The 
disclaimer must be in easily legible print or type and in a size no less 
than that required by Sec. 101.7(i) 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 shall be no less than one-half the size of the claim but 
no smaller than one-sixteenth of an inch unless the package complies 
with

[[Page 90]]

Sec. 101.2(c)(5), in which case the disclaimer may be in type of not 
less less than one thirty-second of an inch, or
    (3) The statement does not in any way implicitly characterize the 
level of the nutrient in the food 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. 101.62(b)(6).
    (j) A food may bear a statement that compares the level of a 
nutrient in the food with the level of a nutrient in a reference food. 
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 food must be compared to an amount of 
nutrient in an appropriate reference food as specified below.
    (i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the 
reference food may be a dissimilar food within a product category that 
can generally be substituted for one another in the diet (e.g., potato 
chips as reference for pretzels, orange juice as a reference for vitamin 
C tablets) or a similar food (e.g., potato chips as reference for potato 
chips, one brand of multivitamin as reference for another brand of 
multivitamin).
    (B) For ``light,'' ``reduced,'' ``added,'' ``extra,'' ``plus,'' 
``fortified,'' and ``enriched'' claims, the reference food shall be a 
similar food (e.g., potato chips as a reference for potato chips, one 
brand of multivitamin for another brand of multivitamin), and
    (ii)(A) For ``light'' claims, the reference food shall be 
representative of the type of food that includes the product that bears 
the claim. The nutrient value for the reference food shall be 
representative of a broad base of foods 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 food 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 food 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. 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 label is internally consistent to (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 food 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 foods bearing relative claims:
    (i) The label or labeling must state the identity of the reference 
food and the percentage (or fraction) of the amount of the nutrient in 
the reference food by which the nutrient in the labeled food differs 
(e.g., ``50 percent less fat than (reference food)'' or ``1/3 fewer 
calories than (reference food)''),
    (ii) This information shall be immediately adjacent to the most 
prominent claim. The type size shall be in accordance with paragraph 
(h)(4)(i) of this section.
    (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;

[[Page 91]]

    (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 with that in 
the reference food; and
    (B) This statement shall appear adjacent to the most prominent claim 
or to the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2.
    (3) A relative claim for decreased levels of a nutrient may not be 
made on the label or in labeling of a food if the nutrient content of 
the reference food meets the requirement for a ``low'' claim for that 
nutrient (e.g., 3 g fat or less).
    (k) The term ``modified'' may be used in the statement of identity 
of a food 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 
cheesecake''). This statement of identity must be immediately followed 
by the comparative statement such as ``Contains 35 percent less fat than 
___.'' 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 product shall be 
defined as a food that:
    (1) Makes a major contribution to the total diet by:
    (i) Weighing at least 10 ounces (oz) per labeled serving; and
    (ii) Containing not less than three 40-g 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 group;
    (B) Fruits and vegetables group;
    (C) Milk, yogurt, and cheese group;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts group; except 
that;
    (E) These foods shall not be sauces (except for foods in the above 
four food groups 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 
breakfast, lunch, dinner, or meal. Such representations may be made 
either by statements, photographs, or vignettes.
    (m) For purposes of making a claim, a ``main dish product'' shall be 
defined as a food that:
    (1) Makes a major contribution to a meal by
    (i) Weighing at least 6 oz per labeled serving; and
    (ii) Containing not less than 40 g of food, or combinations of 
foods, from each of at least two of the following four food groups, 
except as noted in paragraph (m)(1)(ii)(E) of this section.
    (A) Bread, cereal, rice, and pasta group;
    (B) Fruits and vegetables group;
    (C) Milk, yogurt, and cheese group;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts groups; except 
that:
    (E) These foods shall not be sauces (except for foods in the above 
four food groups 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 either by statements, photographs, or vignettes.
    (n) Nutrition labeling in accordance with Sec. 101.9, Sec. 101.10, 
or Sec. 101.36, as applicable, shall be provided for any food for which 
a nutrient content claim is made.
    (o) Except as provided in Sec. 101.10, compliance with requirements 
for nutrient content claims in this section and in the regulations in 
subpart D of this part, will be determined using the analytical 
methodology prescribed for determining compliance with nutrition 
labeling in Sec. 101.9.
    (p)(1) Unless otherwise specified, the reference amount customarily 
consumed set forth in Sec. 101.12(b) through (f) shall be used in 
determining whether a

[[Page 92]]

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. 101.12(g) 
(e.g., ``very low sodium, 35 mg or less per 240 milliliters (8 fl 
oz.)'').
    (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 in 
accordance with paragraph (h)(4)(i) of this section.
    (q) The following exemptions apply:
    (1) Nutrient content claims that have not been defined by regulation 
and that are contained in the brand name of a specific food product that 
was the brand name in use on such food before October 25, 1989, may 
continue to be used as part of that brand name for such product, 
provided that they are not false or misleading under section 403(a) of 
the Federal Food, Drug, and Cosmetic Act (the act). However, foods 
bearing such claims must comply with section 403(f), (g), and (h) of the 
act;
    (2) A soft drink that used the term diet as part of its brand name 
before October 25, 1989, and whose use of that term was in compliance 
with Sec. 105.66 of this chapter as that regulation appeared in the 
Code of Federal Regulations on that date, may continue to use that term 
as part of its brand name, provided that its use of the term is not 
false or misleading under section 403(a) of the act. Such claims are 
exempt from the requirements of section 403(r)(2) of the act (e.g., the 
disclosure statement also required by Sec. 101.13(h)). Soft drinks 
marketed after October 25, 1989, may use the term ``diet'' provided they 
are in compliance with the current Sec. 105.66 of this chapter and the 
requirements of Sec. 101.13.
    (3)(i) 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. 101.9 may be made on 
the label or in labeling of a food without a regulation authorizing such 
a claim for a specific vitamin or mineral unless such claim is expressly 
prohibited by regulation under section 403(r)(2)(A)(vi) of the act.
    (ii) Percentage claims for dietary supplements. Under section 
403(r)(2)(F) of the act, a statement that characterizes the percentage 
level of a dietary ingredient for which a reference daily intake (RDI) 
or daily reference value (DRV) has not been established may be made on 
the label or in labeling of dietary supplements without a regulation 
that specifically defines such a statement. All such claims shall be 
accompanied by any disclosure statement required under paragraph (h) of 
this section.
    (A) Simple percentage claims. Whenever a statement is made that 
characterizes the percentage level of a dietary ingredient for which 
there is no RDI or DRV, the statement of the actual amount of the 
dietary ingredient per serving shall be declared next to the percentage 
statement (e.g., ``40 percent omega-3 fatty acids, 10 mg per capsule'').
    (B) Comparative percentage claims. Whenever a statement is made that 
characterizes the percentage level of a dietary ingredient for which 
there is no RDI or DRV and the statement draws a comparison to the 
amount of the dietary ingredient in a reference food, the reference food 
shall be clearly identified, the amount of that food shall be 
identified, and the information on the actual amount of the dietary 
ingredient in both foods shall be declared in accordance with paragraph 
(j)(2)(iv) of this section (e.g., ``twice the omega-3 fatty acids per 
capsule (80 mg) as in 100 mg of menhaden oil (40 mg)'').
    (4) The requirements of this section do not apply to:
    (i) Infant formulas subject to section 412(h) of the act; and
    (ii) Medical foods defined by section 5(b) of the Orphan Drug Act.
    (5) A nutrient content claim used on food that is served in 
restaurants or other establishments in which food is served for 
immediate human consumption or which is sold for sale or use in such 
establishments shall comply with the requirements of this section and

[[Page 93]]

the appropriate definition in subpart D of this part, except that:
    (i) Such claim is exempt from the requirements for disclosure 
statements in paragraph (h) of this section and Sec. Sec. 101.54(d), 
101.62(c), (d)(1)(ii)(D), (d)(2)(iii)(C), (d)(3), (d)(4)(ii)(C), and 
(d)(5)(ii)(C); and
    (ii) In lieu of analytical testing, compliance may be determined 
using a reasonable basis for concluding that the food that bears the 
claim meets the definition for the claim. This reasonable basis may 
derive from recognized data bases for raw and processed foods, recipes, 
and other means to compute nutrient levels in the foods or meals and may 
be used provided reasonable steps are taken to ensure that the method of 
preparation adheres to the factors on which the reasonable basis was 
determined (e.g., types and amounts of ingredients, cooking 
temperatures, etc.). Firms making claims on foods based on this 
reasonable basis criterion are required to provide to appropriate 
regulatory officials on request the specific information on which their 
determination is based and reasonable assurance of operational adherence 
to the preparation methods or other basis for the claim; and
    (iii) A term or symbol that may in some contexts constitute a claim 
under this section may be used, provided that the use of the term or 
symbol does not characterize the level of a nutrient, and a statement 
that clearly explains the basis for the use of the term or symbol is 
prominently displayed and does not characterize the level of a nutrient. 
For example, a term such as ``lite fare'' followed by an asterisk 
referring to a note that makes clear that in this restaurant ``lite 
fare'' means smaller portion sizes than normal; or an item bearing a 
symbol referring to a note that makes clear that this item meets the 
criteria for the dietary guidance established by a recognized dietary 
authority would not be considered a nutrient content claim under Sec. 
101.13.
    (6) Nutrient content claims that were part of the common or usual 
names of foods that were subject to a standard of identity on November 
8, 1990, are not subject to the requirements of paragraphs (b) and (h) 
of this section or to definitions in subpart D of this part.
    (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 the Food 
and Drug Administration. Petitions requesting approval of such a claim 
may be submitted under Sec. 101.69(o).
    (8) The term fluoridated, fluoride added or with added fluoride may 
be used on the label or in labeling of bottled water that contains added 
fluoride.

[58 FR 2410, Jan. 6, 1993; 58 FR 17341, 17342, Apr. 2, 1993, as amended 
at 58 FR 44030, Aug. 18, 1993; 59 FR 393, Jan. 4, 1994; 59 FR 15051, 
Mar. 31, 1994; 60 FR 17205, Apr. 5, 1995; 61 FR 11731, Mar. 22, 1996; 61 
FR 40332, Aug. 2, 1996; 61 FR 67452, Dec. 23, 1996; 62 FR 31339, June 9, 
1997; 62 FR 49867, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 63 FR 
26980, May 15, 1998; 81 FR 59131, Aug. 29, 2016]



Sec. 101.14  Health claims: general requirements.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    (1) Health claim means any claim made on the label or in labeling of 
a food, including a dietary supplement, that expressly or by 
implication, including ``third party'' references, written statements 
(e.g., a brand name including a term such as ``heart''), symbols (e.g., 
a heart symbol), or vignettes, characterizes the relationship of any 
substance to a disease or health-related condition. Implied health 
claims include those statements, symbols, vignettes, or other forms of 
communication that suggest, within the context in which they are 
presented, that a relationship exists between the presence or level of a 
substance in the food and a disease or health-related condition.
    (2) Substance means a specific food or component of food, regardless 
of whether the food is in conventional food form or a dietary supplement 
that includes vitamins, minerals, herbs, or other similar nutritional 
substances.
    (3) Nutritive value means a value in sustaining human existence by 
such processes as promoting growth, replacing loss of essential 
nutrients, or providing energy.
    (4) Disqualifying nutrient levels means the levels of total fat, 
saturated fat, cholesterol, or sodium in a food above

[[Page 94]]

which the food will be disqualified from making a health claim. These 
levels are 13.0 grams (g) of fat, 4.0 g of saturated fat, 60 milligrams 
(mg) of cholesterol, or 480 mg of sodium, per reference amount 
customarily consumed, per label serving size, and, only for foods with 
reference amounts customarily consumed of 30 g or less or 2 tablespoons 
or less, per 50 g. For dehydrated foods that must have water added to 
them prior to typical consumption, the per 50-g criterion refers to the 
as prepared form. Any one of the levels, on a per reference amount 
customarily consumed, a per label serving size or, when applicable, a 
per 50 g basis, will disqualify a food from making a health claim unless 
an exception is provided in subpart E of this part, except that:
    (i) The levels for a meal product as defined in Sec. 101.13(l) are 
26.0 g of fat, 8.0 g of saturated fat, 120 mg of cholesterol, or 960 mg 
of sodium per label serving size, and
    (ii) The levels for a main dish product as defined in Sec. 
101.13(m) are 19.5 g of fat, 6.0 g of saturated fat, 90 mg of 
cholesterol, or 720 mg of sodium per label serving size.
    (5) Disease or health-related condition means damage to an organ, 
part, structure, or system of the body such that it does not function 
properly (e.g., cardiovascular disease), or a state of health leading to 
such dysfunctioning (e.g., hypertension); except that diseases resulting 
from essential nutrient deficiencies (e.g., scurvy, pellagra) are not 
included in this definition (claims pertaining to such diseases are 
thereby not subject to Sec. 101.14 or Sec. 101.70).
    (b) Eligibility. For a substance to be eligible for a health claim:
    (1) The substance must be associated with a disease or health-
related condition for which the general U.S. population, or an 
identified U.S. population subgroup (e.g., the elderly) is at risk, or, 
alternatively, the petition submitted by the proponent of the claim 
otherwise explains the prevalence of the disease or health-related 
condition in the U.S. population and the relevance of the claim in the 
context of the total daily diet and satisfies the other requirements of 
this section.
    (2) If the substance is to be consumed as a component of a 
conventional food at decreased dietary levels, the substance must be a 
nutrient listed in 21 U.S.C. 343(q)(1)(C) or (q)(1)(D), or one that the 
Food and Drug Administration (FDA) has required to be included in the 
label or labeling under 21 U.S.C. 343(q)(2)(A); or
    (3) If the substance is to be consumed at other than decreased 
dietary levels:
    (i) The substance must, regardless of whether the food is a 
conventional food or a dietary supplement, contribute taste, aroma, or 
nutritive value, or any other technical effect listed in Sec. 170.3(o) 
of this chapter, to the food and must retain that attribute when 
consumed at levels that are necessary to justify a claim; and
    (ii) The substance must be a food or a food ingredient or a 
component of a food ingredient whose use at the levels necessary to 
justify a claim has been demonstrated by the proponent of the claim, to 
FDA's satisfaction, to be safe and lawful under the applicable food 
safety provisions of the Federal Food, Drug, and Cosmetic Act.
    (c) Validity requirement. FDA will promulgate regulations 
authorizing a health claim only when it determines, based on the 
totality of publicly available scientific evidence (including evidence 
from well-designed studies conducted in a manner which is consistent 
with generally recognized scientific procedures and principles), that 
there is significant scientific agreement, among experts qualified by 
scientific training and experience to evaluate such claims, that the 
claim is supported by such evidence.
    (d) General health claim labeling requirements. (1) When FDA 
determines that a health claim meets the validity requirements of 
paragraph (c) of this section, FDA will propose a regulation in subpart 
E of this part to authorize the use of that claim. If the claim pertains 
to a substance not provided for in Sec. 101.9 or Sec. 101.36, FDA will 
propose amending that regulation to include declaration of the 
substance.
    (2) When FDA has adopted a regulation in subpart E of this part 
providing for a health claim, firms may make claims based on the 
regulation in subpart E of this part, provided that:

[[Page 95]]

    (i) All label or labeling statements about the substance-disease 
relationship that is the subject of the claim are based on, and 
consistent with, the conclusions set forth in the regulations in subpart 
E of this part;
    (ii) The claim is limited to describing the value that ingestion (or 
reduced ingestion) of the substance, as part of a total dietary pattern, 
may have on a particular disease or health-related condition;
    (iii) The claim is complete, truthful, and not misleading. Where 
factors other than dietary intake of the substance affect the 
relationship between the substance and the disease or health-related 
condition, such factors may be required to be addressed in the claim by 
a specific regulation in subpart E of this part;
    (iv) All information required to be included in the claim appears in 
one place without other intervening material, except that the principal 
display panel of the label or labeling may bear the reference statement, 
``See ___ for information about the relationship between ___ and ___,'' 
with the blanks filled in with the location of the labeling containing 
the health claim, the name of the substance, and the disease or health-
related condition (e.g., ``See attached pamphlet for information about 
calcium and osteoporosis''), with the entire claim appearing elsewhere 
on the other labeling, Provided that, where any graphic material (e.g., 
a heart symbol) constituting an explicit or implied health claim appears 
on the label or labeling, the reference statement or the complete claim 
shall appear in immediate proximity to such graphic material;
    (v) The claim enables the public to comprehend the information 
provided and to understand the relative significance of such information 
in the context of a total daily diet; and
    (vi) If the claim is about the effects of consuming the substance at 
decreased dietary levels, the level of the substance in the food is 
sufficiently low to justify the claim. To meet this requirement, if a 
definition for use of the term low has been established for that 
substance under this part, the substance must be present at a level that 
meets the requirements for use of that term, unless a specific 
alternative level has been established for the substance in subpart E of 
this part. If no definition for ``low'' has been established, the level 
of the substance must meet the level established in the regulation 
authorizing the claim; or
    (vii) If the claim is about the effects of consuming the substance 
at other than decreased dietary levels, the level of the substance is 
sufficiently high and in an appropriate form to justify the claim. To 
meet this requirement, if a definition for use of the term high for that 
substance has been established under this part, the substance must be 
present at a level that meets the requirements for use of that term, 
unless a specific alternative level has been established for the 
substance in subpart E of this part. If no definition for ``high'' has 
been established (e.g., where the claim pertains to a food either as a 
whole food or as an ingredient in another food), the claim must specify 
the daily dietary intake necessary to achieve the claimed effect, as 
established in the regulation authorizing the claim; Provided That:
    (A) Where the food that bears the claim meets the requirements of 
paragraphs (d)(2)(vi) or (d)(2)(vii) of this section based on its 
reference amount customarily consumed, and the labeled serving size 
differs from that amount, the claim shall be followed by a statement 
explaining that the claim is based on the reference amount rather than 
the labeled serving size (e.g., ``Diets low in sodium may reduce the 
risk of high blood pressure, a disease associated with many factors. A 
serving of _ ounces of this product conforms to such a diet.'').
    (B) Where the food that bears the claim is sold in a restaurant or 
in other establishments in which food that is ready for immediate human 
consumption is sold, the food can meet the requirements of paragraphs 
(d)(2)(vi) or (d)(2)(vii) of this section if the firm that sells the 
food has a reasonable basis on which to believe that the food that bears 
the claim meets the requirements of paragraphs (d)(2)(vi) or (d)(2)(vii) 
of this section and provides that basis upon request.
    (3) Nutrition labeling shall be provided in the label or labeling of 
any

[[Page 96]]

food for which a health claim is made in accordance with Sec. 101.9; 
for restaurant foods, in accordance with Sec. 101.10; or for dietary 
supplements, in accordance with Sec. 101.36.
    (e) Prohibited health claims. No expressed or implied health claim 
may be made on the label or in labeling for a food, regardless of 
whether the food is in conventional food form or dietary supplement 
form, unless:
    (1) The claim is specifically provided for in subpart E of this 
part; and
    (2) The claim conforms to all general provisions of this section as 
well as to all specific provisions in the appropriate section of subpart 
E of this part;
    (3) None of the disqualifying levels identified in paragraph (a)(4) 
of this section is exceeded in the food, unless specific alternative 
levels have been established for the substance in subpart E of this 
part; or unless FDA has permitted a claim despite the fact that a 
disqualifying level of a nutrient is present in the food based on a 
finding that such a claim will assist consumers in maintaining healthy 
dietary practices, and, in accordance with the regulation in subpart E 
of this part that makes such a finding, the label bears a disclosure 
statement that complies with Sec. 101.13(h), highlighting the nutrient 
that exceeds the disqualifying level;
    (4) Except as provided in paragraph (e)(3) of this section, no 
substance is present at an inappropriate level as determined in the 
specific provision authorizing the claim in subpart E of this part;
    (5) The label does not represent or purport that the food is for 
infants and toddlers less than 2 years of age except if the claim is 
specifically provided for in subpart E of this part; and
    (6) Except for dietary supplements or where provided for in other 
regulations in part 101, subpart E, the food contains 10 percent or more 
of the Reference Daily Intake or the Daily Reference Value for vitamin 
A, vitamin C, iron, calcium, protein, or fiber per reference amount 
customarily consumed prior to any nutrient addition.
    (f) The requirements of this section do not apply to:
    (1) Infant formulas subject to section 412(h) of the Federal Food, 
Drug, and Cosmetic Act, and
    (2) Medical foods defined by section 5(b) of the Orphan Drug Act.
    (g) Applicability. The requirements of this section apply to foods 
intended for human consumption that are offered for sale, regardless of 
whether the foods are in conventional food form or dietary supplement 
form.

[58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 58 
FR 44038, Aug. 18, 1993; 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31, 
1994; 61 FR 40332, Aug. 2, 1996; 62 FR 49867, Sept. 23, 1997; 63 FR 
26980, May 15, 1998; 66 FR 17358, Mar. 30, 2001]



Sec. 101.15  Food; prominence of required statements.

    (a) A word, statement, or other information required by or under 
authority of the act to appear on the label may lack that prominence and 
conspicuousness required by section 403(f) of the act by reason (among 
other reasons) of:
    (1) The failure of such word, statement, or information to appear on 
the part or panel of the label which is presented or displayed under 
customary conditions of purchase;
    (2) The failure of such word, statement, or information to appear on 
two or more parts or panels of the label, each of which has sufficient 
space therefor, and each of which is so designed as to render it likely 
to be, under customary conditions of purchase, the part or panel 
displayed;
    (3) The failure of the label to extend over the area of the 
container or package available for such extension, so as to provide 
sufficient label space for the prominent placing of such word, 
statement, or information;
    (4) Insufficiency of label space (for the prominent placing of such 
word, statement, or information) resulting from the use of label space 
for any word, statement, design, or device which is not required by or 
under authority of the act to appear on the label;
    (5) Insufficiency of label space (for the prominent placing of such 
word, statement, or information) resulting from the use of label space 
to give materially greater conspicuousness to any

[[Page 97]]

other word, statement, or information, or to any design or device; or
    (6) Smallness or style of type in which such word, statement, or 
information appears, insufficient background contrast, obscuring designs 
or vignettes, or crowding with other written, printed, or graphic 
matter.
    (b) No exemption depending on insufficiency of label space, as 
prescribed in regulations promulgated under section 403 (e) or (i) of 
the act, shall apply if such insufficiency is caused by:
    (1) The use of label space for any word, statement, design, or 
device which is not required by or under authority of the act to appear 
on the label;
    (2) The use of label space to give greater conspicuousness to any 
word, statement, or other information than is required by section 403(f) 
of the act; or
    (3) The use of label space for any representation in a foreign 
language.
    (c)(1) 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 articles distributed solely in the Commonwealth of Puerto Rico 
or in a Territory where the predominant language is one other than 
English, the predominant language may be substituted for English.
    (2) If the label contains any representation in a foreign language, 
all words, statements, and other information required by or under 
authority of the act to appear on the label shall appear thereon in the 
foreign language: Provided, however, That individual serving-size 
packages of foods containing no more than 1\1/2\ avoirdupois ounces or 
no more than 1\1/2\ fluid ounces served with meals in restaurants, 
institutions, and passenger carriers and not intended for sale at retail 
are exempt from the requirements of this paragraph (c)(2), if the only 
representation in the foreign language(s) is the name of the food.
    (3) If any article of labeling (other than a label) contains any 
representation in a foreign language, all words, statements, and other 
information required by or under authority of the act to appear on the 
label or labeling shall appear on such article of labeling.



Sec. 101.17  Food labeling warning, notice, and safe handling 
statements.

    (a) Self-pressurized containers. (1) The label of a food packaged in 
a self-pressurized container and intended to be expelled from the 
package under pressure shall bear the following warning:

    WARNING--Avoid spraying in eyes. Contents under pressure. Do not 
puncture or incinerate. Do not store at temperature above 120 [deg]F. 
Keep out of reach of children.

    (2) In the case of products intended for use by children, the phrase 
``except under adult supervision'' may be added at the end of the last 
sentence in the warning required by paragraph (a)(1) of this section.
    (3) In the case of products packaged in glass containers, the word 
``break'' may be substituted for the word ``puncture'' in the warning 
required by paragraph (a)(1) of this section.
    (4) The words ``Avoid spraying in eyes'' may be deleted from the 
warning required by paragraph (a)(1) of this section in the case of a 
product not expelled as a spray.
    (b) Self-pressurized containers with halocarbon or hydrocarbon 
propellants. (1) In addition to the warning required by paragraph (a) of 
this section, the label of a food packaged in a self-pressurized 
container in which the propellant consists in whole or in part of a 
halocarbon or a hydrocarbon shall bear the following warning:

    WARNING--Use only as directed. Intentional misuse by deliberately 
concentrating and inhaling the contents can be harmful or fatal.

    (2) The warning required by paragraph (b)(1) of this section is not 
required for the following products:
    (i) Products expelled in the form of a foam or cream, which contain 
less than 10 percent propellant in the container.
    (ii) Products in a container with a physical barrier that prevents 
escape of the propellant at the time of use.
    (iii) Products of a net quantity of contents of less than 2 ounces 
that are designed to release a measured amount of product with each 
valve actuation.
    (iv) Products of a net quantity of contents of less than one-half 
ounce.
    (c) Food containing or manufactured with a chloro fluoro carbon or 
other ozone-

[[Page 98]]

depleting substance. Labeling requirements for foods that contain or are 
manufactured with a chlorofluorocarbon or other ozone-depleting 
substance designated by the Environmental Protection Agency (EPA) are 
set forth in 40 CFR part 82.
    (d) Protein products. (1) The label and labeling of any food product 
in liquid, powdered, tablet, capsule, or similar forms that derives more 
than 50 percent of its total caloric value from either whole protein, 
protein hydrolysates, amino acid mixtures, or a combination of these, 
and that is represented for use in reducing weight shall bear the 
following warning:

    WARNING: Very low calorie protein diets (below 400 Calories per day) 
may cause serious illness or death. Do Not Use for Weight Reduction in 
Such Diets Without Medical Supervision. Not for use by infants, 
children, or pregnant or nursing women.

    (2) Products described in paragraph (d)(1) of this section are 
exempt from the labeling requirements of that paragraph if the protein 
products are represented as part of a nutritionally balanced diet plan 
providing 400 or more Calories (kilocalories) per day and the label or 
labeling of the product specifies the diet plan in detail or provides a 
brief description of that diet plan and adequate information describing 
where the detailed diet plan may be obtained and the label and labeling 
bear the following statement:

    Notice: For weight reduction, use only as directed in the 
accompanying diet plan (the name and specific location in labeling of 
the diet plan may be included in this statement in place of 
``accompanying diet plan''). Do not use in diets supplying less than 400 
Calories per day without medical supervision.

    (3) The label and labeling of food products represented or intended 
for dietery (food) supplementation that derive more than 50 percent of 
their total caloric value from either whole protein, protein 
hydrolysates, amino acid mixtures, or a combination of these, that are 
represented specifically for purposes other than weight reduction; and 
that are not covered by the requirements of paragraph (d) (1) and (2) of 
this section; shall bear the following statement:

    Notice: Use this product as a food supplement only. Do not use for 
weight reduction.

    (4) The provisions of this paragraph are separate from and in 
addition to any labeling requirements promulgated by the Federal Trade 
Commission for protein supplements.
    (5) Protein products shipped in bulk form for use solely in the 
manufacture of other foods and not for distribution to consumers in such 
container are exempt from the labeling requirements of this paragraph.
    (6) The warning and notice statements required by paragraphs (d) 
(1), (2), and (3) of this section shall appear prominently and 
conspicuously on the principal display panel of the package label and 
any other labeling.
    (e) Dietary supplements containing iron or iron salts. (1) The 
labeling of any dietary supplement in solid oral dosage form (e.g., 
tablets or capsules) that contains iron or iron salts for use as an iron 
source shall bear the following statement:

    WARNING: Accidental overdose of iron-containing products is a 
leading cause of fatal poisoning in children under 6. Keep this product 
out of reach of children. In case of accidental overdose, call a doctor 
or poison control center immediately.

    (2)(i) The warning statement required by paragraph (e)(1) of this 
section shall appear prominently and conspicuously on the information 
panel of the immediate container label.
    (ii) If a product is packaged in unit-dose packaging, and if the 
immediate container bears labeling but not a label, the warning 
statement required by paragraph (e)(1) of this section shall appear 
prominently and conspicuously on the immediate container labeling in a 
way that maximizes the likelihood that the warning is intact until all 
of the dosage units to which it applies are used.
    (3) Where the immediate container is not the retail package, the 
warning statement required by paragraph (e)(1) of this section shall 
also appear prominently and conspicuously on the information panel of 
the retail package label.
    (4) The warning statement shall appear on any labeling that contains 
warnings.

[[Page 99]]

    (5) The warning statement required by paragraph (e)(1) of this 
section shall be set off in a box by use of hairlines.
    (f) Foods containing psyllium husk. (1) Foods containing dry or 
incompletely hydrated psyllium husk, also known as psyllium seed husk, 
and bearing a health claim on the association between soluble fiber from 
psyllium husk and reduced risk of coronary heart disease, shall bear a 
label statement informing consumers that the appropriate use of such 
foods requires consumption with adequate amounts of fluids, alerting 
them of potential consequences of failing to follow usage 
recommendations, and informing persons with swallowing difficulties to 
avoid consumption of the product (e.g., ``NOTICE: This food should be 
eaten with at least a full glass of liquid. Eating this product without 
enough liquid may cause choking. Do not eat this product if you have 
difficulty in swallowing.''). However, a product in conventional food 
form may be exempt from this requirement if a viscous adhesive mass is 
not formed when the food is exposed to fluids.
    (2) The statement shall appear prominently and conspicuously on the 
information panel or principal display panel of the package label and 
any other labeling to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use. The 
statement shall be preceded by the word ``NOTICE'' in capital letters.
    (g) Juices that have not been specifically processed to prevent, 
reduce, or eliminate the presence of pathogens. (1) For purposes of this 
paragraph (g), ``juice'' means the aqueous liquid expressed or extracted 
from one or more fruits or vegetables, purees of the edible portions of 
one or more fruits or vegetables, or any concentrate of such liquid or 
puree.
    (2) The label of:
    (i) Any juice that has not been processed in the manner described in 
paragraph (g)(7) of this section; or
    (ii) Any beverage containing juice where neither the juice 
ingredient nor the beverage has been processed in the manner described 
in paragraph (g)(7) of this section, shall bear the following warning 
statement:

    WARNING: This product has not been pasteurized and, therefore, may 
contain harmful bacteria that can cause serious illness in children, the 
elderly, and persons with weakened immune systems.

    (3) The warning statement required by this paragraph (g) shall not 
apply to juice that is not for distribution to retail consumers in the 
form shipped and that is for use solely in the manufacture of other 
foods or that is to be processed, labeled, or repacked at a site other 
than originally processed, provided that for juice that has not been 
processed in the manner described in paragraph (g)(7) of this section, 
the lack of such processing is disclosed in documents accompanying the 
juice, in accordance with the practice of the trade.
    (4) The warning statement required by paragraph (g)(2) of this 
section shall appear prominently and conspicuously on the information 
panel or on the principal display panel of the label of the container.
    (5) The word ``WARNING'' shall be capitalized and shall appear in 
bold type.
    (6) The warning statement required by paragraph (g)(2) of this 
section, when on a label, shall be set off in a box by use of hairlines.
    (7)(i) The requirements in this paragraph (g) shall not apply to a 
juice that has been processed in a manner that will produce, at a 
minimum, a reduction in the pertinent microorganism for a period at 
least as long as the shelf life of the product when stored under normal 
and moderate abuse conditions, of the following magnitude:
    (A) A 5-log (i.e., 100,000-fold) reduction; or
    (B) A reduction that is equal to, or greater than, the criterion 
established for process controls by any final regulation requiring the 
application of Hazard Analysis and Critical Control Point (HACCP) 
principles to the processing of juice.
    (ii) For the purposes of this paragraph (g), the ``pertinent 
microorganism'' is the most resistant microorganism of public health 
significance that is likely to occur in the juice.

[[Page 100]]

    (h) Shell eggs. (1) The label of all shell eggs, whether in 
intrastate or interstate commerce, shall bear the following statement:

    SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep 
eggs refrigerated, cook eggs until yolks are firm, and cook foods 
containing eggs thoroughly.

    (2) The label statement required by paragraph (h)(1) of this section 
shall appear prominently and conspicuously, with the words ``SAFE 
HANDLING INSTRUCTIONS'' in bold type, on the principal display panel, 
the information panel, or on the inside of the lid of egg cartons. If 
this statement appears on the inside of the lid, the words ``Keep 
Refrigerated'' must appear on the principal display panel or information 
panel.
    (3) The label statement required by paragraph (h)(1) of this section 
shall be set off in a box by use of hairlines.
    (4) Shell eggs that have been, before distribution to consumers, 
specifically processed to destroy all viable Salmonella shall be exempt 
from the requirements of paragraph (h) of this section.
    (5) The safe handling statement for shell eggs that are not for 
direct sale to consumers, e.g., those that are to be repacked or labeled 
at a site other than where originally processed, or are sold for use in 
food service establishments, may be provided on cartons or in labeling, 
e.g., invoices or bills of lading in accordance with the practice of the 
trade.
    (6) Under sections 311 and 361 of the Public Health Service Act (PHS 
Act), any State or locality that is willing and able to assist the 
agency in the enforcement of paragraphs (h)(1) through (h)(5) of this 
section, and is authorized to inspect or regulate establishments 
handling packed shell eggs, may in its own jurisdiction, enforce 
paragraphs (h)(1) through (h)(5) of this section through inspections 
under paragraph (h)(8) of this section and through administrative 
enforcement remedies identified in paragraph (h)(7) of this section 
until FDA notifies the State or locality in writing that such assistance 
is no longer needed. When providing such assistance, a State or locality 
may follow the hearing procedures set out in paragraphs (h)(7)(ii)(C) 
through (h)(7)(ii)(D) of this section, substituting, where necessary, 
appropriate State or local officials for designated FDA officials or may 
utilize State or local hearing procedures if such procedures satisfy due 
process.
    (7) This paragraph (h) is established under authority of both the 
Federal Food, Drug, and Cosmetic Act (the act) and the PHS Act. Under 
the act, the agency can enforce the food misbranding provisions under 21 
U.S.C. 331, 332, 333, and 334. However, 42 U.S.C. 264 provides for the 
issuance of implementing enforcement regulations; therefore, FDA has 
established the following administrative enforcement procedures for the 
relabeling, diversion, or destruction of shell eggs and informal 
hearings under the PHS Act:
    (i) Upon finding that any shell eggs are in violation of this 
section an authorized FDA representative or State or local 
representative in accordance with paragraph (h)(6) of this section may 
order such eggs to be relabeled under the supervision of said 
representative, diverted, under the supervision of said representative 
for processing in accordance with the Egg Products Inspection Act (EPIA) 
(21 U.S.C. 1031 et seq.), or destroyed by or under the supervision of an 
officer or employee of the FDA, or, if applicable, of the State or 
locality, in accordance with the following procedures:
    (A) Order for relabeling, diversion, or destruction under the PHS 
Act. Any division office of FDA or any State or locality acting under 
paragraph (h)(6) of this section, upon finding shell eggs held in 
violation of this section, may serve upon the person in whose possession 
such eggs are found a written order that such eggs be relabeled with the 
required statement in paragraph (h)(1) of this section before further 
distribution. If the person chooses not to relabel, the division office 
of FDA or, if applicable, the appropriate State or local agency may 
serve upon the person a written order that such eggs be diverted (from 
direct consumer sale, e.g., to food service) under the supervision of an 
officer or employee of the issuing entity, for processing in accordance 
with the EPIA (21 U.S.C. 1031 et seq.) or destroyed by or under the 
supervision of the issuing entity, within

[[Page 101]]

10 working days from the date of receipt of the order.
    (B) Issuance of order. The order shall include the following 
information:
    (1) A statement that the shell eggs identified in the order are 
subject to relabeling, diversion for processing in accordance with the 
EPIA, or destruction;
    (2) A detailed description of the facts that justify the issuance of 
the order;
    (3) The location of the eggs;
    (4) A statement that these eggs shall not be sold, distributed, or 
otherwise disposed of or moved except as provided in paragraph 
(h)(7)(i)(E) of this section;
    (5) Identification or description of the eggs;
    (6) The order number;
    (7) The date of the order;
    (8) The text of this entire section;
    (9) A statement that the order may be appealed by written appeal or 
by requesting an informal hearing;
    (10) The name and phone number of the person issuing the order; and
    (11) The location and telephone number of the responsible office or 
agency and the name of its director.
    (C) Approval of director. An order, before issuance, shall be 
approved by the director of the office or agency issuing the order. If 
prior written approval is not feasible, prior oral approval shall be 
obtained and confirmed by written memorandum as soon as possible.
    (D) Labeling or marking of shell eggs under order. An FDA, State, or 
local representative issuing an order under paragraph (h)(7)(i)(A) of 
this section shall label or mark the shell eggs with official tags that 
include the following information:
    (1) A statement that the shell eggs are detained in accordance with 
regulations issued under section 361(a) of the PHS Act (42 U.S.C. 
264(a)).
    (2) A statement that the shell eggs shall not be sold, distributed 
or otherwise disposed of or moved except, after notifying the issuing 
entity in writing, to:
    (i) Relabel, divert them for processing in accordance with the EPIA, 
or destroy them, or
    (ii) Move them to another location for holding pending appeal.
    (3) A statement that the violation of the order or the removal or 
alteration of the tag is punishable by fine or imprisonment or both 
(section 368 of the PHS Act, 42 U.S.C. 271).
    (4) The order number and the date of the order, and the name of the 
government representative who issued the order.
    (E) Sale or other disposition of shell eggs under order. After 
service of the order, the person in possession of the shell eggs that 
are the subject of the order shall not sell, distribute, or otherwise 
dispose of or move any eggs subject to the order unless and until the 
notice is withdrawn after an appeal except, after notifying FDA's 
division office or, if applicable, the State or local agency in writing, 
to:
    (1) Relabel, divert, or destroy them as specified in paragraph 
(h)(7)(i) of this section, or
    (2) Move them to another location for holding pending appeal.
    (ii) The person on whom the order for relabeling, diversion, or 
destruction is served may either comply with the order or appeal the 
order to an Office of Regulatory Affairs Program Director.
    (A) Appeal of a detention order. Any appeal shall be submitted in 
writing to the FDA Division Director in whose division the shell eggs 
are located within 5 working days of the issuance of the order. If the 
appeal includes a request for an informal hearing, the hearing shall be 
held within 5 working days after the appeal is filed or, if requested by 
the appellant, at a later date, which shall not be later than 20 
calendar days after the issuance of the order. The order may also be 
appealed within the same period of 5 working days by any other person 
having an ownership or proprietary interest in such shell eggs. The 
appellant of an order shall state the ownership or proprietary interest 
the appellant has in the shell eggs.
    (B) Summary decision. A request for a hearing may be denied, in 
whole or in part and at any time after a request for a hearing has been 
submitted, if the Office of Regulatory Affairs Program Director or 
another FDA official senior to an FDA Division Director determines that 
no genuine and substantial issue of fact has been raised by the material 
submitted in connection with the

[[Page 102]]

hearing or from matters officially noticed. If the presiding FDA 
official determines that a hearing is not justified, written notice of 
the determination will be given to the parties explaining the reason for 
denial.
    (C) Informal hearing. Appearance by any appellant at the hearing may 
be by mail or in person, with or without counsel. The informal hearing 
shall be conducted by an Office of Regulatory Affairs Program Director 
or another FDA official senior to an FDA Division Director, and a 
written summary of the proceedings shall be prepared by the presiding 
FDA official.
    (1) The presiding FDA official may direct that the hearing be 
conducted in any suitable manner permitted by law and this section. The 
presiding FDA official has the power to take such actions and make such 
rulings as are necessary or appropriate to maintain order and to conduct 
an informal, fair, expeditious, and impartial hearing, and to enforce 
the requirements concerning the conduct of hearings.
    (2) Employees of FDA will first give a full and complete statement 
of the action which is the subject of the hearing, together with the 
information and reasons supporting it, and may present oral or written 
information relevant to the hearing. The party requesting the hearing 
may then present oral or written information relevant to the hearing. 
All parties may conduct reasonable examination of any person (except for 
the presiding officer and counsel for the parties) who makes any 
statement on the matter at the hearing.
    (3) The hearing shall be informal in nature, and the rules of 
evidence do not apply. No motions or objections relating to the 
admissibility of information and views will be made or considered, but 
any party may comment upon or rebut any information and views presented 
by another party.
    (4) The party requesting the hearing may have the hearing 
transcribed, at the party's expense, in which case a copy of the 
transcript is to be furnished to FDA. Any transcript of the hearing will 
be included with the presiding FDA official's report of the hearing.
    (5) The presiding FDA official shall prepare a written report of the 
hearing. All written material presented at the hearing will be attached 
to the report. Whenever time permits, the presiding FDA official may 
give the parties the opportunity to review and comment on the report of 
the hearing.
    (6) The presiding FDA official shall include as part of the report 
of the hearing a finding on the credibility of witnesses (other than 
expert witnesses) whenever credibility is a material issue, and shall 
include a recommended decision, with a statement of reasons.
    (D) Written appeal. If the appellant appeals the detention order but 
does not request a hearing, the presiding FDA official shall render a 
decision on the appeal affirming or revoking the detention within 5-
working days after the receipt of the appeal.
    (E) Presiding FDA official's decision. If, based on the evidence 
presented at the hearing or by the appellant in a written appeal, the 
presiding FDA official finds that the shell eggs were held in violation 
of this section, he shall affirm the order that they be relabeled, 
diverted under the supervision of an officer or employee of FDA for 
processing under the EPIA, or destroyed by or under the supervision of 
an officer or employee of FDA; otherwise, the presiding FDA official 
shall issue a written notice that the prior order is withdrawn. If the 
presiding FDA official affirms the order, he shall order that the 
relabeling, diversion, or destruction be accomplished within 10-working 
days from the date of the issuance of his decision. The presiding FDA 
official's decision shall be accompanied by a statement of the reasons 
for the decision. The decision of the presiding FDA official shall 
constitute final agency action, reviewable in the courts.
    (F) No appeal. If there is no appeal of the order and the person in 
possession of the shell eggs that are subject to the order fails to 
relabel, divert, or destroy them within 10 working days, or if the 
demand is affirmed by the presiding FDA official after an appeal and the 
person in possession of such eggs fails to relabel, divert, or destroy 
them within 10 working days, the FDA division office, or, if applicable, 
the State or local agency may designate an officer or employee to divert 
or destroy

[[Page 103]]

such eggs. It shall be unlawful to prevent or to attempt to prevent such 
diversion or destruction of the shell eggs by the designated officer or 
employee.
    (8) Persons engaged in handling or storing packed shell eggs for 
retail distribution shall permit authorized representatives of FDA to 
make at any reasonable time such inspection of the establishment in 
which shell eggs are being held, including inspection and sampling of 
the labeling of such eggs as may be necessary in the judgment of such 
representatives to determine compliance with the provisions of this 
section. Inspections may be made with or without notice and will 
ordinarily be made during regular business hours.
    (9) No State or local governing entity shall establish or continue 
in effect any law, rule, regulation, or other requirement requiring safe 
handling instructions on unpasteurized shell eggs that are less 
stringent than those required in paragraphs (h)(1) through (h)(5) of 
this section.

[42 FR 14308, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 
101.17, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 101.18  Misbranding of food.

    (a) Among representations in the labeling of a food which render 
such food misbranded is a false or misleading representation with 
respect to another food or a drug, device, or cosmetic.
    (b) The labeling of a food which contains two or more ingredients 
may be misleading by reason (among other reasons) of the designation of 
such food in such labeling by a name which includes or suggests the name 
of one or more but not all such ingredients, even though the names of 
all such ingredients are stated elsewhere in the labeling.
    (c) Among representations in the labeling of a food which render 
such food misbranded is any representation that expresses or implies a 
geographical origin of the food or any ingredient of the food except 
when such representation is either:
    (1) A truthful representation of geographical origin.
    (2) A trademark or trade name provided that as applied to the 
article in question its use is not deceptively misdescriptive. A 
trademark or trade name composed in whole or in part of geographical 
words shall not be considered deceptively misdescriptive if it:
    (i) Has been so long and exclusively used by a manufacturer or 
distributor that it is generally understood by the consumer to mean the 
product of a particular manufacturer or distributor; or
    (ii) Is so arbitrary or fanciful that it is not generally understood 
by the consumer to suggest geographic origin.
    (3) A part of the name required by applicable Federal law or 
regulation.
    (4) A name whose market significance is generally understood by the 
consumer to connote a particular class, kind, type, or style of food 
rather than to indicate geographical origin.



              Subpart B_Specific Food Labeling Requirements



Sec. 101.22  Foods; labeling of spices, flavorings, colorings
and chemical preservatives.

    (a)(1) The term artificial flavor or artificial flavoring means any 
substance, the function of which is to impart flavor, which is not 
derived from a spice, fruit or fruit juice, vegetable or vegetable 
juice, edible yeast, herb, bark, bud, root, leaf or similar plant 
material, meat, fish, poultry, eggs, dairy products, or fermentation 
products thereof. Artificial flavor includes the substances listed in 
Sec. Sec. 172.515(b) and 182.60 of this chapter except where these are 
derived from natural sources.
    (2) The term spice means any aromatic vegetable substance in the 
whole, broken, or ground form, except for those substances which have 
been traditionally regarded as foods, such as onions, garlic and celery; 
whose significant function in food is seasoning rather than nutritional; 
that is true to name; and from which no portion of any volatile oil or 
other flavoring principle has been removed. Spices include the spices 
listed in Sec. 182.10 and part 184 of this chapter, such as the 
following:

Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed, 
Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel 
seed, Fenugreek, Ginger,

[[Page 104]]

Horseradish, Mace, Marjoram, Mustard flour, Nutmeg, Oregano, Paprika, 
Parsley, Pepper, black; Pepper, white; Pepper, red; Rosemary, Saffron, 
Sage, Savory, Star aniseed, Tarragon, Thyme, Turmeric.


Paprika, turmeric, and saffron or other spices which are also colors, 
shall be declared as ``spice and coloring'' unless declared by their 
common or usual name.
    (3) The term natural flavor or natural 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 similar plant material, meat, seafood, poultry, eggs, dairy products, 
or fermentation products thereof, whose significant function in food is 
flavoring rather than nutritional. Natural flavors include the natural 
essence or extractives obtained from plants listed in Sec. Sec. 182.10, 
182.20, 182.40, and 182.50 and part 184 of this chapter, and the 
substances listed in Sec. 172.510 of this chapter.
    (4) The term artificial color or artificial coloring means any 
``color additive'' as defined in Sec. 70.3(f) of this chapter.
    (5) The term chemical preservative means any chemical that, when 
added to food, tends to prevent or retard deterioration thereof, but 
does not include common salt, sugars, vinegars, spices, or oils 
extracted from spices, substances added to food by direct exposure 
thereof to wood smoke, or chemicals applied for their insecticidal or 
herbicidal properties.
    (b) A food which is subject to the requirements of section 403(k) of 
the act shall bear labeling, even though such food is not in package 
form.
    (c) A statement of artificial flavoring, artificial coloring, or 
chemical preservative shall be placed on the food or on its container or 
wrapper, or on any two or all three of these, as may be necessary to 
render such statement likely to be read by the ordinary person under 
customary conditions of purchase and use of such food. The specific 
artificial color used in a food shall be identified on the labeling when 
so required by regulation in part 74 of this chapter to assure safe 
conditions of use for the color additive.
    (d) A food shall be exempt from compliance with the requirements of 
section 403(k) of the act if it is not in package form and the units 
thereof are so small that a statement of artificial flavoring, 
artificial coloring, or chemical preservative, as the case may be, 
cannot be placed on such units with such conspicuousness as to render it 
likely to be read by the ordinary individual under customary conditions 
of purchase and use.
    (e) A food shall be exempt while held for sale from the requirements 
of section 403(k) of the act (requiring label statement of any 
artificial flavoring, artificial coloring, or chemical preservatives) if 
said food, having been received in bulk containers at a retail 
establishment, is displayed to the purchaser with either (1) the 
labeling of the bulk container plainly in view or (2) a counter card, 
sign, or other appropriate device bearing prominently and conspicuously 
the information required to be stated on the label pursuant to section 
403(k).
    (f) A fruit or vegetable shall be exempt from compliance with the 
requirements of section 403(k) of the act with respect to a chemical 
preservative applied to the fruit or vegetable as a pesticide chemical 
prior to harvest.
    (g) A flavor shall be labeled in the following way when shipped to a 
food manufacturer or processor (but not a consumer) for use in the 
manufacture of a fabricated food, unless it is a flavor for which a 
standard of identity has been promulgated, in which case it shall be 
labeled as provided in the standard:
    (1) If the flavor consists of one ingredient, it shall be declared 
by its common or usual name.
    (2) If the flavor consists of two or more ingredients, the label 
either may declare each ingredient by its common or usual name or may 
state ``All flavor ingredients contained in this product are approved 
for use in a regulation of the Food and Drug Administration.'' Any 
flavor ingredient not contained in one of these regulations, and any 
nonflavor ingredient, shall be separately listed on the label.

[[Page 105]]

    (3) In cases where the flavor contains a solely natural flavor(s), 
the flavor shall be so labeled, e.g., ``strawberry flavor'', ``banana 
flavor'', or ``natural strawberry flavor''. In cases where the flavor 
contains both a natural flavor and an artificial flavor, the flavor 
shall be so labeled, e.g., ``natural and artificial strawberry flavor''. 
In cases where the flavor contains a solely artificial flavor(s), the 
flavor shall be so labeled, e.g., ``artificial strawberry flavor''.
    (h) The label of a food to which flavor is added shall declare the 
flavor in the statement of ingredients in the following way:
    (1) Spice, natural flavor, and artificial flavor may be declared as 
``spice'', ``natural flavor'', or ``artificial flavor'', or any 
combination thereof, as the case may be.
    (2) An incidental additive in a food, originating in a spice or 
flavor used in the manufacture of the food, need not be declared in the 
statement of ingredients if it meets the requirements of Sec. 
101.100(a)(3).
    (3) Substances obtained by cutting, grinding, drying, pulping, or 
similar processing of tissues derived from fruit, vegetable, meat, fish, 
or poultry, e.g., powdered or granulated onions, garlic powder, and 
celery powder, are commonly understood by consumers to be food rather 
than flavor and shall be declared by their common or usual name.
    (4) Any salt (sodium chloride) used as an ingredient in food shall 
be declared by its common or usual name ``salt.''
    (5) Any monosodium glutamate used as an ingredient in food shall be 
declared by its common or usual name ``monosodium glutamate.''
    (6) Any pyroligneous acid or other artificial smoke flavors used as 
an ingredient in a food may be declared as artificial flavor or 
artificial smoke flavor. No representation may be made, either directly 
or implied, that a food flavored with pyroligneous acid or other 
artificial smoke flavor has been smoked or has a true smoked flavor, or 
that a seasoning sauce or similar product containing pyroligneous acid 
or other artificial smoke flavor and used to season or flavor other 
foods will result in a smoked product or one having a true smoked 
flavor.
    (7) Because protein hydrolysates function in foods as both 
flavorings and flavor enhancers, no protein hydrolysate used in food for 
its effects on flavor may be declared simply as ``flavor,'' ``natural 
flavor,'' or ``flavoring.'' The ingredient shall be declared by its 
specific common or usual name as provided in Sec. 102.22 of this 
chapter.
    (i) If the label, labeling, or advertising of a food makes any 
direct or indirect representations with respect to the primary 
recognizable flavor(s), by word, vignette, e.g., depiction of a fruit, 
or other means, or if for any other reason the manufacturer or 
distributor of a food wishes to designate the type of flavor in the food 
other than through the statement of ingredients, such flavor shall be 
considered the characterizing flavor and shall be declared in the 
following way:
    (1) If the food contains no artificial flavor which simulates, 
resembles or reinforces the characterizing flavor, the name of the food 
on the principal display panel or panels of the label shall be 
accompanied by the common or usual name of the characterizing flavor, 
e.g., ``vanilla'', in letters not less than one-half the height of the 
letters used in the name of the food, except that:
    (i) If the food is one that is commonly expected to contain a 
characterizing food ingredient, e.g., strawberries in ``strawberry 
shortcake'', and the food contains natural flavor derived from such 
ingredient and an amount of characterizing ingredient insufficient to 
independently characterize the food, or the food contains no such 
ingredient, the name of the characterizing flavor may be immediately 
preceded by the word ``natural'' and shall be immediately followed by 
the word ``flavored'' in letters not less than one-half the height of 
the letters in the name of the characterizing flavor, e.g., ``natural 
strawberry flavored shortcake,'' or ``strawberry flavored shortcake''.
    (ii) If none of the natural flavor used in the food is derived from 
the product whose flavor is simulated, the food in which the flavor is 
used shall be labeled either with the flavor of the product from which 
the flavor is derived or as ``artificially flavored.''

[[Page 106]]

    (iii) If the food contains both a characterizing flavor from the 
product whose flavor is simulated and other natural flavor which 
simulates, resembles or reinforces the characterizing flavor, the food 
shall be labeled in accordance with the introductory text and paragraph 
(i)(1)(i) of this section and the name of the food shall be immediately 
followed by the words ``with other natural flavor'' in letters not less 
than one-half the height of the letters used in the name of the 
characterizing flavor.
    (2) If the food contains any artificial flavor which simulates, 
resembles or reinforces the characterizing flavor, the name of the food 
on the principal display panel or panels of the label shall be 
accompanied by the common or usual name(s) of the characterizing flavor, 
in letters not less than one-half the height of the letters used in the 
name of the food and the name of the characterizing flavor shall be 
accompanied by the word(s) ``artificial'' or ``artificially flavored'', 
in letters not less than one-half the height of the letters in the name 
of the characterizing flavor, e.g., ``artificial vanilla'', 
``artificially flavored strawberry'', or ``grape artificially 
flavored''.
    (3) Wherever the name of the characterizing flavor appears on the 
label (other than in the statement of ingredients) so conspicuously as 
to be easily seen under customary conditions of purchase, the words 
prescribed by this paragraph shall immediately and conspicuously precede 
or follow such name, without any intervening written, printed, or 
graphic matter, except:
    (i) Where the characterizing flavor and a trademark or brand are 
presented together, other written, printed, or graphic matter that is a 
part of or is associated with the trademark or brand may intervene if 
the required words are in such relationship with the trademark or brand 
as to be clearly related to the characterizing flavor; and
    (ii) If the finished product contains more than one flavor subject 
to the requirements of this paragraph, the statements required by this 
paragraph need appear only once in each statement of characterizing 
flavors present in such food, e.g., ``artificially flavored vanilla and 
strawberry''.
    (iii) If the finished product contains three or more distinguishable 
characterizing flavors, or a blend of flavors with no primary 
recognizable flavor, the flavor may be declared by an appropriately 
descriptive generic term in lieu of naming each flavor, e.g., 
``artificially flavored fruit punch''.
    (4) A flavor supplier shall certify, in writing, that any flavor he 
supplies which is designated as containing no artificial flavor does 
not, to the best of his knowledge and belief, contain any artificial 
flavor, and that he has added no artificial flavor to it. The 
requirement for such certification may be satisfied by a guarantee under 
section 303(c)(2) of the act which contains such a specific statement. A 
flavor user shall be required to make such a written certification only 
where he adds to or combines another flavor with a flavor which has been 
certified by a flavor supplier as containing no artificial flavor, but 
otherwise such user may rely upon the supplier's certification and need 
make no separate certification. All such certifications shall be 
retained by the certifying party throughout the period in which the 
flavor is supplied and for a minimum of three years thereafter, and 
shall be subject to the following conditions:
    (i) The certifying party shall make such certifications available 
upon request at all reasonable hours to any duly authorized office or 
employee of the Food and Drug Administration or any other employee 
acting on behalf of the Secretary of Health and Human Services. Such 
certifications are regarded by the Food and Drug Administration as 
reports to the government and as guarantees or other undertakings within 
the meaning of section 301(h) of the act and subject the certifying 
party to the penalties for making any false report to the government 
under 18 U.S.C. 1001 and any false guarantee or undertaking under 
section 303(a) of the act. The defenses provided under section 303(c)(2) 
of the act shall be applicable to the certifications provided for in 
this section.
    (ii) Wherever possible, the Food and Drug Administration shall 
verify the accuracy of a reasonable number of certifications made 
pursuant to this section, constituting a representative

[[Page 107]]

sample of such certifications, and shall not request all such 
certifications.
    (iii) Where no person authorized to provide such information is 
reasonably available at the time of inspection, the certifying party 
shall arrange to have such person and the relevant materials and records 
ready for verification as soon as practicable: Provided, That, whenever 
the Food and Drug Administration has reason to believe that the supplier 
or user may utilize this period to alter inventories or records, such 
additional time shall not be permitted. Where such additional time is 
provided, the Food and Drug Administration may require the certifying 
party to certify that relevant inventories have not been materially 
disturbed and relevant records have not been altered or concealed during 
such period.
    (iv) The certifying party shall provide, to an officer or 
representative duly designated by the Secretary, such qualitative 
statement of the composition of the flavor or product covered by the 
certification as may be reasonably expected to enable the Secretary's 
representatives to determine which relevant raw and finished materials 
and flavor ingredient records are reasonably necessary to verify the 
certifications. The examination conducted by the Secretary's 
representative shall be limited to inspection and review of inventories 
and ingredient records for those certifications which are to be 
verified.
    (v) Review of flavor ingredient records shall be limited to the 
qualitative formula and shall not include the quantitative formula. The 
person verifying the certifications may make only such notes as are 
necessary to enable him to verify such certification. Only such notes or 
such flavor ingredient records as are necessary to verify such 
certification or to show a potential or actual violation may be removed 
or transmitted from the certifying party's place of business: Provided, 
That, where such removal or transmittal is necessary for such purposes 
the relevant records and notes shall be retained as separate documents 
in Food and Drug Administration files, shall not be copied in other 
reports, and shall not be disclosed publicly other than in a judicial 
proceeding brought pursuant to the act or 18 U.S.C. 1001.
    (j) A food to which a chemical preservative(s) is added shall, 
except when exempt pursuant to Sec. 101.100 bear a label declaration 
stating both the common or usual name of the ingredient(s) and a 
separate description of its function, e.g., ``preservative'', ``to 
retard spoilage'', ``a mold inhibitor'', ``to help protect flavor'' or 
``to promote color retention''.
    (k) The label of a food to which any coloring has been added shall 
declare the coloring in the statement of ingredients in the manner 
specified in paragraphs (k)(1) and (k)(2) of this section, except that 
colorings added to butter, cheese, and ice cream, if declared, may be 
declared in the manner specified in paragraph (k)(3) of this section, 
and colorings added to foods subject to Sec. Sec. 105.62 and 105.65 of 
this chapter shall be declared in accordance with the requirements of 
those sections.
    (1) A color additive or the lake of a color additive subject to 
certification under 721(c) of the act shall be declared by the name of 
the color additive listed in the applicable regulation in part 74 or 
part 82 of this chapter, except that it is not necessary to include the 
``FD&C'' prefix or the term ``No.'' in the declaration, but the term 
``Lake'' shall be included in the declaration of the lake of the 
certified color additive (e.g., Blue 1 Lake). Manufacturers may 
parenthetically declare an appropriate alternative name of the certified 
color additive following its common or usual name as specified in part 
74 or part 82 of this chapter.
    (2) Color additives not subject to certification and not otherwise 
required by applicable regulations in part 73 of this chapter to be 
declared by their respective common or usual names may be declared as 
``Artificial Color,'' ``Artificial Color Added,'' or ``Color Added'' (or 
by an equally informative term that makes clear that a color additive 
has been used in the food). Alternatively, such color additives may be 
declared as ``Colored with ________'' or ``________ color,'' the blank 
to be filled in with the name of the color additive listed in the 
applicable regulation in part 73 of this chapter.

[[Page 108]]

    (3) When a coloring has been added to butter, cheese, or ice cream, 
it need not be declared in the ingredient list unless such declaration 
is required by a regulation in part 73 or part 74 of this chapter to 
ensure safe conditions of use for the color additive. Voluntary 
declaration of all colorings added to butter, cheese, and ice cream, 
however, is recommended.

[42 FR 14308, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 44 
FR 37220, June 26, 1979; 54 FR 24891, June 12, 1989; 58 FR 2875, Jan. 6, 
1993; 63 FR 14818, Mar. 27, 1998; 74 FR 216, Jan. 5, 2009]



Sec. 101.30  Percentage juice declaration for foods purporting to be
beverages that contain fruit or vegetable juice.

    (a) This section applies to any food that purports to be a beverage 
that contains any fruit or vegetable juice (i.e., the product's 
advertising, label, or labeling bears the name of, or variation on the 
name of, or makes any other direct or indirect representation with 
respect to, any fruit or vegetable juice), or the label or labeling 
bears any vignette (i.e., depiction of a fruit or vegetable) or other 
pictorial representation of any fruit or vegetable, or the product 
contains color and flavor that gives the beverage the appearance and 
taste of containing a fruit or vegetable juice. The beverage may be 
carbonated or noncarbonated, concentrated, full-strength, diluted, or 
contain no juice. For example, a soft drink (soda) that does not 
represent or suggest by its physical characteristics, name, labeling, 
ingredient statement, or advertising that it contains fruit or vegetable 
juice does not purport to contain juice and therefore does not require a 
percent juice declaration.
    (b)(1) If the beverage contains fruit or vegetable juice, the 
percentage shall be declared by the words ``Contains _ percent (or %) 
___ juice'' or ``_ percent (or %) juice,'' or a similar phrase, with the 
first blank filled in with the percentage expressed as a whole number 
not greater than the actual percentage of the juice and the second blank 
(if used) filled in with the name of the particular fruit or vegetable 
(e.g., ``Contains 50 percent apple juice'' or ``50 percent juice'').
    (2) If the beverage contains less than 1 percent juice, the total 
percentage juice shall be declared as ``less than 1 percent juice'' or 
``less than 1 percent ___ juice'' with the blank filled in with the name 
of the particular fruit or vegetable.
    (3) If the beverage contains 100 percent juice and also contains 
non-juice ingredients that do not result in a diminution of the juice 
soluble solids or, in the case of expressed juice, in a change in the 
volume, when the 100 percent juice declaration appears on a panel of the 
label that does not also bear the ingredient statement, it must be 
accompanied by the phrase ``with added ___,'' the blank filled in with a 
term such as ``ingredient(s),'' ``preservative,'' or ``sweetener,'' as 
appropriate (e.g., ``100% juice with added sweetener''), except that 
when the presence of the non-juice ingredient(s) is declared as a part 
of the statement of identity of the product, this phrase need not 
accompany the 100 percent juice declaration.
    (c) If a beverage contains minor amounts of juice for flavoring and 
is labeled with a flavor description using terms such as ``flavor'', 
``flavored'', or ``flavoring'' with a fruit or vegetable name and does 
not bear:
    (1) The term ``juice'' on the label other than in the ingredient 
statement; or
    (2) An explicit vignette depicting the fruit or vegetable from which 
the flavor derives, such as juice exuding from a fruit or vegetable; or
    (3) Specific physical resemblance to a juice or distinctive juice 
characteristic such as pulp then total percentage juice declaration is 
not required.
    (d) If the beverage does not meet the criteria for exemption from 
total juice percentage declaration as described in paragraph (c) of this 
section and contains no fruit or vegetable juice, but the labeling or 
color and flavor of the beverage represents, suggests, or implies that 
fruit or vegetable juice may be present (e.g., the product advertising 
or labeling bears the name, a variation of the name, or a pictorial 
representation of any fruit or vegetable, or the product contains color 
and flavor that give the beverage the appearance and taste of containing 
a

[[Page 109]]

fruit or vegetable juice), then the label shall declare ``contains zero 
(0) percent (or %) juice''. Alternatively, the label may declare 
``Containing (or contains) no ___ juice'', or ``no ___ juice'', or 
``does not contain ___ juice'', the blank to be filled in with the name 
of the fruits or vegetables represented, suggested, or implied, but if 
there is a general suggestion that the product contains fruit or 
vegetable juice, such as the presence of fruit pulp, the blank shall be 
filled in with the word ``fruit'' or ``vegetable'' as applicable (e.g., 
``contains no fruit juice'', or ``does not contain fruit juice'').
    (e) If the beverage is sold in a package with an information panel 
as defined in Sec. 101.2, the declaration of amount of juice shall be 
prominently placed on the information panel in lines generally parallel 
to other required information, appearing:
    (1) Near the top of the information panel, with no other printed 
label information appearing above the statement except the brand name, 
product name, logo, or universal product code; and
    (2) In easily legible boldface print or type in distinct contrast to 
other printed or graphic matter, in a height not less than the largest 
type found on the information panel except that used for the brand name, 
product name, logo, universal product code, the title phrase ``Nutrition 
Facts,'' the declaration of ``Serving size,'' ``Calories'' and the 
numerical value for ``Calories appearing in the nutrition information as 
required by Sec. 101.9.
    (f) The percentage juice declaration may also be placed on the 
principal display panel, provided that the declaration is consistent 
with that presented on the information panel.
    (g) If the beverage is sold in a package that does not bear an 
information panel as defined in Sec. 101.2, the percentage juice 
declaration shall be placed on the principal display panel, in type size 
not less than that required for the declaration of net quantity of 
contents statement in Sec. 101.7(i), and be placed near the name of the 
food.
    (h)(1) In enforcing these regulations, the Food and Drug 
Administration will calculate the labeled percentage of juice from 
concentrate found in a juice or juice beverage using the minimum Brix 
levels listed below where single-strength (100 percent) juice has at 
least the specified minimum Brix listed below:

------------------------------------------------------------------------
                                                                   100
                                                                 percent
                             Juice                                juice
                                                                   \1\
------------------------------------------------------------------------
Acerola........................................................      6.0
Apple..........................................................     11.5
Apricot........................................................     11.7
Banana.........................................................     22.0
Blackberry.....................................................     10.0
Blueberry......................................................     10.0
Boysenberry....................................................     10.0
Cantaloupe Melon...............................................      9.6
Carambola......................................................      7.8
Carrot.........................................................      8.0
Casaba Melon...................................................      7.5
Cashew (Caju)..................................................     12.0
Celery.........................................................      3.1
Cherry, dark, sweet............................................     20.0
Cherry, red, sour..............................................     14.0
Crabapple......................................................     15.4
Cranberry......................................................      7.5
Currant (Black)................................................     11.0
Currant (Red)..................................................     10.5
Date...........................................................     18.5
Dewberry.......................................................     10.0
Elderberry.....................................................     11.0
Fig............................................................     18.2
Gooseberry.....................................................      8.3
Grape..........................................................     16.0
Grapefruit.....................................................  \3\10.0
Guanabana (soursop)............................................     16.0
Guava..........................................................      7.7
Honeydew melon.................................................      9.6
Kiwi...........................................................     15.4
Lemon..........................................................  \2\ 4.5
Lime...........................................................    2 4.5
Loganberry.....................................................     10.5
Mango..........................................................     13.0
Nectarine......................................................     11.8
Orange.........................................................  \3\11.8
Papaya.........................................................     11.5
Passion Fruit..................................................     14.0
Peach..........................................................     10.5
Pear...........................................................     12.0
Pineapple......................................................     12.8
Plum...........................................................     14.3
Pomegranate....................................................     16.0
Prune..........................................................     18.5
Quince.........................................................     13.3
Raspberry (Black)..............................................     11.1
Raspberry (Red)................................................      9.2
Rhubarb........................................................      5.7
Strawberry.....................................................      8.0
Tangerine......................................................  \3\11.8
Tomato.........................................................      5.0
Watermelon.....................................................      7.8
Youngberry.....................................................     10.0
------------------------------------------------------------------------
\1\ Indicates Brix value unless other value specified.
\2\ Indicates anhydrous citrus acid percent by weight.
\3\ Brix values determined by refractometer for citrus juices may be
  corrected for citric acid.

    (2) If there is no Brix level specified in paragraph (h)(1) of this 
section, the labeled percentage of that juice from concentrate in a 
juice or juice beverage will be calculated on the basis of the soluble 
solids content of the single-

[[Page 110]]

strength (unconcentrated) juice used to produce such concentrated juice.
    (i) Juices directly expressed from a fruit or vegetable (i.e., not 
concentrated and reconstituted) shall be considered to be 100 percent 
juice and shall be declared as ``100 percent juice.''
    (j) Calculations of the percentage of juice in a juice blend or a 
diluted juice product made directly from expressed juice (i.e., not from 
concentrate) shall be based on the percentage of the expressed juice in 
the product computed on a volume/volume basis.
    (k) If the product is a beverage that contains a juice whose color, 
taste, or other organoleptic properties have been modified to the extent 
that the original juice is no longer recognizable at the time processing 
is complete, or if its nutrient profile has been diminished to a level 
below the normal nutrient range for the juice, then that juice to which 
such a major modification has been made shall not be included in the 
total percentage juice declaration.
    (l) A beverage required to bear a percentage juice declaration on 
its label, that contains less than 100 percent juice, shall not bear any 
other percentage declaration that describes the juice content of the 
beverage in its label or in its labeling (e.g., ``100 percent natural'' 
or ``100 percent pure''). However, the label or labeling may bear 
percentage statements clearly unrelated to juice content (e.g., 
``provides 100 percent of U.S. RDA of vitamin C'').
    (m) Products purporting to be beverages that contain fruit or 
vegetable juices are exempted from the provisions of this section until 
May 8, 1994. All products that are labeled on or after that date shall 
comply with this section.

[58 FR 2925, Jan. 6, 1993, as amended at 58 FR 44063, Aug. 18, 1993; 58 
FR 49192, Sept. 22, 1993; 81 FR 33994, May 27, 2016; 81 FR 59131, Aug. 
29, 2016]



    Subpart C_Specific Nutrition Labeling Requirements and Guidelines

    Source: 55 FR 60890, Nov. 27, 1991, unless otherwise noted.



Sec. 101.36  Nutrition labeling of dietary supplements.

    (a) The label of a dietary supplement that is offered for sale shall 
bear nutrition labeling in accordance with this regulation unless an 
exemption is provided for the product in paragraph (h) of this section.
    (b) The declaration of nutrition information on the label and in 
labeling shall contain the following information, using the subheadings 
and the format specified in paragraph (e) of this section.
    (1) Serving size. (i) The subheading ``Serving Size'' shall be 
placed under the heading ``Supplement Facts'' and aligned on the left 
side of the nutrition label. The serving size shall be determined in 
accordance with Sec. Sec. 101.9(b) and 101.12(b), Table 2. Serving size 
for dietary supplements shall be expressed using a term that is 
appropriate for the form of the supplement, such as ``tablets,'' 
``capsules,'' ``packets,'' or ``teaspoonfuls.''
    (ii) The subheading ``Servings Per Container'' shall be placed under 
the subheading ``Serving Size'' and aligned on the left side of the 
nutrition label, except that this information need not be provided when 
it is stated in the net quantity of contents declaration.
    (2) Information on dietary ingredients that have a Reference Daily 
Intake (RDI) or a Daily Reference Value (DRV) as established in Sec. 
101.9(c) and their subcomponents (hereinafter referred to as ``(b)(2)-
dietary ingredients''). (i) The (b)(2)-dietary ingredients to be 
declared, that is, total calories, total fat, saturated fat, trans fat, 
cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, 
added sugars, protein, vitamin D, calcium, iron, and potassium, shall be 
declared when they are present in a dietary supplement in quantitative 
amounts by weight that exceed the amount that can be declared as zero in 
nutrition labeling of foods in accordance with Sec. 101.9(c). Calories 
from saturated fat, polyunsaturated fat, monounsaturated fat, soluble 
fiber, insoluble fiber, and sugar alcohol may be declared, but they 
shall be declared when a claim is made about them. Any (b)(2)-dietary 
ingredients that are not present, or that are present in amounts that 
can be declared as zero in

[[Page 111]]

Sec. 101.9(c), shall not be declared (e.g., amounts corresponding to 
less than 2 percent of the RDI for vitamins and minerals). Protein shall 
not be declared on labels of products that, other than ingredients added 
solely for technological reasons, contain only individual amino acids.
    (A) The names and the quantitative amounts by weight of each (b)(2)-
dietary ingredient shall be presented under the heading ``Amount Per 
Serving.'' When the quantitative amounts by weight are presented in a 
separate column, the heading may be centered over a column of 
quantitative amounts, described by paragraph (b)(2)(ii) of this section, 
if space permits. A heading consistent with the declaration of the 
serving size, such as ``Each Tablet Contains,'' or ``Amount Per 2 
Tablets'' may be used in place of the heading ``Amount Per Serving.'' 
Other appropriate terms, such as capsule, packet, or teaspoonful, also 
may be used in place of the term ``Serving.''
    (B) The names of dietary ingredients that are declared under 
paragraph (b)(2)(i) of this section shall be presented in a column 
aligned on the left side of the nutritional label in the order and 
manner of indentation specified in Sec. 101.9(c), except that calcium 
and iron shall follow choline, and sodium and potassium shall follow 
chloride. This results in the following order for vitamins and minerals: 
Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, 
riboflavin, niacin, vitamin B6, folate and folic acid, vitamin B12, 
biotin, pantothenic acid, choline, calcium, iron, phosphorus, iodine, 
magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, 
chloride, sodium, potassium, and fluoride. The (b)(2)-dietary 
ingredients shall be listed according to the nomenclature specified in 
Sec. 101.9 or in paragraph (b)(2)(i)(B)(2) of this section.
    (1) When ``Calories'' are declared, they shall be listed first in 
the column of names, beneath a light bar separating the heading ``Amount 
Per Serving'' from the list of names. When ``Calories from saturated 
fat'' are declared, they shall be indented under ``Calories.''
    (2) The following synonyms may be added in parentheses immediately 
following the name of these (b)(2)-dietary ingredients: Vitamin C 
(ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin 
B2), and calories (energy). Energy content per serving may be 
expressed in kilojoule units, added in parentheses immediately following 
the statement of caloric content.
    (3) Beta-carotene may be declared as the percent of vitamin A that 
is present as beta-carotene, except that the declaration is required 
when a claim is made about beta-carotene. When declared, the percent 
shall be declared to the nearest whole percent, immediately adjacent to 
or beneath the name vitamin A (e.g., ``Vitamin A (90% as beta-
carotene)''). The amount of beta-carotene in terms of micrograms (mcg) 
may be included in the parentheses following the percent statement 
(e.g., ``Vitamin A (90% (810 mcg) as beta-carotene)'').
    (ii) The number of calories, if declared, and the quantitative 
amount by weight per serving of each dietary ingredient required to be 
listed under paragraph (b)(2)(i) of this section shall be presented 
either in a separate column aligned to the right of the column of names 
or immediately following the listing of names within the same column. 
The quantitative amounts by weight shall represent the weight of the 
dietary ingredient rather than the weight of the source of the dietary 
ingredient (e.g., the weight of calcium rather than that of calcium 
carbonate).
    (A) The amounts shall be expressed in the increments specified in 
Sec. 101.9(c)(1) through (7), which includes increments for sodium.
    (B) The amounts of vitamins and minerals, excluding sodium, shall be 
the amount of the vitamin or mineral included in one serving of the 
product, using the units of measurement and the levels of significance 
given in Sec. 101.9(c)(8)(iv), except that zeros following decimal 
points may be dropped, and additional levels of significance may be used 
when the number of decimal places indicated is not sufficient to express 
lower amounts (e.g., the RDI for zinc is given in whole milligrams (mg), 
but the quantitative amount may be declared in tenths of a mg). The 
amount of vitamin D may, but is not

[[Page 112]]

required to, be expressed in IUs, in addition to the mandatory 
declaration in mcg. Any declaration of the amount of vitamin D in IUs 
must appear in parentheses after the declaration of the amount of 
vitamin D in mcg.
    (iii) The percent of the Daily Value of all dietary ingredients 
declared under paragraph (b)(2)(i) of this section shall be listed, 
except that the percent Daily Value for protein, when present, shall be 
calculated using the corrected amount of protein as specified in Sec. 
101.9(c)(7)(ii); no percent of the Daily Value shall be given for 
subcomponents for which DRVs or RDIs have not been established (e.g., 
total sugars). Additionally, the percentage of the RDI for protein shall 
be omitted when a food is purported to be for infants through 12 months 
of age.
    (A) When information on the percent of Daily Values is listed, this 
information shall be presented in one column aligned under the heading 
of ``% Daily Value'' and to the right of the column of amounts. The 
headings ``% Daily Value (DV),'' ``% DV,'' ``Percent Daily Value,'' or 
``Percent DV'' may be substituted for ``% Daily Value.'' The heading ``% 
Daily Value'' shall be placed on the same line as the heading ``Amount 
Per Serving.'' When the acronym ``DV'' is unexplained in the heading and 
a footnote is required under (b)(2)(iii)(D), (b)(2)(iii)(F), or 
(b)(3)(iv) of this section, the footnote shall explain the acronym (e.g. 
``Daily Value (DV) not established'').
    (B) The percent of Daily Value shall be calculated by dividing the 
quantitative amount by weight of each (b)(2)-dietary ingredient by the 
RDI as established in Sec. 101.9(c)(8)(iv) or the DRV as established in 
Sec. 101.9(c)(9) for the specified dietary ingredient and multiplying 
by 100, except that the percent of Daily Value for protein, when 
present, shall be calculated as specified in Sec. 101.9(c)(7)(ii). The 
quantitative amount by weight of each dietary ingredient in this 
calculation shall be the unrounded amount, except that for total fat, 
saturated fat, cholesterol, sodium, potassium, total carbohydrate, and 
dietary fiber, the quantitative amount by weight declared on the label 
(i.e, rounded amount) may be used. The numerical value shall be followed 
by the symbol for percent (i.e., %).
    (C) The percentages based on RDI's and on DRV's shall be expressed 
to the nearest whole percent, except that for dietary ingredients for 
which DRV's have been established, ``Less than 1%'' or ``<1%'' shall be 
used to declare the ``% Daily Value'' when the quantitative amount of 
the dietary ingredient by weight is great enough to require that the 
dietary ingredient be listed, but the amount is so small that the ``% 
Daily Value'' when rounded to the nearest percent is zero (e.g., a 
product that contains 1 gram of total carbohydrate would list the 
percent Daily Value as ``Less than 1%'' or ``<1%'').
    (D) If the percent of Daily Value is declared for total fat, 
saturated fat, total carbohydrate, dietary fiber, or protein, or added 
sugars, a symbol shall follow the value listed for those nutrients that 
refers to the same symbol that is placed at the bottom of the nutrition 
label, below the bar required under paragraph (e)(6) of this section and 
inside the box, that is followed by the statement ``Percent Daily Values 
are based on a 2,000 calorie diet.'' If the product is represented or 
purported to be for use by children 1 through 3 years of age, and if the 
percent of Daily Value is declared for total fat, total carbohydrate, 
dietary fiber, or protein, or added sugars, a symbol shall follow the 
value listed for those nutrients that refers to the same symbol that is 
placed at the bottom of the nutrition label, below the bar required 
under paragraph (e)(6) of this section and inside the box, that is 
followed by the statement ``Percent Daily Values are based on a 1,000 
calorie diet.''
    (E) The percent of Daily Value shall be based on RDI or DRV values 
for adults and children 4 or more years of age, unless the product is 
represented or purported to be specifically for infants through 12 
months of age, children 1 through 3 years of age, pregnant women, or 
lactating women, in which case the column heading shall clearly state 
the intended group. If the product is for persons within more than one 
group, the percent of Daily Value for each group shall be presented in 
separate columns as shown in paragraph (e)(11)(ii) of this section.

[[Page 113]]

    (F) For declared subcomponents that have no DRVs or RDIs, a symbol 
(e.g., an asterisk) shall be placed in the ``Percent Daily Value'' 
column that shall refer to the same symbol that is placed at the bottom 
of the nutrition label, below the last heavy bar and inside the box, and 
followed by a statement ``Daily Value not established.''
    (G) When calories or calories from saturated fat are declared, the 
space under the ``% DV'' column shall be left blank for these items. 
When there are no other (b)(2)-dietary ingredients listed for which a 
value must be declared in the ``% DV'' column, the column may be omitted 
as shown in paragraph (e)(11)(vii) of this section. When the ``% DV'' 
column is not required, but the dietary ingredients listed are subject 
to paragraph (b)(2)(iii)(F) of this section, the symbol required in that 
paragraph shall immediately follow the quantitative amount by weight for 
each dietary ingredient listed under ``Amount Per Serving.''
    (3) Information on dietary ingredients for which RDI's and DRV's 
have not been established. (i) Dietary ingredients for which FDA has not 
established RDI's or DRV's and that are not subject to regulation under 
paragraph (b)(2) of this section (hereinafter referred to as ``other 
dietary ingredients'') shall be declared by their common or usual name 
when they are present in a dietary supplement, in a column that is under 
the column of names described in paragraph (b)(2)(i)(B) of this section 
or, as long as the constituents of an other dietary ingredient are not 
listed, in a linear display, under the heavy bar described in paragraph 
(e)(6) of this section, except that if no (b)(2)-dietary ingredients are 
declared, other dietary ingredients shall be declared directly beneath 
the heading ``Amount Per Serving'' described in paragraph (b)(2)(i)(A) 
of this section.
    (ii) The quantitative amount by weight per serving of other dietary 
ingredients shall be presented in the same manner as the corresponding 
information required in paragraph (b)(2)(ii) of this section or, when a 
linear display is used, shall be presented immediately following the 
name of the other dietary ingredient. The quantitative amount by weight 
shall be the weight of the other dietary ingredient listed and not the 
weight of any component, or the source, of that dietary ingredient.
    (A) These amounts shall be expressed using metric measures in 
appropriate units.
    (B) For any dietary ingredient that is a liquid extract from which 
the solvent has not been removed, the quantity listed shall be the 
volume or weight of the total extract. Information on the condition of 
the starting material shall be indicated when it is fresh and may be 
indicated when it is dried. Information may be included on the 
concentration of the dietary ingredient and the solvent used, e.g., 
``fresh dandelion root extract, x (y:z) in 70% ethanol,'' where x is the 
number of milliliters (mL) or mg of the entire extract, y is the weight 
of the starting material and z is the volume (mL) of solvent. Where the 
solvent has been partially removed (not to dryness), the final 
concentration, when indicated, shall be stated (e.g., if the original 
extract was 1:5 and 50 percent of the solvent was removed, then the 
final concentration shall be stated as 1:2.5). Where the name of the 
solvent used is not included in the nutrition label, it is required to 
be listed in the ingredient statement in accordance with Sec. 101.4(g).
    (C) For a dietary ingredient that is an extract from which the 
solvent has been removed, the weight of the ingredient shall be the 
weight of the dried extract.
    (iii) The constituents of a dietary ingredient described in 
paragraph (b)(3)(i) of this section may be listed indented under the 
dietary ingredient and followed by their quantitative amounts by weight 
per serving, except that dietary ingredients described in paragraph 
(b)(2) of this section shall be listed in accordance with that section. 
When the constituents of a dietary ingredient described in paragraph 
(b)(3)(i) of this section are listed, all other dietary ingredients 
shall be declared in a column; however, the constituents themselves may 
be declared in a column or in a linear display.
    (iv) Other dietary ingredients shall bear a symbol (e.g., an 
asterisk) in the column under the heading of ``% Daily Value'' that 
refers to the same symbol

[[Page 114]]

placed at the bottom of the nutrition label and followed by the 
statement ``Daily Value not established,'' except that when the heading 
``% Daily Value'' is not used, the symbol shall follow the quantitative 
amount by weight for each dietary ingredient listed.
    (c) A proprietary blend of dietary ingredients shall be included in 
the list of dietary ingredients described in paragraph (b)(3)(i) of this 
section and identified by the term ``Proprietary Blend'' or other 
appropriately descriptive term or fanciful name and may be highlighted 
by bold type. Except as specified in this paragraph, all other 
requirements for the listing of dietary ingredients in dietary 
supplements are applicable.
    (1) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(2) of this section shall be declared in 
accordance with paragraph (b)(2) of this section.
    (2) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(3) of this section (i.e., ``other dietary 
ingredients'') shall be declared in descending order of predominance by 
weight, in a column or linear fashion, and indented under the term 
``Proprietary Blend'' or other appropriately descriptive term or 
fanciful name.
    (3) The quantitative amount by weight specified for the proprietary 
blend shall be the total weight of all other dietary ingredients 
contained in the proprietary blend and shall be placed on the same line 
to the right of the term ``Proprietary Blend'' or other appropriately 
descriptive term or fanciful name underneath the column of amounts 
described in paragraph (b)(2)(ii) of this section. A symbol (e.g., 
asterisk), which refers to the same symbol placed at the bottom of the 
nutrition label that is followed by the statement ``Daily Value not 
established,'' shall be placed under the heading ``% Daily Value,'' if 
present, or immediately following the quantitative amount by weight for 
the proprietary blend.
    (4) The sample label shown in paragraph (e)(11)(v) of this section 
illustrates one method of nutrition labeling a proprietary blend of 
dietary ingredients.
    (d) The source ingredient that supplies a dietary ingredient may be 
identified within the nutrition label in parentheses immediately 
following or indented beneath the name of a dietary ingredient and 
preceded by the words ``as'' or ``from'', e.g., ``Calcium (as calcium 
carbonate),'' except that manner of presentation is unnecessary when the 
name of the dietary ingredient (e.g., Oriental ginseng) or its synonym 
(e.g., ascorbic acid) is itself the source ingredient. When a source 
ingredient is identified in parentheses within the nutrition label, or 
when the name of the dietary ingredient or its synonym is the source 
ingredient, it shall not be required to be listed again in the 
ingredient statement that appears outside of the nutrition label. When a 
source ingredient is not identified within the nutrition label, it shall 
be listed in an ingredient statement in accordance with Sec. 101.4(g), 
which shall appear outside and immediately below the nutrition label or, 
if there is insufficient space below the nutrition label, immediately 
contiguous and to the right of the nutrition label.
    (1) Source ingredients shall be identified in accordance with Sec. 
101.4 (i.e., shall be listed by common or usual name, and the listing of 
botanicals shall specify the part of the plant from which the ingredient 
is derived) regardless of whether they are listed in an ingredient 
statement or in the nutrition label.
    (2) When source ingredients are listed within the nutrition label, 
and two or more are used to provide a single dietary ingredient, all of 
the sources shall be listed within the parentheses in descending order 
by weight.
    (3) Representations that the source ingredient conforms to an 
official compendium may be included either in the nutrition label or in 
the ingredient list (e.g., ``Calcium (as calcium carbonate USP)'').
    (e) Except as provided for small and intermediate sized packages 
under paragraph (h)(3)(i)(2) of this section, information other than the 
title, headings, and footnotes shall be in uniform type size no smaller 
than 8 point. Type size no smaller than 6 point may be

[[Page 115]]

used for column headings (e.g., ``Amount Per Serving'' and ``% Daily 
Value'') and for footnotes (e.g., ``Percent Daily Values are based on a 
2,000 calorie diet'').
    (1) The title, ``Supplement Facts,'' shall be set in a type size 
larger than all other print size in the nutrition label and, unless 
impractical, shall be set full width of the nutrition label. The title 
and all headings shall be bolded to distinguish them from other 
information.
    (2) The nutrition information shall be enclosed in a box by using 
hairlines.
    (3) All information within the nutrition label shall utilize:
    (i) A single easy-to-read type style,
    (ii) All black or one color type, printed on a white or other 
neutral contrasting background whenever practical,
    (iii) Upper- and lowercase letters, except that all uppercase 
lettering may be utilized for packages that have a total surface area 
available to bear labeling of less than 12 square inches,
    (iv) At least one point leading (i.e., space between lines of text), 
and
    (v) Letters that do not touch.
    (4) Except as provided for small and intermediate-sized packages 
under paragraph (i)(2) of this section, information other than the 
title, headings, and footnotes shall be in uniform type size no smaller 
than 8 point. Type size no smaller than 6 point may be used for column 
headings (e.g., ``Amount Per Serving'' and ``% Daily Value'') and for 
footnotes (e.g., ``Percent Daily Values are based on a 2,000 calorie 
diet'').
    (5) A hairline rule that is centered between the lines of text shall 
separate each dietary ingredient required in paragraph (b)(2) and (b)(3) 
of this section from the dietary ingredient above and beneath it, as 
shown in paragraph (e)(10) of this section.
    (6) A heavy bar shall be placed:
    (i) Beneath the subheading ``Servings Per Container'' except that if 
``Servings Per Container'' is not required and, as a result, not 
declared, the bar shall be placed beneath the subheading ``Serving 
Size,''
    (ii) Beneath the last dietary ingredient to be listed under 
paragraph (b)(2)(i) of this section, if any, and
    (iii) Beneath the last other dietary ingredient to be listed under 
paragraph (b)(3) of this section, if any.
    (7) A light bar shall be placed beneath the headings ``Amount Per 
Serving'' and ``% Daily Value.''
    (8) If the product contains two or more separately packaged dietary 
supplements that differ from each other (e.g., the product has a packet 
of supplements to be taken in the morning and a different packet to be 
taken in the afternoon), the quantitative amounts and percent of Daily 
Value may be presented as specified in this paragraph in individual 
nutrition labels or in one aggregate nutrition label as illustrated in 
paragraph (e)(11)(iii) of this section.
    (9)(i) The quantitative amount by weight (or volume, if permitted) 
and the percent of Daily Value of each dietary ingredient may be 
presented on a ``per unit'' basis in addition to the ``per serving'' 
basis required by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section 
for (b)(2)-dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this 
section for other dietary ingredients. If ``per unit'' information is 
provided, it must be presented in additional columns to the right of the 
``per serving'' information and be clearly identified by appropriate 
headings.
    (ii) Alternatively, if a recommendation is made in other parts of 
the label that a dietary supplement be consumed more than once per day, 
the total quantitative amount by weight (or volume, if permitted) and 
the percent of Daily Value of each dietary ingredient may be presented 
on a ``per day'' basis in addition to the ``per serving'' basis required 
by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section for (b)(2)-
dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this section for 
other dietary ingredients. If ``per day'' information is provided, it 
must be presented in additional columns to the right of the ``per 
serving'' information and be clearly identified by appropriate headings 
and/or be presented in a parenthetical statement as part of the 
``Serving Size'' declaration. A sample illustration for ``per day'' 
information in a column format is provided in paragraph

[[Page 116]]

(e)(11)(viii) of this section. As illustrated, the additional ``Per 
Day'' column heading is followed parenthetically by the number of 
servings recommended per day in other parts of the label (e.g., ``Per 
Day (3 Caplets)''). When the parenthetical statement format following 
the ``Serving Size'' declaration is used as an alternative to the column 
format, the statement must provide no more than simple instructions 
regarding how to calculate the ``per day'' amount for the number of 
servings per day recommended in other parts of the label (e.g., 
``Serving Size: 1 Caplet (Multiply amounts by 3 for total daily 
amount)''). When the parenthetical statement format following the 
``Serving Size'' declaration is used in addition to the column format, 
the statement must provide no more than a simple declaration of the 
number of servings recommended in other parts of the label (e.g., 
``Serving Size: 1 Caplet (Total daily amount: 3 caplets per day)'').
    (10) In the interest of uniformity of presentation, FDA urges that 
the information be presented using the graphic specifications set forth 
in appendix B to part 101, as applicable.
    (11) The following sample labels are presented for the purpose of 
illustration:
[GRAPHIC] [TIFF OMITTED] TR27MY16.413

    (ii) Multiple vitamins for children and adults (excludes Servings 
Per Container which is stated in the net quantity of contents 
declaration):

[[Page 117]]

[GRAPHIC] [TIFF OMITTED] TR21DE18.014


[[Page 118]]


[GRAPHIC] [TIFF OMITTED] TR27MY16.415

    (iv) Dietary supplement containing dietary ingredients with and 
without RDIs and DRVs:
[GRAPHIC] [TIFF OMITTED] TR21DE18.015


[[Page 119]]


[GRAPHIC] [TIFF OMITTED] TR27MY16.417

[GRAPHIC] [TIFF OMITTED] TR27MY16.418

[GRAPHIC] [TIFF OMITTED] TR27MY16.419


[[Page 120]]


    (12) If space is not adequate to list the required information as 
shown in the sample labels in paragraph (e)(11) of this section, the 
list may be split and continued to the right as long as the headings are 
repeated. The list to the right must be set off by a line that 
distinguishes it and sets it apart from the dietary ingredients and 
percent of Daily Value information given to the left. The following 
sample label illustrates this display:
[GRAPHIC] [TIFF OMITTED] TR21DE18.016

    (f)(1) Compliance with this section will be determined in accordance 
with Sec. 101.9(g)(1) through (g)(8), (g)(10), and (g)(11), except that 
the sample for analysis shall consist of a composite of 12 subsamples 
(consumer packages) or 10 percent of the number of packages in the same 
inspection lot, whichever is smaller, randomly selected to be 
representative of the lot. The criteria on class I and class II 
nutrients given in Sec. 101.9(g)(3) and (g)(4) also are applicable to 
other dietary ingredients described in paragraph (b)(3)(i) of this 
section. Reasonable excesses over labeled amounts are acceptable within 
current good manufacturing practice.
    (2) When it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of this section, FDA may permit alternative means of 
compliance or additional exemptions to deal with the situation in 
accordance with Sec. 101.9(g)(9). Firms in need of such special 
allowances shall make their request in writing to the Office of 
Nutrition and Food Labeling (HFS-800), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740.
    (g) Except as provided in paragraphs (i)(2) and (i)(5) of this 
section, the location of nutrition information on a label shall be in 
compliance with Sec. 101.2.
    (h) Dietary supplements are subject to the exemptions specified as 
follows in:
    (1) Section 101.9(j)(1) for foods that are offered for sale by a 
person who makes direct sales to consumers (i.e., a retailer) who has 
annual gross sales or business done in sales to consumers that is not 
more than $500,000 or has annual gross sales made or business done in 
sales of food to consumers of not more than $50,000, and whose labels, 
labeling, and advertising do not provide nutrition information or make a 
nutrient content or health claim;
    (2) Section 101.9(j)(18) for foods that are low-volume products 
(that is, they meet the requirements for units sold in Sec. 
101.9(j)(18)(i) or (j)(18)(ii)); that, except

[[Page 121]]

as provided in Sec. 101.9(j)(18)(iv), are the subject of a claim for an 
exemption that provides the information required under Sec. 
101.9(j)(18)(iv), that is filed before the beginning of the time period 
for which the exemption is claimed, and that is filed by a person, 
whether it is the manufacturer, packer, or distributor, that qualifies 
to claim the exemption under the requirements for average full-time 
equivalent employees in Sec. 101.9(j)(18)(i) or (j)(18)(ii), and whose 
labels, labeling, and advertising do not provide nutrition information 
or make a nutrient content or health claim;
    (3) Section 101.9(j)(9) for foods shipped in bulk form that are not 
for distribution to consumers in such form and that are for use solely 
in the manufacture of other dietary supplements or that are to be 
processed, labeled, or repacked at a site other than where originally 
processed or packed.
    (i)(1) Dietary supplements are subject to the special labeling 
provisions specified in Sec. 101.9(j)(5)(i) for foods other than infant 
formula, represented or purported to be specifically for infants through 
12 months of age and children 1 through 3 years of age.
    (2) Section 101.9(j)(13) for foods in small or intermediate-sized 
packages, except that:
    (i) All information within the nutrition label on small-sized 
packages, which have a total surface area available to labeling of less 
than 12 square inches, shall be in type size no smaller than 4.5 point;
    (ii) All information within the nutrition label on intermediate-
sized packages, which have from 12 to 40 square inches of surface area 
available to bear labeling, shall be in type size no smaller than 6 
point, except that type size no smaller than 4.5 point may be used on 
packages that have less than 20 square inches available for labeling and 
more than 8 dietary ingredients to be listed and on packages that have 
20 to 40 square inches available for labeling and more than 16 dietary 
ingredients to be listed.
    (iii) When the nutrition information is presented on any panel under 
Sec. 101.9(j)(13)(ii)(D), the ingredient list shall continue to be 
located immediately below the nutrition label, or, if there is 
insufficient space below the nutrition label, immediately contiguous and 
to the right of the nutrition label as specified in Sec. 101.4(g).
    (iv) When it is not possible for a small or intermediate-sized 
package that is enclosed in an outer package to comply with these type 
size requirements, the type size of the nutrition label on the primary 
(inner) container may be as small as needed to accommodate all of the 
required label information provided that the primary container is 
securely enclosed in outer packaging, the nutrition labeling on the 
outer packaging meets the applicable type size requirements, and such 
outer packaging is not intended to be separated from the primary 
container under conditions of retail sale.
    (v) Where there is not sufficient space on a small or intermediate-
sized package for a nutrition label that meets minimum type size 
requirements of 4.5 points if hairlines are used in accordance with 
paragraph (e)(5) of this section, the hairlines may be omitted and 
replaced by a row of dots connecting the columns containing the name of 
each dietary ingredient and the quantitative amounts (by weight and as a 
percent of Daily Value).
    (3) Section 101.9(j)(15) for foods in multiunit food containers;
    (4) Section 101.9(j)(16) for foods sold in bulk containers; and
    (5) Section 101.9(j)(17) for foods 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 label information, except 
that the ingredient list shall continue to be located immediately below 
the nutrition label, or, if there is insufficient space below the 
nutrition label, immediately contiguous and to the right of the 
nutrition label as specified in Sec. 101.4(g).
    (j) Dietary supplements shall be subject to the misbranding 
provisions of Sec. 101.9(k).

[62 FR 49849, Sept. 23, 1997, as amended at 63 FR 30620, June 5, 1998; 
66 FR 56035, Nov. 6, 2001; 71 FR 51726, Aug. 31, 2006; 71 FR 74791, Dec. 
13, 2006; 81 FR 33994, May 27, 2016; 83 FR 65502, Dec. 21, 2018]

[[Page 122]]



Sec. 101.42  Nutrition labeling of raw fruit, vegetables, and fish.

    (a) The Food and Drug Administration (FDA) urges food retailers to 
provide nutrition information, as provided in Sec. 101.9(c), for raw 
fruit, vegetables, and fish at the point-of-purchase. If retailers 
choose to provide such information, they should do so in a manner that 
conforms to the guidelines in Sec. 101.45.
    (b) In Sec. 101.44, FDA has listed the 20 varieties of raw fruit, 
vegetables, and fish that are most frequently consumed during a year and 
to which the guidelines apply.
    (c) FDA has also defined in Sec. 101.43, the circumstances that 
constitute substantial compliance by food retailers with the guidelines.
    (d) By May 8, 1993, FDA will issue a report on actions taken by food 
retailers to provide consumers with nutrition information for raw fruit, 
vegetables, and fish under the guidelines established in Sec. 101.45.
    (1) The report will include a determination of whether there is 
substantial compliance, as defined in Sec. 101.43, with the guidelines.
    (2) In evaluating substantial compliance, FDA will consider only the 
20 varieties of raw fruit, vegetables, and fish most frequently consumed 
as identified in Sec. 101.44.
    (e) If FDA finds that there is substantial compliance with the 
guidelines for the nutrition labeling of raw fruit and vegetables or of 
fish, the agency will so state in the report, and the guidelines will 
remain in effect. FDA will reevaluate the market place for substantial 
compliance every 2 years.
    (f) If FDA determines that there is not substantial compliance with 
the guidelines for raw fruit and vegetables or for raw fish, the agency 
will at that time issue proposed regulations requiring that any person 
who offers raw fruit and vegetables or fish to consumers provide, in a 
manner prescribed by regulations, the nutrition information required by 
Sec. 101.9. Final regulations would have to be issued 6 months after 
issuance of proposed regulations, and they would become effective 6 
months after the date of their promulgation.



Sec. 101.43  Substantial compliance of food retailers with the 
guidelines for the voluntary nutrition labeling of raw fruit, 
vegetables, and fish.

    (a) The Food and Drug Administration (FDA) will judge a food 
retailer who sells raw agricultural commodities or raw fish to be in 
compliance with the guidelines in Sec. 101.45 with respect to raw 
agricultural commodities if the retailer displays or provides nutrition 
labeling for at least 90 percent of the raw agricultural commodities 
listed in Sec. 101.44 that it sells, and with respect to raw fish if 
the retailer displays or provides nutrition labeling for at least 90 
percent of the types of raw fish listed in Sec. 101.44 that it sells. 
To be in compliance, the nutrition labeling shall:
    (1) Be presented in the store or other type of establishment in a 
manner that is consistent with Sec. 101.45(a)(1);
    (2) Be presented in content and format that are consistent with 
Sec. 101.45 (a)(2), (a)(3), and (a)(4); and
    (3) Include data that have been provided by FDA in appendices C and 
D to part 101 of this chapter, except that the information on potassium 
is voluntary.
    (b) To determine whether there is substantial compliance by food 
retailers with the guidelines in Sec. 101.45 for the voluntary 
nutrition labeling of raw fruit and vegetables and of raw fish, FDA will 
select a representative sample of 2,000 stores, allocated by store type 
and size, for raw fruit and vegetables and for raw fish.
    (c) FDA will find that there is substantial compliance with the 
guidelines in Sec. 101.45 if it finds based on paragraph (a) of this 
section that at least 60 percent of all stores that are evaluated are in 
compliance.
    (d) FDA will evaluate substantial compliance separately for raw 
agricultural commodities and for raw fish.

[55 FR 60890, Nov. 27, 1991, as amended at 61 FR 42759, Aug. 16, 1996]



Sec. 101.44  What are the 20 most frequently consumed raw fruits, 
vegetables, and fish in the United States?

    (a) The 20 most frequently consumed raw fruits are: Apple, avocado 
(California), banana, cantaloupe, grapefruit, grapes, honeydew melon, 
kiwifruit, lemon, lime, nectarine, orange, peach,

[[Page 123]]

pear, pineapple, plums, strawberries, sweet cherries, tangerine, and 
watermelon.
    (b) The 20 most frequently consumed raw vegetables are: Asparagus, 
bell pepper, broccoli, carrot, cauliflower, celery, cucumber, green 
(snap) beans, green cabbage, green onion, iceberg lettuce, leaf lettuce, 
mushrooms, onion, potato, radishes, summer squash, sweet corn, sweet 
potato, and tomato.
    (c) The 20 most frequently consumed raw fish are: Blue crab, 
catfish, clams, cod, flounder/sole, haddock, halibut, lobster, ocean 
perch, orange roughy, oysters, pollock, rainbow trout, rockfish, salmon 
(Atlantic/coho/Chinook/sockeye, chum/pink), scallops, shrimp, swordfish, 
tilapia, and tuna.

[71 FR 42044, July 25, 2006]



Sec. 101.45  Guidelines for the voluntary nutrition labeling of
raw fruits, vegetables, and fish.

    (a) Nutrition labeling for raw fruits, vegetables, and fish listed 
in Sec. 101.44 should be presented to the public in the following 
manner:
    (1) Nutrition labeling information should be displayed at the point 
of purchase by an appropriate means such as by a label affixed to the 
food or through labeling including shelf labels, signs, posters, 
brochures, notebooks, or leaflets that are readily available and in 
close proximity to the foods. The nutrition labeling information may 
also be supplemented by a video, live demonstration, or other media.
    (2) Serving sizes should be determined, and nutrients declared, in 
accordance with Sec. 101.9 (b) and (c), respectively, except that the 
nutrition labeling data should be based on the raw edible portion for 
fruits and vegetables and on the cooked edible portion for fish. The 
methods used to cook fish should be those that do not add fat, breading, 
or seasoning (e.g., salt or spices).
    (3) When nutrition labeling information is provided for more than 
one raw fruit, vegetable, or fish on signs, posters, brochures, 
notebooks, or leaflets, it may be presented in charts with horizontal or 
vertical columns or as a compilation of individual nutrition labels. 
Nutrition labeling that is presented in a linear display (see Sec. 
101.9(j)(13)(ii)(A)(2)) will not be considered to be in compliance. The 
heading ``Nutrition Facts'' must be in a type size larger than all other 
print in the nutrition label. The required information (i.e., headings, 
serving sizes, list of nutrients, quantitative amounts by weight (except 
for vitamins and minerals), and percent of Daily Values (DV's) (except 
for sugars and protein) must be clearly presented and of sufficient type 
size and color contrast to be plainly legible, with numeric values for 
percent of DV highlighted in contrast to the quantitative amounts by 
weight and hairlines between all nutrients.
    (i) Declaration of the number of servings per container need not be 
included in the nutrition labeling of raw fruits, vegetables, and fish.
    (ii) Except for the statement ``Percent Daily Values are based on a 
2,000 calorie diet,'' the footnote required in Sec. 101.9(d)(9) is not 
required. However, when labeling is provided in brochures, notebooks, 
leaflets, or similar types of materials, retailers are encouraged to 
include the footnote.
    (iii) When retailers provide nutrition labeling information for more 
than one raw fruit or vegetable on signs or posters or in brochures, 
notebooks, or leaflets, the listings for saturated fat, trans fat, and 
cholesterol may be omitted from the charts or individual nutrition 
labels if a footnote states that most fruits and vegetables provide 
negligible amounts of these nutrients, but that avocados contain 0.5 
gram (g) of saturated fat per ounce (e.g., ``Most fruits and vegetables 
provide negligible amounts of saturated fat, trans fat, and cholesterol; 
avocados provide 0.5 g of saturated fat per ounce''). The footnote also 
may contain information about the polyunsaturated and monounsaturated 
fat content of avocados.
    (iv) When retailers provide nutrition labeling information for more 
than one raw fish on signs or posters or in brochures, notebooks, or 
leaflets, the listings for trans fat, dietary fiber, and sugars may be 
omitted from the charts or individual nutrition labels if the following 
footnote is used, ``Fish provide negligible amounts of trans fat, 
dietary fiber, and sugars.''

[[Page 124]]

    (4) When nutrition labeling is provided for individual raw fruits, 
vegetables, or fish on packages or on signs, posters, brochures, 
notebooks, or leaflets, it should be displayed in accordance with Sec. 
101.9, except that the declaration of the number of servings per 
container need not be included. For individual labels provided by 
retailers on signs and posters, the footnote required in Sec. 
101.9(d)(9) may be shortened to ``Percent Daily Values are based on a 
2,000 calorie diet.''
    (b) Nutrition label values provided by the Food and Drug 
Administration (FDA) in Appendices C and D to part 101 for the 20 most 
frequently consumed raw fruits, vegetables, and fish listed in Sec. 
101.44 shall be used to ensure uniformity in declared values. FDA will 
publish proposed updates of the 20 most frequently consumed raw fruits, 
vegetables, and fish and nutrition label data for these foods (or a 
notice that the data sets have not changed from the previous 
publication) at least every 4 years in the Federal Register.
    (1) The agency encourages the submission of data bases with new or 
additional nutrient data for any of the most frequently consumed raw 
fruits, vegetables, and fish to the Office of Nutritional Products, 
Labeling and Dietary Supplements (HFS-800), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, for review and evaluation. FDA may incorporate 
these data in the next revision of the nutrition labeling information 
for the top 20 raw fruits, vegetables, and fish.
    (i) Guidance in the development of data bases may be found in the 
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data 
Bases,'' available from the FDA Office of Food Labeling.
    (ii) The submission to FDA should include, but need not be limited 
to, information on the following: Source of the data (names of 
investigators, name of organization, place of analyses, dates of 
analyses), number of samples, sampling design, analytical methods, and 
statistical treatment of the data. Proposed quantitative label 
declarations may be included. The proposed values for declaration should 
be determined in accordance with the ``FDA Nutrition Labeling Manual: A 
Guide for Developing and Using Data Bases.''
    (2) [Reserved]
    (c) Data bases of nutrient values for raw fruits, vegetables, and 
fish that are not among the 20 most frequently consumed may be used to 
develop nutrition labeling values for these foods. This includes data 
bases of nutrient values for specific varieties, species, or cultivars 
of raw fruits, vegetables, and fish not specifically identified among 
the 20 most frequently consumed.
    (1) The food names and descriptions for the fruits, vegetables, and 
fish should clearly identify these foods as distinct from foods among 
the most frequently consumed list for which FDA has provided data.
    (2) Guidance in the development of data bases may be found in the 
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data 
Bases.''
    (3) Nutrition labeling values computed from data bases are subject 
to the compliance provisions of Sec. 101.9(g).
    (i) Compliance with the provisions of Sec. 101.9(g) may be achieved 
by use of a data base that has been developed following FDA guideline 
procedures and approved by FDA.
    (A) The submission to FDA for approval should include but need not 
be limited to information on the following: Source of the data (names of 
investigators, name of organization, place of analyses, dates of 
analyses), number of samples, sampling design, analytical methods, 
statistical treatment of the data, and proposed quantitative label 
declarations. The values for declaration should be determined in 
accordance with the ``FDA Nutrition Labeling Manual: A Guide for 
Developing and Using Databases.''
    (B) FDA approval of a data base and nutrition labeling values shall 
not be considered granted until the Center for Food Safety and Applied 
Nutrition has agreed to all aspects of the data base in writing. 
Approvals will be in effect for a limited time, e.g., 10 years, and will 
be eligible for renewal in the absence of significant changes in 
agricultural or industry practices (e.g., a change occurs in a 
predominant variety produced). FDA will take steps to revoke

[[Page 125]]

its approval of the data base and nutrition labeling values if FDA 
monitoring suggests that the data base or nutrition labeling values are 
no longer representative of the item sold in this country. Approval 
requests shall be submitted in accordance with the provision of Sec. 
101.30 of this chapter.
    (ii) [Reserved]

[61 FR 42760, Aug. 16, 1996, as amended at 66 FR 56035, Nov. 6, 2001; 71 
FR 42044, July 25, 2006]



       Subpart D_Specific Requirements for Nutrient Content Claims

    Source: 58 FR 2413, Jan. 6, 1993, unless otherwise noted.



Sec. 101.54  Nutrient content claims for ``good source,'' ``high,''
``more,'' and ``high potency.''

    (a) General requirements. Except as provided in paragraph (e) of 
this section, a claim about the level of a nutrient in a food in 
relation to the Reference Daily Intake (RDI) established for that 
nutrient in Sec. 101.9(c)(8)(iv) or Daily Reference Value (DRV) 
established for that nutrient in Sec. 101.9(c)(9), (excluding total 
carbohydrates) may only be made on the label or in labeling of the food 
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. 101.13; and
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
    (b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or 
``excellent source of'' may be used on the label and in the labeling of 
foods, except meal products as defined in Sec. 101.13(l) and main dish 
products as defined in Sec. 101.13(m), provided that the food 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 and in the labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(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 product is 
high in vitamin C).
    (c) ``Good Source'' claims. (1) The terms ``good source,'' 
``contains,'' or ``provides'' may be used on the label and in the 
labeling of foods, except meal products as defined in Sec. 101.13(l) 
and main dish products as defined in Sec. 101.13(m), provided that the 
food 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 and in the labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in 101.13(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 
product 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, that is, that the product is high 
in fiber, a good source of fiber, or that the food contains ``more'' 
fiber, and the food is not ``low'' in total fat as defined in Sec. 
101.62(b)(2) or, in the case of a meal product, as defined in Sec. 
101.13(l), or main dish product, as defined in Sec. 101.13(m), is not 
``low'' in total fat as defined in Sec. 101.62(b)(3), then the label 
shall disclose the level of total fat per labeled serving.
    (2) The disclosure shall appear in immediate proximity to such 
claim, be in a type size no less than one-half the size of the claim and 
precede any disclosure statement required under Sec. 101.13(h) (e.g., 
``contains [x amount] of total fat per serving. See nutrition 
information for fat content'').
    (e) ``More'' claims. (1) A relative claim using the terms ``more,'' 
``fortified,'' ``enriched,'' ``added,'' ``extra,'' and ``plus'' may be 
used on the label or in labeling of foods to describe the level of 
protein, vitamins, minerals, dietary

[[Page 126]]

fiber, or potassium, except as limited by Sec. 101.13(j)(1)(i) and 
except meal products as defined in Sec. 101.13(l) and main dish 
products as defined in Sec. 101.13(m), provided that:
    (i) The food contains at least 10 percent more of the RDI for 
vitamins or minerals or of the DRV for protein, dietary fiber, or 
potassium (expressed as a percent of the Daily Value) per reference 
amount customarily consumed than an appropriate reference food; and
    (ii) Where the claim is based on a nutrient that has been added to 
the food, that fortification is in accordance with the policy on 
fortification of foods in Sec. 104.20 of this chapter; and
    (iii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percentage (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 white 
bread''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Fiber content of white bread is 1 gram (g) per 
serving; (this product) 3.5 g per serving'') is declared adjacent to the 
most prominent claim or to the nutrition label, except that if the 
nutrition label is on the information panel, the quantitative 
information may be located elsewhere on the information panel in 
accordance with Sec. 101.2.
    (2) A relative claim using the terms ``more,'' ``fortified,'' 
``enriched,'' ``added,'' ``extra,'' and ``plus'' may be used on the 
label or in labeling to describe the level of protein, vitamins, 
minerals, dietary fiber or potassium, except as limited in Sec. 
101.13(j)(1)(i), in meal products as defined in Sec. 101.13(l) or main 
dish products as defined in Sec. 101.13(m), provided that:
    (i) The food contains at least 10 percent more of the RDI for 
vitamins or minerals or of the DRV for protein, dietary fiber, or 
potassium (expressed as a percent of the Daily Value) per 100 g of food 
than an appropriate reference food.
    (ii) Where the claim is based on a nutrient that has been added to 
the food, that fortification is in accordance with the policy on 
fortification of foods in Sec. 104.20 of this chapter; and
    (iii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percentage (or 
fraction) that the nutrient was increased 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 oz than 
does `X brand of product' ''), and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``The fiber content of `X brand of product' is 2 g per 3 
oz. This product contains 4.5 g per 3 oz.'') is declared adjacent to the 
most prominent claim or to the nutrition label, except that if the 
nutrition label is on the information panel, the quantitative 
information may be located elsewhere on the information panel in 
accordance with Sec. 101.2.
    (f) ``High potency'' claims. (1)(i) The term ``high potency'' may be 
used on the label or in the labeling of foods to describe individual 
vitamins or minerals that are present at 100 percent or more of the RDI 
per reference amount customarily consumed.
    (ii) When the term ``high potency'' is used to describe individual 
vitamins or minerals in a product that contains other nutrients or 
dietary ingredients, the label or labeling shall clearly identify which 
vitamin or mineral is described by the term ``high potency'' (e.g., 
``Botanical `X' with high potency vitamin E'').
    (2) The term ``high potency'' may be used on the label or in the 
labeling of a multiingredient food product to describe the product if 
the product contains 100 percent or more of the RDI for at least two-
thirds of the vitamins and minerals that are listed in Sec. 
101.9(c)(8)(iv) and that are present in the product at 2 percent or more 
of the RDI (e.g., ``High potency multivitamin, multimineral dietary 
supplement tablets'').
    (3) Where compliance with paragraphs (f)(1)(i), (f)(1)(ii), or 
(f)(2) of this section is based on a nutrient that has

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been added to a food (other than a dietary supplement), that 
fortification shall be in accordance with the policy on fortification of 
foods in Sec. 104.20 of this chapter.
    (g) Nutrient content claims using the term ``antioxidant.'' A 
nutrient content claim that characterizes the level of antioxidant 
nutrients present in a food may be used on the label or in the labeling 
of that food when:
    (1) An RDI has been established for each of the nutrients;
    (2) The nutrients that are the subject of the claim have recognized 
antioxidant activity; that is, when there exists scientific evidence 
that, following absorption from the gastrointestinal tract, the 
substance participates in physiological, biochemical, or cellular 
processes that inactivate free radicals or prevent free radical-
initiated chemical reactions;
    (3) The level of each nutrient that is the subject of the claim is 
sufficient to qualify for the Sec. 101.54 (b), (c), or (e) claim (e.g., 
to bear the claim ''high in antioxidant vitamin C,'' the product must 
contain 20 percent or more of the RDI for vitamin C). Beta-carotene may 
be a subject of the claim when the level of vitamin A present as beta-
carotene in the food that bears the claim is sufficient to qualify for 
the claim. For example, for the claim ``good source of antioxidant beta-
carotene,'' 10 percent or more of the RDI for vitamin A must be present 
as beta-carotene per reference amount customarily consumed; and
    (4) The names of the nutrients that are the subject of the claim are 
included as part of the claim (e.g., ``high in antioxidant vitamins C 
and E''). Alternatively, when used as part of a nutrient content claim, 
the term ``antioxidant'' or ``antioxidants'' (as in ``high in 
antioxidants'') may be linked by a symbol (e.g., an asterisk) that 
refers to the same symbol that appears elsewhere on the same panel of a 
product label followed by the name or names of the nutrients with 
recognized antioxidant activity. The list of nutrients shall appear in 
letters of a type size height no smaller than the larger of one-half of 
the type size of the largest nutrient content claim or \1/16\ inch.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 59 
FR 394, Jan. 4, 1994; 59 FR 15051, Mar. 31, 1994; 60 FR 17206, Apr. 5, 
1995; 61 FR 11731, Mar. 22, 1996; 62 FR 31339, June 9, 1997; 62 FR 
49867, 49880, Sept. 23, 1997; 63 FR 26980, May 15, 1998; 66 FR 17358, 
Mar. 30, 2001]



Sec. 101.56  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. A claim using the term light or lite to 
describe a food may only be made on the label or in labeling of the food 
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. 101.13; and
    (3) The food is labeled in accordance with Sec. 101.9 or Sec. 
101.10, where applicable.
    (b) ``Light'' claims. The terms ``light'' or ``lite'' may be used on 
the label or in the labeling of foods, except meal products as defined 
in Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), 
without further qualification, provided that:
    (1) If the food 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 food as 
specified in Sec. 101.13(j)(1); or
    (2) If the food 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 food; or
    (ii) Its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to the reference food that it 
resembles or for which it substitutes as specified in Sec. 
101.13(j)(1); and
    (3) As required in Sec. 101.13(j)(2) for relative claims:
    (i) The identity of the reference food 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 our regular cheese cake'');

[[Page 128]]

    (ii) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference food that it replaces (e.g., ``lite cheesecake--200 calories, 
4 grams (g) fat per serving; regular cheesecake--300 calories, 8 g fat 
per serving'') is declared adjacent to the most prominent claim or to 
the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2; and
    (iii) If the labeled food 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 food for which the 
reference food meets the definition of ``low fat'' and ``low calorie.''
    (c)(1)(i) A product for which the reference food contains 40 
calories or less and 3 g fat or less per reference amount customarily 
consumed may use the term ``light'' or ``lite'' without further 
qualification if it is reduced by 50 percent or more in sodium content 
compared to the reference food; and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sodium was reduced shall be declared in immediate proximity to 
the most prominent such claim (e.g., 50 percent less sodium than our 
regular soy sauce); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``lite soy sauce 500 milligrams (mg) sodium per serving; regular 
soy sauce 1,000 mg per serving'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with Sec. 
101.2.
    (2)(i) A product for which the reference food contains more than 40 
calories or more than 3 g fat per reference amount customarily consumed 
may use the term ``light in sodium'' or ``lite in sodium'' if it is 
reduced by 50 percent or more in sodium content compared to the 
reference food, 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. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sodium was reduced shall be declared in immediate proximity to 
the most prominent such claim (e.g., 50 percent less sodium than our 
regular canned peas); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``lite canned peas, 175 mg sodium per serving; regular canned 
peas 350 mg per serving'') is declared adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label is 
on the information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
    (iii) Except for meal products as defined in Sec. 101.13(l) and 
main dish products as defined in Sec. 101.13(m), a ``light in sodium'' 
claim may not be made on a food for which the reference food meets the 
definition of ``low in sodium''.
    (d)(1) The terms ``light'' or ``lite'' may be used on the label or 
in the labeling of a meal product as defined in Sec. 101.13(l) and a 
main dish product as defined in Sec. 101.13(m), provided that:
    (i) The food meets the definition of:
    (A) ``Low in calories'' as defined in Sec. 101.60(b)(3); or
    (B) ``Low in fat'' as defined in Sec. 101.62(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 term ``light in sodium'' or ``lite in sodium'' may be 
used on the label or in the labeling of a meal product as defined in 
Sec. 101.13(l) and a main

[[Page 129]]

dish product as defined in Sec. 101.13(m), provided that the food meets 
the definition of ``low in sodium'' as defined in Sec. 101.61(b)(5)(i); 
and
    (ii) ``Light'' or ``lite'' and ``in sodium'' are presented in 
uniform type size, style, color, and prominence.
    (e) Except as provided in paragraphs (b) through (d) of this 
section, the term ``light'' or ``lite'' may not be used to refer to a 
food 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 food 
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 food to reflect a 
physical or organoleptic attribute (e.g., light brown sugar, light corn 
syrup, or light molasses) 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 food as described in Sec. 101.13(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in Sec. 101.61(b)(4), the statement ``not a low sodium food,'' 
shall appear adjacent to the nutrition label of the food bearing the 
claim, or, if the nutrition label is on the information panel, it may 
appear elsewhere on the information panel in accordance with Sec. 101.2 
and the information required to accompany a relative claim shall appear 
on the label or labeling as specified in Sec. 101.13(j)(2).

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 60 
FR 17206, Apr. 5, 1995]



Sec. 101.60  Nutrient content claims for the calorie content of foods.

    (a) General requirements. A claim about the calorie or sugar content 
of a food may only be made on the label or in the labeling of a food 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. 101.13;
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
    (4) For dietary supplements, claims regarding calories may not be 
made on products that meet the criteria in Sec. 101.60(b)(1) or (b)(2) 
for ``calorie free'' or ``low calorie'' claims except when an equivalent 
amount of a similar dietary supplement (e.g., another protein 
supplement) that the labeled food resembles and for which it 
substitutes, normally exceeds the definition for ``low calorie'' in 
Sec. 101.60(b)(2).
    (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 the labeling of foods, provided that:
    (i) The food contains less than 5 calories per reference amount 
customarily consumed and per labeled serving.
    (ii) As required in Sec. 101.13(e)(2), if the food meets this 
condition without the benefit of special processing, alteration, 
formulation, or reformulation to lower the caloric content, it is 
labeled to disclose that calories are not usually present in the food 
(e.g., ``cider vinegar, a calorie free food'').
    (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 foods, except meal products 
as defined in Sec. 101.13(l) and main dish products as defined in Sec. 
101.13(m), provided that:
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 grams (g) or greater than 2 tablespoons and does not provide 
more

[[Page 130]]

than 40 calories per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and does not provide more than 40 calories 
per reference amount customarily consumed and, except for sugar 
substitutes, per 50 g (for dehydrated foods that must be reconstituted 
before typical consumption with water or a diluent containing an 
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients 
per reference amount customarily consumed, the per 50 g criterion refers 
to the ``as prepared'' form).
    (ii) If a food meets these conditions without the benefit of special 
processing, alteration, formulation, or reformulation to vary the 
caloric content, it is labeled to clearly refer to all foods of its type 
and not merely to the particular brand to which the label attaches 
(e.g., ``celery, a low calorie food'').
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of meal products as defined in Sec. 
101.13(l) or main dish products as defined in Sec. 101.13(m), provided 
that:
    (i) The product contains 120 calories or less per 100 g; 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 foods 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 the labeling of foods, 
except as limited by Sec. 101.13(j)(1)(i) and except meal products as 
defined in Sec. 101.13(l) and main dish products as defined in Sec. 
101.13(m), provided that:
    (i) The food contains at least 25 percent fewer calories per 
reference amount customarily consumed than an appropriate reference food 
as described in Sec. 101.13(j)(1); and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the calories differ between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., reduced calorie 
cupcakes ``33\1/3\ percent fewer calories than regular cupcakes''); and
    (B) Quantitative information comparing the level of the nutrient per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``Calorie content has been reduced from 150 to 100 calories per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2.
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or labeling of foods if the reference food 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 the labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), 
provided that:
    (i) The food contains at least 25 percent fewer calories per 100 g 
of food than an appropriate reference food as described in Sec. 
101.13(j)(1); and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the calories differ between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., Larry's Reduced 
Calorie Lasagna, ``25 percent fewer calories per oz (or 3 oz) than our 
regular Lasagna''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Calorie content has been reduced from 108 calories per 
3 oz to 83 calories per 3 oz.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with Sec. 
101.2.
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or labeling of food if the

[[Page 131]]

reference food meets the definition for ``low calorie.''
    (c) Sugar content claims--(1) Use of 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.'' Consumers may 
reasonably be expected to regard terms that represent that the food 
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 food may not be labeled with such terms 
unless:
    (i) The food contains less than 0.5 g of sugars, as defined in Sec. 
101.9(c)(6)(ii), per reference amount customarily consumed and per 
labeled serving or, in the case of a meal product or main dish product, 
less than 0.5 g of sugars per labeled serving; and
    (ii) The food 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 ingredient 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, if a dietary supplement, it meets the definition in 
paragraph (b)(2) of this section for ``low calorie'' but is prohibited 
by Sec. Sec. 101.13(b)(5) and 101.60(a)(4) from bearing the claim; or
    (B) Such term is immediately accompanied, each time it is used, by 
either the statement ``not a reduced calorie food,'' ``not a low calorie 
food,'' 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. 101.9(c)(6)(ii), or any 
other ingredient that contains sugars that functionally substitute for 
added sugars is added during processing or packaging; and
    (ii) The product does not contain an ingredient containing added 
sugars such as jam, jelly, or concentrated fruit juice; and
    (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 food, and a functionally insignificant 
increase in sugars results; and
    (iv) The food that it resembles and for which it substitutes 
normally contains added sugars; and
    (v) The product bears a statement that the food is not ``low 
calorie'' or ``calorie reduced'' (unless the food meets the requirements 
for a ``low'' or ``reduced calorie'' food) 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 food, including foods intended specifically for infants 
and children less than 2 years of age, is unsweetened or contains no 
added sweeteners in the case of a food that contains apparent 
substantial inherent sugar content, e.g., juices.
    (4) The claims provided for in paragraph (c)(1) and (c)(2) of this 
section may be used on labels or in labeling of dietary supplements of 
vitamins or minerals that are intended specifically for use by infants 
and children less than 2 years of age.
    (5) 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 foods, except meal products as 
defined in Sec. 101.13(l), main dish products as defined in Sec. 
101.13(m), and dietary supplements of vitamins or minerals, provided 
that:
    (i) The food contains at least 25 percent less sugar per reference 
amount customarily consumed than an appropriate reference food as 
described in Sec. 101.13(j)(1); and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sugar differs between the two foods are declared in immediate 
proximity to the

[[Page 132]]

most prominent such claim (e.g., ``these corn flakes contain 25 percent 
less sugar than our sugar coated corn flakes''); and
    (B) Quantitative information comparing the level of the sugar in the 
product per labeled serving with that of the reference food that it 
replaces (e.g., ``Sugar content has been lowered from 8 g to 6 g per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2.
    (6) The terms defined in paragraph (c)(5) of this section may be 
used on the label or in the labeling of a meal product as defined in 
Sec. 101.13(l) and a main dish product as defined in Sec. 101.13(m), 
provided that:
    (i) The food contains at least 25 percent less sugars per 100 g of 
food than an appropriate reference food as described in Sec. 
101.13(j)(1), and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sugars differ between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., reduced sweet and sour 
shrimp dinner, ``25 percent less sugar per 3 oz than our regular sweet 
and sour shrimp dinner''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Sugar content has been reduced from 17 g per 3 oz to 
13 g per 3 oz.'') is declared adjacent to the most prominent claim or to 
the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58 
FR 44031, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, 
1995; 62 FR 15342, Mar. 31, 1997; 62 FR 49881, Sept. 23, 1997]



Sec. 101.61  Nutrient content claims for the sodium content of foods.

    (a) General requirements. A claim about the level of sodium or salt 
in a food may only be made on the label or in the labeling of the food 
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. 101.13; and
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
    (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 ``dietary 
insignificant source of sodium'' may be used on the label or in the 
labeling of foods, provided that:
    (i) The food contains less than 5 milligrams (mg) of sodium per 
reference amount customarily consumed and per labeled serving or, in the 
case of a meal product or a main dish product, less than 5 mg of sodium 
per labeled serving; and
    (ii) The food contains no ingredient that is sodium chloride or is 
generally understood by consumers to contain sodium, unless the listing 
of the ingredient in the ingredient 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) As required in Sec. 101.13(e)(2) if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower the sodium content, it is labeled 
to disclose that sodium is not usually present in the food (e.g., ``leaf 
lettuce, a sodium free food'').
    (2) The terms ``very low sodium,'' or ``very low in sodium,'' may be 
used on the label or in labeling of foods, except meal products as 
defined in Sec. 101.13(l) and main dish products as defined in Sec. 
101.13(m), provided that:
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 grams (g) or greater than 2 tablespoons and contains 35 mg or 
less

[[Page 133]]

sodium per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and contains 35 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated foods 
that must be reconstituted before typical consumption with water or a 
diluent containing an insignificant amount, as defined in Sec. 
101.9(f)(1), of all nutrients per reference amount customarily consumed, 
the per 50-g criterion refers to the ``as prepared'' form);
    (ii) If the food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to vary 
the sodium content, it is labeled to clearly refer to all foods of its 
type and not merely to the particular brand to which the label attaches 
(e.g., ``potatoes, a very low-sodium food'').
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of meal products as defined in Sec. 
101.13(l) and main dish products as defined in Sec. 101.13(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 foods of its 
type and not merely to the particular brand to which the label attaches.
    (4) The terms ``low sodium,'' or ``low in sodium,'' ``little 
sodium,'' ``contains a small amount of sodium,'' or ``low source of 
sodium'' may be used on the label or in the labeling of foods, except 
meal products as defined in Sec. 101.13(l) and main dish products as 
defined in Sec. 101.13(m), provided that:
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and contains 140 mg or less 
sodium per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and contains 140 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated foods 
that must be reconstituted before typical consumption with water or a 
diluent containing an insignificant amount, as defined in Sec. 
101.9(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 food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to vary 
the sodium content, it is labeled to clearly refer to all foods of its 
type and not merely to the particular brand to which the label attaches 
(e.g., ``fresh spinach, a low sodium food''); and
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of meal products as defined in Sec. 
101.13(l) and main dish products as defined in Sec. 101.13(m), provided 
that:
    (i) The product contains 140 mg or less sodium per 100 g; 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 foods 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 foods, except meal products as 
defined in Sec. 101.13(l) and main dish products as defined in Sec. 
101.13(m), provided that:
    (i) The food contains at least 25 percent less sodium per reference 
amount customarily consumed than an appropriate reference food as 
described in Sec. 101.13(j)(1).
    (ii) As required for Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sodium differs from the labeled food are declared in immediate 
proximity to the most prominent such claim (e.g., ``reduced sodium ___, 
50 percent less sodium than regular ___''); and
    (B) Quantitative information comparing the level of the sodium in 
the product per labeled serving with that of the reference food that it 
replaces

[[Page 134]]

(e.g., ``Sodium content has been lowered from 300 to 150 mg per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2.
    (iii) Claims described in paragraph (b)(6) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 the labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), 
provided that:
    (i) The food contains at least 25 percent less sodium per 100 g of 
food than an appropriate reference food as described in Sec. 
101.13(j)(1), and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sodium differs from the reference food are declared in 
immediate proximity to the most prominent such claim (e.g., reduced 
sodium eggplant parmigiana dinner ``30 percent less sodium per oz (or 3 
oz) than our regular eggplant parmigiana dinner'').
    (B) Quantitative information comparing the level of sodium in the 
product per specified weight with that of the reference food that it 
replaces (e.g., ``Sodium content has been reduced from 217 mg per 3 oz 
to 150 mg per 3 oz.'') is declared adjacent to the most prominent claim 
or to the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2.
    (iii) Claims described in paragraph (b)(7) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 foods only if the food 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 foods only if:
    (i) No salt is added during processing;
    (ii) The food that it resembles and for which it substitutes is 
normally processed with salt; and
    (iii) If the food is not sodium free, the statement, ``not a sodium 
free food'' or ``not for control of sodium in the diet'' appears 
adjacent to the nutrition label of the food bearing the claim, or, if 
the nutrition label is on the information panel, it may appear elsewhere 
on the information panel in accordance with Sec. 101.2.
    (3) Paragraph (c)(2) of this section shall not apply to a factual 
statement that a food intended specifically for infants and children 
less than 2 years of age is unsalted, provided such statement refers to 
the taste of the food and is not otherwise false and misleading.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58 
FR 44032, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, 
1995]



Sec. 101.62  Nutrient content claims for fat, fatty acid, and
cholesterol content of foods.

    (a) General requirements. A claim about the level of fat, fatty 
acid, and cholesterol in a food may only be made on the label or in the 
labeling of foods 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. 101.13;
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
    (4) For dietary supplements, claims for fat, saturated fat, and 
cholesterol may not be made on products that meet the criteria in Sec. 
101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie'' claims.

[[Page 135]]

    (b) Fat content claims. (1) The terms ``fat free,'' ``free of fat,'' 
``no fat,'' ``zero fat,'' ``without fat,'' ``negligible source of fat,'' 
or ``dietarily insignificant source of fat'' or, in the case of milk 
products, ``skim'' may be used on the label or in labeling of foods, 
provided that:
    (i) The food contains less than 0.5 gram (g) of fat per reference 
amount customarily consumed and per labeled serving or, in the case of a 
meal product or main dish product, less than 0.5 g of fat per labeled 
serving; and
    (ii) The food 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 ingredient 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) As required in Sec. 101.13(e)(2), if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower fat content, it is labeled to 
disclose that fat is not usually present in the food (e.g., ``broccoli, 
a fat free food'').
    (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 or in labeling of foods, except meal products as defined in Sec. 
101.13(l) and main dish products as defined in Sec. 101.13(m), provided 
that:
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and contains 3 g or less of fat 
per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and contains 3 g or less of fat per 
reference amount customarily consumed and per 50 g of food (for 
dehydrated foods that must be reconstituted before typical consumption 
with water or a diluent containing an insignificant amount, as defined 
in Sec. 101.9(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 food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
fat content, it is labeled to clearly refer to all foods of its type and 
not merely to the particular brand to which the label attaches (e.g., 
``frozen perch, a low fat food'').
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of meal products as defined in Sec. 
101.13(l) or main dish products as defined in Sec. 101.13(m), provided 
that:
    (i) The product contains 3 g or less of total fat per 100 g 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 
fat content, it is labeled to clearly refer to all foods 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 the labeling of foods, except meal products as defined in 
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), 
provided that:
    (i) The food contains at least 25 percent less fat per reference 
amount customarily consumed than an appropriate reference food as 
described in Sec. 101.13(j)(1); and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the fat differs between the two foods and are declared in immediate 
proximity to the most prominent such claim (e.g., ``reduced fat--50 
percent less fat than our regular brownies''); and
    (B) Quantitative information comparing the level of fat in the 
product per labeled serving with that of the reference food that it 
replaces (e.g., ``Fat content has been reduced from 8 g to 4 g per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2.

[[Page 136]]

    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 the labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), 
provided that:
    (i) The food contains at least 25 percent less fat per 100 g of food 
than an appropriate reference food as described in Sec. 101.13(j)(1); 
and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the fat differs between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., reduced fat spinach 
souffle, ``33 percent less fat per 3 oz than our regular spinach 
souffle''); and
    (B) Quantitative information comparing the level of fat in the 
product per specified weight with that of the reference food that it 
replaces (e.g., ``Fat content has been reduced from 7.5 g per 3 oz to 5 
g per 3 oz.'') is declared adjacent to the most prominent claim, to the 
nutrition label, or, if the nutrition label is located on the 
information panel, it may appear elsewhere on the information panel in 
accordance with Sec. 101.2.
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low fat.''
    (6) The term ``_ percent fat free'' may be used on the label or in 
the labeling of foods, provided that:
    (i) The food 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 foods 
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.
    (c) Fatty acid content claims. The label or labeling of foods that 
bear claims with respect to the level of saturated fat shall disclose 
the level of total fat and cholesterol in the food in immediate 
proximity to such claim each time the claim is made and in type that 
shall be no less than one-half the size of the type used for the claim 
with respect to the level of saturated fat. Declaration of cholesterol 
content may be omitted when the food contains less than 2 milligrams 
(mg) of cholesterol per reference amount customarily consumed or in the 
case of a meal or main dish product less than 2 mg of cholesterol per 
labeled serving. Declaration of total fat may be omitted with the term 
defined in paragraph (c)(1) of this section when the food contains less 
than 0.5 g of total fat per reference amount customarily consumed or, in 
the case of a meal product or a main dish product, when the product 
contains less than 0.5 g of total fat per labeled serving. The 
declaration of total fat may be omitted with the terms defined in 
paragraphs (c)(2) through (c)(5) of this section when the food contains 
3 g or less of total fat per reference amount customarily consumed or in 
the case of a meal product or a main dish product, when the product 
contains 3 g or less of total fat per 100 g and not more than 30 percent 
calories from fat.
    (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 the labeling of foods, provided that:
    (i) The food contains less than 0.5 g of saturated fat and less than 
0.5 g trans fatty acid per reference amount customarily consumed and per 
labeled serving, or in the case of a meal product or main dish product, 
less than 0.5 g of saturated fat and less than 0.5 g trans fatty acid 
per labeled serving; and
    (ii) The food contains no ingredient that is generally understood by 
consumers to contain saturated fat unless the listing of the ingredient 
in the ingredient statement is followed by an asterisk that refers to 
the statement below the list of ingredients which

[[Page 137]]

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) As required in Sec. 101.13(e)(2), if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower saturated fat content, it is 
labeled to disclose that saturated fat is not usually present in the 
food.
    (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 the 
labeling of foods, except meal products as defined in Sec. 101.13(l) 
and main dish products as defined in Sec. 101.13(m), provided that:
    (i) The food contains 1 g or less of saturated fatty acids per 
reference amount customarily consumed and not more than 15 percent of 
calories from saturated fatty acids; and
    (ii) If a food 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 foods of its type and 
not merely to the particular brand to which the label attaches (e.g., 
``raspberries, a low saturated fat food'').
    (3) The terms defined in paragraph (c)(2) of this section may be 
used on the label or in the labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), 
provided that:
    (i) The product contains 1 g or less of saturated fatty acids 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 foods 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 the labeling of foods, except as limited by Sec. 101.13(j)(1)(i) 
and except meal products as defined in Sec. 101.13(l) and main dish 
products as defined in Sec. 101.13(m), provided that:
    (i) The food contains at least 25 percent less saturated fat per 
reference amount customarily consumed than an appropriate reference food 
as described in Sec. 101.13(j)(1); and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the saturated fat differs between the two foods are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
saturated fat. Contains 50 percent less saturated fat than the national 
average for nondairy creamers''); and
    (B) Quantitative information comparing the level of saturated fat in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Saturated fat reduced from 3 g to 1.5 g per serving'') 
is declared adjacent to the most prominent claim or to the nutrition 
label, except that if the nutrition label is on the information panel, 
the quantitative information may be located elsewhere on the information 
panel in accordance with Sec. 101.2.
    (iii) Claims described in paragraph (c)(4) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 the labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), 
provided that:
    (i) The food contains at least 25 percent less saturated fat per 100 
g of food than an appropriate reference food as described in Sec. 
101.13(j)(1), and
    (ii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food, and the percent (or 
fraction) that the fat differs between the two foods are declared in 
immediate proximity to the most prominent such claim (e.g., reduced 
saturated fat Macaroni and Cheese, ``33 percent less saturated fat per 3 
oz than our regular Macaroni and Cheese'').

[[Page 138]]

    (B) Quantitative information comparing the level of saturated fat in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Saturated fat content has been reduced from 2.5 g per 
3 oz to 1.7 g per 3 oz.'') is declared adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label in 
on the information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
    (iii) Claims described in paragraph (c)(5) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 the labeling of foods, 
provided that:
    (i) For foods that contain 13 g or less of total fat per reference 
amount customarily consumed, per labeled serving, and per 50 g if the 
reference amount customarily consumed is 30 g or less or 2 tablespoons 
or less (for dehydrated foods that must be reconstituted before typical 
consumption with water or a diluent containing an insignificant amount, 
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount 
customarily consumed, the per 50-g criterion refers to the ``as 
prepared'' form), or, in the case of meal products, 26.0 g or less total 
fat per labeled serving, or, in the case of main dish products, 19.5 g 
or less total fat per labeled serving:
    (A) The food contains less than 2 mg of cholesterol per reference 
amount customarily consumed and per labeling serving or, in the case of 
a meal product or main dish product, less than 2 mg of cholesterol per 
labeled serving; and
    (B) The food contains no ingredient that is generally understood by 
consumers to contain cholesterol, unless the listing of the ingredient 
in the ingredient 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;'' and
    (C) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed or, in the case of a meal product 
or main dish product, 2 g or less of saturated fatty acids per labeled 
serving; and
    (D) As required in Sec. 101.13(e)(2), if the food contains less 
than 2 mg of cholesterol per reference amount customarily consumed or in 
the case of a meal product or main dish product, less than 2 mg of 
cholesterol per labeled serving without the benefit of special 
processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to disclose that cholesterol is not 
usually present in the food (e.g., ``applesauce, a cholesterol-free 
food'').
    (ii) For food that contain more than 13 g of total fat per reference 
amount customarily consumed, per labeling serving, or per 50 g if the 
reference amount customarily consumed is 30 g or less or 2 tablespoons 
or less (for dehydrated foods that must be reconstituted before typical 
consumption with water or a diluent containing an insignificant amount, 
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount 
customarily consumed, the per 50-g criterion refers to the ``as 
prepared'' form), or in the case of a meal product, more than 26 g of 
total fat per labeled serving, or, in the case of a main dish product 
more than 19.5 g of total fat per labeled serving:
    (A) The food contains less than 2 mg of cholesterol per reference 
amount customarily consumed and per labeling serving or, in the case of 
a meal product or main dish product, less than 2 mg of cholesterol per 
labeled serving; and
    (B) The food contains no ingredient that is generally understood by 
consumers to contain cholesterol, unless the listing of the ingredient 
in the ingredient 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

[[Page 139]]

cholesterol,'' or ``adds a dietarily insignificant amount of 
cholesterol;'' and
    (C) The food contains 2 g or less of saturated fatty acids per 
reference amount cutomarily consumed or, in the case of a meal product 
or main dish product less than 2 g of saturated fatty acids per labeled 
serving; and
    (D) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec. 101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel, the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
appears more than once on a panel, the disclosure shall be made in 
immediate proximity to the claim that is printed in the largest type; 
and
    (E) As required in Sec. 101.13(e)(2), if the food contains less 
than 2 mg of cholesterol per reference amount customarily consumed or in 
the case of a meal product or main dish product less than 2 mg of 
cholesterol per labeled serving without the benefit of special 
processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to disclose that cholesterol is not 
usually present in the food (e.g., ``canola oil, a cholesterol-free 
food, contains 14 g of fat per serving''); or
    (F) If the food contains less than 2 mg of cholesterol per reference 
amount customarily consumed or in the case of a meal product or main 
dish product less than 2 mg of cholesterol per labeled serving only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is substantially less (i.e., meets 
requirements of paragraph (d)(4)(ii)(A) of this section) than the food 
for which it substitutes as specified in Sec. 101.13(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 margarine, 
contains 100 percent less cholesterol than butter''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Contains no cholesterol compared with 30 mg 
cholesterol in one serving of butter. Contains 13 g of fat per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2.
    (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 
the labeling of foods, except meal products as defined in Sec. 
101.13(l) and main dish products as defined in Sec. 101.13(m), provided 
that:
    (i) For foods that have a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons and contain 13 g or less 
of total fat per reference amount customarily consumed and per labeled 
serving:
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed;
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed; and
    (C) As required in Sec. 101.13(e)(2), if the food 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 foods of that type and not merely to the 
particular brand to which the label attaches (e.g., ``low fat cottage 
cheese, a low cholesterol food.'').
    (ii) For foods that have a reference amount customarily consumed of 
30 g or less or 2 tablespoons or less and contain 13 g or less of total 
fat per reference amount customarily consumed, per labeled serving, and 
per 50 g (for dehydrated foods that must be reconstituted before typical 
consumption with water or a diluent containing an insignificant amount, 
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount 
customarily consumed,

[[Page 140]]

the per 50-g criterion refers to the ``as prepared'' form);
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed and per 50 g (for dehydrated foods that must 
be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec. 101.9(f)(1), of 
all nutrients per reference amount customarily consumed, the per 50-g 
criterion refers to the ``as prepared'' form);
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed; and
    (C) As required in Sec. 101.13(e)(2), if the food 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 foods of that type and not merely to the 
particular brand to which the label attaches (e.g., ``low fat cottage 
cheese, a low cholesterol food'').
    (iii) For foods that have a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons and contain more than 13 
g of total fat per reference amount customarily consumed or per labeled 
serving,
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed;
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec. 101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel, the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
is made more than once on a panel, the disclosure shall be made in 
immediate proximity to the claim that is printed in the largest type; 
and
    (D) As required in Sec. 101.13(e)(2), if the food 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 foods of that type and not merely to the 
particular brand to which the label attaches; or
    (E) If the food contains 20 mg or less of cholesterol only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is substantially less (i.e., meets 
requirements of paragraph (d)(4)(ii)(A) of this section) than the food 
for which it substitutes as specified in Sec. 101.13(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 
peanut butter sandwich crackers, contains 83 percent less cholesterol 
than our regular peanut butter sandwich crackers''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving; 
contains 13 g of fat per serving.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with Sec. 
101.2.
    (iv) For foods that have a reference amount customarily consumed of 
30 g or less or 2 tablespoons or less and contain more than 13 g of 
total fat per reference amount customarily consumed, per labeled 
serving, or per 50 g (for dehydrated foods that must be reconstituted 
before typical consumption with water or a diluent containing an 
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients 
per reference amount customarily consumed, the per 50-g criterion refers 
to the ``as prepared'' form),
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed and per 50 g (for dehydrated foods that must 
be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in

[[Page 141]]

Sec. 101.9(f)(1), of all nutrients per reference amount customarily 
consumed, the per 50-g criterion refers to the ``as prepared'' form),
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec. 101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel, the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
is made more than once on a panel, the disclosure shall be made in 
immediate proximity to the claim that is printed in the largest type; 
and
    (D) As required in Sec. 101.13(e)(2), if the food 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 foods of that type and not merely to the 
particular brand to which the label attaches; or
    (E) If the food contains 20 mg or less of cholesterol only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is substantially less (i.e., meets 
requirements of paragraph (d)(4)(ii)(A) of this section) than the food 
for which it substitutes as specified in Sec. 101.13(d) that has a 
significant (i.e., 5 percent or more of a national or regional market) 
market share. As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 
peanut butter sandwich crackers, contains 83 percent less cholesterol 
than our regular peanut butter sandwich crackers''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving; 
contains 13 g of fat per serving.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with Sec. 
101.2.
    (3) The terms defined in paragraph (d)(2) of this section may be 
used on the label and in labeling of meal products as defined in Sec. 
101.13(l) or a main dish product as defined in Sec. 101.13(m) provided 
that the product meets the requirements of paragraph (d)(2) of this 
section except that the determination as to whether paragraph (d)(2)(i) 
or (d)(2)(iii) of this section applies to the product will be made only 
on the basis of whether the meal product contains 26 g or less of total 
fat per labeled serving or the main dish product contain 19.5 g or less 
of total fat per labeled serving, the requirement in paragraphs 
(d)(2)(i)(A) and (d)(2)(iii)(A) of this section shall be limited to 20 
mg of cholesterol per 100 g, and the requirement in paragraphs 
(d)(2)(i)(B) and (d)(2)(iii)(B) of this section shall be modified to 
require that the food contain 2 g or less of saturated fat per 100 g 
rather than per reference amount customarily consumed.
    (4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,'' 
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' or 
``lower in cholesterol'' except as limited by Sec. 101.13(j)(1)(i) may 
be used on the label or in labeling of foods or foods that substitute 
for those foods as specified in Sec. 101.13(d), excluding meal products 
as defined in Sec. 101.13(l) and main dish products as defined in Sec. 
101.13(m), provided that:
    (i) For foods that contain 13 g or less of total fat per reference 
amount customarily consumed, per labeled serving, and per 50 g if the 
reference amount customarily consumed is 30 g or less or 2 tablespoons 
or less (for dehydrated foods that must be reconstituted before typical 
consumption with water or a diluent containing an insignificant amount, 
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount 
customarily consumed, the per 50-g criterion refers to the ``as 
prepared'' form):

[[Page 142]]

    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec. 101.13(j)(1) and for which it 
substitutes as specified in Sec. 101.13(d) that has a significant 
(i.e., 5 percent or more) market share; and
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed; and
    (C) As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food and the percent (or fraction) 
that the cholesterol has been reduced are declared in immediate 
proximity to the most prominent such claim; and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``[labeled product] 50 mg cholesterol per serving; 
[reference product] 30 mg cholesterol per serving'') is declared 
adjacent to the most prominent claim or to the nutrition label, except 
that if the nutrition label is on the information panel, the 
quantitative information may be located elsewhere on the information 
panel in accordance with Sec. 101.2.
    (ii) For foods that contain more than 13 g of total fat per 
reference amount customarily consumed, per labeled serving, or per 50 g 
if the reference amount customarily consumed is 30 g or less or 2 
tablespoons or less (for dehydrated foods that must be reconstituted 
before typical consumption with water or a diluent containing an 
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients 
per reference amount customarily consumed, the per 50-g criterion refers 
to the ``as prepared'' form):
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec. 101.13(j)(1) and for which it 
substitutes as specified in Sec. 101.13(d) that has a significant 
(i.e., 5 percent or more of a national or regional market) market share;
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec. 101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel, the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
is made more than once on a panel, the disclosure shall be made in 
immediate proximity to the claim that is printed in the largest type; 
and
    (D) As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 ___); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 55 mg to 30 mg per serving. 
Contains 13 g of fat per serving.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with Sec. 
101.2.
    (iii) Claims described in paragraph (d)(4) of this section may not 
be made on the label or in labeling of a food if the nutrient content of 
the reference food 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 the labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), 
provided that:
    (i) For meal products that contain 26.0 g or less of total fat per 
labeled serving or for main dish products that contain 19.5 g or less of 
total fat per labeled serving;
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or

[[Page 143]]

more from the reference food it resembles as defined in Sec. 
101.13(j)(1) and for which it substitutes as specified in Sec. 
101.13(d) that has a significant (e.g., 5 percent or more of a national 
or regional market) market share;
    (B) The food contains 2 g or less of saturated fatty acids per 100 
g; and
    (C) As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food, 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 per 3 oz than ___); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Cholesterol content has been reduced from 35 mg per 3 
oz to 25 mg per 3 oz.'') is declared adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label is 
on the information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
    (ii) For meal products that contain more than 26.0 g of total fat 
per labeled serving or for main dish products that contain more than 
19.5 g of total fat per labeled serving:
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec. 101.13(j)(1) and for which it 
substitutes as specified in Sec. 101.13(d) that has a significant 
(e.g., 5 percent or more of a national or regional market) market share.
    (B) The food contains 2 g or less of saturated fatty acids per 100 
g;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec. 101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
is made more than once on a panel, the disclosure shall be made in 
immediate proximity to the claim that is printed in the largest type; 
and
    (D) As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 ___); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 22 mg per 3 oz of 
product.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec. 101.2.
    (iii) Claims described in paragraph (d)(5) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 foods except meal products as 
defined in Sec. 101.13(l) and main dish products as defined in Sec. 
101.13(m) provided that the food is a seafood or game meat product and 
as packaged contains less than 10 g total fat, 4.5 g or less saturated 
fat, and less than 95 mg cholesterol per reference amount customarily 
consumed and per 100 g;
    (2) The term defined in paragraph (e)(1) of this section may be used 
on the label or in labeling of a mixed dish not measurable with a cup as 
defined in Sec. 101.12(b) in table 2, provided that the food contains 
less than 8 g total fat, 3.5 g or less saturated fat and less than 80 mg 
cholesterol per reference amount customarily consumed;
    (3) The term defined in paragraph (e)(1) of this section may be used 
on the label or in the labeling of meal products as defined in Sec. 
101.13(l) or main dish products as defined in Sec. 101.13(m) provided 
that the food contains less

[[Page 144]]

than 10 g total fat, 4.5 g or less saturated fat, and less than 95 mg 
cholesterol per 100 g and per labeled serving;
    (4) The term ``extra lean'' may be used on the label or in the 
labeling of foods except meal products as defined in Sec. 101.13(l) and 
main dish products as defined in Sec. 101.13(m) provided that the food 
is a discrete seafood or game meat product and as packaged contains less 
than 5 g total fat, less than 2 g saturated fat, and less than 95 mg 
cholesterol per reference amount customarily consumed and per 100 g; and
    (5) The term defined in paragraph (e)(4) of this section may be used 
on the label or in labeling of meal products as defined in Sec. 
101.13(l) and main dish products as defined in Sec. 101.13(m) provided 
that the food contains less than 5 g of fat, less than 2 g of saturated 
fat, and less than 95 mg of cholesterol per 100 g and per labeled 
serving.
    (f) Misbranding. Any label or labeling containing any statement 
concerning fat, fatty acids, or cholesterol that is not in conformity 
with this section shall be deemed to be misbranded under sections 
201(n), 403(a), and 403(r) of the Federal Food, Drug, and Cosmetic Act.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, 17343, Apr. 2, 1993, as amended 
at 58 FR 44032, Aug. 18, 1993; 58 FR 60105, Nov. 15, 1993; 59 FR 394, 
Jan. 4, 1994; 60 FR 17207, Apr. 5, 1995; 61 FR 59001, Nov. 20, 1996; 63 
FR 26980, May 15, 1998; 72 FR 1459, Jan. 12, 2007]



Sec. 101.65  Implied nutrient content claims and related label
statements.

    (a) General requirements. An implied nutrient content claim can only 
be made on the label and in labeling of the food if:
    (1) The claim uses one of the terms described 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. 101.13; and
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
    (b) Label statements that are not implied claims. Certain label 
statements about the nature of a product are not nutrient content claims 
unless such statements are made in a context that would make them an 
implied claim under Sec. 101.13(b)(2). The following types of label 
statements are generally not implied nutrient content claims and, as 
such, are not subject to the requirements of Sec. 101.13 and this 
section:
    (1) A claim that a specific ingredient or food component is absent 
from a product, provided that the purpose of such claim is to facilitate 
avoidance of the substances because of food allergies (see Sec. 105.62 
of this chapter), food intolerance, religious beliefs, or dietary 
practices such as vegetarianism or other nonnutrition related reason, 
e.g., ``100 percent milk free;''
    (2) A claim about a substance that is nonnutritive or that does not 
have a nutritive function, e.g., ``contains no preservatives,'' ``no 
artificial colors;''
    (3) A claim about the presence of an ingredient that is perceived to 
add value to the product, e.g., ``made with real butter,'' ``made with 
whole fruit,'' or ``contains honey,'' except that claims about the 
presence of ingredients other than vitamins or minerals or that are 
represented as a source of vitamins and minerals are not allowed on 
labels or in labeling of dietary supplements of vitamins and minerals 
that are not in conventional food form.
    (4) A statement of identity for a food in which an ingredient 
constitutes essentially 100 percent of a food (e.g., ``corn oil,'' ``oat 
bran,'' ``dietary supplement of vitamin C 60 mg tablet'').
    (5) A statement of identity that names as a characterizing 
ingredient, an ingredient associated with a nutrient benefit (e.g., 
``corn oil margarine,'' ``oat bran muffins,'' or ``whole wheat 
bagels''), unless such claim is made in a context in which label or 
labeling statements, symbols, vignettes, or other forms of communication 
suggest that a nutrient is absent or present in a certain amount; and
    (6) A label statement made in compliance with a specific provision 
of part 105 of this chapter, solely to note that a food has special 
dietary usefulness relative to a physical, physiological, pathological, 
or other condition, where the claim identifies the special diet of which 
the food is intended to be a part.
    (c) Particular implied nutrient content claims. (1) Claims about the 
food or an ingredient therein that suggest that a nutrient or an 
ingredient is absent or

[[Page 145]]

present in a certain amount (e.g., ``high in oat bran'') are implied 
nutrient content claims and must comply with paragraph (a) of this 
section.
    (2) The phrases ``contains the same amount of [nutrient] as a 
[food]'' and ``as much [nutrient] as a [food]'' may be used on the label 
or in the labeling of foods, provided that the amount of the nutrient in 
the reference food is enough to qualify that food as a ``good source'' 
of that nutrient, and the labeled food, on a per serving basis, is an 
equivalent, good source of that nutrient (e.g., ``as much fiber as an 
apple,'' ``Contains the same amount of Vitamin C as an 8 oz glass of 
orange juice.'').
    (3) Claims may be made that a food contains or is made with an 
ingredient that is known to contain a particular nutrient, or is 
prepared in a way that affects the content of a particular nutrient in 
the food, if the finished food is either ``low'' in or a ``good source'' 
of the nutrient that is associated with the ingredient or type of 
preparation. If a more specific level is claimed (e.g., ``high in ___), 
that level of the nutrient must be present in the food. For example, a 
claim that a food contains oat bran is a claim that it is a good source 
of dietary fiber; that a food is made only with vegetable oil is a claim 
that it is low in saturated fat; and that a food contains no oil is a 
claim that it is fat free.
    (d) General nutritional claims. (1) This paragraph covers labeling 
claims that are implied nutrient content claims because they:
    (i) Suggest that a food because of its nutrient content may help 
consumers maintain healthy dietary practices; and
    (ii) Are made in connection with an explicit or implicit claim or 
statement about a nutrient (e.g., ``healthy, contains 3 grams of fat'').
    (2) You may use the term ``healthy'' or related terms (e.g., 
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,'' 
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as an 
implied nutrient content claim on the label or in labeling of a food 
that is useful in creating a diet that is consistent with dietary 
recommendations if:
    (i) The food meets the following conditions for fat, saturated fat, 
cholesterol, and other nutrients:

------------------------------------------------------------------------
                                    The           The
   If the food      The fat      saturated    cholesterol     The food
      is...        level must    fat level     level must       must
                     be...      must be...       be...       contain...
------------------------------------------------------------------------
(A) A raw fruit   Low fat as   Low           The            N/A
 or vegetable      defined in   saturated     disclosure
                   Sec. fat as        level for
                   101.62(b)(   defined in    cholesterol
                   2)           Sec. specified in
                                101.62(c)(2   Sec.
                                )             101.13(h) or
                                              less
------------------------------------------------------------------------
(B) A single-     Low fat as   Low           The            N/A
 ingredient or a   defined in   saturated     disclosure
 mixture of        Sec. fat as        level for
 frozen or         101.62(b)(   defined in    cholesterol
 canned fruits     2)           Sec. specified in
 and                            101.62(c)(2   Sec.
 vegetables\1\                  )             101.13(h) or
                                              less
------------------------------------------------------------------------
(C) An enriched   Low fat as   Low           The            N/A
 cereal-grain      defined in   saturated     disclosure
 product that      Sec. fat as        level for
 conforms to a     101.62(b)(   defined in    cholesterol
 standard of       2)           Sec. specified in
 identity in                    101.62(c)(2   Sec.
 part 136, 137                  )             101.13(h) or
 or 139 of this                               less
 chapter
------------------------------------------------------------------------
(D) A raw,        Less than 5  Less than 2   Less than 95   At least 10
 single-           grams (g)    g saturated   mg             percent of
 ingredient        total fat    fat per RA    cholesterol    the RDI\3\
 seafood or game   per RA\2\    and per 100   per RA and     or the
 meat              and per      g             per 100 g      DRV\4\ per
                   100 g                                     RA of one
                                                             or more of
                                                             vitamin A,
                                                             vitamin C,
                                                             calcium,
                                                             iron,
                                                             protein, or
                                                             fiber
------------------------------------------------------------------------

[[Page 146]]

 
(E) A meal        Low fat as   Low           90 mg or less  At least 10
 product as        defined in   saturated     cholesterol    percent of
 defined in Sec. Sec. fat as        per LS\5\      the RDI or
   101.13(l) or    101.62(b)(   defined in                   DRV per LS
 a main dish       3)           Sec. of two
 product as                     101.62(c)(3                  nutrients
 defined in Sec. )                            (for a main
   101.13(m)                                                 dish
                                                             product) or
                                                             of three
                                                             nutrients
                                                             (for a meal
                                                             product)
                                                             of: vitamin
                                                             A, vitamin
                                                             C, calcium,
                                                             iron,
                                                             protein, or
                                                             fiber
------------------------------------------------------------------------
(F) A food not    Low fat as   Low           The            At least 10
 specifically      defined in   saturated     disclosure     percent of
 listed in this    Sec. fat as        level for      the RDI or
 table             101.62(b)(   defined in    cholesterol    the DRV per
                   2)           Sec. specified in   RA of one
                                101.62(c)(2   Sec. or more of
                                )             101.13(h) or   vitamin A,
                                              less           vitamin C,
                                                             calcium,
                                                             iron,
                                                             protein or
                                                             fiber
------------------------------------------------------------------------
\1\ May include ingredients whose addition does not change the nutrient
  profile of the fruit or vegetable.
\2\ RA means Reference Amount Customarily Consumed per Eating Occasion
  (Sec. 101.12(b)).
\3\ RDI means Reference Daily Intake (Sec. 101.9(c)(8)(iv)).
\4\ DRV means Daily Reference Value (Sec. 101.9(c)(9)).
\5\ LS means Labeled Serving, i.e., the serving size that is specified
  in the nutrition information on the product label (Sec. 101.9(b)).

    (ii) The food meets the following conditions for sodium:

------------------------------------------------------------------------
         If the food is...               The sodium level must be...
------------------------------------------------------------------------
(A) A food with a RA that is         480 mg or less sodium per RA and
 greater than 30 g or 2 tablespoons   per LS
 (tbsp.)
------------------------------------------------------------------------
(B) A food with a RA that is equal   480 mg or less sodium per 50 g\1\
 to or less than 30 g or 2 tbsp.
------------------------------------------------------------------------
(C) A meal product as defined in     600 mg or less sodium per LS
 Sec. 101.13(l) or a main dish
 product as defined in Sec.
 101.13(m)
------------------------------------------------------------------------
\1\ For dehydrated food that is typically reconstituted with water or a
  liquid that contains insignificant amounts per RA of all nutrients (as
  defined in Sec. 101.9(f)(1)), the 50 g refers to the ``prepared''
  form of the product.

    (iii) The food complies with the definition and declaration 
requirements in this part 101 for any specific nutrient content claim on 
the label or in labeling, and
    (iv) If you add a nutrient to the food specified in paragraphs 
(d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the 
10 percent requirement, that addition must be in accordance with the 
fortification policy for foods in Sec. 104.20 of this chapter.

[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 59 
FR 394, Jan. 4, 1994; 59 FR 24249, May 10, 1994; 59 FR 50828, Oct. 6, 
1994; 62 FR 49858, Sept. 23, 1997; 63 FR 14355, Mar. 25, 1998; 70 FR 
56848, Sept. 29, 2005]



Sec. 101.67  Use of nutrient content claims for butter.

    (a) Claims may be made to characterize the level of nutrients, 
including fat, in butter if:
    (1) The claim complies with the requirements of Sec. 101.13 and 
with the requirements of the regulations in this subpart that define the 
particular nutrient content claim that is used and how it is to be 
presented. In determining whether a claim is appropriate, the 
calculation of the percent fat reduction in milkfat shall be based on 
the 80 percent milkfat requirement provided by the statutory standard 
for butter (21 U.S.C. 321a);
    (2) The product contains cream or milk, including milk constituents 
(including, but not limited to, whey, casein, modified whey, and salts 
of casein), or both, with or without added salt, with or without safe 
and suitable colorings, with or without nutrients added to comply with 
paragraph (a)(3) of this section, and with or without safe and suitable 
bacterial cultures. The product may contain safe and suitable 
ingredients to improve texture, prevent syneresis, add flavor, extend 
shelf life, improve appearance, and add sweetness. The product may 
contain water to replace milkfat although the amount of water in the 
product shall be less than the amount of cream, milk, or milk 
constituents;

[[Page 147]]

    (3) The product is not nutritionally inferior, as defined in Sec. 
101.3(e)(4), to butter as produced under 21 U.S.C. 321a; and
    (4) If the product would violate 21 U.S.C. 321a but for the nutrient 
content claim that characterizes the level of nutrients, that claim 
shall be an explicit claim that is included as part of the common or 
usual name of the product.
    (b) Deviations from the ingredient provisions of 21 U.S.C. 321a must 
be the minimum necessary to achieve similar performance characteristics 
as butter as produced under 21 U.S.C. 321a, or the food will be deemed 
to be adulterated under section 402(b) of the act. The performance 
characteristics (e.g., physical properties, organoleptic 
characteristics, functional properties, shelf life) of the product shall 
be similar to butter as produced under 21 U.S.C. 321a. If there is a 
significant difference in performance characteristics (that materially 
limits the uses of the product compared to butter,) the label shall 
include a statement informing the consumer of such difference (e.g., if 
appropriate, ``not recommended for baking purposes''). Such statement 
shall comply with the requirements of Sec. 101.13(d). The modified 
product shall perform at least one of the principal functions of butter 
substantially as well as butter as produced under 21 U.S.C. 321a.
    (c)(1) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of this part.
    (2) Safe and suitable ingredients added to improve texture, prevent 
syneresis, add flavor, extend shelf life, improve appearance, or add 
sweetness and water added to replace milkfat shall be identified with an 
asterisk in the ingredient statement. The statement ``*Ingredients not 
in regular butter'' shall immediately follow the ingredient statement in 
the same type size.

[58 FR 2455, Jan. 6, 1993]



Sec. 101.69  Petitions for nutrient content claims.

    (a) This section pertains to petitions for claims, expressed or 
implied, that:
    (1) Characterize the level of any nutrient which is of the type 
required to be in the label or labeling of food by section 403(q)(1) or 
(q)(2) of the Federal Food, Drug, and Cosmetic Act (the act); and
    (2) That are not exempted under section 403(r)(5)(A) through 
(r)(5)(C) of the act from the requirements for such claims in section 
403(r)(2).
    (b) Petitions included in this section are:
    (1) Petitions for a new (heretofore unauthorized) nutrient content 
claim;
    (2) Petitions 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) Petitions for the use of an implied claim in a brand name.
    (c) An original and one copy of the petition to be filed under the 
provisions of section 403(r)(4) of the act shall be submitted, or the 
petitioner may submit an original and a computer readable disk 
containing the petition. Contents of the disk should be in a standard 
format, such as ASCII format. Petitioners interested in submitting a 
disk should contact the Food and Drug Administration's (FDA) Center for 
Food Safety and Applied Nutrition for details. If any part of the 
material submitted is in a foreign language, it shall be accompanied by 
an accurate and complete English translation. The petition shall state 
the petitioner's post office address to which published notices as 
required by section 403 of the act may be sent.
    (d) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of FDA. 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 are included in a petition 
submitted under section 403(r)(4) of the act, the petition shall 
include, with respect to each nonclinical study contained in the

[[Page 148]]

petition, 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 this chapter 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 are included in a petition submitted 
under section 403(r)(4) of the act, the petition shall include a 
statement regarding each such clinical investigation relied upon in the 
petition that the study either was conducted in compliance with the 
requirements for institutional review set forth in part 56 of this 
chapter or was not subject to such requirements in accordance with Sec. 
56.104 or Sec. 56.105 of this chapter, and that it was conducted in 
compliance with the requirements for informed consent set forth in part 
50 of this chapter.
    (g) The availability for public disclosure of petitions submitted to 
the agency under this section will be governed by the rules specified in 
Sec. 10.20(j) of this chapter.
    (h) All petitions submitted under this section shall include either 
a claim for a categorical exclusion under Sec. 25.30 or 25.32 of this 
chapter or an environmental assessment under Sec. 25.40 of this 
chapter.
    (i) The data specified under the several lettered headings should be 
submitted on separate sheets or sets of sheets, suitably identified. If 
such data have already been submitted with an earlier application from 
the petitioner, the present petition may incorporate it by specific 
reference to the earlier petition.
    (j) The petition must be signed by the petitioner or by his attorney 
or agent, or (if a corporation) by an authorized official.
    (k) The petition shall include a statement signed by the person 
responsible for the petition, that to the best of his knowledge, it is a 
representative and balanced submission that includes unfavorable 
information, as well as favorable information, known to him pertinent to 
the evaluation of the petition.
    (l) All applicable provisions of part 10--Administrative Practices 
and Procedures, may be used by FDA, the petitioner or any outside party 
with respect to any agency action on the petition.
    (m)(1) Petitions for a new nutrient content claim shall include the 
following data and be submitted in the following form.

(Date) ______
Name of petitioner ______
Post office address ______
Subject of the petition ______
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ____________ submits this petition under section 
403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) with 
respect to (statement of the claim and its proposed use).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. A statement identifying the descriptive term and the nutrient 
that the term is intended to characterize with respect to the level of 
such nutrient. The statement should address why the use of the term as 
proposed will not be misleading. The statement should provide examples 
of the nutrient content claim as it will be used on labels or labeling, 
as well as the types of foods on which the claim will be used. The 
statement shall specify the level at which the nutrient must be present 
or what other conditions concerning the food must be met for the use of 
the term in labels or labeling to be appropriate, as well as any factors 
that would make the use of the term inappropriate.
    B. 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 under section 403(r)(2)(A)(i) of 
the act. If the claim is intended for a specific group within the 
population, the analysis should specifically address nutritional needs 
of such group, and should include scientific data sufficient for such 
purpose.
    C. Analytical data that shows the amount of the nutrient that is the 
subject of the claim and that is present in the types of foods for which 
the claim is intended. The assays should be performed on representative 
samples using the AOAC INTERNATIONAL (AOAC International) methods where 
available. If no AOAC International method is available, the petitioner 
shall submit the

[[Page 149]]

assay method used, and data establishing the validity of the method for 
assaying the nutrient in the particular food. The validation data should 
include a statistical analysis of the analytical and product 
variability.
    D. A detailed analysis of the potential effect of the use of the 
proposed claim on food consumption and of any corresponding changes in 
nutrient intake. The latter item 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.
    E. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter 
or an environmental assessment under Sec. 25.40 of this chapter.
    Yours very truly,
    Petitioner ______
    By ______
    (Indicate authority)

    (2) Within 15 days of receipt of the petition, the petitioner will 
be notified by letter of the date on which the petition was received by 
the agency. Such notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition), and the petitioner will 
subsequently be notified of the agency's decision to file or deny the 
petition; or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) Within 100 days of the date of receipt of the petition, FDA will 
notify the petitioner by letter that the petition has either been filed 
or denied. If denied, the notification shall state the reasons therefor. 
If filed, the date of the notification letter becomes the date of filing 
for the purposes of section 403(r)(4)(A)(i) of the act. If FDA does not 
act within such 100 days, the petition shall be deemed to be denied 
unless an extension is mutually agreed upon by the FDA and the 
petitioner. A petition that has been denied, or has been deemed to be 
denied, without filing shall not be made available to the public. A 
filed petition shall be available to the public as provided under 
paragraph (g) of this section.
    (4) Within 90 days of the date of filing FDA will by letter of 
notification to the petitioner:
    (i) Deny the petition; or
    (ii) Inform the petitioner that a proposed regulation to provide for 
the requested use of the new term will be published in the Federal 
Register. FDA will publish the proposal to amend the regulations to 
provide for the requested use of the nutrient content claim in the 
Federal Register within 90 days of the date of filing. The proposal will 
also announce the availability of the petition for public disclosure.
    (iii) If FDA does not act within 90 days of the date of filing, the 
petition shall be deemed to be denied unless an extension is mutually 
agreed upon by FDA and the petitioner.
    (5) If FDA issues a proposal, the rulemaking shall be completed 
within 540 days of the date of receipt of the petition.
    (n)(1) Petitions for a synonymous term shall include the following 
data and be submitted in the following form.

(Date)______
Name of petitioner ______
Post office address ______
Subject of the petition ______
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ______ submits this petition under section 
403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) 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 section 403(r)(2) of the act).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. A statement identifying the synonymous descriptive term, the 
existing term defined by a regulation under section 403(r)(2)(A)(i) of 
the act with which the synonymous term is claimed to be consistent. The 
statement should address why the proposed synonymous term is consistent 
with the term already defined by the agency, and why the use of the 
synonymous term as proposed will not be misleading. The statement

[[Page 150]]

should provide examples of the nutrient content claim as it will be used 
on labels or labeling, as well as the types of foods on which the claim 
will be used. The statement shall specify whether any limitations not 
applicable to the use of the defined term are intended to apply to the 
use of the synonymous term.
    B. A detailed explanation, supported by any necessary data, of why 
use of the proposed term is requested, including an explanation of 
whether the existing defined term is inadequate for the purpose of 
effectively characterizing the level of a nutrient. This item 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 term defined by regulation. If the claim is intended for a 
specific group within the population, the analysis should specifically 
address nutritional needs of such group, and should include scientific 
data sufficient for such purpose.
    C. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter 
or an environmental assessment under Sec. 25.40 of this chapter.
    Yours very truly,
    Petitioner ______
    By ______
    (Indicate authority)

    (2) Within 15 days of receipt of the petition the petitioner will be 
notified by letter of the date on which the petition was received. Such 
notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition) and the petitioner will 
subsequently be notified of the agency's decision to grant the 
petitioner permission to use the proposed term or to deny the petition; 
or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) Within 90 days of the date of receipt of the petition that is 
accepted for review (i.e., that has not been found to be incomplete and 
consequently denied, FDA will notify the petitioner by letter of the 
agency's decision to grant the petitioner permission to use the proposed 
term, with any conditions or limitations on such use specified, or to 
deny the petition, in which case the letter shall state the reasons 
therefor. Failure of the petition to fully address the requirements of 
this section shall be grounds for denial of the petition.
    (4) As soon as practicable following the agency's decision to either 
grant or deny the petition, FDA will publish a notice in the Federal 
Register informing the public of his decision. If the petition is 
granted the Food and Drug Administration will list, the approved 
synonymous term in the regulations listing terms permitted for use in 
nutrient content claims.
    (o)(1) Petitions for the use of an implied nutrient content claim in 
a brand name shall include the following data and be submitted in the 
following form:

(Date)______
Name of petitioner ______
Post office address ______
Subject of the petition ______
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800),
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ___________ submits this petition under section 
403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) with 
respect to (statement of the implied nutrient content claim and its 
proposed use in a brand name).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. 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 
under section 403(r)(2)(A)(i) of the act, and the brand name of which 
the implied claim is intended to be a part. The statement should address 
why the use of the brandname as proposed will not be misleading. It 
should address in particular what information is required to accompany 
the claim or other ways in which the claim meets the requirements of 
sections 201(n) and 403(a) of the act. The statement should provide 
examples of the types of foods on which the brand name will appear. It 
shall also include data showing that the actual level of the nutrient in 
the food qualifies the food to bear the corresponding term defined by 
regulation. Assay methods used to determine the level of a nutrient 
should meet the requirements stated under petition format item C in 
paragraph (k)(1) of this section.

[[Page 151]]

    B. A detailed explanation, supported by any necessary data, of why 
use of the proposed brand name is requested. This item 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 should specifically address 
nutritional needs of such group and should include scientific data 
sufficient for such purpose.
    C. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter 
or an environmental assessment under Sec. 25.40 of this chapter.
    Yours very truly,
    Petitioner ______
    By ______

    (2) Within 15 days of receipt of the petition the petitioner will be 
notified by letter of the date on which the petition was received. Such 
notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition); or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) FDA will publish a notice of the petition in the Federal 
Register announcing its availability to the public and seeking comment 
on the petition. The petition shall be available to the public to the 
extent provided under paragraph (g) of this section. The notice shall 
allow 30 days for comments.
    (4) Within 100 days of the date of receipt of the petition that is 
accepted for review (i.e., that has not been found to be incomplete and 
subsequently returned to the petitioner), FDA will:
    (i) Notify the petitioner by letter of the agency's decision to 
grant the petitioner permission to use the proposed brand name if such 
use is not misleading, with any conditions or limitations on such use 
specified; or
    (ii) Deny the petition, in which case the letter shall state the 
reasons therefor. Failure of the petition to fully address the 
requirements of this section shall be grounds for denial of the 
petition. Should FDA not notify the petitioner of his decision on the 
petition within 100 days, the petition shall be considered to be 
granted.
    (5) As soon as practicable following the granting of a petition, the 
Commissioner of Food and Drugs will publish a notice in the Federal 
Register informing the public of such fact.

[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 58 
FR 44033, Aug. 18, 1993; 62 FR 40598, July 29, 1997; 63 FR 26718, May 
14, 1998; 63 FR 40024, July 27, 1998; 67 FR 9585, Mar. 4, 2002; 69 FR 
16481, Mar. 30, 2004]



            Subpart E_Specific Requirements for Health Claims



Sec. 101.70  Petitions for health claims.

    (a) Any interested person may petition the Food and Drug 
Administration (FDA) to issue a regulation regarding a health claim. An 
original and one copy of the petition shall be submitted, or the 
petitioner may submit an original and a computer readable disk 
containing the petition. Contents of the disk should be in a standard 
format, such as ASCII format. (Petitioners interested in submitting a 
disk should contact the Center for Food Safety and Applied Nutrition for 
details.) If any part of the material submitted is in a foreign 
language, it shall be accompanied by an accurate and complete English 
translation. The petition shall state the petitioner's post office 
address to which any correspondence required by section 403 of the 
Federal Food, Drug, and Cosmetic Act may be sent.
    (b) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of FDA. Such 
information may include any findings, along with the basis of the 
findings, of an outside panel with expertise in the subject area. Any 
reference to published information shall be accompanied by reprints, or 
easily readable copies of such information.
    (c) If nonclinical laboratory studies are included in a petition, 
the petition shall include, with respect to each nonclinical study 
contained in the petition, either a statement that the study has been 
conducted in compliance with

[[Page 152]]

the good laboratory practice regulations as set forth in part 58 of this 
chapter, or, if any such study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance.
    (d) If clinical or other human investigations are included in a 
petition, the petition shall include a statement that they were either 
conducted in compliance with the requirements for institutional review 
set forth in part 56 of this chapter, or were not subject to such 
requirements in accordance with Sec. 56.104 or Sec. 56.105, and a 
statement that they were conducted in compliance with the requirements 
for informed consent set forth in part 50 of this chapter.
    (e) All data and information in a health claim petition are 
available for public disclosure after the notice of filing of petition 
is issued to the petitioner, except that clinical investigation reports, 
adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information shall only be 
available after deletion of:
    (1) Names and any information that would identify the person using 
the product.
    (2) Names and any information that would identify any third party 
involved with the report, such as a physician or hospital or other 
institution.
    (f) Petitions for a health claim shall include the following data 
and be submitted in the following form:

(Date)______
Name of petitioner ______
Post office address ______
Subject of the petition ______
Food and Drug Administration,
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800),
5001 Campus Dr.,
College Park, MD 20740,
    The undersigned, _________ submits this petition pursuant to section 
403(r)(4) or 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act 
with respect to (statement of the substance and its health claim).
    Attached hereto, and constituting a part of this petition, are the 
following:
    A. Preliminary requirements. A complete explanation of how the 
substance conforms to the requirements of Sec. 101.14(b) (21 CFR 
101.14(b)). For petitions where the subject substance is a food 
ingredient or a component of a food ingredient, the petitioner should 
compile a comprehensive list of the specific ingredients that will be 
added to the food to supply the substance in the food bearing the health 
claim. For each such ingredient listed, the petitioner should state how 
the ingredient complies with the requirements of Sec. 101.14(b)(3)(ii), 
e.g., that its use is generally recognized as safe (GRAS), listed as a 
food additive, or authorized by a prior sanction issued by the agency, 
and what the basis is for the GRAS claim, the food additive status, or 
prior sanctioned status.
    B. Summary of scientific data. The summary of scientific data 
provides the basis upon which authorizing a health claim can be 
justified as providing the health benefit. The summary must establish 
that, based on the totality of publicly available scientific evidence 
(including evidence from well-designed studies conducted in a manner 
which is consistent with generally recognized scientific procedures and 
principles), there is significant scientific agreement among experts 
qualified by scientific training and experience to evaluate such claims, 
that the claim is supported by such evidence.
    The summary shall state what public health benefit will derive from 
use of the claim as proposed. If the claim is intended for a specific 
group within the population, the summary shall specifically address 
nutritional needs of such group and shall include scientific data 
showing how the claim is likely to assist in meeting such needs.
    The summary shall concentrate on the findings of appropriate review 
articles, National Institutes of Health consensus development 
conferences, and other appropriate resource materials. Issues addressed 
in the summary shall include answers to such questions as:
    1. Is there an optimum level of the particular substance to be 
consumed beyond which no benefit would be expected?
    2. Is there any level at which an adverse effect from the substance 
or from foods containing the substance occurs for any segment of the 
population?
    3. Are there certain populations that must receive special 
consideration?
    4. What other nutritional or health factors (both positive and 
negative) are important to consider when consuming the substance?
    In addition, the summary of scientific data shall include a detailed 
analysis of the potential effect of the use of the proposed claim on 
food consumption, specifically any change due to significant alterations 
in eating habits and corresponding changes in nutrient intake resulting 
from such changes in food consumption. The latter item shall 
specifically address the effect on the intake of nutrients that have 
beneficial and negative consequences in the total diet.
    If the claim is intended for a significant subpopulation within the 
general U.S. population, the analysis shall specifically address

[[Page 153]]

the dietary practices of such group, and shall include data sufficient 
to demonstrate that the dietary analysis is representative of such group 
(e.g., adolescents or the elderly).
    If appropriate, the petition shall explain the prevalence of the 
disease or health-related condition in the U.S. population and the 
relevance of the claim in the context of the total daily diet.
    Also, the summary shall demonstrate that the substance that is the 
subject of the proposed claim conforms to the definition of the term 
``substance'' in Sec. 101.14(a)(2).
    C. Analytical data that show the amount of the substance that is 
present in representative foods that would be candidates to bear the 
claim should be obtained from representative samples using methods from 
the AOAC INTERNATIONAL (AOAC), where available. If no AOAC method is 
available, the petitioner shall submit the assay method used and data 
establishing the validity of the method for assaying the substance in 
food. The validation data should include a statistical analysis of the 
analytical and product variability.
    D. Model health claim. One or more model health claims that 
represent label statements that may be used on a food label or in 
labeling for a food to characterize the relationship between the 
substance in a food to a disease or health-related condition that is 
justified by the summary of scientific data provided in section C of the 
petition. The model health claim shall include:
    1. A brief capsulized statement of the relevant conclusions of the 
summary, and
    2. A statement of how this substance helps the consumer to attain a 
total dietary pattern or goal associated with the health benefit that is 
provided.
    E. The petition shall include the following attachments:
    1. Copies of any computer literature searches done by the petitioner 
(e.g., Medline).
    2. Copies of articles cited in the literature searches and other 
information as follows:
    a. All information relied upon for the support of the health claim, 
including copies of publications or other information cited in review 
articles and used to perform meta-analyses.
    b. All information concerning adverse consequences to any segment of 
the population (e.g., sensitivity to the substance).
    c. All information pertaining to the U.S. population.
    F. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter 
or an environmental assessment under Sec. 25.40 of this chapter.
    Yours very truly,
    Petitioner ______
    By ______
    (Indicate authority)

    (g) The data specified under the several lettered headings should be 
submitted on separate pages or sets of pages, suitably identified. If 
such data have already been submitted with an earlier application from 
the petitioner or any other final petition, the present petition may 
incorporate it by specific reference to the earlier petition.
    (h) The petition shall include a statement signed by the person 
responsible for the petition that, to the best of his/her knowledge, it 
is a representative and balanced submission that includes unfavorable 
information as well as favorable information, known to him/her to be 
pertinent to the evaluation of the proposed health claim.
    (i) The petition shall be signed by the petitioner or by his/her 
attorney or agent, or (if a corporation) by an authorized official.
    (j) Agency action on the petition. (1) Within 15 days of receipt of 
the petition, the petitioner will be notified by letter of the date on 
which the petition was received. Such notice will inform the petitioner 
that the petition is undergoing agency review and that the petitioner 
will subsequently be notified of the agency's decision to file for 
comprehensive review or deny the petition.
    (2) Within 100 days of the date of receipt of the petition, FDA will 
notify the petitioner by letter that the petition has either been filed 
for comprehensive review or denied. The agency will deny a petition 
without reviewing the information contained in ``B. Summary of 
Scientific Data'' if the information in ``A. Preliminary Requirements'' 
is inadequate in explaining how the substance conforms to the 
requirements of Sec. 101.14(b). If the petition is denied, the 
notification will state the reasons therefor, including justification of 
the rejection of any report from an authoritative scientific body of the 
U.S. Government. If filed, the date of the notification letter becomes 
the date of filing for the purposes of this regulation. If FDA does not 
act within such 100 days, the petition shall be deemed to be denied 
unless an extension is mutually agreed upon by FDA and the petitioner. A 
petition that has been denied, or has been deemed to be denied, without 
filing will not be made available to the public. A filed petition

[[Page 154]]

will be available to the public to the extent provided under paragraph 
(e) of this section.
    (3) Within 90 days of the date of filing, FDA will by letter of 
notification to the petitioner:
    (i) Deny the petition, or
    (ii) Inform the petitioner that a proposed regulation to provide for 
the requested use of the health claim will be published in the Federal 
Register. If the petition is denied, the notification will state the 
reasons therefor, including justification for the rejection of any 
report from an authoritative scientific body of the U.S. Government. FDA 
will publish the proposal to amend the regulations to provide for the 
requested use of the health claim in the Federal Register within 90 days 
of the date of filing. The proposal will also announce the availability 
of the petition for public review.
    (iii) If FDA does not act within 90 days of the date of filing, the 
petition shall be deemed to be denied unless an extension is mutually 
agreed upon by FDA and the petitioner.
    (4)(i) Within 270 of the date of publication of the proposal, FDA 
will publish a final rule that either authorizes use of the health claim 
or explains why the agency has decided not to authorize one.
    (ii) For cause, FDA may extend, no more than twice, the period in 
which it will publish a final rule; each such extension will be for no 
more than 90 days. FDA will publish a notice of each extension in the 
Federal Register. The document will state the basis for the extension, 
the length of the extension, and the date by which the final rule will 
be published, which date shall be within 540 days of the date of receipt 
of the petition.

[58 FR 2534, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 59 
FR 425, Jan. 4, 1994; 62 FR 28232, May 22, 1997; 62 FR 40599, July 29, 
1997; 63 FR 26719, May 14, 1998; 63 FR 40024, July 27, 1998; 66 FR 
56035, Nov. 6, 2001]



Sec. 101.71  Health claims: claims not authorized.

    Health claims not authorized for foods in conventional food form or 
for dietary supplements of vitamins, minerals, herbs, or other similar 
substances:
    (a) Dietary fiber and cardiovascular disease.
    (b) Zinc and immune function in the elderly.

[58 FR 2534, Jan. 6, 1993, as amended at 58 FR 2548, 2578, 2620, 2639, 
2664, 2714, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993; 59 FR 437, Jan. 4, 
1994; 65 FR 58918, Oct. 3, 2000]



Sec. 101.72  Health claims: calcium, vitamin D, and osteoporosis.

    (a) Relationship between calcium, vitamin D, and osteoporosis. An 
inadequate intake of calcium or calcium and vitamin D contributes to low 
peak bone mass, which has been identified as one of many risk factors in 
the development of osteoporosis. Peak bone mass is the total quantity of 
bone present at maturity, and experts believe that it has the greatest 
bearing on whether a person will be at risk of developing osteoporosis 
and related bone fractures later in life. Another factor that influences 
total bone mass and susceptibility to osteoporosis is the rate of bone 
loss after skeletal maturity. Vitamin D is required for normal 
absorption of calcium and to prevent the occurrence of high serum 
parathyroid hormone (PTH) concentration, which stimulates mobilization 
of calcium from the skeleton and can lower bone mass. Calcium, along 
with vitamin D and several other nutrients, is required for normal bone 
mineralization. While vitamin D is required for optimal bone 
mineralization, it is more effective when calcium intake is adequate. An 
adequate intake of calcium and vitamin D is thought to exert a positive 
effect during adolescence and early adulthood in optimizing the amount 
of bone that is laid down. However, the upper limit of peak bone mass is 
genetically determined. The mechanism through which adequate intakes of 
calcium and vitamin D and optimal peak bone mass reduce the risk of 
osteoporosis is thought to be as follows. All persons lose bone with 
age. Hence, those with higher bone mass at maturity take longer to reach 
the critically reduced mass at which bones can fracture easily. The rate 
of bone loss after skeletal maturity also influences the amount of bone 
present at old age and can influence an individual's risk of developing 
osteoporosis.

[[Page 155]]

Maintenance of adequate intakes of calcium and vitamin D later in life 
is thought to be important in reducing the rate of bone loss 
particularly in the elderly and in women during the first decade 
following menopause, but a significant protective effect is also seen 
among men and younger women.
    (b) Significance of calcium or calcium and vitamin D. Adequate 
calcium intake, or adequate calcium and vitamin D intake, is not the 
only recognized risk factor in the development of osteoporosis, which is 
a multifactorial bone disease. Maintenance of adequate calcium and 
vitamin D intakes throughout life is necessary to achieve optimal peak 
bone mass and to reduce the risk of osteoporosis in later life. However, 
vitamin D is most effective in this regard when calcium intake is 
adequate. Increasing intake of calcium has been shown to have beneficial 
effects on bone health independent of dietary vitamin D.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating calcium or, when appropriate, calcium and vitamin D with a 
reduced risk of osteoporosis may be made on the label or labeling of a 
food described in paragraphs (c)(2)(ii) and (d)(1) of this section, 
provided that:
    (A) The claim makes clear the importance of adequate calcium intake, 
or when appropriate, adequate calcium and vitamin D intake, throughout 
life, in a healthful diet, are essential to reduce osteoporosis risk. 
The claim does not imply that adequate calcium intake, or when 
appropriate, adequate calcium and vitamin D intake, is the only 
recognized risk factor for the development of osteoporosis;
    (B) The claim does not attribute any degree of reduction in risk of 
osteoporosis to maintaining an adequate dietary calcium intake, or when 
appropriate, an adequate dietary calcium and vitamin D intake, 
throughout life.
    (ii) Nature of the food. (A) The food shall meet or exceed the 
requirements for a ``high'' level of calcium as defined in Sec. 
101.54(b);
    (B) The calcium content of the product shall be assimilable;
    (C) Dietary supplements shall meet the United States Pharmacopeia 
(USP) standards for disintegration and dissolution applicable to their 
component calcium salts, except that dietary supplements for which no 
USP standards exist shall exhibit appropriate assimilability under the 
conditions of use stated on the product label;
    (D) A food or total daily recommended supplement intake shall not 
contain more phosphorus than calcium on a weight per weight basis.
    (d) Optional information. (1) The claim may include the term 
``vitamin D'' if the food meets or exceeds the requirements for a 
``high'' level of vitamin D as defined in Sec. 101.54(b);
    (2) The claim may include information from paragraphs (a) and (b) of 
this section.
    (3) The claim may make reference to physical activity.
    (4) The claim may include information on the number of people in the 
United States, including the number of people in certain subpopulations 
in the United States, who have osteoporosis or low bone density. The 
sources of this information must be identified, and it must be current 
information from the National Center for Health Statistics, the National 
Institutes of Health, or the National Osteoporosis Foundation.
    (5) The claim may state that the role of adequate calcium intake, or 
when appropriate, the role of adequate calcium and vitamin D intake, 
throughout life is linked to reduced risk of osteoporosis through the 
mechanism of optimizing peak bone mass during adolescence and early 
adulthood. The phrase ``build and maintain good bone health'' may be 
used to convey the concept of optimizing peak bone mass. The claim may 
also state that adequate intake of calcium, or when appropriate, 
adequate intake of calcium and vitamin D, is linked to reduced risk of 
osteoporosis through the mechanism of slowing the rate of bone loss for 
persons with a family history of the disease, post-menopausal women, and 
elderly men and women.
    (e) Model health claims. The following model health claims may be 
used in food labeling to describe the relationship between calcium and 
osteoporosis:

[[Page 156]]


Adequate calcium throughout life, as part of a well-balanced diet, may 
reduce the risk of osteoporosis.

Adequate calcium as part of a healthful diet, along with physical 
activity, may reduce the risk of osteoporosis in later life.
    (f) Model additional health claims for calcium and vitamin D. The 
following model health claims may be used in food labeling to describe 
the relationship between calcium, vitamin D, and osteoporosis:

Adequate calcium and vitamin D throughout life, as part of a well-
balanced diet, may reduce the risk of osteoporosis.

Adequate calcium and vitamin D as part of a healthful diet, along with 
physical activity, may reduce the risk of osteoporosis in later life.

[73 FR 56486, Sept. 29, 2008]



Sec. 101.73  Health claims: dietary lipids and cancer.

    (a) Relationship between fat and cancer. (1) Cancer is a 
constellation of more than 100 different diseases, each characterized by 
the uncontrolled growth and spread of abnormal cells. Cancer has many 
causes and stages in its development. Both genetic and environmental 
risk factors may affect the risk of cancer. Risk factors include a 
family history of a specific type of cancer, cigarette smoking, alcohol 
consumption, overweight and obesity, ultraviolet or ionizing radiation, 
exposure to cancer-causing chemicals, and dietary factors.
    (2) Among dietary factors, the strongest positive association has 
been found between total fat intake and risk of some types of cancer. 
Based on the totality of the publicly available scientific evidence, 
there is significant scientific agreement among experts, qualified by 
training and experience to evaluate such evidence, that diets high in 
total fat are associated with an increased cancer risk. Research to 
date, although not conclusive, demonstrates that the total amount of 
fats, rather than any specific type of fat, is positively associated 
with cancer risk. The mechanism by which total fat affects cancer has 
not yet been established.
    (3) A question that has been the subject of considerable research is 
whether the effect of fat on cancer is site-specific. Neither human nor 
animal studies are consistent in the association of fat intake with 
specific cancer sites.
    (4) Another question that has been raised is whether the association 
of total fat intake to cancer risk is independently associated with 
energy intakes, or whether the association of fat with cancer risk is 
the result of the higher energy (caloric) intake normally associated 
with high fat intake. FDA has concluded that evidence from both animal 
and human studies indicates that total fat intake alone, independent of 
energy intake, is associated with cancer risk.
    (b) Significance of the relationship between fat intake and risk of 
cancer. (1) Cancer is ranked as a leading cause of death in the United 
States. The overall economic costs of cancer, including direct health 
care costs and losses due to morbidity and mortality, are very high.
    (2) U.S. diets tend to be high in fat and high in calories. The 
average U.S. diet is estimated to contain 36 to 37 percent of calories 
from total fat. Current dietary guidelines from the Federal Government 
and other national health professional organizations recommend that 
dietary fat intake be reduced to a level of 30 percent or less of energy 
(calories) from total fat. In order to reduce intake of total fat, 
individuals should choose diets which are high in vegetables, fruits, 
and grain products (particularly whole grain products), choose lean cuts 
of meats, fish, and poultry, substitute low-fat dairy products for 
higher fat products, and use fats and oils sparingly.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in fat with reduced risk of cancer may be made on 
the label or labeling of a food described in paragraph (c)(2)(ii) of 
this section, provided that:
    (A) The claim states that diets low in fat ``may'' or ``might'' 
reduce the risk of some cancers;
    (B) In specifying the disease, the claim uses the following terms: 
``some types of cancer'' or ``some cancers'';

[[Page 157]]

    (C) In specifying the nutrient, the claim uses the term ``total 
fat'' or ``fat'';
    (D) The claim does not specify types of fat or fatty acid that may 
be related to the risk of cancer;
    (E) The claim does not attribute any degree of cancer risk reduction 
to diets low in fat; and
    (F) The claim indicates that the development of cancer depends on 
many factors.
    (ii) Nature of the food. The food shall meet all of the nutrient 
content requirements of Sec. 101.62 for a ``low fat'' food; except that 
fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey, 
geese, ostrich) may meet the requirements for ``extra lean'' in Sec. 
101.62.
    (d) Optional information. (1) The claim may identify one or more of 
the following risk factors for development of cancer: Family history of 
a specific type of cancer, cigarette smoking, alcohol consumption, 
overweight and obesity, ultraviolet or ionizing radiation, exposure to 
cancer-causing chemicals, and dietary factors.
    (2) The claim may include information from paragraphs (a) and (b) of 
this section which summarize the relationship between dietary fat and 
cancer and the significance of the relationship.
    (3) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and Department of Health and Human Services (DHHS), 
Government Printing Office.
    (4) The claim may include information on the number of people in the 
United States who have cancer. The sources of this information must be 
identified, and it must be current information from the National Center 
for Health Statistics, the National Institutes of Health, or ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS, 
Government Printing Office.
    (e) Model health claims. The following model health claims may be 
used in food labeling to describe the relationship between dietary fat 
and cancer:
    (1) Development of cancer depends on many factors. A diet low in 
total fat may reduce the risk of some cancers.
    (2) Eating a healthful diet low in fat may help reduce the risk of 
some types of cancers. Development of cancer is associated with many 
factors, including a family history of the disease, cigarette smoking, 
and what you eat.

[58 FR 2801, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993]



Sec. 101.74  Health claims: sodium and hypertension.

    (a) Relationship between sodium and hypertension (high blood 
pressure). (1) Hypertension, or high blood pressure, generally means a 
systolic blood pressure of greater than 140 millimeters of mercury (mm 
Hg) or a diastolic blood pressure of greater than 90 mm Hg. 
Normotension, or normal blood pressure, is a systolic blood pressure 
below 140 mm Hg and diastolic blood pressure below 90 mm Hg. Sodium is 
specified here as the chemical entity or electrolyte ``sodium'' and is 
distinguished from sodium chloride, or salt, which is 39 percent sodium 
by weight.
    (2) The scientific evidence establishes that diets high in sodium 
are associated with a high prevalence of hypertension or high blood 
pressure and with increases in blood pressure with age, and that diets 
low in sodium are associated with a low prevalence of hypertension or 
high blood pressure and with a low or no increase of blood pressure with 
age.
    (b) Significance of sodium in relation to high blood pressure. (1) 
High blood pressure is a public health concern primarily because it is a 
major risk factor for mortality from coronary heart disease and stroke. 
Early management of high blood pressure is a major public health goal 
that can assist in reducing mortality associated with coronary heart 
disease and stroke. There is a continuum of mortality risk that 
increases as blood pressures rise. Individuals with high blood pressure 
are at greatest risk, and individuals with moderately high, high normal, 
and normal blood pressure are at steadily decreasing risk. The 
scientific evidence indicates that reducing sodium intake lowers blood 
pressure and associated risks in many but not all hypertensive 
individuals. There is also evidence that reducing sodium intake lowers 
blood pressure and associated risks in many

[[Page 158]]

but not all normotensive individuals as well.
    (2) The populations at greatest risk for high blood pressure, and 
those most likely to benefit from sodium reduction, include those with 
family histories of high blood pressure, the elderly, males because they 
develop hypertension earlier in life than females, and black males and 
females. Although some population groups are at greater risk than 
others, high blood-pressure is a disease of public health concern for 
all population groups. Sodium intake, alcohol consumption, and obesity 
are identified risk factors for high blood pressure.
    (3) Sodium intakes exceed recommended levels in almost every group 
in the United States. One of the major public health recommendations 
relative to high blood pressure is to decrease consumption of salt. On a 
population-wide basis, reducing the average sodium intake would have a 
small but significant effect on reducing the average blood pressure, 
and, consequently, reducing mortality from coronary heart disease and 
stroke.
    (4) Sodium is an essential nutrient, and experts have recommended a 
safe minimum level of 500 milligrams (mg) sodium per day and an upper 
level of 2,400 mg sodium per day, the FDA Daily Value for sodium.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in sodium with reduced risk of high blood pressure 
may be made on the label or labeling of a food described in paragraph 
(c)(2)(ii) of this section, provided that:
    (A) The claim states that diets low in sodium ``may'' or ``might'' 
reduce the risk of high blood pressure;
    (B) In specifying the disease, the claim uses the term ``high blood 
pressure'';
    (C) In specifying the nutrient, the claim uses the term ``sodium'';
    (D) The claim does not attribute any degree of reduction in risk of 
high blood pressure to diets low in sodium; and
    (E) The claim indicates that development of high blood pressure 
depends on many factors.
    (ii) Nature of the food. The food shall meet all of the nutrient 
content requirements of Sec. 101.61 for a ``low sodium'' food.
    (d) Optional information. (1) The claim may identify one or more of 
the following risk factors for development of high blood pressure in 
addition to dietary sodium consumption: Family history of high blood 
pressure, growing older, alcohol consumption, and excess weight.
    (2) The claim may include information from paragraphs (a) and (b) of 
this section, which summarizes the relationship between dietary sodium 
and high blood pressure and the significance of the relationship.
    (3) The claim may include information on the number of people in the 
United States who have high blood pressure. The sources of this 
information must be identified, and it must be current information from 
the National Center for Health Statistics, the National Institutes of 
Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' U.S. Department of Health and Human Services (DHHS) and 
U.S. Department of Argiculture (USDA), Government Printing Office.
    (4) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: U.S. Dietary Guidelines for Americans, DHHS and USDA, 
Government Printing Office.
    (5) In specifying the nutrient, the claim may include the term 
``salt'' in addition to the term ``sodium.''
    (6) In specifying the disease, the claim may include the term 
``hypertension'' in addition to the term ``high blood pressure.''
    (7) The claim may state that individuals with high blood pressure 
should consult their physicians for medical advice and treatment. If the 
claim defines high or normal blood pressure, then the health claim must 
state that individuals with high blood pressure should consult their 
physicians for medical advice and treatment.
    (e) Model health claims. The following are model health claims that 
may be used in food labeling to describe the relationship between 
dietary sodium and high blood pressure:

[[Page 159]]

    (1) Diets low in sodium may reduce the risk of high blood pressure, 
a disease associated with many factors.
    (2) Development of hypertension or high blood pressure depends on 
many factors. [This product] can be part of a low sodium, low salt diet 
that might reduce the risk of hypertension or high blood pressure.

[58 FR 2836, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993]



Sec. 101.75  Health claims: dietary saturated fat and cholesterol
and risk of coronary heart disease.

    (a) Relationship between dietary saturated fat and cholesterol and 
risk of coronary heart disease. (1) Cardiovascular disease means 
diseases of the heart and circulatory system. Coronary heart disease is 
the most common and serious form of cardiovascular disease and refers to 
diseases of the heart muscle and supporting blood vessels. High blood 
total- and low density lipoprotein (LDL)- cholesterol levels are major 
modifiable risk factors in the development of coronary heart disease. 
High coronary heart disease rates occur among people with high blood 
cholesterol levels of 240 milligrams/decaliter (mg/dL) (6.21 millimoles 
per liter (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL 
(4.13 mmol/L) or above. Borderline high risk blood cholesterol levels 
range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL 
(3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary lipids (fats) include 
fatty acids and cholesterol. Total fat, commonly referred to as fat, is 
composed of saturated fat (fatty acids containing no double bonds), and 
monounsaturated and polyunsaturated fat (fatty acids containing one or 
more double bonds).
    (2) The scientific evidence establishes that diets high in saturated 
fat and cholesterol are associated with increased levels of blood total- 
and LDL-cholesterol and, thus, with increased risk of coronary heart 
disease. Diets low in saturated fat and cholesterol are associated with 
decreased levels of blood total- and LDL-cholesterol, and thus, with 
decreased risk of developing coronary heart disease.
    (b) Significance of the relationship between dietary saturated fat 
and cholesterol and risk of coronary heart disease. (1) Coronary heart 
disease is a major public health concern in the United States, primarily 
because it accounts for more deaths than any other disease or group of 
diseases. Early management of risk factors for coronary heart disease is 
a major public health goal that can assist in reducing risk of coronary 
heart disease. There is a continuum of mortality risk from coronary 
heart disease that increases with increasing levels of blood LDL-
cholesterol. Individuals with high blood LDL-cholesterol are at greatest 
risk. A larger number of individuals with more moderately elevated 
cholesterol also have increased risk of coronary events; such 
individuals comprise a substantial proportion of the adult U.S. 
population. The scientific evidence indicates that reducing saturated 
fat and cholesterol intakes lowers blood LDL-cholesterol and risk of 
heart disease in most individuals. There is also evidence that reducing 
saturated fat and cholesterol intakes in persons with blood cholesterol 
levels in the normal range also reduces risk of heart disease.
    (2) Other risk factors for coronary heart disease include a family 
history of heart disease, high blood pressure, diabetes, cigarette 
smoking, obesity (body weight 30 percent greater than ideal body 
weight), and lack of regular physical exercise.
    (3) Intakes of saturated fat exceed recommended levels in many 
people in the United States. Intakes of cholesterol are, on average, at 
or above recommended levels. One of the major public health 
recommendations relative to coronary heart disease risk is to consume 
less than 10 percent of calories from saturated fat, and an average of 
30 percent or less of total calories from all fat. Recommended daily 
cholesterol intakes are 300 mg or less per day.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met, except Sec. 101.14(e)(6) with respect to a raw fruit or 
vegetable.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in saturated fat and cholesterol with reduced risk 
of coronary heart disease may be made on the label

[[Page 160]]

or labeling of a food described in paragraph (c)(2)(ii) of this section 
provided that:
    (A) The claim states that diets low in saturated fat and cholesterol 
``may'' or ``might'' reduce the risk of heart disease;
    (B) In specifying the disease, the claim uses the terms ``heart 
disease'' or ``coronary heart disease;''
    (C) In specifying the nutrient, the claim uses the terms ``saturated 
fat'' and ``cholesterol'' and lists both;
    (D) The claim does not attribute any degree of risk reduction for 
coronary heart disease to diets low in dietary saturated fat and 
cholesterol; and
    (E) The claim states that coronary heart disease risk depends on 
many factors.
    (ii) Nature of the food. (A) The food shall meet all of the nutrient 
content requirements of Sec. 101.62 for a ``low saturated fat'' and 
``low cholesterol'' food.
    (B) The food shall meet the nutrient content requirements of Sec. 
101.62 for a ``low fat'' food, unless it is a raw fruit or vegetable; 
except that fish and game meats (i.e., deer, bison, rabbit, quail, wild 
turkey, geese, and ostrich) may meet the requirements for ``extra lean'' 
in Sec. 101.62.
    (d) Optional information. (1) The claim may identify one or more of 
the following risk factors in addition to saturated fat and cholesterol 
about which there is general scientific agreement that they are major 
risk factors for this disease: A family history of coronary heart 
disease, elevated blood total and LDL-cholesterol, excess body weight, 
high blood pressure, cigarette smoking, diabetes, and physical 
inactivity.
    (2) The claim may indicate that the relationship of saturated fat 
and cholesterol to heart disease is through the intermediate link of 
``blood cholesterol'' or ``blood total- and LDL cholesterol.''
    (3) The claim may include information from paragraphs (a) and (b) of 
this section, which summarize the relationship between dietary saturated 
fat and cholesterol and risk of coronary heart disease, and the 
significance of the relationship.
    (4) In specifying the nutrients, the claim may include the term 
``total fat'' in addition to the terms ``saturated fat'' and 
``cholesterol''.
    (5) The claim may include information on the number of people in the 
United States who have coronary heart disease. The sources of this 
information shall be identified, and it shall be current information 
from the National Center for Health Statistics, the National Institutes 
of Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' U.S. Department of Health and Human Services (DHHS) and 
U.S. Department of Agriculture (USDA), Government Printing Office.
    (6) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' DHHS and USDA, 
Government Printing Office.
    (7) The claim may state that individuals with elevated blood total- 
or LDL-cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total- or LDL-
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment.
    (e) Model health claims.The following are model health claims that 
may be used in food labeling to describe the relationship between 
dietary saturated fat and cholesterol and risk of heart disease:
    (1) While many factors affect heart disease, diets low in saturated 
fat and cholesterol may reduce the risk of this disease;
    (2) Development of heart disease depends upon many factors, but its 
risk may be reduced by diets low in saturated fat and cholesterol and 
healthy lifestyles;
    (3) Development of heart disease depends upon many factors, 
including a family history of the disease, high blood LDL-cholesterol, 
diabetes, high blood pressure, being overweight, cigarette smoking, lack 
of exercise, and the type of dietary pattern. A healthful diet low in 
saturated fat, total fat, and cholesterol, as part of a healthy 
lifestyle, may lower blood cholesterol levels and may reduce the risk of 
heart disease;
    (4) Many factors, such as a family history of the disease, increased 
blood-

[[Page 161]]

and LDL-cholesterol levels, high blood pressure, cigarette smoking, 
diabetes, and being overweight, contribute to developing heart disease. 
A diet low in saturated fat, cholesterol, and total fat may help reduce 
the risk of heart disease; and
    (5) Diets low in saturated fat, cholesterol, and total fat may 
reduce the risk of heart disease. Heart disease is dependent upon many 
factors, including diet, a family history of the disease, elevated blood 
LDL-cholesterol levels, and physical inactivity.

[58 FR 2757, Jan. 6, 1993, as amended at 81 FR 91722, Dec. 19, 2016]



Sec. 101.76  Health claims: fiber-containing grain products, fruits,
and vegetables and cancer.

    (a) Relationship between diets low in fat and high in fiber-
containing grain products, fruits, and vegetables and cancer risk. (1) 
Cancer is a constellation of more than 100 different diseases, each 
characterized by the uncontrolled growth and spread of abnormal cells. 
Cancer has many causes and stages in its development. Both genetic and 
environmental risk factors may affect the risk of cancer. Risk factors 
include: A family history of a specific type of cancer, cigarette 
smoking, overweight and obesity, alcohol consumption, ultraviolet or 
ionizing radiation, exposure to cancer-causing chemicals, and dietary 
factors.
    (2) The scientific evidence establishes that diets low in fat and 
high in fiber-containing grain products, fruits, and vegetables are 
associated with a reduced risk of some types of cancer. Although the 
specific role of total dietary fiber, fiber components, and the multiple 
nutrients and other substances contained in these foods are not yet 
fully understood, many studies have shown that diets low in fat and high 
in fiber-containing foods are associated with reduced risk of some types 
of cancer.
    (b) Significance of the relationship between consumption of diets 
low in fat and high in fiber-containing grain products, fruits, and 
vegetables and risk of cancer. (1) Cancer is ranked as a leading cause 
of death in the United States. The overall economic costs of cancer, 
including direct health care costs and losses due to morbidity and 
mortality, are very high.
    (2) U.S. diets tend to be high in fat and low in grain products, 
fruits, and vegetables. Studies in various parts of the world indicate 
that populations who habitually consume a diet high in plant foods have 
lower risks of some cancers. These diets generally are low in fat and 
rich in many nutrients, including, but not limited to, dietary fiber. 
Current dietary guidelines from Federal government agencies and 
nationally recognized health professional organizations recommend 
decreased consumption of fats (less than 30 percent of calories), 
maintenance of desirable body weight, and increased consumption of 
fruits and vegetables (five or more servings daily), and grain products 
(six or more servings daily).
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in fat and high in fiber-containing grain 
products, fruits, and vegetables with reduced risk of cancer may be made 
on the label or labeling of a food described in paragraph (c)(2)(ii) of 
this section, provided that:
    (A) The claim states that diets low in fat and high in fiber-
containing grain products, fruits, and vegetables ``may'' or ``might'' 
reduce the risk of some cancers;
    (B) In specifying the disease, the claim uses the following terms: 
``some types of cancer,'' or ``some cancers'';
    (C) The claim is limited to grain products, fruits, and vegetables 
that contain dietary fiber;
    (D) The claim indicates that development of cancer depends on many 
factors;
    (E) The claim does not attribute any degree of cancer risk reduction 
to diets low in fat and high in fiber-containing grain products, fruits, 
and vegetables;
    (F) In specifying the dietary fiber component of the labeled food, 
the claim uses the term ``fiber'', ``dietary fiber'' or ``total dietary 
fiber''; and
    (G) The claim does not specify types of dietary fiber that may be 
related to risk of cancer.
    (ii) Nature of the food. (A) The food shall be or shall contain a 
grain product, fruit, or vegetable.

[[Page 162]]

    (B) The food shall meet the nutrient content requirements of Sec. 
101.62 for a ``low fat'' food.
    (C) The food shall meet, without fortification, the nutrient content 
requirements of Sec. 101.54 for a ``good source'' of dietary fiber.
    (d) Optional information. (1) The claim may include information from 
paragraphs (a) and (b) of this section, which summarize the relationship 
between diets low in fat and high in fiber-containing grain products, 
fruits, and vegetables, and some types of cancer and the significance of 
the relationship.
    (2) The claim may identify one or more of the following risk factors 
for development of cancer: Family history of a specific type of cancer, 
cigarette smoking, overweight and obesity, alcohol consumption, 
ultraviolet or ionizing radiation, exposure to cancer causing chemicals, 
and dietary factors.
    (3) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and Department of Health and Human Services (DHHS), 
Government Printing Office.
    (4) The claim may include information on the number of people in the 
United States who have cancer. The sources of this information must be 
identified, and it must be current information from the National Center 
for Health Statistics, the National Institutes of Health, or ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS, 
Government Printing Office.
    (e) Model health claims. The following model health claims may be 
used in food labeling to characterize the relationship between diets low 
in fat and high in fiber-containing grain products, fruits, and 
vegetables and cancer risk:
    (1) Low fat diets rich in fiber-containing grain products, fruits, 
and vegetables may reduce the risk of some types of cancer, a disease 
associated with many factors.
    (2) Development of cancer depends on many factors. Eating a diet low 
in fat and high in grain products, fruits, and vegetables that contain 
dietary fiber may reduce your risk of some cancers.

[58 FR 2548, Jan. 6, 1993]



Sec. 101.77  Health claims: fruits, vegetables, and grain products
that contain fiber, particularly soluble fiber, and risk of coronary
heart disease.

    (a) Relationship between diets low in saturated fat and cholesterol 
and high in fruits, vegetables, and grain products that contain fiber, 
particularly soluble fiber, and risk of coronary heart disease. (1) 
Cardiovascular disease means diseases of the heart and circulatory 
system. Coronary heart disease is the most common and serious form of 
cardiovascular disease and refers to diseases of the heart muscle and 
supporting blood vessels. High blood total- and low density lipoprotein 
(LDL)- cholesterol levels are major modifiable risk factors in the 
development of coronary heart disease. High coronary heart disease rates 
occur among people with high blood cholesterol levels of 240 milligrams 
per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-cholesterol 
levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk blood 
cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 
130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary 
lipids (fats) include fatty acids and cholesterol. Total fat, commonly 
referred to as fat, is composed of saturated fat (fatty acids containing 
no double bonds), and monounsaturated and polyunsaturated fat (fatty 
acids containing one or more double bonds).
    (2) The scientific evidence establishes that diets high in saturated 
fat and cholesterol are associated with increased levels of blood total- 
and LDL-cholesterol and, thus, with increased risk of coronary heart 
disease. Diets low in saturated fat and cholesterol are associated with 
decreased levels of blood total- and LDL-cholesterol, and thus, with 
decreased risk of developing coronary heart disease.
    (3) Populations with relatively low blood cholesterol levels tend to 
have dietary patterns that are not only low in total fat, especially 
saturated fat and cholesterol, but are also relatively high in fruits, 
vegetables, and grain products. Although the specific roles of these 
plant foods are not yet fully understood, many studies have shown that 
diets high in plant foods are associated with reduced risk of coronary

[[Page 163]]

heart disease. These studies correlate diets rich in fruits, vegetables, 
and grain products and nutrients from these diets, such as some types of 
fiber, with reduced coronary heart disease risk. Persons consuming these 
diets frequently have high intakes of dietary fiber, particularly 
soluble fibers. Currently, there is not scientific agreement as to 
whether a particular type of soluble fiber is beneficial, or whether the 
observed protective effects of fruits, vegetables, and grain products 
against heart disease are due to other components, or a combination of 
components, in these diets, including, but not necessarily limited to, 
some types of soluble fiber, other fiber components, other 
characteristics of the complex carbohydrate content of these foods, 
other nutrients in these foods, or displacement of saturated fat and 
cholesterol from the diet.
    (b) Significance of the relationship between diets low in saturated 
fat and cholesterol, and high in fruits, vegetables, and grain products 
that contain fiber, particularly soluble fiber, and risk of coronary 
heart disease. (1) Coronary heart disease is a major public health 
concern in the United States, primarily because it accounts for more 
deaths than any other disease or group of diseases. Early management of 
risk factors for coronary heart disease is a major public health goal 
that can assist in reducing risk of coronary heart disease. There is a 
continuum of mortality risk from coronary heart disease that increases 
with increasing levels of blood LDL-cholesterol. Individuals with high 
blood LDL-cholesterol are at greatest risk. A larger number of 
individuals with more moderately elevated cholesterol also have 
increased risk of coronary events; such individuals comprise a 
substantial proportion of the adult U.S. population. The scientific 
evidence indicates that reducing saturated fat and cholesterol intakes 
lowers blood LDL-cholesterol and risk of heart disease in most 
individuals, including persons with blood cholesterol levels in the 
normal range. Additionally, consuming diets high in fruits, vegetables, 
and grain products, foods that contain soluble fiber, may be a useful 
adjunct to a low saturated fat and low cholesterol diet.
    (2) Other risk factors for coronary heart disease include a family 
history of heart disease, high blood pressure, diabetes, cigarette 
smoking, obesity (body weight 30 percent greater than ideal body 
weight), and lack of regular physical exercise.
    (3) Intakes of saturated fat exceed recommended levels in many 
people in the United States. Intakes of cholesterol are, on average, at 
or above recommended levels. Intakes of fiber-containing fruits, 
vegetables, and grain products are about half of recommended intake 
levels. One of the major public health recommendations relative to 
coronary heart disease risk is to consume less than 10 percent of 
calories from saturated fat, and an average of 30 percent or less of 
total calories from all fat. Recommended daily cholesterol intakes are 
300 mg or less per day. Recommended total dietary fiber intakes are 
about 25 grams (g) daily, of which about 25 percent (about 6 g) should 
be soluble fiber.
    (4) Current dietary guidance recommendations encourage decreased 
consumption of dietary fat, especially saturated fat and cholesterol, 
and increased consumption of fiber-rich foods to help lower blood LDL-
cholesterol levels. Results of numerous studies have shown that fiber-
containing fruits, vegetables, and grain products can help lower blood 
LDL-cholesterol.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in saturated fat and cholesterol and high in 
fruits, vegetables, and grain products that contain fiber, particularly 
soluble fiber, with reduced risk of heart disease may be made on the 
label or labeling of a food described in paragraph (c)(2)(ii) of this 
section, provided that:
    (A) The claim states that diets low in saturated fat and cholesterol 
and high in fruits, vegetables, and grain products that contain fiber 
``may'' or ``might'' reduce the risk of heart disease;
    (B) In specifying the disease, the claim uses the following terms: 
``heart disease'' or ``coronary heart disease;''

[[Page 164]]

    (C) The claim is limited to those fruits, vegetables, and grains 
that contain fiber;
    (D) In specifying the dietary fiber, the claim uses the term 
``fiber,'' ``dietary fiber,'' ``some types of dietary fiber,'' ``some 
dietary fibers,'' or ``some fibers;'' the term ``soluble fiber'' may be 
used in addition to these terms;
    (E) In specifying the fat component, the claim uses the terms 
``saturated fat'' and ``cholesterol;'' and
    (F) The claim indicates that development of heart disease depends on 
many factors; and
    (G) The claim does not attribute any degree of risk reduction for 
coronary heart disease to diets low in saturated fat and cholesterol and 
high in fruits, vegetables, and grain products that contain fiber.
    (ii) Nature of the food. (A) The food shall be or shall contain a 
fruit, vegetable, or grain product.
    (B) The food shall meet the nutrient content requirements of Sec. 
101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low fat'' 
food.
    (C) The food contains, without fortification, at least 0.6 g of 
soluble fiber per reference amount customarily consumed;
    (D) The content of soluble fiber shall be declared in the nutrition 
information panel, consistent with Sec. 101.9(c)(6)(i)(A).
    (d) Optional information. (1) The claim may identify one or more of 
the following risk factors for heart disease about which there is 
general scientific agreement: A family history of coronary heart 
disease, elevated blood-, total- and LDL-cholesterol, excess body 
weight, high blood pressure, cigarette smoking, diabetes, and physical 
inactivity.
    (2) The claim may indicate that the relationship of diets low in 
saturated fat and cholesterol, and high in fruits, vegetables, and grain 
products that contain fiber to heart disease is through the intermediate 
link of ``blood cholesterol'' or ``blood total- and LDL-cholesterol.''
    (3) The claim may include information from paragraphs (a) and (b) of 
this section, which summarize the relationship between diets low in 
saturated fat and cholesterol and high in fruits, vegetables, and grain 
products that contain fiber and coronary heart disease, and the 
significance of the relationship.
    (4) In specifying the nutrients, the claim may include the term 
``total fat'' in addition to the terms ``saturated fat'' and 
``cholesterol.''
    (5) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and Department of Health and Human Services (DHHS), 
Government Printing Office (GPO).
    (6) The claim may state that individuals with elevated blood total- 
and LDL-cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total- and LDL-
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment.
    (7) The claim may include information on the number of people in the 
United States who have heart disease. The sources of this information 
shall be identified, and it shall be current information from the 
National Center for Health Statistics, the National Institutes of 
Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' USDA and DHHS, GPO.
    (e) Model health claims. The following model health claims may be 
used in food labeling to characterize the relationship between diets low 
in saturated fat and cholesterol and high in fruits, vegetables, and 
grain products that contain soluble fiber:
    (1) Diets low in saturated fat and cholesterol and rich in fruits, 
vegetables, and grain products that contain some types of dietary fiber, 
particularly soluble fiber, may reduce the risk of heart disease, a 
disease associated with many factors.
    (2) Development of heart disease depends on many factors. Eating a 
diet low in saturated fat and cholesterol and high in fruits, 
vegetables, and grain products that contain fiber may lower blood 
cholesterol levels and reduce your risk of heart disease.

[58 FR 2578, Jan. 6, 1993]

[[Page 165]]



Sec. 101.78  Health claims: fruits and vegetables and cancer.

    (a) Relationship between substances in diets low in fat and high in 
fruits and vegetables and cancer risk. (1) Cancer is a constellation of 
more than 100 different diseases, each characterized by the uncontrolled 
growth and spread of abnormal cells. Cancer has many causes and stages 
in its development. Both genetic and environmental risk factors may 
affect the risk of cancer. Risk factors include a family history of a 
specific type of cancer, cigarette smoking, alcohol consumption, 
overweight and obesity, ultraviolet or ionizing radiation, exposure to 
cancer-causing chemicals, and dietary factors.
    (2) Although the specific roles of the numerous potentially 
protective substances in plant foods are not yet understood, many 
studies have shown that diets high in plant foods are associated with 
reduced risk of some types of cancers. These studies correlate diets 
rich in fruits and vegetables and nutrients from these diets, such as 
vitamin C, vitamin A, and dietary fiber, with reduced cancer risk. 
Persons consuming these diets frequently have high intakes of these 
nutrients. Currently, there is not scientific agreement as to whether 
the observed protective effects of fruits and vegetables against cancer 
are due to a combination of the nutrient components of diets rich in 
fruits and vegetables, including but not necessarily limited to dietary 
fiber, vitamin A (as beta-carotene) and vitamin C, to displacement of 
fat from such diets, or to intakes of other substances in these foods 
which are not nutrients but may be protective against cancer risk.
    (b) Significance of the relationship between consumption of diets 
low in fat and high in fruits and vegetables and risk of cancer. (1) 
Cancer is ranked as a leading cause of death in the United States. The 
overall economic costs of cancer, including direct health care costs and 
losses due to morbidity and mortality, are very high.
    (2) U.S. diets tend to be high in fat and low in fruits and 
vegetables. Studies in various parts of the world indicate that 
populations who habitually consume a diet high in plant foods have lower 
risks of some cancers. These diets generally are low in fat and rich in 
many nutrients, including, but not limited to, dietary fiber, vitamin A 
(as beta-carotene), and vitamin C. Current dietary guidelines from 
Federal Government agencies and nationally recognized health 
professional organizations recommend decreased consumption of fats (less 
than 30 percent of calories), maintenance of desirable body weight, and 
increased consumption of fruits and vegetables (5 or more servings 
daily), particularly those fruits and vegetables which contain dietary 
fiber, vitamin A, and vitamin C.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating substances in diets low in fat and high in fruits and 
vegetables with reduced risk of cancer may be made on the label or 
labeling of a food described in paragraph (c)(2)(ii) of this section, 
provided that:
    (A) The claim states that diets low in fat and high in fruits and 
vegetables ``may'' or ``might'' reduce the risk of some cancers;
    (B) In specifying the disease, the claim uses the following terms: 
``some types of cancer'', or ``some cancers'';
    (C) The claim characterizes fruits and vegetables as foods that are 
low in fat and may contain vitamin A, vitamin C, and dietary fiber;
    (D) The claim characterizes the food bearing the claim as containing 
one or more of the following, for which the food is a good source under 
Sec. 101.54: dietary fiber, vitamin A, or vitamin C;
    (E) The claim does not attribute any degree of cancer risk reduction 
to diets low in fat and high in fruits and vegetables;
    (F) In specifying the fat component of the labeled food, the claim 
uses the term ``total fat'' or ``fat'';
    (G) The claim does not specify types of fats or fatty acids that may 
be related to risk of cancer;
    (H) In specifying the dietary fiber component of the labeled food, 
the claim uses the term ``fiber'', ``dietary fiber'', or ``total dietary 
fiber'';
    (I) The claim does not specify types of dietary fiber that may be 
related to risk of cancer; and

[[Page 166]]

    (J) The claim indicates that development of cancer depends on many 
factors.
    (ii) Nature of the food. (A) The food shall be or shall contain a 
fruit or vegetable.
    (B) The food shall meet the nutrient content requirements of Sec. 
101.62 for a ``low fat'' food.
    (C) The food shall meet, without fortification, the nutrient content 
requirements of Sec. 101.54 for a ``good source'' of at least one of 
the following: vitamin A, vitamin C, or dietary fiber.
    (d) Optional information. (1) The claim may include information from 
paragraphs (a) and (b) of this section, which summarize the relationship 
between diets low in fat and high in fruits and vegetables and some 
types of cancer and the significance of the relationship.
    (2) The claim may identify one or more of the following risk factors 
for development of cancer: Family history of a specific type of cancer, 
cigarette smoking, alcohol consumption, overweight and obesity, 
ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, 
and dietary factors.
    (3) The claim may use the word ``beta-carotene'' in parentheses 
after the term vitamin A, provided that the vitamin A in the food 
bearing the claim is beta-carotene.
    (4) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and the Department of Health and Human Services 
(DHHS), Government Printing Office.
    (5) The claim may include information on the number of people in the 
United States who have cancer. The sources of this information must be 
identified, and it must be current information from the National Center 
for Health Statistics, the National Institutes of Health, or ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS, 
Government Printing Office.
    (e) Model health claims. The following model health claims may be 
used in food labeling to characterize the relationship between 
substances in diets low in fat and high in fruits and vegetables and 
cancer:
    (1) Low fat diets rich in fruits and vegetables (foods that are low 
in fat and may contain dietary fiber, vitamin A, and vitamin C) may 
reduce the risk of some types of cancer, a disease associated with many 
factors. Broccoli is high in vitamins A and C, and it is a good source 
of dietary fiber.
    (2) Development of cancer depends on many factors. Eating a diet low 
in fat and high in fruits and vegetables, foods that are low in fat and 
may contain vitamin A, vitamin C, and dietary fiber, may reduce your 
risk of some cancers. Oranges, a food low in fat, are a good source of 
fiber and vitamin C.

[58 FR 2639, Jan. 6, 1993]



Sec. 101.79  Health claims: Folate and neural tube defects.

    (a) Relationship between folate and neural tube defects--(1) 
Definition. Neural tube defects are serious birth defects of the brain 
or spinal cord that can result in infant mortality or serious 
disability. The birth defects anencephaly and spina bifida are the most 
common forms of neural tube defects and account for about 90 percent of 
these defects. These defects result from failure of closure of the 
covering of the brain or spinal cord during early embryonic development. 
Because the neural tube forms and closes during early pregnancy, the 
defect may occur before a woman realizes that she is pregnant.
    (2) Relationship. The available data show that diets adequate in 
folate may reduce the risk of neural tube defects. The strongest 
evidence for this relationship comes from an intervention study by the 
Medical Research Council of the United Kingdom that showed that women at 
risk of recurrence of a neural tube defect pregnancy who consumed a 
supplement containing 4 milligrams (mg)(4,000 micrograms (mcg)) folic 
acid daily before conception and continuing into early pregnancy had a 
reduced risk of having a child with a neural tube defect. (Products 
containing this level of folic acid are drugs). In addition, based on 
its review of a Hungarian intervention trial that reported 
periconceptional use of a multivitamin and multimineral preparation 
containing 800 mcg (0.8 mg) of

[[Page 167]]

folic acid, and its review of the observational studies that reported 
periconceptional use of multivitamins containing 0 to 1,000 mcg of folic 
acid, the Food and Drug Administration concluded that most of these 
studies had results consistent with the conclusion that folate, at 
levels attainable in usual diets, may reduce the risk of neural tube 
defects.
    (b) Significance of folate--(1) Public health concern. Neural tube 
defects occur in approximately 0.6 of 1,000 live births in the United 
States (i.e., approximately 6 of 10,000 live births; about 2,500 cases 
among 4 million live births annually). Neural tube defects are believed 
to be caused by many factors. The single greatest risk factor for a 
neural tube defect-affected pregnancy is a personal or family history of 
a pregnancy affected with a such a defect. However, about 90 percent of 
infants with a neural tube defect are born to women who do not have a 
family history of these defects. The available evidence shows that diets 
adequate in folate may reduce the risk of neural tube defects but not of 
other birth defects.
    (2) Populations at risk. Prevalence rates for neural tube defects 
have been reported to vary with a wide range of factors including 
genetics, geography, socioeconomic status, maternal birth cohort, month 
of conception, race, nutrition, and maternal health, including maternal 
age and reproductive history. Women with a close relative (i.e., 
sibling, niece, nephew) with a neural tube defect, those with insulin-
dependent diabetes mellitus, and women with seizure disorders who are 
being treated with valproic acid or carbamazepine are at significantly 
increased risk compared with women without these characteristics. Rates 
for neural tube defects vary within the United States, with lower rates 
observed on the west coast than on the east coast.
    (3) Those who may benefit. Based on a synthesis of information from 
several studies, including those which used multivitamins containing 
folic acid at a daily dose level of =400 mcg (=0.4 
mg), the Public Health Service has inferred that folate alone at levels 
of 400 mcg (0.4 mg) per day may reduce the risk of neural tube defects. 
The protective effect found in studies of lower dose folate measured by 
the reduction in neural tube defect incidence, ranges from none to 
substantial; a reasonable estimate of the expected reduction in the 
United States is 50 percent. It is expected that consumption of adequate 
folate will avert some, but not all, neural tube defects. The underlying 
causes of neural tube defects are not known. Thus, it is not known what 
proportion of neural tube defects will be averted by adequate folate 
consumption. From the available evidence, the Public Health Service 
estimates that there is the potential for averting 50 percent of cases 
that now occur (i.e., about 1,250 cases annually). However, until 
further research is done, no firm estimate of this proportion will be 
available.
    (c) Requirements. The label or labeling of food may contain a 
folate/neural tube defect health claim provided that:
    (1) General requirements. The health claim for a food meets all of 
the general requirements of Sec. 101.14 for health claims, except that 
a food may qualify to bear the health claim if it meets the definition 
of the term ``good source.''
    (2) Specific requirements--(i) Nature of the claim--(A) 
Relationship. A health claim that women who are capable of becoming 
pregnant and who consume adequate amounts of folate daily during their 
childbearing years may reduce their risk of having a pregnancy affected 
by spina bifida or other neural tube defects may be made on the label or 
labeling of food provided that:
    (B) Specifying the nutrient. In specifying the nutrient, the claim 
shall use the terms ``folate,'' ``folic acid,'' ``folacin,'' ``folate, a 
B vitamin,'' ``folic acid, a B vitamin,'' or ``folacin, a B vitamin.''
    (C) Specifying the condition. In specifying the health- related 
condition, the claim shall identify the birth defects as ``neural tube 
defects,'' ``birth defects spina bifida or anencephaly,'' ``birth 
defects of the brain or spinal cord anencephaly or spina bifida,'' 
``spina bifida and anencephaly, birth defects of the brain or spinal 
cord,'' ``birth defects of the brain or spinal cord;'' or ``brain or 
spinal cord birth defects.''
    (D) Multifactorial nature. The claim shall not imply that folate 
intake is

[[Page 168]]

the only recognized risk factor for neural tube defects.
    (E) Reduction in risk. The claim shall not attribute any specific 
degree of reduction in risk of neural tube defects from maintaining an 
adequate folate intake throughout the childbearing years. The claim 
shall state that some women may reduce their risk of a neural tube 
defect pregnancy by maintaining adequate intakes of folate during their 
childbearing years. Optional statements about population-based estimates 
of risk reduction may be made in accordance with paragraph (c)(3)(vi) of 
this section.
    (F) Safe upper limit of daily intake. Claims on foods that contain 
more than 100 percent of the Daily Value (DV) (400 mcg) when labeled for 
use by adults and children 4 or more years of age, or 800 mcg when 
labeled for use by pregnant or lactating women) shall identify the safe 
upper limit of daily intake with respect to the DV. The safe upper limit 
of daily intake value of 1,000 mcg (1 mg) may be included in 
parentheses.
    (G) The claim shall state that folate needs to be consumed as part 
of a healthful diet.
    (ii) Nature of the food--(A) Requirements. The food shall meet or 
exceed the requirements for a ``good source'' of folate as defined in 
Sec. 101.54;
    (B) Dietary supplements. Dietary supplements shall meet the United 
States Pharmacopeia (USP) standards for disintegration and dissolution, 
except that if there are no applicable USP standards, the folate in the 
dietary supplement shall be shown to be bioavailable under the 
conditions of use stated on the product label.
    (iii) Limitation. The claim shall not be made on foods that contain 
more than 100 percent of the RDI for vitamin A as retinol or preformed 
vitamin A or vitamin D per serving or per unit.
    (iv) Nutrition labeling. The nutrition label shall include 
information about the amount of folate in the food. This information 
shall be declared after the declaration for iron if only the levels of 
vitamin A, vitamin C, calcium, and iron are provided, or in accordance 
with Sec. 101.9 (c)(8) and (c)(9) if other optional vitamins or 
minerals are declared.
    (3) Optional information--(i) Risk factors. The claim may 
specifically identify risk factors for neural tube defects. Where such 
information is provided, it may consist of statements from Sec. 
101.79(b)(1) or (b)(2) (e.g., Women at increased risk include those with 
a personal history of a neural tube defect-affected pregnancy, those 
with a close relative (i.e., sibling, niece, nephew) with a neural tube 
defect; those with insulin-dependent diabetes mellitus; those with 
seizure disorders who are being treated with valproic acid or 
carbamazepine) or from other parts of this paragraph (c)(3)(i).
    (ii) Relationship between folate and neural tube defects. The claim 
may include statements from paragraphs (a) and (b) of this section that 
summarize the relationship between folate and neural tube defects and 
the significance of the relationship except for information specifically 
prohibited from the claim.
    (iii) Personal history of a neural tube defect-affected pregnancy. 
The claim may state that women with a history of a neural tube defect 
pregnancy should consult their physicians or health care providers 
before becoming pregnant. If such a statement is provided, the claim 
shall also state that all women should consult a health care provider 
when planning a pregnancy.
    (iv) Daily value. The claim may identify 100 percent of the DV (100% 
DV; 400 mcg) for folate as the target intake goal.
    (v) Prevalence. The claim may provide estimates, expressed on an 
annual basis, of the number of neural tube defect-affected births among 
live births in the United States. Current estimates are provided in 
Sec. 101.79(b)(1), and are approximately 6 of 10,000 live births 
annually (i.e., about 2,500 cases among 4 million live births annually). 
Data provided in Sec. 101.79(b)(1) shall be used, unless more current 
estimates from the U.S. Public Health Service are available, in which 
case the latter may be cited.
    (vi) Reduction in risk. An estimate of the reduction in the number 
of neural tube defect-affected births that might occur in the United 
States if all women consumed adequate folate throughout

[[Page 169]]

their childbearing years may be included in the claim. Information 
contained in paragraph (b)(3) of this section may be used. If such an 
estimate (i.e., 50 percent) is provided, the estimate shall be 
accompanied by additional information that states that the estimate is 
population-based and that it does not reflect risk reduction that may be 
experienced by individual women.
    (vii) Diets adequate in folate. The claim may identify diets 
adequate in folate by using phrases such as ``Sources of folate include 
fruits, vegetables, whole grain products, fortified cereals, and dietary 
supplements.'' or ``Adequate amounts of folate can be obtained from 
diets rich in fruits, dark green leafy vegetables, legumes, whole grain 
products, fortified cereals, or dietary supplements.'' or ``Adequate 
amounts of folate can be obtained from diets rich in fruits, including 
citrus fruits and juices, vegetables, including dark green leafy 
vegetables, legumes, whole grain products, including breads, rice, and 
pasta, fortified cereals, or a dietary supplement.''
    (d) Model health claims. The following are examples of model health 
claims that may be used in food labeling to describe the relationship 
between folate and neural tube defects:
    (1) Examples 1 and 2. Model health claims appropriate for foods 
containing 100 percent or less of the DV for folate per serving or per 
unit (general population). The examples contain only the required 
elements:
    (i) Healthful diets with adequate folate may reduce a woman's risk 
of having a child with a brain or spinal cord birth defect.
    (ii) Adequate folate in healthful diets may reduce a woman's risk of 
having a child with a brain or spinal cord birth defect.
    (2) Example 3. Model health claim appropriate for foods containing 
100 percent or less of the DV for folate per serving or per unit. The 
example contains all required elements plus optional information: Women 
who consume healthful diets with adequate folate throughout their 
childbearing years may reduce their risk of having a child with a birth 
defect of the brain or spinal cord. Sources of folate include fruits, 
vegetables, whole grain products, fortified cereals, and dietary 
supplements.
    (3) Example 4. Model health claim appropriate for foods intended for 
use by the general population and containing more than 100 percent of 
the DV of folate per serving or per unit: Women who consume healthful 
diets with adequate folate may reduce their risk of having a child with 
birth defects of the brain or spinal cord. Folate intake should not 
exceed 250% of the DV (1,000 mcg).

[61 FR 8779, Mar. 5, 1996; 61 FR 48529, Sept. 13, 1996, as amended at 65 
FR 58918, Oct. 3, 2000]



Sec. 101.80  Health claims: dietary noncariogenic carbohydrate 
sweeteners and dental caries.

    (a) Relationship between dietary carbohydrates and dental caries. 
(1) Dental caries, or tooth decay, is a disease caused by many factors. 
Both environmental and genetic factors can affect the development of 
dental caries. Risk factors include tooth enamel crystal structure and 
mineral content, plaque quantity and quality, saliva quantity and 
quality, individual immune response, types and physical characteristics 
of foods consumed, eating behaviors, presence of acid producing oral 
bacteria, and cultural influences.
    (2) The relationship between consumption of fermentable 
carbohydrates, i.e., dietary sugars and starches, and tooth decay is 
well established. Sucrose, also known as sugar, is one of the most, but 
not the only, cariogenic sugars in the diet. Bacteria found in the mouth 
are able to metabolize most dietary carbohydrates, producing acid and 
forming dental plaque. The more frequent and longer the exposure of 
teeth to dietary sugars and starches, the greater the risk for tooth 
decay.
    (3) Dental caries continues to affect a large proportion of 
Americans. Although there has been a decline in the prevalence of dental 
caries among children in the United States, the disease remains 
widespread throughout the population, imposing a substantial burden on 
Americans. Recent Federal government dietary guidelines recommend that 
Americans choose diets that are moderate in sugars and avoid excessive

[[Page 170]]

snacking. Frequent between-meal snacks that are high in sugars and 
starches may be more harmful to teeth than eating such foods at meals 
and then brushing.
    (4) Noncariogenic carbohydrate sweeteners, such as sugar alcohols, 
can be used to replace dietary sugars, such as sucrose and corn 
sweeteners, in foods such as chewing gums and certain confectioneries. 
Noncariogenic carbohydrate sweeteners are significantly less cariogenic 
than dietary sugars and other fermentable carbohydrates.
    (b) Significance of the relationship between noncariogenic 
carbohydrate sweeteners and dental caries. Noncariogenic carbohydrate 
sweeteners do not promote dental caries. The noncariogenic carbohydrate 
sweeteners listed in paragraph (c)(2)(ii) of this section are slowly 
metabolized by bacteria to form some acid. The rate and amount of acid 
production is significantly less than that from sucrose and other 
fermentable carbohydrates and does not cause the loss of important 
minerals from tooth enamel.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met, except that noncariogenic carbohydrate sweetener-
containing foods listed in paragraph (c)(2)(ii) of this section are 
exempt from Sec. 101.14(e)(6).
    (2) Specific requirements--(i) Nature of the claim. A health claim 
relating noncariogenic carbohydrate sweeteners, compared to other 
carbohydrates, and the nonpromotion of dental caries may be made on the 
label or labeling of a food described in paragraph (c)(2)(iii) of this 
section, provided that:
    (A) The claim shall state that frequent between-meal consumption of 
foods high in sugars and starches can promote tooth decay.
    (B) The claim shall state that the noncariogenic carbohydrate 
sweetener present in the food ``does not promote,'' ``may reduce the 
risk of,'' ``useful [or is useful] in not promoting,'' or ``expressly 
[or is expressly] for not promoting'' dental caries.
    (C) In specifying the nutrient, the claim shall state ``sugar 
alcohol,'' ``sugar alcohols,'' or the name or names of the substances 
listed in paragraph (c)(2)(ii) of this section, e.g., ``sorbitol.'' D-
tagatose may be identified as ``tagatose.''
    (D) In specifying the disease, the claim uses the following terms: 
``dental caries'' or ``tooth decay.''
    (E) The claim shall not attribute any degree of the reduction in 
risk of dental caries to the use of the noncariogenic carbohydrate 
sweetener-containing food.
    (F) The claim shall not imply that consuming noncariogenic 
carbohydrate sweetener-containing foods is the only recognized means of 
achieving a reduced risk of dental caries.
    (G) Packages with less than 15 square inches of surface area 
available for labeling are exempt from paragraphs (A) and (C) of this 
section.
    (H) When the substance that is the subject of the claim is a 
noncariogenic sugar, the claim shall identify the substance as a sugar 
that, unlike other sugars, does not promote the development of dental 
caries.
    (ii) Nature of the substance. Eligible noncariogenic carbohydrate 
sweeteners are:
    (A) The sugar alcohols xylitol, sorbitol, mannitol, maltitol, 
isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated 
glucose syrups, and erythritol, or a combination of these.
    (B) The sugars D-tagatose and isomaltulose.
    (C) Sucralose.
    (iii) Nature of the food. (A) The food shall meet the requirement in 
Sec. 101.60(c)(1)(i) with respect to sugars content, except that the 
food may contain D-tagatose or isomaltulose.
    (B) A food whose labeling includes a health claim under this section 
shall contain one or more of the noncariogenic carbohydrate sweeteners 
listed in paragraph (c)(2)(ii) of this section.
    (C) When carbohydrates other than those listed in paragraph 
(c)(2)(ii) of this section are present in the food, the food shall not 
lower plaque pH below 5.7 by bacterial fermentation either during 
consumption or up to 30 minutes after consumption, as measured by the 
indwelling plaque pH test found in ``Identification of Low Caries Risk 
Dietary Components,'' dated 1983, by T.

[[Page 171]]

N. Imfeld, in Volume 11, Monographs in Oral Science, 1983. The Director 
of the Office of the Federal Register has approved the incorporation by 
reference of this material in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain copies from Karger AG Publishing Co., P.O. Box, 
Ch-4009 Basel, Switzerland, or you may examine a copy at the Food and 
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, 
Third Floor, Silver Spring, MD 20993, 301-796-2039, 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.
    (d) Optional information. (1) The claim may include information from 
paragraphs (a) and (b) of this section, which describe the relationship 
between diets containing noncariogenic carbohydrate sweeteners and 
dental caries.
    (2) The claim may indicate that development of dental caries depends 
on many factors and may identify one or more of the following risk 
factors for dental caries: Frequent consumption of fermentable 
carbohydrates, such as dietary sugars and starches; presence of oral 
bacteria capable of fermenting carbohydrates; length of time fermentable 
carbohydrates are in contact with the teeth; lack of exposure to 
fluoride; individual susceptibility; socioeconomic and cultural factors; 
and characteristics of tooth enamel, saliva, and plaque.
    (3) The claim may indicate that oral hygiene and proper dental care 
may help to reduce the risk of dental disease.
    (4) The claim may indicate that a substance listed in paragraph 
(c)(2)(ii) of this section serves as a sweetener.
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between noncariogenic 
carbohydrate sweetener-containing foods and dental caries.
    (1) Examples of the full claim:
    (i) Frequent eating of foods high in sugars and starches as between-
meal snacks can promote tooth decay. The sugar alcohol [name, optional] 
used to sweeten this food may reduce the risk of dental caries.
    (ii) Frequent between-meal consumption of foods high in sugars and 
starches promotes tooth decay. The sugar alcohols in [name of food] do 
not promote tooth decay.
    (iii) Frequent eating of foods high in sugars and starches as 
between-meal snacks can promote tooth decay. [Name of sugar from 
paragraph (c)(2)(ii)(B) of this section], the sugar used to sweeten this 
food, unlike other sugars, may reduce the risk of dental caries.
    (iv) Frequent between-meal consumption of foods high in sugars and 
starches promotes tooth decay. [Name of sugar from paragraph 
(c)(2)(ii)(B) of this section], the sugar in [name of food], unlike 
other sugars, does not promote tooth decay.
    (v) Frequent eating of foods high in sugars and starches as between-
meal snacks can promote tooth decay. Sucralose, the sweetening 
ingredient used to sweeten this food, unlike sugars, does not promote 
tooth decay.
    (2) Example of the shortened claim for small packages:
    (i) Does not promote tooth decay.
    (ii) May reduce the risk of tooth decay.
    (iii) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] 
sugar does not promote tooth decay.
    (iv) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] 
sugar may reduce the risk of tooth decay.

[61 FR 43446, Aug. 23, 1996, as amended at 62 FR 63655, Dec. 2, 1997; 66 
FR 66742, Dec. 27, 2001; 67 FR 71470, Dec. 2, 2002; 71 FR 15563, Mar. 
29, 2006; 72 FR 52789, Sept. 17, 2007; 81 FR 5590, Feb. 3, 2016]



Sec. 101.81  Health claims: Soluble fiber from certain foods and 
risk of coronary heart disease (CHD).

    (a) Relationship between diets that are low in saturated fat and 
cholesterol and that include soluble fiber from certain foods and the 
risk of CHD. (1) Cardiovascular disease means diseases of the heart and 
circulatory system. Coronary heart disease (CHD) is one of the

[[Page 172]]

most common and serious forms of cardiovascular disease and refers to 
diseases of the heart muscle and supporting blood vessels. High blood 
total cholesterol and low density lipoprotein (LDL)-cholesterol levels 
are associated with increased risk of developing coronary heart disease. 
High CHD rates occur among people with high total cholesterol levels of 
240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-
cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high 
risk total cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 
mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. 
The scientific evidence establishes that diets high in saturated fat and 
cholesterol are associated with increased levels of blood total- and 
LDL-cholesterol and, thus, with increased risk of CHD.
    (2) Populations with a low incidence of CHD tend to have relatively 
low blood total cholesterol and LDL-cholesterol levels. These 
populations also tend to have dietary patterns that are not only low in 
total fat, especially saturated fat and cholesterol, but are also 
relatively high in fiber-containing fruits, vegetables, and grain 
products, such as whole oat products.
    (3) Scientific evidence demonstrates that diets low in saturated fat 
and cholesterol may reduce the risk of CHD. Other evidence demonstrates 
that the addition of soluble fiber from certain foods to a diet that is 
low in saturated fat and cholesterol may also help to reduce the risk of 
CHD.
    (b) Significance of the relationship between diets that are low in 
saturated fat and cholesterol and that include soluble fiber from 
certain foods and the risk of CHD. (1) CHD is a major public health 
concern in the United States. It accounts for more deaths than any other 
disease or group of diseases. Early management of risk factors for CHD 
is a major public health goal that can assist in reducing risk of CHD. 
High blood total and LDL-cholesterol are major modifiable risk factors 
in the development of CHD.
    (2) Intakes of saturated fat exceed recommended levels in the diets 
of many people in the United States. One of the major public health 
recommendations relative to CHD risk is to consume less than 10 percent 
of calories from saturated fat and an average of 30 percent or less of 
total calories from all fat. Recommended daily cholesterol intakes are 
300 milligrams (mg) or less per day. Scientific evidence demonstrates 
that diets low in saturated fat and cholesterol are associated with 
lower blood total- and LDL-cholesterol levels. Soluble fiber from 
certain foods, when included in a low saturated fat and cholesterol 
diet, also helps to lower blood total- and LDL-cholesterol levels.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met. The label and labeling of foods containing psyllium husk 
shall be consistent with the provisions of Sec. 101.17(f).
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets that are low in saturated fat and cholesterol and that 
include soluble fiber from certain foods with reduced risk of heart 
disease may be made on the label or labeling of a food described in 
paragraph (c)(2)(iii) of this section, provided that:
    (A) The claim states that diets that are low in saturated fat and 
cholesterol and that include soluble fiber from certain foods ``may'' or 
``might'' reduce the risk of heart disease.
    (B) In specifying the disease, the claim uses the following terms: 
``heart disease'' or ``coronary heart disease'';
    (C) In specifying the substance, the claim uses the term ``soluble 
fiber'' qualified by the name of the eligible source of soluble fiber 
(provided in paragraph (c)(2)(ii)) of this section. Additionally, the 
claim may use the name of the food product that contains the eligible 
source of soluble fiber;
    (D) In specifying the fat component, the claim uses the terms 
``saturated fat'' and ``cholesterol'';
    (E) The claim does not attribute any degree of risk reduction for 
CHD to diets that are low in saturated fat and cholesterol and that 
include soluble fiber from the eligible food sources from paragraph 
(c)(2)(ii) of this section; and
    (F) The claim does not imply that consumption of diets that are low 
in saturated fat and cholesterol and that include soluble fiber from the 
eligible food sources from paragraph (c)(2)(ii) of

[[Page 173]]

this section is the only recognized means of achieving a reduced risk of 
CHD.
    (G) The claim specifies the daily dietary intake of the soluble 
fiber source that is necessary to reduce the risk of coronary heart 
disease and the contribution one serving of the product makes to the 
specified daily dietary intake level. Daily dietary intake levels of 
soluble fiber sources listed in paragraph (c)(2)(ii) of this section 
that have been associated with reduced risk coronary heart disease are:
    (1) 3 g or more per day of [beta]-glucan soluble fiber from either 
whole oats or barley, or a combination of whole oats and barley.
    (2) 7 g or more per day of soluble fiber from psyllium seed husk.
    (ii) Nature of the substance--Eligible sources of soluble fiber. (A) 
Beta ([beta]) glucan soluble fiber from the whole oat and barley sources 
listed below. [beta]-glucan soluble fiber will be determined by method 
No. 992.28 from the ``Official Methods of Analysis of the AOAC 
INTERNATIONAL,'' 16th ed. (1995), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be 
obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined at the Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039, 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;
    (1) Oat bran. Oat bran is produced by grinding clean oat groats or 
rolled oats and separating the resulting oat flour by suitable means 
into fractions such that the oat bran fraction is not more than 50 
percent of the original starting material and provides at least 5.5 
percent (dry weight basis (dwb)) [beta]-glucan soluble fiber and a total 
dietary fiber content of 16 percent (dwb), and such that at least one-
third of the total dietary fiber is soluble fiber;
    (2) Rolled oats. Rolled oats, also known as oatmeal, produced from 
100 percent dehulled, clean oat groats by steaming, cutting, rolling, 
and flaking, and provides at least 4 percent (dwb) of [beta]-glucan 
soluble fiber and a total dietary fiber content of at least 10 percent.
    (3) Whole oat flour. Whole oat flour is produced from 100 percent 
dehulled, clean oat groats by steaming and grinding, such that there is 
no significant loss of oat bran in the final product, and provides at 
least 4 percent (dwb) of [beta]-glucan soluble fiber and a total dietary 
fiber content of at least 10 percent (dwb).
    (4) Oatrim. The soluble fraction of alpha-amylase hydrolyzed oat 
bran or whole oat flour, also known as oatrim. Oatrim is produced from 
either oat bran as defined in paragraph (c)(2)(ii)(A)(1) of this section 
or whole oat flour as defined in paragraph (c)(2)(ii)(A)(3) of this 
section by solubilization of the starch in the starting material with an 
alpha-amylase hydrolysis process, and then removal by centrifugation of 
the insoluble components consisting of a high portion of protein, lipid, 
insoluble dietary fiber, and the majority of the flavor and color 
components of the starting material. Oatrim shall have a beta-glucan 
soluble fiber content up to 10 percent (dwb) and not less than that of 
the starting material (dwb).
    (5) Whole grain barley and dry milled barley. Dehulled and hull-less 
whole grain barley with a [beta]-glucan soluble fiber content of at 
least 4 percent (dwb) and a total dietary fiber content of at least 10 
percent (dwb). Dry milled barley grain products include barley bran, 
barley flakes, barley grits, pearl barley, barley flour, barley meal, 
and sieved barley meal that are produced from clean, sound dehulled or 
hull-less barley grain using standard dry milling techniques, which may 
include steaming or tempering, and that contain at least 4 percent (dwb) 
of [beta]-glucan soluble fiber and at least 8 percent (dwb) of total 
dietary fiber, except barley bran and sieved barley meal for which the 
minimum [beta]-glucan soluble fiber content is 5.5 percent (dwb) and 
minimum total dietary fiber content is 15 percent (dwb). Dehulled 
barley, hull-less barley, barley bran, barley flakes, barley grits, 
pearl barley, and barley flour are

[[Page 174]]

as defined in the Barley Glossary (AACC Method 55-99), published in 
Approved Methods of the American Association of Cereal Chemists, 10th 
ed. (2000), pp. 1 and 2, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be 
obtained from the American Association of Cereal Chemists, Inc., 3340 
Pilot Knob Rd., St. Paul, Minnesota, 55121, or may be examined at the 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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. Barley meal is unsifted, ground barley grain not 
subjected to any processing to separate the bran, germ, and endosperm. 
Sieved barley meal is an endosperm cell wall-enriched fraction of ground 
barley separated from meal by sieving or by air classification.
    (6) Barley betafiber. Barley betafiber is the ethanol precipitated 
soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain 
barley. Barley betafiber is produced by hydrolysis of whole grain barley 
flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section, with a 
cellulase and alpha-amylase enzyme preparation, to produce a clear 
aqueous extract that contains mainly partially hydrolyzed beta-glucan 
and substantially hydrolyzed starch. The soluble, partially hydrolyzed 
beta-glucan is separated from the insoluble material by centrifugation, 
and after removal of the insoluble material, the partially hydrolyzed 
beta-glucan soluble fiber is separated from the other soluble compounds 
by precipitation with ethanol. The product is then dried, milled and 
sifted. Barley betafiber shall have a beta-glucan soluble fiber content 
of at least 70 percent on a dry weight basis.
    (B)(1) Psyllium husk from the dried seed coat (epidermis) of the 
seed of Plantago (P.) ovata, known as blond psyllium or Indian psyllium, 
P. indica, or P. psyllium. To qualify for this claim, psyllium seed 
husk, also known as psyllium husk, shall have a purity of no less than 
95 percent, such that it contains 3 percent or less protein, 4.5 percent 
or less of light extraneous matter, and 0.5 percent or less of heavy 
extraneous matter, but in no case may the combined extraneous matter 
exceed 4.9 percent, as determined by U.S. Pharmacopeia (USP) methods 
described in USP's ``The National Formulary,'' USP 23, NF 18, p. 1341, 
(1995), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies may be obtained from the U.S. 
Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 
20852, or may be examined at the Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, 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;
    (2) FDA will determine the amount of soluble fiber that is provided 
by psyllium husk by using a modification of the Association of Official 
Analytical Chemists' International (AOAC's) method for soluble dietary 
fiber (991.43) described by Lee et al., ``Determination of Soluble and 
Insoluble Dietary Fiber in Psyllium-containing Cereal Products,'' 
Journal of the AOAC International, 78 (No. 3):724-729, 1995, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at 
the Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039 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;
    (iii) Nature of the food eligible to bear the claim. (A) The food 
product shall include:

[[Page 175]]

    (1) One or more of the whole oat or barley foods from paragraphs 
(c)(2)(ii)(A)(1), (2), (3), and (5) of this section, and the whole oat 
or barley foods shall contain at least 0.75 gram (g) of soluble fiber 
per reference amount customarily consumed of the food product; or
    (2) The food containing the oatrim from paragraph (c)(2)(ii)(A)(4) 
of this section or the barley betafiber from paragraph (c)(2)(ii)(A)(6) 
of this section shall contain at least 0.75 g of beta-glucan soluble 
fiber per reference amount customarily consumed of the food product; or
    (3) Psyllium husk that complies with paragraph (c)(2)(ii)(B) of this 
section, and the psyllium food shall contain at least 1.7 g of soluble 
fiber per reference amount customarily consumed of the food product;
    (B) The amount of soluble fiber shall be declared in the nutrition 
label, consistent with Sec. 101.9(c)(6)(i)(A).
    (C) The food shall meet the nutrient content requirement in Sec. 
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
    (D) The food shall meet the nutrient content requirement in Sec. 
101.62(b)(2) for a ``low fat'' food, unless the food exceeds this 
requirement due to fat content derived from whole oat sources listed in 
paragraph (c)(2)(ii)(A) of this section.
    (d) Optional information. (1) The claim may state that the 
development of heart disease depends on many factors and may identify 
one or more of the following risk factors for heart disease about which 
there is general scientific agreement: A family history of CHD; elevated 
blood total and LDL-cholesterol; excess body weight; high blood 
pressure; cigarette smoking; diabetes; and physical inactivity. The 
claim may also provide additional information about the benefits of 
exercise and management of body weight to help lower the risk of heart 
disease;
    (2) The claim may state that the relationship between intake of 
diets that are low in saturated fat and cholesterol and that include 
soluble fiber from the eligible food sources from paragraph (c)(2)(ii) 
of this section and reduced risk of heart disease is through the 
intermediate link of ``blood cholesterol'' or ``blood total- and LDL-
cholesterol;''
    (3) The claim may include information from paragraphs (a) and (b) of 
this section, which summarize the relationship between diets that are 
low in saturated fat and cholesterol and that include soluble fiber from 
certain foods and coronary heart disease and the significance of the 
relationship;
    (4) The claim may specify the name of the eligible soluble fiber;
    (5) The claim may state that a diet low in saturated fat and 
cholesterol that includes soluble fiber from whole oats or barley is 
consistent with ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' U.S. Department of Agriculture (USDA) and Department of 
Health and Human Services (DHHS), Government Printing Office (GPO);
    (6) The claim may state that individuals with elevated blood total- 
and LDL-cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total- and LDL-
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment;
    (7) The claim may include information on the number of people in the 
United States who have heart disease. The sources of this information 
shall be identified, and it shall be current information from the 
National Center for Health Statistics, the National Institutes of 
Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' USDA and DHHS, GPO.
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between diets that 
are low in saturated fat and cholesterol and that include soluble fiber 
from certain foods and reduced risk of heart disease:
    (1) Soluble fiber from foods such as [name of soluble fiber source 
from paragraph (c)(2)(ii) of this section and, if desired, the name of 
food product], as part of a diet low in saturated fat and cholesterol, 
may reduce the risk of heart disease. A serving of [ name of food] 
supplies ____ grams of the [grams of soluble fiber specified in 
paragraph (c)(2)(i)(G) of this section]

[[Page 176]]

soluble fiber from [name of the soluble fiber source from paragraph 
(c)(2)(ii) of this section] necessary per day to have this effect.
    (2) Diets low in saturated fat and cholesterol that include [____ 
grams of soluble fiber specified in paragraph (c)(2)(i)(G) of this 
section] of soluble fiber per day from [name of soluble fiber source 
from paragraph (c)(2)(ii) of this section and, if desired, the name of 
the food product] may reduce the risk of heart disease. One serving of 
[name of food] provides ____ grams of this soluble fiber.

[62 FR 3600, Jan. 23, 1997, as amended at 62 FR 15344, Mar. 31, 1997; 63 
FR 8119, Feb. 18, 1998; 66 FR 66742, Dec. 27, 2001; 67 FR 61782, Oct. 2, 
2002; 68 FR 15355, Mar. 31, 2003; 70 FR 40880, July 15, 2005; 70 FR 
76162, Dec. 23, 2005; 73 FR 9947, Feb. 25, 2008; 73 FR 23953, May 1, 
2008; 81 FR 5590, Feb. 3, 2016]



Sec. 101.82  Health claims: Soy protein and risk of coronary heart
disease (CHD).

    (a) Relationship between diets that are low in saturated fat and 
cholesterol and that include soy protein and the risk of CHD. (1) 
Cardiovascular disease means diseases of the heart and circulatory 
system. CHD is one of the most common and serious forms of 
cardiovascular disease and refers to diseases of the heart muscle and 
supporting blood vessels. High blood total cholesterol and low density 
lipoprotein (LDL)-cholesterol levels are associated with increased risk 
of developing CHD. High CHD rates occur among people with high total 
cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 
millimole per liter (mmol/L)) or above and LDL-cholesterol levels of 160 
mg/dL (4.13 mmol/L) or above. Borderline high risk total cholesterol 
levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 
mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. The scientific evidence 
establishes that diets high in saturated fat and cholesterol are 
associated with increased levels of blood total and LDL-cholesterol and, 
thus, with increased risk of CHD.
    (2) Populations with a low incidence of CHD tend to have relatively 
low blood total cholesterol and LDL-cholesterol levels. These 
populations also tend to have dietary patterns that are not only low in 
total fat, especially saturated fat and cholesterol, but are also 
relatively high in plant foods that contain dietary fiber and other 
components.
    (3) Scientific evidence demonstrates that diets low in saturated fat 
and cholesterol may reduce the risk of CHD. Other evidence demonstrates 
that the addition of soy protein to a diet that is low in saturated fat 
and cholesterol may also help to reduce the risk of CHD.
    (b) Significance of the relationship between diets that are low in 
saturated fat and cholesterol and that include soy protein and the risk 
of CHD. (1) CHD is a major public health concern in the United States. 
It accounts for more deaths than any other disease or group of diseases. 
Early management of risk factors for CHD is a major public health goal 
that can assist in reducing risk of CHD. High blood total and LDL-
cholesterol are major modifiable risk factors in the development of CHD.
    (2) Intakes of saturated fat exceed recommended levels in the diets 
of many people in the United States. One of the major public health 
recommendations relative to CHD risk is to consume less than 10 percent 
of calories from saturated fat and an average of 30 percent or less of 
total calories from all fat. Recommended daily cholesterol intakes are 
300 mg or less per day. Scientific evidence demonstrates that diets low 
in saturated fat and cholesterol are associated with lower blood total 
and LDL-cholesterol levels. Soy protein, when included in a low 
saturated fat and cholesterol diet, also helps to lower blood total and 
LDL-cholesterol levels.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets that are low in saturated fat and cholesterol and that 
include soy protein with reduced risk of heart disease may be made on 
the label or labeling of a food described in paragraph (c)(2)(iii) of 
this section, provided that:
    (A) The claim states that diets that are low in saturated fat and 
cholesterol and that include soy protein ``may'' or ``might'' reduce the 
risk of heart disease;

[[Page 177]]

    (B) In specifying the disease, the claim uses the following terms: 
``heart disease'' or ``coronary heart disease'';
    (C) In specifying the substance, the claim uses the term ``soy 
protein'';
    (D) In specifying the fat component, the claim uses the terms 
``saturated fat'' and ``cholesterol'';
    (E) The claim does not attribute any degree of risk reduction for 
CHD to diets that are low in saturated fat and cholesterol and that 
include soy protein;
    (F) The claim does not imply that consumption of diets that are low 
in saturated fat and cholesterol and that include soy protein is the 
only recognized means of achieving a reduced risk of CHD; and
    (G) The claim specifies the daily dietary intake of soy protein that 
is necessary to reduce the risk of coronary heart disease and the 
contribution one serving of the product makes to the specified daily 
dietary intake level. The daily dietary intake level of soy protein that 
has been associated with reduced risk of coronary heart disease is 25 
grams (g) or more per day of soy protein.
    (ii) Nature of the substance. (A) Soy protein from the legume seed 
Glycine max.
    (B) FDA will assess qualifying levels of soy protein in the 
following fashion: FDA will measure total protein content by the 
appropriate method of analysis given in the ``Official Methods of 
Analysis of the AOAC International,'' as described at Sec. 101.9(c)(7). 
For products that contain no sources of protein other than soy, FDA will 
consider the amount of soy protein as equivalent to the total protein 
content. For products that contain a source or sources of protein in 
addition to soy, FDA will, using the measurement of total protein 
content, calculate the soy protein content based on the ratio of soy 
protein ingredients to total protein ingredients in the product. FDA 
will base its calculation on information identified and supplied by 
manufacturers, such as nutrient data bases or analyses, recipes or 
formulations, purchase orders for ingredients, or any other information 
that reasonably substantiates the ratio of soy protein to total protein. 
Manufacturers must maintain records sufficient to substantiate the claim 
for as long as the products are marketed and provide these records, on 
written request, to appropriate regulatory officials.
    (iii) Nature of the food eligible to bear the claim. (A) The food 
product shall contain at least 6.25 g of soy protein per reference 
amount customarily consumed of the food product;
    (B) The food shall meet the nutrient content requirements in Sec. 
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
    (C) The food shall meet the nutrient content requirement in Sec. 
101.62 for a ``low fat'' food, unless it consists of or is derived from 
whole soybeans and contains no fat in addition to the fat inherently 
present in the whole soybeans it contains or from which it is derived.
    (d) Optional information. (1) The claim may state that the 
development of heart disease depends on many factors and may identify 
one or more of the following risk factors for heart disease about which 
there is general scientific agreement: A family history of CHD; elevated 
blood total and LDL-cholesterol; excess body weight; high blood 
pressure; cigarette smoking; diabetes; and physical inactivity. The 
claim may also provide additional information about the benefits of 
exercise and management of body weight to help lower the risk of heart 
disease;
    (2) The claim may state that the relationship between intake of 
diets that are low in saturated fat and cholesterol and that include soy 
protein and reduced risk of heart disease is through the intermediate 
link of ``blood cholesterol'' or ``blood total and LDL-cholesterol'';
    (3) The claim may include information from paragraphs (a) and (b) of 
this section, which summarize the relationship between diets that are 
low in saturated fat and cholesterol and that include soy protein and 
CHD and the significance of the relationship;
    (4) The claim may state that a diet low in saturated fat and 
cholesterol that includes soy protein is consistent with ``Nutrition and 
Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and Department of Health and Human

[[Page 178]]

Services (DHHS), Government Printing Office (GPO);
    (5) The claim may state that individuals with elevated blood total 
and LDL-cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total and LDL-
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment;
    (6) The claim may include information on the number of people in the 
United States who have heart disease. The sources of this information 
shall be identified, and it shall be current information from the 
National Center for Health Statistics, the National Institutes of 
Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' USDA and DHHS, GPO;
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between diets that 
are low in saturated fat and cholesterol and that include soy protein 
and reduced risk of heart disease:
    (1) 25 grams of soy protein a day, as part of a diet low in 
saturated fat and cholesterol, may reduce the risk of heart disease. A 
serving of [name of food] supplies __ grams of soy protein.
    (2) Diets low in saturated fat and cholesterol that include 25 grams 
of soy protein a day may reduce the risk of heart disease. One serving 
of [name of food] provides __ grams of soy protein.

[64 FR 57732, Oct. 26, 1999]

    Effective Date Note: At 64 FR 57732, Oct. 26, 1999, Sec. 101.82 was 
added. Paragraph (c)(2)(ii)(B) of this section contains information 
collection and recordkeeping requirements and will not become effective 
until approval has been given by the Office of Management and Budget.



Sec. 101.83  Health claims: plant sterol/stanol esters and risk
of coronary heart disease (CHD).

    (a) Relationship between diets that include plant sterol/stanol 
esters and the risk of CHD. (1) Cardiovascular disease means diseases of 
the heart and circulatory system. Coronary heart disease (CHD) is one of 
the most common and serious forms of cardiovascular disease and refers 
to diseases of the heart muscle and supporting blood vessels. High blood 
total cholesterol and low density lipoprotein (LDL) cholesterol levels 
are associated with increased risk of developing coronary heart disease. 
High CHD rates occur among people with high total cholesterol levels of 
240 milligrams per deciliter (mg/dL) (6.21 millimole per liter (mmol/l)) 
or above and LDL cholesterol levels of 160 mg/dL (4.13 mmol/l) or above. 
Borderline high risk blood cholesterol levels range from 200 to 239 mg/
dL (5.17 to 6.18 mmol/l) for total cholesterol, and 130 to 159 mg/dL 
(3.36 to 4.11 mmol/l) of LDL cholesterol.
    (2) Populations with a low incidence of CHD tend to have relatively 
low blood total cholesterol and LDL cholesterol levels. These 
populations also tend to have dietary patterns that are not only low in 
total fat, especially saturated fat and cholesterol, but are also 
relatively high in plant foods that contain dietary fiber and other 
components.
    (3) Scientific evidence demonstrates that diets that include plant 
sterol/stanol esters may reduce the risk of CHD.
    (b) Significance of the relationship between diets that include 
plant sterol/stanol esters and the risk of CHD. (1) CHD is a major 
public health concern in the United States. It accounts for more deaths 
than any other disease or group of diseases. Early management of risk 
factors for CHD is a major public health goal that can assist in 
reducing risk of CHD. High blood total and LDL cholesterol are major 
modifiable risk factors in the development of CHD.
    (2) The scientific evidence establishes that including plant sterol/
stanol esters in the diet helps to lower blood total and LDL cholesterol 
levels.
    (c) Requirements--(1) General. All requirements set forth in Sec. 
101.14 shall be met, except Sec. 101.14(a)(4) with respect to the 
disqualifying level for total fat per 50 grams (g) in dressings for 
salad and spreads and Sec. 101.14(e)(6) with respect to dressings for 
salad.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets that include plant sterol/stanol

[[Page 179]]

esters with reduced risk of heart disease may be made on the label or 
labeling of a food described in paragraph (c)(2)(iii) of this section, 
provided that:
    (A) The claim states that plant sterol/stanol esters should be 
consumed as part of a diet low in saturated fat and cholesterol;
    (B) The claim states that diets that include plant sterol/stanol 
esters ``may'' or ``might'' reduce the risk of heart disease;
    (C) In specifying the disease, the claim uses the following terms: 
``heart disease'' or ``coronary heart disease'';
    (D) In specifying the substance, the claim uses the term ``plant 
sterol esters'' or ``plant stanol esters,'' except that if the sole 
source of the plant sterols or stanols is vegetable oil, the claim may 
use the term ``vegetable oil sterol esters'' or ``vegetable oil stanol 
esters'';
    (E) The claim does not attribute any degree of risk reduction for 
CHD to diets that include plant sterol/stanol esters;
    (F) The claim does not imply that consumption of diets that include 
plant sterol/stanol esters is the only recognized means of achieving a 
reduced risk of CHD; and
    (G) The claim specifies the daily dietary intake of plant sterol or 
stanol esters that is necessary to reduce the risk of CHD and the 
contribution one serving of the product makes to the specified daily 
dietary intake level. Daily dietary intake levels of plant sterol and 
stanol esters that have been associated with reduced risk of are:
    (1) 1.3 g or more per day of plant sterol esters.
    (2) 3.4 g or more per day of plant stanol esters.
    (H) The claim specifies that the daily dietary intake of plant 
sterol or stanol esters should be consumed in two servings eaten at 
different times of the day with other foods.
    (ii) Nature of the substance--(A) Plant sterol esters. (1) Plant 
sterol esters prepared by esterifying a mixture of plant sterols from 
edible oils with food-grade fatty acids. The plant sterol mixture shall 
contain at least 80 percent beta-sitosterol, campesterol, and 
stigmasterol (combined weight).
    (2) FDA will measure plant sterol esters by the method entitled 
``Determination of the Sterol Content in Margarines, Halvarines, 
Dressings, Fat Blends and Sterol Fatty Acid Ester Concentrates by 
Capillary Gas Chromatography,'' developed by Unilever United States, 
Inc., dated February 1, 2000. The method, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, may be 
obtained from the Center for Food Safety and Applied Nutrition, Office 
of Nutrition, Labeling and Dietary Supplements, Nutrition Programs 
Staff, 5001 Campus Dr., College Park, MD 20740, and may be examined at 
the Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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.
    (B) Plant stanol esters. (1) Plant stanol esters prepared by 
esterifying a mixture of plant stanols derived from edible oils or 
byproducts of the kraft paper pulping process with food-grade fatty 
acids. The plant stanol mixture shall contain at least 80 percent 
sitostanol and campestanol (combined weight).
    (2) FDA will measure plant stanol esters by the following methods 
developed by McNeil Consumer Heathcare dated February 15, 2000: 
``Determination of Stanols and Sterols in Benecol Tub Spread''; 
``Determination of Stanols and Sterols in Benecol Dressing''; 
``Determination of Stanols and Sterols in Benecol Snack Bars''; or 
``Determination of Stanols and Sterols in Benecol Softgels.'' These 
methods are incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. Copies may be obtained from the Center for Food 
Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary 
Supplements, Nutrition Programs Staff, 5001 Campus Dr., College Park, MD 
20740, or may be examined at the Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver

[[Page 180]]

Spring, MD 20993, 301-796-2039, and 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.
    (iii) Nature of the food eligible to bear the claim. (A) The food 
product shall contain:
    (1) At least 0.65 g of plant sterol esters that comply with 
paragraph (c)(2)(ii)(A)(1) of this section per reference amount 
customarily consumed of the food products eligible to bear the health 
claim, specifically spreads and dressings for salad, or
    (2) At least 1.7 g of plant stanol esters that comply with paragraph 
(c)(2)(ii)(B)(1) of this section per reference amount customarily 
consumed of the food products eligible to bear the health claim, 
specifically spreads, dressings for salad, snack bars, and dietary 
supplements in softgel form.
    (B) The food shall meet the nutrient content requirements in Sec. 
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
    (C) The food must meet the limit for total fat in Sec. 
101.14(a)(4), except that spreads and dressings for salad are not 
required to meet the limit for total fat per 50 g if the label of the 
food bears a disclosure statement that complies with Sec. 101.13(h); 
and
    (D) The food must meet the minimum nutrient contribution requirement 
in Sec. 101.14(e)(6) unless it is a dressing for salad.
    (d) Optional information. (1) The claim may state that the 
development of heart disease depends on many factors and may identify 
one or more of the following risk factors for heart disease about which 
there is general scientific agreement: A family history of CHD; elevated 
blood total and LDL cholesterol; excess body weight; high blood 
pressure; cigarette smoking; diabetes; and physical inactivity. The 
claim may also provide additional information about the benefits of 
exercise and management of body weight to help lower the risk of heart 
disease.
    (2) The claim may state that the relationship between intake of 
diets that include plant sterol/stanol esters and reduced risk of heart 
disease is through the intermediate link of ``blood cholesterol'' or 
``blood total and LDL cholesterol.''
    (3) The claim may include information from paragraphs (a) and (b) of 
this section, which summarize the relationship between diets that 
include plant sterol/stanol esters and the risk of CHD and the 
significance of the relationship.
    (4) The claim may include information from the following paragraph 
on the relationship between saturated fat and cholesterol in the diet 
and the risk of CHD: The scientific evidence establishes that diets high 
in saturated fat and cholesterol are associated with increased levels of 
blood total and LDL cholesterol and, thus, with increased risk of CHD. 
Intakes of saturated fat exceed recommended levels in the diets of many 
people in the United States. One of the major public health 
recommendations relative to CHD risk is to consume less than 10 percent 
of calories from saturated fat and an average of 30 percent or less of 
total calories from all fat. Recommended daily cholesterol intakes are 
300 mg or less per day. Scientific evidence demonstrates that diets low 
in saturated fat and cholesterol are associated with lower blood total 
and LDL cholesterol levels.
    (5) The claim may state that diets that include plant sterol or 
stanol esters and are low in saturated fat and cholesterol are 
consistent with ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' U.S. Department of Agriculture (USDA) and Department of 
Health and Human Services (DHHS), Government Printing Office (GPO).
    (6) The claim may state that individuals with elevated blood total 
and LDL cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total and LDL 
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment.
    (7) The claim may include information on the number of people in the 
United States who have heart disease. The sources of this information 
shall

[[Page 181]]

be identified, and it shall be current information from the National 
Center for Health Statistics, the National Institutes of Health, or 
``Nutrition and Your Health: Dietary Guidelines for Americans,'' U.S. 
Department of Agriculture (USDA) and Department of Health and Human 
Services (DHHS), Government Printing Office (GPO).
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between diets that 
include plant sterol or stanol esters and reduced risk of heart disease:
    (1) For plant sterol esters: (i) Foods containing at least 0.65 g 
per serving of plant sterol esters, eaten twice a day with meals for a 
daily total intake of at least 1.3 g, as part of a diet low in saturated 
fat and cholesterol, may reduce the risk of heart disease. A serving of 
[name of the food] supplies ___grams of vegetable oil sterol esters.
    (ii) Diets low in saturated fat and cholesterol that include two 
servings of foods that provide a daily total of at least 1.3 g of 
vegetable oil sterol esters in two meals may reduce the risk of heart 
disease. A serving of [name of the food] supplies ___grams of vegetable 
oil sterol esters.
    (2) For plant stanol esters: (i) Foods containing at least 1.7 g per 
serving of plant stanol esters, eaten twice a day with meals for a total 
daily intake of at least 3.4 g, as part of a diet low in saturated fat 
and cholesterol, may reduce the risk of heart disease. A serving of 
[name of the food] supplies ___grams of plant stanol esters.
    (ii) Diets low in saturated fat and cholesterol that include two 
servings of foods that provide a daily total of at least 3.4 g of 
vegetable oil stanol esters in two meals may reduce the risk of heart 
disease. A serving of [name of the food] supplies ___grams of vegetable 
oil stanol esters.

[65 FR 54717, Sept. 8, 2000; 65 FR 70466, Nov. 24, 2000, as amended at 
66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 70 FR 41958, 
July 21, 2005]



Subpart F_Specific Requirements for Descriptive Claims That Are Neither 
                Nutrient Content Claims nor Health Claims



Sec. 101.91  Gluten-free labeling of food.

    (a) Definitions. (1) The term ``gluten-containing grain'' means any 
one of the following grains or their crossbred hybrids (e.g., triticale, 
which is a cross between wheat and rye):
    (i) Wheat, including any species belonging to the genus Triticum;
    (ii) Rye, including any species belonging to the genus Secale; or
    (iii) Barley, including any species belonging to the genus Hordeum.
    (2) The term ``gluten'' means the proteins that naturally occur in a 
gluten-containing grain and that may cause adverse health effects in 
persons with celiac disease (e.g., prolamins and glutelins).
    (3) The labeling claim ``gluten-free'' means:
    (i) That the food bearing the claim in its labeling:
    (A) Does not contain any one of the following:
    (1) An ingredient that is a gluten-containing grain (e.g., spelt 
wheat);
    (2) An ingredient that is derived from a gluten-containing grain and 
that has not been processed to remove gluten (e.g., wheat flour); or
    (3) An ingredient that is derived from a gluten-containing grain and 
that has been processed to remove gluten (e.g., wheat starch), if the 
use of that ingredient results in the presence of 20 parts per million 
(ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more 
gluten per kilogram (kg) of food); or
    (B) Inherently does not contain gluten; and
    (ii) Any unavoidable presence of gluten in the food bearing the 
claim in its labeling is below 20 ppm gluten (i.e., below 20 mg gluten 
per kg of food).
    (b) Requirements. (1) A food that bears the claim ``gluten-free'' in 
its labeling and fails to meet the requirements of paragraph (a)(3) of 
this section and, if applicable, paragraphs (c)(2) through (4) of this 
section will be deemed misbranded.
    (2) A food that bears the claim ``no gluten,'' ``free of gluten,'' 
or ``without gluten'' in its labeling and fails to

[[Page 182]]

meet the requirements of paragraph (a)(3) of this section and, if 
applicable, paragraphs (c)(2) through (4) of this section will be deemed 
misbranded.
    (3) A food that bears the term ``wheat'' in the ingredient list or 
in a separate ``Contains wheat'' statement in its labeling, as required 
by 21 U.S.C. 343(w)(1)(A), and also bears the claim ``gluten-free'' or a 
claim identified in paragraph (b)(2) of this section will be deemed 
misbranded unless the word ``wheat'' in the ingredient list or in the 
``Contains wheat'' statement is followed immediately by an asterisk (or 
other symbol) that refers to another asterisk (or other symbol) in close 
proximity to the ingredient statement that immediately precedes the 
following: ``The wheat has been processed to allow this food to meet the 
Food and Drug Administration (FDA) requirements for gluten-free foods.''
    (c) Compliance. (1) When compliance with paragraph (b) of this 
section is based on an analysis of the food, FDA will use a 
scientifically valid method that can reliably detect and quantify the 
presence of 20 ppm gluten in a variety of food matrices, including both 
raw and cooked or baked products.
    (2) When a scientifically valid method pursuant to paragraph (c)(1) 
of this section is not available because the food is fermented or 
hydrolyzed, the manufacturer of such foods bearing the claim must make 
and keep records regarding the fermented or hydrolyzed food 
demonstrating adequate assurance that:
    (i) The food is ``gluten-free'' in compliance with paragraph (a)(3) 
of this section before fermentation or hydrolysis;
    (ii) The manufacturer has adequately evaluated their processing for 
any potential for gluten cross-contact; and
    (iii) Where a potential for gluten cross-contact has been 
identified, the manufacturer has implemented measures to prevent the 
introduction of gluten into the food during the manufacturing process.
    (3) When a scientifically valid method pursuant to paragraph (c)(1) 
of this section is not available because the food contains one or more 
ingredients that are fermented or hydrolyzed, the manufacturer of such 
foods bearing the claim must make and keep records demonstrating 
adequate assurance that the fermented or hydrolyzed ingredients are 
``gluten-free'' as described in paragraph (c)(2) of this section.
    (4) Records necessary to verify compliance with paragraphs (c)(2) 
and (3) of this section must be retained for at least 2 years after 
introduction or delivery for introduction of the food into interstate 
commerce and may be kept as original records, as true copies, or as 
electronic records. Manufacturers must provide those records to us for 
examination and copying during an inspection upon request.
    (5) When a scientifically valid method pursuant to paragraph (c)(1) 
of this section is not available because the food is distilled, FDA will 
evaluate compliance with paragraph (b) of this section by verifying the 
absence of protein in the distilled component using scientifically valid 
analytical methods that can reliably detect the presence or absence of 
protein or protein fragments in the food.
    (d) Preemption. A State or political subdivision of a State may not 
establish or continue into effect any law, rule, regulation, or other 
requirement that is different from the requirements in this section for 
the definition and use of the claim ``gluten-free,'' as well as the 
claims ``no gluten,'' ``free of gluten,'' or ``without gluten.''

[78 FR 47178, Aug. 5, 2013, as amended at 85 FR 49260, Aug. 13, 2020]



Sec. 101.93  Certain types of statements for dietary supplements.

    (a)(1) No later than 30 days after the first marketing of a dietary 
supplement that bears one of the statements listed in section 403(r)(6) 
or the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer, 
or distributor of the dietary supplement shall notify the Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center 
for Food Safety and Applied Nutrition, Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, that it has included such a 
statement on the label or in the labeling of its product. An original 
and two copies of this notification shall be submitted.

[[Page 183]]

    (2) The notification shall include the following:
    (i) The name and address of the manufacturer, packer, or distributor 
of the dietary supplement that bears the statement;
    (ii) The text of the statement that is being made;
    (iii) The name of the dietary ingredient or supplement that is the 
subject of the statement, if not provided in the text of the statement; 
and
    (iv) The name of the dietary supplement (including brand name), if 
not provided in response to paragraph (a)(2)(iii) on whose label, or in 
whose labeling, the statement appears.
    (3) The notice shall be signed by a responsible individual or the 
person who can certify the accuracy of the information presented and 
contained in the notice. The individual shall certify that the 
information contained in the notice is complete and accurate, and that 
the notifying firm has substantiation that the statement is truthful and 
not misleading.
    (b) Disclaimer. The requirements in this section apply to the label 
or labeling of dietary supplements where the dietary supplement bears a 
statement that is provided for by section 403(r)(6) of the Federal Food, 
Drug, and Cosmetic Act (the act), and the manufacturer, packer, or 
distributor wishes to take advantage of the exemption to section 
201(g)(1)(C) of the act that is provided by compliance with section 
403(r)(6) of the act.
    (c) Text for disclaimer. (1) Where there is one statement, the 
disclaimer shall be placed in accordance with paragraph (d) of this 
section and shall state:

    This statement has not been evaluated by the Food and Drug 
Administration. This product is not intended to diagnose, treat, cure, 
or prevent any disease.

    (2) Where there is more than one such statement on the label or in 
the labeling, each statement shall bear the disclaimer in accordance 
with paragraph (c)(1) of this section, or a plural disclaimer may be 
placed in accordance with paragraph (d) of this section and shall state:
    These statements have not been evaluated by the Food and Drug 
Administration. This product is not intended to diagnose, treat, cure, 
or prevent any disease.
    (d) Placement. The disclaimer shall be placed adjacent to the 
statement with no intervening material or linked to the statement with a 
symbol (e.g., an asterisk) at the end of each such statement that refers 
to the same symbol placed adjacent to the disclaimer specified in 
paragraphs (c)(1) or (c)(2) of this section. On product labels and in 
labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on 
each panel or page where there such is a statement. The disclaimer shall 
be set off in a box where it is not adjacent to the statement in 
question.
    (e) Typesize. The disclaimer in paragraph (c) of this section shall 
appear in boldface type in letters of a typesize no smaller than one-
sixteenth inch.
    (f) Permitted structure/function statements. Dietary supplement 
labels or labeling may, subject to the requirements in paragraphs (a) 
through (e) of this section, bear statements that describe the role of a 
nutrient or dietary ingredient intended to affect the structure or 
function in humans or that characterize the documented mechanism by 
which a nutrient or dietary ingredient acts to maintain such structure 
or function, provided that such statements are not disease claims under 
paragraph (g) of this section. If the label or labeling of a product 
marketed as a dietary supplement bears a disease claim as defined in 
paragraph (g) of this section, the product will be subject to regulation 
as a drug unless the claim is an authorized health claim for which the 
product qualifies.
    (g) Disease claims. (1) For purposes of 21 U.S.C. 343(r)(6), a 
``disease'' is damage to an organ, part, structure, or system of the 
body such that it does not function properly (e.g., cardiovascular 
disease), or a state of health leading to such dysfunctioning (e.g., 
hypertension); except that diseases resulting from essential nutrient 
deficiencies (e.g., scurvy, pellagra) are not included in this 
definition.
    (2) FDA will find that a statement about a product claims to 
diagnose, mitigate, treat, cure, or prevent disease (other than a 
classical nutrient deficiency disease) under 21 U.S.C. 343(r)(6) if it 
meets one or more of the

[[Page 184]]

criteria listed below. These criteria are not intended to classify as 
disease claims statements that refer to the ability of a product to 
maintain healthy structure or function, unless the statement implies 
disease prevention or treatment. In determining whether a statement is a 
disease claim under these criteria, FDA will consider the context in 
which the claim is presented. A statement claims to diagnose, mitigate, 
treat, cure, or prevent disease if it claims, explicitly or implicitly, 
that the product:
    (i) Has an effect on a specific disease or class of diseases;
    (ii) Has an effect on the characteristic signs or symptoms of a 
specific disease or class of diseases, using scientific or lay 
terminology;
    (iii) Has an effect on an abnormal condition associated with a 
natural state or process, if the abnormal condition is uncommon or can 
cause significant or permanent harm;
    (iv) Has an effect on a disease or diseases through one or more of 
the following factors:
    (A) The name of the product;
    (B) A statement about the formulation of the product, including a 
claim that the product contains an ingredient (other than an ingredient 
that is an article included in the definition of ``dietary supplement'' 
under 21 U.S.C. 321(ff)(3)) that has been regulated by FDA as a drug and 
is well known to consumers for its use or claimed use in preventing or 
treating a disease;
    (C) Citation of a publication or reference, if the citation refers 
to a disease use, and if, in the context of the labeling as a whole, the 
citation implies treatment or prevention of a disease, e.g., through 
placement on the immediate product label or packaging, inappropriate 
prominence, or lack of relationship to the product's express claims;
    (D) Use of the term ``disease'' or ``diseased,'' except in general 
statements about disease prevention that do not refer explicitly or 
implicitly to a specific disease or class of diseases or to a specific 
product or ingredient; or
    (E) Use of pictures, vignettes, symbols, or other means;
    (v) Belongs to a class of products that is intended to diagnose, 
mitigate, treat, cure, or prevent a disease;
    (vi) Is a substitute for a product that is a therapy for a disease;
    (vii) Augments a particular therapy or drug action that is intended 
to diagnose, mitigate, treat, cure, or prevent a disease or class of 
diseases;
    (viii) Has a role in the body's response to a disease or to a vector 
of disease;
    (ix) Treats, prevents, or mitigates adverse events associated with a 
therapy for a disease, if the adverse events constitute diseases; or
    (x) Otherwise suggests an effect on a disease or diseases.

[62 FR 49886, Sept. 23, 1997, as amended at 62 FR 49867, Sept. 23, 1997; 
65 FR 1050, Jan. 6, 2000; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 
6, 2001]



Sec. 101.95  ``Fresh,'' ``freshly frozen,'' ``fresh frozen,''
``frozen fresh.''

    The terms defined in this section may be used on the label or in 
labeling of a food in conformity with the provisions of this section. 
The requirements of the section pertain to any use of the subject terms 
as described in paragraphs (a) and (b) of this section that expressly or 
implicitly refers to the food on labels or labeling, including use in a 
brand name and use as a sensory modifier. However, the use of the term 
``fresh'' on labels or labeling is not subject to the requirements of 
paragraph (a) of this section if the term does not suggest or imply that 
a food is unprocessed or unpreserved. For example, the term ``fresh'' 
used to describe pasteurized whole milk is not subject to paragraph (a) 
of this section because the term does not imply that the food is 
unprocessed (consumers commonly understand that milk is nearly always 
pasteurized). However, the term ``fresh'' to describe pasta sauce that 
has been pasteurized or that contains pasteurized ingredients would be 
subject to paragraph (a) of this section because the term implies that 
the food is not processed or preserved. Uses of fresh not subject to 
this regulation will be governed by the provisions of 403(a) of the 
Federal Food, Drug, and Cosmetic Act (the act).

[[Page 185]]

    (a) The term ``fresh,'' when used on the label or in labeling of a 
food in a manner that suggests or implies that the food is unprocessed, 
means that the food is in its raw state and has not been frozen or 
subjected to any form of thermal processing or any other form of 
preservation, except as provided in paragraph (c) of this section.
    (b) The terms ``fresh frozen'' and ``frozen fresh,'' when used on 
the label or in labeling of a food, mean that the food was quickly 
frozen while still fresh (i.e., the food had been recently harvested 
when frozen). Blanching of the food before freezing will not preclude 
use of the term ``fresh frozen'' to describe the food. ``Quickly 
frozen'' means frozen by a freezing system such as blast-freezing (sub-
zero Fahrenheit temperature with fast moving air directed at the food) 
that ensures the food is frozen, even to the center of the food, quickly 
and that virtually no deterioration has taken place.
    (c) Provisions and restrictions. (1) The following do not preclude 
the food from use of the term ``fresh:''
    (i) The addition of approved waxes or coatings;
    (ii) The post-harvest use of approved pesticides;
    (iii) The application of a mild chlorine wash or mild acid wash on 
produce; or
    (iv) The treatment of raw foods with ionizing radiation not to 
exceed the maximum dose of 1 kiloGray in accordance with Sec. 179.26 of 
this chapter.
    (2) A food meeting the definition in paragraph (a) of this section 
that is refrigerated is not precluded from use of ``fresh'' as provided 
by this section.

[58 FR 2426, Jan. 6, 1993]



          Subpart G_Exemptions From Food Labeling Requirements



Sec. 101.100  Food; exemptions from labeling.

    (a) The following foods are exempt from compliance with the 
requirements of section 403(i)(2) of the act (requiring a declaration on 
the label of the common or usual name of each ingredient when the food 
is fabricated from two or more ingredients).
    (1) An assortment of different items of food, when variations in the 
items that make up different packages packed from such assortment 
normally occur in good packing practice and when such variations result 
in variations in the ingredients in different packages, with respect to 
any ingredient that is not common to all packages. Such exemption, 
however, shall be on the condition that the label shall bear, in 
conjunction with the names of such ingredients as are common to all 
packages, a statement (in terms that are as informative as practicable 
and that are not misleading) indicating by name other ingredients which 
may be present.
    (2) A food having been received in bulk containers at a retail 
establishment, if displayed to the purchaser with either:
    (i) The labeling of the bulk container plainly in view, provided 
ingredient information appears prominently and conspicuously in 
lettering of not less than one-fourth of an inch in height; or
    (ii) A counter card, sign, or other appropriate device bearing 
prominently and conspicuously, but in no case with lettering of less 
than one-fourth of an inch in height, the information required to be 
stated on the label pursuant to section 403(i)(2) of the Federal Food, 
Drug, and Cosmetic Act (the act).
    (3) Incidental additives that are present in a food at insignificant 
levels and do not have any technical or functional effect in that food. 
For the purposes of this paragraph (a)(3), incidental additives are:
    (i) Substances that have no technical or functional effect but are 
present in a food by reason of having been incorporated into the food as 
an ingredient of another food, in which the substance did have a 
functional or technical effect.
    (ii) Processing aids, which are as follows:
    (a) Substances that are added to a food during the processing of 
such food but are removed in some manner from the food before it is 
packaged in its finished form.
    (b) Substances that are added to a food during processing, are 
converted into constituents normally present in

[[Page 186]]

the food, and do not significantly increase the amount of the 
constitutents naturally found in the food.
    (c) Substances that are added to a food for their technical or 
functional effect in the processing but are present in the finished food 
at insignificant levels and do not have any technical or functional 
effect in that food.
    (iii) Substances migrating to food from equipment or packaging or 
otherwise affecting food that are not food additives as defined in 
section 201(s) of the act; or if they are food additives as so defined, 
they are used in conformity with regulations established pursuant to 
section 409 of the act.
    (4) For the purposes of paragraph (a)(3) of this section, any 
sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, 
potassium bisulfite, sodium metabisulfite, and potassium metabisulfite) 
that has been added to any food or to any ingredient in any food and 
that has no technical effect in that food will be considered to be 
present in an insignificant amount only if no detectable amount of the 
agent is present in the finished food. A detectable amount of sulfiting 
agent is 10 parts per million or more of the sulfite in the finished 
food. Compliance with this paragraph will be determined using sections 
20.123-20.125, ``Total Sulfurous Acid,'' in ``Official Methods of 
Analysis of the Association of Official Analytical Chemists,'' 14th Ed. 
(1984), which is incorporated by reference and the refinements of the 
``Total Sulfurous Acid'' procedure in the ``Monier-Williams Procedure 
(with Modifications) for Sulfites in Foods,'' which is appendix A to 
part 101. A copy of sections 20.123-20-125 of the Official Methods of 
Analysis of the Association of Official Analytical Chemists'' is 
available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or 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) A food repackaged in a retail establishment is exempt from the 
following provisions of the act if the conditions specified are met.
    (1) Section 403(e)(1) of the act (requiring a statement on the label 
of the name and place of business of the manufacturer, packer, or 
distributor).
    (2) Section 403(g)(2) of the act (requiring the label of a food 
which purports to be or is represented as one for which a definition and 
standard of identity has been prescribed to bear the name of the food 
specified in the definition and standard and, insofar as may be required 
by the regulation establishing the standard the common names of the 
optional ingredients present in the food), if the food is displayed to 
the purchaser with its interstate labeling clearly in view, or with a 
counter card, sign, or other appropriate device bearing prominently and 
conspicuously the information required by these provisions.
    (3) Section 403(i)(1) of the act (requiring the label to bear the 
common or usual name of the food), if the food is displayed to the 
purchaser with its interstate labeling clearly in view, or with a 
counter card, sign, or other appropriate device bearing prominently and 
conspicuously the common or usual name of the food, or if the common or 
usual name of the food is clearly revealed by its appearance.
    (c) An open container (a container of rigid or semirigid 
construction, which is not closed by lid, wrapper, or otherwise other 
than by an uncolored transparent wrapper which does not obscure the 
contents) of a fresh fruit or fresh vegetable, the quantity of contents 
of which is not more than 1 dry quart, shall be exempt from the labeling 
requirements of sections 403(e), (g)(2) (with respect to the name of the 
food specified in the definition and standard), and (i)(1) of the act; 
but such exemption shall be on the condition that if two or more such 
containers are enclosed in a crate or other shipping package, such crate 
or package shall bear labeling showing the number of such containers 
enclosed therein and the quantity of the contents of each.
    (d) Except as provided by paragraphs (e) and (f) of this section, a 
shipment or other delivery of a food which is, in accordance with the 
practice of the trade, to be processed, labeled, or repacked in

[[Page 187]]

substantial quantity at an establishment other than that where 
originally processed or packed, shall be exempt, during the time of 
introduction into and movement in interstate commerce and the time of 
holding in such establishment, from compliance with the labeling 
requirements of section 403 (c), (e), (g), (h), (i), (k), and (q) of the 
act if:
    (1) The person who introduced such shipment or delivery into 
interstate commerce is the operator of the establishment where such food 
is to be processed, labeled, or repacked; or
    (2) In case such person is not such operator, such shipment or 
delivery is made to such establishment under a written agreement, signed 
by and containing the post office addresses of such person and such 
operator, and containing such specifications for the processing, 
labeling, or repacking, as the case may be, of such food in such 
establishment as will ensure, if such specifications are followed, that 
such food will not be adulterated or misbranded within the meaning of 
the act upon completion of such processing, labeling, or repacking. Such 
person and such operator shall each keep a copy of such agreement until 
2 years after the final shipment or delivery of such food from such 
establishment, and shall make such copies available for inspection at 
any reasonable hour to any officer or employee of the Department who 
requests them.
    (3) The article is an egg product subject to a standard of identity 
promulgated in part 160 of this chapter, is to be shipped under the 
conditions specified in paragraph (d) (1) or (2) of this section and for 
the purpose of pasteurization or other treatment as required in such 
standard, and each container of such egg product bears a conspicuous tag 
or label reading ``Caution--This egg product has not been pasteurized or 
otherwise treated to destroy viable Salmonella microorganisms''. In 
addition to safe and suitable bactericidal processes designed 
specifically for Salmonella destruction in egg products, the term 
``other treatment'' in the first sentence of this paragraph shall 
include use in acidic dressings in the processing of which the pH is not 
above 4.1 and the acidity of the aqueous phase, expressed as acetic 
acid, is not less than 1.4 percent, subject also to the conditions that:
    (i) The agreement required in paragraph (d)(2) of this section shall 
also state that the operator agrees to utilize such unpasteurized egg 
products in the processing of acidic dressings according to the 
specifications for pH and acidity set forth in this paragraph, agrees 
not to deliver the acidic dressing to a user until at least 72 hours 
after such egg product is incorporated in such acidic dressing, and 
agrees to maintain for inspection adequate records covering such 
processing for 2 years after such processing.
    (ii) In addition to the caution statement referred to above, the 
container of such egg product shall also bear the statement 
``Unpasteurized ___ for use in acidic dressings only'', the blank being 
filled in with the applicable name of the eggs or egg product.
    (e) Conditions affecting expiration of exemptions:
    (1) An exemption of a shipment or other delivery of a food under 
paragraph (d) (1) or (3) of this section shall, at the beginning of the 
act of removing such shipment or delivery, or any part thereof, from 
such establishment become void ab initio if the food comprising such 
shipment, delivery, or part is adulterated or misbranded within the 
meaning of the act when so removed.
    (2) An exemption of a shipment or other delivery of a food under 
paragraph (d) (2) or (3) of this section shall become void ab initio 
with respect to the person who introduced such shipment or delivery into 
interstate commerce upon refusal by such person to make available for 
inspection a copy of the agreement, as required by paragraph (d) (2) or 
(3) of this section.
    (3) An exemption of a shipment or other delivery of a food under 
paragraph (d) (2) or (3) of this section shall expire:
    (i) At the beginning of the act of removing such shipment or 
delivery, or any part thereof, from such establishment if the food 
constituting such shipment, delivery, or part is adulterated or 
misbranded within the meaning of the act when so removed; or
    (ii) Upon refusal by the operator of the establishment where such 
food is to

[[Page 188]]

be processed, labeled, or repacked, to make available for inspection a 
copy of the agreement, as required by such paragraph.
    (f) The word ``processed'' as used in this paragraph shall include 
the holding of cheese in a suitable warehouse at a temperature of not 
less than 35 [deg]F for the purpose of aging or curing to bring the 
cheese into compliance with requirements of an applicable definition and 
standard of identity. The exemptions provided for in paragraph (d) of 
this section shall apply to cheese which is, in accordance with the 
practice of the trade, shipped to a warehouse for aging or curing, on 
condition that the cheese is identified in the manner set forth in one 
of the applicable following paragraphs, and in such case the provisions 
of paragraph (e) of this section shall also apply:
    (1) In the case of varieties of cheese for which definitions and 
standards of identity require a period of aging whether or not they are 
made from pasteurized milk, each such cheese shall bear on the cheese a 
legible mark showing the date at which the preliminary manufacturing 
process has been completed and at which date curing commences, and to 
each cheese, on its wrapper or immediate container, shall be affixed a 
removable tag bearing the statement ``Uncured ___ cheese for completion 
of curing and proper labeling'', the blank being filled in with the 
applicable name of the variety of cheese. In the case of swiss cheese, 
the date at which the preliminary manufacturing process had been 
completed and at which date curing commences is the date on which the 
shaped curd is removed from immersion in saturated salt solution as 
provided in the definition and standard of identity for swiss cheese, 
and such cheese shall bear a removable tag reading, ``To be cured and 
labeled as `swiss cheese,' but if eyes do not form, to be labeled as 
`swiss cheese for manufacturing' ''.
    (2) In the case of varieties of cheeses which when made from 
unpasteurized milk are required to be aged for not less than 60 days, 
each such cheese shall bear a legible mark on the cheese showing the 
date at which the preliminary manufacturing process has been completed 
and at which date curing commences, and to each such cheese or its 
wrapper or immediate container shall be affixed a removable tag reading, 
``___ cheese made from unpasteurized milk. For completion of curing and 
proper labeling'', the blank being filled in with the applicable name of 
the variety of cheese.
    (3) In the case of cheddar cheese, washed curd cheese, colby cheese, 
granular cheese, and brick cheese made from unpasteurized milk, each 
such cheese shall bear a legible mark on the cheese showing the date at 
which the preliminary manufacturing process has been completed and at 
which date curing commences, and to each such cheese or its wrapper or 
immediate container shall be affixed a removable tag reading ``___ 
cheese made from unpasteurized milk. For completion of curing and proper 
labeling, or for labeling as ___ cheese for manufacturing'', the blank 
being filled in with the applicable name of the variety of cheese.
    (g) The label declaration of a harmless marker used to identify a 
particular manufacturer's product may result in unfair competition 
through revealing a trade secret. Exemption from the label declaration 
of such a marker is granted, therefore, provided that the following 
conditions are met:
    (1) The person desiring to use the marker without label declaration 
of its presence has submitted to the Commissioner of Food and Drugs full 
information concerning the proposed usage and the reasons why he 
believes label declaration of the marker should be subject to this 
exemption; and
    (2) The person requesting the exemption has received from the 
Commissioner of Food and Drugs a finding that the marker is harmless and 
that the exemption has been granted.
    (h) Wrapped fish fillets of nonuniform weight intended to be 
unpacked and marked with the correct weight at or before the point of 
retail sale in an establishment other than that where originally packed 
shall be exempt from the requirement of section 403(e)(2) of the act 
during introduction and movement in interstate commerce and while held 
for sale prior to weighing and marking:

[[Page 189]]

    (1) Provided, That (i) The outside container bears a label 
declaration of the total net weight; and
    (ii) The individual packages bear a conspicuous statement ``To be 
weighed at or before time of sale'' and a correct statement setting 
forth the weight of the wrapper;
    (2) Provided further, That it is the practice of the retail 
establishment to weigh and mark the individual packages with a correct 
net-weight statement prior to or at the point of retail sale. A 
statement of the weight of the wrapper shall be set forth so as to be 
readily read and understood, using such term as ``wrapper tare--ounce'', 
the blank being filled in with the correct average weight of the wrapper 
used.
    (3) The act of delivering the wrapped fish fillets during the retail 
sale without the correct net-weight statement shall be deemed an act 
which results in the product's being misbranded while held for sale. 
Nothing in this paragraph shall be construed as requiring net-weight 
statements for wrapped fish fillets delivered into institutional trade 
provided the outside container bears the required information.
    (i) Wrapped clusters (consumer units) of bananas of nonuniform 
weight intended to be unpacked from a master carton or container and 
weighed at or before the point of retail sale in an establishment other 
than that where originally packed shall be exempt from the requirements 
of section 403(e)(2) of the act during introduction and movement in 
interstate commerce and while held for sale prior to weighing:
    (1) Provided, That (i) The master carton or container bears a label 
declaration of the total net weight; and
    (ii) The individual packages bear a conspicuous statement ``To be 
weighed at or before the time of sale'' and a correct statement setting 
forth the weight of the wrapper; using such term as ``wrapper tare _ 
ounce'', the blank being filled in with the correct average weight of 
the wrapper used;
    (2) Provided further, That it is the practice of the retail 
establishment to weigh the individual packages either prior to or at the 
time of retail sale.
    (3) The act of delivering the wrapped clusters (consumer units) 
during the retail sale without an accurate net weight statement or 
alternatively without weighing at the time of sale shall be deemed an 
act which results in the product's being misbranded while held for sale. 
Nothing in this paragraph shall be construed as requiring net-weight 
statements for clusters (consumer units) delivered into institutional 
trade, provided that the master container or carton bears the required 
information.

[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986; 58 
FR 2188, 2876, Jan. 6, 1993; 66 FR 17358, Mar. 30, 2001]



Sec. 101.108  Temporary exemptions for purposes of conducting 
authorized food labeling experiments.

    (a) The food industry is encouraged to experiment voluntarily, under 
controlled conditions and in collaboration with the Food and Drug 
Administration, with and other formats for presenting nutrition and 
other related food labeling information that is consistent with the 
current quantitative system in Sec. Sec. 101.9 and 105.66 of this 
chapter.
    (b) Any firm that intends to undertake a labeling experiment that 
requires exemptions from certain requirements of Sec. Sec. 101.9 and 
105.66 of this chapter should submit a written proposal containing a 
thorough discussion of each of the following information items that 
apply to the particular experiment:
    (1) A description of the labeling format to be tested;
    (2) A statement of the criteria to be used in the experiment for 
assigning foods to categories, e.g., nutrient or other values defining 
``low'' and ``reduced'';
    (3) A draft of the material to be used in the store, e.g., shelf 
tags, booklets, posters, etc.;
    (4) The dates on which the experiment will begin and end and on 
which a written report of analysis of the experimental data will be 
submitted to FDA, together with a commitment not to continue the 
experiment beyond the proposed ending date without FDA approval;
    (5) The geographic area or areas in which the experiment is to be 
conducted;

[[Page 190]]

    (6) The mechanism to measure the effectiveness of the experiment;
    (7) The method for conveying to consumers the required nutrition and 
other labeling information that is exempted from the label during the 
experiment;
    (8) The method that will be or has been used to determine the actual 
nutritional characteristics of foods for which a claim is made; and
    (9) A statement of the sections of the regulations for which an 
exemption is sought.
    (c) The written proposal should be sent to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. The proposal should be clearly identified 
as a request for a temporary exemption for purposes of conducting 
authorized food labeling experiments and submitted as a citizen petition 
under Sec. 10.30 of this chapter.
    (d) Approval for food labeling experiments will be given by FDA in 
writing. Foods labeled in violation of existing regulations will be 
subject to regulatory action unless an FDA-approved exemption to the 
specific regulation has been granted for that specific product.
    (e) Reporting requirements contained in Sec. 101.108(b) have been 
approved by this Office of Management and Budget and assigned number 
0910-0151.

[48 FR 15240, Apr. 8, 1983, as amended at 59 FR 14364, Mar. 28, 1994; 62 
FR 15343, Mar. 31, 1997]





      Sec. Appendix A to Part 101--Monier-Williams Procedure (With 
Modifications) for Sulfites in Food, Center for Food Safety and Applied 
         Nutrition, Food and Drug Administration (November 1985)

    The AOAC official method for sulfites (Official Methods of Analysis, 
14th Edition, 20.123-20.125, AOAC INTERNATIONAL) has been modified, in 
FDA laboratories, to facilitate the determination of sulfites at or near 
10 ppm in food. Method instructions, including modifications, are 
described below.
    Apparatus--The apparatus shown diagrammatically (Figure 1) is 
designed to accomplish the selective transfer of sulfur dioxide from the 
sample in boiling aqueous hydrochloric acid to a solution of 3% hydrogen 
peroxide. This apparatus is easier to assemble than the official 
apparatus and the back pressure inside the apparatus is limited to the 
unavoidable pressure due to the height of the 3% 
H2O2 solution above the tip of the bubbler (F). 
Keeping the backpressure as low as possible reduces the likelihood that 
sulfur dioxide will be lost through leaks.
    The apparatus should be assembled as shown in Fig. 1 with a thin 
film of stopcock grease on the sealing surfaces of all the joints except 
the joint between the separatory funnel and the flask. Each joint should 
be clamped together to ensure a complete seal throughout the analysis. 
The separatory funnel, B, should have a capacity of 100 ml or greater. 
An inlet adapter, A, with a hose connector (Kontes K-183000 or 
equivalent) is required to provide a means of applying a head of 
pressure above the solution. (A pressure equalizing dropping funnel is 
not recommended because condensate, perhaps with sulfur dioxide, is 
deposited in the funnel and the side arm.) The round bottom flask, C, is 
a 1000 ml flask with three 24/40 tapered joints. The gas inlet tube, D, 
(Kontes K-179000 or equivalent) should be of sufficient length to permit 
introduction of the nitrogen within 2.5 cm of the bottom of the flask. 
The Allihn condenser, E, (Kontes K-431000-2430 or equivalent) has a 
jacket length of 300 mm. The bubbler, F, was fabricated from glass 
according to the dimensions given in Fig. 2. The 3% hydrogen peroxide 
solution can be contained in a vessel, G, with an i.d. of ca. 2.5 cm and 
a depth of 18 cm.
    Buret--A 10 ml buret (Fisher Cat. No. 03-848-2A or equivalent) with 
overflow tube and hose connections for an Ascarite tube or equivalent 
air scrubbing apparatus. This will permit the maintenance of a carbon 
dioxide-free atmosphere over the standardized 0.01N sodium hydroxide.
    Chilled Water Circulator--The condensor must be chilled with a 
coolant, such as 20% methanol-water, maintained at 5 [deg]C. A 
circulating pump equivalent to the Neslab Coolflow 33 is suitable.

                                Reagents

    (a) Aqueous hydrochloric acid, 4N.--For each analysis prepare 90 ml 
of hydrochloric acid by adding 30 ml of concentrated hydrochloric acid 
(12N) to 60 ml of distilled water.
    (b) Methyl red indicator--Dissolve 250 mg of methyl red in 100 ml 
ethanol.
    (c) Hydrogen peroxide solution, 3%--Dilute ACS reagent grade 30% 
hydrogen peroxide to 3% with distilled water. Just prior to use, add 
three drops of methyl red indicator and titrate to a yellow end-point 
using 0.01N sodium hydroxide. If the end-point is exceeded discard the 
solution and prepare another 3% H2O2 solution.
    (d) Standardized titrant, 0.01N NaOH--Certified reagent may be used 
(Fisher SO-5-284).

[[Page 191]]

It should be standardized with reference standard potassium hydrogen 
phthalate.
    (e) Nitrogen--A source of high purity nitrogen is required with a 
flow regulator that will maintain a flow of 200 cc per minute. To guard 
against the presence of oxygen in the nitrogen, an oxygen scrubbing 
solution such as an alkaline pyrogallol trap may be used. Prepare 
pyrogallol trap as follows:
    1. Add 4.5 g pyrogallol to the trap.
    2. Purge trap with nitrogen for 2 to 3 minutes.
    3. Prepare a KOH solution prepared by adding 65g KOH to 85 ml 
distilled water (caution: heat).
    4. Add the KOH solution to the trap while maintaining an atmosphere 
of nitrogen in the trap.

                              Determination

    Assemble the apparatus as shown in Fig. 1. The flask C must be 
positioned in a heating mantle that is controlled by a power regulating 
device such as Variac or equivalent. Add 400 ml of distilled water to 
flask C. Close the stopcock of separatory funnel, B, and add 90 ml of 4N 
hydrochloric acid to the separatory funnel. Begin the flow of nitrogen 
at a rate of 20010 cc/min. The condenser coolant 
flow must be initiated at this time. Add 30 ml of 3% hydrogen peroxide, 
which has been titrated to a yellow end-point with 0.01N NaOH, to 
container G. After fifteen minutes the apparatus and the distilled water 
will be thoroughly de-oxygenated and the apparatus is ready for sample 
introduction.
    Sample preparation (solids)--Transfer 50 g of food, or a quantity of 
food with a convenient quantity of SO2 (500 to 1500 mcg 
SO2), to a food processor or blender. Add 100 ml of 5% 
ethanol in water and briefly grind the mixture. Grinding or blending 
should be continued only until the food is chopped into pieces small 
enough to pass through the 24/40 point of flask C.
    Sample preparation (liquids)--Mix 50 g of the sample, or a quantity 
with a convenient quantity of SO2 (500 to 1500 mcg 
SO2), with 100 ml of 5% ethanol in water.
    Sample introduction and distillation--Remove the separatory funnel 
B, and quantitatively transfer the food sample in aqueous ethanol to 
flask C. Wipe the tapered joint clean with a laboratory tissue, apply 
stopcock grease to the outer joint of the separatory funnel, and return 
the separatory funnel, B, to tapered joint flask C. The nitrogen flow 
through the 3% hydrogen peroxide solution should resume as soon as the 
funnel, B, is re-inserted into the appropriate joint in flask C. Examine 
each joint to ensure that it is sealed.
    Apply a head pressure above the hydrochloric acid solution in B with 
a rubber bulb equipped with a valve. Open the stopcock in B and permit 
the hydrochloric acid solution to flow into flask C. Continue to 
maintain sufficient pressure above the acid solution to force the 
solution into the flask C. The stopcock may be closed, if necessary, to 
pump up the pressure above the acid and then opened again. Close the 
stopcock before the last few milliliters drain out of the separatory 
funnel, B, to guard against the escape of sulfur dioxide into the 
separatory funnel.
    Apply the power to the heating mantle. Use a power setting which 
will cause 80 to 90 drops per minute of condensate to return to the 
flask from condenser, E. After 1.75 hours of boiling the contents of the 
1000 ml flask and remove trap G.
    Titration.--Titrate the contents with 0.01N sodium hydroxide. 
Titrate with 0.01N NaOH to a yellow end-point that persists for at least 
twenty seconds. Compute the sulfite content, expressed as micrograms 
sulfur dioxide per gram of food (ppm) as follows:

ppm = (32.03 x VB x N x 1000) / Wt

where 32.03 = milliequivalent weight of sulfur dioxide; VB = 
          volume of sodium hydroxide titrant of normality, N, required 
          to reach endpoint; the factor, 1000, converts milliequivalents 
          to microequivalents and Wt = weight (g) of food sample 
          introduced into the 1000 ml flask.

[[Page 192]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.362

      Figure 1. The optimized Monier-Williams apparatus. Component 
                    identification is given in text.

[[Page 193]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.363

 Figure 2. Diagram of bubbler (F in Figure 1). Lengths are given in mm.

[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986]

[[Page 194]]



    Sec. Appendix B to Part 101--Graphic Enhancements Used by the FDA
[GRAPHIC] [TIFF OMITTED] TR21DE18.017


[[Page 195]]


[GRAPHIC] [TIFF OMITTED] TR21DE18.018


[83 FR 65504, Dec. 21, 2018]

[[Page 196]]



    Sec. Appendix C to Part 101--Nutrition Facts for Raw Fruits and 
                               Vegetables
[GRAPHIC] [TIFF OMITTED] TR17AU06.007


[[Page 197]]


[GRAPHIC] [TIFF OMITTED] TR17AU06.008

                      [71 FR 47439, Aug. 17, 2006]



                                  Sec. 

[[Page 198]]

         Appendix D to Part 101--Nutrition Facts for Cooked Fish
[GRAPHIC] [TIFF OMITTED] TR17AU06.009

                      [71 FR 47439, Aug. 17, 2006]

[[Page 199]]



PART 102_COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS--
Table of Contents



                      Subpart A_General Provisions

Sec.
102.5 General principles.
102.19 Petitions.

        Subpart B_Requirements for Specific Nonstandardized Foods

102.22 Protein hydrolysates.
102.23 Peanut spreads.
102.26 Frozen ``heat and serve'' dinners.
102.28 Foods packaged for use in the preparation of ``main dishes'' or 
          ``dinners.''
102.33 Beverages that contain fruit or vegetable juice.
102.37 Mixtures of edible fat or oil and olive oil.
102.39 Onion rings made from diced onion.
102.41 Potato chips made from dried potatoes.
102.45 Fish sticks or portions made from minced fish.
102.46 Pacific whiting.
102.47 Bonito.
102.49 Fried clams made from minced clams.
102.50 Crabmeat.
102.54 Seafood cocktails.
102.55 Nonstandardized breaded composite shrimp units.
102.57 Greenland turbot (Reinhardtius hippoglossoides).

    Authority: 21 U.S.C. 321, 343, 371.

    Source: 42 FR 14322, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 102 appear at 81 FR 
49895, July 29, 2016.



                      Subpart A_General Provisions



Sec. 102.5  General principles.

    (a) The common or usual name of a food, which may be a coined term, 
shall accurately identify or describe, in as simple and direct terms as 
possible, the basic nature of the food or its characterizing properties 
or ingredients. The name shall be uniform among all identical or similar 
products and may not be confusingly similar to the name of any other 
food that is not reasonably encompassed within the same name. Each class 
or subclass of food shall be given its own common or usual name that 
states, in clear terms, what it is in a way that distinguishes it from 
different foods.
    (b) The common or usual name of a food shall include the 
percentage(s) of any characterizing ingredient(s) or component(s) when 
the proportion of such ingredient(s) or component(s) in the food has a 
material bearing on price or consumer acceptance or when the labeling or 
the appearance of the food may otherwise create an erroneous impression 
that such ingredient(s) or component(s) is present in an amount greater 
than is actually the case. The following requirements shall apply unless 
modified by a specific regulation in subpart B of this part.
    (1) The percentage of a characterizing ingredient or component shall 
be declared on the basis of its quantity in the finished product (i.e., 
weight/weight in the case of solids, or volume/volume in the case of 
liquids).
    (2) The percentage of a characterizing ingredient or component shall 
be declared by the words ``containing (or contains) _ percent (or %) 
___'' or ``_ percent (or %) ___'' with the first blank filled in with 
the percentage expressed as a whole number not greater than the actual 
percentage of the ingredient or component named and the second blank 
filled in with the common or usual name of the ingredient or component. 
The word ``containing'' (or ``contains''), when used, shall appear on a 
line immediately below the part of the common or usual name of the food 
required by paragraph (a) of this section. For each characterizing 
ingredient or component, the words ``_ percent or %) ___'' shall appear 
following or directly below the word ``containing'' (or contains), or 
directly below the part of the common or usual name of the food required 
by paragraph (a) of this section when the word ``containing'' (or 
contains) is not used, in easily legible boldface print or type in 
distinct contrast to other printed or graphic matter, and in a height 
not less than the larger of the following alternatives:
    (i) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or

[[Page 200]]

    (ii) Not less than one-half the height of the largest type appearing 
in the part of the common or usual name of the food required by 
paragraph (a) of this section.
    (c) The common or usual name of a food shall include a statement of 
the presence or absence of any characterizing ingredient(s) or 
component(s) and/or the need for the user to add any characterizing 
ingredient(s) or component(s) when the presence or absence of such 
ingredient(s) or component(s) in the food has a material bearing on 
price or consumer acceptance or when the labeling or the appearance of 
the food may otherwise create an erroneous impression that such 
ingredient(s) or component(s) is present when it is not, and consumers 
may otherwise be misled about the presence or absence of the 
ingredient(s) or component(s) in the food. The following requirements 
shall apply unless modified by a specific regulation in subpart B of 
this part.
    (1) The presence or absence of a characterizing ingredient or 
component shall be declared by the words ``containing (or contains) 
___'' or ``containing (or contains) no ___'' or ``no ___'' or ``does not 
contain ___'', with the blank being filled in with the common or usual 
name of the ingredient or component.
    (2) The need for the user of a food to add any characterizing 
ingredient(s) or component(s) shall be declared by an appropriate 
informative statement.
    (3) The statement(s) required under paragraph (c)(1) and/or (2) of 
this section shall appear following or directly below the part of the 
common or usual name of the food required by paragraphs (a) and (b) of 
this section, in easily legible boldface print or type in distinct 
contrast to other printed or graphic matter, and in a height not less 
than the larger of the alternatives established under paragraphs (b)(2) 
(i) and (ii) of this section.
    (d) A common or usual name of a food may be established by common 
usage or by establishment of a regulation in subpart B of this part, in 
part 104 of this chapter, in a standard of identity, or in other 
regulations in this chapter.



Sec. 102.19  Petitions.

    (a) The Commissioner of Food and Drugs, either on his own initiative 
or on behalf of any interested person who has submitted a petition, may 
publish a proposal to issue, amend, or revoke, under this part, a 
regulation prescribing a common or usual name for a food, pursuant to 
part 10 of this chapter.
    (b) If the principal display panel of a food for which a common or 
usual name regulation is established is too small to accommodate all 
mandatory requirements, the Commissioner may establish by regulation an 
acceptable alternative, e.g., a smaller type size. A petition requesting 
such a regulation, which would amend the applicable regulation, shall be 
submitted pursuant to part 10 of this chapter.

[42 FR 14322, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]



        Subpart B_Requirements for Specific Nonstandardized Foods



Sec. 102.22  Protein hydrolysates.

    The common or usual name of a protein hydrolysate shall be specific 
to the ingredient and shall include the identity of the food source from 
which the protein was derived.
    (a) ``Hydrolyzed wheat gluten,'' ``hydrolyzed soy protein,'' and 
``autolyzed yeast extract'' are examples of acceptable names. 
``Hydrolyzed casein'' is also an example of an acceptable name, whereas 
``hydrolyzed milk protein'' is not an acceptable name for this 
ingredient because it is not specific to the ingredient (hydrolysates 
can be prepared from other milk proteins). The names ``hydrolyzed 
vegetable protein'' and ``hydrolyzed protein'' are not acceptable 
because they do not identify the food source of the protein.
    (b) [Reserved]

[58 FR 2876, Jan. 6, 1993]



Sec. 102.23  Peanut spreads.

    (a) The common or usual name of a spreadable peanut product that 
does not conform to Sec. 164.150 of this chapter, and more than 10 
percent of which consists of nonpeanut ingredients, shall

[[Page 201]]

consist of the term ``peanut spread'' and a statement of the percentage 
by weight of peanuts in the product in the manner set forth in Sec. 
102.5(b), except that peanut percentages shall be based on the amount of 
peanuts used to make the finished food and shall be declared in 5-
percent increments expressed as a multiple of 5, not to exceed the 
actual percentage of peanuts in the products.
    (b) A spreadable peanut product that is nutritionally inferior to 
peanut butter shall be labeled as an imitation of peanut butter under 
Sec. 101.3(e)(2) of this chapter; a spreadable peanut product shall be 
considered nutritionally equivalent to peanut butter if it meets all of 
the following conditions:
    (1) Protein. (i) The protein content of the product is at least 24 
percent by weight of the finished product, and the overall biological 
quality of the protein contained in the product is at least 68 percent 
that of casein; or
    (ii) The protein content of the product is at least 16.6 percent by 
weight of the finished product, and the overall biological quality of 
the protein contained in the product is equal to or greater than that of 
casein.
    (2) Other nutrients. The product contains the following levels of 
nutrients per 100 grams of product:

------------------------------------------------------------------------
                                                               Amount
                         Nutrient                           (milligrams)
------------------------------------------------------------------------
Niacin....................................................         15.3
Vitamin B6................................................         0.33
Folic acid................................................         0.08
Iron......................................................          2.0
Zinc......................................................          2.9
Magnesium.................................................        173.0
Copper....................................................          0.6
------------------------------------------------------------------------

    (c) Compliance with the requirements of paragraph (b) of this 
section shall be determined by methods described in the following 
references except that in determining protein quantity in products with 
mixed protein sources a nitrogen conversion factor of 6.25 may be used.
    (1) Protein quantity: ``Official Methods of Analysis of the 
Association of Official Analytical Chemists'' (AOAC), 13th Ed. (1980), 
using the method described in section 27.007, which is incorporated by 
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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.
    (2) Biological quality of protein: AOAC, 13th Ed. (1980), using the 
method described in sections 43.212-43.216, which is incorporated by 
reference. The availability of this incorporation by reference is given 
in paragraph (c)(1) of this section.
    (3) Niacin: AOAC, 13th Ed. (1980), using the method described in 
sections 43.044-43.046, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(1) of this section.
    (4) Vitamin B6: AOAC, 13th Ed. (1980), using the method 
described in sections 43.188-43.193, which is incorporated by reference. 
The availability of this incorporation by reference is given in 
paragraph (c)(1) of this section.
    (5) Folic acid: Using the method described in U.S. Department of 
Agriculture Handbook No. 29, modified by use of ascorbate buffer as 
described by Ford and Scott, Journal of Dairy Research, 35:85-90 (1968), 
which is incorporated by reference. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-800), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, or 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.
    (6) Iron: AOAC, 13th Ed. (1980), using the method described in 
sections 43.217-43.219, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(1) of this section.
    (7) Zinc: AOAC, 13th Ed. (1980), using the method described in 
sections 25.150-25.153, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(1) of this section.

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    (8) Copper: AOAC, 13th Ed. (1980), using the method described in 
sections 25.038-25.043, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(1) of this section.
    (9) Magnesium: AOAC, 13th Ed. (1980), using the method described in 
sections 2.109-2.113, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(1) of this section.

[42 FR 36455, July 15, 1977, as amended at 47 FR 11821, Mar. 19, 1982; 
49 FR 5609, Feb. 14, 1984; 54 FR 24891, June 12, 1989; 61 FR 14479, Apr. 
2, 1996; 63 FR 14035, Mar. 24, 1998; 66 FR 17358, Mar. 30, 2001; 66 FR 
56035, Nov. 6, 2001]



Sec. 102.26  Frozen ``heat and serve'' dinners.

    (a) A frozen ``heat and serve'' dinner:
    (1) Shall contain at least three components, one of which shall be a 
significant source of protein and each of which shall consist of one or 
more of the following: meat, poultry, fish, cheese, eggs, vegetables, 
fruit, potatoes, rice, or other cereal based products (other than bread 
or rolls).
    (2) May also contain other servings of food (e.g., soup, bread or 
rolls, beverage, dessert).
    (b) The common or usual name of the food consists of all of the 
following:
    (1) The phrase ``frozen `heat and serve' dinner,'' except that the 
name of the predominant characterizing ingredient or other appropriately 
descriptive term may immediately precede the word ``dinner'' (e.g., 
``frozen chicken dinner'' or ``frozen heat and serve beef dinner''). The 
words ``heat and serve'' are optional. The word ``frozen'' is also 
optional, provided that the words ``Keep Frozen'' or the equivalent are 
prominently and conspicuously placed on the principal display panel in 
type size not less than that specified in Sec. 102.5(b)(2)(i).
    (2) The phrase ``containing (or contains) ___'' the blank to be 
filled in with an accurate description of each of the three or more dish 
components listed in paragraph (a)(1) of this section in their order of 
descending predominance by weight (e.g., ham, mashed potatoes, and 
peas), followed by any of the other servings specified in paragraph 
(a)(2) of this section contained in the package (e.g., onion soup, 
enriched white bread, and artificially flavored vanilla pudding) in 
their order of descending predominance by weight. This part of the name 
shall be placed immediately following or directly below the part 
specified in paragraph (b)(1) of this section in the manner set forth in 
Sec. 102.5(c)(3). The words ``contains'' or ``containing'' are 
optional.
    (3) If the labeling implies that the package contains other foods 
and these foods are not present in the package, e.g., if a vignette on 
the package depicts a ``serving suggestion'' which includes any foods 
not present in the package, the principal display panel shall bear a 
statement that such foods are not present, in type size not less than 
that specified in Sec. 102.5(b)(2)(i).



Sec. 102.28  Foods packaged for use in the preparation of 
``main dishes'' or ``dinners.''

    (a) The common or usual name of a packaged food which is represented 
on the principal display panel by word or vignette to be used in the 
preparation of a ``main dish'', ``dinner'', or other such food serving, 
and to which some other important characterizing ingredient(s) or 
component(s) not present in the package must be added, consists of all 
the following:
    (1) The common or usual name of each important ingredient or 
component in the package, in descending order of predominance by weight 
(e.g., ``noodles and tomato sauce'').
    (2) An appropriate informative statement identifying the food to be 
prepared by use of the package contents (e.g., ``for preparation of 
chicken casserole'').
    (3) An appropriate informative statement that additional 
characterizing ingredient(s) or component(s) must be added and which 
names the additional characterizing ingredient(s) or component(s) (e.g., 
``you must add ___ to complete the recipe,'' the blank to be filled in 
with the name(s) of the important characterizing ingredient(s) or 
component(s) that must be added).
    (b) The labeling required by paragraph (a) of this section shall 
appear on the principal display panel.
    (1) No word in the statement required by paragraph (a)(2) of this 
section may

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appear on the principal display panel more conspicuously or in larger 
type than the smallest and least conspicuous type employed on the panel 
for any word, phrase or statement within the scope of paragraph (a)(1) 
of this section.
    (2) Every word in the statement required by paragraph (a)(3) of this 
section shall appear on the principal display panel in easily legible 
bold face print or type in distinct contrast to other printed or graphic 
matter, and in a height not less than the larger of the following 
alternatives:
    (i) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (ii) Not less than one-half the height of the largest type appearing 
in the part of the common or usual name of the food required by 
paragraphs (a) (1) and (2) of this section.
    (c) Any vignette which shows any food or characterizing 
ingredient(s) or component(s) not included in the package shall be 
accompanied either by the statement required by paragraph (a)(3) of this 
section or by a separate statement specifying the food or characterizing 
ingredient(s) or component(s) shown in the vignette but not included in 
the package.
    (d) If the statement specified in paragraph (a)(2) of this section 
is used on any panel in addition to the principal display panel as a 
product identification statement, the complete common or usual name 
shall appear on such panel in the manner specified in paragraph (b) of 
this section.
    (e) When a brand name or other prominent product designation 
contains a word or words that includes or suggests an important 
characterizing ingredient(s) or component(s) that must be added, or 
otherwise states or implies that the package contains a complete main 
dish, dinner, or other food serving, the part of the common or usual 
name of the food required by paragraph (a)(3) of this section shall 
appear in direct conjunction with such brand name or other designation 
and in type size not less than one-half the height of the largest type 
appearing in such brand name or other designation.



Sec. 102.33  Beverages that contain fruit or vegetable juice.

    (a) For a carbonated or noncarbonated beverage that contains less 
than 100 percent and more than 0 percent fruit or vegetable juice, the 
common or usual name shall be a descriptive name that meets the 
requirements of Sec. 102.5(a) and, if the common or usual name uses the 
word ``juice,'' shall include a qualifying term such as ``beverage,'' 
``cocktail,'' or ``drink'' appropriate to advise the consumer that the 
product is less than 100 percent juice (e.g., ``diluted grape juice 
beverage'' or ``grape juice drink'').
    (b) If the product is a diluted multiple-juice beverage or blend of 
single-strength juices and names, other than in the ingredient 
statement, more than one juice, then the names of those juices, except 
in the ingredient statement, must be in descending order of predominance 
by volume unless the name specifically shows that the juice with the 
represented flavor is used as a flavor (e.g., raspberry-flavored apple 
and pear juice drink). In accordance with Sec. 101.22(i)(1)(iii) of 
this chapter, the presence of added natural flavors is not required to 
be declared in the name of the beverage unless the declared juices alone 
do not characterize the product before the addition of the added 
flavors.
    (c) If a diluted multiple-juice beverage or blend of single-strength 
juices contains a juice that is named or implied on the label or 
labeling other than in the ingredient statement (represented juice), and 
also contains a juice other than the named or implied juice 
(nonrepresented juice), then the common or usual name for the product 
shall indicate that the represented juice is not the only juice present 
(e.g., ``Apple blend; apple juice in a blend of two other fruit 
juices.'')
    (d) In a diluted multiple-juice beverage or blend of single-strength 
juices where one or more, but not all, of the juices are named on the 
label other than in the ingredient statement, and where the named juice 
is not the predominant juice, the common or usual name for the product 
shall:

[[Page 204]]

    (1) Indicate that the named juice is present as a flavor or 
flavoring (e.g., ``Raspcranberry''; raspberry and cranberry flavored 
juice drink); or
    (2) Include the amount of the named juice, declared in a 5- percent 
range (e.g., Raspcranberry; raspberry and cranberry juice beverage, 10- 
to 15-percent cranberry juice and 3- to 8-percent raspberry juice). The 
5-percent range, when used, shall be declared in the manner set forth in 
Sec. 102.5(b)(2).
    (e) The common or usual name of a juice that has been modified shall 
include a description of the exact nature of the modification (e.g., 
``acid-reduced cranberry juice,'' ``deflavored, de colored grape 
juice'').
    (f) If the product is a beverage that contains a juice whose color, 
taste, or other organoleptic properties have been modified to the extent 
that the original juice is no longer recognizable at the time processing 
is complete, or if its nutrient profile has been diminished to a level 
below the normal nutrient range for the juice, then the source fruits or 
vegetables from which the modified juice was derived may not be depicted 
on the label by vignette or other pictorial representation.
    (g)(1) If one or more juices in a juice beverage is made from 
concentrate, the name of the juice must include a term indicating that 
fact, such as ``from concentrate,'' or ``reconstituted.'' Such terms 
must be included in the name of each individual juice or it may be 
stated once adjacent to the product name so that it applies to all the 
juices, (e.g., ``cherry juice (from concentrate) in a blend of two other 
juices'' or ``cherry juice in a blend of 2 other juices (from 
concentrate)''). The term shall be in a type size no less than one-half 
the height of the letters in the name of the juice.
    (2) If the juice is 100 percent single species juice consisting of 
juice directly expressed from a fruit or vegetable whose Brix level has 
been raised by the addition of juice concentrate from the same fruit or 
vegetable, the name of the juice need not include a statement that the 
juice is from concentrate. However, if water is added to this 100 
percent juice mixture to adjust the Brix level, the product shall be 
labeled with the term ``from concentrate'' or ``reconstituted.''

[58 FR 2926, Jan. 6, 1993; 58 FR 17103, Apr. 1, 1993, as amended at 58 
FR 44063, Aug. 18, 1993; 62 FR 15343, Mar. 31, 1997]



Sec. 102.37  Mixtures of edible fat or oil and olive oil.

    The common or usual name of a mixture of edible fats and oils 
containing less than 100 percent and more than 0 percent olive oil shall 
be as follows:
    (a) A descriptive name for the product meeting the requirements of 
Sec. 102.5(a), e.g., ``cottonseed oil and olive oil'' or another 
descriptive phrase, and
    (b) When the label bears any representation, other than in the 
ingredient listing, of the presence of olive oil in the mixture, the 
descriptive name shall be followed by a statement of the percentage of 
olive oil contained in the product in the manner set forth in Sec. 
102.5(b)(2).



Sec. 102.39  Onion rings made from diced onion.

    (a) The common or usual name of the food product that resembles and 
is of the same composition as onion rings, except that it is composed of 
comminuted onions, shall be as follows:
    (1) When the product is composed of dehydrated onions, the name 
shall be ``onion rings made from dried diced onions.''
    (2) When the product is composed of any form of onion other than 
dehydrated, the name shall be ``onion rings made from diced onions.''
    (b) The words ``made from dried diced onions'' or ``made from diced 
onions'' shall immediately follow or appear on a line(s) immediately 
below the words ``onion rings'' in easily legible boldface print or type 
in distinct contrast to other printed or graphic matter, and in a height 
not less than the larger of the following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``onion rings.''

[[Page 205]]



Sec. 102.41  Potato chips made from dried potatoes.

    (a) The common or usual name of the food product that resembles and 
is of the same composition as potato chips, except that it is composed 
of dehydrated potatoes (buds, flakes, granules, or other form), shall be 
``potato chips made from dried potatoes.''
    (b) The words ``made from dried potatoes'' shall immediately follow 
or appear on a line(s) immediately below the words ``potato chips'' in 
easily legible boldface print or type in distinct contrast to other 
printed or graphic matter, and in a height not less than the larger of 
the following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``potato chips.''



Sec. 102.45  Fish sticks or portions made from minced fish.

    (a) The common or usual name of the food product that resembles and 
is of the same composition as fish sticks or fish portions, except that 
it is composed of comminuted fish flesh, shall be ``fish ___ made from 
minced fish,'' the blank to be filled in with the word ``sticks'' or 
``portions'' as the case may be.
    (b) The words ``made from minced fish'' shall immediately follow or 
appear on a line(s) immediately below the words ``fish ___'' in easily 
legible boldface print or type in distinct contrast to other printed or 
graphic matter, and in a height not less than the larger of the 
following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``fish ___.''



Sec. 102.46  Pacific whiting.

    ``Pacific whiting'' or ``North Pacific whiting'' is the common or 
usual name of the food fish Merluccius productus.

[44 FR 45617, Aug. 3, 1979]



Sec. 102.47  Bonito.

    ``Bonito'' or ``bonito fish'' is the common or usual name of the 
following food fishes:

Cybiosarda elegans (Whitely, 1935)--Leaping bonito
Gymnosarda unicolor (Ruppell, 1838)--Dogtooth tuna
Orcynopsis unicolor (Geoffroy St. Hilaire, 1817)--Plain bonito
Sarda australis (Macleay, 1880)--Australian bonito
Sarda chiliensis (Cuvier, 1831)--Eastern Pacific bonito
Sarda orientalis (Temminck and Schlegel, 1844)--Striped bonito
Sarda sarda (Bloch, 1793)--Atlantic bonito

[55 FR 45797, Oct. 31, 1990]



Sec. 102.49  Fried clams made from minced clams.

    (a) The common or usual name of the food product that resembles and 
is of the same composition as fried clams, except that it is composed of 
comminuted clams, shall be ``fried clams made from minced clams.''
    (b) The words ``made from minced clams'' shall immediately follow or 
appear on a line(s) immediately below the words ``fried clams'' and in 
easily legible boldface print or type in distinct contrast to other 
printed or graphic matter, and in a height not less than the larger of 
the following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``fried clams.''



Sec. 102.50  Crabmeat.

    The common or usual name of crabmeat derived from each of the 
following designated species of crabs shall be as follows:

[[Page 206]]



------------------------------------------------------------------------
                                               Common or usual name of
          Scientific name of crab                     crabmeat
------------------------------------------------------------------------
Chionoecetes opilio, Chionoecetes tanneri,  Snow crabmeat.
 Chionoecetes bairdii, and Chionoecetes
 angulatus.
Erimacrus isenbeckii......................  Korean variety crabmeat or
                                             Kegani crabmeat.
Lithodes aequispinus......................  Golden King crabmeat.
Paralithodes brevipes.....................  King crabmeat or Hanasaki
                                             crabmeat.
Paralithodes camtschaticus and              King crabmeat.
 Paralithodes platypus.
------------------------------------------------------------------------


[42 FR 14322, Mar. 15, 1977, as amended at 60 FR 34460, July 3, 1995; 83 
FR 19431, May 3, 2018]



Sec. 102.54  Seafood cocktails.

    The common or usual name of a seafood cocktail in package form 
fabricated with one or more seafood ingredients shall be:
    (a) When the cocktail contains only one seafood ingredient, the name 
of the seafood ingredient followed by the word ``cocktail'' (e.g., 
shrimp cocktail, crabmeat cocktail) and a statement of the percentage by 
weight of that seafood ingredient in the product in the manner set forth 
in Sec. 102.5(b).
    (b) When the cocktail contains more than one seafood ingredient, the 
term ``seafood cocktail'' and a statement of the percentage by weight of 
each seafood ingredient in the product in the manner set forth in Sec. 
102.5(b).



Sec. 102.55  Nonstandardized breaded composite shrimp units.

    (a) The common on usual name of the food product that conforms to 
the definition and standard of identity described by Sec. 161.175(c)(6) 
of this chapter, except that the food is made from comminuted shrimp and 
is not in raw frozen form, shall be ``___ made from minced shrimp,'' the 
blank to be filled in with the words ``breaded shrimp sticks'' or 
``breaded shrimp cutlets'' depending upon the shape of the product, or 
if prepared in a shape other than that of sticks or cutlets ``breaded 
shrimp ___ made from minced shrimp,'' the blank to be filled by a word 
or phrase that accurately describes the shape and that is not 
misleading.
    (b) The words ``made from minced shrimp'' shall immediately follow 
or appear on a line(s) immediately below the other words required by 
this section in easily legible boldface print or type in distinct 
contrast to other printed or graphic matter, and in a height not less 
than the larger of the following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and no 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``breaded shrimp sticks'' or the other comparable words 
required by this section.



Sec. 102.57  Greenland turbot (Reinhardtius hippoglossoides).

    ``Greenland turbot'' is the common or usual name of the food fish 
Reinhardtius hippoglossoides, a species of Pleuronectidae right-eye 
flounders. The term ``halibut'' may be associated only with Atlantic 
halibut (Hippoglossus hippoglossus) or Pacific halibut (Hippoglossus 
stenolepis).



PART 104_NUTRITIONAL QUALITY GUIDELINES FOR FOODS--Table of Contents



                      Subpart A_General Provisions

Sec.
104.5 General principles.

                     Subpart B_Fortification Policy

104.20 Statement of purpose.

            Subpart C_Specific Nutritional Quality Guidelines

104.47 Frozen ``heat and serve'' dinner.

    Authority: 21 U.S.C. 321, 343, 371(a).

    Source: 42 FR 14327, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 104.5  General principles.

    (a) A nutritional quality guideline prescribes the minimum level or 
range of nutrient composition (nutritional

[[Page 207]]

quality) appropriate for a given class of food.
    (b) Labeling for a product which complies with all of the 
requirements of the nutritional quality guideline established for its 
class of food may state ``This product provides nutrients in amounts 
appropriate for this class of food as determined by the U.S. 
Government,'' except that the words ``this product'' are optional. This 
statement, if used, shall be printed on the principal display panel, and 
may also be printed on the information panel, in letters not larger than 
twice the size of the minimum type required for the declaration of net 
quantity of contents by Sec. 101.7 of this chapter. Labeling of 
noncomplying products may not include any such statement or otherwise 
represent, suggest, or imply the product as being, in whole or in part, 
in compliance with a guideline.
    (c) A product bearing the statement provided for in paragraph (b) of 
this section, in addition to meeting the requirements of the applicable 
nutritional quality guideline, shall comply with the following 
requirements:
    (1) The label of the product shall bear the common or usual name of 
the food in accordance with the provisions of the guideline and 
Sec. Sec. 101.3 and 102.5(a) of this chapter.
    (2) The label of the product shall bear nutrition labeling in 
accordance with Sec. Sec. 101.2 and 101.9 of this chapter and all other 
labeling required by applicable sections of part 101 of this chapter.
    (d) No claim or statement may be made on the label or in labeling 
representing, suggesting, or implying any nutritional or other 
differences between a product to which nutrient addition has or has not 
been made in order to meet the guideline, except that a nutrient 
addition shall be declared in the ingredient statement.
    (e) Compliance with a nutrient level specified in a nutritional 
quality guideline shall be determined by the procedures and requirements 
established in Sec. 101.9(g) of this chapter.
    (f) A product within a class of food for which a nutritional quality 
guideline has been established and to which has been added a discrete 
nutrient either for which no minimum nutrient level or nutrient range or 
other allowance has been established as appropriate in the nutritional 
quality guideline, or at a level that exceeds any maximum established as 
appropriate in the guideline, shall be ineligible to bear the guideline 
statement provided for in paragraph (b) of this section, and such a 
product shall also be deemed to be misbranded under the act unless the 
label and all labeling bear the following prominent and conspicuous 
statement: ``The addition of ___ to (or ``The addition of ___ at the 
level contained in) this product has been determined by the U.S. 
Government to be unnecessary and inappropriate and does not increase the 
dietary value of the food,'' the blank to be filled in with the common 
or usual name of the nutrient(s) involved.

[42 FR 14327, Mar. 15, 1977, as amended at 63 FR 14818, Mar. 27, 1998; 
81 FR 59131, Aug. 29, 2016]



                     Subpart B_Fortification Policy



Sec. 104.20  Statement of purpose.

    (a) The fundamental objective of this subpart is to establish a 
uniform set of principles that will serve as a model for the rational 
addition of nutrients to foods. The achievement and maintenance of a 
desirable level of nutritional quality in the nation's food supply is an 
important public health objective. The addition of nutrients to specific 
foods can be an effective way of maintaining and improving the overall 
nutritional quality of the food supply. However, random fortification of 
foods could result in over- or underfortification in consumer diets and 
create nutrient imbalances in the food supply. It could also result in 
deceptive or misleading claims for certain foods. The Food and Drug 
Administration does not encourage indiscriminate addition of nutrients 
to foods, nor does it consider it appropriate to fortify fresh produce; 
meat, poultry, or fish products; sugars; or snack foods such as candies 
and carbonated beverages. To preserve a balance of nutrients in the 
diet, manufacturers who elect to fortify foods are urged to utilize 
these principles when adding nutrients to food. It is reasonable to 
anticipate that the Reference Daily Intakes (RDI's) as delineated in 
Sec. 101.9 of this chapter and

[[Page 208]]

in paragraph (d) of this section will be amended from time to time to 
list additional nutrients and/or to change the levels of specific RDI's 
as improved knowledge about human nutrient requirements and allowances 
develops. The policy set forth in this section is based on U.S. dietary 
practices and nutritional needs and may not be applicable in other 
countries.
    (b) A nutrient(s) listed in paragraph (d)(3) of this section may 
appropriately be added to a food to correct a dietary insufficiency 
recognized by the scientific community to exist and known to result in 
nutritional deficiency disease if:
    (1) Sufficient information is available to identify the nutritional 
problem and the affected population groups, and the food is suitable to 
act as a vehicle for the added nutrients. Manufacturers contemplating 
using this principle are urged to contact the Food and Drug 
Administration before implementing a fortification plan based on this 
principle.
    (2) The food is not the subject of any other Federal regulation for 
a food or class of food that requires, permits, or prohibits nutrient 
additions. (Other Federal regulations include, but are not limited to, 
standards of identity promulgated under section 401 of the Federal Food, 
Drug, and Cosmetic Act, nutritional quality guidelines established in 
subpart C of this part, and common or usual name regulations established 
in part 102 of this chapter.)
    (c) A nutrient(s) listed in paragraph (d)(3) of this section may 
appropriately be added to a food to restore such nutrient(s) to a 
level(s) representative of the food prior to storage, handling, and 
processing, when:
    (1) The nutrient is shown by adequate scientific documentation to 
have been lost in storage, handling, or processing in a measurable 
amount equal to at least 2 percent of the Daily Reference Value (DRV) of 
protein and of potassium and 2 percent of the Reference Daily Intake 
(RDI) in a normal serving of the food.
    (2) Good manufacturing practices and normal storage and handling 
procedures cannot prevent the loss of such nutrient(s),
    (3) All nutrients, including protein, iodine and vitamin D, that are 
lost in a measurable amount are restored and all ingredients of the food 
product that contribute nutrients are considered in determining 
restoration levels; and
    (4) The food is not the subject of any other Federal regulation that 
requires or prohibits nutrient addition(s), or the food has not been 
fortified in accordance with any other Federal regulation that permits 
voluntary nutrient additions.
    (d) A nutrient(s) listed in paragraph (d)(3) of this section may be 
added to a food in proportion to the total caloric content of the food, 
to balance the vitamin, mineral, and protein content if:
    (1) A normal serving of the food contains at least 40 kilocalories 
(that is, 2 percent of a daily intake of 2,000 kilocalories);
    (2) The food is not the subject of any other Federal regulation for 
a food or class of food that requires, permits, or prohibits nutrient 
additions; and
    (3) The food contains all of the following nutrients per 100 
calories based on 2,000 calorie total intake as a daily standard:

------------------------------------------------------------------------
                                                                 Amount
         Nutrient              Unit of measurement      DRV or   per 100
                                                       RDI \1\  calories
------------------------------------------------------------------------
Protein...................  grams (g)................     50       2.5
Vitamin A.................  International Unit (IU)..  5,000     250
Vitamin C.................  milligrams (mg)..........     60       3
Calcium...................  g........................      1       0.05
Iron......................  mg.......................     18       0.9
Vitamin D.................  IU.......................    400      20
Vitamin E.................  do.......................     30       1.5
Thiamin...................  mg.......................      1.5     0.08
Riboflavin................  do.......................      1.7     0.09
Niacin....................  do.......................     20       1
Vitamin B6................  do.......................      2.0     0.1
Folate....................  micrograms ([micro]g)....    400      20
Vitamin B12...............  do.......................      6.0     0.3
Biotin....................  mg.......................      0.3     0.015
Pantothenic acid..........  do.......................     10       0.5
Phosphorus................  g........................      1.0     0.05
Magnesium.................  mg.......................    400      20
Zinc......................  do.......................     15       0.8
Iodine....................  [micro]g.................    150       7.5
Copper....................  mg.......................      2.0     0.1
Potassium.................  do.......................  3,500     175
------------------------------------------------------------------------
\1\ RDI's for adults and children 4 or more years of age.

    (e) A nutrient(s) may appropriately be added to a food that replaces 
traditional food in the diet to avoid nutritional inferiority in 
accordance with Sec. 101.3(e)(2) of this chapter.
    (f) Nutrient(s) may be added to foods as permitted or required by 
applicable

[[Page 209]]

regulations established elsewhere in this chapter.
    (g) A nutrient added to a food is appropriate only when the 
nutrient:
    (1) Is stable in the food under customary conditions of storage, 
distribution, and use;
    (2) Is physiologically available from the food;
    (3) Is present at a level at which there is a reasonable assurance 
that consumption of the food containing the added nutrient will not 
result in an excessive intake of the nutrient, considering cumulative 
amounts from other sources in the diet; and
    (4) Is suitable for its intended purpose and is in compliance with 
applicable provisions of the act and regulations governing the safety of 
substances in food.
    (h) Any claims or statements in the labeling of food about the 
addition of a vitamin, mineral, or protein to a food shall be made only 
if the claim or statement is not false or misleading and otherwise 
complies with the act and any applicable regulations. The following 
label claims are acceptable:
    (1) The labeling claim ``fully restored with vitamins and minerals'' 
or ``fully restored with vitamins and minerals to the level of 
unprocessed ___'' (the blank to be filled in with the common or usual 
name of the food) may be used to describe foods fortified in accordance 
with the principles established in paragraph (c) of the section.
    (2) The labeling claim, ``vitamins and minerals (and ``protein'' 
when appropriate) added are in proportion to caloric content'' may be 
used to describe food fortified in accordance with the principles 
established in paragraph (d) of this section.
    (3) When labeling claims are permitted, the term ``enriched,'' 
``fortified,'' ``added,'' or similar terms may be used interchangeably 
to indicate the addition of one or more vitamins or minerals or protein 
to a food, unless an applicable Federal regulation requires the use of 
specific words or statements.
    (i) It is inappropriate to make any claim or statement on a label or 
in labeling, other than in a listing of the nutrient ingredients as part 
of the ingredient statement, that any vitamin, mineral, or protein has 
been added to a food to which nutrients have been added pursuant to 
paragraph (e) of this section.

[45 FR 6323, Jan. 25, 1980, as amended at 58 FR 2228, Jan. 6, 1993]



            Subpart C_Specific Nutritional Quality Guidelines



Sec. 104.47  Frozen ``heat and serve'' dinner.

    (a) A product, for which a common or usual name is established in 
Sec. 102.26 of this chapter, in order to be eligible to bear the 
guideline statement set forth at Sec. 104.5(b), shall contain at least 
the following three components:
    (1) One or more sources of protein derived from meat, poultry, fish, 
cheese, or eggs.
    (2) One or more vegetables or vegetable mixtures other than 
potatoes, rice, or cereal-based product.
    (3) Potatoes, rice, or cereal-based product (other than bread or 
rolls) or another vegetable or vegetable mixture.
    (b) The three or more components named in paragraph (a) of this 
section, including their sauces, gravies, breading, etc.:
    (1) Shall contribute not less than the minimum levels of nutrients 
prescribed in paragraph (d) of this section.
    (2) Shall be selected so that one or more of the listed protein 
sources of paragraph (a)(1) of this section, excluding their sauces, 
gravies, breading, etc., shall provide not less than 70 percent of the 
total protein supplied by the components named in paragraph (a) of this 
section.
    (c) If it is necessary to add any nutrient(s) in order to meet the 
minimum nutrient levels prescribed in paragraph (d) of this section, the 
addition of each such nutrient may not result in a total nutrient level 
exceeding 150 percent of the minimum level prescribed. Nutrients used 
for such addition shall be biologically available in the final product.
    (d) Minimum levels of nutrients for a frozen ``heat and serve'' 
dinner are as follows:

[[Page 210]]



------------------------------------------------------------------------
                                                    Minimum levels for
                                                     frozen ``heat and
                                                     serve'' dinner--
                                                 -----------------------
                                                   For each
                                                      100
                    Nutrient                       Calories     For the
                                                   (keal) of     total
                                                   the total  components
                                                  components   specified
                                                   specified    in par.
                                                    in par.       (a)
                                                      (a)
------------------------------------------------------------------------
Protein, grams..................................        4.60        16.0
Vitamin A, IU...................................      150.00       520.0
Thiamine, mg....................................         .05          .2
Riboflavin, mg..................................         .06          .2
Niacin, mg......................................         .99         3.4
Pantothenic acid, mg............................         .32         1.1
Vitamin, B6, mg.................................         .15          .5
Vitamin, B1.....................................         .33         1.1
Iron, mg........................................         .62         2.2
------------------------------------------------------------------------

    (1) A frozen ``heat and serve'' dinner prepared from conventional 
food ingredients listed in paragraph (a) of this section will also 
contain folic acid, magnesium, iodine, calcium, and zinc. Minimum levels 
for these nutrients cannot be established at the present time but may be 
specified as additional data are obtained.
    (2) The minimum levels for pantothenic acid, vitamin B-6, and 
vitamin B-12 are tentative. Final levels will be established when 
sufficient data are available. Until final levels are established, a 
product containing less than the tentative levels will not be deemed to 
be misbranded when labeled in accordance with Sec. 104.5(b).
    (3) When technologically practicable, iodized salt shall be used or 
iodine shall be present at a level equivalent to that which would be 
present if iodized salt were used in the manufacture of the product.
    (4) When technologically practicable, product components and 
ingredients shall be selected to obtain the desirable calcium to 
phosphorous ratio of 1:1. Technological addition of phosphates shall be 
minimized and shall not exceed the amount necessary for the intended 
effect.
    (e) If the product includes servings of food which are not 
prescribed by paragraph (a) of this section (e.g., soup, bread or rolls, 
beverage, or dessert), their contribution shall not be considered in 
determining compliance with the nutrient levels established in paragraph 
(d) of this section but shall be included in any nutrition labeling.
    (f) For the purposes of labeling, an ``average serving'' shall be 
one entire frozen ``heat and serve'' dinner.

[42 FR 14327, Mar. 5, 1977]



PART 105_FOODS FOR SPECIAL DIETARY USE--Table of Contents



                      Subpart A_General Provisions

Sec.
105.3 Definitions and interpretations.

                       Subpart B_Label Statements

105.62 Hypoallergenic foods.
105.65 Infant foods.
105.66 Label statements relating to usefulness in reducing or 
          maintaining body weight.

Subpart C [Reserved]

Subpart D--Standards of Identity [Reserved]

    Authority: 21 U.S.C. 321, 341, 343, 348, 350, 371, 379e.

    Source: 42 FR 14328, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 105.3  Definitions and interpretations.

    The definitions and interpretations of terms contained in section 
201 of the Federal Food, Drug, and Cosmetic Act (hereafter ``the act'') 
shall be applicable with the following additions:
    (a)(1) The term special dietary uses, as applied to food for man, 
means particular (as distinguished from general) uses of food, as 
follows:
    (i) Uses for supplying particular dietary needs which exist by 
reason of a physical, physiological, pathological or other condition, 
including but not limited to the conditions of diseases, convalescence, 
pregnancy, lactation, allergic hypersensitivity to food, underweight, 
and overweight;
    (ii) Uses for supplying particular dietary needs which exist by 
reason of age, including but not limited to the ages of infancy and 
childhood;
    (iii) Uses for supplementing or fortifying the ordinary or usual 
diet with any vitamin, mineral, or other dietary property. Any such 
particular use of a food is a special dietary use, regardless

[[Page 211]]

of whether such food also purports to be or is represented for general 
use.
    (2) The use of an artificial sweetener in a food, except when 
specifically and solely used for achieving a physical characteristic in 
the food which cannot be achieved with sugar or other nutritive 
sweetener, shall be considered a use for regulation of the intake of 
calories and available carbohydrate, or for use in the diets of 
diabetics and is therefore a special dietary use.
    (b)-(d) [Reserved]
    (e) For the purposes of the regulations in this part, the terms 
infant, child, and adult mean persons not more than 12 months old, more 
than 12 months but less than 12 years old, and 12 years or more old, 
respectively.

[42 FR 14328, Mar. 15, 1977, as amended at 44 FR 16006, Mar. 16, 1979; 
44 FR 49665, Aug. 24, 1979]



                       Subpart B_Label Statements



Sec. 105.62  Hypoallergenic foods.

    If a food purports to be or is represented for special dietary use 
by reason of the decrease or absence of any allergenic property or by 
reason of being offered as food suitable as a substitute for another 
food having an allergenic property, the label shall bear:
    (a) The common or usual name and the quantity or proportion of each 
ingredient (including spices, flavoring, and coloring) in case the food 
is fabricated from two or more ingredients.
    (b) A qualification of the name of the food, or the name of each 
ingredient thereof in case the food is fabricated from two or more 
ingredients, to reveal clearly the specific plant or animal that is the 
source of such food or of such ingredient, if such food or such 
ingredient consists in whole or in part of plant or animal matter and 
such name does not reveal clearly the specific plant or animal that is 
such a source.
    (c) An informative statement of the nature and effect of any 
treatment or processing of the food or any ingredient thereof, if the 
changed allergenic property results from such treatment or processing.



Sec. 105.65  Infant foods.

    (a) If a food (other than a dietary supplement of vitamins and/or 
minerals alone) purports to be or is represented for special dietary use 
for infants, the label shall bear, if such food is fabricated from two 
or more ingredients, the common or usual name of each ingredient, 
including spices, flavoring, and coloring.
    (b) If such food, or any ingredient thereof, consists in whole or in 
part of plant or animal matter and the name of such food or ingredient 
does not clearly reveal the specific plant or animal which is its 
source, such name shall be so qualified as to reveal clearly the 
specific plant or animal that is such source.

[42 FR 14328, Mar. 15, 1977, as amended at 47 FR 947, Jan. 8, 1982; 49 
FR 10090, Mar. 19, 1984; 50 FR 1840, Jan. 14, 1985]



Sec. 105.66  Label statements relating to usefulness in reducing 
or maintaining body weight.

    (a) General requirements. Any food that purports to be or is 
represented for special dietary use because of usefulness in reducing or 
maintaining body weight shall bear:
    (1) Nutrition labeling in conformity with Sec. 101.9, or, where 
applicable, Sec. 101.36 of this chapter, unless exempt under that 
section; and
    (2) A conspicuous statement of the basis upon which the food claims 
to be of special dietary usefulness.
    (b) Nonnutritive ingredients. (1) Any food 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 food may contain a nonnutritive sweetener or 
other ingredient only if the ingredient is safe for use in the food 
under the applicable law and regulations of this chapter. Any food 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

[[Page 212]]

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 food purporting to be ``low calorie'' 
must comply with the criteria set forth for such foods in Sec. 
101.60(b)(2) and (b)(3) of this chapter.
    (d) ``Reduced calorie'' foods and other comparative calorie claims. 
A food purporting to be ``reduced calorie'' or otherwise containing 
fewer calories than a reference food must comply with the criteria set 
forth for such food in Sec. 101.60(b)(4) and (b)(5) of this chapter.
    (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, and in Sec. 101.13(q)(2) of this chapter for soft drinks, 
a food may be labeled with terms such as ``diet,'' ``dietetic,'' 
``artificially sweetened,'' or ``sweetened with nonnutritive sweetener'' 
only if the claim is not false and misleading, and the food is labeled 
``low calorie'' or ``reduced calorie'' or bears another comparative 
calorie claim in compliance with part 101 of this chapter and this 
section.
    (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 food 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 food 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. 101.60(c) of this chapter.

[58 FR 2430, Jan. 6, 1993]

Subpart C [Reserved]

Subpart D--Standards of Identity [Reserved]



 PART 106_INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD
 MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS,
 RECORDS AND REPORTS, AND NOTIFICATIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
106.1 Status and applicability of the regulations in part 106.
106.3 Definitions.

              Subpart B_Current Good Manufacturing Practice

106.5 Current good manufacturing practice.
106.6 Production and in-process control system.
106.10 Controls to prevent adulteration by workers.
106.20 Controls to prevent adulteration caused by facilities.
106.30 Controls to prevent adulteration caused by equipment or utensils.
106.35 Controls to prevent adulteration due to automatic (mechanical or 
          electronic) equipment.
106.40 Controls to prevent adulteration caused by ingredients, 
          containers, and closures.
106.50 Controls to prevent adulteration during manufacturing.
106.55 Controls to prevent adulteration from microorganisms.
106.60 Controls to prevent adulteration during packaging and labeling of 
          infant formula.
106.70 Controls on the release of finished infant formula.
106.80 Traceability.
106.90 Audits of current good manufacturing practice.

                  Subpart C_Quality Control Procedures

106.91 General quality control.
106.92 Audits of quality control procedures.

                       Subpart D_Conduct of Audits

106.94 Audit plans and procedures.

              Subpart E_Quality Factors for Infant Formulas

106.96 Requirements for quality factors for infant formulas.

[[Page 213]]

                      Subpart F_Records and Reports

106.100 Records.

    Subpart G_Registration, Submission, and Notification Requirements

106.110 New infant formula registration.
106.120 New infant formula submission.
106.121 Quality factor assurances for infant formulas.
106.130 Verification submission.
106.140 Submission concerning a change in infant formula that may 
          adulterate the product.
106.150 Notification of an adulterated or misbranded infant formula.
106.160 Incorporation by reference.

    Authority: 21 U.S.C. 321, 342, 350a, 371.

    Source: 79 FR 8059, Feb. 10, 2014, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 106 appear at 81 FR 
49895, July 29, 2016.



                      Subpart A_General Provisions



Sec. 106.1  Status and applicability of the regulations in part 106.

    (a) The criteria set forth in subparts B, C, and D of this part 
prescribe the steps that manufacturers shall take under section 
412(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350a(b)(2) and (b)(3)) in processing infant formula. If the 
processing of the formula does not comply with any regulation in 
subparts B, C, or D of this part, the formula will be deemed to be 
adulterated under section 412(a)(3) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The criteria set forth in subpart E of this part prescribe the 
requirements for quality factors that infant formula shall meet under 
section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act. If the 
formula fails to comply with any regulation in subpart E of this part, 
it will be deemed to be adulterated under section 412(a)(2) of the 
Federal Food, Drug, and Cosmetic Act.
    (c) The criteria set forth in subpart F of this part prescribe 
records requirements for quality factors under section 412(b)(1) of the 
Federal Food, Drug, and Cosmetic Act and for good manufacturing 
practices and quality control procedures, including distribution and 
audit records, under section 412(b)(2). If an infant formula 
manufacturer fails to comply with the quality factor record requirements 
in subpart F of this part with respect to an infant formula, the formula 
will be deemed to be adulterated under section 412(a)(2) of the Federal 
Food, Drug, and Cosmetic Act. If an infant formula manufacturer fails to 
comply with the good manufacturing practices or quality control 
procedures record requirements in subpart F of this part with respect to 
an infant formula, the infant formula will be deemed to be adulterated 
under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act. The 
criteria set forth in subpart F of this part also implement record 
retention requirements under section 412(b)(4) of the Federal Food, 
Drug, and Cosmetic Act. Failure to comply with any regulation in subpart 
F of this part is a violation of section 301(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331(e)).
    (d) The criteria set forth in subpart G of this part describe, in 
part, certain good manufacturing practices, quality control procedures, 
and quality factor records requirements under section 412(b)(1) and 
(b)(2) of the Federal Food, Drug and Cosmetic Act. If an infant formula 
manufacturer fails to comply with such records requirements with respect 
to an infant formula, the infant formula will be deemed to be 
adulterated under section 412(a)(2) or (a)(3) of the Federal Food, Drug, 
and Cosmetic Act, as applicable. The criteria set forth in subpart G of 
this part also describe the circumstances in which an infant formula 
manufacturer is required to register with, submit to, or notify the Food 
and Drug Administration, and the content of a registration, submission, 
or notification, under section 412(c), (d), and (e) of the Federal Food, 
Drug, and Cosmetic Act. Failure to comply with any regulation in subpart 
G of this part is a violation of section 301(s) of the Federal Food, 
Drug, and Cosmetic Act.



Sec. 106.3  Definitions.

    The definitions in this section and the definitions contained in 
section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) 
shall apply to infant formula requirements in 21 CFR parts 106 and 107 
of this chapter.

[[Page 214]]

    Eligible infant formula means an infant formula that could be 
lawfully distributed in the United States on December 8, 2014.
    Final product stage means the point in the manufacturing process, 
before distribution of an infant formula, at which the infant formula is 
homogeneous and is not subject to further degradation due to processing.
    Indicator nutrient means a nutrient whose concentration is measured 
during the manufacture of an infant formula to confirm complete addition 
and uniform distribution of a premix or other substance of which the 
indicator nutrient is a part.
    Infant means a person not more than 12 months of age.
    Infant formula means a food which purports to be or is represented 
for special dietary use solely as a food for infants by reason of its 
simulation of human milk or its suitability as a complete or partial 
substitute for human milk.
    In-process production aggregate means a combination of ingredients 
at any point in the manufacturing process before packaging.
    Major change in an infant formula means any new formulation, or any 
change of ingredients or processes where experience or theory would 
predict a possible significant adverse impact on levels of nutrients or 
bioavailability of nutrients, or any change that causes an infant 
formula to differ fundamentally in processing or in composition from any 
previous formulation produced by the manufacturer. Examples of infant 
formulas deemed to differ fundamentally in processing or in composition 
include:
    (1) Any infant formula produced by a manufacturer who is entering 
the U.S. market;
    (2) Any infant formula powder processed and distributed by a 
manufacturer who previously only produced liquids (or vice versa);
    (3) Any infant formula having a significant revision, addition, or 
substitution of a macronutrient (i.e., protein, fat, or carbohydrate), 
with which the manufacturer has not had previous experience;
    (4) Any infant formula manufactured on a new processing line or in a 
new plant;
    (5) Any infant formula manufactured containing a new constituent not 
listed in section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350a(i)), such as taurine or L-carnitine;
    (6) Any infant formula processed by a manufacturer on new equipment 
that utilizes a new technology or principle (e.g., from terminal 
sterilization to aseptic processing); or
    (7) An infant formula for which there has been a fundamental change 
in the type of packaging used (e.g., changing from metal cans to plastic 
pouches).
    Manufacturer means a person who prepares, reconstitutes, or 
otherwise changes the physical or chemical characteristics of an infant 
formula or packages or labels the product in a container for 
distribution. The term ``manufacturer'' does not include a person who 
prepares, reconstitutes, or mixes infant formula exclusively for an 
infant under his/her direct care or the direct care of the institution 
employing such person.
    Microorganisms means yeasts, molds, bacteria, and viruses and 
includes, but is not limited to, species having public health 
significance.
    New infant formula means:
    (1) An infant formula manufactured by a person that has not 
previously manufactured an infant formula, and
    (2) An infant formula manufactured by a person that has previously 
manufactured infant formula and in which there is a major change in 
processing or formulation from a current or any previous formulation 
produced by such manufacturer, or which has not previously been the 
subject of a submission under section 412(c) of the Federal Food, Drug, 
and Cosmetic Act for the U.S. market.
    Nutrient means any vitamin, mineral, or other substance or 
ingredient that is required in accordance with the ``Nutrients'' table 
set out in section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act 
or by regulations issued under section 412(i)(2) or that is identified 
as essential for infants by the Food and Nutrition Board of the 
Institute of Medicine through its development of a Dietary Reference 
Intake, or that has

[[Page 215]]

been identified as essential for infants by the Food and Drug 
Administration through a Federal Register publication.
    Nutrient premix means a combination of ingredients containing two or 
more nutrients received from a supplier or prepared by an infant formula 
manufacturer.
    Production aggregate means a quantity of product, or, in the case of 
an infant formula produced by continuous process, a specific identified 
amount produced in a unit of time, that is intended to have uniform 
composition, character, and quality, within specified limits, and is 
produced according to a master manufacturing order.
    Production unit means a specific quantity of an infant formula 
produced during a single cycle of manufacture that has uniform 
composition, character, and quality, within specified limits.
    Production unit number or production aggregate number means any 
distinctive combination of letters, numbers, symbols, or any combination 
of them, from which the complete history of the manufacture, processing, 
packing, holding, and distribution of a production aggregate or a 
production unit of infant formula can be determined.
    Quality factors means those factors necessary to demonstrate the 
safety of the infant formula and the bioavailability of its nutrients, 
as prepared for market and when fed as the sole source of nutrition, to 
ensure the healthy growth of infants.
    Representative sample means a sample that consists of a number of 
units that are drawn based on rational criteria, such as random 
sampling, and intended to ensure that the sample accurately portrays the 
material being sampled.
    Shall is used to state mandatory requirements.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33070, June 10, 2014]



              Subpart B_Current Good Manufacturing Practice



Sec. 106.5  Current good manufacturing practice.

    (a) The regulations set forth in this subpart define the minimum 
current good manufacturing practices that are to be used in, and the 
facilities or controls that are to be used for, the manufacture, 
processing, packing, or holding of an infant formula. Compliance with 
these provisions is necessary to ensure that such infant formula 
provides the nutrients required under Sec. 107.100 of this chapter and 
is manufactured in a manner designed to prevent its adulteration. A 
liquid infant formula that is a thermally processed low-acid food 
packaged in a hermetically sealed container is also subject to the 
regulations in part 113 of this chapter, and an infant formula that is 
an acidified food, as defined in Sec. 114.3(b) of this chapter, is also 
subject to the regulations in part 114 of this chapter.
    (b) The failure to comply with any regulation in this subpart in the 
manufacture, processing, packing, or holding of an infant formula shall 
render such infant formula adulterated under section 412(a)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)(3)); the failure 
to comply with any regulation in part 113 of this chapter in the 
manufacture, processing, packing, or holding of a liquid infant formula 
shall render such infant formula adulterated under section 412(a)(3); 
and the failure to comply with any regulation in part 114 of this 
chapter in the manufacture, processing, packing, or holding of an infant 
formula that is an acidified food shall render such infant formula 
adulterated under section 412(a)(3).



Sec. 106.6  Production and in-process control system.

    (a) A manufacturer shall conform to the requirements of this subpart 
by implementing a system of production and in-process controls. This 
production and in-process control system shall cover all stages of 
processing, from the receipt and acceptance of the raw materials, 
ingredients, and components through the storage and distribution of the 
finished product and shall be designed to ensure that all the 
requirements of this subpart are met.
    (b) The production and in-process control system shall be set out in 
a written plan or set of procedures that is designed to ensure that an 
infant formula is manufactured in a manner

[[Page 216]]

that will prevent adulteration of the infant formula.
    (c) At any point, step, or stage in the production process where 
control is necessary to prevent adulteration, a manufacturer shall:
    (1) Establish specifications to be met;
    (2) Monitor the production and in-process control point, step, or 
stage;
    (3) Establish a corrective action plan for use when a specification 
established in accordance with paragraph (c)(1) of this section is not 
met;
    (4) Review the results of the monitoring required by paragraph 
(c)(2) of this section, and review and evaluate the public health 
significance of any deviation from specifications that have been 
established in accordance with paragraph (c)(1) of this section. For any 
specification established in accordance with paragraph (c)(1) of this 
section that a manufacturer fails to meet, an individual qualified by 
education, training, or experience shall conduct a documented review and 
shall make a material disposition decision to reject the affected 
article, to reprocess or otherwise recondition the affected article, or 
to approve and release the article for use or distribution; and
    (5) Establish recordkeeping procedures, in accordance with Sec. 
106.100(e)(3), that ensure that compliance with the requirements of this 
section is documented.
    (d) Any article that fails to meet a specification established in 
accordance with paragraph (c)(1) of this section shall be controlled 
under a quarantine system designed to prevent its use pending the 
completion of a documented review and material disposition decision.



Sec. 106.10  Controls to prevent adulteration by workers.

    (a) A manufacturer shall employ sufficient personnel, qualified by 
education, training, or experience, to perform all operations, including 
all required recordkeeping, in the manufacture, processing, packing, and 
holding of each infant formula and to supervise such operations to 
ensure that the operations are correctly and fully performed.
    (b) Personnel working directly with infant formula, infant formula 
raw materials, infant formula packaging, or infant formula equipment or 
utensil contact surfaces shall practice good personal hygiene to protect 
the infant formula against contamination. Good personal hygiene 
includes:
    (1) Wearing clean outer garments and, as necessary, protective 
apparel such as head, face, hand, and arm coverings; and
    (2) Washing hands thoroughly in a hand washing facility with soap 
and running water at a suitable temperature before starting work, after 
each absence from the work station, and at any other time when the hands 
may become soiled or contaminated.
    (c) Any person who reports that he or she has, or appears by medical 
examination or supervisory observation to have, an illness, open lesion 
(including boils, sores, or infected wounds), or any other source of 
microbial contamination that creates a reasonable possibility that the 
safety of an infant formula may be adversely affected, shall be excluded 
from direct contact with ingredients, containers, closures, in-process 
materials, equipment, utensils, and infant formula product until the 
condition is corrected or determined by competent medical personnel not 
to jeopardize the safety of the infant formula.



Sec. 106.20  Controls to prevent adulteration caused by facilities.

    (a) Buildings used in the manufacture, processing, packing, or 
holding of infant formula shall be maintained in a clean and sanitary 
condition and shall have space for the separation of incompatible 
operations, such as the handling of raw materials, the manufacture of 
the product, and packaging and labeling operations.
    (b) Separate areas or another system of separation, such as a 
computerized inventory control, a written card system, or an automated 
system of segregation, shall be used for holding raw materials, in-
process materials, and final infant formula product at the following 
times:
    (1) Pending release for use in infant formula production or pending 
release of the final product;
    (2) After rejection for use in, or as, infant formula; and

[[Page 217]]

    (3) After release for use in infant formula production or after 
release of the final product.
    (c) Lighting shall allow easy identification of raw materials, 
packaging, labeling, in-process materials, and finished products that 
have been released for use in infant formula production and shall permit 
the easy reading of instruments and controls necessary in processing, 
packaging, and laboratory analysis. Any lighting fixtures directly over 
or adjacent to exposed raw materials, in-process materials, or bulk 
(unpackaged) finished product shall be protected to prevent glass from 
contaminating the product in the event of breakage.
    (d) A manufacturer shall provide adequate ventilation or control 
equipment to minimize odors and vapors (including steam and noxious 
fumes) in areas where they may contaminate the infant formula; and shall 
minimize the potential for contamination of raw materials, in-process 
materials, final product infant formula, packing materials, and infant 
formula-contact surfaces, through the use of appropriate measures, which 
may include the use of air filtration.
    (e) All rodenticides, insecticides, fungicides, fumigating agents, 
and cleaning and sanitizing agents shall be stored and used in a manner 
that protects against contamination of infant formula.
    (f) Potable water used in the manufacture of infant formula shall 
meet the standards prescribed in the Environmental Protection Agency's 
(EPA's) Primary Drinking Water regulations in 40 CFR part 141, except 
that the water used in infant formula manufacturing shall not be 
fluoridated or shall be defluoridated to a level as low as possible 
prior to use.
    (1) The water shall be supplied under continuous positive pressure 
in a plumbing system that is free of defects that could contaminate an 
infant formula.
    (2) A manufacturer shall test representative samples of the potable 
water drawn at a point in the system at which the water is in the same 
condition that it will be when it is used in infant formula 
manufacturing.
    (3) A manufacturer shall conduct the tests required by paragraph 
(f)(2) of this section with sufficient frequency to ensure that the 
water meets the EPA's Primary Drinking Water Regulations but shall not 
conduct these tests less frequently than annually for chemical 
contaminants, every 4 years for radiological contaminants, and weekly 
for bacteriological contaminants.
    (4) A manufacturer shall make and retain records, in accordance with 
Sec. 106.100(f)(1), of the frequency and results of testing of the 
water used in the production of infant formula.
    (g) There shall be no backflow from, or cross-connection between, 
piping systems that discharge waste water or sewage and piping systems 
that carry water for infant formula manufacturing.
    (h) Only culinary steam shall be used at all direct infant formula 
product contact points. Culinary steam shall be in compliance with the 
3-A Sanitary Standards, No. 60903, which is incorporated by reference at 
Sec. 106.160. Boiler water additives in the steam shall be used in 
accordance with Sec. 173.310 of this chapter.
    (i) Each infant formula manufacturing site shall provide its 
employees with readily accessible toilet facilities and hand washing 
facilities that include hot and cold water, soap or detergent, single-
service towels or air dryers in toilet facilities. These facilities 
shall be maintained in good repair and in a sanitary condition at all 
times. These facilities shall provide for proper disposal of the sewage. 
Doors to the toilet facility shall not open into areas where infant 
formula, ingredients, containers, or closures are processed, handled, or 
stored, except where alternate means have been taken to protect against 
contamination.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33070, June 10, 2014]



Sec. 106.30  Controls to prevent adulteration caused by equipment
or utensils.

    (a) A manufacturer shall ensure that equipment and utensils used in 
the manufacture, processing, packing, or

[[Page 218]]

holding of an infant formula are of appropriate design and are installed 
to facilitate their intended function and their cleaning and 
maintenance.
    (b) A manufacturer shall ensure that equipment and utensils used in 
the manufacture, processing, packing, or holding of an infant formula 
are constructed so that surfaces that contact ingredients, in-process 
materials, or infant formula are made of nontoxic materials and are not 
reactive or absorptive. A manufacturer shall ensure that such equipment 
and utensils are designed to be easily cleanable and to withstand the 
environment of their intended use and that all surfaces that contact 
ingredients, in-process materials, or infant formula are cleaned and 
sanitized, as necessary, and are maintained to protect infant formula 
from being contaminated by any source. All sanitizing agents used on 
such equipment and utensils that are regulated as pesticide chemicals 
under 21 U.S.C. 346a(a) shall comply with the Environmental Protection 
Agency's regulations established under such section, and all other such 
sanitizers shall comply with all applicable Food and Drug Administration 
laws and regulations.
    (c) A manufacturer shall ensure that any substance, such as a 
lubricant or a coolant, that is required for operation of infant formula 
manufacturing equipment and which would render the infant formula 
adulterated if such substance were to come in contact with the formula, 
does not come in contact with formula ingredients, containers, closures, 
in-process materials, or with infant formula product during the 
manufacture of an infant formula.
    (d) A manufacturer shall ensure that each instrument used for 
measuring, regulating, or controlling mixing time and speed, 
temperature, pressure, moisture, water activity, or other parameter at 
any point, step, or stage where control is necessary to prevent 
adulteration of an infant formula during processing is accurate, easily 
read, properly maintained, and present in sufficient number for its 
intended use.
    (1) The instruments and controls shall be calibrated against a known 
reference standard at the time of or before first use and thereafter at 
routine intervals, as specified in writing by the manufacturer of the 
instrument or control, or as otherwise deemed necessary to ensure the 
accuracy of the instrument or control. The known reference standard 
shall be certified for accuracy at the intervals specified in writing by 
the manufacturer of the instrument or control, or at routine intervals 
otherwise deemed necessary to ensure the accuracy of the instrument or 
control. A manufacturer shall make and retain records of the calibration 
activities in accordance with Sec. 106.100(f)(2).
    (2) Instruments and controls that cannot be adjusted to agree with 
the reference standard shall be repaired or replaced.
    (3) If calibration of an instrument shows a failure to meet a 
specification for a point where control is deemed necessary to prevent 
adulteration of infant formula product, a written evaluation of all 
affected product, and of any actions that need to be taken with respect 
to that product, shall be made, in accordance with Sec. 106.100(f)(2).
    (e) The following provisions apply to thermal processing and cold 
storage of infant formulas:
    (1) Equipment and procedures for thermal processing of infant 
formula packaged in hermetically sealed containers shall conform to the 
requirements in 21 CFR parts 108 and 113.
    (2)(i) Except as provided in paragraph (e)(2)(ii) of this section, a 
manufacturer shall maintain all areas of cold storage at a temperature 
of 40 [deg]F (4.4 [deg]C) or below.
    (ii) A manufacturer may maintain a cold storage area for an in-
process infant formula or for a final infant formula at a temperature 
not to exceed 45 [deg]F (7.2 [deg]C) for a defined period of time 
provided that the manufacturer has scientific data and other information 
to demonstrate that the time and temperature conditions of such storage 
are sufficient to ensure that there is no significant growth of 
microorganisms of public health significance during the period of 
storage of the in-process or final infant formula product.
    (3)(i) Cold storage compartments and thermal processing equipment 
shall be equipped with easily readable, accurate temperature-indicating 
devices.

[[Page 219]]

    (ii) A manufacturer shall ensure that the temperature of each cold 
storage compartment is maintained by:
    (A) Monitoring the temperature of the cold storage compartment on a 
temperature-indicating device and recording this temperature in a record 
with such frequency as is necessary to ensure that temperature control 
is maintained;
    (B) Equipping the cold storage compartment with one or more 
temperature-recording devices that will reflect, on a continuing basis, 
the true temperature, within the compartment;
    (C) Equipping the cold storage compartment with a high temperature 
alarm that has been validated to function properly and recording the 
temperature in a record with such frequency as is necessary to ensure 
that temperature control is maintained; or
    (D) Equipping the cold storage compartment with a maximum-indicating 
thermometer that has been validated to function properly and recording 
this temperature in a record with such frequency as is necessary to 
ensure that temperature control is maintained.
    (iii) A manufacturer shall, in accordance with Sec. 106.100(f)(3), 
make and retain records of the temperatures recorded in compliance with 
Sec. 106.30(e)(3)(ii).
    (4) When a manufacturer uses a temperature-recording device for a 
cold storage compartment, such device shall not read lower than the 
reference temperature-indicating device.
    (5) A manufacturer shall monitor the temperature in thermal 
processing equipment at points where temperature control is necessary to 
prevent adulteration. Such monitoring shall be at such frequency as is 
required by regulation or is necessary to ensure that temperature 
control is maintained.
    (f) A manufacturer shall ensure that equipment and utensils used in 
the manufacture of infant formula are cleaned, sanitized, and maintained 
at regular intervals to prevent adulteration of the infant formula.
    (1) An individual qualified by education, training, or experience to 
conduct such a review shall review all cleaning, sanitizing, and 
maintenance to ensure that it has been satisfactorily completed.
    (2) A manufacturer shall make and retain records on equipment 
cleaning, sanitizing, and maintenance, in accordance with Sec. 
106.100(f)(4).
    (g) A manufacturer shall ensure that compressed air or other gases 
that are mechanically introduced into infant formula, that are used to 
clean any equipment, or that come into contact with any other surface 
that contacts ingredients, in-process materials, or infant formula 
product are treated in such a way that their use will not contaminate 
the infant formula with unlawful or other chemical, physical, or 
microbiological contaminants. When compressed gases are used at product 
filling machines to replace air removed from the headspace of 
containers, a manufacturer shall install, as close as practical to the 
end of the gas line that feeds gas into the space, a filter capable of 
retaining particles 0.5 micrometer or smaller.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



Sec. 106.35  Controls to prevent adulteration due to automatic
(mechanical or electronic) equipment.

    (a) For the purposes of this section:
    (1) ``Hardware'' means all automatic equipment, including mechanical 
and electronic equipment (such as computers), that is used in production 
or quality control of infant formula.
    (2) ``Software'' means any programs, procedures, rules, and 
associated documentation used in the operation of a system.
    (3) ``System'' means a collection of components (including software 
and hardware) organized to accomplish a specific function or set of 
functions in a specified environment.
    (4) ``Validation'' means establishing documented evidence that 
provides a high degree of assurance that a system will consistently 
produce a product meeting its predetermined specifications and quality 
characteristics. Validation can be accomplished through any suitable 
means, such as verification studies or modeling.
    (b) All systems shall be designed, installed, tested, and maintained 
in a manner that will ensure that they are capable of performing their 
intended function and of producing or analyzing

[[Page 220]]

infant formula in accordance with this subpart and subpart C of this 
part.
    (1) A manufacturer shall ensure, at any point, step, or stage where 
control is necessary to prevent adulteration of the infant formula, that 
all hardware is routinely inspected and checked according to written 
procedures and that hardware that is capable of being calibrated is 
routinely calibrated according to written procedures.
    (2) A manufacturer shall check and document the accuracy of input 
into, and output generated by, any system used in the production or 
quality control of an infant formula to ensure that the infant formula 
is not adulterated. The degree and frequency of input/output 
verification shall be based on the complexity and reliability of the 
system and the level of risk associated with the safe operation of the 
system.
    (3) A manufacturer shall ensure that each system is validated prior 
to the release for distribution of any infant formula manufactured using 
the system.
    (4) A manufacturer shall ensure that any system that is modified is 
revalidated following the modification and prior to the release for 
distribution of any infant formula manufactured using the modified 
system. All modifications to software shall be made by a designated 
individual and shall be checked by the infant formula manufacturer to 
ensure that infant formula that is produced or analyzed using the 
modified software complies with this subpart and with subpart C of this 
part.
    (c) A manufacturer shall make and retain records, in accordance with 
Sec. 106.100(f)(5), concerning mechanical or electronic equipment.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



Sec. 106.40  Controls to prevent adulteration caused by ingredients,
containers, and closures.

    (a) The only substances that may be used in an infant formula are 
substances that are safe and suitable for use in infant formula under 
the applicable food safety provisions of the Federal Food, Drug, and 
Cosmetic Act; that is, a substance is used in accordance with the 
Agency's food additive regulations, is generally recognized as safe 
(GRAS) for such use, or is authorized by a prior sanction.
    (b) Infant formula containers and closures shall not be reactive or 
absorptive so as to affect the safety of the infant formula. The 
following substances may be used as packaging material that comes in 
contact with an infant formula:
    (1) A food additive that is the subject of a regulation issued under 
section 409(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
348(c)) and is used consistent with the conditions of use of that 
regulation;
    (2) A food contact substance that is the subject of an effective 
notification under section 409(h) of the Federal Food, Drug, and 
Cosmetic Act and is used consistent with the conditions of use in that 
notification;
    (3) A substance that is exempt from regulation as a food additive 
under Sec. 170.39 of this chapter and its use conforms to the use 
identified in the exemption letter;
    (4) A substance that is generally recognized as safe for use in or 
on infant formula or for use in infant formula packaging;
    (5) A substance the use of which is authorized by a prior sanction 
from the Food and Drug Administration or from the U.S. Department of 
Agriculture; and
    (6) A substance that is not a food additive within the meaning of 
section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(s)) because the substance is not reasonably expected to become a 
component of food or otherwise affect the characteristics of food.
    (c) Ingredients, containers, and closures used in the manufacture of 
infant formula shall be identified with a lot number to be used in 
recording their disposition.
    (d) A manufacturer shall develop written specifications for 
ingredients, containers, and closures used in manufacturing infant 
formula and shall develop and follow written procedures to determine 
whether all ingredients, containers, and closures meet these 
specifications. When any specification is not met, an individual 
qualified by education, training, or experience shall

[[Page 221]]

conduct a documented review, shall determine whether a failure to meet 
such a specification could result in an adulterated infant formula, and 
shall make and document a material disposition decision to reject the 
ingredient, container, or closure or the affected infant formula; to 
reprocess or otherwise recondition the ingredient, container, or closure 
or the affected infant formula; or to approve and release the 
ingredient, container, or closure or the affected infant formula for 
use.
    (e) Ingredients, containers, and closures shall be stored in 
separate areas or separated by a system of segregation, such as a 
computerized inventory control, a written card system, or an automated 
system of segregation, clearly designated for materials pending release 
for use; materials released for use; or materials rejected for use in 
infant formula production.
    (1) Any lot of an ingredient, a container, or a closure that does 
not meet the manufacturer's specifications shall be quarantined under a 
system designed to prevent its use in the manufacture of infant formula 
until an individual qualified by education, training, or experience has 
conducted a documented review, has determined whether such failure could 
result in an adulterated infant formula, and has made and documented a 
material disposition decision to reject the ingredient, container, 
closure, or the affected infant formula; to reprocess or otherwise 
recondition the ingredient, container, closure, or the affected infant 
formula; or to approve and release the ingredient, container, closure, 
or the affected infant formula for use.
    (2) Any ingredient, container, or closure that has been reprocessed 
or otherwise reconditioned shall be the subject of a documented review 
and material disposition decision by an individual qualified by 
education, training, or experience to determine whether it may be 
released for use.
    (3) A manufacturer shall not reprocess or otherwise recondition an 
ingredient, container, or closure rejected because it is contaminated 
with microorganisms of public health significance or other contaminants, 
such as heavy metals.
    (f) If an ingredient, container, or closure that complies with a 
manufacturer's specifications, or that has been released for use 
following a material review and disposition decision, is subsequently 
exposed to air, heat, or other conditions that may adversely affect it, 
or if a manufacturer reasonably believes that an ingredient, container, 
or closure that complies with a manufacturer's specifications, or that 
has been released for use following a material review and disposition 
decision, has been exposed to air, heat, or other conditions that may 
adversely affect it, the ingredient, container, or closure shall be 
quarantined under a system designed to prevent its use in the 
manufacture of infant formula until an individual qualified by 
education, training, or experience has conducted a documented review and 
has made and documented a material disposition decision to reject the 
ingredient, container, or closure; to reprocess or otherwise recondition 
the ingredient, container, or closure; or to approve and release the 
ingredient, container, or closure for use.
    (1) Any ingredient, container, or closure that is reprocessed or 
otherwise reconditioned shall be retested or reexamined and be the 
subject of a documented review and material disposition decision by an 
individual qualified by education, training, or experience to determine 
whether the ingredient, container, or closure should be rejected, 
further reprocessed or otherwise further reconditioned, or approved and 
released for use.
    (2) Any rejected ingredient, container, or closure shall be clearly 
identified as having been rejected for use in infant formula 
manufacturing or processing operations and shall be controlled under a 
quarantine system designed to prevent its use in infant formula 
manufacturing or processing operations.
    (3) Any ingredient, container, or closure that has not been 
manufactured, packaged, labeled, or held under conditions to prevent 
adulteration under section 402(a)(1) through (a)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) through (a)(4)) shall not be 
approved and released for use.

[[Page 222]]

    (g) A manufacturer shall make and retain records, in accordance with 
Sec. 106.100(f)(6), on the ingredients, containers, and closures used 
in the manufacture of infant formula.



Sec. 106.50  Controls to prevent adulteration during manufacturing.

    (a) A manufacturer shall prepare and follow a written master 
manufacturing order that establishes controls and procedures for the 
production of an infant formula.
    (1) The manufacturer shall make and retain records, in accordance 
with Sec. 106.100(e), that include complete information relating to the 
production and control of the production aggregate. An individual 
qualified by education, training, or experience shall conduct an 
investigation of any deviations from the master manufacturing order and 
document any corrective action taken.
    (2) Changes made to the master manufacturing order shall be reviewed 
and approved by a responsible official and include an evaluation of the 
effect of the change on the nutrient content and the suitability of the 
formula for infants.
    (b) A manufacturer shall establish controls to ensure that each raw 
or in-process ingredient required by the master manufacturing order is 
examined by one person and checked by a second person or system. This 
checking shall ensure that the correct ingredient is added during the 
manufacturing process, that the ingredient has been released for use in 
infant formula, and that the correct weight or measure of the ingredient 
is added to the production unit.
    (c) A manufacturer shall establish a system of identification for 
the contents of all compounding and storage containers, processing 
lines, and major equipment used during the manufacture of a production 
aggregate of an infant formula. The system shall permit the 
identification of the processing stage and the unique identification 
number for the particular production unit or production aggregate of 
infant formula.
    (d) A manufacturer shall establish controls to ensure that the 
nutrient levels required by Sec. 107.100 of this chapter are maintained 
in the formula, and that the formula is not contaminated with 
microorganisms or other contaminants. Such controls shall include:
    (1) The mixing time; the speed, temperature, and flow rate of 
product; and other critical parameters necessary to ensure the addition 
of required ingredients to, and the homogeneity of, the formula;
    (2) The spray-drying process for powdered infant formula, including 
the filtering of the intake air before heating, to prevent microbial and 
other contamination;
    (3) The removal of air from the finished product to ensure that 
nutrient deterioration does not occur;
    (4) Ensuring that each container of finished product is properly 
sealed. Such controls shall involve use of established procedures, 
specifications, and intervals of examination that are designed by 
qualified individuals and are sufficient to:
    (i) Detect visible closure or seal defects, and
    (ii) Determine closure strength through destructive testing. A 
manufacturer of a liquid infant formula that is a thermally processed 
low-acid food packaged in a hermetically sealed container shall perform 
such closure integrity testing in accordance with Sec. 113.60(a) of 
this chapter.
    (e) A manufacturer shall establish controls that ensure that the 
equipment used at points where control is deemed necessary to prevent 
adulteration is monitored, so that personnel will be alerted to 
malfunctions.
    (f) A manufacturer shall establish controls for in-process material 
as follows:
    (1) For any specification established in accordance with Sec. 
106.6(c)(1) that a manufacturer fails to meet for in-process material, 
an individual qualified by education, training, or experience shall 
conduct a documented review and shall make a material disposition 
decision to reject the affected in-process material, to reprocess or 
otherwise recondition the affected in-process material, or to approve 
and release the affected in-process material for use or distribution;
    (2) Pending a documented review and material disposition decision, 
any in-process material that fails to meet any

[[Page 223]]

specification established in accordance with Sec. 106.6(c)(1) shall be 
clearly identified as such and shall be controlled under a quarantine 
system designed to prevent its use in manufacturing or processing 
operations until completion of the documented review and material 
disposition decision;
    (3) Any in-process material that has been reprocessed or otherwise 
reconditioned shall be the subject of a documented review and material 
disposition decision by an individual qualified by education, training, 
or experience to determine whether it may be released for use; and
    (4) Any rejected in-process material shall be clearly identified as 
having been rejected for use in infant formula and shall be controlled 
under a quarantine system designed to prevent its use in infant formula 
manufacturing or processing operations.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



Sec. 106.55  Controls to prevent adulteration from microorganisms.

    (a) A manufacturer of infant formula shall establish a system of 
process controls covering all stages of processing that is designed to 
ensure that infant formula does not become adulterated due to the 
presence of microorganisms in the formula or in the processing 
environment.
    (b) A manufacturer of liquid infant formula shall comply, as 
appropriate, with the procedures specified in part 113 of this chapter 
for thermally processed low-acid foods packaged in hermetically sealed 
containers and part 114 of this chapter for acidified foods.
    (c) A manufacturer of powdered infant formula shall test 
representative samples of each production aggregate of powdered infant 
formula at the final product stage, before distribution, to ensure that 
each production aggregate meets the microbiological quality standards in 
the table in paragraph (e) of this section.
    (d) A manufacturer shall make and retain records, in accordance with 
Sec. 106.100(e)(5)(ii) and (f)(7), on the testing of infant formulas 
for microorganisms.
    (e) A powdered infant formula that contains any microorganism that 
exceeds the M value listed for that microorganism in the table in 
paragraph (e) of this section shall be deemed adulterated under sections 
402(a)(1), 402(a)(4), and 412(a)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350a(a)(3)). The Food and Drug Administration 
will determine compliance with the M values listed below using the 
latest edition of the Bacteriological Analytical Manual (BAM) (http://
www.fda.gov/Food/FoodScienceResearch/ LaboratoryMethods/ 
BacteriologicalAnalyticalManualBAM/default.htm) (accessed April 8, 
2013).

----------------------------------------------------------------------------------------------------------------
                 Microorganism                       n \1\                 Sample size                M value
----------------------------------------------------------------------------------------------------------------
Cronobacter spp...............................              30  10 g (grams)....................          \2\ 0.
Salmonella spp................................              60  25 g............................          \2\ 0.
----------------------------------------------------------------------------------------------------------------
\1\ Number of samples.
\2\ None detected.



Sec. 106.60  Controls to prevent adulteration during packaging
and labeling of infant formula.

    (a) A manufacturer shall examine packaged and labeled infant formula 
during finishing operations to ensure that all containers and packages 
in the production aggregate have the correct label, the correct use-by 
date, and the correct code established under Sec. 106.80.
    (b) Labels shall be designed, printed, and applied so that the 
labels remain legible and attached during the conditions of processing, 
storage, handling, distribution, and use.
    (c) Packaging used to hold multiple containers of an infant formula 
product shall be labeled as follows:
    (1) Where all containers are the same infant formula product and all 
bear the same code established under Sec. 106.80, the packaging label 
shall include the product name, the name of the manufacturer, 
distributor, or shipper, and the code established under Sec. 106.80.

[[Page 224]]

    (2) Where the containers are not the same infant formula product or 
do not all bear the same code established under Sec. 106.80, the 
packaging label shall:
    (i) Include the product name of each product, the name of the 
manufacturer, distributor, or shipper of each product, the code 
established under Sec. 106.80 for each product, and a ``use by'' date 
that is no later than the ``use by'' date of the container exhibiting 
the closest ``use by'' date applied to satisfy the requirement of Sec. 
107.20(c) of this chapter; or
    (ii) Include a unique identification number assigned by the 
packager, provided that the distributor of the package maintains a 
record linked to such unique number that identifies the product name of 
each product, the name of the manufacturer, distributor, or shipper of 
each product, the code established under Sec. 106.80 for each product, 
and the ``use by'' date for each product applied to satisfy the 
requirement of Sec. 107.20(c) of this chapter.



Sec. 106.70  Controls on the release of finished infant formula.

    (a) A manufacturer shall control under a quarantine system designed 
to prevent use or distribution of each production aggregate of infant 
formula until it determines that the production aggregate meets all of 
the manufacturer's specifications, including those adopted to meet the 
standards of Sec. 106.55 on microbiological contamination and of Sec. 
106.91(a) on quality control procedures, or until the documented review 
of the failure to meet any of the manufacturer's specifications finds 
that the failure does not result in, or could not lead to, adulteration 
of the product.
    (b) Any production aggregate of infant formula that fails to meet 
any of the manufacturer's specifications shall be quarantined under a 
system designed to prevent its use in the manufacture of infant formula 
or its distribution until an individual qualified by education, 
training, or experience has conducted a documented review and has made 
and documented a material disposition decision to reject the infant 
formula; to reprocess or otherwise recondition the infant formula; or to 
approve and release the infant formula. Any production aggregate of 
infant formula that is reprocessed or otherwise reconditioned shall be 
the subject of a documented review and material disposition decision by 
an individual qualified by education, training, or experience to 
determine whether it may be released for use or distribution.
    (c) Any rejected infant formula shall be clearly identified as 
having been rejected for use and shall be controlled under a quarantine 
system designed to prevent its release or distribution.
    (d) A production aggregate of infant formula, including a 
reprocessed or reconditioned production aggregate, that does not meet 
the nutrient requirements of section 412(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350a(i)) or that has not been manufactured, 
packaged, labeled, and held under conditions to prevent adulteration 
under sections 402(a)(1) through (a)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342(a)(1) through (a)(4)) shall not be approved 
and released for distribution.



Sec. 106.80  Traceability.

    Each production aggregate of infant formula shall be coded with a 
sequential number that identifies the product and the establishment 
where the product was packed and that permits tracing of all stages of 
manufacture of that production aggregate, including the year, the days 
of the year, and the period during those days that the product was 
packed, and the receipt and handling of raw materials used.



Sec. 106.90  Audits of current good manufacturing practice.

    (a) A manufacturer of an infant formula, or an agent of such 
manufacturer, shall conduct regularly scheduled audits to determine 
whether the manufacturer has complied with the current good 
manufacturing practice regulations in this subpart. Such audits shall be 
conducted at a frequency that is required to ensure compliance with such 
regulations.
    (b) The audits required by paragraph (a) of this section shall be 
performed by an individual or a team of individuals who, as a result of 
education, training, or experience, is knowledgeable in all

[[Page 225]]

aspects of infant formula production and of the Agency's regulations 
concerning current good manufacturing practice that such individual or 
team is responsible for auditing. This individual or team of individuals 
shall have no direct responsibility for the matters that such individual 
or team is auditing and shall have no direct interest in the outcome of 
the audit.



                  Subpart C_Quality Control Procedures



Sec. 106.91  General quality control.

    (a) During manufacture, a manufacturer shall test each production 
aggregate for nutrients as follows:
    (1) Each nutrient premix used in the manufacture of an infant 
formula shall be tested for each nutrient (required under Sec. 107.100 
of this chapter or otherwise added by the manufacturer) that the 
manufacturer is relying on the premix to provide, to ensure that the 
premix is in compliance with the manufacturer's specifications;
    (2) During the manufacturing process, after the addition of the 
premix, or at the final product stage but before distribution, each 
production aggregate of infant formula shall be tested for at least one 
indicator nutrient for each of the nutrient premixes used in the infant 
formula to confirm that the nutrients supplied by each of the premixes 
are present, in the proper concentration, in the production aggregate of 
infant formula.
    (3) At the final product stage, before distribution of an infant 
formula, each production aggregate shall be tested for vitamins A, C, E, 
and thiamin.
    (4) During the manufacturing process or at the final product stage, 
before distribution, each production aggregate shall be tested for all 
nutrients required to be included in such formula under Sec. 107.100 of 
this chapter for which testing is not conducted for compliance with 
paragraphs (a)(1) or (a)(3) of this section and for any nutrient added 
by the manufacturer for which testing is not conducted for compliance 
with paragraph (a)(1) of this section.
    (b) A manufacturer shall test each production aggregate of finished 
product for nutrients as follows:
    (1)(i) For an infant formula that is a new infant formula the 
manufacturer shall collect, from each manufacturing site and at the 
final product stage, a representative sample of the first production 
aggregate of packaged, finished formula in each physical form (powder, 
ready-to-feed, or concentrate) and evaluate the levels of all nutrients 
required under Sec. 107.100 of this chapter and all other nutrients 
added by the manufacturer. The manufacturer shall repeat such testing 
every 4 months thereafter throughout the shelf life of the product.
    (ii) The Food and Drug Administration will exempt the manufacturer 
from the requirements of paragraph (b)(1)(i) of this section if the 
manufacturer of a new infant formula requests an exemption and provides 
analytical data, as required under Sec. 106.120(b)(7), that 
demonstrates that the stability of the new infant formula will likely 
not differ from the stability of formulas with similar composition, 
processing, and packaging for which there are extensive stability data. 
A manufacturer exempt from the requirements of paragraph (b)(1)(i) of 
this section would be required to test the first production aggregate 
according to the requirements of Sec. 106.91(b)(2).
    (2) The manufacturer shall collect, from each manufacturing site and 
at the final product stage, a representative sample of each subsequent 
production aggregate of packaged, finished formula in each physical form 
(powder, ready-to-feed, or concentrate) and evaluate the levels of all 
nutrients required under Sec. 107.100 of this chapter and all other 
nutrients added by the manufacturer. The manufacturer shall repeat such 
testing at the end of the shelf life of the product.
    (3) If the results of the testing required by paragraph (b)(1) of 
this section do not substantiate the shelf life of the infant formula, 
the manufacturer shall address, as appropriate, all production 
aggregates of formula released and pending release for distribution that 
are implicated by the testing results, such as by conducting the testing 
required by paragraph (b)(1) of this section on a subsequently produced 
production aggregate to substantiate the shelf life of the infant 
formula or

[[Page 226]]

revising the use by date for such product so that such date is 
substantiated by the stability testing results.
    (4) If results of the testing required by paragraph (b)(2) of this 
section show that any required nutrient is not present in the production 
aggregate of infant formula at the level required by Sec. 107.100 of 
this chapter or that any nutrient added by the manufacturer is not 
present at the level declared on the label of the production aggregate 
of infant formula, the manufacturer shall:
    (i) Investigate the cause of such variance in the level of any 
required or added nutrient;
    (ii) Evaluate the significance, if any, of the results for other 
production aggregates of the same formula that have been released for 
distribution;
    (iii) Address, as appropriate, all production aggregates of formula 
released and pending release for distribution that are implicated by the 
testing results; and
    (iv) Determine whether it is necessary to conduct the testing 
required by paragraph (b)(1) of this section.
    (5) The testing required by paragraphs (b)(1) and (b)(2) of this 
section is not required to evaluate the level of minerals present in the 
infant formula.
    (c) All quality control testing shall be conducted using 
appropriate, scientifically valid test methods.
    (d) A manufacturer shall make and retain quality control records in 
accordance with Sec. 106.100(e)(5)(i).

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



Sec. 106.92  Audits of quality control procedures.

    (a) A manufacturer of an infant formula, or an agent of such a 
manufacturer, shall conduct regularly scheduled audits to determine 
whether the manufacturer has complied with the requirements for quality 
control procedures that are necessary to ensure that an infant formula 
provides nutrients in accordance with section 412(b) and (i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b) and (i)) and is 
manufactured in a manner designed to prevent adulteration of the infant 
formula under section 412(a)(1) and (a)(3) of the Federal Food, Drug, 
and Cosmetic Act. Such audits shall be conducted at a frequency that is 
required to ensure compliance with the requirements for quality control 
procedures.
    (b) The audits required by paragraph (a) of this section shall be 
performed by an individual or a team of individuals who, as a result of 
education, training, or experience, is knowledgeable in all aspects of 
infant formula production and of the regulations concerning quality 
control procedures that such individual or team is responsible for 
auditing. This individual or team of individuals shall have no direct 
responsibility for the matters that such individual or team is auditing 
and shall have no direct interest in the outcome of the audit.



                       Subpart D_Conduct of Audits



Sec. 106.94  Audit plans and procedures.

    (a) A manufacturer shall develop and follow a written audit plan 
that is available at the manufacturing facility for Food and Drug 
Administration inspection.
    (b) The audit plan shall include audit procedures that set out the 
methods the manufacturer uses to determine whether the facility is 
operating in accordance with current good manufacturing practice, with 
the quality control procedures that are necessary to ensure that an 
infant formula provides nutrients in accordance with sections 412(b) and 
(i) of the Federal Food, Drug, and Cosmetic Act, and in a manner 
designed to prevent adulteration of the infant formula.
    (c) The audit procedures shall include:
    (1) An evaluation of the production and in-process control system 
established under Sec. 106.6(b) by:
    (i) Observing the production of infant formula and comparing the 
observed process to the written production and in-process control plan 
required under Sec. 106.6(b);
    (ii) Reviewing records of the monitoring of points, steps, or stages 
where control is deemed necessary to prevent adulteration; and
    (iii) Reviewing records of how deviations from any specification at 
points, steps, or stages where control is deemed necessary to prevent 
adulteration were handled; and

[[Page 227]]

    (2) A review of a representative sample of all records maintained in 
accordance with Sec. 106.100(e) and (f).



              Subpart E_Quality Factors for Infant Formulas



Sec. 106.96  Requirements for quality factors for infant formulas.

    The regulations set forth in this subpart define the minimum 
requirements for quality factors for infant formulas:
    (a) An infant formula shall meet the quality factor of normal 
physical growth.
    (b) A manufacturer of an infant formula that is not an eligible 
infant formula shall demonstrate that a formula supports normal physical 
growth in infants when fed as a sole source of nutrition by conducting, 
in accordance with good clinical practice, an adequate and well-
controlled growth monitoring study of the infant formula that:
    (1) Is no less than 15 weeks in duration, enrolling infants no more 
than 2 weeks old at time of entry into the study;
    (2) Includes the collection and maintenance of data on formula 
intake and anthropometric measures of physical growth, including body 
weight, recumbent length, head circumference, average daily weight 
increment, and average daily recumbent length increment;
    (3) Includes anthropometric measurements made at the beginning and 
end of the study, and at least four additional measurements made at 
intermediate time points with three of the six total measurements made 
within the first 4 weeks of the study and three measurements made at 
approximately 4-week intervals over the remaining 11 weeks of the study;
    (4) Compares the anthropometric data for the test group to a 
concurrent control group or groups at each time point and compares the 
anthropometric data for each infant (body weight for age, body length 
for age, head circumference for age, and weight for length) in the test 
group and the control group to the 2009 CDC growth charts, which are 
incorporated by reference at Sec. 106.160; and
    (5) Compares the data on formula intake of the test group with a 
concurrent control group or groups and a scientifically appropriate 
reference.
    (c) The Food and Drug Administration will exempt a manufacturer from 
the requirements of paragraph (b) of this section, if:
    (1) The manufacturer requests an exemption and provides assurances, 
as required under Sec. 106.121(b), that the changes made by the 
manufacturer to an existing infant formula are limited to changing the 
type of packaging of an existing infant formula (e.g., changing from 
metal cans to plastic pouches); or
    (2) The manufacturer requests an exemption and provides assurances, 
as required under Sec. 106.121, which demonstrate that:
    (i) An alternative method or study design that is based on sound 
scientific principles is available to show that the formula supports 
normal physical growth in infants when the formula is fed as the sole 
source of nutrition;
    (ii) The change made by the manufacturer to an existing formula does 
not affect the ability of the formula to support normal physical growth; 
or
    (iii) The manufacturer markets a formulation in more than one form 
(e.g., liquid and powdered forms) and the quality factor requirements 
are met by the form of the formula that is processed using the method 
that has the greatest potential for adversely affecting nutrient content 
and bioavailability.
    (d) A manufacturer of a new infant formula that is not an eligible 
infant formula shall, in accordance with Sec. 106.100(p)(1), make and 
retain records demonstrating that the formula meets the quality factor 
of normal physical growth.
    (e) An infant formula shall meet the quality factor of sufficient 
biological quality of protein.
    (f) A manufacturer of an infant formula that is not an eligible 
infant formula shall demonstrate that a formula meets the quality factor 
of sufficient biological quality of protein by establishing the 
biological quality of the protein in the infant formula when fed as the 
sole source of nutrition using an

[[Page 228]]

appropriate modification of the Protein Efficiency Ratio (PER) rat 
bioassay described in the ``Official Methods of Analysis of AOAC 
International,'' 18th ed., sections 45.3.04 and 45.3.05, ``AOAC Official 
Method 960.48 Protein Efficiency Ratio Rat Bioassay,'' which is 
incorporated by reference at Sec. 106.160. The PER rat bioassay shall 
be conducted on a formula and the results evaluated prior to the 
initiation of a growth monitoring study of the formula that is required 
under paragraph (b) of this section.
    (g) The Food and Drug Administration will exempt a manufacturer from 
the requirements of paragraph (f) of this section, if:
    (1) The manufacturer requests an exemption and provides assurances 
as required under Sec. 106.121(g) that the changes made by the 
manufacturer to an existing infant formula are limited to changing the 
type of packaging of an existing infant formula (e.g., changing from 
metal cans to plastic pouches); or
    (2) The manufacturer requests an exemption and provides assurances, 
as required under Sec. 106.121(h), that demonstrate that the change 
made by the manufacturer to an existing formula does not affect the 
bioavailability of the protein.
    (3) The manufacturer requests an exemption and provides assurances, 
as required under Sec. 106.121(i), that demonstrate that an alternative 
method to the PER that is based on sound scientific principles is 
available to demonstrate that the formula supports the quality factor 
for the biological quality of the protein.
    (h) A manufacturer of a new infant formula that is not an eligible 
infant formula shall, in accordance with Sec. 106.100(q), make and 
retain records demonstrating that the formula meets the quality factor 
of sufficient biological quality of protein.
    (i) The following provisions for requirements for quality factors 
apply only to an ``eligible infant formula'' as defined in Sec. 106.3:
    (1) An eligible infant formula that fulfills one or more of the 
following criteria meets the quality factor of normal physical growth:
    (i) The scientific evidence on such infant formula meets the 
requirements of paragraph (b) of this section that apply to infant 
formula that is not an eligible infant formula;
    (ii) The scientific evidence on such infant formula meets the 
following provisions:
    (A) The evidence is an adequate and well-controlled growth study, 
conducted in accordance with good clinical practice, to determine 
whether an infant formula supports normal physical growth in infants 
when the formula is fed as the sole source of nutrition;
    (B) The growth study is no less than 4 months in duration, enrolling 
infants no more than 1 month old at time of entry into the study;
    (C) The growth study collects from the study subjects data on 
anthropometric measures of physical growth, including body weight, 
recumbent length, head circumference, and average daily weight 
increment, and plots the data on the following charts from ``Physical 
Growth: National Center for Health Statistics Percentiles'' for body 
weight, body length, and head circumference, which are incorporated by 
reference at Sec. 106.160:
    (1) Figure 1. Length by age percentiles for girls aged birth-36 
months (p. 609);
    (2) Figure 2. Length by age percentiles for boys aged birth-36 
months (p. 610);
    (3) Figure 3. Weight by age percentiles for girls aged birth-36 
months (p. 611);
    (4) Figure 4. Weight by age percentiles for boys aged birth-36 
months (p. 612);
    (5) Figure 5. Head circumference by age percentiles for girls aged 
birth-36 months (p. 613);
    (6) Figure 6. Weight by length percentiles for girls aged birth-36 
months (p. 613);
    (7) Figure 7. Head circumference by age percentiles for boys aged 
birth-36 months (p. 614); and
    (8) Figure 8. Weight by length percentiles for boys aged birth-36 
months (p. 614); and
    (D) The growth study collects anthropometric measurements at the 
beginning of the growth study, at 2 weeks, at 4 weeks, at least monthly 
thereafter, and at the conclusion of the study; or

[[Page 229]]

    (iii) The scientific evidence on such infant formula otherwise 
demonstrates that such formula supports normal physical growth.
    (2) An eligible infant formula that fulfills one or more of the 
following criteria meets the quality factor of sufficient biological 
quality of the protein:
    (i) The scientific evidence on such infant formula meets the 
requirements of paragraph (f) of this section that apply to infant 
formula that is not an eligible infant formula;
    (ii) The scientific evidence on such infant formula is a study that 
establishes the biological quality of the protein in an infant formula 
by demonstrating that the protein source supports adequate growth using 
the Protein Efficiency Ratio (PER) rat bioassay described in sections 
45.3.04 and 45.3.05 of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 16th ed., which are 
incorporated by reference at Sec. 106.160; or
    (iii) The scientific evidence on such infant formula otherwise 
demonstrates that the protein in such infant formula is of sufficient 
biological quality.
    (3) The manufacturer of an eligible infant formula may, not later 
than November 12, 2015, submit a petition to the Food and Drug 
Administration under Sec. 10.30 of this chapter that:
    (i) Demonstrates that such formula fulfills one or more of the 
criteria in paragraph (i)(1) of this section; or
    (ii) Demonstrates that such formula fulfills one or more of the 
criteria in paragraph (i)(2) of this section.
    (4) A petition filed under paragraph (i)(3) of this section shall 
address only one infant formula formulation and shall contain all data 
and information relied upon by the manufacturer to demonstrate that such 
formulation fulfills one or more of the criteria in paragraph (i)(1) or 
in paragraph (i)(2) of this section. A manufacturer may combine 
petitions submitted under paragraphs (i)(3)(i) and (i)(3)(ii) of this 
section that relate to the same formulation.
    (5) The manufacturer of each eligible infant formula shall make and 
retain, in accordance with Sec. 106.100(p)(2), records to demonstrate 
that such formula supports normal physical growth in infants when fed as 
the sole source of nutrition and shall make and retain, in accordance 
with Sec. 106.100(q)(2), records to demonstrate that that the protein 
in such infant formula is of sufficient biological quality. The records 
required by this paragraph shall include all relevant scientific data 
and information and a narrative explanation of why the data and 
information demonstrate that the formula supports normal physical growth 
and a narrative explanation of why the data and information demonstrate 
that the protein in such infant formula is of sufficient biological 
quality.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



                      Subpart F_Records and Reports



Sec. 106.100  Records.

    (a) Every manufacturer of infant formula shall maintain the records 
specified in this regulation in order to permit the Food and Drug 
Administration to determine whether each manufacturer is in compliance 
with section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a)).
    (b) The manufacturer shall maintain all records that pertain to 
food-packaging materials subject to Sec. 174.5 of this chapter and that 
bear on whether such materials would cause an infant formula to be 
adulterated within the meaning of section 402(a)(2)(C) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(2)(C)).
    (c) The manufacturer shall maintain all records that pertain to 
nutrient premix testing that it generates or receives. Such records 
shall include, but are not limited to:
    (1) Any results of testing conducted to ensure that each nutrient 
premix is in compliance with the premix certificate and guarantee and 
specifications that have been provided to the manufacturer by the premix 
supplier, including tests conducted when nutrients exceed their 
expiration date or shelf life (retest date).
    (2) All certificates and guarantees given by premix suppliers 
concerning the nutrients required by section 412(i) of the Federal Food, 
Drug, and Cosmetic Act and Sec. 107.100 of this chapter.

[[Page 230]]

    (d) The premix supplier shall maintain the results of all testing 
conducted to provide all certificates and guarantees concerning nutrient 
premixes for infant formulas. Such records shall include but are not 
limited to:
    (1) The results of tests conducted to determine the purity of each 
nutrient required by section 412(i) of the Federal Food, Drug, and 
Cosmetic Act or Sec. 107.100 of this chapter and any other nutrient 
listed in the certificate and guarantee;
    (2) The weight of each nutrient added;
    (3) The results of any quantitative tests conducted to determine the 
amount of each nutrient certified or guaranteed; and
    (4) The results of any quantitative tests conducted to identify the 
nutrient levels present when nutrient premixes exceed their expiration 
date or shelf life (retest date).
    (e) For each production aggregate of infant formula, a manufacturer 
shall prepare and maintain records that include complete information 
relating to the production and control of the production aggregate. 
These records shall include:
    (1) The master manufacturing order. The master manufacturing order 
shall include:
    (i) The significant steps in the production of the production 
aggregate and the date on which each significant step occurred;
    (ii) For a manufacturing facility that has more than one set of 
equipment or more than one processing line, the identity of equipment 
and processing lines for which the manufacturer has identified points, 
steps, or stages in the production process where control is necessary to 
prevent adulteration;
    (iii) The identity of each lot of ingredients, containers, and 
closures used in producing the production aggregate of formula;
    (iv) The amount of each ingredient to be added to the production 
aggregate of infant formula and a check (verification) that the correct 
amount was added; and
    (v) A copy of each infant formula label used on a finished 
production aggregate of infant formula and the results of examinations 
conducted during the finishing operations to provide assurance that the 
containers and packages have the correct label.
    (2) Any deviations from the master manufacturing order and any 
corrective actions taken because of the deviations.
    (3) Documentation, in accordance with Sec. 106.6(c), of the 
monitoring at any point, step, or stage in the manufacturer 's 
production process where control is deemed necessary to prevent 
adulteration. These records shall include:
    (i) A list of the specifications established at each point, step, or 
stage in the production process where control is deemed necessary to 
prevent adulteration, in accordance with Sec. 106.6(c)(1), including 
documentation of the scientific basis for each specification;
    (ii) The actual values obtained during the monitoring operation, any 
deviations from established specifications, and any corrective actions 
taken; and
    (iii) Identification of the person monitoring each point, step, or 
stage in the production process where control is deemed necessary to 
prevent adulteration.
    (4) The conclusions and followup, along with the identity of the 
individual qualified by education, training, or experience who 
investigated:
    (i) Any deviation from the master manufacturing order and any 
corrective actions taken;
    (ii) A finding that a production aggregate or any of its ingredients 
failed to meet the infant formula manufacturer's specifications; and
    (iii) A failure to meet any specification at any point, step, or 
stage in the production process where control is deemed necessary to 
prevent adulteration.
    (5) The results of all testing performed on the production aggregate 
of infant formula, including testing on the in-process production 
aggregate, at the final product stage, and on finished product 
throughout the shelf life of the product. The results recorded shall 
include:
    (i) The results of all quality control testing conducted in 
accordance with Sec. 106.91(a) and (b) to verify that each nutrient 
required by Sec. 107.100 of this chapter is present in each production

[[Page 231]]

aggregate of infant formula at the level required by Sec. 107.100 of 
this chapter, and that all other nutrients added by the manufacturer are 
present at the appropriate level. The record of the results of the 
quality control testing shall include:
    (A) A summary document identifying the stages of the manufacturing 
process at which the nutrient analysis for each required nutrient is 
conducted as required under Sec. 106.91(a); and
    (B) A summary document on the stability testing program conducted 
under Sec. 106.91(b), including the nutrients tested and the frequency 
of nutrient testing throughout the shelf life of the product.
    (ii) For powdered infant formula, the results of any testing 
conducted in accordance with Sec. 106.55(c) to verify compliance with 
the microbiological quality standards in Sec. 106.55(e).
    (f) A manufacturer shall make and retain all records described in 
subparts B and C of this part, including:
    (1) Records, in accordance with Sec. 106.20(f)(4), of the frequency 
and results of testing of the water used in the production of infant 
formula;
    (2) Records, in accordance with Sec. 106.30(d), of accuracy checks 
of instruments and controls. A certification of accuracy of any known 
reference standard used and a history of recertification shall be 
maintained. At a minimum, such records shall specify the instrument or 
control being checked, the date of the accuracy check, the standard 
used, the calibration method used, the results found, any actions taken 
if the instrument is found to be out of calibration, and the initials or 
name of the individual performing the test. If calibration of an 
instrument shows that a specification at a point, step, or stage in the 
production process where control is deemed necessary to prevent 
adulteration has not been met, a written evaluation of all affected 
product, and any actions that need to be taken with respect to that 
product, shall be made.
    (3) Records, in accordance with Sec. 106.30(e)(3)(iii).
    (4) Records, in accordance with Sec. 106.30(f), on equipment 
cleaning, sanitizing, and maintenance that show the date and time of 
such cleaning, sanitizing, and maintenance and the production aggregate 
number of each infant formula processed between equipment startup and 
shutdown for cleaning, sanitizing, and maintenance. The person 
performing and checking the cleaning, sanitizing, and maintenance shall 
date and sign or initial the record indicating that the work was 
performed.
    (5) Records, in accordance with Sec. 106.35(c), on all mechanical 
and electronic equipment used in the production or quality control of 
infant formula. These records shall include:
    (i) A list of all systems used with a description of the computer 
files and the defined capabilities and inherent limitations of each 
system;
    (ii) A copy of all software used;
    (iii) Records that document installation, calibration, testing or 
validation, and maintenance of the systems used;
    (iv) A list of all persons authorized to create or modify software;
    (v) Records that document modifications to software, including the 
identity of the person who modified the software;
    (vi) Records that document retesting or revalidation of modified 
systems; and
    (vii) A backup file of data entered into a computer or related 
system. The backup file shall consist of a hard copy or alternative 
system, such as duplicate electronic records, tapes, or microfilm, 
designed to ensure that backup data are exact and complete, and that 
they are secure from alteration, inadvertent erasures, or loss.
    (6) Records, in accordance with Sec. 106.40(g), on ingredients, 
containers, and closures used in the manufacture of infant formula. 
These records shall include:
    (i) The identity and quantity of each lot of ingredients, 
containers, and closures;
    (ii) The name of the supplier;
    (iii) The supplier's lot numbers;
    (iv) The name and location of the manufacturer of the ingredient, 
container, or closure, if different from the supplier;
    (v) The date of receipt;
    (vi) The receiving code as specified; and

[[Page 232]]

    (vii) The results of any test or examination (including retesting 
and reexamination) performed on the ingredients, containers, or closures 
and the conclusions derived there from and the disposition of all 
ingredients, containers, or closures.
    (7) A full description of the methodology used to test powdered 
infant formula to verify compliance with the microbiological quality 
standards of Sec. 106.55(c) and the methodology used to do quality 
control testing, in accordance with Sec. 106.91(a).
    (g) A manufacturer shall maintain all records pertaining to 
distribution of the infant formula, including records that show that 
formula produced for export only is exported. Such records shall include 
all information and data necessary to effect and monitor recalls of the 
manufacturer's infant formula products in accordance with subpart E of 
part 107 of this chapter.
    (h) The manufacturer shall maintain all records pertaining to the 
microbiological quality and purity of raw materials and finished 
powdered infant formula.
    (i) [Reserved]
    (j) The manufacturer shall make and retain records pertaining to 
regularly scheduled audits, including the audit plans and procedures, 
the findings of the audit, and a listing of any changes made in response 
to these findings. The manufacturer shall make readily available for 
authorized inspection the audit plans and procedures and a statement of 
assurance that the regularly scheduled audits are being conducted. The 
findings of the audit and any changes made in response to these findings 
shall be maintained for the time period required under paragraph (n) of 
this section, but need not be made available to the Food and Drug 
Administration.
    (k) The manufacturer shall maintain procedures describing how all 
written and oral complaints regarding infant formula will be handled. 
The manufacturer shall follow these procedures and shall include in them 
provisions for the review of any complaint involving an infant formula 
and for determining the need for an investigation of the possible 
existence of a hazard to health.
    (1) For purposes of this section, every manufacturer shall interpret 
a ``complaint'' as any communication that contains any allegation, 
written or oral, expressing dissatisfaction with a product for any 
reason, including concerns about the possible existence of a hazard to 
health and about appearance, taste, odor, and quality. Correspondence 
about prices, package size or shape, or other matters that could not 
possibly reveal the existence of a hazard to health shall not, for 
compliance purposes, be considered a complaint and therefore need not be 
made available to a Food and Drug Administration investigator.
    (2) When a complaint shows that a hazard to health possibly exists, 
the manufacturer shall conduct an investigation into the validity of the 
complaint. Where such an investigation is conducted, the manufacturer 
shall include in its file on the complaint the determination as to 
whether a hazard to health exists and the basis for that determination. 
No investigation is necessary when the manufacturer determines that 
there is no possibility of a hazard to health. When no investigation is 
necessary, the manufacturer shall include in the record the reason that 
an investigation was found to be unnecessary and the name of the 
responsible person making that determination.
    (3) When there is a reasonable possibility of a causal relationship 
between the consumption of an infant formula and an infant's death, the 
manufacturer shall, within 15 days of receiving such information, 
conduct an investigation and notify the Agency as required in Sec. 
106.150.
    (4) The manufacturer shall maintain in designated files all records 
pertaining to the complaints it receives. The manufacturer shall 
separate the files into two classes:
    (i) Those complaints that allege that the infant became ill from 
consuming the product or required treatment by a physician or health 
care provider and
    (ii) Those complaints that may involve a possible existence of a 
hazard to health but do not refer to an infant becoming ill or the need 
for treatment by physician or a health care provider.
    (5) The manufacturer shall include in a complaint file the following 
information concerning the complaint:

[[Page 233]]

    (i) The name of the infant formula;
    (ii) The production aggregate number;
    (iii) The name of complainant;
    (iv) A copy of the complaint or a memo of the telephone conversation 
or meeting and all correspondence with the complainant;
    (v) By reference or copy, all the associated manufacturing records 
and complaint investigation records needed to evaluate the complaint. 
When copies of such records are not maintained in the complaint file, 
they must be available within 24 hours when requested by a Food and Drug 
Administration official.
    (vi) All actions taken to followup on the complaint; and
    (vii) All findings and evaluations of the complaint.
    (6) The manufacturer should maintain the files regarding infant 
formula complaints at the establishment where the infant formula was 
manufactured, processed, or packed. When the manufacturer wishes to 
maintain all consumer complaints for the entire firm at one location 
other than at the facility where an infant formula was manufactured, 
processed, or packed, the manufacturer may do so as long as all records 
required by this section are available within 24 hours of request for 
inspection at that facility. However, all records of consumer 
complaints, including summaries, any reports, and any files, maintained 
at the manufacturing facility or at any other facility shall be made 
available to investigators for review and copying upon request.
    (l) The manufacturer shall make readily available for authorized 
inspection all records required under this part or copies of such 
records. Records shall be available at any reasonable time at the 
establishment where the activities described in such records occurred. 
(Infant formula complaint files may be maintained at one facility, as 
provided in paragraph (k)(6) of this section, if all required records 
are readily available at that facility.) These records or copies thereof 
shall be subject to photocopying or other means of reproduction as part 
of such inspection. Records that can be immediately retrieved from 
another location by electronic means shall be considered as meeting the 
requirements of this paragraph.
    (m) A manufacturer shall maintain all records required under this 
part in a manner that ensures that both the manufacturer and the Food 
and Drug Administration can be provided with access to such records 
within 24 hours. The manufacturer may maintain the records required 
under this part as original records, as true copies such as photocopies, 
microfilm, microfiche, or other accurate reproductions of the original 
records, or as electronic records. Where reduction techniques, such as 
microfilming, are used, suitable reader and photocopying equipment shall 
be readily available. All electronic records maintained under this part 
shall comply with part 11 of this chapter.
    (n) Production control, product testing, testing results, 
complaints, and distribution records necessary to verify compliance with 
parts 106, 107, 109, 110, 113, and 117 of this chapter, or with other 
appropriate regulations, shall be retained for 1 year after the 
expiration of the shelf life of the infant formula or 3 years from the 
date of manufacture, whichever is greater.
    (o) The manufacturer shall maintain quality control records that 
contain sufficient information to permit a public health evaluation of 
any production aggregate of infant formula.
    (p) A manufacturer shall make and retain records that demonstrate 
that the formula meets the quality factor of normal physical growth.
    (1) For an infant formula that is not an eligible infant formula, in 
accordance with Sec. 106.96(d), these records shall include:
    (i) Records demonstrating compliance with the requirements in Sec. 
106.96(b), including records made in compliance with Sec. 106.121; or
    (ii) Records demonstrating satisfaction of an applicable exemption 
under Sec. 106.96(c), including records made in compliance with Sec. 
106.121.
    (2) For an eligible infant formula, in accordance with Sec. 
106.96(i)(5), these records shall include records demonstrating that the 
formula fulfills one or more of the criteria listed in Sec. 
106.96(i)(1).

[[Page 234]]

    (q) A manufacturer shall make and retain records that demonstrate 
that a formula meets the quality factor of sufficient biological quality 
of protein.
    (1) For an infant formula that is not an eligible infant formula, in 
accordance with Sec. 106.96(h), these records shall include:
    (i) Records demonstrating compliance with the requirements in Sec. 
106.96(f), including records made in compliance with Sec. 106.121; or
    (ii) Records demonstrating satisfaction of an applicable exemption 
under Sec. 106.96(g), including records made in compliance with Sec. 
106.121.
    (2) For an eligible infant formula, in accordance with Sec. 
106.96(i)(5), these records shall include records demonstrating that the 
formula fulfills one or more of the criteria listed in Sec. 
106.96(i)(2).
    (r) The failure to comply with the records requirements in this 
section applicable to the quality factors shall render the formula 
adulterated under section 412(a)(2) of the Federal Food, Drug, and 
Cosmetic Act. The failure to comply with the records requirements in 
this section applicable to the good manufacturing practices and quality 
control procedures, including distribution and audit records 
requirements, with respect to an infant formula shall render the formula 
adulterated under section 412(a)(3) of the Federal Food, Drug, and 
Cosmetic Act. A failure to retain or make available records applicable 
to the quality factor requirements, quality control procedures, or 
current good manufacturing practices requirements in compliance with 
paragraph (l), (m), or (n) of this section with respect to a formula 
shall render the formula adulterated under section 412(a)(2) or (a)(3) 
of the Federal Food, Drug, and Cosmetic Act, as applicable.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014; 80 
FR 56144, Sept. 17, 2015]



    Subpart G_Registration, Submission, and Notification Requirements



Sec. 106.110  New infant formula registration.

    (a) Before a new infant formula may be introduced or delivered for 
introduction into interstate commerce, including a new infant formula 
for export only, the manufacturer of the formula shall register with the 
Food and Drug Administration, Center for Food Safety and Applied 
Nutrition, Office of Nutrition, Labeling, and Dietary Supplements, 
Infant Formula and Medical Foods Staff (HFS-850), 5001 Campus Dr., 
College Park, MD 20740-3835.
    (b) The new infant formula registration shall include:
    (1) The name of the new infant formula;
    (2) The name of the manufacturer;
    (3) The street address of the place of business of the manufacturer; 
and
    (4) The name and street address of each establishment at which the 
manufacturer intends to manufacture such new infant formula.



Sec. 106.120  New infant formula submission.

    (a) At least 90 days before a new infant formula is introduced or 
delivered for introduction into interstate commerce, a manufacturer 
shall submit notice of its intent to do so to the Food and Drug 
Administration at the address given in Sec. 106.110(a). An original and 
two paper copies of such notice of intent shall be submitted, unless the 
notice is submitted in conformance with part 11 of this chapter, in 
which case a single copy shall be sufficient.
    (b) The new infant formula submission shall include:
    (1) The name and description of the physical form (e.g., powder, 
ready-to feed, or concentrate) of the infant formula;
    (2) An explanation of why the formula is a new infant formula;
    (3) The quantitative formulation of each form of the infant formula 
that is the subject of the notice in units per volume or units per 
weight for liquid formulas, specified either as sold or as fed, and 
units per dry weight for powdered formulas, and the weight of powder to 
be reconstituted with a specified volume of water, and, when applicable, 
a description of any reformulation of the infant formula, including a 
listing of each new or changed ingredient and a discussion of the effect 
of such changes on the nutrient levels in the formulation;

[[Page 235]]

    (4) A description, when applicable, of any change in processing of 
the infant formula. Such description shall identify the specific change 
in processing, including side-by-side, detailed schematic diagrams 
comparing the new processing to the previous processing and processing 
times and temperatures;
    (5) Assurance that the infant formula will not be marketed unless 
the formula meets the requirements for quality factors of section 
412(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a(b)(1)) and the nutrient content requirements of section 412(i) of 
the Federal Food, Drug, and Cosmetic Act.
    (i) Assurance that the formula meets the requirements for quality 
factors, which are set forth in Sec. 106.96, shall be provided by a 
submission that complies with Sec. 106.121;
    (ii) Assurance that the formula complies with the nutrient content 
requirements, which are set forth in Sec. 107.100 of this chapter, 
shall be provided by a statement that the formula will not be marketed 
unless it meets the nutrient requirements of Sec. 107.100 of this 
chapter, as demonstrated by testing required under subpart C of this 
part; and
    (6) Assurance that the processing of the infant formula complies 
with section 412(b)(2) of the Federal Food, Drug, and Cosmetic Act. Such 
assurance shall include:
    (i) A statement that the formula will be produced in accordance with 
subparts B and C of this part; and
    (ii) The basis on which each ingredient meets the requirements of 
Sec. 106.40(a), e.g. that it is an approved food additive, that it is 
authorized by a prior sanction, or that it is generally recognized as 
safe (GRAS) for its intended use. Any claim that an ingredient is GRAS 
shall be supported by a citation to the Agency's regulations or by an 
explanation, including a list of published studies and a copy of those 
publications, for why, based on the published studies, there is general 
recognition of the safety of the use of the ingredient in infant 
formula.
    (7) If the manufacturer is requesting an exemption under Sec. 
106.91(b)(1)(ii), the manufacturer shall include the scientific evidence 
that the manufacturer is relying on to demonstrate that the stability of 
the new infant formula will likely not differ from the stability of 
formulas with similar composition, processing, and packaging for which 
there are extensive stability data.
    (c) For a new infant formula for export only, a manufacturer may 
submit, in lieu of the information required under paragraphs (b)(5) and 
(b)(6) of this section, a statement certifying that the infant formula 
meets the specifications of the foreign purchaser, the infant formula 
does not conflict with the laws of the country to which it is intended 
for export, the infant formula is labeled on the outside of the shipping 
package to indicate that it is intended for export only, and the infant 
formula will not be sold or offered for sale in domestic commerce. Such 
manufacturer shall also submit a statement certifying that it has 
adequate controls in place to ensure that such formula is actually 
exported.
    (d) The submission will not constitute notice under section 412 of 
the Federal Food, Drug, and Cosmetic Act unless it complies fully with 
paragraph (b) of this section, as applicable, and the information that 
it contains is set forth in a manner that is readily understandable. The 
Agency will notify the manufacturer if the notice is not complete 
because it does not meet the requirements in section 412(c) and (d) of 
the Federal Food, Drug, and Cosmetic Act.
    (e) If a new infant formula submission contains all the information 
required by paragraph (b) of this section, as applicable, the Food and 
Drug Administration will acknowledge its receipt and notify the 
manufacturer of the date of receipt. The date that the Agency receives a 
new infant formula submission that is complete is the filing date for 
such submission. The manufacturer shall not market the new infant 
formula before the date that is 90 days after the filing date. If the 
information in the submission does not provide the assurances required 
under section 412(d)(1) of the Federal Food, Drug, and Cosmetic Act and 
the regulations of this chapter, the Food and Drug Administration will 
so notify the manufacturer before the expiration of the 90th day.

[[Page 236]]

    (f) If the manufacturer provides additional information in support 
of a new infant formula submission, the Agency will determine whether 
the additional information is a substantive amendment to the new infant 
formula submission. If the Agency determines that the new submission is 
a substantive amendment, the Food and Drug Administration will assign 
the new infant formula submission a new filing date. The Food and Drug 
Administration will acknowledge receipt of the additional information 
and, when applicable, notify the manufacturer of the new filing date, 
which is the date of receipt by the Food and Drug Administration of the 
information that constitutes the substantive amendment to the new infant 
formula submission.
    (g) Submissions relating to exempt infant formulas are subject to 
the provisions of Sec. 107.50 of this chapter.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014]



Sec. 106.121  Quality factor assurances for infant formulas.

    To provide assurance that an infant formula meets the requirements 
for quality factors set forth in Sec. 106.96, the manufacturer shall 
submit the following data and information:
    (a) Unless the manufacturer of a new infant formula can claim an 
exemption under Sec. 106.96(c)(1) or (c)(2), the following assurances 
shall be provided to ensure that the requirements of Sec. 106.96(a) and 
(b) have been met:
    (1) An explanation, in narrative form, setting forth how 
requirements for quality factors in Sec. 106.96(b) have been met;
    (2) Records that contain the information required by Sec. 106.96(b) 
to be collected during the study for each infant enrolled in the study. 
The records shall be identified by subject number, age, feeding group, 
gender, and study day of collection.
    (3) Data, which shall include:
    (i) Statistical evaluation for all measurements, including group 
means, group standard deviations, and measures of statistical 
significance for all measurements for each feeding group at the 
beginning of the study and at every point where measurements were made 
throughout the study, and
    (ii) Calculations of the statistical power of the study before study 
initiation and at study completion.
    (4) A report on attrition and on all occurrences of adverse events 
during the study, which shall include:
    (i) Identification of the infant by subject number and feeding group 
and a complete description of the adverse event, including comparisons 
of the frequency and nature of occurrence in each feeding group and 
information on the health of the infant during the course of the study, 
including the occurrence and duration of any illness;
    (ii) A clinical assessment by a health care provider of the infant's 
health during each suspected adverse event; and
    (iii) A list of all subjects who did not complete the study, 
including the subject number and the reason that each subject did not 
complete the study.
    (b) If the manufacturer is requesting an exemption from the growth 
monitoring study requirements under Sec. 106.96(c)(1), the manufacturer 
shall include a detailed description of the change made by the 
manufacturer to an existing infant formula and an explanation of why the 
change made by the manufacturer to an existing infant formula satisfies 
the criteria of Sec. 106.96(c)(1).
    (c) If the manufacturer is requesting an exemption under Sec. 
106.96(c)(2)(i), the manufacturer shall include a detailed description 
of the alternative method or alternative study design, an explanation of 
why the method or study design is based on sound scientific principles, 
and data that demonstrate that the formula supports normal physical 
growth in infants when the formula is fed as the sole source of 
nutrition.
    (d) If the manufacturer is requesting an exemption under Sec. 
106.96(c)(2)(ii), the manufacturer shall include a detailed description 
of the change and an explanation of why the change made by the 
manufacturer to an existing infant formula does not the affect the 
ability of the formula to support normal physical growth.
    (e) If the manufacturer is requesting an exemption under Sec. 
106.96(c)(2)(iii), the manufacturer shall include a detailed description 
of the two formulations and an explanation of why the

[[Page 237]]

quality factor requirement of normal physical growth is met by the form 
of the formula that is processed using the method that has the greatest 
potential for adversely affecting nutrient content and bioavailability.
    (f) Unless the manufacturer of a new infant formula is requesting an 
exemption under Sec. 106.96(g), the results of the Protein Efficiency 
Ratio bioassay shall be provided in accordance with Sec. 106.96(f).
    (g) If the manufacturer is requesting an exemption under Sec. 
106.96(g)(1), the manufacturer shall include a detailed description of 
the change made by the manufacturer to an existing infant formula and an 
explanation of why the change made by the manufacturer to an existing 
infant formula satisfies the criteria listed in Sec. 106.96(g)(1).
    (h) If the manufacturer is requesting an exemption under Sec. 
106.96(g)(2), the manufacturer shall include a detailed description of 
the change and an explanation of why the change made by the manufacturer 
to an existing infant formula does not affect the bioavailability of the 
protein.
    (i) If the manufacturer is requesting an exemption under Sec. 
106.96(g)(3), the manufacturer shall include a detailed explanation of 
the alternative method, an explanation of why the method is based on 
sound scientific principles, and the data that demonstrate that the 
quality factor for the biological quality of the protein has been met.
    (j) A statement certifying that the manufacturer has collected and 
considered all information and data concerning the ability of the infant 
formula to meet the requirements for quality factors and that the 
manufacturer is not aware of any information or data that would show 
that the formula does not meet the requirements for quality factors.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014]



Sec. 106.130  Verification submission.

    (a) A manufacturer shall, after the first production and before the 
introduction into interstate commerce of a new infant formula (except 
for a new infant formula that is for export only for which a submission 
is received in compliance with Sec. 106.120(c)), verify in a written 
submission to the Food and Drug Administration at the address given in 
Sec. 106.110(a) that the infant formula complies with the requirements 
of the Federal Food, Drug, and Cosmetic Act and is not adulterated.
    (b) The verification submission shall include the following 
information:
    (1) The name of the new infant formula; the filing date for the new 
infant formula submission, in accordance with Sec. 106.120, for the 
subject formula; and the identification number assigned by the Agency to 
the new infant formula submission:
    (2) A statement that the infant formula to be introduced into 
interstate commerce is the same as the infant formula that was the 
subject of the new infant formula notification and for which the 
manufacturer provided assurances in accordance with the requirements of 
Sec. 106.120;
    (3) A summary of test results of the level of each nutrient required 
by Sec. 107.100 of this chapter and any nutrient added by the 
manufacturer in the formula, presented in units per 100 kilocalories at 
the final product stage.
    (4) A certification that the manufacturer has established current 
good manufacturing practices, including quality control procedures and 
in-process controls, and testing required by current good manufacturing 
practice, designed to prevent adulteration of this formula in accordance 
with subparts B and C of this part.
    (c) The submission shall not constitute written verification under 
section 412(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a(d)(2)) when any data prescribed in paragraph (b) of this section 
are lacking or are not set forth so as to be readily understood. In such 
circumstances, the Agency will notify the manufacturer that the notice 
is not adequate.



Sec. 106.140  Submission concerning a change in infant formula that
may adulterate the product.

    (a) When a manufacturer makes a change in the formulation or 
processing of the formula that may affect whether the formula is 
adulterated under section 412(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a(a)), the manufacturer shall,

[[Page 238]]

before the first processing of such formula, make a submission to the 
Food and Drug Administration at the address given in Sec. 106.110(a). 
An original and two copies shall be submitted.
    (b) The submission shall include:
    (1) The name and physical form of the infant formula (i.e., powder, 
ready-to-feed, or concentrate);
    (2)(i) An explanation of why the change in formulation or processing 
may affect whether the formula is adulterated; and
    (ii) What steps will be taken to ensure that, before the formula is 
introduced into interstate commerce, the formula will not be 
adulterated; and
    (3) A statement that the submission complies with Sec. 
106.120(b)(3), (b)(4), (b)(5), and (b)(6). When appropriate, a statement 
to the effect that the information required by Sec. 106.120(b)(3), 
(b)(4), (b)(5), or (b)(6) has been provided to the Agency previously and 
has not been affected by the changes that are the subject of the current 
submission, together with the identification number assigned by the 
Agency to the relevant infant formula submission, may be provided in 
lieu of such statement.
    (c) The submission shall not constitute notice under section 412 of 
the Federal Food, Drug, and Cosmetic Act unless it complies fully with 
paragraph (b) of this section, and the information that it contains is 
set forth in a manner that is readily understandable. The Agency will 
notify the manufacturer if the notice is not adequate because it does 
not meet the requirements of section 412(d)(3) of the Federal Food, 
Drug, and Cosmetic Act.



Sec. 106.150  Notification of an adulterated or misbranded infant
formula.

    (a) A manufacturer shall promptly notify the Food and Drug 
Administration in accordance with paragraph (b) of this section when the 
manufacturer has knowledge (that is, actual knowledge that the 
manufacturer had, or the knowledge which a reasonable person would have 
had under like circumstances or which would have been obtained upon the 
exercise of due care) that reasonably supports the conclusion that an 
infant formula that has been processed by the manufacturer and that has 
left an establishment subject to the control of the manufacturer:
    (1) May not provide the nutrients required by section 412(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C 350d(i)) or by 
regulations issued under section 412(i)(2); or
    (2) May be otherwise adulterated or misbranded.
    (b) The notification made according to paragraph (a) of this section 
shall be made by telephone, to the Director of the appropriate Food and 
Drug Administration district office. After normal business hours (8 a.m. 
to 4:30 p.m.), the Food and Drug Administration's emergency number, 1-
866-300-4374 shall be used. The manufacturer shall promptly send written 
confirmation of the notification to the Food and Drug Administration, 
Center for Food Safety and Applied Nutrition, Office of Compliance, 
Division of Enforcement (HFS-605), Recall Coordinator, 5001 Campus Dr., 
College Park, MD 20740, and to the appropriate Food and Drug 
Administration district office.



Sec. 106.160  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part 
with the approval of the Director of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51. To enforce any edition other than that 
specified in this section, the Food and Drug Administration must publish 
notice of change in the Federal Register and the material must be 
available to the public. All approved material is available for 
inspection at the Food and Drug Administration library at 10903 New 
Hampshire Ave., Building 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039, and is available from the sources listed below. This material 
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) 3-A Sanitary Standards, Inc., 6888 Elm St., Suite 2D, McLean, VA 
22101-3829, 703-790-0295, and may be ordered online at http://www.3-
a.org/:

[[Page 239]]

    (1) 3-A Sanitary Standards, No. 609-03: A Method of Producing 
Culinary Steam, adopted November 21, 2004, into Sec. 106.20(h).
    (2) [Reserved]
    (c) American Society for Nutrition, 9650 Rockville Pike, Bethesda, 
MD 20814-3998, 301-634-7279, http://www.nutrition.org:
    (1) Physical growth: National Center for Health Statistics 
percentiles, Hamill, P.V.V., T.A. Drizd, C.L. Johnson, R.B. Reed, A.F. 
Roche, and W.M. Moore, American Journal of Clinical Nutrition, vol. 32, 
pp. 607-614, dated March 1979, into Sec. 106.96(i)(1)(ii)(c).
    (2) [Reserved]
    (d) AOAC International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2417, 301-924-7078:
    (1) Official Methods of Analysis of AOAC International, 16th ed., 
dated 1995, into Sec. 106.96(i)(2)(ii):
    (i) Section 45.3.04, AOAC Official Method 960.48 Protein Efficiency 
Ratio Rat Bioassay, and
    (ii) Section 45.3.05, AOAC Official Method 982.30 Protein Efficiency 
Ratio Calculation Method.
    (2) Official Methods of Analysis of AOAC International, 18th ed., 
dated 2005, into Sec. 106.96(f):
    (i) Section 45.3.04, AOAC Official Method 960.48 Protein Efficiency 
Ratio Rat Bioassay, and
    (ii) Section 45.3.05, AOAC Official Method 982.30 Protein Efficiency 
Ratio Calculation Method.
    (e) Centers for Disease Control and Prevention, 1600 Clifton Rd., 
Atlanta, GA 30333, 1-800-232-4636, http://www.cdc.gov/growthcharts /
who_charts.htm.
    (1) Birth to 24 months: Boys Head circumference-for-age and Weight-
for-length percentiles, dated November 1, 2009, into Sec. 106.96(b)(4).
    (2) Birth to 24 months: Boys Length-for-age and Weight-for-age 
percentiles, dated November 1, 2009, into Sec. 106.96(b)(4).
    (3) Birth to 24 months: Girls Head circumference-for-age and Weight-
for-length percentiles, dated November 1, 2009, into Sec. 106.96(b)(4).
    (4) Birth to 24 months: Girls Length-for-age and Weight-for-age 
percentiles, dated November 1, 2009, into Sec. 106.96(b)(4).



PART 107_INFANT FORMULA--Table of Contents



                      Subpart A_General Provisions

Sec.
107.1 Status and applicability of the regulations in part 107.
107.3 Definitions.

                           Subpart B_Labeling

107.10 Nutrient information.
107.20 Directions for use.
107.30 Exemptions.

                    Subpart C_Exempt Infant Formulas

107.50 Terms and conditions.

                     Subpart D_Nutrient Requirements

107.100 Nutrient specifications.

                    Subpart E_Infant Formula Recalls

107.200 Food and Drug Administration-required recall.
107.210 Firm-initiated product removals.
107.220 Scope and effect of infant formula recalls.
107.230 Elements of an infant formula recall.
107.240 Notification requirements.
107.250 Termination of an infant formula recall.
107.260 Revision of an infant formula recall.
107.270 Compliance with this subpart.
107.280 Records retention.

    Authority: 21 U.S.C. 321, 343, 350a, 371.

    Source: 50 FR 1840, Jan. 14, 1985, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 107 appear at 81 FR 
49895, July 29, 2016.



                      Subpart A_General Provisions



Sec. 107.1  Status and applicability of the regulations in part 107.

    (a) The criteria in subpart B of this part describe the labeling 
requirements applicable to infant formula under section 403 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C 343). Failure to comply 
with any regulation in subpart B of this part will render an infant 
formula misbranded under section 403 of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The criteria in subpart C of this part describe the terms and 
conditions for the exemption of an infant formula from the requirements 
of section 412(a), (b), and (c) of the Federal Food, Drug,

[[Page 240]]

and Cosmetic Act (21 U.S.C. 350a(a), (b), and (c)). Failure to comply 
with any regulations in subpart C of this part will result in withdrawal 
of the exemption given under section 412(h)(1) of the Federal Food, 
Drug, and Cosmetic Act.
    (c) Subpart D of this part contains the nutrient requirements for 
infant formula under section 412(i) of the Federal Food, Drug, and 
Cosmetic Act. Failure to comply with any regulation in subpart D of this 
part will render an infant formula adulterated under section 412(a)(1) 
of the Federal Food, Drug, and Cosmetic Act.
    (d) An exempt infant formula is subject to the provisions of Sec. 
107.50 and other applicable Food and Drug Administration food 
regulations.

[79 FR 8074, Feb. 10, 2014]



Sec. 107.3  Definitions.

    The following definitions shall apply, in addition to the 
definitions contained in section 201 of the Federal Food, Drug, and 
Cosmetic Act (the act):
    Exempt formula. An exempt infant formula is an infant formula 
intended for commercial or charitable distribution that is represented 
and labeled for use by infants who have inborn errors of metabolism or 
low birth weight, or who otherwise have unusual medical or dietary 
problems.
    Manufacturer. A person who prepares, reconstitutes, or otherwise 
changes the physical or chemical characteristics of an infant formula or 
packages or labels the product in a container for distribution. The term 
``manufacturer'' does not include a person who prepares, reconstitutes, 
or mixes infant formula exclusively for an infant under his/her direct 
care or the direct care of the institution employing such person.
    References. References in this part to regulatory sections of the 
Code of Federal Regulations are to chapter I of title 21, unless 
otherwise noted.

[50 FR 48186, Nov. 22, 1985, as amended at 79 FR 8074, Feb. 10, 2014]



                           Subpart B_Labeling



Sec. 107.10  Nutrient information.

    (a) The labeling of infant formulas, as defined in section 201(z) of 
the Federal Food, Drug, and Cosmetic Act, shall bear in the order given, 
in the units specified, and in tabular format, the following information 
regarding the product as prepared in accordance with label directions 
for infant consumption:
    (1) A statement of the number of fluid ounces supplying 100 
kilocalories (in case of food label statements, a kilocalorie is 
represented by the word ``Calorie''); and
    (2) A statement of the amount, supplied by 100 kilocalories, of each 
of the following nutrients and of any other nutrient added by the 
manufacturer:

------------------------------------------------------------------------
                 Nutrients                       Unit of measurement
------------------------------------------------------------------------
Protein...................................  Grams
Fat.......................................  Do.
Carbohydrate..............................  Do.
Water.....................................  Do.
Linoleic acid.............................  Milligrams
------------------------------------------------------------------------
                                Vitamins
------------------------------------------------------------------------
Vitamin A.................................  International Units
Vitamin D.................................  Do.
Vitamin E.................................  Do.
Vitamin K.................................  Micrograms
Thiamine (Vitamin B1).....................  Do.
Riboflavin (Vitamin B2)...................  Do.
Vitamin B6................................  Do.
Vitamin B12...............................  Do.
Niacin....................................  Do.
Folic acid (Folacin)......................  Do.
Pantothenic acid..........................  Do.
Biotin....................................  Do.
Vitamin C (Ascorbic acid).................  Milligrams
Choline...................................  Do.
Inositol..................................  Do.
------------------------------------------------------------------------
                                Minerals
------------------------------------------------------------------------
Calcium...................................  Milligrams
Phosphorus................................  Do.
Magnesium.................................  Do.
Iron......................................  Do.
Zinc......................................  Do.
Manganese.................................  Micrograms
Copper....................................  Do.
Iodine....................................  Do.
Selenium..................................  Do.
Sodium....................................  Milligrams
Potassium.................................  Do.
Chloride..................................  Do.
------------------------------------------------------------------------

    (b) In addition the following apply:
    (1) Vitamin A content may also be declared on the label in units of 
microgram retinol equivalents, vitamin D content in units of micrograms 
cholecalciferol, vitamin E content in units of milligram alpha-
tocopherol equivalents, and sodium, potassium, and chloride content in 
units of millimoles, micromoles, or milliequivalents. When these 
declarations

[[Page 241]]

are made they shall appear in parentheses immediately following the 
declarations in International Units for vitamins A, D, and E, and 
immediately following the declarations in milligrams for sodium, 
potassium, and chloride.
    (2) Biotin, choline, and inositol content shall be declared except 
when they are not added to milk-based infant formulas.
    (3) Each of the listed nutrients, and the caloric density, may also 
be declared on the label on other bases, such as per 100 milliliters or 
per liter, as prepared for infant consumption.
    (4) One of the following statements shall appear on the principal 
display panel, as appropriate:
    (i) The statement ``Infant Formula With Iron'', or a similar 
statement, if the product contains 1 milligram or more of iron in a 
quantity of product that supplies 100 kilocalories when prepared in 
accordance with label directions for infant consumption.
    (ii) The statement ``Additional Iron May Be Necessary'', or a 
similar statement, if the product contains less than 1 milligram of iron 
in a quantity of product that supplies 100 kilocalories when prepared in 
accordance with label directions for infant consumption.
    (5) Any additional vitamin may be declared at the bottom of the 
vitamin list and any additional minerals may be declared between iodine 
and sodium, provided that any additionally declared nutrient:
    (i) Has been identified as essential by the Food and Nutrition Board 
of the Institute of Medicine through its development of a Dietary 
Reference Intake, or has been identified as essential by the Food and 
Drug Administration through a Federal Register publication; and
    (ii) Is provided at a level considered in these publications as 
having biological significance, when these levels are known.

[50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002; 79 
FR 8074, Feb. 10, 2014; 80 FR 35840, June 23, 2015]



Sec. 107.20  Directions for use.

    In addition to the applicable labeling requirements in parts 101 and 
105 of this chapter, the product label shall bear:
    (a) Under the heading ``Directions For Preparation and Use'', 
directions for:
    (1) Storage of infant formula before and after the container has 
been opened, including a statement indicating that prolonged storage at 
excessive temperatures should be avoided;
    (2) Agitating liquid infant formula before opening the container, 
such as ``Shake Well Before Opening'';
    (3) ``Sterilization'' of water, bottle, and nipples when necessary 
for preparing infant formula for use;
    (4) Dilution of infant formula, when appropriate. Directions for 
powdered infant formula shall contain the weight and volume of powdered 
formula to be reconstituted.
    (b) In close proximity to the ``Directions for Preparation and Use'' 
a pictogram depicting the major steps for preparation of that infant 
formula, such as (for a concentrated formula):

[[Page 242]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.366

    (c) A ``Use by ___'' date, the blank to be filled in with the month 
and year selected by the manufacturer, packer, or distributor of the 
infant formula on the basis of tests or other information showing that 
the infant formula, until that date, under the conditions of handling, 
storage, preparation, and use prescribed by label directions, will: (1) 
when consumed, contain not less than the quantity of each nutrient, as 
set forth on its label; and (2) otherwise be of an acceptable quality 
(e.g., pass through an ordinary bottle nipple).
    (d) The statement ``Add Water'' or ``Do Not Add Water'', as 
appropriate, to appear on the principal display panel of concentrated or 
ready-to-feed infant formulas. In close proximity to the statement ``Add 
Water'', a symbol such as
[GRAPHIC] [TIFF OMITTED] TC01MR93.000


if the addition of water is necessary. The symbol shall be placed on a 
white background encircled by a dark border.
    (e) A warning statement beneath or in close proximity to the 
``Directions For Preparation and Use'' that cautions against improper 
preparation or use of an infant formula, such as ``THE HEALTH OF YOUR 
INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND 
USE''.
    (f) A statement indicating that parents should consult their 
physicians about the use of infant formulas, such as ``USE AS DIRECTED 
BY A PHYSICIAN''.

[50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002]



Sec. 107.30  Exemptions.

    When containers of ready-to-feed infant formula, to be sold at the 
retail level, are contained within a multiunit package, the labels of 
the individual containers shall contain all of the label information 
required by section 403 of the Federal Food, Drug, and Cosmetic Act (the 
act), Sec. Sec. 107.10 and 107.20, and all appropriate sections of part 
101 of this chapter, except that the labels of the individual containers 
contained within the outer package shall be exempt from compliance with 
the requirements of section 403 (e)(1) and (i)(2) of the act; and 
Sec. Sec. 107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided 
that (a) the multiunit package meets all the requirements of this part; 
(b) individual containers are securely enclosed within and are not 
intended to be separated

[[Page 243]]

from the retail package under conditions of retail sale; and (c) the 
label on each individual container includes the statement ``This Unit 
Not Intended For Individual Sale'' in type size not less than one-
sixteenth inch in height. The word ``Retail'' may be used in lieu of or 
immediately following the word ``Individual'' in the statement.



                    Subpart C_Exempt Infant Formulas



Sec. 107.50  Terms and conditions.

    (a) Terms and conditions. Section 412(f)(1) of the act exempts from 
the requirements of section 412(a), (b), and (c)(1)(A) of the act infant 
formulas that are represented and labeled for use by an infant who has 
an inborn error of metabolism or low brith weight or who otherwise has 
an unusual medical or dietary problem, if such formulas comply with 
regulations prescribed by the Secretary. The regulations in this subpart 
establish the terms and conditions that a manufacturer must meet with 
respect to such infant formulas.
    (b) Infant formulas generally available at the retail level. (1) 
These exempt infant formulas can generally be purchased from retail 
store shelves that are readily available to the public. Such formulas 
are also typically represented and labeled for use to provide dietary 
management for diseases or conditions that are not clinically serious or 
life-threatening, even though such formulas may also be represented and 
labeled for use in clinically serious or life-threatening disorders.
    (2) Except as provided in paragraphs (b)(4) and (5) of this section, 
an infant formula manufacturer shall, with respect to each formula 
covered by this paragraph, comply with the nutrient requirements of 
section 412(g) of the act or of regulations promulgated under section 
412(a)(2) of the act, the quality control procedure requirements of part 
106, and the labeling requirements of subpart B of this part.
    (3) To retain the exempt status of an infant formula covered by this 
paragraph, the manufacturer shall submit to the Food and Drug 
Administration (FDA), at the address specified in paragraph (e)(1) of 
this section, on or before May 21, 1986, or on or before the 90th day 
before the first processing of the infant formula for commercial or 
charitable distribution, whichever occurs later, the label and other 
labeling of the infant formula, a complete quantitative formulation for 
the infant formula, and a detailed description of the medical conditions 
for which the infant formula is represented. FDA will review the 
information under paragraph (d) of this section.
    (4) To retain the exempt status of an infant formula covered by this 
paragraph, when any change in ingredients or processes that may result 
in an adverse impact on levels of nutrients or availability of nutrients 
is instituted, the manufacturer shall submit to FDA at the address 
specified in paragraph (e)(1) of this section, before the first 
processing of the infant formula, the label and other labeling of the 
infant formula, a complete quantitative formulation for the infant 
formula, a detailed description of the reformulation and the rationale 
for the reformulation, a complete description of the change in 
processing, and a detailed description of the medical conditions for 
which the infant formula is represented. FDA will review that 
information under paragraph (d) of this section.
    (5) A manufacturer may deviate from the requirements of paragraph 
(b)(2) of this section only with respect to those specific requirements 
for which it submits to FDA, at the address specified in paragraph 
(e)(1) of this section, the medical, nutritional, scientific, or 
technological rationale (including any appropriate animal or human 
clinical studies). FDA will review that information under paragraph (d) 
of this section.
    (c) Infant formulas not generally available at the retail level. (1) 
These exempt infant formulas are not generally found on retail shelves 
for general consumer purchase. Such formulas typically are prescribed by 
a physician, and must be requested from a pharmacist or are distributed 
directly to institutions such as hospitals, clinics, and State or 
Federal agencies. Such formulas are also generally represented and 
labeled solely to provide dietary management for specific diseases or 
conditions that are clinically serious or life-threatening

[[Page 244]]

and generally are required for prolonged periods of time. Exempt infant 
formulas distributed directly to institutions such as hospitals, 
clinics, and State or Federal agencies that are of the same formulation 
as those generally available at the retail level are subject to the 
requirements of paragraph (b) of this section rather than to the 
requirements of this paragraph.
    (2) Except as provided for in paragraph (c)(5) of this section, an 
infant formula manufacturer shall, with respect to each formula covered 
by this paragraph, comply with the nutrient requirements of section 
412(g) of the act or of regulations promulgated under section 412(a)(2) 
of the act, and the labeling requirements of subpart B of this part.
    (3) Each manufacturer of an infant formula covered by this paragraph 
shall establish quality control procedures designed to ensure that the 
infant formula meets applicable nutrient requirements of this section, 
including any special nutritional characteristics for the specific 
disorders or conditions for which the formula is represented for use. 
Each manufacturer shall maintain records of such quality control 
procedures sufficient to permit a public health evaluation of each 
manufactured batch of infant formula and shall permit any authorized FDA 
employee at all reasonable times to have access to and to copy and 
verify the records referred to in this paragraph.
    (4) To retain the exempt status of an infant formula covered by this 
paragraph, the manufacturer shall submit the information required by 
paragraphs (b)(3) and (4) of this section.
    (5) A manufacturer may deviate from the requirements of paragraph 
(c)(2) of this section only with respect to those specific requirements 
for which it submits to FDA, at the address specified in paragraph 
(e)(1) of this section, the medical, nutritional, scientific, or 
technological rationale (including any appropriate animal or human 
clinical studies). FDA will review that information under paragaraph (d) 
of this section.
    (6) The requirements of this section do not apply to an infant 
formula specially and individually prepared for one or more specific 
infants on a physician's request.
    (d) FDA review of exempt status. (1) FDA's Center for Food Safety 
and Applied Nutrition will review information submitted by infant 
formula manufacturers under paragraph (b) (3), (b) (4), or (c)(4) of 
this section. On the basis of such review and other information 
available to the agency, the Center for Food Safety and Applied 
Nutrition may impose additional conditions on, or modify requirements 
for, the quality control procedures, nutrient specifications, or 
labeling of an infant formula, or withdraw a product's exempt status. 
Such determinations will be made by the Director of the Center for Food 
Safety and Applied Nutrition.
    (2)(i) If after completing its review of all information submitted, 
the Center for Food Safety and Applied Nutrition concludes that 
additional or modified quality control, nutrient, or labeling 
requirements are needed, or that a product's exempt status is withdrawn, 
the Center for Food Safety and Applied Nutrition will so notify the 
manufacturer and this notification will specify the reasons therefor. 
Upon receipt of this notification, the manufacturer has 10 working days 
to have the decision reviewed under Sec. 10.75 by the office of the 
Commissioner of Food and Drugs. A determination by the Director of the 
Center for Food Safety and Applied Nutrition that is not appealed 
becomes a final agency decision.
    (ii) After a final decision by the Director or by the office of the 
Commissioner that a product's exempt status is withdrawn, the 
manufacturer shall comply with the nutrient requirements of section 
412(g) of the act or of regulations promulgated under section 412(a)(2) 
of the act, the quality control requirements of part 106, and the 
labeling requirements of subpart B of this part.
    (iii) The compliance date for the withdrawal of a product's exempt 
status or the imposition of additional or modified quality control, 
nutrient, or labeling requirements is 60 calendar days after issuance of 
the final decision except as otherwise provided for reasons stated in 
the decision. If the agency determines that a health hazard

[[Page 245]]

may exist and so notifies the manufacturer, withdrawal of a product's 
exempt status shall be effective on the date of receipt of notification 
from the Director of the Center for Food Safety and Applied Nutrition. 
Additional or modified requirements, or the withdrawal of an exemption, 
apply only to those formulas that are manufactured after the compliance 
date. A postponement of the compliance date may be granted for good 
cause.
    (3) FDA may decide that withdrawal of an exemption is necessary 
when, on the basis of its review under paragraph (d)(1) of this section, 
it concludes that quality control procedures are not adequate to ensure 
that the formula contains all required nutrients, that deviations in 
nutrient levels are not supported by generally accepted scientific, 
nutritional, or medical rationale, or that deviations from subpart B of 
this part are not necessary to provide appropriate directions for 
preparation and use of the infant formula, or that additional labeling 
information is necessary.
    (4) FDA will use the following criteria in determining whether 
deviations from the requirements of this subpart are necessary and will 
adequately protect the public health:
    (i) A deviation from the nutrient requirements of section 412(g) of 
the act or of regulations promulgated under section 412(a)(2) of the act 
is necessary to provide an infant formula that is appropriate for the 
dietary management of a specific disease, disorder, or medical 
condition;
    (ii) For exempt infant formulas subject to paragraph (b) of this 
section, a deviation from the quality control procedures requirements of 
part 106 is necessary because of unusal or difficult technological 
problems in manufacturing the infant formula; and
    (iii) A deviation from the labeling requirements of subpart B of 
this part is necessary because label information, including pictograms 
and symbols required by those regulations, could lead to inappropriate 
use of the product.
    (e) Notification requirements. (1) Information required by 
paragraphs (b) and (c) of this section shall be submitted to the Food 
and Drug Administration, Center for Food Safety and Applied Nutrition, 
Office of Nutrition, Labeling, and Dietary Supplements, Infant Formula 
and Medical Foods Staff (HFS-850), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740.
    (2) The manufacturer shall promptly notify the Food and Drug 
Administration when the manufacturer has knowledge (as defined in 
section 412(c)(2) of the Federal Food, Drug, and Cosmetic Act) that 
reasonably supports the conclusion that an exempt infant formula that 
has been processed by the manufacturer and that has left an 
establishment subject to the control of the manufacturer may not provide 
the nutrients required by paragraph (b) or (c) of this section, or when 
there is an exempt infant formula that may be otherwise adulterated or 
misbranded and if so adulterated or misbranded presents a risk of human 
health. This notification shall be made, by telephone, to the Director 
of the appropriate Food and Drug Administration district office 
specified in part 5, subpart M of this chapter. After normal business 
hours (8 a.m. to 4:30 p.m.), contact the Food and Drug Administration 
Emergency Call Center at 866-300-4374. The manufacturer shall send a 
followup written confirmation to the Center for Food Safety and Applied 
Nutrition (HFS-605), Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, and to the appropriate FDA district office 
specified in part 5, subpart M of this chapter.

[50 FR 48187, Nov. 22, 1985, as amended at 61 FR 14479, Apr. 2, 1996; 66 
FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 67 FR 9585, Mar. 4, 
2002; 75 FR 32659, June 9, 2010; 79 FR 8074, Feb. 10, 2014]



                     Subpart D_Nutrient Requirements



Sec. 107.100  Nutrient specifications.

    (a) An infant formula shall contain the following nutrients at a 
level not less than the minimum level specified and not more than the 
maximum level specified for each 100 kilocalories of the infant formula 
in the form prepared for consumption as directed on the container:

[[Page 246]]



----------------------------------------------------------------------------------------------------------------
                 Nutrients                         Unit of measurement          Minimum level     Maximum level
----------------------------------------------------------------------------------------------------------------
Protein....................................  Grams..........................               1.8               4.5
Fat........................................  Do.............................               3.3               6.0
                                             Percent calories...............                30                54
Linoleic acid..............................  Milligrams.....................               300
                                             Percent calories...............               2.7
----------------------------------------------------------------------------------------------------------------
                                                    Vitamins
----------------------------------------------------------------------------------------------------------------
Vitamin A..................................  International Units............               250               750
Vitamin D..................................  Do.............................                40               100
Vitamin E..................................  Do.............................               0.7
Vitamin K..................................  Micrograms.....................                 4
Thiamine (Vitamin B1)......................  Do.............................                40
Riboflavin (Vitamin B2)....................  Do.............................                60
Vitamin B6.................................  Do.............................                35
Vitamin B12................................  Do.............................              0.15
Niacin \1\.................................  Do.............................               250
Folic acid (Folacin).......................  Do.............................                 4
Pantothenic acid...........................  Do.............................               300
Biotin \2\.................................  Do.............................               1.5
Vitamin C (Ascorbic acid)..................  Milligrams.....................                 8
Choline \2\................................  Do.............................                 7
Inositol \2\...............................  Do.............................                 4
----------------------------------------------------------------------------------------------------------------
                                                    Minerals
----------------------------------------------------------------------------------------------------------------
Calcium....................................  Do.............................                60
Phosphorus.................................  Do.............................                30
Magnesium..................................  Do.............................                 6
Iron.......................................  Do.............................              0.15               3.0
Zinc.......................................  Do.............................               0.5
Manganese..................................  Micrograms.....................                 5
Copper.....................................  Do.............................                60
Iodine.....................................  Do.............................                 5                75
Selenium...................................  Do.............................                 2                 7
Sodium.....................................  Milligrams.....................                20                60
Potassium..................................  Do.............................                80               200
Chloride...................................  Do.............................                55               150
----------------------------------------------------------------------------------------------------------------
\1\ The generic term ``niacin'' includes niacin (nicotinic acid) and niacinamide (nicotinamide).
\2\ Required only for non-milk-based infant formulas.

    (b) Vitamin E shall be present at a level of at least 0.7 
International Unit of vitamin E per gram of linoleic acid.
    (c) Any vitamin K added shall be in the form of phylloquinone.
    (d) Vitamin B6 shall be present at a level of at least 15 
micrograms of vitamin B6 for each gram of protein in excess 
of 1.8 grams of protein per 100 kilocalories of infant formula in the 
form prepared for consumption as directed on the container.
    (e) The ratio of calcium to phosphorus in infant formula in the form 
prepared for consumption as directed on the container shall be no less 
than 1.1 and not more than 2.0.
    (f) Protein shall be present in an amount not to exceed 4.5 grams 
per 100 kilocalories regardless of quality, and not less than 1.8 grams 
per 100 kilocalories of infant formula in the form prepared for 
consumption as directed on the container when its biological quality is 
equivalent to or better than that of casein. If the biological quality 
of the protein is less than that of casein, the minimum amount of 
protein shall be increased proportionately to compensate for its lower 
biological quality. For example, an infant formula containing protein 
with a biological quality of 75 percent of casein shall contain at least 
2.4 grams of protein (1.8/0.75). No protein with a biological quality 
less than 70 percent of casein shall be used.

[50 FR 45108, Oct. 30, 1985, as amended at 80 FR 35841, June 23, 2015]



                    Subpart E_Infant Formula Recalls

    Source: 54 FR 4008, Jan. 27, 1989, unless otherwise noted.

[[Page 247]]



Sec. 107.200  Food and Drug Administration-required recall.

    When the Food and Drug Administration determines that an adulterated 
or misbranded infant formula presents a risk to human health, a 
manufacturer shall immediately take all actions necessary to recall that 
formula, extending to and including the retail level, consistent with 
the requirements of this subpart.



Sec. 107.210  Firm-initiated product removals.

    (a) If a manufacturer has determined to recall voluntarily from the 
market an infant formula that is not subject to Sec. 107.200 but that 
otherwise violates the laws and regulations administered by the Food and 
Drug Administration (FDA) and that would be subject to legal action, the 
manufacturer, upon prompt notification to FDA, shall administer such 
voluntary recall consistent with the requirements of this subpart.
    (b) If a manufacturer has determined to withdraw voluntarily from 
the market an infant formula that is adulterated or misbranded in only a 
minor way and that would not be subject to legal action, such removal 
from the market is deemed to be a market withdrawal, as defined in Sec. 
7.3(j) of this chapter. As required by Sec. 107.240(a), the 
manufacturer shall promptly notify FDA of such violative formula and 
may, but is not required to, conduct such market withdrawal consistent 
with the requirements of this subpart pertaining to product recalls.



Sec. 107.220  Scope and effect of infant formula recalls.

    (a) The requirements of this subpart apply:
    (1) When the Food and Drug Administration has determined that it is 
necessary to remove from the market a distributed infant formula that is 
in violation of the laws and regulations administered by the Food and 
Drug Administration and that poses a risk to human health; or
    (2) When a manufacturer has determined that it is necessary to 
remove from the market a distributed infant formula that:
    (i) Is no longer subject to the manufacturer's control;
    (ii) Is in violation of the laws and regulations administered by the 
Food and Drug Administration and against which the agency could initiate 
legal or regulatory action; and
    (iii) Does not present a human risk.
    (b) The Food and Drug Administration will monitor continually the 
recall action and will take appropriate actions to ensure that the 
violative infant formula is removed from the market.



Sec. 107.230  Elements of an infant formula recall.

    A recalling firm shall conduct an infant formula recall with the 
following elements:
    (a) The recalling firm shall evaluate in writing the hazard to human 
health associated with the use of the infant formula. This health hazard 
evaluation shall include consideration of any disease, injury, or other 
adverse physiological effect that has been or that could be caused by 
the infant formula and of the seriousness, likelihood, and consequences 
of the diseases, injury, or other adverse physiological effect. The Food 
and Drug Administration will conduct its own health hazard evaluation 
and promptly notify the recalling firm of the results of that evaluation 
if the criteria for recall under Sec. 107.200 have been met.
    (b) The recalling firm shall devise a written recall strategy suited 
to the individual circumstances of the particular recall. The recall 
strategy shall take into account the health hazard evaluation and 
specify the following: The extent of the recall; if necessary, the 
public warning to be given about any hazard presented by the infant 
formula; the disposition of the recalled infant formula; and the 
effectiveness checks that will be made to determine that the recall is 
carried out.
    (c) The recalling firm shall promptly notify each of its affected 
direct accounts about the recall. The format of a recall communication 
shall be distinctive, and the content and extent of a recall 
communication shall be commensurate with the hazard of the infant 
formula being recalled and the strategy developed for the recall. The

[[Page 248]]

recall communication shall instruct consignees to report back quickly to 
the recalling firm about whether they are in possession of the recalled 
infant formula and shall include a means of doing so. The recalled 
communication shall also advise consignees how to return the recall 
infant formula to the manufacturer or otherwise dispose of it. The 
recalling firm shall send a followup recall communication to any 
consignee that does not respond to the initial recall communication.
    (d) If the infant formula presents a risk to human health, the 
recalling firm shall request that each establishment, at which such 
infant formula is sold or available for sale, post at the point of 
purchase of such formula a notice of such recall at such establishment. 
The notice shall be provided by the recalling firm after approval of the 
notice by the Food and Drug Administration. The recalling firm shall 
also request that each retail establishment maintain such notice on 
display until such time as the Food and Drug Administration notifies the 
recalling firm that the agency considers the recall completed.
    (e) The recalling firm shall furnish promptly to the appropriate 
Food and Drug Administration district office listed in part 5, subpart M 
of this chapter, as they are available, copies of the health hazard 
evaluation, the recall strategy, and all recall communications 
(including, for a recall under Sec. 107.200, the notice to be displayed 
at retail establishments) directed to consignees, distributors, 
retailers, and members of the public.

[54 FR 4008, Jan. 27, 1989, as amended at 66 FR 17358, Mar. 30, 2001; 69 
FR 17291, Apr. 2, 2004]



Sec. 107.240  Notification requirements.

    (a) Telephone report. When a determination is made that an infant 
formula is to be recalled, the recalling firm shall telephone within 24 
hours the appropriate Food and Drug Administration district office 
listed in Sec. 5.115 of this chapter and shall provide relevant 
information about the infant formula that is to be recalled.
    (b) Initial written report. Within 14 days after the recall has 
begun, the recalling firm shall provide a written report to the 
appropriate FDA district office. The report shall contain relevant 
information, including the following cumulative information concerning 
the infant formula that is being recalled:
    (1) Number of consignees notified of the recall and date and method 
of notification, including recalls required by Sec. 107.200, 
information about the notice provided for retail display, and the 
request for its display.
    (2) Number of consignees responding to the recall communication and 
quantity of recalled infant formula on hand at each consignee at the 
time the communication was received.
    (3) Quantity of recalled infant formula returned or corrected by 
each consignee contacted and the quantity of recalled infant formula 
accounted for.
    (4) Number and results of effectiveness checks that were made.
    (5) Estimated timeframes for completion of the recall.
    (c) Status reports. The recalling firm shall submit to the 
appropriate FDA district office a written status report on the recall at 
least every 14 days until the recall is terminated. The status report 
shall describe the steps taken by the recalling firm to carry out the 
recall since the last report and the results of these steps.

[79 FR 8074, Feb. 10, 2014]



Sec. 107.250  Termination of an infant formula recall.

    The recalling firm may submit a recommendation for termination of 
the recall to the appropriate FDA district office for transmittal to the 
Recall Coordinator, Division of Enforcement (HFS-605), Office of 
Compliance, Center for Food Safety and Applied Nutrition, 5001 Campus 
Dr., College Park, MD 20740, or by email to [email protected], 
for action. Any such recommendation shall contain information supporting 
a conclusion that the recall strategy has been effective. The Agency 
will respond within 15 days of receipt by the Division of Enforcement of 
the request for termination. The recalling firm shall

[[Page 249]]

continue to implement the recall strategy until it receives final 
written notification from the Agency that the recall has been 
terminated. The Agency will send such notification, unless the Agency 
has information from FDA's own audits or from other sources 
demonstrating that the recall has not been effective. The Agency may 
conclude that a recall has not been effective if:
    (a) The recalling firm's distributors have failed to retrieve the 
recalled infant formula; or
    (b) Stocks of the recalled infant formula remain in distribution 
channels that are not in direct control of the recalling firm.

[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66 
FR 17359, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004; 79 FR 8075, Feb. 10, 
2014]



Sec. 107.260  Revision of an infant formula recall.

    If after a review of the recalling firm's recall strategy or 
periodic reports or other monitoring of the recall, the Food and Drug 
Administration concludes that the actions of the recalling firm are 
deficient, the agency shall notify the recalling firm of any serious 
deficiency. The agency may require the firm to:
    (a) Change the extent of the recall, if the agency concludes on the 
basis of available data that the depth of the recall is not adequate in 
light of the risk to human health presented by the infant formula.
    (b) Carry out additional effectiveness checks, if the agency's 
audits, or other information, demonstrate that the recall has not been 
effective.
    (c) Issue additional notifications to the firm's direct accounts, if 
the agency's audits, or other information demonstrate that the original 
notifications were not received, or were disregarded in a significant 
number of cases.



Sec. 107.270  Compliance with this subpart.

    A recalling firm may satisfy the requirements of this subpart by any 
means reasonable calculated to meet the obligations set forth in this 
Subpart E. The recall guidance in subpart C of part 7 of this chapter 
specify procedures that may be useful to a recalling firm in determining 
how to comply with these regulations.

[54 FR 4008, Jan. 27, 1989, as amended at 65 FR 56479, Sept. 19, 2000]



Sec. 107.280  Records retention.

    Each manufacturer of an infant formula shall make and retain such 
records respecting the distribution of the infant formula through any 
establishment owned or operated by such manufacturer as may be necessary 
to effect and monitor recalls of the formula. Such records shall be 
retained for at least 1 year after the expiration of the shelf life of 
the infant formula.

[54 FR 4008, Jan. 27, 1989, as amended at 67 FR 9585, Mar. 4, 2002]



PART 108_EMERGENCY PERMIT CONTROL--Table of Contents



                      Subpart A_General Provisions

Sec.
108.3 Definitions.
108.5 Determination of the need for a permit.
108.6 Revocation of determination of need for permit.
108.7 Issuance or denial of permit.
108.10 Suspension and reinstatement of permit.
108.12 Manufacturing, processing, or packing without a permit, or in 
          violation of a permit.
108.19 Establishment of requirements for exemption from section 404 of 
          the act.

  Subpart B_Specific Requirements and Conditions for Exemption From or 
                   Compliance With an Emergency Permit

108.25 Acidified foods.
108.35 Thermal processing of low-acid foods packaged in hermetically 
          sealed containers.

    Authority: 21 U.S.C. 342, 344, 371.

    Source: 42 FR 14334, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 108 appear at 81 FR 
49896, July 29, 2016.



                      Subpart A_General Provisions



Sec. 108.3  Definitions.

    (a) The definitions contained in section 201 of the Federal Food, 
Drug, and Cosmetic Act are applicable to such terms when used in this 
part.

[[Page 250]]

    (b) Commissioner means the Commissioner of Food and Drugs.
    (c) Act means the Federal Food, Drug, and Cosmetic Act, as amended.
    (d) Permit means an emergency permit issued by the Commissioner 
pursuant to section 404 of the act for such temporary period of time as 
may be necessary to protect the public health.
    (e) Manufacture, processing, or packing of food in any locality 
means activities conducted in a single plant or establishment, a series 
of plants under a single management, or all plants in an industry or 
region, by a manufacturer, processor, or packer.



Sec. 108.5  Determination of the need for a permit.

    (a) Whenever the Commissioner determines after investigation that a 
manufacturer, processor, or packer of a food for which a regulation has 
been promulgated in subpart B of this part does not meet the mandatory 
conditions and requirements established in such regulation, he shall 
issue to such manufacturer, processor, or packer an order determining 
that a permit shall be required before the food may be introduced or 
delivered for introduction into interstate commerce by that person. The 
order shall specify the mandatory conditions and requirements with which 
there is a lack of compliance.
    (1) The manufacturer, processor, or packer shall have 3 working days 
after receipt of such order within which to file objections. Such 
objections may be filed by telegram, telex, or any other mode of written 
communication addressed to the Center for Food Safety and Applied 
Nutrition, Food and Drug Administration (HFS-605), 5001 Campus Dr., 
College Park, MD 20740. If such objections are filed, the determination 
is stayed pending a hearing to be held within 5 working days after the 
filing of objections on the issues involved unless the Commissioner 
determines that the objections raise no genuine and substantial issue of 
fact to justify a hearing.
    (2) If the Commissioner finds that there is an imminent hazard to 
health, the order shall contain this finding and the reasons therefor, 
and shall state that the determination of the need for a permit is 
effective immediately pending an expedited hearing.
    (b) A hearing under this section shall be conducted by the 
Commissioner or his designee at a location agreed upon by the objector 
and the Commissioner or, if such agreement cannot be reached, at a 
location designated by the Commissioner. The manufacturer, processor, or 
packer shall have the right to cross-examine the Food and Drug 
Administration's witnesses and to present witnesses on his own behalf.
    (c) Within 5 working days after the hearing, and based on the 
evidence presented at the hearing, the Commissioner shall determine 
whether a permit is required and shall so inform the manufacturer, 
processor, or packer in writing, with the reasons for his decision.
    (d) The Commissioner's determination of the need for a permit 
constitutes final agency action from which appeal lies to the courts. 
The Commissioner will not stay a determination of the need for a permit 
pending court appeal except in unusual circumstances, but will 
participate in expediting any such appeal.

[42 FR 14334, Mar. 15, 1977, as amended at 54 FR 24891, June 12, 1989; 
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]



Sec. 108.6  Revocation of determination of need for permit.

    (a) A permit shall be required only during such temporary period as 
is necessary to protect the public health.
    (b) Whenever the Commissioner has reason to believe that a permit 
holder is in compliance with the mandatory requirements and conditions 
established in subpart B of this part and is likely to remain in 
compliance, he shall, on his own initiative or on the application of the 
permit holder, revoke both the determination of need for a permit and 
the permit that had been issued. If denied, the applicant shall, upon 
request, be afforded a hearing conducted in accordance with Sec. 108.5 
(b) and (c) as soon as practicable. Such revocation is without prejudice 
to the initiation of further permit proceedings with respect to the same 
manufacturer, processor, or packer should later information again show 
the need for a permit.

[[Page 251]]



Sec. 108.7  Issuance or denial of permit.

    (a) After a determination and notification by the Commissioner in 
accordance with the provisions of Sec. 108.5 that a manufacturer, 
processor, or packer requires a permit, such manufacturer, processor, or 
packer may not thereafter introduce or deliver for introduction into 
interstate commerce any such food manufactured, processed, or packed by 
him unless he holds a permit issued by the Commissioner or obtains 
advance written approval of the Food and Drug Administration pursuant to 
Sec. 108.12(a).
    (b) Any manufacturer, processor, or packer for whom the Commissioner 
has made a determination that a permit is necessary may apply to the 
Commissioner for the issuance of such a permit. The application shall 
contain such data and information as is necessary to show that all 
mandatory requirements and conditions for the manufacturer, processing 
or packing of a food for which regulations are established in subpart B 
of this part are met and, in particular, shall show that the deviations 
specified in the Commissioner's determination of the need for a permit 
have been corrected or suitable interim measures established. Within 10 
working days after receipt of such application, (except that the 
Commissioner may extend such time an additional 10 working days where 
necessary), the Commissioner shall issue a permit, deny the permit, or 
offer the applicant a hearing conducted in accordance with Sec. 108.5 
(b) and (c) as to whether the permit should be issued. The Commissioner 
shall issue such a permit to which shall be attached, in addition to the 
mandatory requirements and conditions of subpart B of this part, any 
additional requirements or conditions which may be necessary to protect 
the public health if he finds that all mandatory requirements and 
conditions of subpart B of this part are met or suitable interim 
measures are established.
    (c) Denial of a permit constitutes final agency action from which 
appeal lies to the courts. The Commissioner will not stay such denial 
pending court appeal except in unusual circumstances, but will 
participate in expediting any such appeal.



Sec. 108.10  Suspension and reinstatement of permit.

    (a) Whenever the Commissioner finds that a permit holder is not in 
compliance with the mandatory requirements and conditions established by 
the permit, he shall immediately suspend the permit and so inform the 
permit holder, with the reasons for the suspension.
    (b) Upon application for reinstatement of a permit, the Commissioner 
shall, within 10 working days, reinstate the permit if he finds that the 
person is in compliance with the mandatory requirements and conditions 
established by the permit or deny the application.
    (c) Any person whose permit has been suspended or whose application 
for reinstatement has been denied may request a hearing. The hearing 
shall be conducted by the Commissioner or his designee within 5 working 
days of receipt of the request at a location agreed upon by the objector 
and the Commissioner or, if an agreement cannot be reached, at a 
location designated by the Commissioner. The permit holder shall have 
the right to present witnesses on his own behalf and to cross-examine 
the Food and Drug Administration's witnesses.
    (d) Within 5 working days after the hearing, and based on the 
evidence presented at the hearing, the Commissioner shall determine 
whether the permit shall be reinstated and shall so inform the permit 
holder, with the reasons for his decision.
    (e) Denial of an application for reinstatement of a permit 
constitutes final agency action from which appeal lies to the courts. 
The Commissioner will not stay such denial pending court appeal except 
in unusual circumstances, but will participate in expediting any such 
appeal.



Sec. 108.12  Manufacturing, processing, or packing without a permit, 
or in violation of a permit.

    (a) A manufacturer, processor, or packer may continue at his own 
risk to manufacture, process, or pack without a permit a food for which 
the Commissioner has determined that a permit is required. All food so 
manufactured, processed, or packed during such period without a permit 
shall be retained by the manufacturer, processor, or packer

[[Page 252]]

and may not be introduced or delivered for introduction into interstate 
commerce without the advance written approval of the Food and Drug 
Administration. Such approval may be granted only upon an adequate 
showing that such food is free from microorganisms of public health 
significance. The manufacturer, processor, or packer may provide to the 
Commissioner, for his consideration in making any such determination, an 
evaluation of the potential public health significance of such food by a 
competent authority in accordance with procedures recognized as being 
adequate to detect any potential hazard to public health. Within 20 
working days after receipt of a written request for such written 
approval the Food and Drug Administration shall either issue such 
written approval or deny the request. If the request is denied, the 
applicant shall, upon request, be afforded a prompt hearing conducted in 
accordance with Sec. 108.5 (b) and (c).
    (b) Except as provided in paragraph (a) of this section, no 
manufacturer, processor, or packer may introduce or deliver for 
introduction into interstate commerce without a permit or in violation 
of a permit a food for which the Commissioner has determined that a 
permit is required. Where a manufacturer, processor, or packer utilizes 
a consolidation warehouse or other storage facility under his control, 
interstate shipment of any such food from the point of production to 
that warehouse or storage facility shall not violate this paragraph, 
provided that no further introduction or delivery for introduction into 
interstate commerce is made from that consolidated warehouse or storage 
facility except as provided in paragraph (a) of this section.



Sec. 108.19  Establishment of requirements for exemption from section
404 of the act.

    (a) Whenever the Commissioner finds after investigation that the 
distribution in interstate commerce of any class of food may, by reason 
of contamination with microorganisms during the manufacture, processing, 
or packing thereof in any locality, be injurious to health, and that 
such injurious nature cannot be adequately determined after such 
articles have entered interstate commerce, he shall promulgate 
regulations in Subpart B of this part establishing requirements and 
conditions governing the manufacture, processing, or packing of the food 
necessary to protect the public health. Such regulations may be proposed 
by the Commissioner on his own initiative or in response to a petition 
from any interested person pursuant to part 10 of this chapter.
    (b) A manufacturer, processor, or packer of a food for which a 
regulation has been promulgated in subpart B of this part shall be 
exempt from the requirement for a permit only if he meets all of the 
mandatory requirements and conditions established in that regulation.

[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]



  Subpart B_Specific Requirements and Conditions for Exemption From or 
                   Compliance With an Emergency Permit



Sec. 108.25  Acidified foods.

    (a) Inadequate or improper manufacture, processing, or packing of 
acidified foods may result in the distribution in interstate commerce of 
processed foods that may be injurious to health. The harmful nature of 
such foods cannot be adequately determined after these foods have 
entered into interstate commerce. The Commissioner of Food and Drugs 
therefore finds that, to protect the public health, it may be necessary 
to require any commericial processor, in any establishment engaged in 
the manufacture, processing, or packing of acidified foods, to obtain 
and hold a temporary emergency permit provided for under section 404 of 
the Federal Food, Drug, and Cosmetic Act. Such a permit may be required 
whenever the Commissioner finds, after investigation, that the 
commercial processor has failed to fulfill all the requirements of this 
section, including registration and filing of process information, and 
the mandatory portions of Sec. Sec. 114.10, 114.80(a) (1) and (2), and 
(b), 114.83, 114.89, and 114.100 (b), (c), and (d)

[[Page 253]]

of this chapter as they relate to acidified foods. These requirements 
are intended to ensure safe manufacturing, processing, and packing 
processes and to permit the Food and Drug Administration to verify that 
these processes are being followed. Failure to meet these requirements 
shall constitute a prima facie basis for the immediate application of 
the emergency permit control provisions of section 404 of the act to 
that establishment, under the procedures established in subpart A of 
this part.
    (b) The definitions in Sec. 114.3 of this chapter are applicable 
when those terms are used in this section.
    (c)(1) Registration. A commercial processor, when first engaging in 
the manufacture, processing, or packing of acidified foods in any State, 
as defined in section 201(a)(1) of the act, shall, not later than 10 
days after first so engaging, register and file with the Food and Drug 
Administration on Form FDA 2541 (food canning establishment 
registration) information including, but not limited to, the name of the 
establishment, principal place of business, the location of each 
establishment in which that processing is carried on, the processing 
method in terms of acidity and pH control, and a list of foods so 
processed in each establishment. These forms are available from the LACF 
Registration Coordinator (HFS-303), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, or at any Food and Drug Administration district office. The 
completed form shall be submitted to the Center for Food Safety and 
Applied Nutrition (HFS-565), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740. These forms also are available on the Food 
and Drug Administration's Web site at http://www.fda.gov/Food/
GuidanceRegulation/ FoodFacilityRegistration/AcidifiedLACFRegistration /
ucm2007436.htm. For electronic submission go to FDA's Industry Systems 
Web site at www.access.fda.gov. Foreign processors shall register before 
any offering of foods for import into the United States. Commercial 
processors duly registered under this section shall notify the Food and 
Drug Administration not later than 90 days after the commercial 
processor ceases or discontinues the manufacture, processing, or packing 
of the foods in any establishment, except that this notification shall 
not be required for temporary cessations due to the seasonal character 
of an establishment's production or by temporary conditions including, 
but not limited to, labor disputes, fire, or acts of God.
    (2) Process filing. A commercial processor engaged in the processing 
of acidified foods shall, not later than 60 days after registration, and 
before packing any new product, provide the Food and Drug Administration 
information on the scheduled processes including, as necessary, 
conditions for heat processing and control of pH, salt, sugar, and 
preservative levels and source and date of the establishment of the 
process, for each acidified food in each container size. Filing of this 
information does not constitute approval of the information by the Food 
and Drug Administration, and information concerning processes and other 
data so filed shall be regarded as trade secrets within the meaning of 
21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted 
on Form FDA 2541e (Food Process Filing for Acidified Method). Forms are 
available from the LACF Registration Coordinator (HFS-303), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, or at any Food and Drug 
Administration district office. The completed form shall be submitted to 
the LACF Registration Coordinator (HFS-618), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740. These forms also are available on the Food and 
Drug Administration's Web site at http://www.fda.gov/Food/
GuidanceRegulation/ FoodFacilityRegistration /AcidifiedLACFRegistration/ 
ucm2007436.htm. For electronic submission go to FDA's Industry Systems 
Web site at www.access.fda.gov.
    (3) Process adherence and information--(i) Scheduling. A commercial 
processor engaged in processing acidified foods in any registered 
establishment shall process each food in conformity with at

[[Page 254]]

least the scheduled processes filed under paragraph (c)(2) of this 
section.
    (ii) Process and pH information availability. When requested by the 
Food and Drug Administration in writing, a commercial processor engaged 
in the processing of acidified foods shall provide the Food and Drug 
Administration with any process and procedure information that the Food 
and Drug Administration deems necessary to determine the adequacy of the 
process. Furnishing of this information does not constitute approval by 
the Food and Drug Administration of the content of the information 
filed, and the information concerning processes and other data so 
furnished shall be considered trade secrets within the meaning of 21 
U.S.C. 331(j) and 18 U.S.C. 1905 (to the extent that they qualify under 
those provisions).
    (d) A commercial processor engaged in the processing of acidified 
foods shall promptly report to the Food and Drug Administration any 
instance of spoilage, process deviation, or contamination with 
microorganisms, the nature of which has potential health-endangering 
significance, where any lot of such food has in whole or in part entered 
distribution in commerce.
    (e) A commercial processor engaged in the processing of acidified 
foods shall prepare and maintain files on a current procedure for use 
for products under the processor's control, which that processor will 
ask the distributor to follow, including plans for recalling products 
that may be injurious to health; for identifying, collecting, ware 
housing, and controlling products; for determining the effectiveness of 
recalls; for notifying the Food and Drug Administration of any recalls; 
and for implementing recall programs.
    (f) All plant personnel involved in acidification, pH control, heat 
treatment, or other critical factors of the operation shall be under the 
operating supervision of a person who has attended a school approved by 
the Commissioner for giving instruction in food-handling techniques, 
food protection principles, personal hygiene, plant sanitation 
practices, pH controls, and critical factors in acidification, and who 
has satisfactorily completed the prescribed course of instruction. The 
Commissioner will consider students who have satisfactorily completed 
the required portions of the courses presented under Sec. 108.35 and 
part 113 of this chapter before March 16, 1979, as having satisfactorily 
completed the prescribed course of instruction under this section and 
part 114 of this chapter. The Commissioner will not withhold approval of 
any school qualified to give such instruction.
    (g) A commercial processor engaged in the processing of acidified 
foods shall prepare, review, and retain at the processing plant or other 
reasonably accessible location for a period of 3 years from the date of 
manufacture, all records of processing, deviations in processing, pH, 
and other records specified in part 114 of this chapter. Upon written 
demand during the course of a factory inspection under section 704 of 
the act by a duly authorized employee of the Food and Drug 
Administration, a commercial processor shall permit the inspection and 
copying by that employee of these records to verify the pH and the 
adequacy of processing.
    (h) This section shall not apply to the commercial processing of any 
food processed under the continuous inspection of the meat and poultry 
inspection program of the Food Safety and Inspection Service of the 
Department of Agriculture under the Federal Meat Inspection Act (34 
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the 
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat. 
791 (21 U.S.C. 451 et seq.)).
    (i) Wherever the Commissioner finds that any State regulates the 
commercial processing of acidified foods under effective regulations 
specifying at least the requirements of part 114 of this chapter, the 
Commissioner shall issue a notice stating that compliance with such 
State regulations shall constitute compliance with this section, if the 
State through its regulatory agency or each processor of acidified foods 
in the State files with the Food and Drug Administration the 
registration information and the processing information prescribed in 
paragraph (c) of this section.
    (j) Imports. (1) This section applies to any foreign commercial 
processor engaged in the processing of acidified

[[Page 255]]

foods and offering those foods for import into the United States except 
that, in lieu of providing for the issuance of an emergency permit under 
paragraph (a) of this section, the Commissioner will request the 
Secretary of the Treasury to refuse admission into the United States, 
under section 801 of the act, to any acidified foods which the 
Commissioner determines, after investigation, may result in the 
distribution in interstate commerce of processed foods that may be 
injurious to health as set forth in paragraph (a) of this section.
    (2) Any acidified food so refused admission shall not be admitted 
until the Commissioner determines that the commercial processor offering 
the food for import has complied with the requirements of this section 
and that the food is not injurious to health. To assist the Commissioner 
in making this determination, a duly authorized employee of the Food and 
Drug Administration shall be permitted to inspect the commercial 
processor's manufacturing, processing, and packing facilities.
    (k) The following information submitted to the Food and Drug 
Administration under this section is not available for public disclosure 
unless it has been previously disclosed to the public as defined in 
Sec. 20.81 of this chapter or it relates to a product or ingredient 
that has been abandoned and no longer represents a trade secret or 
confidential commercial or financial information as defined in Sec. 
20.61 of this chapter:
    (1) Manufacturing methods or processes, including quality control 
information.
    (2) Production, sales, distribution, and similar information, except 
that any compilation of the information aggregated and prepared in a way 
that does not reveal information which is not available for public 
disclosure under this provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.

[44 FR 16207, Mar. 16, 1979, as amended at 54 FR 24891, June 12, 1989; 
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001; 81 FR 46831, July 
19, 2016]



Sec. 108.35  Thermal processing of low-acid foods packaged in
hermetically sealed containers.

    (a) Inadequate or improper manufacture, processing, or packing of 
thermally processed low-acid foods in hermetically sealed containers may 
result in the distribution in interstate commerce of processed foods 
that may be injurious to health. The harmful nature of such foods cannot 
be adequately determined after these foods have entered into interstate 
commerce. The Commissioner of Food and Drugs therefore finds that, in 
order to protect the public health, it may be necessary to require any 
commercial processor, in any establishment engaged in the manufacture, 
processing, or packing of thermally processed low-acid foods in 
hermetically sealed containers, to obtain and hold a temporary emergency 
permit provided for under section 404 of the Federal Food, Drug, and 
Cosmetic Act. Such a permit may be required whenever the Commissioner 
finds, after investigation, that the commercial processor has failed to 
fulfill all the requirements of this section, including registration and 
the filing of process information, and the mandatory portions of part 
113 of this chapter. These requirements are intended to ensure safe 
manufacture, processing, and packing procedures and to permit the Food 
and Drug Administration to verify that these procedures are being 
followed. Such failure shall constitute a prima facie basis for the 
immediate application of the emergency permit control provisions of 
section 404 of the act to that establishment, pursuant to the procedures 
established in subpart A of this part.
    (b) The definitions in Sec. 113.3 of this chapter are applicable 
when such terms are used in this section.
    (c) Registration and process filing--(1) Registration. A commercial 
processor when first engaging in the manufacture, processing, or packing 
of thermally processed low-acid foods in hermetically sealed containers 
in any State, as defined in section 201(a)(1) of the act, shall, not 
later than 10 days after first so engaging, register with the Food and 
Drug Administration on

[[Page 256]]

Form FDA 2541 (food canning establishment registration) information 
including (but not limited to) his name, principal place of business, 
the location of each establishment in which such processing is carried 
on, the processing method in terms of the type of processing equipment 
employed, and a list of the low-acid foods so processed in each such 
establishment. These forms are available from the LACF Registration 
Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
or at any Food and Drug Administration district office. The completed 
form shall be submitted to the LACF Registration Coordinator (HFS-618), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740. These forms 
also are available on the Food and Drug Administration's Web site at 
http://www.fda.gov/Food/GuidanceRegulation/ FoodFacilityRegistration/ 
AcidifiedLACFRegistration/default.htm. For electronic submission go to 
FDA's Industry Systems Web site at www.access.fda.gov. Commercial 
processors duly registered in accordance with this section shall notify 
the Food and Drug Administration not later than 90 days after such 
commercial processor ceases or discontinues the manufacture, processing, 
or packing of thermally processed foods in any establishment: Provided, 
that such notification shall not be required as to the temporary 
cessation necessitated by the seasonal character of the particular 
establishment's production or caused by temporary conditions including 
but not limited to strikes, lockouts, fire, or acts of God.
    (2) Process filing. A commercial processor engaged in the thermal 
processing of low-acid foods packaged in hermetically sealed containers 
shall, not later than 60 days after registration and prior to the 
packing of a new product, provide the Food and Drug Administration 
information as to the scheduled processes including but not limited to 
the processing method, type of retort or other thermal processing 
equipment employed, minimum initial temperatures, times and temperatures 
of processing, sterilizing value (Fo), or other equivalent scientific 
evidence of process adequacy, critical control factors affecting heat 
penetration, and source and date of the establishment of the process, 
for each such low-acid food in each container size: Provided, that the 
filing of such information does not constitute approval of the 
information by the Food and Drug Administration, and that information 
concerning processes and other data so filed shall be regarded as trade 
secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This 
information shall be submitted on the following forms as appropriate: 
Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method), Form 
FDA 2541f (Food Process Filing for Water Activity/Formulation Control 
Method), or Form FDA 2541g (Food Process Filing for Low-Acid Aseptic 
Systems). These forms are available from the LACF Registration 
Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
or at any Food and Drug Administration district office. The completed 
form(s) shall be submitted to the LACF Registration Coordinator (HFS-
303), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740. These forms 
also are available on the Food and Drug Administration's Web site at 
http://www.fda.gov/Food/GuidanceRegulation/ FoodFacilityRegistration/ 
AcidifiedLACFRegistration/ default.htm. For electronic submission, go to 
FDA's Industry Systems Web site at www.access.fda.gov.
    (i) If all the necessary information is not available for existing 
products, the processor shall, at the time the existing information is 
provided to the Food and Drug Administration request in writing an 
extension of time for submission of such information, specifying what 
additional information is to be supplied and the date by which it is to 
be submitted. Within 30 working days after receipt of such request the 
Food and Drug Administration shall either grant or deny such request in 
writing.
    (ii) If a packer intentionally makes a change in a previously filed 
scheduled

[[Page 257]]

process by reducing the initial temperature or retort temperature, 
reducing the time of processing, or changing the product formulation, 
the container, or any other condition basic to the adequacy of scheduled 
process, he shall prior to using such changed process obtain 
substantiation by qualified scientific authority as to its adequacy. 
Such substantiation may be obtained by telephone, telegram, or other 
media, but must be promptly recorded, verified in writing by the 
authority, and contained in the packer's files for review by the Food 
and Drug Administration. Within 30 days after first use, the packer 
shall submit to the LACF Registration Coordinator (HFS-303), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740 a complete description of the 
modifications made and utilized, together with a copy of his file record 
showing prior substantiation by a qualified scientific authority as to 
the safety of the changed process. Any intentional change of a 
previously filed scheduled process or modification thereof in which the 
change consists solely of a higher initial temperature, a higher retort 
temperature, or a longer processing time, shall not be considered a 
change subject to this paragraph, but if that modification is thereafter 
to be regularly scheduled, the modified process shall be promptly filed 
as a scheduled process, accompanied by full information on the specified 
forms as provided in this paragraph.
    (iii) Many packers employ an ``operating'' process in which retort 
operators are instructed to use retort temperatures and/or processing 
times slightly in excess of those specified in the scheduled process as 
a safety factor to compensate for minor fluctuations in temperature or 
time to assure that the minimum times and temperatures in the scheduled 
process are always met. This would not constitute a modification of the 
scheduled process.
    (3) Process adherence and information. (i) A commercial processor 
engaged in the thermal processing of low-acid foods packaged in 
hermetically sealed containers in any registered establishment shall 
process each low-acid food in each container size in conformity with at 
least the scheduled processes and modifications filed pursuant to 
paragraph (c)(2) of this section.
    (ii) Process information availability: When requested by the Food 
and Drug Administration in writing, a commercial processor engaged in 
thermal processing of low-acid foods packaged in hermetically sealed 
containers shall provide the Food and Drug Administration with any 
information concerning processes and procedures which is deemed 
necessary by the Food and Drug Administration to determine the adequacy 
of the process: Provided, That the furnishing of such information does 
not constitute approval of the information by the Food and Drug 
Administration, and that the information concerning processes and other 
data so furnished shall be regarded as trade secrets within the meaning 
of 21 U.S.C. 331(j) and 18 U.S.C. 1905.
    (d) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall promptly 
report to the Food and Drug Administration any instance of spoilage or 
process deviation the nature of which indicates potential health 
significance where any lot of such food has in whole or in part entered 
distribution.
    (e) A commercial processor engaged in thermal processing of low-acid 
foods packaged in hermetically sealed containers shall promptly report 
to the Food and Drug Administration any instance wherein any lot of such 
food, which may be injurious to health by reason of contamination with 
microorganisms, has in whole or in part entered distribution.
    (f) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall have 
prepared and in his files a current procedure which he will use for 
products under his control and which he will ask his distributor to 
follow, including plans for effecting recalls of any product that may be 
injurious to health; for identifying, collecting, warehousing, and 
controlling the product; for determining the effectiveness of such 
recall; for notifying the Food and Drug Administration of

[[Page 258]]

any such recall; and for implementing such recall program.
    (g) All operators of retorts, thermal processing systems, aseptic 
processing and packaging systems, or other thermal processing systems, 
and container closure inspectors shall be under the operating 
supervision of a person who has attended a school approved by the 
Commissioner for giving instruction in retort operations, aseptic 
processing and packaging systems operations or other thermal processing 
systems operations, and container closure inspections, and has 
satisfactorily completed the prescribed course of instruction: Provided, 
That this requirement shall not apply in the State of California as 
listed in paragraph (j) of this section. The Commissioner will not 
withhold approval of any school qualified to give such instruction.
    (h) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall prepare, 
review, and retain at the processing plant for a period of not less than 
one year, and at the processing plant or other reasonably accessible 
location for an additional two years, all records of processing, 
deviations in processing, container closure inspections, and other 
records specified in part 113 of this chapter. If during the first year 
of the three-year record retention period the processing plant is closed 
for a prolonged period between seasonal packs, the records may be 
transferred to some other reasonably accessible location at the end of 
the seasonal pack. Upon written demand during the course of a factory 
inspection pursuant to section 704 of the act by a duly authorized 
employee of the Food and Drug Administration, a commercial processor 
shall permit the inspection and copying by such employee of these 
records to verify the adequacy of processing, the integrity of container 
closures, and the coding of the products.
    (i) This section shall not apply to the commercial processing of any 
food processed under the continuous inspection of the meat and poultry 
inspection program of the Food Safety and Inspection Service of the 
Department of Agriculture under the Federal Meat Inspection Act (34 
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the 
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat. 
791 (21 U.S.C. 451 et seq.)).
    (j) Compliance with State regulations. (1) Wherever the Commissioner 
finds that any State regulates the commercial thermal processing of low-
acid foods in accordance with effective regulations specifying at least 
the requirements of part 113 of this chapter, he shall issue a notice 
stating that compliance with such State regulations shall constitute 
compliance with part 113 of this chapter. However, the provisions of 
this section shall remain applicable to the commercial processing of 
low-acid foods in any such State, except that, either the State through 
its regulatory agency or each processor of low-acid foods in such State 
shall file with the Center for Food Safety and Applied Nutrition the 
registration information and the processing information prescribed in 
paragraph (c) of this section.
    (2) The Commissioner finds that the regulations adopted by the State 
of California under the laws relating to cannery inspections governing 
thermal processing of low-acid foods packaged in hermetically sealed 
containers satisfy the requirements of part 113 of this chapter.


Accordingly, processors, who under the laws relating to cannery 
inspections are licensed by the State of California and who comply with 
such state regulations, shall be deemed to comply with the requirements 
of part 113 of this chapter.
    (k) Imports. (1) This section shall apply to any foreign commercial 
processor engaged in the thermal processing of low-acid foods packaged 
in hermetically sealed containers and offering such foods for import 
into the United States except that, in lieu of providing for the 
issuance of an emergency permit under paragraph (a) of this section, the 
Commissioner will request the Secretary of the Treasury to refuse 
admission into the United States, pursuant to section 801 of the act, of 
any such low-acid foods which the Commissioner determines, after 
investigation, may result in the distribution in interstate commerce of 
processed foods that may be injurious to

[[Page 259]]

health as set forth in paragraph (a) of this section.
    (2) Any such food refused admission shall not be admitted until such 
time as the Commissioner may determine that the commercial processor 
offering the food for import is in compliance with the requirements and 
conditions of this section and that such food is not injurious to 
health. For the purpose of making such determination, the Commissioner 
reserves the right for a duly authorized employee of the Food and Drug 
Administration to inspect the commercial processor's manufacturing, 
processing, and packing facilities.
    (l) The following data and information submitted to the Food and 
Drug Administration pursuant to this section are not available for 
public disclosure unless they have been previously disclosed to the 
public as defined in Sec. 20.81 of this chapter or they relate to a 
product or ingredient that has been abandoned and they no longer 
represent a trade secret or confidential commercial or financial 
information as defined in Sec. 20.81 of this chapter:
    (1) Manufacturing methods or processes, including quality control 
information.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this 
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.

[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
54 FR 24891, June 12, 1989; 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 
6, 2001; 81 FR 46831, July 19, 2016]



PART 109_UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION 
AND FOOD-PACKAGING MATERIAL--Table of Contents



                      Subpart A_General Provisions

Sec.
109.3 Definitions and interpretations.
109.4 Establishment of tolerances, regulatory limits, and action levels.
109.6 Added poisonous or deleterious substances.
109.7 Unavoidability.
109.15 Use of polychlorinated biphenyls (PCB's) in establishments 
          manufacturing food-packaging materials.
109.16 Ornamental and decorative ceramicware.

Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances

109.30 Tolerances for polychlorinated biphenyls (PCB's).

Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances 
[Reserved]

Subpart D--Naturally Occurring Poisonous or Deleterious Substances 
[Reserved]

    Authority: 21 U.S.C. 321, 336, 342, 346, 346a, 348, 371.

    Source: 42 FR 52819, Sept. 30, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 109 appear at 81 FR 
49896, July 29, 2016.



                      Subpart A_General Provisions



Sec. 109.3  Definitions and interpretations.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) The definitions of terms contained in section 201 of the act are 
applicable to such terms when used in this part unless modified in this 
section.
    (c) A naturally occurring poisonous or deleterious substance is a 
poisonous or deleterious substance that is an inherent natural 
constituent of a food and is not the result of environmental, 
agricultural, industrial, or other contamination.
    (d) An added poisonous or deleterious substance is a poisonous or 
deleterious substance that is not a naturally occurring poisonous or 
deleterious substance. When a naturally occurring poisonous or 
deleterious substance is increased to abnormal levels through 
mishandling or other intervening acts, it is an added poisonous or 
deleterious substance to the extent of such increase.
    (e) Food includes human food and substances migrating to food from 
food-contact articles.

[[Page 260]]



Sec. 109.4  Establishment of tolerances, regulatory limits,
and action levels.

    (a) When appropriate under the criteria of Sec. 109.6, a tolerance 
for an added poisonous or deleterious substance, which may be a food 
additive, may be established by regulation in subpart B of this part 
under the provisions of section 406 of the act. A tolerance may prohibit 
any detectable amount of the substance in food.
    (b) When appropriate under the criteria of Sec. 109.6, and under 
section 402(a)(1) of the act, a regulatory limit for an added poisonous 
or deleterious substance, which may be a food additive, may be 
established by regulation in subpart C of this part under the provisions 
of sections 402(a)(1) and 701(a) of the act. A regulatory limit may 
prohibit any detectable amount of the substance in food. The regulatory 
limit established represents the level at which food is adulterated 
within the meaning of section 402(a)(1) of the act.
    (c)(1) When appropriate under the criteria of Sec. 109.6, an action 
level for an added poisonous or deleterious substance, which may be a 
food additive, may be established to define a level of contamination at 
which a food may be regarded as adulterated.
    (2) Whenever an action level is established or changed, a notice 
shall be published in the Federal Register as soon as practicable 
thereafter. The notice shall call attention to the material supporting 
the action level which shall be on file with the Division of Dockets 
Management before the notice is published. The notice shall invite 
public comment on the action level.
    (d) A regulation may be established in subpart D of this part to 
identify a food containing a naturally occurring poisonous or 
deleterious substance which will be deemed to be adulterated under 
section 402(a)(1) of the act. These regulations do not constitute a 
complete list of such foods.

[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]



Sec. 109.6  Added poisonous or deleterious substances.

    (a) Use of an added poisonous or deleterious substance, other than a 
pesticide chemical, that is also a food additive, will be controlled by 
a regulation issued under section 409 of the act when possible. When 
such a use cannot be approved under the criteria of section 409 of the 
act, or when the added poisonous or deleterious substance is not a food 
additive, a tolerance, regulatory limit, or action level may be 
established pursuant to the criteria in paragraphs (b), (c), or (d) of 
this section. Residues resulting from the use of an added poisonous or 
deleterious substance that is also a pesticide chemical will ordinarily 
be controlled by a tolerance established in a regulation issued under 
sections 406, 408, or 409 of the act by the U.S. Environmental 
Protection Agency (EPA). When such a regulation has not been issued, an 
action level for an added poisonous or deleterious substance that is 
also a pesticide chemical may be established by the Food and Drug 
Administration. The Food and Drug Administration will request EPA to 
recommend such an action level pursuant to the criteria established in 
paragraph (d) of this section.
    (b) A tolerance for an added poisonous or deleterious substance in 
any food may be established when the following criteria are met:
    (1) The substance cannot be avoided by good manufacturing practice.
    (2) The tolerance established is sufficient for the protection of 
the public health, taking into account the extent to which the presence 
of the substance cannot be avoided and the other ways in which the 
consumer may be affected by the same or related poisonous or deleterious 
substances.
    (3) No technological or other changes are foreseeable in the near 
future that might affect the appropriateness of the tolerance 
established. Examples of changes that might affect the appropriateness 
of the tolerance include anticipated improvements in good manufacturing 
practice that would change the extent to which use of the substance is 
unavoidable and anticipated studies expected to provide significant new 
toxicological or use data.
    (c) A regulatory limit for an added poisonous or deleterious 
substance in any food may be established when each of the following 
criteria is met:
    (1) The substance cannot be avoided by current good manufacturing 
practices.

[[Page 261]]

    (2) There is no tolerance established for the substance in the 
particular food under sections 406, 408, or 409 of the act.
    (3) There is insufficient information by which a tolerance may be 
established for the substance under section 406 of the act or 
technological changes appear reasonably possible that may affect the 
appropriateness of a tolerance. The regulatory limit established 
represents the level at which food is adulterated within the meaning of 
section 402(a)(1) of the act.
    (d) An action level for an added poisonous or deleterious substance 
in any food may be established when the criteria in paragraph (b) of 
this section are met, except that technological or other changes that 
might affect the appropriateness of the tolerance are foreseeable in the 
near future. An action level for an added poisonous or deleterious 
substance in any food may be established at a level at which the Food 
and Drug Administration may regard the food as adulterated within the 
meaning of section 402(a)(1) of the act, without regard to the criteria 
in paragraph (b) of this section or in section 406 of the act. An action 
level will be withdrawn when a tolerance or regulatory limit for the 
same substance and use has been established.
    (e) Tolerances will be established under authority appropriate for 
action levels (sections 306, 402(a), and 701(a) of the act, together 
with section 408 or 409 of the act, if appropriate) as well as under 
authority appropriate for tolerances (sections 406 and 701 of the act). 
In the event the effectiveness of a tolerance is stayed pursuant to 
section 701(e)(2) of the act by the filing of an objection, the order 
establishing the tolerance shall be deemed to be an order establishing 
an action level until final action is taken upon such objection.

[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]



Sec. 109.7  Unavoidability.

    (a) Tolerances and action levels in this part are established at 
levels based on the unavoidability of the poisonous or deleterious 
substance concerned and do not establish a permissible level of 
contamination where it is avoidable.
    (b) Compliance with tolerances, regulatory limits, and action levels 
does not excuse failure to observe either the requirement in section 
402(a)(4) of the act that food may not be prepared, packed, or held 
under insanitary conditions or the other requirements in this chapter 
that food manufacturers must observe current good manufacturing 
practices. Evidence obtained through factory inspection or otherwise 
indicating such a violation renders the food unlawful, even though the 
amounts of poisonous or deleterious substances are lower than the 
currently established tolerances, regulatory limits, or action levels. 
The manufacturer of food must at all times utilize quality control 
procedures which will reduce contamination to the lowest level currently 
feasible.

[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]



Sec. 109.15  Use of polychlorinated biphenyls (PCB's) in
establishments manufacturing food-packaging materials.

    (a) Polychlorinated biphenyls (PCB's) represent a class of toxic 
industrial chemicals manufactured and sold under a variety of trade 
names, including: Aroclor (United States); Phenoclor (France); Colphen 
(Germany); and Kanaclor (Japan). PCB's are highly stable, heat 
resistant, and nonflammable chemicals. Industrial uses of PCB's include, 
or did include in the past, their use as electrical transformer and 
capacitor fluids, heat transfer fluids, hydraulic fluids, and 
plasticizers, and in formulations of lubricants, coatings, and inks. 
Their unique physical and chemical properties and widespread, 
uncontrolled industrial applications have caused PCB's to be a 
persistent and ubiquitous contaminant in the environment, causing the 
contamination of certain foods. In addition, incidents have occurred in 
which PCB's have directly contaminated animal feeds as a result of 
industrial accidents (leakage or spillage of PCB fluids from plant 
equipment). These accidents in turn caused the contamination of food 
products intended for human consumption (meat, milk and eggs). 
Investigations by the Food and Drug Administration

[[Page 262]]

have revealed that a significant percentage of paper food-packaging 
material contains PCB's which can migrate to the packaged food. The 
origin of PCB's in such material is not fully understood. Reclaimed 
fibers containing carbonless copy paper (contains 3 to 5 percent PCB's) 
have been identified as a primary source of PCB's in paper products. 
Some virgin paper products have also been found to contain PCB's, the 
source of which is generally attributed to direct contamination from 
industrial accidents from the use of PCB-containing equipment and 
machinery in food packaging manufacturing establishments. Since PCB's 
are toxic chemicals, the PCB contamination of food-packaging materials 
as a result of industrial accidents, which can cause the PCB 
contamination of food, represents a hazard to public health. It is 
therefore necessary to place certain restrictions on the industrial uses 
of PCB's in establishments manufacturing food-packaging materials.
    (b) The following special provisions are necessary to preclude the 
accidental PCB contamination of food-packaging materials:
    (1) New equipment or machinery for manufacturing food-packaging 
materials shall not contain or use PCB's.
    (2) On or before September 4, 1973, the management of establishments 
manufacturing food-packaging materials shall:
    (i) Have the heat exchange fluid used in existing equipment for 
manufacturing food-packaging materials sampled and tested to determine 
whether it contains PCB's or verify the absence of PCB's in such 
formulations by other appropriate means. On or before Sept. 4, 1973, any 
such fluid formulated with PCB's must to the fullest extent possible 
commensurate with current good manufacturing practices be replaced with 
a heat exchange fluid that does not contain PCB's.
    (ii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the establishment any other 
PCB-containing equipment, machinery and materials wherever there is a 
reasonable expectation that such articles could cause food-packaging 
materials to become contaminated with PCB's either as a result of normal 
use or as a result of accident, breakage, or other mishap.
    (iii) The toxicity and other characteristics of fluids selected as 
PCB replacements must be adequately determined so that the least 
potentially hazardous replacement is used. In making this determination 
with respect to a given fluid, consideration should be given to (a) its 
toxicity; (b) the maximum quantity that could be spilled onto a given 
quantity of food before it would be noticed, taking into account its 
color and odor; (c) possible signaling devices in the equipment to 
indicate a loss of fluid, etc.; and (d) its environmental stability and 
tendency to survive and be concentrated through the food chain. The 
judgment as to whether a replacement fluid is sufficiently non-hazardous 
is to be made on an individual installation and operation basis.
    (c) The provisions of this section do not apply to electrical 
transformers and condensers containing PCB's in sealed containers.



Sec. 109.16  Ornamental and decorative ceramicware.

    (a) Lead is a toxic metal that is used as a component of glazes and 
decorative decals on ceramics, including some ornamental and decorative 
ceramicware. The use of ornamental or decorative ceramicware to prepare, 
serve, or hold food may result in the leaching of lead from the glaze or 
decoration into the food. The provisions of paragraph (b) of this 
section are necessary to ensure that ornamental or decorative 
ceramicware bear adequate indications that they are not to be used for 
food-handling purposes.
    (b) Ornamental or decorative ceramicware initially introduced or 
initially delivered for introduction into interstate commerce on or 
after July 13, 1994 appears to be suitable for food use will be 
considered to be for food use unless:
    (1) It bears:
    (i) A conspicuous stick-on label on a surface clearly visible to 
consumers that states in legible script in letters at least 3.2 
millimeters (0.125 inch) in height one of the following messages: ``Not 
for Food Use. May Poison Food,'' ``Not for Food Use. Glaze contains 
lead.

[[Page 263]]

Food Use May Result in Lead Poisoning,'' and ``Not for Food Use--Food 
Consumed from this Vessel May be Harmful,'' and
    (ii) A conspicuous and legible permanent statement of the message 
selected from paragraph (b)(1)(i) of this section molded or fired onto 
the exterior surface of the base or, when the ceramicware is not fired 
after decoration, permanently painted onto the exterior surface of the 
base. This permanent statement shall be in letters at least 3.2 
millimeters (0.125 inch) in height, except that if insufficient space 
exists for the permanent statement in letters of such height, the 
statement shall be in the largest letters that will allow it to fit on 
the base of the piece, provided that the letters are at least 1.6 
millimeters (0.062 inch) in height; or
    (2) A hole is bored through the potential food-contact surface.
    (c) In addition to steps required under paragraphs (b)(1) and (b)(2) 
of this section, the following optional information may be provided on 
the ware:
    (1) A further explanatory statement concerning the decorative nature 
of the piece, such as ``Decorative'' or ``For Decorative Purposes 
Only,'' may be used; however, such additional statement shall be placed 
after the required statement.
    (2) A symbol may be used to advise that a piece of ornamental or 
decorative ceramicware is not to be used with food, as illustrated 
below.
[GRAPHIC] [TIFF OMITTED] TR01JA93.368


The circle of the above symbol should be at least 2.54 centimeters (1 
inch) in diameter. The symbol may be used on the temporary label or 
applied to the base of the piece in the same manner as the permanent 
statement.

[59 FR 1641, Jan. 12, 1994]



Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances



Sec. 109.30  Tolerances for polychlorinated biphenyls (PCB's).

    (a) Polychlorinated biphenyls (PCB's) are toxic, industrial 
chemicals. Because of their widespread, uncontrolled industrial 
applications, PCB's have become a persistent and ubiquitous contaminant 
in the environment. As a result, certain foods and animal feeds, 
principally those of animal and marine origin, contain PCB's as 
unavoidable, environmental contaminants. PCB's are transmitted to the 
food portion (meat, milk, and eggs) of food-producing animals ingesting 
PCB-contaminated animal feed. In addition, a significant percentage of 
paper food-packaging materials contain PCB's which may migrate to the 
packaged food. The source of PCB's in paper food-packaging materials is 
primarily of certain types of carbonless copy paper (containing 3 to 5 
percent PCB's) in waste paper stocks used for manufacturing recycled 
paper. Therefore, temporary tolerances for residues of PCB's as 
unavoidable environmental or industrial contaminants are established for 
a sufficient period of time following the effective date of this 
paragraph to permit the elimination of such contaminants at the earliest 
practicable time. For the purposes of this paragraph, the term 
``polychlorinated biphenyls (PCB's)'' is applicable to mixtures of 
chlorinated biphenyl compounds, irrespective of which mixture of PCB's 
is present as the residue. The temporary tolerances for residues of 
PCB's are as follows:
    (1) 1.5 parts per million in milk (fat basis).
    (2) 1.5 parts per million in manufactured dairy products (fat 
basis).
    (3) 3 parts per million in poultry (fat basis).
    (4) 0.3 parts per million in eggs.
    (5) 0.2 parts per million in finished animal feed for food-producing 
animals (except the following finished animal feeds: feed concentrates, 
feed supplements, and feed premixes).
    (6) 2 parts per million in animal feed components of animal origin, 
including

[[Page 264]]

fishmeal and other by-products of marine origin and in finished animal 
feed concentrates, supplements, and premixes intended for food producing 
animals.
    (7) 2 parts per million in fish and shellfish (edible portion). The 
edible portion of fish excludes head, scales, viscera, and inedible 
bones.
    (8) 0.2 parts per million in infant and junior foods.
    (9) 10 parts per million in paper food-packaging material intended 
for or used with human food, finished animal feed and any components 
intended for animal feeds. The tolerance shall not apply to paper food-
packaging material separated from the food therein by a functional 
barrier which is impermeable to migration of PCB's.
    (b) A compilation entitled ``Analytical Methodology for 
Polychlorinated Biphenyls, June 1979'' for determining compliance with 
the tolerances established in this section is available from the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    (c) A barrier is functional for purposes of paragraph (a)(9) of this 
section if the barrier limits migration of PCB's from the packaging 
material to food to a level not exceeding the migration which occurs 
under the same test conditions from packaging material containing 10 
parts per million PCB without the use of a barrier. A class of barrier 
material is functional for purposes of paragraph (a)(9) of this section 
if a representative barrier of the class limits migration of PCB's from 
the packaging material to food to a level not exceeding the migration 
which occurs under the same test conditions from packaging material 
containing 10 parts per million PCB without the use of a barrier. 
Migration levels shall be determined for purpose of this paragraph 
solely by use of testing conditions described in ``Test Procedures for 
Determination of PCB Permeability of Food Packaging, Inner-Wraps, 
September 1976, revised May 1983'', which is incorporated by reference. 
Copies are available from the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852, or 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. A 
class of barrier material shall be deemed functional only if the 
definition of the class and the designation of one or more 
representative barriers has been approved by the Director, Center for 
Food Safety and Applied Nutrition, Food and Drug Administration. In the 
event that the Director, Center for Food Safety and Applied Nutrition, 
does not approve a proposal made to the Center regarding the definition 
of a class of barrier material or the designation of representative 
barriers, the Director shall advise the person making the proposal of 
the reasons for the Center's disapproval within 90 days of receipt of 
the proposal. All proposals for definition of classes and determinations 
of the Food and Drug Administration regarding such proposals shall be on 
file with the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    (d) Any person who asserts that a barrier or class of barriers is 
functional shall submit the results of tests conducted to determine the 
functionality of the barrier or class of barriers to Center for Food 
Safety and Applied Nutrition (HFS-308), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740. All barriers or classes of 
barriers shall be tested with the four solid food receptors specified in 
``Test Procedures for Determination of PCB Permeability of Food 
Packaging, Inner-Wraps, September 1976, revised May 1983'', which is 
incorporated by reference. The availability of this reference is given 
in paragraph (c) of this section. The test results as to each barrier 
shall be accompanied by (1) a description of the barrier's composition 
adequate to enable identification; and (2) a specific definition of the 
barrier by relevant technical characteristics. The Center for Food 
Safety and Applied Nutrition shall review submitted test results 
promptly. Within 60 days of the receipt of test results, the Director,

[[Page 265]]

Center for Food Safety and Applied Nutrition, shall notify the person 
submitting the test results whether the tests were conducted in 
accordance with the ``Analytical Methodology for Polychlorinated 
Biphenyls; June 1979'', which is incorporated by reference, or the 
``Test Procedures for Determination of PCB Permeability of Food 
Packaging, Inner-Wraps, September 1976, revised May 1983'' and whether, 
therefore, the barrier or class of barriers is deemed functional within 
the meaning of paragraph (c) of this section. The test results and any 
response of the Food and Drug Administration shall be placed on file 
with the Division of Dockets Management, Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

[42 FR 52819, Sept. 30, 1977, as amended at 44 FR 38340, June 29, 1979; 
46 FR 8459, Jan. 27, 1981; 48 FR 10811, Mar. 15, 1983; 48 FR 37021, Aug. 
16, 1983; 54 FR 24892, June 12, 1989; 59 FR 14364, Mar. 28, 1994; 61 FR 
14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]

    Effective Date Note: At 38 FR 22794, Aug. 24, 1973, the following 
appeared concerning Sec. 109.30(a)(9) (formerly 122.10(a)(9)):
* * * Sec. 109.30(a)(9) is hereby stayed pending full review of the 
objections and requests for hearing. * * *
    In the interim, as stated in the final order (38 FR 18098) the Food 
and Drug Administration will enforce the temporary tolerance level 
established by Sec. 109.30(a)(9) by seizing any paper food-packaging 
material shipped in interstate commerce after September 4, 1973 
containing higher than the specified level of PCB's as adulterated in 
violation of sec. 402 of the act.

Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances 
[Reserved]

Subpart D--Naturally Occurring Posionous or Deleterious Substances 
[Reserved]



PART 110_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, 
PACKING, OR HOLDING HUMAN FOOD--Table of Contents



                      Subpart A_General Provisions

Sec.
110.3 Definitions.
110.5 Current good manufacturing practice.
110.10 Personnel.
110.19 Exclusions.

                   Subpart B_Buildings and Facilities

110.20 Plant and grounds.
110.35 Sanitary operations.
110.37 Sanitary facilities and controls.

                           Subpart C_Equipment

110.40 Equipment and utensils.

Subpart D [Reserved]

                Subpart E_Production and Process Controls

110.80 Processes and controls.
110.93 Warehousing and distribution.

Subpart F [Reserved]

                     Subpart G_Defect Action Levels

110.110 Natural or unavoidable defects in food for human use that 
          present no health hazard.

    Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.

    Source: 51 FR 22475, June 19, 1986, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 110 appear at 81 FR 
49896, July 29, 2016.



                      Subpart A_General Provisions



Sec. 110.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the act) are applicable to such 
terms when used in this part. The following definitions shall also 
apply:
    (a) Acid foods or acidified foods means foods that have an 
equilibrium pH of 4.6 or below.
    (b) Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    (c) Batter means a semifluid substance, usually composed of flour 
and other ingredients, into which principal components of food are 
dipped or with which they are coated, or which may be used directly to 
form bakery foods.
    (d) Blanching, except for tree nuts and peanuts, means a 
prepackaging

[[Page 266]]

heat treatment of foodstuffs for a sufficient time and at a sufficient 
temperature to partially or completely inactivate the naturally 
occurring enzymes and to effect other physical or biochemical changes in 
the food.
    (e) Critical control point means a point in a food process where 
there is a high probability that improper control may cause, allow, or 
contribute to a hazard or to filth in the final food or decomposition of 
the final food.
    (f) Food means food as defined in section 201(f) of the act and 
includes raw materials and ingredients.
    (g) Food-contact surfaces are those surfaces that contact human food 
and those surfaces from which drainage onto the food or onto surfaces 
that contact the food ordinarily occurs during the normal course of 
operations. ``Food-contact surfaces'' includes utensils and food-contact 
surfaces of equipment.
    (h) Lot means the food produced during a period of time indicated by 
a specific code.
    (i) Microorganisms means yeasts, molds, bacteria, and viruses and 
includes, but is not limited to, species having public health 
significance. The term ``undesirable microorganisms'' includes those 
microorganisms that are of public health significance, that subject food 
to decomposition, that indicate that food is contaminated with filth, or 
that otherwise may cause food to be adulterated within the meaning of 
the act. Occasionally in these regulations, FDA used the adjective 
``microbial'' instead of using an adjectival phrase containing the word 
microorganism.
    (j) Pest refers to any objectionable animals or insects including, 
but not limited to, birds, rodents, flies, and larvae.
    (k) Plant means the building or facility or parts thereof, used for 
or in connection with the manufacturing, packaging, labeling, or holding 
of human food.
    (l) Quality control operation means a planned and systematic 
procedure for taking all actions necessary to prevent food from being 
adulterated within the meaning of the act.
    (m) Rework means clean, unadulterated food that has been removed 
from processing for reasons other than insanitary conditions or that has 
been successfully reconditioned by reprocessing and that is suitable for 
use as food.
    (n) Safe-moisture level is a level of moisture low enough to prevent 
the growth of undesirable microorganisms in the finished product under 
the intended conditions of manufacturing, storage, and distribution. The 
maximum safe moisture level for a food is based on its water activity 
(aw). An aw will be considered safe for a food if 
adequate data are available that demonstrate that the food at or below 
the given aw will not support the growth of undesirable 
microorganisms.
    (o) Sanitize means to adequately treat food-contact surfaces by a 
process that is effective in destroying vegetative cells of 
microorganisms of public health significance, and in substantially 
reducing numbers of other undesirable microorganisms, but without 
adversely affecting the product or its safety for the consumer.
    (p) Shall is used to state mandatory requirements.
    (q) Should is used to state recommended or advisory procedures or 
identify recommended equipment.
    (r) Water activity (aw) is a measure of the free moisture 
in a food and is the quotient of the water vapor pressure of the 
substance divided by the vapor pressure of pure water at the same 
temperature.



Sec. 110.5  Current good manufacturing practice.

    (a) The criteria and definitions in this part shall apply in 
determining whether a food is adulterated (1) within the meaning of 
section 402(a)(3) of the act in that the food has been manufactured 
under such conditions that it is unfit for food; or (2) within the 
meaning of section 402(a)(4) of the act in that the food 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. The criteria and definitions in this part 
also apply in determining whether a food is in violation of section 361 
of the Public Health Service Act (42 U.S.C. 264).

[[Page 267]]

    (b) Food covered by specific current good manufacturing practice 
regulations also is subject to the requirements of those regulations.



Sec. 110.10  Personnel.

    The plant management shall take all reasonable measures and 
precautions to ensure the following:
    (a) Disease control. Any person who, by medical examination or 
supervisory observation, is shown to have, or appears to have, an 
illness, open lesion, including boils, sores, or infected wounds, or any 
other abnormal source of microbial contamination by which there is a 
reasonable possibility of food, food-contact surfaces, or food-packaging 
materials becoming contaminated, shall be excluded from any operations 
which may be expected to result in such contamination until the 
condition is corrected. Personnel shall be instructed to report such 
health conditions to their supervisors.
    (b) Cleanliness. All persons working in direct contact with food, 
food-contact surfaces, and food-packaging materials shall conform to 
hygienic practices while on duty to the extent necessary to protect 
against contamination of food. The methods for maintaining cleanliness 
include, but are not limited to:
    (1) Wearing outer garments suitable to the operation in a manner 
that protects against the contamination of food, food-contact surfaces, 
or food-packaging materials.
    (2) Maintaining adequate personal cleanliness.
    (3) Washing hands thoroughly (and sanitizing if necessary to protect 
against contamination with undesirable microorganisms) in an adequate 
hand-washing facility before starting work, after each absence from the 
work station, and at any other time when the hands may have become 
soiled or contaminated.
    (4) Removing all unsecured jewelry and other objects that might fall 
into food, equipment, or containers, and removing hand jewelry that 
cannot be adequately sanitized during periods in which food is 
manipulated by hand. If such hand jewelry cannot be removed, it may be 
covered by material which can be maintained in an intact, clean, and 
sanitary condition and which effectively protects against the 
contamination by these objects of the food, food-contact surfaces, or 
food-packaging materials.
    (5) Maintaining gloves, if they are used in food handling, in an 
intact, clean, and sanitary condition. The gloves should be of an 
impermeable material.
    (6) Wearing, where appropriate, in an effective manner, hair nets, 
headbands, caps, beard covers, or other effective hair restraints.
    (7) Storing clothing or other personal belongings in areas other 
than where food is exposed or where equipment or utensils are washed.
    (8) Confining the following to areas other than where food may be 
exposed or where equipment or utensils are washed: eating food, chewing 
gum, drinking beverages, or using tobacco.
    (9) Taking any other necessary precautions to protect against 
contamination of food, food-contact surfaces, or food-packaging 
materials with microorganisms or foreign substances including, but not 
limited to, perspiration, hair, cosmetics, tobacco, chemicals, and 
medicines applied to the skin.
    (c) Education and training. Personnel responsible for identifying 
sanitation failures or food contamination should have a background of 
education or experience, or a combination thereof, to provide a level of 
competency necessary for production of clean and safe food. Food 
handlers and supervisors should receive appropriate training in proper 
food handling techniques and food-protection principles and should be 
informed of the danger of poor personal hygiene and insanitary 
practices.
    (d) Supervision. Responsibility for assuring compliance by all 
personnel with all requirements of this part shall be clearly assigned 
to competent supervisory personnel.

[51 FR 22475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]



Sec. 110.19  Exclusions.

    (a) The following operations are not subject to this part: 
Establishments engaged solely in the harvesting, storage, or 
distribution of one or more ``raw agricultural commodities,'' as defined 
in section 201(r) of the act, which

[[Page 268]]

are ordinarily cleaned, prepared, treated, or otherwise processed before 
being marketed to the consuming public.
    (b) FDA, however, will issue special regulations if it is necessary 
to cover these excluded operations.



                   Subpart B_Buildings and Facilities



Sec. 110.20  Plant and grounds.

    (a) Grounds. The grounds about a food plant under the control of the 
operator shall be kept in a condition that will protect against the 
contamination of food. The methods for adequate maintenance of grounds 
include, but are not limited to:
    (1) Properly storing equipment, removing litter and waste, and 
cutting weeds or grass within the immediate vicinity of the plant 
buildings or structures that may constitute an attractant, breeding 
place, or harborage for pests.
    (2) Maintaining roads, yards, and parking lots so that they do not 
constitute a source of contamination in areas where food is exposed.
    (3) Adequately draining areas that may contribute contamination to 
food by seepage, foot-borne filth, or providing a breeding place for 
pests.
    (4) Operating systems for waste treatment and disposal in an 
adequate manner so that they do not constitute a source of contamination 
in areas where food is exposed.


If the plant grounds are bordered by grounds not under the operator's 
control and not maintained in the manner described in paragraph (a) (1) 
through (3) of this section, care shall be exercised in the plant by 
inspection, extermination, or other means to exclude pests, dirt, and 
filth that may be a source of food contamination.
    (b) Plant construction and design. Plant buildings and structures 
shall be suitable in size, construction, and design to facilitate 
maintenance and sanitary operations for food-manufacturing purposes. The 
plant and facilities shall:
    (1) Provide sufficient space for such placement of equipment and 
storage of materials as is necessary for the maintenance of sanitary 
operations and the production of safe food.
    (2) Permit the taking of proper precautions to reduce the potential 
for contamination of food, food-contact surfaces, or food-packaging 
materials with microorganisms, chemicals, filth, or other extraneous 
material. The potential for contamination may be reduced by adequate 
food safety controls and operating practices or effective design, 
including the separation of operations in which contamination is likely 
to occur, by one or more of the following means: location, time, 
partition, air flow, enclosed systems, or other effective means.
    (3) Permit the taking of proper precautions to protect food in 
outdoor bulk fermentation vessels by any effective means, including:
    (i) Using protective coverings.
    (ii) Controlling areas over and around the vessels to eliminate 
harborages for pests.
    (iii) Checking on a regular basis for pests and pest infestation.
    (iv) Skimming the fermentation vessels, as necessary.
    (4) Be constructed in such a manner that floors, walls, and ceilings 
may be adequately cleaned and kept clean and kept in good repair; that 
drip or condensate from fixtures, ducts and pipes does not contaminate 
food, food-contact surfaces, or food-packaging materials; and that 
aisles or working spaces are provided between equipment and walls and 
are adequately unobstructed and of adequate width to permit employees to 
perform their duties and to protect against contaminating food or food-
contact surfaces with clothing or personal contact.
    (5) Provide adequate lighting in hand-washing areas, dressing and 
locker rooms, and toilet rooms and in all areas where food is examined, 
processed, or stored and where equipment or utensils are cleaned; and 
provide safety-type light bulbs, fixtures, skylights, or other glass 
suspended over exposed food in any step of preparation or otherwise 
protect against food contamination in case of glass breakage.
    (6) Provide adequate ventilation or control equipment to minimize 
odors and vapors (including steam and noxious fumes) in areas where they 
may

[[Page 269]]

contaminate food; and locate and operate fans and other air-blowing 
equipment in a manner that minimizes the potential for contaminating 
food, food-packaging materials, and food-contact surfaces.
    (7) Provide, where necessary, adequate screening or other protection 
against pests.



Sec. 110.35  Sanitary operations.

    (a) General maintenance. Buildings, fixtures, and other physical 
facilities of the plant shall be maintained in a sanitary condition and 
shall be kept in repair sufficient to prevent food from becoming 
adulterated within the meaning of the act. Cleaning and sanitizing of 
utensils and equipment shall be conducted in a manner that protects 
against contamination of food, food-contact surfaces, or food-packaging 
materials.
    (b) Substances used in cleaning and sanitizing; storage of toxic 
materials. (1) Cleaning compounds and sanitizing agents used in cleaning 
and sanitizing procedures shall be free from undesirable microorganisms 
and shall be safe and adequate under the conditions of use. Compliance 
with this requirement may be verified by any effective means including 
purchase of these substances under a supplier's guarantee or 
certification, or examination of these substances for contamination. 
Only the following toxic materials may be used or stored in a plant 
where food is processed or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and 
operation; and
    (iv) Those necessary for use in the plant's operations.
    (2) Toxic cleaning compounds, sanitizing agents, and pesticide 
chemicals shall be identified, held, and stored in a manner that 
protects against contamination of food, food-contact surfaces, or food-
packaging materials. All relevant regulations promulgated by other 
Federal, State, and local government agencies for the application, use, 
or holding of these products should be followed.
    (c) Pest control. No pests shall be allowed in any area of a food 
plant. Guard or guide dogs may be allowed in some areas of a plant if 
the presence of the dogs is unlikely to result in contamination of food, 
food-contact surfaces, or food-packaging materials. Effective measures 
shall be taken to exclude pests from the processing areas and to protect 
against the contamination of food on the premises by pests. The use of 
insecticides or rodenticides is permitted only under precautions and 
restrictions that will protect against the contamination of food, food-
contact surfaces, and food-packaging materials.
    (d) Sanitation of food-contact surfaces. All food-contact surfaces, 
including utensils and food-contact surfaces of equipment, shall be 
cleaned as frequently as necessary to protect against contamination of 
food.
    (1) Food-contact surfaces used for manufacturing or holding low-
moisture food shall be in a dry, sanitary condition at the time of use. 
When the surfaces are wet-cleaned, they shall, when necessary, be 
sanitized and thoroughly dried before subsequent use.
    (2) In wet processing, when cleaning is necessary to protect against 
the introduction of microorganisms into food, all food-contact surfaces 
shall be cleaned and sanitized before use and after any interruption 
during which the food-contact surfaces may have become contaminated. 
Where equipment and utensils are used in a continuous production 
operation, the utensils and food-contact surfaces of the equipment shall 
be cleaned and sanitized as necessary.
    (3) Non-food-contact surfaces of equipment used in the operation of 
food plants should be cleaned as frequently as necessary to protect 
against contamination of food.
    (4) Single-service articles (such as utensils intended for one-time 
use, paper cups, and paper towels) should be stored in appropriate 
containers and shall be handled, dispensed, used, and disposed of in a 
manner that protects against contamination of food or food-contact 
surfaces.
    (5) Sanitizing agents shall be adequate and safe under conditions of 
use. Any facility, procedure, or machine is

[[Page 270]]

acceptable for cleaning and sanitizing equipment and utensils if it is 
established that the facility, procedure, or machine will routinely 
render equipment and utensils clean and provide adequate cleaning and 
sanitizing treatment.
    (e) Storage and handling of cleaned portable equipment and utensils. 
Cleaned and sanitized portable equipment with food-contact surfaces and 
utensils should be stored in a location and manner that protects food-
contact surfaces from contamination.

[51 FR 22475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]



Sec. 110.37  Sanitary facilities and controls.

    Each plant shall be equipped with adequate sanitary facilities and 
accommodations including, but not limited to:
    (a) Water supply. The water supply shall be sufficient for the 
operations intended and shall be derived from an adequate source. Any 
water that contacts food or food-contact surfaces shall be safe and of 
adequate sanitary quality. Running water at a suitable temperature, and 
under pressure as needed, shall be provided in all areas where required 
for the processing of food, for the cleaning of equipment, utensils, and 
food-packaging materials, or for employee sanitary facilities.
    (b) Plumbing. Plumbing shall be of adequate size and design and 
adequately installed and maintained to:
    (1) Carry sufficient quantities of water to required locations 
throughout the plant.
    (2) Properly convey sewage and liquid disposable waste from the 
plant.
    (3) Avoid constituting a source of contamination to food, water 
supplies, equipment, or utensils or creating an unsanitary condition.
    (4) Provide adequate floor drainage in all areas where floors are 
subject to flooding-type cleaning or where normal operations release or 
discharge water or other liquid waste on the floor.
    (5) Provide that there is not backflow from, or cross-connection 
between, piping systems that discharge waste water or sewage and piping 
systems that carry water for food or food manufacturing.
    (c) Sewage disposal. Sewage disposal shall be made into an adequate 
sewerage system or disposed of through other adequate means.
    (d) Toilet facilities. Each plant shall provide its employees with 
adequate, readily accessible toilet facilities. Compliance with this 
requirement may be accomplished by:
    (1) Maintaining the facilities in a sanitary condition.
    (2) Keeping the facilities in good repair at all times.
    (3) Providing self-closing doors.
    (4) Providing doors that do not open into areas where food is 
exposed to airborne contamination, except where alternate means have 
been taken to protect against such contamination (such as double doors 
or positive air-flow systems).
    (e) Hand-washing facilities. Hand-washing facilities shall be 
adequate and convenient and be furnished with running water at a 
suitable temperature. Compliance with this requirement may be 
accomplished by providing:
    (1) Hand-washing and, where appropriate, hand-sanitizing facilities 
at each location in the plant where good sanitary practices require 
employees to wash and/or sanitize their hands.
    (2) Effective hand-cleaning and sanitizing preparations.
    (3) Sanitary towel service or suitable drying devices.
    (4) Devices or fixtures, such as water control valves, so designed 
and constructed to protect against recontamination of clean, sanitized 
hands.
    (5) Readily understandable signs directing employees handling 
unprotected food, unprotected food-packaging materials, of food-contact 
surfaces to wash and, where appropriate, sanitize their hands before 
they start work, after each absence from post of duty, and when their 
hands may have become soiled or contaminated. These signs may be posted 
in the processing room(s) and in all other areas where employees may 
handle such food, materials, or surfaces.
    (6) Refuse receptacles that are constructed and maintained in a 
manner that protects against contamination of food.

[[Page 271]]

    (f) Rubbish and offal disposal. Rubbish and any offal shall be so 
conveyed, stored, and disposed of as to minimize the development of 
odor, minimize the potential for the waste becoming an attractant and 
harborage or breeding place for pests, and protect against contamination 
of food, food-contact surfaces, water supplies, and ground surfaces.



                           Subpart C_Equipment



Sec. 110.40  Equipment and utensils.

    (a) All plant equipment and utensils shall be so designed and of 
such material and workmanship as to be adequately cleanable, and shall 
be properly maintained. The design, construction, and use of equipment 
and utensils shall preclude the adulteration of food with lubricants, 
fuel, metal fragments, contaminated water, or any other contaminants. 
All equipment should be so installed and maintained as to facilitate the 
cleaning of the equipment and of all adjacent spaces. Food-contact 
surfaces shall be corrosion-resistant when in contact with food. They 
shall be made of nontoxic materials and designed to withstand the 
environment of their intended use and the action of food, and, if 
applicable, cleaning compounds and sanitizing agents. Food-contact 
surfaces shall be maintained to protect food from being contaminated by 
any source, including unlawful indirect food additives.
    (b) Seams on food-contact surfaces shall be smoothly bonded or 
maintained so as to minimize accumulation of food particles, dirt, and 
organic matter and thus minimize the opportunity for growth of 
microorganisms.
    (c) Equipment that is in the manufacturing or food-handling area and 
that does not come into contact with food shall be so constructed that 
it can be kept in a clean condition.
    (d) Holding, conveying, and manufacturing systems, including 
gravimetric, pneumatic, closed, and automated systems, shall be of a 
design and construction that enables them to be maintained in an 
appropriate sanitary condition.
    (e) Each freezer and cold storage compartment used to store and hold 
food capable of supporting growth of microorganisms shall be fitted with 
an indicating thermometer, temperature-measuring device, or temperature-
recording device so installed as to show the temperature accurately 
within the compartment, and should be fitted with an automatic control 
for regulating temperature or with an automatic alarm system to indicate 
a significant temperature change in a manual operation.
    (f) Instruments and controls used for measuring, regulating, or 
recording temperatures, pH, acidity, water activity, or other conditions 
that control or prevent the growth of undesirable microorganisms in food 
shall be accurate and adequately maintained, and adequate in number for 
their designated uses.
    (g) Compressed air or other gases mechanically introduced into food 
or used to clean food-contact surfaces or equipment shall be treated in 
such a way that food is not contaminated with unlawful indirect food 
additives.

Subpart D [Reserved]



                Subpart E_Production and Process Controls



Sec. 110.80  Processes and controls.

    All operations in the receiving, inspecting, transporting, 
segregating, preparing, manufacturing, packaging, and storing of food 
shall be conducted in accordance with adequate sanitation principles. 
Appropriate quality control operations shall be employed to ensure that 
food is suitable for human consumption and that food-packaging materials 
are safe and suitable. Overall sanitation of the plant shall be under 
the supervision of one or more competent individuals assigned 
responsibility for this function. All reasonable precautions shall be 
taken to ensure that production procedures do not contribute 
contamination from any source. Chemical, microbial, or extraneous-
material testing procedures shall be used where necessary to identify 
sanitation failures or possible food contamination. All food that has 
become contaminated to the extent that it is adulterated within the 
meaning of

[[Page 272]]

the act shall be rejected, or if permissible, treated or processed to 
eliminate the contamination.
    (a) Raw materials and other ingredients. (1) Raw materials and other 
ingredients shall be inspected and segregated or otherwise handled as 
necessary to ascertain that they are clean and suitable for processing 
into food and shall be stored under conditions that will protect against 
contamination and minimize deterioration. Raw materials shall be washed 
or cleaned as necessary to remove soil or other contamination. Water 
used for washing, rinsing, or conveying food shall be safe and of 
adequate sanitary quality. Water may be reused for washing, rinsing, or 
conveying food if it does not increase the level of contamination of the 
food. Containers and carriers of raw materials should be inspected on 
receipt to ensure that their condition has not contributed to the 
contamination or deterioration of food.
    (2) Raw materials and other ingredients shall either not contain 
levels of microorganisms that may produce food poisoning or other 
disease in humans, or they shall be pasteurized or otherwise treated 
during manufacturing operations so that they no longer contain levels 
that would cause the product to be adulterated within the meaning of the 
act. Compliance with this requirement may be verified by any effective 
means, including purchasing raw materials and other ingredients under a 
supplier's guarantee or certification.
    (3) Raw materials and other ingredients susceptible to contamination 
with aflatoxin or other natural toxins shall comply with current Food 
and Drug Administration regulations and action levels for poisonous or 
deleterious substances before these materials or ingredients are 
incorporated into finished food. Compliance with this requirement may be 
accomplished by purchasing raw materials and other ingredients under a 
supplier's guarantee or certification, or may be verified by analyzing 
these materials and ingredients for aflatoxins and other natural toxins.
    (4) Raw materials, other ingredients, and rework susceptible to 
contamination with pests, undesirable microorganisms, or extraneous 
material shall comply with applicable Food and Drug Administration 
regulations and defect action levels for natural or unavoidable defects 
if a manufacturer wishes to use the materials in manufacturing food. 
Compliance with this requirement may be verified by any effective means, 
including purchasing the materials under a supplier's guarantee or 
certification, or examination of these materials for contamination.
    (5) Raw materials, other ingredients, and rework shall be held in 
bulk, or in containers designed and constructed so as to protect against 
contamination and shall be held at such temperature and relative 
humidity and in such a manner as to prevent the food from becoming 
adulterated within the meaning of the act. Material scheduled for rework 
shall be identified as such.
    (6) Frozen raw materials and other ingredients shall be kept frozen. 
If thawing is required prior to use, it shall be done in a manner that 
prevents the raw materials and other ingredients from becoming 
adulterated within the meaning of the act.
    (7) Liquid or dry raw materials and other ingredients received and 
stored in bulk form shall be held in a manner that protects against 
contamination.
    (b) Manufacturing operations. (1) Equipment and utensils and 
finished food containers shall be maintained in an acceptable condition 
through appropriate cleaning and sanitizing, as necessary. Insofar as 
necessary, equipment shall be taken apart for thorough cleaning.
    (2) All food manufacturing, including packaging and storage, shall 
be conducted under such conditions and controls as are necessary to 
minimize the potential for the growth of microorganisms, or for the 
contamination of food. One way to comply with this requirement is 
careful monitoring of physical factors such as time, temperature, 
humidity, aw, pH, pressure, flow rate, and manufacturing 
operations such as freezing, dehydration, heat processing, 
acidification, and refrigeration to ensure that mechanical breakdowns, 
time delays, temperature fluctuations, and other factors do not 
contribute to the decomposition or contamination of food.

[[Page 273]]

    (3) Food that can support the rapid growth of undesirable 
microorganisms, particularly those of public health significance, shall 
be held in a manner that prevents the food from becoming adulterated 
within the meaning of the act. Compliance with this requirement may be 
accomplished by any effective means, including:
    (i) Maintaining refrigerated foods at 45 [deg]F (7.2 [deg]C) or 
below as appropriate for the particular food involved.
    (ii) Maintaining frozen foods in a frozen state.
    (iii) Maintaining hot foods at 140 [deg]F (60 [deg]C) or above.
    (iv) Heat treating acid or acidified foods to destroy mesophilic 
microorganisms when those foods are to be held in hermetically sealed 
containers at ambient temperatures.
    (4) Measures such as sterilizing, irradiating, pasteurizing, 
freezing, refrigerating, controlling pH or controlling aw 
that are taken to destroy or prevent the growth of undesirable 
microorganisms, particularly those of public health significance, shall 
be adequate under the conditions of manufacture, handling, and 
distribution to prevent food from being adulterated within the meaning 
of the act.
    (5) Work-in-process shall be handled in a manner that protects 
against contamination.
    (6) Effective measures shall be taken to protect finished food from 
contamination by raw materials, other ingredients, or refuse. When raw 
materials, other ingredients, or refuse are unprotected, they shall not 
be handled simultaneously in a receiving, loading, or shipping area if 
that handling could result in contaminated food. Food transported by 
conveyor shall be protected against contamination as necessary.
    (7) Equipment, containers, and utensils used to convey, hold, or 
store raw materials, work-in-process, rework, or food shall be 
constructed, handled, and maintained during manufacturing or storage in 
a manner that protects against contamination.
    (8) Effective measures shall be taken to protect against the 
inclusion of metal or other extraneous material in food. Compliance with 
this requirement may be accomplished by using sieves, traps, magnets, 
electronic metal detectors, or other suitable effective means.
    (9) Food, raw materials, and other ingredients that are adulterated 
within the meaning of the act shall be disposed of in a manner that 
protects against the contamination of other food. If the adulterated 
food is capable of being reconditioned, it shall be reconditioned using 
a method that has been proven to be effective or it shall be reexamined 
and found not to be adulterated within the meaning of the act before 
being incorporated into other food.
    (10) Mechanical manufacturing steps such as washing, peeling, 
trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, 
shredding, extruding, drying, whipping, defatting, and forming shall be 
performed so as to protect food against contamination. Compliance with 
this requirement may be accomplished by providing adequate physical 
protection of food from contaminants that may drip, drain, or be drawn 
into the food. Protection may be provided by adequate cleaning and 
sanitizing of all food-contact surfaces, and by using time and 
temperature controls at and between each manufacturing step.
    (11) Heat blanching, when required in the preparation of food, 
should be effected by heating the food to the required temperature, 
holding it at this temperature for the required time, and then either 
rapidly cooling the food or passing it to subsequent manufacturing 
without delay. Thermophilic growth and contamination in blanchers should 
be minimized by the use of adequate operating temperatures and by 
periodic cleaning. Where the blanched food is washed prior to filling, 
water used shall be safe and of adequate sanitary quality.
    (12) Batters, breading, sauces, gravies, dressings, and other 
similar preparations shall be treated or maintained in such a manner 
that they are protected against contamination. Compliance with this 
requirement may be accomplished by any effective means, including one or 
more of the following:
    (i) Using ingredients free of contamination.

[[Page 274]]

    (ii) Employing adequate heat processes where applicable.
    (iii) Using adequate time and temperature controls.
    (iv) Providing adequate physical protection of components from 
contaminants that may drip, drain, or be drawn into them.
    (v) Cooling to an adequate temperature during manufacturing.
    (vi) Disposing of batters at appropriate intervals to protect 
against the growth of microorganisms.
    (13) Filling, assembling, packaging, and other operations shall be 
performed in such a way that the food is protected against 
contamination. Compliance with this requirement may be accomplished by 
any effective means, including:
    (i) Use of a quality control operation in which the critical control 
points are identified and controlled during manufacturing.
    (ii) Adequate cleaning and sanitizing of all food-contact surfaces 
and food containers.
    (iii) Using materials for food containers and food- packaging 
materials that are safe and suitable, as defined in Sec. 130.3(d) of 
this chapter.
    (iv) Providing physical protection from contamination, particularly 
airborne contamination.
    (v) Using sanitary handling procedures.
    (14) Food such as, but not limited to, dry mixes, nuts, intermediate 
moisture food, and dehydrated food, that relies on the control of 
aw for preventing the growth of undesirable microorganisms 
shall be processed to and maintained at a safe moisture level. 
Compliance with this requirement may be accomplished by any effective 
means, including employment of one or more of the following practices:
    (i) Monitoring the aw of food.
    (ii) Controlling the soluble solids-water ratio in finished food.
    (iii) Protecting finished food from moisture pickup, by use of a 
moisture barrier or by other means, so that the aw of the 
food does not increase to an unsafe level.
    (15) Food such as, but not limited to, acid and acidified food, that 
relies principally on the control of pH for preventing the growth of 
undesirable microorganisms shall be monitored and maintained at a pH of 
4.6 or below. Compliance with this requirement may be accomplished by 
any effective means, including employment of one or more of the 
following practices:
    (i) Monitoring the pH of raw materials, food in process, and 
finished food.
    (ii) Controlling the amount of acid or acidified food added to low-
acid food.
    (16) When ice is used in contact with food, it shall be made from 
water that is safe and of adequate sanitary quality, and shall be used 
only if it has been manufactured in accordance with current good 
manufacturing practice as outlined in this part.
    (17) Food-manufacturing areas and equipment used for manufacturing 
human food should not be used to manufacture nonhuman food-grade animal 
feed or inedible products, unless there is no reasonable possibility for 
the contamination of the human food.

[51 FR 22475, June 19, 1986, as amended at 65 FR 56479, Sept. 19, 2000]



Sec. 110.93  Warehousing and distribution.

    Storage and transportation of finished food shall be under 
conditions that will protect food against physical, chemical, and 
microbial contamination as well as against deterioration of the food and 
the container.

Subpart F [Reserved]



                     Subpart G_Defect Action Levels



Sec. 110.110  Natural or unavoidable defects in food for human use 
that present no health hazard.

    (a) Some foods, even when produced under current good manufacturing 
practice, contain natural or unavoidable defects that at low levels are 
not hazardous to health. The Food and Drug Administration establishes 
maximum levels for these defects in foods produced under current good 
manufacturing practice and uses these levels in deciding whether to 
recommend regulatory action.

[[Page 275]]

    (b) Defect action levels are established for foods whenever it is 
necessary and feasible to do so. These levels are subject to change upon 
the development of new technology or the availability of new 
information.
    (c) Compliance with defect action levels does not excuse violation 
of the requirement in section 402(a)(4) of the act that food not be 
prepared, packed, or held under unsanitary conditions or the 
requirements in this part that food manufacturers, distributors, and 
holders shall observe current good manufacturing practice. Evidence 
indicating that such a violation exists causes the food to be 
adulterated within the meaning of the act, even though the amounts of 
natural or unavoidable defects are lower than the currently established 
defect action levels. The manufacturer, distributor, and holder of food 
shall at all times utilize quality control operations that reduce 
natural or unavoidable defects to the lowest level currently feasible.
    (d) The mixing of a food containing defects above the current defect 
action level with another lot of food is not permitted and renders the 
final food adulterated within the meaning of the act, regardless of the 
defect level of the final food.
    (e) A compilation of the current defect action levels for natural or 
unavoidable defects in food for human use that present no health hazard 
may be obtained upon request from the Center for Food Safety and Applied 
Nutrition (HFS-565), Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740.

[51 FR 22475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66 
FR 56035, Nov. 6, 2001]



PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
--Table of Contents



                      Subpart A_General Provisions

Sec.
111.1 Who is subject to this part?
111.3 What definitions apply to this part?
111.5 Do other statutory provisions and regulations apply?

                           Subpart B_Personnel

111.8 What are the requirements under this subpart B for written 
          procedures?
111.10 What requirements apply for preventing microbial contamination 
          from sick or infected personnel and for hygienic practices?
111.12 What personnel qualification requirements apply?
111.13 What supervisor requirements apply?
111.14 Under this subpart B, what records must you make and keep?

                  Subpart C_Physical Plant and Grounds

111.15 What sanitation requirements apply to your physical plant and 
          grounds?
111.16 What are the requirements under this subpart C for written 
          procedures?
111.20 What design and construction requirements apply to your physical 
          plant?
111.23 Under this subpart C, what records must you make and keep?

                    Subpart D_Equipment and Utensils

111.25 What are the requirements under this subpart D for written 
          procedures?
111.27 What requirements apply to the equipment and utensils that you 
          use?
111.30 What requirements apply to automated, mechanical, or electronic 
          equipment?
111.35 Under this subpart D, what records must you make and keep?

  Subpart E_Requirement to Establish a Production and Process Control 
                                 System

111.55 What are the requirements to implement a production and process 
          control system?
111.60 What are the design requirements for the production and process 
          control system?
111.65 What are the requirements for quality control operations?
111.70 What specifications must you establish?
111.73 What is your responsibility for determining whether established 
          specifications are met?
111.75 What must you do to determine whether specifications are met?
111.77 What must you do if established specifications are not met?
111.80 What representative samples must you collect?
111.83 What are the requirements for reserve samples?
111.87 Who conducts a material review and makes a disposition decision?

[[Page 276]]

111.90 What requirements apply to treatments, in-process adjustments, 
          and reprocessing when there is a deviation or unanticipated 
          occurrence or when a specification established in accordance 
          with Sec. 111.70 is not met?
111.95 Under this subpart E, what records must you make and keep?

   Subpart F_Production and Process Control System: Requirements for 
                             Quality Control

111.103 What are the requirements under this subpart F for written 
          procedures?
111.105 What must quality control personnel do?
111.110 What quality control operations are required for laboratory 
          operations associated with the production and process control 
          system?
111.113 What quality control operations are required for a material 
          review and disposition decision?
111.117 What quality control operations are required for equipment, 
          instruments, and controls?
111.120 What quality control operations are required for components, 
          packaging, and labels before use in the manufacture of a 
          dietary supplement?
111.123 What quality control operations are required for the master 
          manufacturing record, the batch production record, and 
          manufacturing operations?
111.127 What quality control operations are required for packaging and 
          labeling operations?
111.130 What quality control operations are required for returned 
          dietary supplements?
111.135 What quality control operations are required for product 
          complaints?
111.140 Under this subpart F, what records must you make and keep?

   Subpart G_Production and Process Control System: Requirements for 
 Components, Packaging, and Labels and for Product That You Receive for 
              Packaging or Labeling as a Dietary Supplement

111.153 What are the requirements under this subpart G for written 
          procedures?
111.155 What requirements apply to components of dietary supplements?
111.160 What requirements apply to packaging and labels received?
111.165 What requirements apply to a product received for packaging or 
          labeling as a dietary supplement (and for distribution rather 
          than for return to the supplier)?
111.170 What requirements apply to rejected components, packaging, and 
          labels, and to rejected products that are received for 
          packaging or labeling as a dietary supplement?
111.180 Under this subpart G, what records must you make and keep?

 Subpart H_Production and Process Control System: Requirements for the 
                       Master Manufacturing Record

111.205 What is the requirement to establish a master manufacturing 
          record?
111.210 What must the master manufacturing record include?

 Subpart I_Production and Process Control System: Requirements for the 
                         Batch Production Record

111.255 What is the requirement to establish a batch production record?
111.260 What must the batch record include?

   Subpart J_Production and Process Control System: Requirements for 
                          Laboratory Operations

111.303 What are the requirements under this subpart J for written 
          procedures?
111.310 What are the requirements for the laboratory facilities that you 
          use?
111.315 What are the requirements for laboratory control processes?
111.320 What requirements apply to laboratory methods for testing and 
          examination?
111.325 Under this subpart J, what records must you make and keep?

   Subpart K_Production and Process Control System: Requirements for 
                        Manufacturing Operations

111.353 What are the requirements under this subpart K for written 
          procedures?
111.355 What are the design requirements for manufacturing operations?
111.360 What are the requirements for sanitation?
111.365 What precautions must you take to prevent contamination?
111.370 What requirements apply to rejected dietary supplements?
111.375 Under this subpart K, what records must you make and keep?

   Subpart L_Production and Process Control System: Requirements for 
                    Packaging and Labeling Operations

111.403 What are the requirements under this subpart L for written 
          procedures?
111.410 What requirements apply to packaging and labels?
111.415 What requirements apply to filling, assembling, packaging, 
          labeling, and related operations?
111.420 What requirements apply to repackaging and relabeling?

[[Page 277]]

111.425 What requirements apply to a packaged and labeled dietary 
          supplement that is rejected for distribution?
111.430 Under this subpart L, what records must you make and keep?

                   Subpart M_Holding and Distributing

111.453 What are the requirements under this subpart M for written 
          procedures?
111.455 What requirements apply to holding components, dietary 
          supplements, packaging, and labels?
111.460 What requirements apply to holding in-process material?
111.465 What requirements apply to holding reserve samples of dietary 
          supplements?
111.470 What requirements apply to distributing dietary supplements?
111.475 Under this subpart M, what records must you make and keep?

                 Subpart N_Returned Dietary Supplements

111.503 What are the requirements under this subpart N for written 
          procedures?
111.510 What requirements apply when a returned dietary supplement is 
          received?
111.515 When must a returned dietary supplement be destroyed, or 
          otherwise suitably disposed of?
111.520 When may a returned dietary supplement be salvaged?
111.525 What requirements apply to a returned dietary supplement that 
          quality control personnel approve for reprocessing?
111.530 When must an investigation be conducted of your manufacturing 
          processes and other batches?
111.535 Under this subpart N, what records must you make and keep?

                      Subpart O_Product Complaints

111.553 What are the requirements under this subpart O for written 
          procedures?
111.560 What requirements apply to the review and investigation of a 
          product complaint?
111.570 Under this subpart O, what records must you make and keep?

                   Subpart P_Records and Recordkeeping

111.605 What requirements apply to the records that you make and keep?
111.610 What records must be made available to FDA?

    Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 
264.

    Source: 72 FR 34942, June 25, 2007, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 111.1  Who is subject to this part?

    (a) Except as provided by paragraph (b) of this section, you are 
subject to this part if you manufacture, package, label, or hold a 
dietary supplement, including:
    (1) A dietary supplement you manufacture but that is packaged or 
labeled by another person; and
    (2) A dietary supplement imported or offered for import in any State 
or territory of the United States, the District of Columbia, or the 
Commonwealth of Puerto Rico.
    (b) The requirements pertaining to holding dietary supplements do 
not apply to you if you are holding those dietary supplements at a 
retail establishment for the sole purpose of direct retail sale to 
individual consumers. A retail establishment does not include a 
warehouse or other storage facility for a retailer or a warehouse or 
other storage facility that sells directly to individual consumers.



Sec. 111.3  What definitions apply to this part?

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when 
used in this part. For the purpose of this part, the following 
definitions also apply:
    Actual yield means the quantity that is actually produced at any 
appropriate step of manufacture or packaging of a particular dietary 
supplement.
    Batch means a specific quantity of a dietary supplement that is 
uniform, that is intended to meet specifications for identity, purity, 
strength, and composition, and that is produced during a specified time 
period according to a single manufacturing record during the same cycle 
of manufacture.
    Batch number, lot number, or control number means any distinctive 
group of letters, numbers, or symbols, or any combination of them, from 
which the complete history of the manufacturing, packaging, labeling, 
and/or holding of a batch or lot of dietary supplements can be 
determined.
    Component means any substance intended for use in the manufacture of 
a dietary supplement, including those

[[Page 278]]

that may not appear in the finished batch of the dietary supplement. 
Component includes dietary ingredients (as described in section 201(ff) 
of the act) and other ingredients.
    Contact surface means any surface that contacts a component or 
dietary supplement, and those surfaces from which drainage onto the 
component or dietary supplement, or onto surfaces that contact the 
component or dietary supplement, occurs during the normal course of 
operations. Examples of contact surfaces include containers, utensils, 
tables, contact surfaces of equipment, and packaging.
    Ingredient means any substance that is used in the manufacture of a 
dietary supplement and that is intended to be present in the finished 
batch of the dietary supplement. An ingredient includes, but is not 
necessarily limited to, a dietary ingredient as defined in section 
201(ff) of the act.
    In-process material means any material that is fabricated, 
compounded, blended, ground, extracted, sifted, sterilized, derived by 
chemical reaction, or processed in any other way for use in the 
manufacture of a dietary supplement.
    Lot means a batch, or a specific identified portion of a batch, that 
is uniform and that is intended to meet specifications for identity, 
purity, strength, and composition; or, in the case of a dietary 
supplement produced by continuous process, a specific identified amount 
produced in a specified unit of time or quantity in a manner that is 
uniform and that is intended to meet specifications for identity, 
purity, strength, and composition.
    Microorganisms means yeasts, molds, bacteria, viruses, and other 
similar microscopic organisms having public health or sanitary concern. 
This definition includes species that:
    (1) May have public health significance;
    (2) May cause a component or dietary supplement to decompose;
    (3) Indicate that the component or dietary supplement is 
contaminated with filth; or
    (4) Otherwise may cause the component or dietary supplement to be 
adulterated.
    Must is used to state a requirement.
    Pest means any objectionable insect or other animal including birds, 
rodents, flies, mites, and larvae.
    Physical plant means all or any part of a building or facility used 
for or in connection with manufacturing, packaging, labeling, or holding 
a dietary supplement.
    Product complaint means any communication that contains any 
allegation, written, electronic, or oral, expressing concern, for any 
reason, with the quality of a dietary supplement, that could be related 
to current good manufacturing practice. Examples of product complaints 
are: Foul odor, off taste, illness or injury, disintegration time, color 
variation, tablet size or size variation, under-filled container, 
foreign material in a dietary supplement container, improper packaging, 
mislabeling, or dietary supplements that are superpotent, subpotent, or 
contain the wrong ingredient, or contain a drug or other contaminant 
(e.g., bacteria, pesticide, mycotoxin, glass, lead).
    Quality means that the dietary supplement consistently meets the 
established specifications for identity, purity, strength, and 
composition, and limits on contaminants, and has been manufactured, 
packaged, labeled, and held under conditions to prevent adulteration 
under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act.
    Quality control means a planned and systematic operation or 
procedure for ensuring the quality of a dietary supplement.
    Quality control personnel means any person, persons, or group, 
within or outside of your organization, who you designate to be 
responsible for your quality control operations.
    Representative sample means a sample that consists of an adequate 
number of units that are drawn based on rational criteria, such as 
random sampling, and that are intended to ensure that the sample 
accurately portrays the material being sampled.
    Reprocessing means using, in the manufacture of a dietary 
supplement, clean, uncontaminated components or dietary supplements that 
have been

[[Page 279]]

previously removed from manufacturing and that have been made suitable 
for use in the manufacture of a dietary supplement.
    Reserve sample means a representative sample of product that is held 
for a designated period of time.
    Sanitize means to adequately treat cleaned equipment, containers, 
utensils, or any other cleaned contact surface by a process that is 
effective in destroying vegetative cells of microorganisms of public 
health significance, and in substantially reducing numbers of other 
microorganisms, but without adversely affecting the product or its 
safety for the consumer.
    Theoretical yield means the quantity that would be produced at any 
appropriate step of manufacture or packaging of a particular dietary 
supplement, based upon the quantity of components or packaging to be 
used, in the absence of any loss or error in actual production.
    Water activity (aw) is a measure of the free moisture in 
a component or dietary supplement and is the quotient of the water vapor 
pressure of the substance divided by the vapor pressure of pure water at 
the same temperature.
    We means the U.S. Food and Drug Administration (FDA).
    You means a person who manufactures, packages, labels, or holds 
dietary supplements.



Sec. 111.5  Do other statutory provisions and regulations apply?

    In addition to this part, you must comply with other applicable 
statutory provisions and regulations under the act related to dietary 
supplements. For importers of dietary supplements and dietary supplement 
components, the regulation on foreign supplier verification programs can 
be found in subpart L of part 1 of this chapter.

[72 FR 34942, June 25, 2007, as amended at 80 FR 74352, Nov. 27, 2015]



                           Subpart B_Personnel



Sec. 111.8  What are the requirements under this subpart B for written
procedures?

    You must establish and follow written procedures for fulfilling the 
requirements of this subpart.



Sec. 111.10  What requirements apply for preventing microbial 
contamination from sick or infected personnel and for hygienic
practices?

    (a) Preventing microbial contamination. You must take measures to 
exclude from any operations any person who might be a source of 
microbial contamination, due to a health condition, where such 
contamination may occur, of any material, including components, dietary 
supplements, and contact surfaces used in the manufacture, packaging, 
labeling, or holding of a dietary supplement. Such measures include the 
following:
    (1) Excluding from working in any operations that may result in 
contamination any person who, by medical examination, the person's 
acknowledgement, or supervisory observation, is shown to have, or 
appears to have, an illness, infection, open lesion, or any other 
abnormal source of microbial contamination, that could result in 
microbial contamination of components, dietary supplements, or contact 
surfaces, until the health condition no longer exists; and
    (2) Instructing your employees to notify their supervisor(s) if they 
have or if there is a reasonable possibility that they have a health 
condition described in paragraph (a)(1) of this section that could 
result in microbial contamination of any components, dietary 
supplements, or any contact surface.
    (b) Hygienic practices. If you work in an operation during which 
adulteration of the component, dietary supplement, or contact surface 
could occur, you must use hygienic practices to the extent necessary to 
protect against such contamination of components, dietary supplements, 
or contact surfaces. These hygienic practices include the following:
    (1) Wearing outer garments in a manner that protects against the 
contamination of components, dietary supplements, or any contact 
surface;
    (2) Maintaining adequate personal cleanliness;
    (3) Washing hands thoroughly (and sanitizing if necessary to protect 
against contamination with microorganisms) in an adequate hand-washing 
facility:
    (i) Before starting work; and

[[Page 280]]

    (ii) At any time when the hands may have become soiled or 
contaminated;
    (4) Removing all unsecured jewelry and other objects that might fall 
into components, dietary supplements, equipment, or packaging, and 
removing hand jewelry that cannot be adequately sanitized during periods 
in which components or dietary supplements are manipulated by hand. If 
hand jewelry cannot be removed, it must be covered by material that is 
maintained in an intact, clean, and sanitary condition and that 
effectively protects against contamination of components, dietary 
supplements, or contact surfaces;
    (5) Maintaining gloves used in handling components or dietary 
supplements in an intact, clean, and sanitary condition. The gloves must 
be of an impermeable material;
    (6) Wearing, where appropriate, in an effective manner, hair nets, 
caps, beard covers, or other effective hair restraints;
    (7) Not storing clothing or other personal belongings in areas where 
components, dietary supplements, or any contact surfaces are exposed or 
where contact surfaces are washed;
    (8) Not eating food, chewing gum, drinking beverages, or using 
tobacco products in areas where components, dietary supplements, or any 
contact surfaces are exposed, or where contact surfaces are washed; and
    (9) Taking any other precautions necessary to protect against the 
contamination of components, dietary supplements, or contact surfaces 
with microorganisms, filth, or any other extraneous materials, including 
perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied 
to the skin.



Sec. 111.12  What personnel qualification requirements apply?

    (a) You must have qualified employees who manufacture, package, 
label, or hold dietary supplements.
    (b) You must identify who is responsible for your quality control 
operations. Each person who is identified to perform quality control 
operations must be qualified to do so and have distinct and separate 
responsibilities related to performing such operations from those 
responsibilities that the person otherwise has when not performing such 
operations.
    (c) Each person engaged in manufacturing, packaging, labeling, or 
holding, or in performing any quality control operations, must have the 
education, training, or experience to perform the person's assigned 
functions.



Sec. 111.13  What supervisor requirements apply?

    (a) You must assign qualified personnel to supervise the 
manufacturing, packaging, labeling, or holding of dietary supplements.
    (b) Each supervisor whom you use must be qualified by education, 
training, or experience to supervise.



Sec. 111.14  Under this subpart B, what records must you make and keep?

    (a) You must make and keep records required under this subpart B in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart B; and
    (2) Documentation of training, including the date of the training, 
the type of training, and the person(s) trained.



                  Subpart C_Physical Plant and Grounds



Sec. 111.15  What sanitation requirements apply to your physical 
plant and grounds?

    (a) Grounds. You must keep the grounds of your physical plant in a 
condition that protects against the contamination of components, dietary 
supplements, or contact surfaces. The methods for adequate ground 
maintenance include:
    (1) Properly storing equipment, removing litter and waste, and 
cutting weeds or grass within the immediate vicinity of the physical 
plant so that it does not attract pests, harbor pests, or provide pests 
a place for breeding;
    (2) Maintaining roads, yards, and parking lots so that they do not 
constitute a source of contamination in areas where components, dietary 
supplements, or contact surfaces are exposed;

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    (3) Adequately draining areas that may contribute to the 
contamination of components, dietary supplements, or contact surfaces by 
seepage, filth or any other extraneous materials, or by providing a 
breeding place for pests;
    (4) Adequately operating systems for waste treatment and disposal so 
that they do not constitute a source of contamination in areas where 
components, dietary supplements, or contact surfaces are exposed; and
    (5) If your plant grounds are bordered by grounds not under your 
control, and if those other grounds are not maintained in the manner 
described in this section, you must exercise care in the plant by 
inspection, extermination, or other means to exclude pests, dirt, and 
filth or any other extraneous materials that may be a source of 
contamination.
    (b) Physical plant facilities. (1) You must maintain your physical 
plant in a clean and sanitary condition; and
    (2) You must maintain your physical plant in repair sufficient to 
prevent components, dietary supplements, or contact surfaces from 
becoming contaminated.
    (c) Cleaning compounds, sanitizing agents, pesticides, and other 
toxic materials. (1) You must use cleaning compounds and sanitizing 
agents that are free from microorganisms of public health significance 
and that are safe and adequate under the conditions of use.
    (2) You must not use or hold toxic materials in a physical plant in 
which components, dietary supplements, or contact surfaces are 
manufactured or exposed, unless those materials are necessary as 
follows:
    (i) To maintain clean and sanitary conditions;
    (ii) For use in laboratory testing procedures;
    (iii) For maintaining or operating the physical plant or equipment; 
or
    (iv) For use in the plant's operations.
    (3) You must identify and hold cleaning compounds, sanitizing 
agents, pesticides, pesticide chemicals, and other toxic materials in a 
manner that protects against contamination of components, dietary 
supplements, or contact surfaces.
    (d) Pest control. (1) You must not allow animals or pests in any 
area of your physical plant. Guard or guide dogs are allowed in some 
areas of your physical plant if the presence of the dogs will not result 
in contamination of components, dietary supplements, or contact 
surfaces;
    (2) You must take effective measures to exclude pests from the 
physical plant and to protect against contamination of components, 
dietary supplements, and contact surfaces on the premises by pests; and
    (3) You must not use insecticides, fumigants, fungicides, or 
rodenticides, unless you take precautions to protect against the 
contamination of components, dietary supplements, or contact surfaces.
    (e) Water supply. (1) You must provide water that is safe and 
sanitary, at suitable temperatures, and under pressure as needed, for 
all uses where water does not become a component of the dietary 
supplement.
    (2) Water that is used in a manner such that the water may become a 
component of the dietary supplement, e.g., when such water contacts 
components, dietary supplements, or any contact surface, must, at a 
minimum, comply with applicable Federal, State, and local requirements 
and not contaminate the dietary supplement.
    (f) Plumbing. The plumbing in your physical plant must be of an 
adequate size and design and be adequately installed and maintained to:
    (1) Carry sufficient amounts of water to required locations 
throughout the physical plant;
    (2) Properly convey sewage and liquid disposable waste from your 
physical plant;
    (3) Avoid being a source of contamination to components, dietary 
supplements, water supplies, or any contact surface, or creating an 
unsanitary condition;
    (4) Provide adequate floor drainage in all areas where floors are 
subject to flooding-type cleaning or where normal operations release or 
discharge water or other liquid waste on the floor; and
    (5) Not allow backflow from, or cross connection between, piping 
systems that discharge waste water or sewage and piping systems that 
carry water used for manufacturing dietary supplements, for cleaning 
contact surfaces, or

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for use in bathrooms or hand-washing facilities.
    (g) Sewage disposal. You must dispose of sewage into an adequate 
sewage system or through other adequate means.
    (h) Bathrooms. You must provide your employees with adequate, 
readily accessible bathrooms. The bathrooms must be kept clean and must 
not be a potential source of contamination to components, dietary 
supplements, or contact surfaces.
    (i) Hand-washing facilities. You must provide hand-washing 
facilities that are designed to ensure that an employee's hands are not 
a source of contamination of components, dietary supplements, or any 
contact surface, by providing facilities that are adequate, convenient, 
and furnish running water at a suitable temperature.
    (j) Trash disposal. You must convey, store, and dispose of trash to:
    (1) Minimize the development of odors;
    (2) Minimize the potential for the trash to attract, harbor, or 
become a breeding place for pests;
    (3) Protect against contamination of components, dietary 
supplements, any contact surface, water supplies, and grounds 
surrounding your physical plant; and
    (4) Control hazardous waste to prevent contamination of components, 
dietary supplements, and contact surfaces.
    (k) Sanitation supervisors. You must assign one or more employees to 
supervise overall sanitation. Each of these supervisors must be 
qualified by education, training, or experience to develop and supervise 
sanitation procedures.



Sec. 111.16  What are the requirements under this subpart C for 
written procedures?

    You must establish and follow written procedures for cleaning the 
physical plant and for pest control.



Sec. 111.20  What design and construction requirements apply to your
physical plant?

    Any physical plant you use in the manufacture, packaging, labeling, 
or holding of dietary supplements must:
    (a) Be suitable in size, construction, and design to facilitate 
maintenance, cleaning, and sanitizing operations;
    (b) Have adequate space for the orderly placement of equipment and 
holding of materials as is necessary for maintenance, cleaning, and 
sanitizing operations and to prevent contamination and mixups of 
components and dietary supplements during manufacturing, packaging, 
labeling, or holding;
    (c) Permit the use of proper precautions to reduce the potential for 
mixups or contamination of components, dietary supplements, or contact 
surfaces, with microorganisms, chemicals, filth, or other extraneous 
material. Your physical plant must have, and you must use, separate or 
defined areas of adequate size or other control systems, such as 
computerized inventory controls or automated systems of separation, to 
prevent contamination and mixups of components and dietary supplements 
during the following operations:
    (1) Receiving, identifying, holding, and withholding from use, 
components, dietary supplements, packaging, and labels that will be used 
in or during the manufacturing, packaging, labeling, or holding of 
dietary supplements;
    (2) Separating, as necessary, components, dietary supplements, 
packaging, and labels that are to be used in manufacturing from 
components, dietary supplements, packaging, or labels that are awaiting 
material review and disposition decision, reprocessing, or are awaiting 
disposal after rejection;
    (3) Separating the manufacturing, packaging, labeling, and holding 
of different product types including different types of dietary 
supplements and other foods, cosmetics, and pharmaceutical products;
    (4) Performing laboratory analyses and holding laboratory supplies 
and samples;
    (5) Cleaning and sanitizing contact surfaces;
    (6) Packaging and label operations; and
    (7) Holding components or dietary supplements.
    (d) Be designed and constructed in a manner that prevents 
contamination of components, dietary supplements, or contact surfaces.

[[Page 283]]

    (1) The design and construction must include:
    (i) Floors, walls, and ceilings that can be adequately cleaned and 
kept clean and in good repair;
    (ii) Fixtures, ducts, and pipes that do not contaminate components, 
dietary supplements, or contact surfaces by dripping or other leakage, 
or condensate;
    (iii) Adequate ventilation or environmental control equipment such 
as airflow systems, including filters, fans, and other air-blowing 
equipment, that minimize odors and vapors (including steam and noxious 
fumes) in areas where they may contaminate components, dietary 
supplements, or contact surfaces;
    (iv) Equipment that controls temperature and humidity, when such 
equipment is necessary to ensure the quality of the dietary supplement; 
and
    (v) Aisles or working spaces between equipment and walls that are 
adequately unobstructed and of adequate width to permit all persons to 
perform their duties and to protect against contamination of components, 
dietary supplements, or contact surfaces with clothing or personal 
contact.
    (2) When fans and other air-blowing equipment are used, such fans 
and equipment must be located and operated in a manner that minimizes 
the potential for microorganisms and particulate matter to contaminate 
components, dietary supplements, or contact surfaces;
    (e) Provide adequate light in:
    (1) All areas where components or dietary supplements are examined, 
processed, or held;
    (2) All areas where contact surfaces are cleaned; and
    (3) Hand-washing areas, dressing and locker rooms, and bathrooms.
    (f) Use safety-type light bulbs, fixtures, skylights, or other glass 
or glass-like materials when the light bulbs, fixtures, skylights or 
other glass or glass-like materials are suspended over exposed 
components or dietary supplements in any step of preparation, unless 
your physical plant is otherwise constructed in a manner that will 
protect against contamination of components or dietary supplements in 
case of breakage of glass or glass-like materials.
    (g) Provide effective protection against contamination of components 
and dietary supplements in bulk fermentation vessels, by, for example:
    (1) Use of protective coverings;
    (2) Placement in areas where you can eliminate harborages for pests 
over and around the vessels;
    (3) Placement in areas where you can check regularly for pests, pest 
infestation, filth or any other extraneous materials; and
    (4) Use of skimming equipment.
    (h) Use adequate screening or other protection against pests, where 
necessary.



Sec. 111.23  Under this subpart C, what records must you make 
and keep?

    (a) You must make and keep records required under this subpart C in 
accordance with subpart P of this part.
    (b) You must make and keep records of the written procedures for 
cleaning the physical plant and for pest control.
    (c) You must make and keep records that show that water, when used 
in a manner such that the water may become a component of the dietary 
supplement, meets the requirements of Sec. 111.15(e)(2).



                    Subpart D_Equipment and Utensils



Sec. 111.25  What are the requirements under this subpart D for
written procedures?

    You must establish and follow written procedures for fulfilling the 
requirements of this subpart D, including written procedures for:
    (a) Calibrating instruments and controls that you use in 
manufacturing or testing a component or dietary supplement;
    (b) Calibrating, inspecting, and checking automated, mechanical, and 
electronic equipment; and
    (c) Maintaining, cleaning, and sanitizing, as necessary, all 
equipment, utensils, and any other contact surfaces that are used to 
manufacture, package, label, or hold components or dietary supplements.

[[Page 284]]



Sec. 111.27  What requirements apply to the equipment and utensils
that you use?

    (a) You must use equipment and utensils that are of appropriate 
design, construction, and workmanship to enable them to be suitable for 
their intended use and to be adequately cleaned and properly maintained.
    (1) Equipment and utensils include the following:
    (i) Equipment used to hold or convey;
    (ii) Equipment used to measure;
    (iii) Equipment using compressed air or gas;
    (iv) Equipment used to carry out processes in closed pipes and 
vessels; and
    (v) Equipment used in automated, mechanical, or electronic systems.
    (2) You must use equipment and utensils of appropriate design and 
construction so that use will not result in the contamination of 
components or dietary supplements with:
    (i) Lubricants;
    (ii) Fuel;
    (iii) Coolants;
    (iv) Metal or glass fragments;
    (v) Filth or any other extraneous material;
    (vi) Contaminated water; or
    (vii) Any other contaminants.
    (3) All equipment and utensils you use must be:
    (i) Installed and maintained to facilitate cleaning the equipment, 
utensils, and all adjacent spaces;
    (ii) Corrosion-resistant if the equipment or utensils contact 
components or dietary supplements;
    (iii) Made of nontoxic materials;
    (iv) Designed and constructed to withstand the environment in which 
they are used, the action of components or dietary supplements, and, if 
applicable, cleaning compounds and sanitizing agents; and
    (v) Maintained to protect components and dietary supplements from 
being contaminated by any source.
    (4) Equipment and utensils you use must have seams that are smoothly 
bonded or maintained to minimize accumulation of dirt, filth, organic 
material, particles of components or dietary supplements, or any other 
extraneous materials or contaminants.
    (5) Each freezer, refrigerator, and other cold storage compartment 
you use to hold components or dietary supplements:
    (i) Must be fitted with an indicating thermometer, temperature-
measuring device, or temperature-recording device that indicates and 
records, or allows for recording by hand, the temperature accurately 
within the compartment; and
    (ii) Must have an automated device for regulating temperature or an 
automated alarm system to indicate a significant temperature change in a 
manual operation.
    (6) Instruments or controls used in the manufacturing, packaging, 
labeling, or holding of a dietary supplement, and instruments or 
controls that you use to measure, regulate, or record temperatures, 
hydrogen-ion concentration (pH), water activity, or other conditions, to 
control or prevent the growth of microorganisms or other contamination 
must be:
    (i) Accurate and precise;
    (ii) Adequately maintained; and
    (iii) Adequate in number for their designated uses.
    (7) Compressed air or other gases you introduce mechanically into or 
onto a component, dietary supplement, or contact surface or that you use 
to clean any contact surface must be treated in such a way that the 
component, dietary supplement, or contact surface is not contaminated.
    (b) You must calibrate instruments and controls you use in 
manufacturing or testing a component or dietary supplement. You must 
calibrate:
    (1) Before first use; and
    (2) At the frequency specified in writing by the manufacturer of the 
instrument and control; or
    (3) At routine intervals or as otherwise necessary to ensure the 
accuracy and precision of the instrument and control.
    (c) You must repair or replace instruments or controls that cannot 
be adjusted to agree with the reference standard.
    (d) You must maintain, clean, and sanitize, as necessary, all 
equipment, utensils, and any other contact surfaces used to manufacture, 
package,

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label, or hold components or dietary supplements.
    (1) Equipment and utensils must be taken apart as necessary for 
thorough maintenance, cleaning, and sanitizing.
    (2) You must ensure that all contact surfaces, used for 
manufacturing or holding low-moisture components or dietary supplements, 
are in a dry and sanitary condition when in use. When the surfaces are 
wet-cleaned, they must be sanitized, when necessary, and thoroughly 
dried before subsequent use.
    (3) If you use wet processing during manufacturing, you must clean 
and sanitize all contact surfaces, as necessary, to protect against the 
introduction of microorganisms into components or dietary supplements. 
When cleaning and sanitizing is necessary, you must clean and sanitize 
all contact surfaces before use and after any interruption during which 
the contact surface may have become contaminated. If you use contact 
surfaces in a continuous production operation or in consecutive 
operations involving different batches of the same dietary supplement, 
you must adequately clean and sanitize the contact surfaces, as 
necessary.
    (4) You must clean surfaces that do not come into direct contact 
with components or dietary supplements as frequently as necessary to 
protect against contaminating components or dietary supplements.
    (5) Single-service articles (such as utensils intended for one-time 
use, paper cups, and paper towels) must be:
    (i) Stored in appropriate containers; and
    (ii) Handled, dispensed, used, and disposed of in a manner that 
protects against contamination of components, dietary supplements, or 
any contact surface.
    (6) Cleaning compounds and sanitizing agents must be adequate for 
their intended use and safe under their conditions of use;
    (7) You must store cleaned and sanitized portable equipment and 
utensils that have contact surfaces in a location and manner that 
protects them from contamination.

[72 FR 34942, June 25, 2007, as amended at 73 FR 13124, Mar. 12, 2008]



Sec. 111.30  What requirements apply to automated, mechanical, 
or electronic equipment?

    For any automated, mechanical, or electronic equipment that you use 
to manufacture, package, label, or hold a dietary supplement, you must:
    (a) Design or select equipment to ensure that dietary supplement 
specifications are consistently met;
    (b) Determine the suitability of the equipment by ensuring that your 
equipment is capable of operating satisfactorily within the operating 
limits required by the process;
    (c) Routinely calibrate, inspect, or check the equipment to ensure 
proper performance. Your quality control personnel must periodically 
review these calibrations, inspections, or checks;
    (d) Establish and use appropriate controls for automated, 
mechanical, and electronic equipment (including software for a computer 
controlled process) to ensure that any changes to the manufacturing, 
packaging, labeling, holding, or other operations are approved by 
quality control personnel and instituted only by authorized personnel; 
and
    (e) Establish and use appropriate controls to ensure that the 
equipment functions in accordance with its intended use. These controls 
must be approved by quality control personnel.



Sec. 111.35  Under this subpart D, what records must you make and keep?

    (a) You must make and keep records required under this subpart D in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart, including written procedures for:
    (i) Calibrating instruments and controls that you use in 
manufacturing or testing a component or dietary supplement;
    (ii) Calibrating, inspecting, and checking automated, mechanical, 
and electronic equipment; and
    (iii) Maintaining, cleaning, and sanitizing, as necessary, all 
equipment, utensils, and any other contact surfaces that are used to 
manufacture, package, label, or hold components or dietary supplements;

[[Page 286]]

    (2) Documentation, in individual equipment logs, of the date of the 
use, maintenance, cleaning, and sanitizing of equipment, unless such 
documentation is kept with the batch record;
    (3) Documentation of any calibration, each time the calibration is 
performed, for instruments and controls that you use in manufacturing or 
testing a component or dietary supplement. In your documentation, you 
must:
    (i) Identify the instrument or control calibrated;
    (ii) Provide the date of calibration;
    (iii) Identify the reference standard used including the 
certification of accuracy of the known reference standard and a history 
of recertification of accuracy;
    (iv) Identify the calibration method used, including appropriate 
limits for accuracy and precision of instruments and controls when 
calibrating;
    (v) Provide the calibration reading or readings found;
    (vi) Identify the recalibration method used, and reading or readings 
found, if accuracy or precision or both accuracy and precision limits 
for instruments and controls were not met; and
    (vii) Include the initials of the person who performed the 
calibration and any recalibration.
    (4) Written records of calibrations, inspections, and checks of 
automated, mechanical, and electronic equipment;
    (5) Backup file(s) of current software programs (and of outdated 
software that is necessary to retrieve records that you are required to 
keep in accordance with subpart P of this part, when current software is 
not able to retrieve such records) and of data entered into computer 
systems that you use to manufacture, package, label, or hold dietary 
supplements.
    (i) Your backup file (e.g., a hard copy of data you have entered, 
diskettes, tapes, microfilm, or compact disks) must be an exact and 
complete record of the data you entered.
    (ii) You must keep your backup software programs and data secure 
from alterations, inadvertent erasures, or loss; and
    (6) Documentation of the controls that you use to ensure that 
equipment functions in accordance with its intended use.



  Subpart E_Requirement to Establish a Production and Process Control 
                                 System



Sec. 111.55  What are the requirements to implement a production 
and process control system?

    You must implement a system of production and process controls that 
covers all stages of manufacturing, packaging, labeling, and holding of 
the dietary supplement to ensure the quality of the dietary supplement 
and that the dietary supplement is packaged and labeled as specified in 
the master manufacturing record.



Sec. 111.60  What are the design requirements for the production 
and process control system?

    (a) Your production and in-process control system must be designed 
to ensure that the dietary supplement is manufactured, packaged, 
labeled, and held in a manner that will ensure the quality of the 
dietary supplement and that the dietary supplement is packaged and 
labeled as specified in the master manufacturing record; and
    (b) The production and in-process control system must include all 
requirements of subparts E through L of this part and must be reviewed 
and approved by quality control personnel.



Sec. 111.65  What are the requirements for quality control operations?

    You must implement quality control operations in your manufacturing, 
packaging, labeling, and holding operations for producing the dietary 
supplement to ensure the quality of the dietary supplement and that the 
dietary supplement is packaged and labeled as specified in the master 
manufacturing record.



Sec. 111.70  What specifications must you establish?

    (a) You must establish a specification for any point, step, or stage 
in the manufacturing process where control is necessary to ensure the 
quality of the dietary supplement and that the dietary supplement is 
packaged and labeled as specified in the master manufacturing record.

[[Page 287]]

    (b) For each component that you use in the manufacture of a dietary 
supplement, you must establish component specifications as follows:
    (1) You must establish an identity specification;
    (2) You must establish component specifications that are necessary 
to ensure that specifications for the purity, strength and composition 
of dietary supplements manufactured using the components are met; and
    (3) You must establish limits on those types of contamination that 
may adulterate or may lead to adulteration of the finished batch of the 
dietary supplement to ensure the quality of the dietary supplement.
    (c) For the in-process production:
    (1) You must establish in-process specifications for any point, 
step, or stage in the master manufacturing record where control is 
necessary to help ensure that specifications are met for the identity, 
purity, strength, and composition of the dietary supplements and, as 
necessary, for limits on those types of contamination that may 
adulterate or may lead to adulteration of the finished batch of the 
dietary supplement;
    (2) You must provide adequate documentation of your basis for why 
meeting the in-process specifications, in combination with meeting 
component specifications, will help ensure that the specifications are 
met for the identity, purity, strength, and composition of the dietary 
supplements and for limits on those types of contamination that may 
adulterate or may lead to adulteration of the finished batch of the 
dietary supplement; and
    (3) Quality control personnel must review and approve the 
documentation that you provide under paragraph (c)(2) of this section.
    (d) You must establish specifications for dietary supplement labels 
(label specifications) and for packaging that may come in contact with 
dietary supplements (packaging specifications). Packaging that may come 
into contact with dietary supplements must be safe and suitable for its 
intended use and must not be reactive or absorptive or otherwise affect 
the safety or quality of the dietary supplement.
    (e) For each dietary supplement that you manufacture you must 
establish product specifications for the identity, purity, strength, and 
composition of the finished batch of the dietary supplement, and for 
limits on those types of contamination that may adulterate, or that may 
lead to adulteration of, the finished batch of the dietary supplement to 
ensure the quality of the dietary supplement.
    (f) If you receive a product from a supplier for packaging or 
labeling as a dietary supplement (and for distribution rather than for 
return to the supplier), you must establish specifications to provide 
sufficient assurance that the product you receive is adequately 
identified and is consistent with your purchase order.
    (g) You must establish specifications for the packaging and labeling 
of the finished packaged and labeled dietary supplements, including 
specifications that ensure that you used the specified packaging and 
that you applied the specified label.



Sec. 111.73  What is your responsibility for determining whether 
established specifications are met?

    You must determine whether the specifications you establish under 
Sec. 111.70 are met.



Sec. 111.75  What must you do to determine whether specifications 
are met?

    (a) Before you use a component, you must:
    (1)(i) Conduct at least one appropriate test or examination to 
verify the identity of any component that is a dietary ingredient, 
unless you petition the agency under paragraph (a)(1)(ii) of this 
section and the agency exempts you from such testing;
    (ii) You may submit a petition, under 21 CFR 10.30, to request an 
exemption from the testing requirements in paragraph (a)(1)(i) of this 
section. The petition must set forth the scientific rationale, and must 
be accompanied by the supporting data and information, for proposed 
alternative testing that will demonstrate that there is no material 
diminution of assurance, compared to the assurance provided by 100 
percent identity testing, of the identity of

[[Page 288]]

the dietary ingredient before use when the dietary ingredient is 
obtained from one or more suppliers identified in the petition. If FDA 
grants the petition, you must conduct the tests and examinations for the 
dietary ingredient, otherwise required under Sec. 111.75(a)(1)(i), 
under the terms specified by FDA when the petition is granted; and
    (2) Confirm the identity of other components and determine whether 
other applicable component specifications established in accordance with 
Sec. 111.70(b) are met. To do so, you must either:
    (i) Conduct appropriate tests or examinations; or
    (ii) Rely on a certificate of analysis from the supplier of the 
component that you receive, provided that:
    (A) You first qualify the supplier by establishing the reliability 
of the supplier's certificate of analysis through confirmation of the 
results of the supplier's tests or examinations;
    (B) The certificate of analysis includes a description of the test 
or examination method(s) used, limits of the test or examinations, and 
actual results of the tests or examinations;
    (C) You maintain documentation of how you qualified the supplier;
    (D) You periodically re-confirm the supplier's certificate of 
analysis; and
    (E) Your quality control personnel review and approve the 
documentation setting forth the basis for qualification (and re-
qualification) of any supplier.
    (b) You must monitor the in-process points, steps, or stages where 
control is necessary to ensure the quality of the finished batch of 
dietary supplement to:
    (1) Determine whether the in-process specifications are met; and
    (2) Detect any deviation or unanticipated occurrence that may result 
in a failure to meet specifications.
    (c) For a subset of finished dietary supplement batches that you 
identify through a sound statistical sampling plan (or for every 
finished batch), you must verify that your finished batch of the dietary 
supplement meets product specifications for identity, purity, strength, 
composition, and for limits on those types of contamination that may 
adulterate or that may lead to adulteration of the finished batch of the 
dietary supplement. To do so:
    (1) You must select one or more established specifications for 
identity, purity, strength, composition, and the limits on those types 
of contamination that may adulterate or that may lead to adulteration of 
the dietary supplement that, if tested or examined on the finished 
batches of the dietary supplement, would verify that the production and 
process control system is producing a dietary supplement that meets all 
product specifications (or only those product specifications not 
otherwise exempted from this provision by quality control personnel 
under paragraph (d) of this section);
    (2) You must conduct appropriate tests or examinations to determine 
compliance with the specifications selected in paragraph (c)(1) of this 
section;
    (3) You must provide adequate documentation of your basis for 
determining that compliance with the specification(s) selected under 
paragraph (c)(1) of this section, through the use of appropriate tests 
or examinations conducted under paragraph (c)(2) of this section, will 
ensure that your finished batch of the dietary supplement meets all 
product specifications for identity, purity, strength, and composition, 
and the limits on those types of contamination that may adulterate, or 
that may lead to the adulteration of, the dietary supplement; and
    (4) Your quality control personnel must review and approve the 
documentation that you provide under paragraph (c)(3) of this section.
    (d)(1) You may exempt one or more product specifications from 
verification requirements in paragraph (c)(1) of this section if you 
determine and document that the specifications you select under 
paragraph (c)(1) of this section for determination of compliance with 
specifications are not able to verify that the production and process 
control system is producing a dietary supplement that meets the exempted 
product specification and there is no scientifically valid method for 
testing or examining such exempted product specification at the finished 
batch stage. In such a case, you must

[[Page 289]]

document why, for example, any component and in-process testing, 
examination, or monitoring, and any other information, will ensure that 
such exempted product specification is met without verification through 
periodic testing of the finished batch; and
    (2) Your quality control personnel must review and approve the 
documentation that you provide under paragraph (d)(1) of this section.
    (e) Before you package or label a product that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier), you must visually examine the 
product and have documentation to determine whether the specifications 
that you established under Sec. 111.70 (f) are met.
    (f)(1) Before you use packaging, you must, at a minimum, conduct a 
visual identification of the containers and closures and review the 
supplier's invoice, guarantee, or certification to determine whether the 
packaging specifications are met; and
    (2) Before you use labels, you must, at a minimum, conduct a visual 
examination of the label and review the supplier's invoice, guarantee, 
or certification to determine whether label specifications are met.
    (g) You must, at a minimum, conduct a visual examination of the 
packaging and labeling of the finished packaged and labeled dietary 
supplements to determine whether you used the specified packaging and 
applied the specified label.
    (h)(1) You must ensure that the tests and examinations that you use 
to determine whether the specifications are met are appropriate, 
scientifically valid methods.
    (2) The tests and examinations that you use must include at least 
one of the following:
    (i) Gross organoleptic analysis;
    (ii) Macroscopic analysis;
    (iii) Microscopic analysis;
    (iv) Chemical analysis; or
    (v) Other scientifically valid methods.
    (i) You must establish corrective action plans for use when an 
established specification is not met.

[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007; 
73 FR 27727, May 14, 2008]



Sec. 111.77  What must you do if established specifications are
not met?

    (a) For specifications established under Sec. 111.70(a), (b)(2), 
(b)(3), (c), (d), (e), and (g) that you do not meet, quality control 
personnel, in accordance with the requirements in subpart F of this 
part, must reject the component, dietary supplement, package or label 
unless such personnel approve a treatment, an in-process adjustment, or 
reprocessing that will ensure the quality of the finished dietary 
supplement and that the dietary supplement is packaged and labeled as 
specified in the master manufacturing record. No finished batch of 
dietary supplements may be released for distribution unless it complies 
with Sec. 111.123(b).
    (b) For specifications established under Sec. 111.70(b)(1) that you 
do not meet, quality control personnel must reject the component and the 
component must not be used in manufacturing the dietary supplement.
    (c) For specifications established under Sec. 111.70(f) that you do 
not meet, quality control personnel must reject the product and the 
product may not be packaged or labeled for distribution as a dietary 
supplement.



Sec. 111.80  What representative samples must you collect?

    The representative samples that you must collect include:
    (a) Representative samples of each unique lot of components, 
packaging, and labels that you use to determine whether the components, 
packaging, and labels meet specifications established in accordance with 
Sec. 111.70(b) and (d), and as applicable, Sec. 111.70(a) (and, when 
you receive components, packaging, or labels from a supplier, 
representative samples of each unique shipment, and of each unique lot 
within each unique shipment);
    (b) Representative samples of in-process materials for each 
manufactured batch at points, steps, or stages,

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in the manufacturing process as specified in the master manufacturing 
record where control is necessary to ensure the identity, purity, 
strength, and composition of dietary supplements to determine whether 
the in-process materials meet specifications established in accordance 
with Sec. 111.70(c), and as applicable, Sec. 111.70(a);
    (c) Representative samples of a subset of finished batches of each 
dietary supplement that you manufacture, which you identify through a 
sound statistical sampling plan (or otherwise every finished batch), 
before releasing for distribution to verify that the finished batch of 
dietary supplement meets product specifications established in 
accordance with Sec. 111.70(e), and as applicable, Sec. 111.70(a);
    (d) Representative samples of each unique shipment, and of each 
unique lot within each unique shipment, of product that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier) to determine whether the 
received product meets specifications established in accordance with 
Sec. 111.70(f), and as applicable, Sec. 111.70(a); and
    (e) Representative samples of each lot of packaged and labeled 
dietary supplements to determine whether the packaging and labeling of 
the finished packaged and labeled dietary supplements meet 
specifications established in accordance with Sec. 111.70(g), and as 
applicable, Sec. 111.70(a).



Sec. 111.83  What are the requirements for reserve samples?

    (a) You must collect and hold reserve samples of each lot of 
packaged and labeled dietary supplements that you distribute.
    (b) The reserve samples must:
    (1) Be held using the same container-closure system in which the 
packaged and labeled dietary supplement is distributed, or if 
distributing dietary supplements to be packaged and labeled, using a 
container-closure system that provides essentially the same 
characteristics to protect against contamination or deterioration as the 
one in which it is distributed for packaging and labeling elsewhere;
    (2) Be identified with the batch, lot, or control number;
    (3) Be retained for 1 year past the shelf life date (if shelf life 
dating is used), or for 2 years from the date of distribution of the 
last batch of dietary supplements associated with the reserve sample, 
for use in appropriate investigations; and
    (4) Consist of at least twice the quantity necessary for all tests 
or examinations to determine whether or not the dietary supplement meets 
product specifications.



Sec. 111.87  Who conducts a material review and makes a disposition decision?

    Quality control personnel must conduct all required material reviews 
and make all required disposition decisions.



Sec. 111.90  What requirements apply to treatments, in-process 
adjustments, and reprocessing when there is a deviation or 
unanticipated occurrence or when a specification established in
accordance with Sec. 111.70 is not met?
          

    (a) You must not reprocess a rejected dietary supplement or treat or 
provide an in-process adjustment to a component, packaging, or label to 
make it suitable for use in the manufacture of a dietary supplement 
unless:
    (1) Quality control personnel conduct a material review and make a 
disposition decision to approve the reprocessing, treatment, or in-
process adjustment; and
    (2) The reprocessing, treatment, or in-process adjustment is 
permitted by Sec. 111.77;
    (b) You must not reprocess any dietary supplement or treat or 
provide an in-process adjustment to a component to make it suitable for 
use in the manufacture of a dietary supplement, unless:
    (1) Quality control personnel conduct a material review and make a 
disposition decision that is based on a scientifically valid reason and 
approves the reprocessing, treatment, or in-process adjustment; and
    (2) The reprocessing, treatment or in-process adjustment is 
permitted by Sec. 111.77;

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    (c) Any batch of dietary supplement that is reprocessed, that 
contains components that you have treated, or to which you have made in-
process adjustments to make them suitable for use in the manufacture of 
the dietary supplement must be approved by quality control personnel and 
comply with Sec. 111.123(b) before releasing for distribution.



Sec. 111.95  Under this subpart E, what records must you make and
keep?

    (a) You must make and keep records required under this subpart E in 
accordance with subpart P of this part.
    (b) Under this subpart E, you must make and keep the following 
records:
    (1) The specifications established;
    (2) Documentation of your qualification of a supplier for the 
purpose of relying on the supplier's certificate of analysis;
    (3) Documentation for why meeting in-process specifications, in 
combination with meeting component specifications, helps ensure that the 
dietary supplement meets the specifications for identity, purity, 
strength, and composition; and for limits on those types of 
contamination that may adulterate or may lead to adulteration of the 
finished batch of the dietary supplement; and
    (4) Documentation for why the results of appropriate tests or 
examinations for the product specifications selected under Sec. 
111.75(c)(1) ensure that the dietary supplement meets all product 
specifications;
    (5) Documentation for why any component and in-process testing, 
examination, or monitoring, and any other information, will ensure that 
a product specification that is exempted under Sec. 111.75(d) is met 
without verification through periodic testing of the finished batch, 
including documentation that the selected specifications tested or 
examined under Sec. 111.75 (c)(1) are not able to verify that the 
production and process control system is producing a dietary supplement 
that meets the exempted product specification and there is no 
scientifically valid method for testing or examining such exempted 
product specification at the finished batch stage.
    (6) Documentation of FDA's response to a petition submitted under 
Sec. 111.75(a)(1)(ii) providing for an exemption from the provisions of 
Sec. 111.75(a)(1)(i).

[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007]



   Subpart F_Production and Process Control System: Requirements for 
                             Quality Control



Sec. 111.103  What are the requirements under this subpart F for
written procedures?

    You must establish and follow written procedures for the 
responsibilities of the quality control operations, including written 
procedures for conducting a material review and making a disposition 
decision, and for approving or rejecting any reprocessing.



Sec. 111.105  What must quality control personnel do?

    Quality control personnel must ensure that your manufacturing, 
packaging, labeling, and holding operations ensure the quality of the 
dietary supplement and that the dietary supplement is packaged and 
labeled as specified in the master manufacturing record. To do so, 
quality control personnel must perform operations that include:
    (a) Approving or rejecting all processes, specifications, written 
procedures, controls, tests, and examinations, and deviations from or 
modifications to them, that may affect the identity, purity, strength, 
or composition of a dietary supplement;
    (b) Reviewing and approving the documentation setting forth the 
basis for qualification of any supplier;
    (c) Reviewing and approving the documentation setting forth the 
basis for why meeting in-process specifications, in combination with 
meeting component specifications, will help ensure that the identity, 
purity, strength, and composition of the dietary supplement are met;
    (d) Reviewing and approving the documentation setting forth the 
basis for why the results of appropriate tests or examinations for each 
product specification selected under Sec. 111.75(c)(1) will ensure that 
the finished batch of the

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dietary supplement meets product specifications;
    (e) Reviewing and approving the basis and the documentation for why 
any product specification is exempted from the verification requirements 
in Sec. 111.75(c)(1), and for why any component and in-process testing, 
examination, or monitoring, or other methods will ensure that such 
exempted product specification is met without verification through 
periodic testing of the finished batch;
    (f) Ensuring that required representative samples are collected;
    (g) Ensuring that required reserve samples are collected and held;
    (h) Determining whether all specifications established under Sec. 
111.70(a) are met; and
    (i) Performing other operations required under this subpart.



Sec. 111.110  What quality control operations are required for 
laboratory operations associated with the production and process
control system?

    Quality control operations for laboratory operations associated with 
the production and process control system must include:
    (a) Reviewing and approving all laboratory control processes 
associated with the production and process control system;
    (b) Ensuring that all tests and examinations required under Sec. 
111.75 are conducted; and
    (c) Reviewing and approving the results of all tests and 
examinations required under Sec. 111.75.



Sec. 111.113  What quality control operations are required for 
a material review and disposition decision?

    (a) Quality control personnel must conduct a material review and 
make a disposition decision if:
    (1) A specification established in accordance with Sec. 111.70 is 
not met;
    (2) A batch deviates from the master manufacturing record, including 
when any step established in the master manufacturing record is not 
completed and including any deviation from specifications;
    (3) There is any unanticipated occurrence during the manufacturing 
operations that adulterates or may lead to adulteration of the 
component, dietary supplement, or packaging, or could lead to the use of 
a label not specified in the master manufacturing record;
    (4) Calibration of an instrument or control suggests a problem that 
may have resulted in a failure to ensure the quality of a batch or 
batches of a dietary supplement; or
    (5) A dietary supplement is returned.
    (b)(1) When there is a deviation or unanticipated occurrence during 
the production and in-process control system that results in or could 
lead to adulteration of a component, dietary supplement, or packaging, 
or could lead to the use of a label not specified in the master 
manufacturing record, quality control personnel must reject the 
component, dietary supplement, packaging, or label unless it approves a 
treatment, an in-process adjustment, or reprocessing to correct the 
applicable deviation or occurrence.
    (2) When a specification established in accordance with Sec. 111.70 
is not met, quality control personnel must reject the component, dietary 
supplement, package or label, unless quality control personnel approve a 
treatment, an in-process adjustment, or reprocessing, as permitted in 
Sec. 111.77.
    (c) The person who conducts a material review and makes the 
disposition decision must, at the time of performance, document that 
material review and disposition decision.



Sec. 111.117  What quality control operations are required for 
equipment, instruments, and controls?

    Quality control operations for equipment, instruments, and controls 
must include:
    (a) Reviewing and approving all processes for calibrating 
instruments and controls;
    (b) Periodically reviewing all records for calibration of 
instruments and controls;
    (c) Periodically reviewing all records for calibrations, 
inspections, and checks of automated, mechanical, or electronic 
equipment; and
    (d) Reviewing and approving controls to ensure that automated, 
mechanical, or electronic equipment functions in accordance with its 
intended use.

[[Page 293]]



Sec. 111.120  What quality control operations are required for
components, packaging, and labels before use in the manufacture
of a dietary supplement?

    Quality control operations for components, packaging, and labels 
before use in the manufacture of a dietary supplement must include:
    (a) Reviewing all receiving records for components, packaging, and 
labels;
    (b) Determining whether all components, packaging, and labels 
conform to specifications established under Sec. 111.70 (b) and (d);
    (c) Conducting any required material review and making any required 
disposition decision;
    (d) Approving or rejecting any treatment and in-process adjustments 
of components, packaging, or labels to make them suitable for use in the 
manufacture of a dietary supplement; and
    (e) Approving, and releasing from quarantine, all components, 
packaging, and labels before they are used.



Sec. 111.123  What quality control operations are required for the 
master manufacturing record, the batch production record, and 
manufacturing operations?

    (a) Quality control operations for the master manufacturing record, 
the batch production record, and manufacturing operations must include:
    (1) Reviewing and approving all master manufacturing records and all 
modifications to the master manufacturing records;
    (2) Reviewing and approving all batch production-related records;
    (3) Reviewing all monitoring required under subpart E;
    (4) Conducting any required material review and making any required 
disposition decision;
    (5) Approving or rejecting any reprocessing;
    (6) Determining whether all in-process specifications established in 
accordance with Sec. 111.70(c) are met;
    (7) Determining whether each finished batch conforms to product 
specifications established in accordance with Sec. 111.70(e); and
    (8) Approving and releasing, or rejecting, each finished batch for 
distribution, including any reprocessed finished batch.
    (b) Quality control personnel must not approve and release for 
distribution:
    (1) Any batch of dietary supplement for which any component in the 
batch does not meet its identity specification;
    (2) Any batch of dietary supplement, including any reprocessed 
batch, that does not meet all product specifications established in 
accordance with Sec. 111.70(e);
    (3) Any batch of dietary supplement, including any reprocessed 
batch, that has not been manufactured, packaged, labeled, and held under 
conditions to prevent adulteration under section 402(a)(1), (a)(2), 
(a)(3), and (a)(4) of the act; and
    (4) Any product received from a supplier for packaging or labeling 
as a dietary supplement (and for distribution rather than for return to 
the supplier) for which sufficient assurance is not provided to 
adequately identify the product and to determine that the product is 
consistent with your purchase order.



Sec. 111.127  What quality control operations are required for 
packaging and labeling operations?

    Quality control operations for packaging and labeling operations 
must include:
    (a) Reviewing the results of any visual examination and 
documentation to ensure that specifications established under Sec. 
111.70(f) are met for all products that you receive for packaging and 
labeling as a dietary supplement (and for distribution rather than for 
return to the supplier);
    (b) Approving, and releasing from quarantine, all products that you 
receive for packaging or labeling as a dietary supplement (and for 
distribution rather than for return to the supplier) before they are 
used for packaging or labeling;
    (c) Reviewing and approving all records for packaging and label 
operations;
    (d) Determining whether the finished packaged and labeled dietary 
supplement conforms to specifications established in accordance with 
Sec. 111.70(g);

[[Page 294]]

    (e) Conducting any required material review and making any required 
disposition decision;
    (f) Approving or rejecting any repackaging of a packaged dietary 
supplement;
    (g) Approving or rejecting any relabeling of a packaged and labeled 
dietary supplement; and
    (h) Approving for release, or rejecting, any packaged and labeled 
dietary supplement (including a repackaged or relabeled dietary 
supplement) for distribution.



Sec. 111.130  What quality control operations are required for 
returned dietary supplements?

    Quality control operations for returned dietary supplements must 
include:
    (a) Conducting any required material review and making any required 
disposition decision; including:
    (1) Determining whether tests or examination are necessary to 
determine compliance with product specifications established in 
accordance with Sec. 111.70(e); and
    (2) Reviewing the results of any tests or examinations that are 
conducted to determine compliance with product specifications 
established in accordance with Sec. 111.70(e);
    (b) Approving or rejecting any salvage and redistribution of any 
returned dietary supplement;
    (c) Approving or rejecting any reprocessing of any returned dietary 
supplement; and
    (d) Determining whether the reprocessed dietary supplement meets 
product specifications and either approving for release, or rejecting, 
any returned dietary supplement that is reprocessed.



Sec. 111.135  What quality control operations are required for 
product complaints?

    Quality control operations for product complaints must include 
reviewing and approving decisions about whether to investigate a product 
complaint and reviewing and approving the findings and followup action 
of any investigation performed.



Sec. 111.140  Under this subpart F, what records must you make and
keep?

    (a) You must make and keep the records required under this subpart F 
in accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for the responsibilities of the quality 
control operations, including written procedures for conducting a 
material review and making a disposition decision and written procedures 
for approving or rejecting any reprocessing;
    (2) Written documentation, at the time of performance, that quality 
control personnel performed the review, approval, or rejection 
requirements by recording the following:
    (i) Date that the review, approval, or rejection was performed; and
    (ii) Signature of the person performing the review, approval, or 
rejection; and
    (3) Documentation of any material review and disposition decision 
and followup. Such documentation must be included in the appropriate 
batch production record and must include:
    (i) Identification of the specific deviation or the unanticipated 
occurrence;
    (ii) Description of your investigation into the cause of the 
deviation from the specification or the unanticipated occurrence;
    (iii) Evaluation of whether or not the deviation or unanticipated 
occurrence has resulted in or could lead to a failure to ensure the 
quality of the dietary supplement or a failure to package and label the 
dietary supplement as specified in the master manufacturing record;
    (iv) Identification of the action(s) taken to correct, and prevent a 
recurrence of, the deviation or the unanticipated occurrence;
    (v) Explanation of what you did with the component, dietary 
supplement, packaging, or label;
    (vi) A scientifically valid reason for any reprocessing of a dietary 
supplement that is rejected or any treatment or in-process adjustment of 
a component that is rejected; and
    (vii) The signature of the individual(s) designated to perform the

[[Page 295]]

quality control operation, who conducted the material review and made 
the disposition decision, and of each qualified individual who provides 
information relevant to that material review and disposition decision.



   Subpart G_Production and Process Control System: Requirements for 
 Components, Packaging, and Labels and for Product That You Receive for 
              Packaging or Labeling as a Dietary Supplement



Sec. 111.153  What are the requirements under this subpart G for
written procedures?

    You must establish and follow written procedures for fulfilling the 
requirements of this subpart G.



Sec. 111.155  What requirements apply to components of dietary
supplements?

    (a) You must visually examine each immediate container or grouping 
of immediate containers in a shipment that you receive for appropriate 
content label, container damage, or broken seals to determine whether 
the container condition may have resulted in contamination or 
deterioration of the components;
    (b) You must visually examine the supplier's invoice, guarantee, or 
certification in a shipment you receive to ensure the components are 
consistent with your purchase order;
    (c) You must quarantine components before you use them in the 
manufacture of a dietary supplement until:
    (1) You collect representative samples of each unique lot of 
components (and, for components that you receive, of each unique 
shipment, and of each unique lot within each unique shipment);
    (2) Quality control personnel review and approve the results of any 
tests or examinations conducted on components; and
    (3) Quality control personnel approve the components for use in the 
manufacture of a dietary supplement, including approval of any treatment 
(including in-process adjustments) of components to make them suitable 
for use in the manufacture of a dietary supplement, and releases them 
from quarantine.
    (d)(1) You must identify each unique lot within each unique shipment 
of components that you receive and any lot of components that you 
produce in a manner that allows you to trace the lot to the supplier, 
the date received, the name of the component, the status of the 
component (e.g., quarantined, approved, or rejected); and to the dietary 
supplement that you manufactured and distributed.
    (2) You must use this unique identifier whenever you record the 
disposition of each unique lot within each unique shipment of components 
that you receive and any lot of components that you produce.
    (e) You must hold components under conditions that will protect 
against contamination and deterioration, and avoid mixups.



Sec. 111.160  What requirements apply to packaging and labels 
received?

    (a) You must visually examine each immediate container or grouping 
of immediate containers in a shipment for appropriate content label, 
container damage, or broken seals to determine whether the container 
condition may have resulted in contamination or deterioration of the 
packaging and labels.
    (b) You must visually examine the supplier's invoice, guarantee, or 
certification in a shipment to ensure that the packaging or labels are 
consistent with your purchase order.
    (c) You must quarantine packaging and labels before you use them in 
the manufacture of a dietary supplement until:
    (1) You collect representative samples of each unique shipment, and 
of each unique lot within each unique shipment, of packaging and labels 
and, at a minimum, conduct a visual identification of the immediate 
containers and closures;
    (2) Quality control personnel review and approve the results of any 
tests or examinations conducted on the packaging and labels; and
    (3) Quality control personnel approve the packaging and labels for 
use in the manufacture of a dietary supplement and release them from 
quarantine.

[[Page 296]]

    (d)(1) You must identify each unique lot within each unique shipment 
of packaging and labels in a manner that allows you to trace the lot to 
the supplier, the date received, the name of the packaging and label, 
the status of the packaging and label (e.g., quarantined, approved, or 
rejected); and to the dietary supplement that you distributed; and
    (2) You must use this unique identifier whenever you record the 
disposition of each unique lot within each unique shipment of packaging 
and labels.
    (e) You must hold packaging and labels under conditions that will 
protect against contamination and deterioration, and avoid mixups.



Sec. 111.165  What requirements apply to a product received for
packaging or labeling as a dietary supplement (and for distribution
rather than for return to the supplier)?
          

    (a) You must visually examine each immediate container or grouping 
of immediate containers in a shipment of product that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier) for appropriate content label, 
container damage, or broken seals to determine whether the container 
condition may have resulted in contamination or deterioration of the 
received product.
    (b) You must visually examine the supplier's invoice, guarantee, or 
certification in a shipment of the received product to ensure that the 
received product is consistent with your purchase order.
    (c) You must quarantine the received product until:
    (1) You collect representative samples of each unique shipment, and 
of each unique lot within each unique shipment, of received product;
    (2) Quality control personnel review and approve the documentation 
to determine whether the received product meets the specifications that 
you established under Sec. 111.70(f); and
    (3) Quality control personnel approve the received product for 
packaging or labeling as a dietary supplement and release the received 
product from quarantine.
    (d)(1) You must identify each unique lot within each unique shipment 
of received product in a manner that allows you to trace the lot to the 
supplier, the date received, the name of the received product, the 
status of the received product (e.g., quarantined, approved, or 
rejected), and to the product that you packaged or labeled and 
distributed as a dietary supplement.
    (2) You must use this unique identifier whenever you record the 
disposition of each unique lot within each unique shipment of the 
received product.
    (e) You must hold the received product under conditions that will 
protect against contamination and deterioration, and avoid mixups.



Sec. 111.170  What requirements apply to rejected components, 
packaging, and labels, and to rejected products that are received
for packaging or labeling as a dietary supplement?
          

    You must clearly identify, hold, and control under a quarantine 
system for appropriate disposition any component, packaging, and label, 
and any product that you receive for packaging or labeling as a dietary 
supplement (and for distribution rather than for return to the 
supplier), that is rejected and unsuitable for use in manufacturing, 
packaging, or labeling operations.



Sec. 111.180  Under this subpart G, what records must you make 
and keep?

    (a) You must make and keep records required under this subpart G in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart.
    (2) Receiving records (including records such as certificates of 
analysis, suppliers' invoices, and suppliers' guarantees) for 
components, packaging, and labels and for products that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier); and
    (3) Documentation that the requirements of this subpart were met.
    (i) The person who performs the required operation must document, at

[[Page 297]]

the time of performance, that the required operation was performed.
    (ii) The documentation must include:
    (A) The date that the components, packaging, labels, or products 
that you receive for packaging or labeling as a dietary supplement were 
received;
    (B) The initials of the person performing the required operation;
    (C) The results of any tests or examinations conducted on 
components, packaging, or labels, and of any visual examination of 
product that you receive for packaging or labeling as a dietary 
supplement; and
    (D) Any material review and disposition decision conducted on 
components, packaging, labels, or products that you receive for 
packaging or labeling as a dietary supplement.



 Subpart H_Production and Process Control System: Requirements for the 
                       Master Manufacturing Record



Sec. 111.205  What is the requirement to establish a master 
manufacturing record?

    (a) You must prepare and follow a written master manufacturing 
record for each unique formulation of dietary supplement that you 
manufacture, and for each batch size, to ensure uniformity in the 
finished batch from batch to batch.
    (b) The master manufacturing record must:
    (1) Identify specifications for the points, steps, or stages in the 
manufacturing process where control is necessary to ensure the quality 
of the dietary supplement and that the dietary supplement is packaged 
and labeled as specified in the master manufacturing record; and
    (2) Establish controls and procedures to ensure that each batch of 
dietary supplement that you manufacture meets the specifications 
identified in accordance with paragraph (b)(1) of this section.
    (c) You must make and keep master manufacturing records in 
accordance with subpart P of this part.



Sec. 111.210  What must the master manufacturing record include?

    The master manufacturing record must include:
    (a) The name of the dietary supplement to be manufactured and the 
strength, concentration, weight, or measure of each dietary ingredient 
for each batch size;
    (b) A complete list of components to be used;
    (c) An accurate statement of the weight or measure of each component 
to be used;
    (d) The identity and weight or measure of each dietary ingredient 
that will be declared on the Supplement Facts label and the identity of 
each ingredient that will be declared on the ingredients list of the 
dietary supplement;
    (e) A statement of any intentional overage amount of a dietary 
ingredient;
    (f) A statement of theoretical yield of a manufactured dietary 
supplement expected at each point, step, or stage of the manufacturing 
process where control is needed to ensure the quality of the dietary 
supplement, and the expected yield when you finish manufacturing the 
dietary supplement, including the maximum and minimum percentages of 
theoretical yield beyond which a deviation investigation of a batch is 
necessary and material review is conducted and disposition decision is 
made;
    (g) A description of packaging and a representative label, or a 
cross-reference to the physical location of the actual or representative 
label;
    (h) Written instructions, including the following:
    (1) Specifications for each point, step, or stage in the 
manufacturing process where control is necessary to ensure the quality 
of the dietary supplement and that the dietary supplement is packaged 
and labeled as specified in the master manufacturing record;
    (2) Procedures for sampling and a cross-reference to procedures for 
tests or examinations;
    (3) Specific actions necessary to perform and verify points, steps, 
or stages in the manufacturing process where

[[Page 298]]

control is necessary to ensure the quality of the dietary supplement and 
that the dietary supplement is packaged and labeled as specified in the 
master manufacturing record.
    (i) Such specific actions must include verifying the weight or 
measure of any component and verifying the addition of any component; 
and
    (ii) For manual operations, such specific actions must include:
    (A) One person weighing or measuring a component and another person 
verifying the weight or measure; and
    (B) One person adding the component and another person verifying the 
addition.
    (4) Special notations and precautions to be followed; and
    (5) Corrective action plans for use when a specification is not met.



 Subpart I_Production and Process Control System: Requirements for the 
                         Batch Production Record



Sec. 111.255  What is the requirement to establish a batch production 
record?

    (a) You must prepare a batch production record every time you 
manufacture a batch of a dietary supplement;
    (b) Your batch production record must include complete information 
relating to the production and control of each batch;
    (c) Your batch production record must accurately follow the 
appropriate master manufacturing record and you must perform each step 
in the production of the batch; and
    (d) You must make and keep batch production records in accordance 
with subpart P of this part.



Sec. 111.260  What must the batch record include?

    The batch production record must include the following:
    (a) The batch, lot, or control number:
    (1) Of the finished batch of dietary supplement; and
    (2) That you assign in accordance with Sec. 111.415(f) for the 
following:
    (i) Each lot of packaged and labeled dietary supplement from the 
finished batch of dietary supplement;
    (ii) Each lot of dietary supplement, from the finished batch of 
dietary supplement, that you distribute to another person for packaging 
or labeling;
    (b) The identity of equipment and processing lines used in producing 
the batch;
    (c) The date and time of the maintenance, cleaning, and sanitizing 
of the equipment and processing lines used in producing the batch, or a 
cross-reference to records, such as individual equipment logs, where 
this information is retained;
    (d) The unique identifier that you assigned to each component (or, 
when applicable, to a product that you receive from a supplier for 
packaging or labeling as a dietary supplement), packaging, and label 
used;
    (e) The identity and weight or measure of each component used;
    (f) A statement of the actual yield and a statement of the 
percentage of theoretical yield at appropriate phases of processing;
    (g) The actual results obtained during any monitoring operation;
    (h) The results of any testing or examination performed during the 
batch production, or a cross-reference to such results;
    (i) Documentation that the finished dietary supplement meets 
specifications established in accordance with Sec. 111.70(e) and (g);
    (j) Documentation, at the time of performance, of the manufacture of 
the batch, including:
    (1) The date on which each step of the master manufacturing record 
was performed; and
    (2) The initials of the persons performing each step, including:
    (i) The initials of the person responsible for weighing or measuring 
each component used in the batch;
    (ii) The initials of the person responsible for verifying the weight 
or measure of each component used in the batch;
    (iii) The initials of the person responsible for adding the 
component to the batch; and
    (iv) The initials of the person responsible for verifying the 
addition of components to the batch;

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    (k) Documentation, at the time of performance, of packaging and 
labeling operations, including:
    (1) The unique identifier that you assigned to packaging and labels 
used, the quantity of the packaging and labels used, and, when label 
reconciliation is required, reconciliation of any discrepancies between 
issuance and use of labels;
    (2) An actual or representative label, or a cross-reference to the 
physical location of the actual or representative label specified in the 
master manufacturing record; and
    (3) The results of any tests or examinations conducted on packaged 
and labeled dietary supplements (including repackaged or relabeled 
dietary supplements), or a cross-reference to the physical location of 
such results;
    (l) Documentation at the time of performance that quality control 
personnel:
    (1) Reviewed the batch production record, including:
    (i) Review of any monitoring operation required under subpart E of 
this part; and
    (ii) Review of the results of any tests and examinations, including 
tests and examinations conducted on components, in-process materials, 
finished batches of dietary supplements, and packaged and labeled 
dietary supplements;
    (2) Approved or rejected any reprocessing or repackaging; and
    (3) Approved and released, or rejected, the batch for distribution, 
including any reprocessed batch; and
    (4) Approved and released, or rejected, the packaged and labeled 
dietary supplement, including any repackaged or relabeled dietary 
supplement.
    (m) Documentation at the time of performance of any required 
material review and disposition decision.
    (n) Documentation at the time of performance of any reprocessing.



   Subpart J_Production and Process Control System: Requirements for 
                          Laboratory Operations



Sec. 111.303  What are the requirements under this subpart J for
written procedures?

    You must establish and follow written procedures for laboratory 
operations, including written procedures for the tests and examinations 
that you conduct to determine whether specifications are met.



Sec. 111.310  What are the requirements for the laboratory facilities
that you use?

    You must use adequate laboratory facilities to perform whatever 
testing and examinations are necessary to determine whether:
    (a) Components that you use meet specifications;
    (b) In-process specifications are met as specified in the master 
manufacturing record; and
    (c) Dietary supplements that you manufacture meet specifications.



Sec. 111.315  What are the requirements for laboratory control processes?

    You must establish and follow laboratory control processes that are 
reviewed and approved by quality control personnel, including the 
following:
    (a) Use of criteria for establishing appropriate specifications;
    (b) Use of sampling plans for obtaining representative samples, in 
accordance with subpart E of this part, of:
    (1) Components, packaging, and labels;
    (2) In-process materials;
    (3) Finished batches of dietary supplements;
    (4) Product that you receive for packaging or labeling as a dietary 
supplement (and for distribution rather than for return to the 
supplier); and
    (5) Packaged and labeled dietary supplements.
    (c) Use of criteria for selecting appropriate examination and 
testing methods;
    (d) Use of criteria for selecting standard reference materials used 
in performing tests and examinations; and

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    (e) Use of test methods and examinations in accordance with 
established criteria.



Sec. 111.320  What requirements apply to laboratory methods for 
testing and examination?

    (a) You must verify that the laboratory examination and testing 
methodologies are appropriate for their intended use.
    (b) You must identify and use an appropriate scientifically valid 
method for each established specification for which testing or 
examination is required to determine whether the specification is met.



Sec. 111.325  Under this subpart J, what records must you make 
and keep?

    (a) You must make and keep records required under this subpart J in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for laboratory operations, including written 
procedures for the tests and examinations that you conduct to determine 
whether specifications are met;
    (2) Documentation that laboratory methodology established in 
accordance with this subpart J is followed.
    (i) The person who conducts the testing and examination must 
document, at the time of performance, that laboratory methodology 
established in accordance with this subpart J is followed.
    (ii) The documentation for laboratory tests and examinations must 
include the results of the testing and examination.



   Subpart K_Production and Process Control System: Requirements for 
                        Manufacturing Operations



Sec. 111.353  What are the requirements under this subpart K for 
written procedures?

    You must establish and follow written procedures for manufacturing 
operations.



Sec. 111.355  What are the design requirements for manufacturing
operations?

    You must design or select manufacturing processes to ensure that 
product specifications are consistently met.



Sec. 111.360  What are the requirements for sanitation?

    You must conduct all manufacturing operations in accordance with 
adequate sanitation principles.



Sec. 111.365  What precautions must you take to prevent contamination?

    You must take all the necessary precautions during the manufacture 
of a dietary supplement to prevent contamination of components or 
dietary supplements. These precautions include:
    (a) Performing manufacturing operations under conditions and 
controls that protect against the potential for growth of microorganisms 
and the potential for contamination;
    (b) Washing or cleaning components that contain soil or other 
contaminants;
    (c) Using water that, at a minimum, complies with the applicable 
Federal, State, and local requirements and does not contaminate the 
dietary supplement when the water may become a component of the finished 
batch of dietary supplement;
    (d) Performing chemical, microbiological, or other testing, as 
necessary to prevent the use of contaminated components;
    (e) Sterilizing, pasteurizing, freezing, refrigerating, controlling 
hydrogen-ion concentration (pH), controlling humidity, controlling water 
activity (aw), or using any other effective means to remove, 
destroy, or prevent the growth of microorganisms and prevent 
decomposition;
    (f) Holding components and dietary supplements that can support the 
rapid growth of microorganisms of public health significance in a manner 
that prevents the components and dietary supplements from becoming 
adulterated;
    (g) Identifying and holding any components or dietary supplements, 
for which a material review and disposition decision is required, in a 
manner

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that protects components or dietary supplements that are not under a 
material review against contamination and mixups with those that are 
under a material review;
    (h) Performing mechanical manufacturing steps (such as cutting, 
sorting, inspecting, shredding, drying, grinding, blending, and sifting) 
by any effective means to protect the dietary supplements against 
contamination, by, for example:
    (1) Cleaning and sanitizing contact surfaces;
    (2) Using temperature controls; and
    (3) Using time controls.
    (i) Using effective measures to protect against the inclusion of 
metal or other foreign material in components or dietary supplements, 
by, for example:
    (1) Filters or strainers,
    (2) Traps,
    (3) Magnets, or
    (4) Electronic metal detectors.
    (j) Segregating and identifying all containers for a specific batch 
of dietary supplements to identify their contents and, when necessary, 
the phase of manufacturing; and
    (k) Identifying all processing lines and major equipment used during 
manufacturing to indicate their contents, including the name of the 
dietary supplement and the specific batch or lot number and, when 
necessary, the phase of manufacturing.



Sec. 111.370  What requirements apply to rejected dietary supplements?

    You must clearly identify, hold, and control under a quarantine 
system for appropriate disposition any dietary supplement that is 
rejected and unsuitable for use in manufacturing, packaging, or labeling 
operations.



Sec. 111.375  Under this subpart K, what records must you make and keep?

    (a) You must make and keep records required under this subpart K in 
accordance with subpart P of this part.
    (b) You must make and keep records of the written procedures for 
manufacturing operations.



   Subpart L_Production and Process Control System: Requirements for 
                    Packaging and Labeling Operations



Sec. 111.403  What are the requirements under this subpart L for 
written procedures?

    You must establish and follow written procedures for packaging and 
labeling operations.



Sec. 111.410  What requirements apply to packaging and labels?

    (a) You must take necessary actions to determine whether packaging 
for dietary supplements meets specifications so that the condition of 
the packaging will ensure the quality of your dietary supplements;
    (b) You must control the issuance and use of packaging and labels 
and reconciliation of any issuance and use discrepancies. Label 
reconciliation is not required for cut or rolled labels if a 100-percent 
examination for correct labels is performed by appropriate electronic or 
electromechanical equipment during or after completion of finishing 
operations; and
    (c) You must examine, before packaging and labeling operations, 
packaging and labels for each batch of dietary supplement to determine 
whether the packaging and labels conform to the master manufacturing 
record; and
    (d) You must be able to determine the complete manufacturing history 
and control of the packaged and labeled dietary supplement through 
distribution.



Sec. 111.415  What requirements apply to filling, assembling, 
packaging, labeling, and related operations?

    You must fill, assemble, package, label, and perform other related 
operations in a way that ensures the quality of the dietary supplement 
and that the dietary supplement is packaged and labeled as specified in 
the master manufacturing record. You must do this using any effective 
means, including the following:
    (a) Cleaning and sanitizing all filling and packaging equipment, 
utensils, and dietary supplement packaging, as appropriate;

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    (b) Protecting manufactured dietary supplements from contamination, 
particularly airborne contamination;
    (c) Using sanitary handling procedures;
    (d) Establishing physical or spatial separation of packaging and 
label operations from operations on other components and dietary 
supplements to prevent mixups;
    (e) Identifying, by any effective means, filled dietary supplement 
containers that are set aside and held in unlabeled condition for future 
label operations, to prevent mixups;
    (f) Assigning a batch, lot, or control number to:
    (1) Each lot of packaged and labeled dietary supplement from a 
finished batch of dietary supplement; and,
    (2) Each lot of dietary supplement, from a finished batch of dietary 
supplement, that you distribute to another person for packaging or 
labeling.
    (g) Examining a representative sample of each batch of the packaged 
and labeled dietary supplement to determine whether the dietary 
supplement meets specifications established in accordance with Sec. 
111.70(g); and
    (h) Suitably disposing of labels and packaging for dietary 
supplements that are obsolete or incorrect to ensure that they are not 
used in any future packaging and label operations.



Sec. 111.420  What requirements apply to repackaging and relabeling?

    (a) You may repackage or relabel dietary supplements only after 
quality control personnel have approved such repackaging or relabeling.
    (b) You must examine a representative sample of each batch of 
repackaged or relabeled dietary supplements to determine whether the 
repackaged or relabeled dietary supplements meet all specifications 
established in accordance with Sec. 111.70(g).
    (c) Quality control personnel must approve or reject each batch of 
repackaged or relabeled dietary supplement prior to its release for 
distribution.



Sec. 111.425  What requirements apply to a packaged and labeled 
dietary supplement that is rejected for distribution?

    You must clearly identify, hold, and control under a quarantine 
system for appropriate disposition any packaged and labeled dietary 
supplement that is rejected for distribution.



Sec. 111.430  Under this subpart L, what records must you make 
and keep?

    (a) You must make and keep records required under this subpart L in 
accordance with subpart P of this part.
    (b) You must make and keep records of the written procedures for 
packaging and labeling operations.



                   Subpart M_Holding and Distributing



Sec. 111.453  What are the requirements under this subpart for M
written procedures?

    You must establish and follow written procedures for holding and 
distributing operations.



Sec. 111.455  What requirements apply to holding components, dietary
supplements, packaging, and labels?

    (a) You must hold components and dietary supplements under 
appropriate conditions of temperature, humidity, and light so that the 
identity, purity, strength, and composition of the components and 
dietary supplements are not affected.
    (b) You must hold packaging and labels under appropriate conditions 
so that the packaging and labels are not adversely affected.
    (c) You must hold components, dietary supplements, packaging, and 
labels under conditions that do not lead to the mixup, contamination, or 
deterioration of components, dietary supplements, packaging, and labels.



Sec. 111.460  What requirements apply to holding in-process material?

    (a) You must identify and hold in-process material under conditions 
that protect against mixup, contamination, and deterioration.
    (b) You must hold in-process material under appropriate conditions 
of temperature, humidity, and light.



Sec. 111.465  What requirements apply to holding reserve samples of
dietary supplements?

    (a) You must hold reserve samples of dietary supplements in a manner 
that

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protects against contamination and deterioration. This includes:
    (1) Holding the reserve samples under conditions consistent with 
product labels or, if no storage conditions are recommended on the 
label, under ordinary storage conditions; and
    (2) Using the same container-closure system in which the packaged 
and labeled dietary supplement is distributed, or if distributing 
dietary supplements to be packaged and labeled, using a container-
closure system that provides essentially the same characteristics to 
protect against contamination or deterioration as the one in which you 
distribute the dietary supplement for packaging and labeling elsewhere.
    (b) You must retain reserve samples for 1 year past the shelf life 
date (if shelf life dating is used), or for 2 years from the date of 
distribution of the last batch of dietary supplements associated with 
the reserve samples, for use in appropriate investigations.



Sec. 111.470  What requirements apply to distributing dietary 
supplements?

    You must distribute dietary supplements under conditions that will 
protect the dietary supplements against contamination and deterioration.



Sec. 111.475  Under this subpart M, what records must you make and keep?

    (a) You must make and keep records required under this subpart M in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for holding and distributing operations; and
    (2) Records of product distribution.



                 Subpart N_Returned Dietary Supplements



Sec. 111.503  What are the requirements under this subpart N for 
written procedures?

    You must establish and follow written procedures to fulfill the 
requirements of this subpart.



Sec. 111.510  What requirements apply when a returned dietary 
supplement is received?

    You must identify and quarantine returned dietary supplements until 
quality control personnel conduct a material review and make a 
disposition decision.



Sec. 111.515  When must a returned dietary supplement be destroyed, 
or otherwise suitably disposed of?

    You must destroy, or otherwise suitably dispose of, any returned 
dietary supplement unless the outcome of a material review and 
disposition decision is that quality control personnel do the following:
    (a) Approve the salvage of the returned dietary supplement for 
redistribution or
    (b) Approve the returned dietary supplement for reprocessing.



Sec. 111.520  When may a returned dietary supplement be salvaged?

    You may salvage a returned dietary supplement only if quality 
control personnel conduct a material review and make a disposition 
decision to allow the salvage.



Sec. 111.525  What requirements apply to a returned dietary supplement
that quality control personnel approve for reprocessing?

    (a) You must ensure that any returned dietary supplements that are 
reprocessed meet all product specifications established in accordance 
with Sec. 111.70(e); and
    (b) Quality control personnel must approve or reject the release for 
distribution of any returned dietary supplement that is reprocessed.



Sec. 111.530  When must an investigation be conducted of your 
manufacturing processes and other batches?

    If the reason for a dietary supplement being returned implicates 
other batches, you must conduct an investigation of your manufacturing 
processes and each of those other batches to determine compliance with 
specifications.

[[Page 304]]



Sec. 111.535  Under this subpart N, what records must you make and
keep?

    (a) You must make and keep records required under this subpart N in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart N.
    (2) Any material review and disposition decision on a returned 
dietary supplement;
    (3) The results of any testing or examination conducted to determine 
compliance with product specifications established under Sec. 
111.70(e); and,
    (4) Documentation of the reevaluation by quality control personnel 
of any dietary supplement that is reprocessed and the determination by 
quality control personnel of whether the reprocessed dietary supplement 
meets product specifications established in accordance with Sec. 
111.70(e).



                      Subpart O_Product Complaints



Sec. 111.553  What are the requirements under this subpart O for
written procedures?

    You must establish and follow written procedures to fulfill the 
requirements of this subpart O.



Sec. 111.560  What requirements apply to the review and investigation
of a product complaint?

    (a) A qualified person must:
    (1) Review all product complaints to determine whether the product 
complaint involves a possible failure of a dietary supplement to meet 
any of its specifications, or any other requirements of this part 111, 
including those specifications and other requirements that, if not met, 
may result in a risk of illness or injury; and
    (2) Investigate any product complaint that involves a possible 
failure of a dietary supplement to meet any of its specifications, or 
any other requirements of this part, including those specifications and 
other requirements that, if not met, may result in a risk of illness or 
injury.
    (b) Quality control personnel must review and approve decisions 
about whether to investigate a product complaint and review and approve 
the findings and followup action of any investigation performed.
    (c) The review and investigation of the product complaint by a 
qualified person, and the review by quality control personnel about 
whether to investigate a product complaint, and the findings and 
followup action of any investigation performed, must extend to all 
relevant batches and records.



Sec. 111.570  Under this subpart O, what records must you make and keep?

    (a) You must make and keep the records required under this subpart O 
in accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart,
    (2) A written record of every product complaint that is related to 
good manufacturing practice,
    (i) The person who performs the requirements of this subpart must 
document, at the time of performance, that the requirement was 
performed.
    (ii) The written record of the product complaint must include the 
following:
    (A) The name and description of the dietary supplement;
    (B) The batch, lot, or control number of the dietary supplement, if 
available;
    (C) The date the complaint was received and the name, address, or 
telephone number of the complainant, if available;
    (D) The nature of the complaint including, if known, how the product 
was used;
    (E) The reply to the complainant, if any; and
    (F) Findings of the investigation and followup action taken when an 
investigation is performed.



                   Subpart P_Records and Recordkeeping



Sec. 111.605  What requirements apply to the records that you make
and keep?

    (a) You must keep written records required by this part for 1 year 
past the shelf life date, if shelf life dating is used, or 2 years 
beyond the date of distribution of the last batch of dietary

[[Page 305]]

supplements associated with those records.
    (b) Records must be kept as original records, as true copies (such 
as photocopies, microfilm, microfiche, or other accurate reproductions 
of the original records), or as electronic records.
    (c) All electronic records must comply with part 11 of this chapter.



Sec. 111.610  What records must be made available to FDA?

    (a) You must have all records required under this part, or copies of 
such records, readily available during the retention period for 
inspection and copying by FDA when requested.
    (b) If you use reduction techniques, such as microfilming, you must 
make suitable reader and photocopying equipment readily available to 
FDA.



PART 112_STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING
OF PRODUCE FOR HUMAN CONSUMPTION--Table of Contents



                      Subpart A_General Provisions

Sec.
112.1 What food is covered by this part?
112.2 What produce is not covered by this part?
112.3 What definitions apply to this part?
112.4 Which farms are subject to the requirements of this part?
112.5 Which farms are eligible for a qualified exemption and associated 
          modified requirements based on average monetary value of all 
          food sold and direct farm marketing?
112.6 What modified requirements apply to me if my farm is eligible for 
          a qualified exemption in accordance with Sec. 112.5?
112.7 What records must I establish and keep if my farm is eligible for 
          a qualified exemption in accordance with Sec. 112.5?

                     Subpart B_General Requirements

112.11 What general requirements apply to persons who are subject to 
          this part?
112.12 Are there any alternatives to the requirements established in 
          this part?

             Subpart C_Personnel Qualifications and Training

112.21 What requirements apply regarding qualifications and training for 
          personnel who handle (contact) covered produce or food contact 
          surfaces?
112.22 What minimum requirements apply for training personnel who 
          conduct a covered activity?
112.23 What requirements apply regarding supervisors?
112.30 Under this subpart, what requirements apply regarding records?

                      Subpart D_Health and Hygiene

112.31 What measures must I take to prevent ill or infected persons from 
          contaminating covered produce with microorganisms of public 
          health significance?
112.32 What hygienic practices must personnel use?
112.33 What measures must I take to prevent visitors from contaminating 
          covered produce and food contact surfaces with microorganisms 
          of public health significance?

                      Subpart E_Agricultural Water

112.41 What requirements apply to the quality of agricultural water?
112.42 What requirements apply to my agricultural water sources, water 
          distribution system, and pooling of water?
112.43 What requirements apply to treating agricultural water?
112.44 What specific microbial quality criteria apply to agricultural 
          water used for certain intended uses?
112.45 What measures must I take if my agricultural water does not meet 
          the requirements of Sec. 112.41 or Sec. 112.44?
112.46 How often must I test agricultural water that is subject to the 
          requirements of Sec. 112.44?
112.47 Who must perform the tests required under Sec. 112.46 and what 
          methods must be used?
112.48 What measures must I take for water that I use during harvest, 
          packing, and holding activities for covered produce?
112.49 What alternatives may I establish and use in lieu of the 
          requirements of this subpart?
112.50 Under this subpart, what requirements apply regarding records?

  Subpart F_Biological Soil Amendments of Animal Origin and Human Waste

112.51 What requirements apply for determining the status of a 
          biological soil amendment of animal origin?
112.52 How must I handle, convey, and store biological soil amendments 
          of animal origin?
112.53 What prohibitions apply regarding use of human waste?
112.54 What treatment processes are acceptable for a biological soil 
          amendment of animal origin that I apply in the growing of 
          covered produce?

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112.55 What microbial standards apply to the treatment processes in 
          Sec. 112.54?
112.56 What application requirements and minimum application intervals 
          apply to biological soil amendments of animal origin?
112.60 Under this subpart, what requirements apply regarding records?

Subpart G-H [Reserved]

                 Subpart I_Domesticated and Wild Animals

112.81 How do the requirements of this subpart apply to areas where 
          covered activities take place?
112.83 What requirements apply regarding grazing animals, working 
          animals, and animal intrusion?
112.84 Does this regulation require covered farms to take actions that 
          would constitute a ``taking'' of threatened or endangered 
          species; to take measures to exclude animals from outdoor 
          growing areas; or to destroy animal habitat or otherwise clear 
          farm borders around outdoor growing areas or drainages?

Subpart J [Reserved]

     Subpart K_Growing, Harvesting, Packing, and Holding Activities

112.111 What measures must I take if I grow, harvest, pack or hold both 
          covered and excluded produce?
112.112 What measures must I take immediately prior to and during 
          harvest activities?
112.113 How must I handle harvested covered produce during covered 
          activities?
112.114 What requirements apply to dropped covered produce?
112.115 What measures must I take when packaging covered produce?
112.116 What measures must I take when using food-packing (including 
          food packaging) material?

          Subpart L_Equipment, Tools, Buildings, and Sanitation

112.121 What equipment and tools are subject to the requirements of this 
          subpart?
112.122 What buildings are subject to the requirements of this subpart?
112.123 What requirements apply regarding equipment and tools subject to 
          this subpart?
112.124 What requirements apply to instruments and controls used to 
          measure, regulate, or record?
112.125 What requirements apply to equipment that is subject to this 
          subpart used in the transport of covered produce?
112.126 What requirements apply to my buildings?
112.127 What requirements apply regarding domesticated animals in and 
          around a fully-enclosed building?
112.128 What requirements apply regarding pest control in buildings?
112.129 What requirements apply to toilet facilities?
112.130 What requirements apply for hand-washing facilities?
112.131 What must I do to control and dispose of sewage?
112.132 What must I do to control and dispose of trash, litter, and 
          waste in areas used for covered activities?
112.133 What requirements apply to plumbing?
112.134 What must I do to control animal excreta and litter from 
          domesticated animals that are under my control?
112.140 Under this subpart, what requirements apply regarding records?

                            Subpart M_Sprouts

112.141 What commodities are subject to this subpart?
112.142 What requirements apply to seeds or beans used to grow sprouts?
112.143 What measures must I take for growing, harvesting, packing, and 
          holding sprouts?
112.144 What testing must I do during growing, harvesting, packing, and 
          holding sprouts?
112.145 What requirements apply to testing the environment for Listeria 
          species or L. monocytogenes?
112.146 What actions must I take if the growing, harvesting, packing, or 
          holding environment tests positive for Listeria species or L. 
          monocytogenes?
112.147 What must I do to collect and test samples of spent sprout 
          irrigation water or sprouts for pathogens?
112.148 What actions must I take if the samples of spent sprout 
          irrigation water or sprouts test positive for a pathogen?
112.150 Under this subpart, what requirements apply regarding records?

                      Subpart N_Analytical Methods

112.151 What methods must I use to test the quality of water to satisfy 
          the requirements of Sec. 112.46?
112.152 What methods must I use to test the growing, harvesting, 
          packing, and holding environment for Listeria species or L. 
          monocytogenes to satisfy the requirements of Sec. 112.144(a)?
112.153 What methods must I use to test spent sprout irrigation water 
          (or sprouts) from each production batch of sprouts for 
          pathogens to satisfy the requirements of Sec. 112.144(b) and 
          (c)?

[[Page 307]]

                            Subpart O_Records

112.161 What general requirements apply to records required under this 
          part?
112.162 Where must I store records?
112.163 May I use existing records to satisfy the requirements of this 
          part?
112.164 How long must I keep records?
112.165 What formats are acceptable for the records I keep?
112.166 What requirements apply for making records available and 
          accessible to FDA?
112.167 Can records that I provide to FDA be disclosed to persons 
          outside of FDA?

                           Subpart P_Variances

112.171 Who may request a variance from the requirements of this part?
112.172 How may a State, tribe, or foreign country request a variance 
          from one or more requirements of this part?
112.173 What must be included in the Statement of Grounds in a petition 
          requesting a variance?
112.174 What information submitted in a petition requesting a variance 
          or submitted in comments on such a petition are publicly 
          available?
112.175 Who responds to a petition requesting a variance?
112.176 What process applies to a petition requesting a variance?
112.177 Can an approved variance apply to any person other than those 
          identified in the petition requesting that variance?
112.178 Under what circumstances may FDA deny a petition requesting a 
          variance?
112.179 When does a variance approved by FDA become effective?
112.180 Under what circumstances may FDA modify or revoke an approved 
          variance?
112.181 What procedures apply if FDA determines that an approved 
          variance should be modified or revoked?
112.182 What are the permissible types of variances that may be granted?

                  Subpart Q_Compliance and Enforcement

112.192 What is the applicability and status of this part?
112.193 What are the provisions for coordination of education and 
          enforcement?

               Subpart R_Withdrawal of Qualified Exemption

112.201 Under what circumstances can FDA withdraw a qualified exemption 
          in accordance with the requirements of Sec. 112.5?
112.202 What procedure will FDA use to withdraw an exemption?
112.203 What information must FDA include in an order to withdraw a 
          qualified exemption?
112.204 What must I do if I receive an order to withdraw a qualified 
          exemption applicable to my farm?
112.205 Can I appeal or request a hearing on an order to withdraw a 
          qualified exemption applicable to my farm?
112.206 What is the procedure for submitting an appeal?
112.207 What is the procedure for requesting an informal hearing?
112.208 What requirements are applicable to an informal hearing?
112.209 Who is the presiding officer for an appeal and for an informal 
          hearing?
112.210 What is the timeframe for issuing a decision on an appeal?
112.211 When is an order to withdraw a qualified exemption applicable to 
          a farm revoked?
112.213 If my qualified exemption is withdrawn, under what circumstances 
          would FDA reinstate my qualified exemption?

    Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 
271.

    Source: 80 FR 74547, Nov. 27, 2015, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 112 appear at 81 FR 
49896, July 29, 2016.



                      Subpart A_General Provisions



Sec. 112.1  What food is covered by this part?

    (a) Unless it is excluded from this part under Sec. 112.2, food 
that is produce within the meaning of this part and that is a raw 
agricultural commodity (RAC) is covered by this part. This includes a 
produce RAC that is grown domestically and a produce RAC that will be 
imported or offered for import in any State or territory of the United 
States, the District of Columbia, or the Commonwealth of Puerto Rico.
    (b) For the purpose of this part and subject to the exemptions and 
qualified exemptions therein, covered produce includes all of the 
following:
    (1) Fruits and vegetables such as almonds, apples, apricots, 
apriums, Artichokes-globe-type, Asian pears, avocados, babacos, bananas, 
Belgian endive, blackberries, blueberries, boysenberries, brazil nuts, 
broad beans, broccoli, Brussels sprouts, burdock, cabbages, Chinese 
cabbages (Bok Choy, mustard, and Napa), cantaloupes, carambolas, 
carrots, cauliflower, celeriac, celery, chayote fruit, cherries (sweet), 
chestnuts, chicory (roots and tops), citrus (such as clementine,

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grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and 
uniq fruit), cowpea beans, cress-garden, cucumbers, curly endive, 
currants, dandelion leaves, fennel-Florence, garlic, genip, 
gooseberries, grapes, green beans, guavas, herbs (such as basil, chives, 
cilantro, oregano, and parsley), honeydew, huckleberries, Jerusalem 
artichokes, kale, kiwifruit, kohlrabi, kumquats, leek, lettuce, lychees, 
macadamia nuts, mangos, other melons (such as Canary, Crenshaw and 
Persian), mulberries, mushrooms, mustard greens, nectarines, onions, 
papayas, parsnips, passion fruit, peaches, pears, peas, peas-pigeon, 
peppers (such as bell and hot), pine nuts, pineapples, plantains, plums, 
plumcots, quince, radishes, raspberries, rhubarb, rutabagas, scallions, 
shallots, snow peas, soursop, spinach, sprouts (such as alfalfa and mung 
bean), strawberries, summer squash (such as patty pan, yellow and 
zucchini), sweetsop, Swiss chard, taro, tomatoes, turmeric, turnips 
(roots and tops), walnuts, watercress, watermelons, and yams; and
    (2) Mixes of intact fruits and vegetables (such as fruit baskets).



Sec. 112.2  What produce is not covered by this part?

    (a) The following produce is not covered by this part:
    (1) Produce that is rarely consumed raw, specifically the produce on 
the following exhaustive list: Asparagus; beans, black; beans, great 
Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, 
garden (roots and tops); beets, sugar; cashews; cherries, sour; 
chickpeas; cocoa beans; coffee beans; collards; corn, sweet; 
cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; 
hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; 
potatoes; pumpkins; squash, winter; sweet potatoes; and water chestnuts.
    (2) Produce that is produced by an individual for personal 
consumption or produced for consumption on the farm or another farm 
under the same management; and
    (3) Produce that is not a raw agricultural commodity.
    (b) Produce is eligible for exemption from the requirements of this 
part (except as noted in paragraphs (b)(1), (2), and (3) of this 
section) under the following conditions:
    (1) The produce receives commercial processing that adequately 
reduces the presence of microorganisms of public health significance. 
Examples of commercial processing that adequately reduces the presence 
of microorganisms of public health significance are processing in 
accordance with the requirements of part 113, 114, or 120 of this 
chapter, treating with a validated process to eliminate spore-forming 
microorganisms (such as processing to produce tomato paste or shelf-
stable tomatoes), and processing such as refining, distilling, or 
otherwise manufacturing/processing produce into products such as sugar, 
oil, spirits, wine, beer or similar products; and
    (2) You must disclose in documents accompanying the produce, in 
accordance with the practice of the trade, that the food is ``not 
processed to adequately reduce the presence of microorganisms of public 
health significance;'' and
    (3) You must either:
    (i) Annually obtain written assurance, subject to the requirements 
of paragraph (b)(6) of this section, from the customer that performs the 
commercial processing described in paragraph (b)(1) of this section that 
the customer has established and is following procedures (identified in 
the written assurance) that adequately reduce the presence of 
microorganisms of public health significance; or
    (ii) Annually obtain written assurance, subject to the requirements 
of paragraph (b)(6) of this section, from your customer that an entity 
in the distribution chain subsequent to the customer will perform 
commercial processing described in paragraph (b)(1) of this section and 
that the customer:
    (A) Will disclose in documents accompanying the food, in accordance 
with the practice of the trade, that the food is ``not processed to 
adequately reduce the presence of microorganisms of public health 
significance''; and
    (B) Will only sell to another entity that agrees, in writing, it 
will either:

[[Page 309]]

    (1) Follow procedures (identified in a written assurance) that 
adequately reduce the presence of microorganisms of public health 
significance; or
    (2) Obtain a similar written assurance from its customer that the 
produce will receive commercial processing described in paragraph (b)(1) 
of this section, and that there will be disclosure in documents 
accompanying the food, in accordance with the practice of the trade, 
that the food is ``not processed to adequately reduce the presence of 
microorganisms of public health significance''; and
    (4) You must establish and maintain documentation of your compliance 
with applicable requirements in paragraphs (b)(2) and (3) in accordance 
with the requirements of subpart O of this part, including:
    (i) Documents containing disclosures required under paragraph (b)(2) 
of this section; and
    (ii) Annual written assurances obtained from customers required 
under paragraph (b)(3) of this section; and
    (5) The requirements of this subpart and subpart Q of this part 
apply to such produce; and
    (6) An entity that provides a written assurance under Sec. 
112.2(b)(3)(i) or (ii) must act consistently with the assurance and 
document its actions taken to satisfy the written assurance.



Sec. 112.3  What definitions apply to this part?

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this part. The following definitions also apply:
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    Adequately reduce microorganisms of public health significance means 
reduce the presence of such microorganisms to an extent sufficient to 
prevent illness.
    Agricultural tea means a water extract of biological materials (such 
as stabilized compost, manure, non-fecal animal byproducts, peat moss, 
pre-consumer vegetative waste, table waste, or yard trimmings), 
excluding any form of human waste, produced to transfer microbial 
biomass, fine particulate organic matter, and soluble chemical 
components into an aqueous phase. Agricultural teas are held for longer 
than one hour before application. Agricultural teas are soil amendments 
for the purposes of this rule.
    Agricultural tea additive means a nutrient source (such as molasses, 
yeast extract, or algal powder) added to agricultural tea to increase 
microbial biomass.
    Agricultural water means water used in covered activities on covered 
produce where water is intended to, or is likely to, contact covered 
produce or food contact surfaces, including water used in growing 
activities (including irrigation water applied using direct water 
application methods, water used for preparing crop sprays, and water 
used for growing sprouts) and in harvesting, packing, and holding 
activities (including water used for washing or cooling harvested 
produce and water used for preventing dehydration of covered produce).
    Animal excreta means solid or liquid animal waste.
    Application interval means the time interval between application of 
an agricultural input (such as a biological soil amendment of animal 
origin) to a growing area and harvest of covered produce from the 
growing area where the agricultural input was applied.
    Biological soil amendment means any soil amendment containing 
biological materials such as stabilized compost, manure, non-fecal 
animal byproducts, peat moss, pre-consumer vegetative waste, sewage 
sludge biosolids, table waste, agricultural tea, or yard trimmings, 
alone or in combination.
    Biological soil amendment of animal origin means a biological soil 
amendment which consists, in whole or in part, of materials of animal 
origin, such as manure or non-fecal animal byproducts including animal 
mortalities, or table waste, alone or in combination. The term 
``biological soil amendment of animal origin'' does not include any form 
of human waste.
    Composting means a process to produce stabilized compost in which 
organic material is decomposed by the actions of microorganisms under 
thermophilic conditions for a designated period of time (for example, 3

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days) at a designated temperature (for example, 131 [deg]F (55 [deg]C)), 
followed by a curing stage under cooler conditions.
    Covered activity means growing, harvesting, packing, or holding 
covered produce on a farm. Covered activity includes manufacturing/
processing of covered produce on a farm, but only to the extent that 
such activities are performed on raw agricultural commodities and only 
to the extent that such activities are within the meaning of ``farm'' as 
defined in this chapter. Providing, acting consistently with, and 
documenting actions taken in compliance with written assurances as 
described in Sec. 112.2(b) are also covered activities. This part does 
not apply to activities of a facility that are subject to part 117 of 
this chapter.
    Covered produce means produce that is subject to the requirements of 
this part in accordance with Sec. Sec. 112.1 and 112.2. The term 
``covered produce'' refers to the harvestable or harvested part of the 
crop.
    Curing means the final stage of composting, which is conducted after 
much of the readily metabolized biological material has been decomposed, 
at cooler temperatures than those in the thermophilic phase of 
composting, to further reduce pathogens, promote further decomposition 
of cellulose and lignin, and stabilize composition. Curing may or may 
not involve insulation, depending on environmental conditions.
    Direct water application method means using agricultural water in a 
manner whereby the water is intended to, or is likely to, contact 
covered produce or food contact surfaces during use of the water.
    Farm means:
    (1) Primary production farm. A primary production farm is an 
operation under one management in one general (but not necessarily 
contiguous) physical location devoted to the growing of crops, the 
harvesting of crops, the raising of animals (including seafood), or any 
combination of these activities. The term ``farm'' includes operations 
that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food 
used in such activities is either consumed on that farm or another farm 
under the same management, or is processed food identified in paragraph 
(1)(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or 
another farm under the same management; or
    (B) Any manufacturing/processing of food that is not consumed on 
that farm or another farm under the same management consists only of:
    (1) Drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce 
raisins), and packaging and labeling such commodities, without 
additional manufacturing/processing (an example of additional 
manufacturing/processing is slicing);
    (2) Treatment to manipulate the ripening of raw agricultural 
commodities (such as by treating produce with ethylene gas), and 
packaging and labeling treated raw agricultural commodities, without 
additional manufacturing/processing; and
    (3) Packaging and labeling raw agricultural commodities, when these 
activities do not involve additional manufacturing/processing (an 
example of additional manufacturing/processing is irradiation); or
    (2) Secondary activities farm. A secondary activities farm is an 
operation, not located on a primary production farm, devoted to 
harvesting (such as hulling or shelling), packing, and/or holding of raw 
agricultural commodities, provided that the primary production farm(s) 
that grows, harvests, and/or raises the majority of the raw agricultural 
commodities harvested, packed, and/or held by the secondary activities 
farm owns, or jointly owns, a majority interest in the secondary 
activities farm. A secondary activities farm may also conduct those 
additional activities allowed on a primary production farm as described 
in paragraphs (1)(ii) and (iii) of this definition.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act and includes seeds and beans used to grow 
sprouts.

[[Page 311]]

    Food contact surfaces means those surfaces that contact human food 
and those surfaces from which drainage, or other transfer, onto the food 
or onto surfaces that contact the food ordinarily occurs during the 
normal course of operations. ``Food contact surfaces'' includes food 
contact surfaces of equipment and tools used during harvest, packing and 
holding.
    Ground water means the supply of fresh water found beneath the 
Earth's surface, usually in aquifers, which supply wells and springs. 
Ground water does not include any water that meets the definition of 
surface water.
    Growth media means material that acts as a substrate during the 
growth of covered produce (such as mushrooms and some sprouts) that 
contains, may contain, or consists of components that may include any 
animal waste (such as stabilized compost, manure, non-fecal animal 
byproducts or table waste).
    Harvesting applies to farms and farm mixed-type facilities and means 
activities that are traditionally performed on farms for the purpose of 
removing raw agricultural commodities from the place they were grown or 
raised and preparing them for use as food. Harvesting is limited to 
activities performed on raw agricultural commodities, or on processed 
foods created by drying/dehydrating a raw agricultural commodity without 
additional manufacturing/processing, on a farm. Harvesting does not 
include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the Federal Food, Drug, 
and Cosmetic Act. Examples of harvesting include cutting (or otherwise 
separating) the edible portion of the raw agricultural commodity from 
the crop plant and removing or trimming part of the raw agricultural 
commodity (e.g., foliage, husks, roots or stems). Examples of harvesting 
also include cooling, field coring, filtering, gathering, hulling, 
shelling, sifting, threshing, trimming of outer leaves of, and washing 
raw agricultural commodities grown on a farm.
    Hazard means any biological agent that has the potential to cause 
illness or injury in the absence of its control.
    Holding means storage of food and also includes activities performed 
incidental to storage of a food (e.g., activities performed for the safe 
or effective storage of that food, such as fumigating food during 
storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed 
as a practical necessity for the distribution of that food (such as 
blending of the same raw agricultural commodity and breaking down 
pallets), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities 
could include warehouses, cold storage facilities, storage silos, grain 
elevators, and liquid storage tanks.
    Known or reasonably foreseeable hazard means a biological hazard 
that is known to be, or has the potential to be, associated with the 
farm or the food.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating, 
extracting juice, formulating, freezing, grinding, homogenizing, 
labeling, milling, mixing, packaging (including modified atmosphere 
packaging), pasteurizing, peeling, rendering, treating to manipulate 
ripening, trimming, washing, or waxing. For farms and farm mixed-type 
facilities, manufacturing/processing does not include activities that 
are part of harvesting, packing, or holding.
    Manure means animal excreta, alone or in combination with litter 
(such as straw and feathers used for animal bedding) for use as a soil 
amendment.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and 
microscopic parasites and includes species having public health 
significance. The term ``undesirable microorganisms'' includes those 
microorganisms that are

[[Page 312]]

of public health significance, that subject food to decomposition, that 
indicate that food is contaminated with filth, or that otherwise may 
cause food to be adulterated.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but that also conducts activities outside the farm definition that 
require the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or 
measurements to assess whether a process, point or procedure is under 
control and, when required, to produce an accurate record of the 
observation or measurement.
    Non-fecal animal byproduct means solid waste (other than manure) 
that is animal in origin (such as meat, fat, dairy products, eggs, 
carcasses, blood meal, bone meal, fish meal, shellfish waste (such as 
crab, shrimp, and lobster waste), fish emulsions, and offal) and is 
generated by commercial, institutional, or agricultural operations.
    Packing means placing food into a container other than packaging the 
food and also includes re-packing and activities performed incidental to 
packing or re-packing a food (e.g., activities performed for the safe or 
effective packing or re-packing of that food (such as sorting, culling, 
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act.
    Pest means any objectionable animals or insects, including birds, 
rodents, flies, and larvae.
    Pre-consumer vegetative waste means solid waste that is purely 
vegetative in origin, not considered yard trash, and derived from 
commercial, institutional, or agricultural operations without coming in 
contact with animal products, byproducts or manure or with an end user 
(consumer). Pre-consumer vegetative waste includes material generated by 
farms, packing houses, canning operations, wholesale distribution 
centers and grocery stores; products that have been removed from their 
packaging (such as out-of-date juice, vegetables, condiments, and 
bread); and associated packaging that is vegetative in origin (such as 
paper or corn-starch based products). Pre-consumer vegetative waste does 
not include table waste, packaging that has come in contact with 
materials (such as meat) that are not vegetative in origin, or any waste 
generated by restaurants.
    Produce means any fruit or vegetable (including mixes of intact 
fruits and vegetables) and includes mushrooms, sprouts (irrespective of 
seed source), peanuts, tree nuts, and herbs. A fruit is the edible 
reproductive body of a seed plant or tree nut (such as apple, orange, 
and almond) such that fruit means the harvestable or harvested part of a 
plant developed from a flower. A vegetable is the edible part of an 
herbaceous plant (such as cabbage or potato) or fleshy fruiting body of 
a fungus (such as white button or shiitake) grown for an edible part 
such that vegetable means the harvestable or harvested part of any plant 
or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, 
bulbs, stems, leaves, or flower parts are used as food and includes 
mushrooms, sprouts, and herbs (such as basil or cilantro). Produce does 
not include food grains meaning the small, hard fruits or seeds of 
arable crops, or the crops bearing these fruits or seeds, that are 
primarily grown and processed for use as meal, flour, baked goods, 
cereals and oils rather than for direct consumption as small, hard 
fruits or seeds (including cereal grains, pseudo cereals, oilseeds and 
other plants used in the same fashion). Examples of food grains include 
barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, 
quinoa, buckwheat, and oilseeds (e.g., cotton seed, flax seed, rapeseed, 
soybean, and sunflower seed).
    Production batch of sprouts means all sprouts that are started at 
the same time in a single growing unit (e.g., a single drum or bin, or a 
single rack of

[[Page 313]]

trays that are connected to each other), whether or not the sprouts are 
grown from a single lot of seed (including, for example, when multiple 
types of seeds are grown in a single growing unit).
    Qualified end-user, with respect to a food, means the consumer of 
the food (where the term consumer does not include a business); or a 
restaurant or retail food establishment (as those terms are defined in 
Sec. 1.227) that is located:
    (1) In the same State or the same Indian reservation as the farm 
that produced the food; or
    (2) Not more than 275 miles from such farm.
    Raw agricultural commodity (RAC) means ``raw agricultural 
commodity'' as defined in section 201(r) of the Federal Food, Drug, and 
Cosmetic Act.
    Sanitize means to adequately treat cleaned surfaces by a process 
that is effective in destroying vegetative cells of microorganisms of 
public health significance, and in substantially reducing numbers of 
other undesirable microorganisms, but without adversely affecting the 
product or its safety for the consumer.
    Sewage sludge biosolids means the solid or semi-solid residue 
generated during the treatment of domestic sewage in a treatment works 
within the meaning of the definition of ``sewage sludge'' in 40 CFR 
503.9(w).
    Small business means a farm that is subject to any of the 
requirements of this part and, on a rolling basis, the average annual 
monetary value of produce (as defined in this section) the farm sold 
during the previous 3-year period is no more than $500,000; and the farm 
is not a very small business as defined in this section.
    Soil amendment means any chemical, biological, or physical material 
(such as elemental fertilizers, stabilized compost, manure, non-fecal 
animal byproducts, peat moss, perlite, pre-consumer vegetative waste, 
sewage sludge biosolids, table waste, agricultural tea and yard 
trimmings) intentionally added to the soil to improve the chemical or 
physical condition of soil in relation to plant growth or to improve the 
capacity of the soil to hold water. The term soil amendment also 
includes growth media that serve as the entire substrate during the 
growth of covered produce (such as mushrooms and some sprouts).
    Spent sprout irrigation water means water that has been used in the 
growing of sprouts.
    Stabilized compost means a stabilized (i.e., finished) biological 
soil amendment produced through a controlled composting process.
    Static composting means a process to produce stabilized compost in 
which air is introduced into biological material (in a pile (or row) 
that may or may not be covered with insulating material, or in an 
enclosed vessel) by a mechanism that does not include turning. Examples 
of structural features for introducing air include embedded perforated 
pipes and a constructed permanent base that includes aeration slots. 
Examples of mechanisms for introducing air include passive diffusion and 
mechanical means (such as blowers that suction air from the composting 
material or blow air into the composting material using positive 
pressure).
    Surface water means all water open to the atmosphere (rivers, lakes, 
reservoirs, streams, impoundments, seas, estuaries, etc.) and all 
springs, wells, or other collectors that are directly influenced by 
surface water.
    Table waste means any post-consumer food waste, irrespective of 
whether the source material is animal or vegetative in origin, derived 
from individuals, institutions, restaurants, retail operations, or other 
sources where the food has been served to a consumer.
    Turned composting means a process to produce stabilized compost in 
which air is introduced into biological material (in a pile, row, or 
enclosed vessel) by turning on a regular basis. Turning is the process 
of mechanically mixing biological material that is undergoing a 
composting process with the specific intention of moving the outer, 
cooler sections of the material being composted to the inner, hotter 
sections.
    Very small business means a farm that is subject to any of the 
requirements of this part and, on a rolling basis, the average annual 
monetary value of produce (as defined in this section) the farm sold 
during the previous 3-year period is no more than $250,000.

[[Page 314]]

    Visitor means any person (other than personnel) who enters your 
covered farm with your permission.
    Water distribution system means a system to carry water from its 
primary source to its point of use, including pipes, sprinklers, 
irrigation canals, pumps, valves, storage tanks, reservoirs, meters, and 
fittings.
    We means the U.S. Food and Drug Administration (FDA).
    Yard trimmings means purely vegetative matter resulting from 
landscaping maintenance or land clearing operations, including materials 
such as tree and shrub trimmings, grass clippings, palm fronds, trees, 
tree stumps, untreated lumber, untreated wooden pallets, and associated 
rocks and soils.
    You, for purposes of this part, means the owner, operator, or agent 
in charge of a covered farm that is subject to some or all of the 
requirements of this part.

[80 FR 74547, Nov. 27, 2015, as amended at 81 FR 26467, May 3, 2016]



Sec. 112.4  Which farms are subject to the requirements of this part?

    (a) Except as provided in paragraph (b) of this section, a farm or 
farm mixed-type facility with an average annual monetary value of 
produce (as ``produce'' is defined in Sec. 112.3) sold during the 
previous 3-year period of more than $25,000 (on a rolling basis), 
adjusted for inflation using 2011 as the baseline year for calculating 
the adjustment, is a ``covered farm'' subject to this part. Covered 
farms subject to this part must comply with all applicable requirements 
of this part when conducting a covered activity on covered produce.
    (b) A farm is not a covered farm if it satisfies the requirements in 
Sec. 112.5 and we have not withdrawn the farm's exemption in accordance 
with the requirements of subpart R of this part.

[80 FR 74547, Nov. 27, 2015, as amended at 84 FR 12490, Apr. 2, 2019]



Sec. 112.5  Which farms are eligible for a qualified exemption and
associated modified requirements based on average monetary value of
all food sold and direct farm marketing?
          

    (a) A farm is eligible for a qualified exemption and associated 
modified requirements in a calendar year if:
    (1) During the previous 3-year period preceding the applicable 
calendar year, the average annual monetary value of the food (as defined 
in Sec. 112.3) the farm sold directly to qualified end-users (as 
defined in Sec. 112.3) during such period exceeded the average annual 
monetary value of the food the farm sold to all other buyers during that 
period; and
    (2) The average annual monetary value of all food (as defined in 
Sec. 112.3) the farm sold during the 3-year period preceding the 
applicable calendar year was less than $500,000, adjusted for inflation.
    (b) For the purpose of determining whether the average annual 
monetary value of all food sold during the 3-year period preceding the 
applicable calendar year was less than $500,000, adjusted for inflation, 
the baseline year for calculating the adjustment for inflation is 2011.

[80 FR 74547, Nov. 27, 2015, as amended at 84 FR 12490, Apr. 2, 2019]



Sec. 112.6  What modified requirements apply to me if my farm is
eligible for a qualified exemption in accordance with Sec. 112.5?

    (a) If your farm is eligible for a qualified exemption in accordance 
with Sec. 112.5, you are subject to the requirements of:
    (1) This subpart (General Provisions);
    (2) Subpart O of this part (Records);
    (3) Subpart Q of this part (Compliance and Enforcement); and
    (4) Subpart R of this part (Withdrawal of Qualified Exemption).
    (b) In addition, you are subject to the following modified 
requirements:
    (1) When a food packaging label is required on food that would 
otherwise be covered produce under the Federal Food, Drug, and Cosmetic 
Act or its implementing regulations, you must include prominently and 
conspicuously on the food packaging label the name and the complete 
business address of the farm where the produce was grown.

[[Page 315]]

    (2) When a food packaging label is not required on food that would 
otherwise be covered produce under the Federal Food, Drug, and Cosmetic 
Act, you must prominently and conspicuously display, at the point of 
purchase, the name and complete business address of the farm where the 
produce was grown, on a label, poster, sign, placard, or documents 
delivered contemporaneously with the produce in the normal course of 
business, or, in the case of Internet sales, in an electronic notice.
    (3) The complete business address that you must include in 
accordance with the requirements of paragraph (b)(1) or (2) of this 
section must include the street address or post office box, city, state, 
and zip code for domestic farms, and comparable full address information 
for foreign farms.



Sec. 112.7  What records must I establish and keep if my farm is
eligible for a qualified exemption in accordance with Sec. 112.5?

    If your farm is eligible for a qualified exemption in accordance 
with Sec. 112.5:
    (a) You must establish and keep records required under this 
provision in accordance with the requirements of subpart O of this part, 
except that the requirement in Sec. 112.161(a)(4) for a signature or 
initial of the person performing the activity is not required for sales 
receipts kept in the normal course of business. Such receipts must be 
dated as required under Sec. 112.161(a)(4).
    (b) You must establish and keep adequate records necessary to 
demonstrate that your farm satisfies the criteria for a qualified 
exemption that are described in Sec. 112.5, including a written record 
reflecting that you have performed an annual review and verification of 
your farm's continued eligibility for the qualified exemption.



                     Subpart B_General Requirements



Sec. 112.11  What general requirements apply to persons who are
subject to this part?

    You must take appropriate measures to minimize the risk of serious 
adverse health consequences or death from the use of, or exposure to, 
covered produce, including those measures reasonably necessary to 
prevent the introduction of known or reasonably foreseeable hazards into 
covered produce, and to provide reasonable assurances that the produce 
is not adulterated under section 402 of the Federal Food, Drug, and 
Cosmetic Act on account of such hazards.



Sec. 112.12  Are there any alternatives to the requirements established
in this part?

    (a) You may establish alternatives to certain specific requirements 
of subpart E of this part, as specified in Sec. 112.49, provided that 
you satisfy the requirements of paragraphs (b) and (c) of this section.
    (b) You may establish and use an alternative to any of the 
requirements specified in paragraph (a) of this section, provided you 
have adequate scientific data or information to support a conclusion 
that the alternative would provide the same level of public health 
protection as the applicable requirement established in this part, and 
would not increase the likelihood that your covered produce will be 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic 
Act, in light of your covered produce, practices, and conditions.
    (c) Scientific data and information used to support an alternative 
to a requirement specified in paragraph (a) of this section may be 
developed by you, available in the scientific literature, or available 
to you through a third party. You must establish and maintain 
documentation of the scientific data and information on which you rely 
in accordance with the requirements of subpart O of this part. You are 
not required to notify or seek prior approval from FDA regarding your 
decision to establish or use an alternative under this section.



             Subpart C_Personnel Qualifications and Training



Sec. 112.21  What requirements apply regarding qualifications and
training for personnel who handle (contact) covered produce 
or food contact surfaces?

    All of the following requirements apply regarding 
    qualifications and

[[Page 316]]

training for personnel who handle (contact) covered produce or food 
contact surfaces:
    (a) All personnel (including temporary, part time, seasonal, and 
contracted personnel) who handle covered produce or food contact 
surfaces, or who are engaged in the supervision thereof, must receive 
adequate training, as appropriate to the person's duties, upon hiring, 
and periodically thereafter, at least once annually.
    (b) All personnel (including temporary, part time, seasonal, and 
contracted personnel) who handle covered produce or food contact 
surfaces, or who are engaged in the supervision thereof, must have a 
combination of education, training, and experience necessary to perform 
the person's assigned duties in a manner that ensures compliance with 
this part.
    (c) Training must be conducted in a manner that is easily understood 
by personnel being trained.
    (d) Training must be repeated as necessary and appropriate in light 
of observations or information indicating that personnel are not meeting 
standards established by FDA in subparts C through O of this part.



Sec. 112.22  What minimum requirements apply for training personnel
who conduct a covered activity?

    (a) At a minimum, all personnel who handle (contact) covered produce 
during covered activities or supervise the conduct of such activities 
must receive training that includes all of the following:
    (1) Principles of food hygiene and food safety;
    (2) The importance of health and personal hygiene for all personnel 
and visitors, including recognizing symptoms of a health condition that 
is reasonably likely to result in contamination of covered produce or 
food contact surfaces with microorganisms of public health significance; 
and
    (3) The standards established by FDA in subparts C through O of this 
part that are applicable to the employee's job responsibilities.
    (b) Persons who conduct harvest activities for covered produce must 
also receive training that includes all of the following:
    (1) Recognizing covered produce that must not be harvested, 
including covered produce that may be contaminated with known or 
reasonably foreseeable hazards;
    (2) Inspecting harvest containers and equipment to ensure that they 
are functioning properly, clean, and maintained so as not to become a 
source of contamination of covered produce with known or reasonably 
foreseeable hazards; and
    (3) Correcting problems with harvest containers or equipment, or 
reporting such problems to the supervisor (or other responsible party), 
as appropriate to the person's job responsibilities.
    (c) At least one supervisor or responsible party for your farm must 
have successfully completed food safety training at least equivalent to 
that received under standardized curriculum recognized as adequate by 
the Food and Drug Administration.



Sec. 112.23  What requirements apply regarding supervisors?

    You must assign or identify personnel to supervise (or otherwise be 
responsible for) your operations to ensure compliance with the 
requirements of this part.



Sec. 112.30  Under this subpart, what requirements apply regarding
records?

    (a) You must establish and keep records required under this subpart 
in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep records of training that document 
required training of personnel, including the date of training, topics 
covered, and the persons(s) trained.



                      Subpart D_Health and Hygiene



Sec. 112.31  What measures must I take to prevent ill or infected
persons from contaminating covered produce with microorganisms of
public health significance?

    (a) You must take measures to prevent contamination of covered 
produce and food contact surfaces with microorganisms of public health 
significance from any person with an applicable

[[Page 317]]

health condition (such as communicable illnesses that present a public 
health risk in the context of normal work duties, infection, open 
lesion, vomiting, or diarrhea).
    (b) The measures you must take to satisfy the requirements of 
paragraph (a) of this section must include all of the following 
measures:
    (1) Excluding any person from working in any operations that may 
result in contamination of covered produce or food contact surfaces with 
microorganisms of public health significance when the person (by medical 
examination, the person's acknowledgement, or observation) is shown to 
have, or appears to have, an applicable health condition, until the 
person's health condition no longer presents a risk to public health; 
and
    (2) Instructing personnel to notify their supervisor(s) (or a 
responsible party) if they have, or if there is a reasonable possibility 
that they have an applicable health condition.



Sec. 112.32  What hygienic practices must personnel use?

    (a) Personnel who work in an operation in which covered produce or 
food contact surfaces are at risk of contamination with known or 
reasonably foreseeable hazards must use hygienic practices while on duty 
to the extent necessary to protect against such contamination.
    (b) The hygienic practices that personnel use to satisfy the 
requirements of paragraph (a) of this section when handling (contacting) 
covered produce or food contact surfaces during a covered activity must 
include all of the following practices:
    (1) Maintaining adequate personal cleanliness to protect against 
contamination of covered produce and food contact surfaces;
    (2) Avoiding contact with animals other than working animals, and 
taking appropriate steps to minimize the likelihood of contamination of 
covered produce when in direct contact with working animals;
    (3) Washing hands thoroughly, including scrubbing with soap (or 
other effective surfactant) and running water that satisfies the 
requirements of Sec. 112.44(a) (as applicable) for water used to wash 
hands, and drying hands thoroughly using single-service towels, sanitary 
towel service, electric hand dryers, or other adequate hand drying 
devices:
    (i) Before starting work;
    (ii) Before putting on gloves;
    (iii) After using the toilet;
    (iv) Upon return to the work station after any break or other 
absence from the work station;
    (v) As soon as practical after touching animals (including livestock 
and working animals), or any waste of animal origin; and
    (vi) At any other time when the hands may have become contaminated 
in a manner that is reasonably likely to lead to contamination of 
covered produce with known or reasonably foreseeable hazards;
    (4) If you choose to use gloves in handling covered produce or food 
contact surfaces, maintaining gloves in an intact and sanitary condition 
and replacing such gloves when no longer able to do so;
    (5) Removing or covering hand jewelry that cannot be adequately 
cleaned and sanitized during periods in which covered produce is 
manipulated by hand; and
    (6) Not eating, chewing gum, or using tobacco products in an area 
used for a covered activity (however, drinking beverages is permitted in 
designated areas).



Sec. 112.33  What measures must I take to prevent visitors from 
contaminating covered produce and food contact surfaces with 
microorganisms of public health  significance?
         

    (a) You must make visitors aware of policies and procedures to 
protect covered produce and food contact surfaces from contamination by 
people and take all steps reasonably necessary to ensure that visitors 
comply with such policies and procedures.
    (b) You must make toilet and hand-washing facilities accessible to 
visitors.

[[Page 318]]



                      Subpart E_Agricultural Water



Sec. 112.41  What requirements apply to the quality of agricultural 
water?

    All agricultural water must be safe and of adequate sanitary quality 
for its intended use.



Sec. 112.42  What requirements apply to my agricultural water sources,
water distribution system, and pooling of water?

    (a) At the beginning of a growing season, as appropriate, but at 
least once annually, you must inspect all of your agricultural water 
systems, to the extent they are under your control (including water 
sources, water distribution systems, facilities, and equipment), to 
identify conditions that are reasonably likely to introduce known or 
reasonably foreseeable hazards into or onto covered produce or food 
contact surfaces in light of your covered produce, practices, and 
conditions, including consideration of the following:
    (1) The nature of each agricultural water source (for example, 
ground water or surface water);
    (2) The extent of your control over each agricultural water source;
    (3) The degree of protection of each agricultural water source;
    (4) Use of adjacent and nearby land; and
    (5) The likelihood of introduction of known or reasonably 
foreseeable hazards to agricultural water by another user of 
agricultural water before the water reaches your covered farm.
    (b) You must adequately maintain all agricultural water distribution 
systems to the extent they are under your control as necessary and 
appropriate to prevent the water distribution system from being a source 
of contamination to covered produce, food contact surfaces, areas used 
for a covered activity, or water sources, including by regularly 
inspecting and adequately storing all equipment used in the system.
    (c) You must adequately maintain all agricultural water sources to 
the extent they are under your control (such as wells). Such maintenance 
includes regularly inspecting each source to identify any conditions 
that are reasonably likely to introduce known or reasonably foreseeable 
hazards into or onto covered produce or food contact surfaces; 
correcting any significant deficiencies (e.g., repairs to well cap, well 
casing, sanitary seals, piping tanks and treatment equipment, and 
control of cross-connections); and keeping the source free of debris, 
trash, domesticated animals, and other possible sources of contamination 
of covered produce to the extent practicable and appropriate under the 
circumstances.
    (d) As necessary and appropriate, you must implement measures 
reasonably necessary to reduce the potential for contamination of 
covered produce with known or reasonably foreseeable hazards as a result 
of contact of covered produce with pooled water. For example, such 
measures may include using protective barriers or staking to keep 
covered produce from touching the ground or using an alternative 
irrigation method.



Sec. 112.43  What requirements apply to treating agricultural water?

    (a) When agricultural water is treated in accordance with Sec. 
112.45:
    (1) Any method you use to treat agricultural water (such as with 
physical treatment, including using a pesticide device as defined by the 
U.S. Environmental Protection Agency (EPA); EPA-registered antimicrobial 
pesticide product; or other suitable method) must be effective to make 
the water safe and of adequate sanitary quality for its intended use 
and/or meet the relevant microbial quality criteria in Sec. 112.44, as 
applicable.
    (2) You must deliver any treatment of agricultural water in a manner 
to ensure that the treated water is consistently safe and of adequate 
sanitary quality for its intended use and/or consistently meets the 
relevant microbial quality criteria in Sec. 112.44, as applicable.
    (b) You must monitor any treatment of agricultural water at a 
frequency adequate to ensure that the treated water is consistently safe 
and of adequate sanitary quality for its intended use and/or 
consistently meets the relevant microbial quality criteria in Sec. 
112.44, as applicable.

[[Page 319]]



Sec. 112.44  What specific microbial quality criteria apply to 
agricultural water used for certain intended uses?

    (a) When you use agricultural water for any one or more of these 
following purposes, you must ensure there is no detectable generic 
Escherichia coli (E. coli) in 100 milliliters (mL) of agricultural 
water, and you must not use untreated surface water for any of these 
purposes:
    (1) Used as sprout irrigation water;
    (2) Applied in any manner that directly contacts covered produce 
during or after harvest activities (for example, water that is applied 
to covered produce for washing or cooling activities, and water that is 
applied to harvested crops to prevent dehydration before cooling), 
including when used to make ice that directly contacts covered produce 
during or after harvest activities;
    (3) Used to contact food contact surfaces, or to make ice that will 
contact food contact surfaces; and
    (4) Used for washing hands during and after harvest activities.
    (b) When you use agricultural water during growing activities for 
covered produce (other than sprouts) using a direct water application 
method, the following criteria apply (unless you establish and use 
alternative criteria in accordance with Sec. 112.49):
    (1) A geometric mean (GM) of your agricultural water samples of 126 
or less colony forming units (CFU) of generic E. coli per 100 mL of 
water (GM is a measure of the central tendency of your water quality 
distribution); and
    (2) A statistical threshold value (STV) of your agricultural water 
samples of 410 or less CFU of generic E. coli per 100 mL of water (STV 
is a measure of variability of your water quality distribution, derived 
as a model-based calculation approximating the 90th percentile using the 
lognormal distribution).



Sec. 112.45  What measures must I take if my agricultural water
does not meet the requirements of Sec. 112.41 or Sec. 112.44?

    (a) If you have determined or have reason to believe that your 
agricultural water is not safe or of adequate sanitary quality for its 
intended use as required under Sec. 112.41 and/or if your agricultural 
water does not meet the microbial quality criterion for the specified 
purposes as required under Sec. 112.44(a), you must immediately 
discontinue that use(s), and before you may use the water source and/or 
distribution system again for the intended use(s), you must either:
    (1) Re-inspect the entire affected agricultural water system to the 
extent it is under your control, identify any conditions that are 
reasonably likely to introduce known or reasonably foreseeable hazards 
into or onto covered produce or food contact surfaces, make necessary 
changes, and take adequate measures to determine if your changes were 
effective and, as applicable, adequately ensure that your agricultural 
water meets the microbial quality criterion in Sec. 112.44(a); or
    (2) Treat the water in accordance with the requirements of Sec. 
112.43.
    (b) If you have determined that your agricultural water does not 
meet the microbial quality criteria (or any alternative microbial 
quality criteria, if applicable) required under Sec. 112.44(b), as soon 
as practicable and no later than the following year, you must 
discontinue that use, unless you either:
    (1) Apply a time interval(s) (in days) and/or a (calculated) log 
reduction by:
    (i) Applying a time interval between last irrigation and harvest 
using either:
    (A) A microbial die-off rate of 0.5 log per day to achieve a 
(calculated) log reduction of your geometric mean (GM) and statistical 
threshold value (STV) to meet the microbial quality criteria in Sec. 
112.44(b) (or any alternative microbial criteria, if applicable), but no 
greater than a maximum time interval of 4 consecutive days; or
    (B) An alternative microbial die-off rate and any accompanying 
maximum time interval, in accordance with Sec. 112.49; and/or
    (ii) Applying a time interval between harvest and end of storage 
using an appropriate microbial die-off rate between harvest and end of 
storage, and/or applying a (calculated) log reduction using appropriate 
microbial removal rates during activities such as commercial washing, to 
meet the microbial

[[Page 320]]

quality criteria in Sec. 112.44(b) (or any alternative microbial 
criteria, if applicable), and any accompanying maximum time interval or 
log reduction, provided you have adequate supporting scientific data and 
information;
    (2) Re-inspect the entire affected agricultural water system to the 
extent it is under your control, identify any conditions that are 
reasonably likely to introduce known or reasonably foreseeable hazards 
into or onto covered produce or food contact surfaces, make necessary 
changes, and take adequate measures to determine if your changes were 
effective and adequately ensure that your agricultural water meets the 
microbial quality criteria in Sec. 112.44(b) (or any alternative 
microbial criteria, if applicable); or
    (3) Treat the water in accordance with the requirements of Sec. 
112.43.



Sec. 112.46  How often must I test agricultural water that is
subject to the requirements of Sec. 112.44?

    (a) There is no requirement to test any agricultural water that is 
subject to the requirements of Sec. 112.44 when:
    (1) You receive water from a Public Water System, as defined under 
the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that 
furnishes water that meets the microbial requirements under those 
regulations or under the regulations of a State (as defined in 40 CFR 
141.2) approved to administer the SDWA public water supply program, and 
you have Public Water System results or certificates of compliance that 
demonstrate that the water meets that requirement;
    (2) You receive water from a public water supply that furnishes 
water that meets the microbial quality requirement described in Sec. 
112.44(a), and you have public water system results or certificates of 
compliance that demonstrate that the water meets that requirement; or
    (3) You treat water in accordance with the requirements of Sec. 
112.43.
    (b) Except as provided in paragraph (a) of this section, you must 
take the following steps for each source of water used for purposes that 
are subject to the requirements of Sec. 112.44(b):
    (1) Conduct an initial survey to develop a microbial water quality 
profile of the agricultural water source.
    (i) The initial survey must be conducted:
    (A) For an untreated surface water source, by taking a minimum total 
of 20 samples of agricultural water (or an alternative testing frequency 
that you establish and use, in accordance with Sec. 112.49) over a 
minimum period of 2 years, but not greater than 4 years.
    (B) For an untreated ground water source, by taking a minimum total 
of four samples of agricultural water during the growing season or over 
a period of 1 year.
    (ii) The samples of agricultural water must be representative of 
your use of the water and must be collected as close in time as 
practicable to, but prior to, harvest. The microbial water quality 
profile initially consists of the geometric mean (GM) and the 
statistical threshold value (STV) of generic Escherichia coli (E. coli) 
(colony forming units (CFU) per 100 milliliter (mL)) calculated using 
this data set. You must determine the appropriate way(s) in which the 
water may be used based on your microbial water quality profile in 
accordance with Sec. 112.45(b).
    (iii) You must update the microbial water quality profile annually 
as required under paragraph (b)(2) of this section, and otherwise 
required under paragraph (b)(3) of this section.
    (2) Conduct an annual survey to update the microbial water quality 
profile of your agricultural water.
    (i) After the initial survey described in paragraph (b)(1)(i) of 
this section, you must test the water annually to update your existing 
microbial water quality profile to confirm that the way(s) in which the 
water is used continues to be appropriate. You must analyze:
    (A) For an untreated surface water source, a minimum number of five 
samples per year (or an alternative testing frequency that you establish 
and use, in accordance with Sec. 112.49).
    (B) For an untreated ground water source, a minimum of one sample 
per year.
    (ii) The samples of agricultural water must be representative of 
your use of the water and must be collected as

[[Page 321]]

close in time as practicable to, but prior to, harvest.
    (iii) To update the microbial water quality profile, you must 
calculate revised GM and STV values using your current annual survey 
data, combined with your most recent initial or annual survey data from 
within the previous 4 years, to make up a rolling data set of:
    (A) At least 20 samples for untreated surface water sources; and
    (B) At least 4 samples for untreated ground water sources.
    (iv) You must modify your water use, as appropriate, based on the 
revised GM and STV values in your updated microbial water quality 
profile in accordance with Sec. 112.45(b).
    (3) If you have determined or have reason to believe that your 
microbial water quality profile no longer represents the quality of your 
water (for example, if there are significant changes in adjacent land 
use that are reasonably likely to adversely affect the quality of your 
water source), you must develop a new microbial water quality profile 
reflective of the time period at which you believe your microbial water 
quality profile changed.
    (i) To develop a new microbial water quality profile, you must 
calculate new GM and STV values using your current annual survey data 
(if taken after the time of the change), combined with new data, to make 
up a data set of:
    (A) At least 20 samples for untreated surface water sources; and
    (B) At least 4 samples for untreated ground water sources.
    (ii) You must modify your water use based on the new GM and STV 
values in your new microbial water quality profile in accordance with 
Sec. 112.45(b).
    (c) If you use untreated ground water for the purposes that are 
subject to the requirements of Sec. 112.44(a), you must initially test 
the microbial quality of each source of the untreated ground water at 
least four times during the growing season or over a period of 1 year, 
using a minimum total of four samples collected to be representative of 
the intended use(s). Based on these results, you must determine whether 
the water can be used for that purpose, in accordance with Sec. 
112.45(a). If your four initial sample results meet the microbial 
quality criteria of Sec. 112.44(a), you may test once annually 
thereafter, using a minimum of one sample collected to be representative 
of the intended use(s). You must resume testing at least four times per 
growing season or year if any annual test fails to meet the microbial 
quality criteria in Sec. 112.44(a).



Sec. 112.47  Who must perform the tests required under Sec. 112.46
and what methods must be used?

    (a) You may meet the requirements related to agricultural water 
testing required under Sec. 112.46 using:
    (1) Test results from your agricultural water source(s) performed by 
you, or by a person or entity acting on your behalf; or
    (2) Data collected by a third party or parties, provided the water 
source(s) sampled by the third party or parties adequately represent 
your agricultural water source(s) and all other applicable requirements 
of this part are met.
    (b) Agricultural water samples must be aseptically collected and 
tested using a method as set forth in Sec. 112.151.



Sec. 112.48  What measures must I take for water that I use during
harvest, packing, and holding activities for covered produce?

    (a) You must manage the water as necessary, including by 
establishing and following water-change schedules for re-circulated 
water, to maintain its safety and adequate sanitary quality and minimize 
the potential for contamination of covered produce and food contact 
surfaces with known or reasonably foreseeable hazards (for example, 
hazards that may be introduced into the water from soil adhering to the 
covered produce).
    (b) You must visually monitor the quality of water that you use 
during harvest, packing, and holding activities for covered produce (for 
example, water used for washing covered produce in dump tanks, flumes, 
or wash tanks, and water used for cooling covered produce in 
hydrocoolers) for buildup of organic material (such as soil and plant 
debris).
    (c) You must maintain and monitor the temperature of water at a 
temperature that is appropriate for the commodity and operation 
(considering the time and depth of submersion) and is

[[Page 322]]

adequate to minimize the potential for infiltration of microorganisms of 
public health significance into covered produce.



Sec. 112.49  What alternatives may I establish and use in lieu of
the requirements of this subpart?

    Provided you satisfy the requirements of Sec. 112.12, you may 
establish and use one or more of the following alternatives:
    (a) An alternative microbial quality criterion (or criteria) using 
an appropriate indicator of fecal contamination, in lieu of the 
microbial quality criteria in Sec. 112.44(b);
    (b) An alternative microbial die-off rate and an accompanying 
maximum time interval, in lieu of the microbial die-off rate and maximum 
time interval in Sec. 112.45(b)(1)(i);
    (c) An alternative minimum number of samples used in the initial 
survey for an untreated surface water source, in lieu of the minimum 
number of samples required under Sec. 112.46(b)(1)(i)(A); and
    (d) An alternative minimum number of samples used in the annual 
survey for an untreated surface water source, in lieu of the minimum 
number of samples required under Sec. 112.46(b)(2)(i)(A).



Sec. 112.50  Under this subpart, what requirements apply regarding
records?

    (a) You must establish and keep records required under this subpart 
in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep the following records:
    (1) The findings of the inspection of your agricultural water system 
in accordance with the requirements of Sec. 112.42(a);
    (2) Documentation of the results of all analytical tests conducted 
on agricultural water for purposes of compliance with this subpart;
    (3) Scientific data or information you rely on to support the 
adequacy of a method used to satisfy the requirements of Sec. 
112.43(a)(1) and (2);
    (4) Documentation of the results of water treatment monitoring under 
Sec. 112.43(b);
    (5) Scientific data or information you rely on to support the 
microbial die-off or removal rate(s) that you used to determine the time 
interval (in days) between harvest and end of storage, including other 
activities such as commercial washing, as applicable, used to achieve 
the calculated log reduction of generic Escherichia coli (E. coli), in 
accordance with Sec. 112.45(b)(1)(ii);
    (6) Documentation of actions you take in accordance with Sec. 
112.45. With respect to any time interval or (calculated) log reduction 
applied in accordance with Sec. 112.45(b)(1)(i) and/or (ii), such 
documentation must include the specific time interval or log reduction 
applied, how the time interval or log reduction was determined, and the 
dates of corresponding activities such as the dates of last irrigation 
and harvest, the dates of harvest and end of storage, and/or the dates 
of activities such as commercial washing);
    (7) Annual documentation of the results or certificates of 
compliance from a public water system required under Sec. 112.46(a)(1) 
or (2), if applicable;
    (8) Scientific data or information you rely on to support any 
alternative that you establish and use in accordance with Sec. 112.49; 
and
    (9) Any analytical methods you use in lieu of the method that is 
incorporated by reference in Sec. 112.151(a).



  Subpart F_Biological Soil Amendments of Animal Origin and Human Waste



Sec. 112.51  What requirements apply for determining the status of
a biological soil amendment of animal origin?

    (a) A biological soil amendment of animal origin is treated if it 
has been processed to completion to adequately reduce microorganisms of 
public health significance in accordance with the requirements of Sec. 
112.54, or, in the case of an agricultural tea, the biological materials 
of animal origin used to make the tea have been so processed, the water 
used to make the tea is not untreated surface water, and the water used 
to make the tea has no detectable generic Escherichia coli (E. coli) in 
100 milliliters (mL) of water.
    (b) A biological soil amendment of animal origin is untreated if it:

[[Page 323]]

    (1) Has not been processed to completion in accordance with the 
requirements of Sec. 112.54, or in the case of an agricultural tea, the 
biological materials of animal origin used to make the tea have not been 
so processed, or the water used to make the tea is untreated surface 
water, or the water used to make the tea has detectable generic E. coli 
in 100 mL of water;
    (2) Has become contaminated after treatment;
    (3) Has been recombined with an untreated biological soil amendment 
of animal origin;
    (4) Is or contains a component that is untreated waste that you know 
or have reason to believe is contaminated with a hazard or has been 
associated with foodborne illness; or
    (5) Is an agricultural tea made with biological materials of animal 
origin that contains an agricultural tea additive.



Sec. 112.52  How must I handle, convey, and store biological soil
amendments of animal origin?

    (a) You must handle, convey and store any biological soil amendment 
of animal origin in a manner and location such that it does not become a 
potential source of contamination to covered produce, food contact 
surfaces, areas used for a covered activity, water sources, water 
distribution systems, and other soil amendments. Agricultural teas that 
are biological soil amendments of animal origin may be used in water 
distribution systems provided that all other requirements of this rule 
are met.
    (b) You must handle, convey and store any treated biological soil 
amendment of animal origin in a manner and location that minimizes the 
risk of it becoming contaminated by an untreated or in-process 
biological soil amendment of animal origin.
    (c) You must handle, convey, and store any biological soil amendment 
of animal origin that you know or have reason to believe may have become 
contaminated as if it was untreated.



Sec. 112.53  What prohibitions apply regarding use of human waste?

    You may not use human waste for growing covered produce, except 
sewage sludge biosolids used in accordance with the requirements of 40 
CFR part 503, subpart D, or equivalent regulatory requirements.



Sec. 112.54  What treatment processes are acceptable for a biological
soil amendment of animal origin that I apply in the growing of
covered produce?

    Each of the following treatment processes are acceptable for a 
biological soil amendment of animal origin that you apply in the growing 
of covered produce, provided that the resulting biological soil 
amendments are applied in accordance with the applicable requirements of 
Sec. 112.56:
    (a) A scientifically valid controlled physical process (e.g., 
thermal), chemical process (e.g., high alkaline pH), biological process 
(e.g., composting), or a combination of scientifically valid controlled 
physical, chemical and/or biological processes that has been validated 
to satisfy the microbial standard in Sec. 112.55(a) for Listeria 
monocytogenes (L. monocytogenes), Salmonella species, and E. coli 
O157:H7; or
    (b) A scientifically valid controlled physical, chemical, or 
biological process, or a combination of scientifically valid controlled 
physical, chemical, and/or biological processes, that has been validated 
to satisfy the microbial standard in Sec. 112.55(b) for Salmonella 
species and fecal coliforms. Examples of scientifically valid controlled 
biological (e.g., composting) processes that meet the microbial standard 
in Sec. 112.55(b) include:
    (1) Static composting that maintains aerobic (i.e., oxygenated) 
conditions at a minimum of 131 [deg]F (55 [deg]C) for 3 consecutive days 
and is followed by adequate curing; and
    (2) Turned composting that maintains aerobic conditions at a minimum 
of 131 [deg]F (55 [deg]C) for 15 days (which do not have to be 
consecutive), with a minimum of five turnings, and is followed by 
adequate curing.



Sec. 112.55  What microbial standards apply to the treatment processes
in Sec. 112.54?

    The following microbial standards apply to the treatment processes 
in Sec. 112.54 as set forth in that section.

[[Page 324]]

    (a) For L. monocytogenes, Salmonella species, and E. coli O157:H7, 
the relevant standards in the table in this paragraph (a); or

------------------------------------------------------------------------
        For the microorganism--            The microbial standard is--
------------------------------------------------------------------------
(1) L. monocytogenes...................  Not detected using a method
                                          that can detect one colony
                                          forming unit (CFU) per 5 gram
                                          (or milliliter, if liquid is
                                          being sampled) analytical
                                          portion.
(2) Salmonella species.................  Not detected using a method
                                          that can detect three most
                                          probable numbers (MPN) per 4
                                          grams (or milliliter, if
                                          liquid is being sampled) of
                                          total solids.
(3) E. coli O157:H7....................  Not detected using a method
                                          that can detect 0.3 MPN per 1
                                          gram (or milliliter, if liquid
                                          is being sampled) analytical
                                          portion.
------------------------------------------------------------------------

    (b) Salmonella species are not detected using a method that can 
detect three MPN Salmonella species per 4 grams (or milliliter, if 
liquid is being sampled) of total solids; and less than 1,000 MPN fecal 
coliforms per gram (or milliliter, if liquid is being sampled) of total 
solids.

[80 FR 74547, Nov. 27, 2015, as amended at 81 FR 26468, May 3, 2016]



Sec. 112.56  What application requirements and minimum application 
intervals apply to biological soil amendments of animal origin?

    (a) You must apply the biological soil amendments of animal origin 
specified in the first column of the table in this paragraph (a) in 
accordance with the application requirements specified in the second 
column of the table in this paragraph (a) and the minimum application 
intervals specified in the third column of the table in this paragraph 
(a).

------------------------------------------------------------------------
                                  Then the biological     And then the
    If the biological soil         soil amendment of         minimum
amendment of animal origin is--  animal origin must be     application
                                       applied--          interval is--
------------------------------------------------------------------------
(1)(i) Untreated..............  In a manner that does   [Reserved].
                                 not contact covered
                                 produce during
                                 application and
                                 minimizes the
                                 potential for contact
                                 with covered produce
                                 after application.
(ii) Untreated................  In a manner that does   0 days.
                                 not contact covered
                                 produce during or
                                 after application.
(2) Treated by a                In a manner that        0 days.
 scientifically valid            minimizes the
 controlled physical,            potential for contact
 chemical, or biological         with covered produce
 process, or combination of      during and after
 scientifically valid            application.
 controlled physical,
 chemical, and/or biological
 processes, in accordance with
 the requirements of Sec.
 112.54(b) to meet the
 microbial standard in Sec.
 112.55(b).
(3) Treated by a                In any manner (i.e.,    0 days.
 scientifically valid            no restrictions).
 controlled physical,
 chemical, or biological
 process, or combination of
 scientifically valid
 controlled physical,
 chemical, or biological
 processes, in accordance with
 the requirements of Sec.
 112.54(a) to meet the
 microbial standard in Sec.
 112.55(a).
------------------------------------------------------------------------

    (b) [Reserved]



Sec. 112.60  Under this subpart, what requirements apply regarding 
records?

    (a) You must establish and keep records required under this subpart 
in accordance with the requirements of subpart O of this part.
    (b) For any biological soil amendment of animal origin you use, you 
must establish and keep the following records:
    (1) For a treated biological soil amendment of animal origin you 
receive from a third party, documentation (such as a Certificate of 
Conformance) at least annually that:

[[Page 325]]

    (i) The process used to treat the biological soil amendment of 
animal origin is a scientifically valid process that has been carried 
out with appropriate process monitoring; and
    (ii) The biological soil amendment of animal origin has been 
handled, conveyed and stored in a manner and location to minimize the 
risk of contamination by an untreated or in process biological soil 
amendment of animal origin; and
    (2) For a treated biological soil amendment of animal origin you 
produce for your own covered farm(s), documentation that process 
controls (for example, time, temperature, and turnings) were achieved.

Subpart G-H [Reserved]



                 Subpart I_Domesticated and Wild Animals



Sec. 112.81  How do the requirements of this subpart apply to areas 
where covered activities take place?

    (a) The requirements of this subpart apply when a covered activity 
takes place in an outdoor area or a partially-enclosed building and 
when, under the circumstances, there is a reasonable probability that 
animals will contaminate covered produce.
    (b) The requirements of this subpart do not apply:
    (1) When a covered activity takes place in a fully-enclosed 
building; or
    (2) To fish used in aquaculture operations.



Sec. 112.83  What requirements apply regarding grazing animals, 
working animals, and animal intrusion?

    (a) You must take the steps set forth in paragraph (b) of this 
section if under the circumstances there is a reasonable probability 
that grazing animals, working animals, or animal intrusion will 
contaminate covered produce.
    (b) You must:
    (1) Assess the relevant areas used for a covered activity for 
evidence of potential contamination of covered produce as needed during 
the growing season (based on your covered produce; your practices and 
conditions; and your observations and experience); and
    (2) If significant evidence of potential contamination is found 
(such as observation of animals, animal excreta or crop destruction), 
you must evaluate whether the covered produce can be harvested in 
accordance with the requirements of Sec. 112.112 and take measures 
reasonably necessary during growing to assist you later during harvest 
when you must identify, and not harvest, covered produce that is 
reasonably likely to be contaminated with a known or reasonably 
foreseeable hazard.



Sec. 112.84  Does this regulation require covered farms to take actions 
that would constitute a ``taking'' of threatened or endangered species; 
to take 
          measures to exclude animals from outdoor growing areas; or to 
          destroy animal habitat or otherwise clear farm borders around 
          outdoor growing areas or drainages?

    No. Nothing in this regulation authorizes the ``taking'' of 
threatened or endangered species as that term is defined by the 
Endangered Species Act (16 U.S.C. 1531-1544) (i.e., to harass, harm, 
pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to 
attempt to engage in any such conduct), in violation of the Endangered 
Species Act. This regulation does not require covered farms to take 
measures to exclude animals from outdoor growing areas, or to destroy 
animal habitat or otherwise clear farm borders around outdoor growing 
areas or drainages.

Subpart J [Reserved]



     Subpart K_Growing, Harvesting, Packing, and Holding Activities



Sec. 112.111  What measures must I take if I grow, harvest, pack or hold
both covered and excluded produce?

    If you grow, harvest, pack or hold produce that is not covered in 
this part (i.e., excluded produce in accordance with Sec. 112.2) and 
also conduct such activities on covered produce, and the excluded 
produce is not grown, harvested, packed or held in accordance with this 
part, you must take measures during these covered activities, as 
applicable, to:

[[Page 326]]

    (a) Keep covered produce separate from excluded produce (except when 
covered produce and excluded produce are placed in the same container 
for distribution); and
    (b) Adequately clean and sanitize, as necessary, any food contact 
surfaces that contact excluded produce before using such food contact 
surfaces for covered activities on covered produce.



Sec. 112.112  What measures must I take immediately prior to and during
harvest activities?

    You must take all measures reasonably necessary to identify, and not 
harvest, covered produce that is reasonably likely to be contaminated 
with a known or reasonably foreseeable hazard, including steps to 
identify and not harvest covered produce that is visibly contaminated 
with animal excreta. At a minimum, identifying and not harvesting 
covered produce that is reasonably likely to be contaminated with animal 
excreta or that is visibly contaminated with animal excreta requires a 
visual assessment of the growing area and all covered produce to be 
harvested, regardless of the harvest method used.



Sec. 112.113  How must I handle harvested covered produce during
covered activities?

    You must handle harvested covered produce during covered activities 
in a manner that protects against contamination with known or reasonably 
foreseeable hazards--for example, by avoiding, to the degree 
practicable, contact of cut surfaces of harvested produce with soil.



Sec. 112.114  What requirements apply to dropped covered produce?

    You must not distribute dropped covered produce. Dropped covered 
produce is covered produce that drops to the ground before harvest. 
Dropped covered produce does not include root crops that grow 
underground (such as carrots), crops that grow on the ground (such as 
cantaloupe), or produce that is intentionally dropped to the ground as 
part of harvesting (such as almonds).



Sec. 112.115  What measures must I take when packaging covered
produce?

    You must package covered produce in a manner that prevents the 
formation of Clostridium botulinum toxin if such toxin is a known or 
reasonably foreseeable hazard (such as for mushrooms).



Sec. 112.116  What measures must I take when using food-packing
(including food packaging) material?

    (a) You must use food-packing material that is adequate for its 
intended use, which includes being:
    (1) Cleanable or designed for single use; and
    (2) Unlikely to support growth or transfer of bacteria.
    (b) If you reuse food-packing material, you must take adequate steps 
to ensure that food contact surfaces are clean, such as by cleaning 
food-packing containers or using a clean liner.



          Subpart L_Equipment, Tools, Buildings, and Sanitation



Sec. 112.121  What equipment and tools are subject to the requirements
of this subpart?

    Equipment and tools subject to the requirements of this subpart are 
those that are intended to, or likely to, contact covered produce; and 
those instruments or controls used to measure, regulate, or record 
conditions to control or prevent the growth of microorganisms of public 
health significance. Examples include knives, implements, mechanical 
harvesters, waxing machinery, cooling equipment (including 
hydrocoolers), grading belts, sizing equipment, palletizing equipment, 
and equipment used to store or convey harvested covered produce (such as 
containers, bins, food-packing material, dump tanks, flumes, and 
vehicles or other equipment used for transport that are intended to, or 
likely to, contact covered produce).



Sec. 112.122  What buildings are subject to the requirements of this
subpart?

    Buildings subject to the requirements of this subpart include:
    (a) Any fully- or partially-enclosed building used for covered 
activities, including minimal structures that have a roof but do not 
have any walls; and

[[Page 327]]

    (b) Storage sheds, buildings, or other structures used to store food 
contact surfaces (such as harvest containers and food-packing 
materials).



Sec. 112.123  What general requirements apply regarding equipment
and tools subject to this subpart?

    All of the following requirements apply regarding equipment and 
tools subject to this subpart:
    (a) You must use equipment and tools that are of adequate design, 
construction, and workmanship to enable them to be adequately cleaned 
and properly maintained; and
    (b) Equipment and tools must be:
    (1) Installed and maintained as to facilitate cleaning of the 
equipment and of all adjacent spaces; and
    (2) Stored and maintained to protect covered produce from being 
contaminated with known or reasonably foreseeable hazards and to prevent 
the equipment and tools from attracting and harboring pests.
    (c) Seams on food contact surfaces of equipment and tools that you 
use must be either smoothly bonded, or maintained to minimize 
accumulation of dirt, filth, food particles, and organic material and 
thus minimize the opportunity for harborage or growth of microorganisms.
    (d)(1) You must inspect, maintain, and clean and, when necessary and 
appropriate, sanitize all food contact surfaces of equipment and tools 
used in covered activities as frequently as reasonably necessary to 
protect against contamination of covered produce.
    (2) You must maintain and clean all non-food-contact surfaces of 
equipment and tools subject to this subpart used during harvesting, 
packing, and holding as frequently as reasonably necessary to protect 
against contamination of covered produce.
    (e) If you use equipment such as pallets, forklifts, tractors, and 
vehicles such that they are intended to, or likely to, contact covered 
produce, you must do so in a manner that minimizes the potential for 
contamination of covered produce or food contact surfaces with known or 
reasonably foreseeable hazards.



Sec. 112.124  What requirements apply to instruments and controls 
used to measure, regulate, or record?

    Instruments or controls you use to measure, regulate, or record 
temperatures, hydrogen-ion concentration (pH), sanitizer efficacy or 
other conditions, in order to control or prevent the growth of 
microorganisms of public health significance, must be:
    (a) Accurate and precise as necessary and appropriate in keeping 
with their purpose;
    (b) Adequately maintained; and
    (c) Adequate in number for their designated uses.



Sec. 112.125  What requirements apply to equipment that is subject to 
this subpart used in the transport of covered produce?

    Equipment that is subject to this subpart that you use to transport 
covered produce must be:
    (a) Adequately clean before use in transporting covered produce; and
    (b) Adequate for use in transporting covered produce.



Sec. 112.126  What requirements apply to my buildings?

    (a) All of the following requirements apply regarding buildings:
    (1) Buildings must be suitable in size, construction, and design to 
facilitate maintenance and sanitary operations for covered activities to 
reduce the potential for contamination of covered produce or food 
contact surfaces with known or reasonably foreseeable hazards. Buildings 
must:
    (i) Provide sufficient space for placement of equipment and storage 
of materials;
    (ii) Permit proper precautions to be taken to reduce the potential 
for contamination of covered produce, food contact surfaces, or packing 
materials with known or reasonably foreseeable hazards. The potential 
for contamination must be reduced by effective design including the 
separation of operations in which contamination is likely to occur, by 
one or more of the following means: Location, time, partition, enclosed 
systems, or other effective means; and

[[Page 328]]

    (2) You must provide adequate drainage in all areas where normal 
operations release or discharge water or other liquid waste on the 
ground or floor of the building.
    (b) You must implement measures to prevent contamination of your 
covered produce and food contact surfaces in your buildings, as 
appropriate, considering the potential for such contamination through:
    (1) Floors, walls, ceilings, fixtures, ducts, or pipes; and
    (2) Drip or condensate.



Sec. 112.127  What requirements apply regarding domesticated animals
in and around a fully-enclosed building?

    (a) You must take reasonable precautions to prevent contamination of 
covered produce, food contact surfaces, and food-packing materials in 
fully-enclosed buildings with known or reasonably foreseeable hazards 
from domesticated animals by:
    (1) Excluding domesticated animals from fully-enclosed buildings 
where covered produce, food contact surfaces, or food-packing material 
is exposed; or
    (2) Separating domesticated animals in a fully enclosed building 
from an area where a covered activity is conducted on covered produce by 
location, time, or partition.
    (b) Guard or guide dogs may be allowed in some areas of a fully 
enclosed building if the presence of the dogs is unlikely to result in 
contamination of produce, food contact surfaces, or food-packing 
materials.



Sec. 112.128  What requirements apply regarding pest control in 
buildings?

    (a) You must take those measures reasonably necessary to protect 
covered produce, food contact surfaces, and food-packing materials from 
contamination by pests in buildings, including routine monitoring for 
pests as necessary and appropriate.
    (b) For fully-enclosed buildings, you must take measures to exclude 
pests from your buildings.
    (c) For partially-enclosed buildings, you must take measures to 
prevent pests from becoming established in your buildings (such as by 
use of screens or by monitoring for the presence of pests and removing 
them when present).



Sec. 112.129  What requirements apply to toilet facilities?

    All of the following requirements apply to toilet facilities:
    (a) You must provide personnel with adequate, readily accessible 
toilet facilities, including toilet facilities readily accessible to 
growing areas during harvesting activities.
    (b) Your toilet facilities must be designed, located, and maintained 
to:
    (1) Prevent contamination of covered produce, food contact surfaces, 
areas used for a covered activity, water sources, and water distribution 
systems with human waste;
    (2) Be directly accessible for servicing, be serviced and cleaned at 
a frequency sufficient to ensure suitability of use, and be kept 
supplied with toilet paper; and
    (3) Provide for the sanitary disposal of waste and toilet paper.
    (c) During growing activities that take place in a fully-enclosed 
building, and during covered harvesting, packing, or holding activities, 
you must provide a hand-washing station in sufficiently close proximity 
to toilet facilities to make it practical for persons who use the toilet 
facility to wash their hands.



Sec. 112.130  What requirements apply for hand-washing facilities?

    All of the following requirements apply to hand-washing facilities:
    (a) You must provide personnel with adequate, readily accessible 
hand-washing facilities during growing activities that take place in a 
fully-enclosed building, and during covered harvest, packing, or holding 
activities.
    (b) Your hand-washing facilities must be furnished with:
    (1) Soap (or other effective surfactant);
    (2) Running water that satisfies the requirements of Sec. 112.44(a) 
for water used to wash hands; and
    (3) Adequate drying devices (such as single service towels, sanitary 
towel service, or electric hand dryers).
    (c) You must provide for appropriate disposal of waste (for example, 
waste water and used single-service towels)

[[Page 329]]

associated with a hand-washing facility and take appropriate measures to 
prevent waste water from a hand-washing facility from contaminating 
covered produce, food contact surfaces, areas used for a covered 
activity, agricultural water sources, and agricultural water 
distribution systems with known or reasonably foreseeable hazards.
    (d) You may not use antiseptic hand rubs as a substitute for soap 
(or other effective surfactant) and water.



Sec. 112.131  What must I do to control and dispose of sewage?

    All of the following requirements apply for the control and disposal 
of sewage:
    (a) You must dispose of sewage into an adequate sewage or septic 
system or through other adequate means.
    (b) You must maintain sewage and septic systems in a manner that 
prevents contamination of covered produce, food contact surfaces, areas 
used for a covered activity, agricultural water sources, and 
agricultural water distribution systems with known or reasonably 
foreseeable hazards.
    (c) You must manage and dispose of leakages or spills of human waste 
in a manner that prevents contamination of covered produce, and prevents 
or minimizes contamination of food contact surfaces, areas used for a 
covered activity, agricultural water sources, or agricultural water 
distribution systems.
    (d) After a significant event (such as flooding or an earthquake) 
that could negatively impact a sewage or septic system, you must take 
appropriate steps to ensure that sewage and septic systems continue to 
operate in a manner that does not contaminate covered produce, food 
contact surfaces, areas used for a covered activity, agricultural water 
sources, or agricultural water distribution systems.



Sec. 112.132  What must I do to control and dispose of trash, litter, 
and waste in areas used for covered activities?

    All of the following requirements apply to the control and disposal 
of trash, litter, and waste in areas used for covered activities:
    (a) You must convey, store, and dispose of trash, litter and waste 
to:
    (1) Minimize the potential for trash, litter, or waste to attract or 
harbor pests; and
    (2) Protect against contamination of covered produce, food contact 
surfaces, areas used for a covered activity, agricultural water sources, 
and agricultural water distribution systems with known or reasonably 
foreseeable hazards.
    (b) You must adequately operate systems for waste treatment and 
disposal so that they do not constitute a potential source of 
contamination in areas used for a covered activity.



Sec. 112.133  What requirements apply to plumbing?

    The plumbing must be of an adequate size and design and be 
adequately installed and maintained to:
    (a) Distribute water under pressure as needed, in sufficient 
quantities, in all areas where used for covered activities, for sanitary 
operations, or for hand-washing and toilet facilities;
    (b) Properly convey sewage and liquid disposable waste;
    (c) Avoid being a source of contamination to covered produce, food 
contact surfaces, areas used for a covered activity, or agricultural 
water sources; and
    (d) Not allow backflow from, or cross connection between, piping 
systems that discharge waste water or sewage and piping systems that 
carry water used for a covered activity, for sanitary operations, or for 
use in hand-washing facilities.



Sec. 112.134  What must I do to control animal excreta and litter 
from domesticated animals that are under my control?

    (a) If you have domesticated animals, to prevent contamination of 
covered produce, food contact surfaces, areas used for a covered 
activity, agricultural water sources, or agricultural water distribution 
systems with animal waste, you must:
    (1) Adequately control their excreta and litter; and
    (2) Maintain a system for control of animal excreta and litter.
    (b) [Reserved]

[[Page 330]]



Sec. 112.140  Under this subpart, what requirements apply regarding
records?

    (a) You must establish and keep records required under this subpart 
in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep documentation of the date and method 
of cleaning and sanitizing of equipment subject to this subpart used in:
    (1) Growing operations for sprouts; and
    (2) Covered harvesting, packing, or holding activities.



                            Subpart M_Sprouts



Sec. 112.141  What commodities are subject to this subpart?

    The requirements of this subpart apply to growing, harvesting, 
packing, and holding of all sprouts, except soil- or substrate-grown 
sprouts harvested without their roots.



Sec. 112.142  What requirements apply to seeds or beans used to grow
sprouts?

    In addition to the requirements of this part, all of the following 
requirements apply to seeds or beans used to grow sprouts.
    (a) You must take measures reasonably necessary to prevent the 
introduction of known or reasonably foreseeable hazards into or onto 
seeds or beans that you will use for sprouting.
    (b) Except as provided in paragraph (c) of this section, if you know 
or have reason to believe that a lot of seeds or beans may be 
contaminated with a pathogen (either because it has been associated with 
foodborne illness; or based on microbial test results, including a 
positive finding of a pathogen in tests required under Sec. 
112.144(b)), you must:
    (1) Discontinue use of all seeds or beans from that lot for sprout 
production and ensure that sprouts grown from that lot of seeds or beans 
do not enter commerce; and
    (2) Report the information (association with illness and/or findings 
of microbial testing) to the seed grower, distributor, supplier, or 
other entity from whom you received the seeds or beans.
    (c) If your reason to believe that a lot of seeds or beans may be 
contaminated was based only on microbial test results:
    (1) You are not required to take the steps set forth in paragraph 
(b)(1) of this section if you treat your lot of seeds or beans with a 
process that is reasonably certain to achieve destruction or elimination 
in the seeds or beans of the most resistant microorganisms of public 
health significance that are likely to occur in the seeds or beans; or
    (2) You are not required to take the steps set forth in paragraphs 
(b)(1) and (2) of this section if you later reasonably determine, 
through appropriate followup actions, that the lot of seeds or beans is 
not the source of contamination (e.g., the lot of seeds or beans is not 
the source of a pathogen found in spent sprout irrigation water or 
sprouts).
    (d) You must visually examine seeds and beans, and packaging used to 
ship seeds or beans, for signs of potential contamination with known or 
reasonably foreseeable hazards.
    (e) You must either:
    (1) Treat seeds or beans that will be used to grow sprouts using a 
scientifically valid method to reduce microorganisms of public health 
significance; or
    (2) Rely on prior treatment of seeds or beans conducted by a grower, 
distributor, or supplier of the seeds or beans (whether to fulfill this 
requirement completely or for the purpose of considering such prior 
treatment when applying appropriate additional treatment of the seeds or 
beans at the covered farm immediately before sprouting), provided that 
you obtain documentation (such as a Certificate of Conformance) from the 
grower, distributor, or supplier that:
    (i) The prior treatment was conducted using a scientifically valid 
method to reduce microorganisms of public health significance; and
    (ii) The treated seeds or beans were handled and packaged following 
the treatment in a manner that minimizes the potential for 
contamination.

[[Page 331]]



Sec. 112.143  What measures must I take for growing, harvesting, packing,
and holding sprouts?

    You must take all of the following measures for growing, harvesting, 
packing, and holding sprouts:
    (a) You must grow, harvest, pack, and hold sprouts in a fully-
enclosed building.
    (b) Any food contact surfaces you use to grow, harvest, pack, or 
hold sprouts must be cleaned and sanitized before contact with sprouts 
or seeds or beans used to grow sprouts.
    (c) You must conduct testing during growing, harvesting, packing, 
and holding sprouts, as specified in Sec. 112.144.
    (d) You must establish and implement a written environmental 
monitoring plan as specified in Sec. 112.145.
    (e) You must take certain actions if you detect Listeria species or 
L. monocytogenes in the growing, harvesting, packing, or holding 
environment, as specified in Sec. 112.146.
    (f) You must establish and implement a written sampling plan to test 
spent sprout irrigation water or sprouts for pathogens as specified in 
Sec. 112.147.
    (g) You must take certain actions if the samples of spent sprout 
irrigation water or sprouts test positive for a pathogen as specified in 
Sec. 112.148.



Sec. 112.144  What testing must I do during growing, harvesting, packing,
and holding sprouts?

    All of the following testing must be done during growing, 
harvesting, packing, and holding sprouts:
    (a) You must test the growing, harvesting, packing, and holding 
environment for Listeria species or L. monocytogenes in accordance with 
the requirements of Sec. 112.145.
    (b) You must either:
    (1) Test spent sprout irrigation water from each production batch of 
sprouts for E. coli O157:H7, Salmonella species, and any pathogens 
meeting the criteria in paragraph (c) of this section, in accordance 
with the requirements of Sec. 112.147; or
    (2) If testing spent sprout irrigation water is not practicable (for 
example, soil-grown sprouts harvested with roots or for hydroponically 
grown sprouts that use very little water), test each production batch of 
sprouts at the in-process stage (i.e., while sprouts are still growing) 
for E. coli O157:H7, Salmonella species, and any pathogens meeting the 
criteria in paragraph (c) of this section, in accordance with the 
requirements of Sec. 112.147.
    (c) In addition to E. coli O157:H7 and Salmonella species, you must 
conduct tests as provided in paragraph (b) of this section for 
additional pathogens when the following conditions are met:
    (1) Testing for the pathogen is reasonably necessary to minimize the 
risk of serious adverse health consequences or death from use of, or 
exposure to, sprouts; and
    (2) A scientifically valid test method for the pathogen is available 
to detect the pathogen in spent sprout irrigation water (or sprouts).



Sec. 112.145  What requirements apply to testing the environment for 
Listeria species or L. monocytogenes?

    All of the following testing requirements apply for the growing, 
harvesting, packing, and holding environment for Listeria species or L. 
monocytogenes.
    (a) You must establish and implement a written environmental 
monitoring plan that is designed to identify L. monocytogenes if it is 
present in the growing, harvesting, packing, or holding environment.
    (b) Your written environmental monitoring plan must be directed to 
sampling and testing for either Listeria species or L. monocytogenes.
    (c) Your written environmental monitoring plan must include a 
sampling plan that specifies:
    (1) What you will test collected samples for (i.e., Listeria species 
or L. monocytogenes);
    (2) How often you will collect environmental samples, which must be 
no less than monthly, and at what point during production you will 
collect the samples; and
    (3) Sample collection sites; the number and location of sampling 
sites must be sufficient to determine whether measures are effective and 
must include appropriate food contact surfaces and non-food-contact 
surfaces of equipment, and other surfaces within the growing, 
harvesting, packing, and holding environment.

[[Page 332]]

    (d) You must aseptically collect environmental samples and test them 
for Listeria species or L. monocytogenes using a method as set forth in 
Sec. 112.152.
    (e) Your written environmental monitoring plan must include a 
corrective action plan that, at a minimum, requires you to take the 
actions in Sec. 112.146, and details when and how you will accomplish 
those actions, if the growing, harvesting, packing, or holding 
environment tests positive for Listeria species or L. monocytogenes.



Sec. 112.146  What actions must I take if the growing, harvesting, 
packing, or holding environment tests positive for Listeria species 
or L. monocytogenes?

    You must, at a minimum, take the following actions if you detect 
Listeria species or L. monocytogenes in the growing, harvesting, 
packing, or holding environment:
    (a) Conduct additional testing of surfaces and areas surrounding the 
area where Listeria species or L. monocytogenes was detected to evaluate 
the extent of the problem, including the potential for Listeria species 
or L. monocytogenes to have become established in a niche;
    (b) Clean and sanitize the affected surfaces and surrounding areas;
    (c) Conduct additional sampling and testing to determine whether the 
Listeria species or L. monocytogenes has been eliminated;
    (d) Conduct finished product testing when appropriate;
    (e) Perform any other actions necessary to prevent recurrence of the 
contamination; and
    (f) Take appropriate action to prevent any food that is adulterated 
under section 402 of the Federal Food, Drug, and Cosmetic Act from 
entering into commerce.



Sec. 112.147  What must I do to collect and test samples of spent
sprout irrigation water or sprouts for pathogens?

    All of the following requirements apply for collecting and testing 
samples of spent sprout irrigation water or sprouts for pathogens as 
required in Sec. 112.144(b):
    (a) You must establish and implement a written sampling plan that 
identifies the number and location of samples (of spent sprout 
irrigation water or sprouts) to be collected for each production batch 
of sprouts to ensure that the collected samples are representative of 
the production batch when testing for contamination.
    (b) In accordance with the written sampling plan required under 
paragraph (a) of this section, you must aseptically collect samples of 
spent sprout irrigation water or sprouts, and test the collected samples 
for pathogens using a method as set forth in Sec. 112.153. You must not 
allow the production batch of sprouts to enter into commerce unless the 
results of the testing of spent sprout irrigation water or sprouts are 
negative for E. coli O157:H7, Salmonella species, and, if applicable, a 
pathogen meeting the criteria in Sec. 112.144(c).
    (c) Your written sampling plan must include a corrective action plan 
that at a minimum, requires you to take the actions in Sec. 112.148, 
and details when and how you will accomplish those actions, if the 
samples of spent sprout irrigation water or sprouts test positive for E. 
coli O157:H7, Salmonella species, or a pathogen meeting the criteria in 
Sec. 112.144(c).



Sec. 112.148  What actions must I take if the samples of spent sprout
irrigation water or sprouts test positive for a pathogen?

    You must, at a minimum, take the following actions if the samples of 
spent sprout irrigation water or sprouts test positive for E. coli 
O157:H7, Salmonella species, or a pathogen meeting the criteria in Sec. 
112.144(c):
    (a) Take appropriate action to prevent any food that is adulterated 
under section 402 of the Federal Food, Drug, and Cosmetic Act from 
entering into commerce;
    (b) Take the steps required in Sec. 112.142(b) with respect to the 
lot of seeds or beans used to grow the affected production batch of 
sprouts (except as allowed under Sec. 112.142(c));
    (c) Clean and sanitize the affected surfaces and surrounding areas; 
and
    (d) Perform any other actions necessary to prevent reoccurrence of 
the contamination.

[[Page 333]]



Sec. 112.150  Under this subpart, what requirements apply regarding records?

    (a) You must establish and keep records required under this subpart 
in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep the following records:
    (1) Documentation of your treatment of seeds or beans to reduce 
microorganisms of public health significance in the seeds or beans, at 
your farm; or alternatively, documentation (such as a Certificate of 
Conformance) from your seed supplier that seeds or beans are treated to 
reduce microorganisms of public health significance and are 
appropriately handled and packaged following the treatment, in 
accordance with the requirements of Sec. 112.142(e);
    (2) Your written environmental monitoring plan in accordance with 
the requirements of Sec. 112.145;
    (3) Your written sampling plan for each production batch of sprouts 
in accordance with the requirements of Sec. 112.147(a) and (c);
    (4) Documentation of the results of all analytical tests conducted 
for purposes of compliance with this subpart;
    (5) Any analytical methods you use in lieu of the methods that are 
incorporated by reference in Sec. Sec. 112.152 and 112.153; and
    (6) Documentation of actions you take in accordance with Sec. Sec. 
112.142(b) and (c), 112.146, and 112.148.



                      Subpart N_Analytical Methods



Sec. 112.151  What methods must I use to test the quality of water
to satisfy the requirements of Sec. 112.46?

    You must test the quality of water using:
    (a) The method of analysis published by the U.S. Environmental 
Protection Agency (EPA), ``Method 1603: Escherichia coli (E. coli) in 
Water by Membrane Filtration Using Modified membrane-Thermotolerant 
Escherichia coli Agar (Modified mTEC), EPA-821-R-09-007),'' December, 
2009. The Director of the Federal Register approves this incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You 
may obtain a copy from EPA, Office of Water (4303T), 1200 Pennsylvania 
Avenue NW., Washington, DC 20460. You may inspect a copy at FDA's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, 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; or
    (b)(1) A scientifically valid method that is at least equivalent to 
the method of analysis in Sec. 112.151(a) in accuracy, precision, and 
sensitivity; or
    (2) For any other indicator of fecal contamination you may test for 
pursuant to Sec. 112.49(a), a scientifically valid method.



Sec. 112.152  What methods must I use to test the growing, harvesting,
packing, and holding environment for Listeria species or L. 
monocytogenes to satisfy the requirements of Sec. 112.144(a)?
          

    You must test the growing, harvesting, packing, and holding 
environment for Listeria species or L. monocytogenes using:
    (a) The method of analysis described in ``Testing Methodology for 
Listeria species or L. monocytogenes in Environmental Samples,'' Version 
1, October 2015, U.S. Food and Drug Administration. The Director of the 
Federal Register approves this incorporation by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 5. You may obtain a copy from, and/
or inspect a copy at, the Division of Produce Safety, Center for Food 
Safety and Applied Nutrition (CFSAN), U.S. Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1600; FDA's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039; http://www.fda.gov/fsma; 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; or
    (b) A scientifically valid method that is at least equivalent to the 
method of

[[Page 334]]

analysis in Sec. 112.152(a) in accuracy, precision, and sensitivity.



Sec. 112.153  What methods must I use to test spent sprout irrigation 
water (or sprouts) from each production batch of sprouts for pathogens
to satisfy the requirements of Sec. 112.144(b) and (c)?
          

    You must test spent sprout irrigation water (or sprouts) from each 
production batch for pathogens using:
    (a) For E. coli O157:H7, Salmonella species:
    (1) The method of analysis described in ``Testing Methodologies for 
E. coli O157:H7 and Salmonella species in Spent Sprout Irrigation Water 
(or Sprouts),'' Version 1, October 2015, U.S. Food and Drug 
Administration. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 5. You may obtain a copy from, and/or inspect a copy at, the 
Division of Produce Safety, Center for Food Safety and Applied Nutrition 
(CFSAN), Food and Drug Administration, 5001 Campus Dr., College Park, MD 
20740, 240-402-1600; FDA's Main Library, 10903 New Hampshire Ave., Bldg. 
2, Third Floor, Silver Spring, MD 20993, 301-796-2039; http://
www.fda.gov/fsma; 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; or
    (2) A scientifically valid method that is at least equivalent to the 
method of analysis in Sec. 112.153(a)(1) in accuracy, precision, and 
sensitivity; and
    (b) For any other pathogen(s) meeting the criteria in Sec. 
112.144(c), a scientifically valid method.



                            Subpart O_Records



Sec. 112.161  What general requirements apply to records required
under this part?

    (a) Except as otherwise specified, all records required under this 
part must:
    (1) Include, as applicable:
    (i) The name and location of your farm;
    (ii) Actual values and observations obtained during monitoring;
    (iii) An adequate description (such as the commodity name, or the 
specific variety or brand name of a commodity, and, when available, any 
lot number or other identifier) of covered produce applicable to the 
record;
    (iv) The location of a growing area (for example, a specific field) 
or other area (for example, a specific packing shed) applicable to the 
record; and
    (v) The date and time of the activity documented;
    (2) Be created at the time an activity is performed or observed;
    (3) Be accurate, legible, and indelible; and
    (4) Be dated, and signed or initialed by the person who performed 
the activity documented.
    (b) Records required under Sec. Sec. 112.7(b), 112.30(b), 
112.50(b)(2), (4), and (6), 112.60(b)(2), 112.140(b)(1) and (2), and 
112.150(b)(1), (4), and (6), must be reviewed, dated, and signed, within 
a reasonable time after the records are made, by a supervisor or 
responsible party.

[80 FR 74547, Nov. 27, 2015, as amended at 84 FR 12491, Apr. 2, 2019]



Sec. 112.162  Where must I store records?

    (a) Offsite storage of records is permitted if such records can be 
retrieved and provided onsite within 24 hours of request for official 
review.
    (b) Electronic records are considered to be onsite at your farm if 
they are accessible from an onsite location at your farm.



Sec. 112.163  May I use existing records to satisfy the requirements 
of this part?

    (a) Existing records (e.g., records that are kept to comply with 
other Federal, State, or local regulations, or for any other reason) do 
not need to be duplicated if they contain all of the required 
information and satisfy the requirements of this part. Existing records 
may be supplemented as necessary to include all of the required 
information and satisfy the requirements of this part.
    (b) The information required by this part does not need to be kept 
in one set of records. If existing records contain some of the required 
information, any new information required by this part

[[Page 335]]

may be kept either separately or combined with the existing records.



Sec. 112.164  How long must I keep records?

    (a)(1) You must keep records required by this part for at least 2 
years past the date the record was created.
    (2) Records that a farm relies on during the 3-year period preceding 
the applicable calendar year to satisfy the criteria for a qualified 
exemption, in accordance with Sec. Sec. 112.5 and 112.7, must be 
retained as long as necessary to support the farm's status during the 
applicable calendar year.
    (b) Records that relate to the general adequacy of the equipment or 
processes or records that relate to analyses, sampling, or action plans 
being used by a farm, including the results of scientific studies, 
tests, and evaluations, must be retained at the farm for at least 2 
years after the use of such equipment or processes, or records related 
to analyses, sampling, or action plans, is discontinued.



Sec. 112.165  What formats are acceptable for the records I keep?

    You must keep records as:
    (a) Original records;
    (b) True copies (such as photocopies, pictures, scanned copies, 
microfilm, microfiche, or other accurate reproductions of the original 
records); or
    (c) Electronic records. Records that are established or maintained 
to satisfy the requirements of this part and that meet the definition of 
electronic records in Sec. 11.3(b)(6) of this chapter are exempt from 
the requirements of part 11 of this chapter. Records that satisfy the 
requirements of this part, but that also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.



Sec. 112.166  What requirements apply for making records available
and accessible to FDA?

    (a) You must have all records required under this part readily 
available and accessible during the retention period for inspection and 
copying by FDA upon oral or written request, except that you have 24 
hours to obtain records you keep offsite and make them available and 
accessible to FDA for inspection and copying.
    (b) If you use electronic techniques to keep records, or to keep 
true copies of records, or if you use reduction techniques such as 
microfilm to keep true copies of records, you must provide the records 
to FDA in a format in which they are accessible and legible.
    (c) If your farm is closed for a prolonged period, the records may 
be transferred to some other reasonably accessible location but must be 
returned to your farm within 24 hours for official review upon request.



Sec. 112.167  Can records that I provide to FDA be disclosed to 
persons outside of FDA?

    Records obtained by FDA in accordance with this part are subject to 
the disclosure requirements under part 20 of this chapter.



                           Subpart P_Variances



Sec. 112.171  Who may request a variance from the requirements of
this part?

    A State, Federally-recognized tribe (or ``tribe''), or a foreign 
country from which food is imported into the United States may request a 
variance from one or more requirements of this part, where the State, 
tribe, or foreign country determines that:
    (a) The variance is necessary in light of local growing conditions; 
and
    (b) The procedures, processes, and practices to be followed under 
the variance are reasonably likely to ensure that the produce is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic 
Act and to provide the same level of public health protection as the 
requirements of this part.



Sec. 112.172  How may a State, tribe, or foreign country request
a variance from one or more requirements of this part?

    To request a variance from one or more requirements of this part, 
the competent authority (i.e., the regulatory authority for food safety) 
for a State, tribe, or a foreign country must submit a petition under 
Sec. 10.30 of this chapter.

[[Page 336]]



Sec. 112.173  What must be included in the Statement of Grounds
in a petition requesting a variance?

    In addition to the requirements set forth in Sec. 10.30 of this 
chapter, the Statement of Grounds in a petition requesting a variance 
must:
    (a) Provide a statement that the applicable State, tribe, or foreign 
country has determined that the variance is necessary in light of local 
growing conditions and that the procedures, processes, and practices to 
be followed under the variance are reasonably likely to ensure that the 
produce is not adulterated under section 402 of the Federal Food, Drug 
and Cosmetic Act and to provide the same level of public health 
protection as the requirements of this part;
    (b) Describe with particularity the variance requested, including 
the persons to whom the variance would apply and the provision(s) of 
this part to which the variance would apply;
    (c) Present information demonstrating that the procedures, 
processes, and practices to be followed under the variance are 
reasonably likely to ensure that the produce is not adulterated under 
section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) 
and to provide the same level of public health protection as the 
requirements of this part.



Sec. 112.174  What information submitted in a petition requesting
a variance or submitted in comments on such a petition are publicly
available?

    We will presume that information submitted in a petition requesting 
a variance and comments submitted on such a petition, including a 
request that a variance be applied to its similarly situated persons, 
does not contain information exempt from public disclosure under part 20 
of this chapter and will be made public as part of the docket associated 
with this request.



Sec. 112.175  Who responds to a petition requesting a variance?

    The Director or Deputy Directors of the Center for Food Safety and 
Applied Nutrition (CFSAN), or the Director, Office of Compliance, CFSAN, 
responds to a request for a variance.



Sec. 112.176  What process applies to a petition requesting a variance?

    (a) In general, the procedures set forth in Sec. 10.30 of this 
chapter govern our response to a petition requesting a variance.
    (b) Under Sec. 10.30(h)(3) of this chapter, we will publish a 
notice in the Federal Register, requesting information and views on a 
filed petition, including information and views from persons who could 
be affected by the variance if the petition were to be granted (e.g., 
because their farm is covered by the petition or as a person similarly 
situated to persons covered by the petition).
    (c) Under Sec. 10.30(e)(3) of this chapter, we will respond to the 
petitioner in writing and will also make public a notice on FDA's Web 
site announcing our decision to either grant or deny the petition.
    (1) If we grant the petition, either in whole or in part, we will 
specify the persons to whom the variance applies and the provision(s) of 
this part to which the variance applies.
    (2) If we deny the petition (including partial denials), our written 
response to the petitioner and our public notice announcing our decision 
to deny the petition will explain the reason(s) for the denial.
    (d) We will make readily accessible to the public, and periodically 
update, a list of filed petitions requesting variances, including the 
status of each petition (for example, pending, granted, or denied).



Sec. 112.177  Can an approved variance apply to any person other than 
those identified in the petition requesting that variance?

    (a) A State, tribe, or a foreign country that believes that a 
variance requested by a petition submitted by another State, tribe, or 
foreign country should also apply to similarly situated persons in its 
jurisdiction may request that the variance be applied to its similarly 
situated persons by submitting comments in accordance with Sec. 10.30 
of this chapter. These comments must include the information required in 
Sec. 112.173. If FDA determines that these comments should instead be 
treated as a separate request for a variance, FDA will notify the State, 
tribe,

[[Page 337]]

or foreign country that submitted these comments that a separate request 
must be submitted in accordance with Sec. Sec. 112.172 and 112.173.
    (b) If we grant a petition requesting a variance, in whole or in 
part, we may specify that the variance also applies to persons in a 
specific location who are similarly situated to those identified in the 
petition.
    (c) If we specify that the variance also applies to persons in a 
specific location who are similarly situated to those identified in the 
petition, we will inform the applicable State, tribe, or foreign country 
where the similarly situated persons are located of our decision in 
writing and will publish a notice on our Web site announcing our 
decision to apply the variance to similarly situated persons in that 
particular location.



Sec. 112.178  Under what circumstances may FDA deny a petition 
requesting a variance?

    We may deny a variance request if it does not provide the 
information required under Sec. 112.173 (including the requirements of 
Sec. 10.30 of this chapter), or if we determine that the variance is 
not reasonably likely to ensure that the produce is not adulterated 
under section 402 of the Federal Food, Drug and Cosmetic Act and to 
provide the same level of public health protection as the requirements 
of this part.



Sec. 112.179  When does a variance approved by FDA become effective?

    A variance approved by FDA becomes effective on the date of our 
written decision on the petition.



Sec. 112.180  Under what circumstances may FDA modify or revoke 
an approved variance?

    We may modify or revoke a variance if we determine that such 
variance is not reasonably likely to ensure that the produce is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic 
Act and to provide the same level of public health protection as the 
requirements of this part.



Sec. 112.181  What procedures apply if FDA determines that an approved variance should be modified or revoked?

    (a) We will provide the following notifications:
    (1) We will notify a State, tribe, or a foreign country directly, in 
writing at the address identified in its petition, if we determine that 
a variance granted in response to its petition should be modified or 
revoked. Our direct, written notification will provide the State, tribe, 
or foreign country with an opportunity to request an informal hearing 
under part 16 of this chapter.
    (2) We will publish a notice of our determination that a variance 
should be modified or revoked in the Federal Register. This notice will 
establish a public docket so that interested parties may submit written 
comments on our determination.
    (3) When applicable, we will:
    (i) Notify in writing any States, tribes, or foreign countries where 
a variance applies to similarly situated persons of our determination 
that the variance should be modified or revoked;
    (ii) Provide those States, tribes, or foreign countries with an 
opportunity to request an informal hearing under part 16 of this 
chapter; and
    (iii) Include in the Federal Register notice described in paragraph 
(a)(2) of this section public notification of our decision to modify or 
revoke the variance granted to States, tribes, or foreign countries in 
which similarly situated persons are located.
    (b) We will consider submissions from affected States, tribes, or 
foreign countries and from other interested parties as follows:
    (1) We will consider requests for hearings by affected States, 
tribes, or foreign countries under part 16 of this chapter.
    (i) If FDA grants a hearing, we will provide the State, tribe, or 
foreign country with an opportunity to make an oral submission. We will 
provide notice on our Web site of the hearing, including the time, date, 
and place of the hearing.
    (ii) If more than one State, tribe, or foreign country requests an 
informal hearing under part 16 of this chapter

[[Page 338]]

about our determination that a particular variance should be modified or 
revoked, we may consolidate such requests (for example, into a single 
hearing).
    (2) We will consider written submissions submitted to the public 
docket from interested parties.
    (c) We will provide notice of our final decision as follows:
    (1) On the basis of the administrative record, FDA will issue a 
written decision, as provided for under part 16 of this chapter.
    (2) We will publish a notice of our decision in the Federal 
Register. The effective date of the decision will be the date of 
publication of the notice.



Sec. 112.182  What are the permissible types of variances that may
be granted?

    A variance(s) may be requested for one or more requirements in 
subparts A through O of this part. Examples of permissible types of 
variances include:
    (a) Variance from the microbial quality criteria when agricultural 
water is used during growing activities for covered produce (other than 
sprouts) using a direct water application method, established in Sec. 
112.44(b);
    (b) Variance from the microbial die-off rate that is used to 
determine the time interval between last irrigation and harvest, and/or 
the accompanying maximum time interval, established in Sec. 
112.45(b)(1)(i); and
    (c) Variance from the approach or frequency for testing water used 
for purposes that are subject to the requirements of Sec. 112.44(b), 
established in Sec. 112.46(b).



                  Subpart Q_Compliance and Enforcement



Sec. 112.192  What is the applicability and status of this part?

    (a) The failure to comply with the requirements of this part, issued 
under section 419 of the Federal Food, Drug, and Cosmetic Act, is a 
prohibited act under section 301(vv) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The criteria and definitions in this part apply in determining 
whether a food is:
    (1) Adulterated within the meaning of:
    (i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in 
that the food has been grown, harvested, packed, or held under such 
conditions that it is unfit for food; or
    (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act 
in that the food 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;
    or
    (2) In violation of section 361 of the Public Health Service Act (42 
U.S.C. 264).



Sec. 112.193  What are the provisions for coordination of education
and enforcement?

    Under section 419(b)(2)(A) of the Federal Food, Drug, and Cosmetic 
Act, FDA coordinates education and enforcement activities by State, 
territorial, tribal, and local officials by helping develop education, 
training, and enforcement approaches.



               Subpart R_Withdrawal of Qualified Exemption



Sec. 112.201  Under what circumstances can FDA withdraw a qualified 
exemption in accordance with the requirements of Sec. 112.5?

    (a) We may withdraw your qualified exemption under Sec. 112.5:
    (1) In the event of an active investigation of a foodborne illness 
outbreak that is directly linked to your farm; or
    (2) If we determine that it is necessary to protect the public 
health and prevent or mitigate a foodborne illness outbreak based on 
conduct or conditions associated with your farm that are material to the 
safety of the food that would otherwise be covered produce grown, 
harvested, packed or held at your farm.
    (b) Before FDA issues an order to withdraw your qualified exemption, 
FDA:
    (1) May consider one or more other actions to protect the public 
health and prevent or mitigate a foodborne illness outbreak, including a 
warning

[[Page 339]]

letter, recall, administrative detention, refusal of food offered for 
import, seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the farm, 
in writing, of circumstances that may lead FDA to withdraw the 
exemption, and provide an opportunity for the owner, operator, or agent 
in charge of the farm to respond in writing, within 15 calendar days of 
the date of receipt of the notification, to FDA's notification; and
    (3) Must consider the actions taken by the farm to address the 
circumstances that may lead FDA to withdraw the exemption.



Sec. 112.202  What procedure will FDA use to withdraw an exemption?

    (a) An FDA Division Director in whose division the farm is located 
(or, in the case of a foreign farm, the Director of the Office of 
Compliance in the Center for Food Safety and Applied Nutrition), or an 
FDA official senior to either such Director, must approve an order to 
withdraw the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to 
withdraw the exemption after it has been approved in accordance with 
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner, 
operator, or agent in charge of the farm.
    (d) FDA must issue an order to withdraw the exemption in writing, 
signed and dated by the officer or qualified employee of FDA who is 
issuing the order.

[80 FR 74547, Nov. 27, 2015, as amended at 85 FR 16552, Mar. 24, 2020]



Sec. 112.203  What information must FDA include in an order to withdraw a qualified exemption?

    An order to withdraw a qualified exemption applicable to a farm 
under Sec. 112.5 must include the following information:
    (a) The date of the order;
    (b) The name, address and location of the farm;
    (c) A brief, general statement of the reasons for the order, 
including information relevant to one or both of the following 
circumstances that leads FDA to issue the order:
    (1) An active investigation of a foodborne illness outbreak that is 
directly linked to the farm; or
    (2) Conduct or conditions associated with a farm that are material 
to the safety of the food that would otherwise be covered produce grown, 
harvested, packed and held at such farm.
    (d) A statement that the farm must either:
    (1) Comply with subparts B through O of this part on the date that 
is 120 calendar days from the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec. 112.206.
    (e) A statement that a farm may request that FDA reinstate an 
exemption that was withdrawn by following the procedures in Sec. 
112.213;
    (f) The text of section 419(f) of the Federal Food, Drug, and 
Cosmetic Act and of this subpart;
    (g) A statement that any informal hearing on an appeal of the order 
must be conducted as a regulatory hearing under part 16 of this chapter, 
with certain exceptions described in Sec. 112.208;
    (h) The mailing address, telephone number, email address, fax 
number, and name of the FDA Division Director in whose division the farm 
is located (or for foreign farms, the same information for the Director 
of the Office of Compliance in the Center for Food Safety and Applied 
Nutrition); and
    (i) The name and the title of the FDA representative who approved 
the order.

[80 FR 74547, Nov. 27, 2015, as amended at 85 FR 16552, Mar. 24, 2020]



Sec. 112.204  What must I do if I receive an order to withdraw 
a qualified exemption applicable to my farm?

    The owner, operator, or agent in charge of a farm that receives an 
order to withdraw a qualified exemption applicable to that farm under 
Sec. 112.5 must either:

[[Page 340]]

    (a) Comply with applicable requirements of this part within 120 
calendar days of the date from receipt of the order or, if operations 
have ceased and will not resume within 120 calendar days, before the 
beginning of operations in the next growing season, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (b) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec. 112.206.



Sec. 112.205  Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm?

    (a) Submission of an appeal, including submission of a request for 
an informal hearing, will not operate to delay or stay any 
administrative action, including enforcement action by FDA, unless the 
Commissioner of Food and Drugs, as a matter of discretion, determines 
that delay or a stay is in the public interest.
    (b) If the owner, operator, or agent in charge of the farm appeals 
the order, and FDA confirms the order:
    (1) The owner, operator, or agent in charge of the farm must comply 
with applicable requirements of this part within 120 calendar days from 
the date of receipt of the order, or, if operations have ceased and will 
not resume within 120 calendar days, before the beginning of operations 
in the next growing season, or within a reasonable timeframe, agreed to 
by FDA, based on a written justification, submitted to FDA, for a 
timeframe that exceeds 120 calendar days from the date of receipt of the 
order; and
    (2) The owner, operator, or agent in charge of the farm is no longer 
subject to the modified requirements in Sec. Sec. 112.6 and 112.7.



Sec. 112.206  What is the procedure for submitting an appeal?

    (a) To appeal an order to withdraw a qualified exemption applicable 
to a farm under Sec. 112.5, the owner, operator, or agent in charge of 
the farm must:
    (1) Submit the appeal in writing to the FDA Division Director in 
whose division the farm is located (or in the case of a foreign farm, 
the Director of the Office of Compliance in the Center for Food Safety 
and Applied Nutrition), at the mailing address, email address, or fax 
number identified in the order within 15 calendar days of the date of 
receipt of the order; and
    (2) Respond with particularity to the facts and issues contained in 
the order, including any supporting documentation upon which the owner, 
operator or agent in charge of the farm relies.
    (b) In a written appeal of the order withdrawing an exemption 
provided under Sec. 112.5, the owner, operator, or agent in charge of 
the farm may include a written request for an informal hearing as 
provided in Sec. 112.207.

[80 FR 74547, Nov. 27, 2015, as amended at 85 FR 16552, Mar. 24, 2020]



Sec. 112.207  What is the procedure for requesting an informal hearing?

    (a) If the owner, operator, or agent in charge of the farm appeals 
the order, the owner, operator, or agent in charge of the farm:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with 
its written appeal submitted in accordance with Sec. 112.206 within 15 
calendar days of the date of receipt of the order.
    (b) A request for an informal hearing may be denied, in whole or in 
part, if the presiding officer determines that no genuine and 
substantial issue of material fact has been raised by the material 
submitted. If the presiding officer determines that a hearing is not 
justified, a written notice of the determination will be given to the 
owner, operator, or agent in charge of the farm explaining the reason 
for the denial.



Sec. 112.208  What requirements are applicable to an informal hearing?

    If the owner, operator, or agent in charge of the farm requests an 
informal hearing, and FDA grants the request:
    (a) The hearing will be held within 15 calendar days after the date 
the appeal is filed or, if applicable, within a timeframe agreed upon in 
writing by the

[[Page 341]]

owner, operator, or agent in charge of the farm and FDA.
    (b) The presiding officer may require that a hearing conducted under 
this subpart be completed within 1 calendar day, as appropriate.
    (c) FDA must conduct the hearing in accordance with part 16 of this 
chapter, except that:
    (1) The order withdrawing an exemption under Sec. 112.5, rather 
than the notice under Sec. 16.22(a) of this chapter, provides notice of 
the opportunity for a hearing under this section and is part of the 
administrative record of the regulatory hearing under Sec. 16.80(a) of 
this chapter.
    (2) A request for a hearing under this subpart must be addressed to 
the FDA Division Director (or, in the case of a foreign farm, the 
Director of the Office of Compliance in the Center for Food Safety and 
Applied Nutrition) as provided in the order withdrawing an exemption.
    (3) Section 112.209, rather than Sec. 16.42(a) of this chapter, 
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a 
hearing under this subpart. The presiding officer must prepare a written 
report of the hearing. All written material presented at the hearing 
will be attached to the report. The presiding officer must include as 
part of the report of the hearing a finding on the credibility of 
witnesses (other than expert witnesses) whenever credibility is a 
material issue, and must include a proposed decision, with a statement 
of reasons. The hearing participant may review and comment on the 
presiding officer's report within 2 calendar days of issuance of the 
report. The presiding officer will then issue the final decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing under this subpart. The presiding officer's report of 
the hearing and any comments on the report by the hearing participant 
under Sec. 112.208(c)(4) are part of the administrative record.
    (6) No party shall have the right, under Sec. 16.119 of this 
chapter to petition the Commissioner of Food and Drugs for 
reconsideration or a stay of the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of 
an order withdrawing an exemption, the hearing must be conducted as a 
regulatory hearing under a regulation in accordance with part 16 of this 
chapter, except that Sec. 16.95(b) does not apply to a hearing under 
this subpart. With respect to a regulatory hearing under this subpart, 
the administrative record of the hearing specified in Sec. Sec. 
16.80(a)(1), (2), (3), and (5) of this chapter and 112.208(c)(5) 
constitutes the exclusive record for the presiding officer's final 
decision. For purposes of judicial review under Sec. 10.45 of this 
chapter, the record of the administrative proceeding consists of the 
record of the hearing and the presiding officer's final decision.

[80 FR 74547, Nov. 27, 2015, as amended at 85 FR 16552, Mar. 24, 2020]



Sec. 112.209  Who is the presiding officer for an appeal and for
an informal hearing?

    The presiding officer for an appeal, and for an informal hearing, 
must be an Office of Regulatory Affairs Program Director or another FDA 
official senior to an FDA Division Director.

[85 FR 16552, Mar. 24, 2020]



Sec. 112.210  What is the timeframe for issuing a decision on an appeal?

    (a) If the owner, operator, or agent in charge of a farm appeals the 
order without requesting a hearing, the presiding officer must issue a 
written report that includes a final decision confirming or revoking the 
withdrawal by the 10th calendar day after the appeal is filed.
    (b) If the owner, operator, or agent in charge of a farm appeals the 
order and requests an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is held, 
the presiding officer must provide a 2 calendar day opportunity for the 
hearing participants to review and submit comments on the report of the 
hearing under Sec. 112.208(c)(4), and must issue a final decision 
within 10 calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer 
must

[[Page 342]]

issue a final decision on the appeal confirming or revoking the 
withdrawal within 10 calendar days after the date the appeal is filed.



Sec. 112.211  When is an order to withdraw a qualified exemption 
applicable to a farm revoked?

    An order to withdraw a qualified exemption applicable to a farm 
under Sec. 112.5 is revoked if:
    (a) The owner, operator, or agent in charge of the farm appeals the 
order and requests an informal hearing, FDA grants the request for an 
informal hearing, and the presiding officer does not confirm the order 
within the 10 calendar days after the hearing, or issues a decision 
revoking the order within that time; or
    (b) The owner, operator, or agent in charge of the farm appeals the 
order and requests an informal hearing, FDA denies the request for an 
informal hearing, and FDA does not confirm the order within the 10 
calendar days after the appeal is filed, or issues a decision revoking 
the order within that time; or
    (c) The owner, operator, or agent in charge of the farm appeals the 
order without requesting an informal hearing, and FDA does not confirm 
the order within the 10 calendar days after the appeal is filed, or 
issues a decision revoking the order within that time.
    (d) Confirmation of a withdrawal order by the presiding officer is 
considered a final Agency action for purposes of 5 U.S.C. 702.



Sec. 112.213  If my qualified exemption is withdrawn, under what 
circumstances would FDA reinstate my qualified exemption?

    (a) If the FDA Division Director in whose division your farm is 
located (or, in the case of a foreign farm, the Director of the Office 
of Compliance in the Center for Food Safety and Applied Nutrition) 
determines that the farm has adequately resolved any problems with the 
conduct and conditions that are material to the safety of the food 
produced or harvested at such farm, and that continued withdrawal of the 
exemption is not necessary to protect the public health or prevent or 
mitigate a foodborne illness outbreak, the FDA Division Director in 
whose division your farm is located (or, in the case of a foreign farm, 
the Director of the Office of Compliance in the Center for Food Safety 
and Applied Nutrition) will, on his or her own initiative or at the 
request of a farm, reinstate the qualified exemption.
    (b) You may ask FDA to reinstate a qualified exemption that has been 
withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA Division Director in 
whose division your farm is located (or, in the case of a foreign farm, 
the Director of the Office of Compliance in the Center for Food Safety 
and Applied Nutrition); and
    (2) Present, in writing, data and information to demonstrate that 
you have adequately resolved any problems with the conduct and 
conditions that are material to the safety of the food produced and 
harvested at your farm, such that continued withdrawal of the exemption 
is not necessary to protect the public health and prevent or mitigate a 
foodborne illness outbreak.
    (c) If your qualified exemption was withdrawn under Sec. 
112.201(a)(1) and FDA later determines, after finishing the active 
investigation of a foodborne illness outbreak, that the outbreak is not 
directly linked to your farm, FDA will reinstate your qualified 
exemption under Sec. 112.5, and FDA will notify you in writing that 
your exempt status has been reinstated.
    (d) If your qualified exemption was withdrawn under Sec. 
112.201(a)(1) and (2) and FDA later determines, after finishing the 
active investigation of a foodborne illness outbreak, that the outbreak 
is not directly linked to your farm, FDA will inform you of this 
finding, and you may ask FDA to reinstate your qualified exemption under 
Sec. 112.5, in accordance with the requirements of paragraph (b) of 
this section.

[80 FR 74547, Nov. 27, 2015, as amended at 85 FR 16552, Mar. 24, 2020]

[[Page 343]]



PART 113_THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY
SEALED CONTAINERS--Table of Contents



                      Subpart A_General Provisions

Sec.
113.3 Definitions.
113.5 Current good manufacturing practice.
113.10 Personnel.

Subpart B [Reserved]

                           Subpart C_Equipment

113.40 Equipment and procedures.

Subpart D_Control of Components, Food Product Containers, Closures, and 
                           In-Process Material

113.60 Containers.

                Subpart E_Production and Process Controls

113.81 Product preparation.
113.83 Establishing scheduled processes.
113.87 Operations in the thermal processing room.
113.89 Deviations in processing, venting, or control of critical 
          factors.

                      Subpart F_Records and Reports

113.100 Processing and production records.

    Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.

    Source: 44 FR 16215, Mar. 16, 1979, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 113.3  Definitions.

    For the purposes of this part, the following definitions apply:
    (a) Aseptic processing and packaging means the filling of a 
commercially sterilized cooled product into pre sterilized containers, 
followed by aseptic hermetical sealing, with a presterilized closure, in 
an atmosphere free of microorganisms.
    (b) Bleeders means openings used to remove air that enters with 
steam from retorts and steam chambers and to promote circulation of 
steam in such retorts and steam chambers. Bleeders may serve as a means 
of removing condensate.
    (c) Come-up-time means the time which elapses between the 
introduction of steam into the closed retort and the time when the 
retort reaches the required processing temperature.
    (d) Commercial processor includes any person engaged in commercial, 
custom, or institutional (church, school, penal, or other organization) 
processing of food, including pet food. Persons engaged in the 
production of foods that are to be used in market or consumer tests are 
also included.
    (e) Commercial sterility: (1) ``Commercial sterility'' of thermally 
processed food means the condition achieved--
    (i) By the application of heat which renders the food free of--
    (a) Microorganisms capable of reproducing in the food under normal 
nonrefrigerated conditions of storage and distribution; and
    (b) Viable microorganisms (including spores) of public health 
significance; or
    (ii) By the control of water activity and the application of heat, 
which renders the food free of microorga nisms capable of reproducing in 
the food under normal nonrefrigerated conditions of storage and 
distribution.
    (2) ``Commercial sterility'' of equipment and containers used for 
aseptic processing and packaging of food means the condition achieved by 
application of heat, chemical sterilant(s), or other appropriate 
treatment that renders the equipment and containers free of viable 
microorganisms having public health significance, as well as 
microorganisms of nonhealth significance, capable of reproducing in the 
food under normal nonrefrigerated conditions of storage and 
distribution.
    (f) Critical factor means any property, characteristic, condition, 
aspect, or other parameter, variation of which may affect the scheduled 
process and the attainment of commercial sterility.
    (g) Flame sterilizer means an apparatus in which hermetically sealed 
containers are agitated at atmospheric pressure, by either continuous, 
discontinuous, or reciprocating movement, with impinging gas flames to 
achieve sterilization temperatures. A holding period in a heated section 
may follow the initial heating period.

[[Page 344]]

    (h) Headspace, gross is 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 (the top of the double seam of a can 
or the top edge of a glass jar).
    (i) Headspace, net of a container is the vertical distance between 
the level of the product (generally the liquid surface) in the upright 
rigid container and the inside surface of the lid.
    (j) Hermetically sealed container means a container that is designed 
and intended to be secure against the entry of microorganisms and 
thereby to maintain the commercial sterility of its contents after 
processing.
    (k) Incubation means the holding of a sample(s) at a specified 
temperature for a specified period of time for the purpose of permitting 
or stimulating the growth of microorganisms.
    (l) Initial temperature means the average temperature of the 
contents of the coldest container to be processed at the time the 
thermal processing cycle begins, as determined after thorough stirring 
or shaking of the filled and sealed container.
    (m) Lot means that amount of a product produced during a period of 
time indicated by a specific code.
    (n) Low-acid foods means any foods, other than alcoholic beverages, 
with a finished equilibrium pH greater than 4.6 and a water activity 
(aw) greater than 0.85. Tomatoes and tomato products having a 
finished equilibrium pH less than 4.7 are not classed as low-acid foods.
    (o) Minimum thermal process means the application of heat to food, 
either before or after sealing in a hermetically sealed container, for a 
period of time and at a temperature scientifically determined to be 
adequate to ensure destruction of microorganisms of public health 
significance.
    (p) Operating process means the process selected by the processor 
that equals or exceeds the minimum requirements set forth in the 
scheduled process.
    (q) Retort means any closed vessel or other equipment used for the 
thermal processing of foods.
    (r) Scheduled process means the process selected by the processor as 
adequate under the conditions of manufacture for a given product to 
achieve commercial sterility. This process may be in excess of that 
necessary to ensure destruction of microorganisms of public health 
significance, and shall be at least equivalent to the process 
established by a competent processing authority to achieve commercial 
sterility.
    (s) Shall is used to state mandatory requirements.
    (t) Should is used to state recommended or advisory procedures or to 
identify recommended equipment.
    (u) Vacuum-packed products means those products that are sealed in a 
container under the vacuum specified in the scheduled process, the 
maintenance of which vacuum is critical to the adequacy of the scheduled 
process.
    (v) Vents means openings through the retort shell, controlled by 
gate, plug cock, or other adequate valves used for the elimination of 
air during the venting period.
    (w) Water activity (aw) is a measure of the free moisture 
in a product and is the quotient of the water vapor pressure of the 
substance divided by the vapor pressure of pure water at the same 
temperature.



Sec. 113.5  Current good manufacturing practice.

    The criteria in Sec. Sec. 113.10, 113.40, 113.60, 113.81, 113.83, 
113.87, 113.89, and 113.100 shall apply in determining whether the 
facilities, methods, practices, and controls used by the commercial 
processor in the manufacture, processing, or packing of low-acid foods 
in hermetically sealed containers are operated or administered in a 
manner adequate to protect the public health.



Sec. 113.10  Personnel.

    The operators of processing systems, retorts, aseptic processing and 
packaging systems and product formulating systems (including systems 
wherein water activity is used in conjunction with thermal processing) 
and container closure inspectors shall be under the operating 
supervision of a person who has attended a school approved by the 
Commissioner for giving instruction

[[Page 345]]

appropriate to the preservation technology involved and who has been 
identified by that school as having satisfactorily completed the 
prescribed course of instruction. This person shall supervise only in 
those areas for which a school approved by the Commissioner identifies 
the person as having satisfactorily completed training.

Subpart B [Reserved]



                           Subpart C_Equipment



Sec. 113.40  Equipment and procedures.

    (a) Equipment and procedures for pressure processing in steam in 
still retorts--(1) Temperature-indicating device. Each retort shall be 
equipped with at least one temperature-indicating device that accurately 
indicates the temperature during processing. Each temperature-indicating 
device shall have a sensor and a display. Each temperature-indicating 
device and each reference device that is maintained by the processor 
shall be tested for accuracy against a reference device for which the 
accuracy is traceable to a National Institute of Standards and 
Technology (NIST), or other national metrology institute, standard 
reference device by appropriate standard procedures, upon installation 
and at least once a year thereafter, or more frequently if necessary, to 
ensure accuracy during processing. Each temperature-indicating device 
and each reference device that is maintained by the processor shall have 
a tag, seal, or other means of identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device 
and of a reference device that is maintained by the processor shall be 
established and maintained in accordance with Sec. 113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot be 
adjusted to the accurate calibrated reference device shall be repaired 
before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F 
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer 
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of 
graduated scale. A mercury-in-glass thermometer that has a divided 
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The temperature-indicating device 
sensor shall be installed either within the retort shell or in external 
wells attached to the retort. External wells or pipes shall be connected 
to the retort through at least a \3/4\-inch (2 centimeters) diameter 
opening and equipped with a \1/16\-inch (1.5 millimeters) or larger 
bleeder opening so located as to provide a full flow of steam past the 
length of the temperature-indicating device sensor. The bleeders for 
external wells shall emit steam continuously during the entire 
processing period. The temperature-indicating device--not the 
temperature recording device--shall be the reference instrument for 
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Each temperature-recording device shall 
have a sensor and a mechanism for recording temperatures to a permanent 
record, such as a temperature-recording chart. The temperature-recording 
device sensor shall be installed either within the retort shell or in a 
well attached to the shell. Each temperature-recording device sensor 
well shall have a \1/16\-inch (1.5 millimeters) or larger bleeder that 
emits steam continuously during the processing period.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) of 
the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the

[[Page 346]]

parameters of the process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as data 
loggers, that record numbers or create other digital records may be 
used. Such a device shall record the temperature at intervals that will 
assure that the parameters of the process time and process temperature 
have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted with sufficient frequency to ensure agreement as nearly as 
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized 
changes in adjustment shall be provided. A lock or a notice from 
management posted at or near the temperature-recording device that 
provides a warning that only authorized persons are permitted to make 
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may be 
combined with the steam controller and may be a recorder-controller.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or 
less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recorder-controller when combined with a temperature-recording 
device. The steam controller may be air-operated and actuated by a 
temperature sensor positioned near the temperature-indicating device in 
the retort. Air-operated temperature controllers should have adequate 
filter systems to ensure a supply of clean, dry air. A steam controller 
activated by the steam pressure of the retort is acceptable if it is 
carefully maintained mechanically so that it operates satisfactorily.
    (5) Steam inlet. The steam inlet to each still retort shall be large 
enough to provide sufficient steam for proper operation of the retort. 
Steam may enter either the top portion or the bottom portion of the 
retort but, in any case, shall enter the portion of the retort opposite 
the vent; for example, steam inlet in bottom portion and vent in top 
portion.
    (6) Crate supports. A bottom crate support shall be used in vertical 
still retorts. Baffle plates shall not be used in the bottom of still 
retorts.
    (7) Steam spreaders. Steam spreaders are continuations of the steam 
inlet line inside the retort. Horizontal still retorts shall be equipped 
with steam spreaders that extend the length of the retort. For steam 
spreaders along the bottom of the retort, the perforations should be 
along the top 90[deg] of the pipe, that is, within 45[deg] on either 
side of the top center. Horizontal still retorts over 30 feet (9.1 
meters) long should have two steam inlets connected to the spreader. In 
vertical still retorts, the steam spreaders, if used, should be 
perforated along the center line of the pipe facing the interior of the 
retort or along the sides of the pipe. The number of perforations should 
be such that the total cross-sectional area of the perforations is equal 
to 1.5 to 2 times the cross-sectional area of the smallest restriction 
in the steam inlet line.
    (8) Bleeders. Bleeders, except those for temperature-indicating 
device wells, shall be 1/8-inch (3 millimeters) or larger 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 (30.5 centimeters) 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 meters) apart along the top. Bleeders 
may be installed at positions other than those specified in this 
paragraph, as long as there is evidence in the form of heat distribution 
data that they accomplish adequate removal of air and circulation of 
steam within the retort. Vertical retorts shall have at least one 
bleeder opening located in that portion of the retort opposite the steam 
inlet. In retorts having top steam inlet and bottom venting, a bleeder 
shall be installed in the bottom of the retort to remove condensate. All 
bleeders shall be arranged so that the operator can observe that they 
are functioning properly.
    (9) Stacking equipment and position of containers. Crates, trays, 
gondolas, etc.,

[[Page 347]]

for holding containers shall be made of strap iron, adequately 
perforated sheet metal, or other suitable material. When perforated 
sheet metal is used for the bottoms, the perforations should be 
approximately the equivalent of 1-inch (2.5 centimeters) holes on 2-inch 
(5.1 centimeters) centers. If dividers are used between the layers of 
containers, they should be perforated as stated in this paragraph. The 
positioning of containers in the retort, when specified in the scheduled 
process, shall be in accordance with that process.
    (10) Air valves. Retorts using air for pressure cooling shall be 
equipped with a suitable valve to prevent air leakage into the retort 
during processing.
    (11) Water valves. Retorts using water for cooling shall be equipped 
with a suitable valve to prevent leakage of water into the retort during 
processing.
    (12) Vents. Vents shall be installed in such a way that air is 
removed from the retort before timing of the process is started. Vents 
shall be controlled by gate, plug cock, or other adequate type valves 
which shall be fully open to permit rapid discharge of air from the 
retort during the venting period. Vents shall not be connected directly 
to a closed drain system. If the overflow is used as a vent, there shall 
be an atmospheric break in the line before it connects to a closed 
drain. The vent shall be located in that portion of the retort opposite 
the steam inlet; for example, steam inlet in bottom portion and vent in 
top portion. Where a retort manifold connects several vent pipes from a 
single still retort, it shall be controlled by a gate, plug cock, or 
other adequate type of valve. The retort manifold shall be of a size 
that the cross-sectional area of the pipe is larger than the total 
cross-sectional area of all connecting vents. The discharge shall not be 
directly 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 that the cross-sectional 
area is at least equal to the total cross-sectional area of all 
connecting retort manifold pipes from all retorts venting 
simultaneously. Timing of the process shall not begin until the retort 
has been properly vented and the processing temperature has been 
reached. Some typical installations and operating procedures reflecting 
the requirements of this section for venting still retorts without 
divider plates are given in paragraphs (a)(12)(i)(A) through 
(a)(12)(i)(D) and (a)(12)(ii)(A) and (a)(12)(ii)(B) of this section.
    (i) Venting horizontal retorts. (A) Venting through multiple 1-inch 
(2.5 centimeters) vents discharging directly to atmosphere.
[GRAPHIC] [TIFF OMITTED] TR03MR11.000


[[Page 348]]


    (1) Specifications. One 1-inch (2.5 centimeters) vent for every 5 
feet (1.5 meters) of retort length equipped with a gate or plug cock 
valve and discharging to atmosphere; end vents not more than 2.5 feet 
(76 centimeters) from ends of retort.
    (2) Venting method. Vent valves should be wide open for at least 5 
minutes and to at least 225 [deg]F (107 [deg]C), or at least 7 minutes 
and to at least 220 [deg]F (104.5 [deg]C).
    (B) Venting through multiple 1-inch (2.5 centimeters) vents 
discharging through a manifold to atmosphere.
[GRAPHIC] [TIFF OMITTED] TR03MR11.001

    (1) Specifications. One 1-inch (2.5 centimeters) vent for every 5 
feet (1.5 meters) of retort length; and vents not over 2.5 feet (76 
centimeters) from ends of retort. Size of manifold--for retorts less 
than 15 feet (4.6 meters) in length, 2.5 inches (6.4 centimeters); for 
retorts 15 feet (4.6 meters) and over in length, 3 inches (7.6 
centimeters).
    (2) Venting method. Manifold vent gate or plug cock valve should be 
wide open for at least 6 minutes and to at least 225 [deg]F (107 
[deg]C), or for at least 8 minutes and to at least 220 [deg]F (104.5 
[deg]C).
    (C) Venting through water spreaders.

[[Page 349]]

[GRAPHIC] [TIFF OMITTED] TR03MR11.002

    (1) Size of vent and vent valve. For retorts less than 15 feet (4.6 
meters) in length, 2 inches (5.1 centimeters); for retorts 15 feet (4.6 
meters) and over in length, 2.5 inches (6.4 centimeters).
    (2) Size of water spreader. For retorts less than 15 feet (4.6 
meters) in length, 1.5 inches (3.8 centimeters); for retorts 15 feet 
(4.6 meters) and over in length, 2 inches (5.1 centimeters). The number 
of holes should be such that their total cross-sectional area is 
approximately equal to the cross-sectional area of the vent pipe inlet.
    (3) Venting method. Water spreader vent gate or plug cock valve 
should be wide open for at least 5 minutes and to at least 225 [deg]F 
(107 [deg]C), or for at least 7 minutes and to at least 220 [deg]F 
(104.5 [deg]C).
    (D) Venting through a single 2.5-inch (6.4 centimeters) top vent 
(for retorts not exceeding 15 feet (4.6 meters) in length).
[GRAPHIC] [TIFF OMITTED] TR03MR11.003


[[Page 350]]


    (1) Specifications. A 2.5-inch (6.4 centimeters) vent equipped with 
a 2.5-inch (6.4 centimeters) gate or plug cock valve and located within 
2 feet (61 centimeters) of the center of the retort.
    (2) Venting method. Vent gate or plug cock valve should be wide open 
for at least 4 minutes and to at least 220 [deg]F (104.5 [deg]C).
    (ii) Venting vertical retorts. (A) Venting through a 1.5-inch (3.8 
centimeters) overflow.
[GRAPHIC] [TIFF OMITTED] TR03MR11.004

    (1) Specifications. A 1.5-inch (3.8 centimeters) overflow pipe 
equipped with a 1.5-inch (3.8 centimeters) gate or plug cock valve and 
with not more than 6 feet (1.8 meters) of 1.5-inch (3.8 centimeters) 
pipe beyond the valve before break to the atmosphere or to a manifold 
header.
    (2) Venting method. Vent gate or plug cock valve should be wide open 
for at least 4 minutes and to at least 218 [deg]F (103.5 [deg]C), or for 
at least 5 minutes and to at least 215 [deg]F (102 [deg]C).
    (B) Venting through a single 1-inch (2.5 centimeters) side or top 
vent.

[[Page 351]]

[GRAPHIC] [TIFF OMITTED] TR03MR11.005

    (1) Specifications. A 1-inch (2.5 centimeters) vent in lid or top 
side, equipped with a 1-inch (2.5 centimeters) gate or plug cock valve 
and discharging directly into the atmosphere or to a manifold header.
    (2) Venting method. Vent gate or plug cock valve should 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 (104.5 [deg]C).
    (iii) Other procedures. Other installations and operating procedures 
that deviate from the requirements in paragraph (a)(12) of this section 
may be used if there is evidence in the form of heat distribution data, 
which shall be kept on file, that they accomplish adequate venting of 
air.
    (13) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the 
scheduled process, it shall be measured and recorded at intervals of 
sufficient frequency to ensure that the weight of the product does not 
exceed the maximum for the given container size specified in the 
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be 
observed and recorded at intervals of sufficient frequency to ensure 
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals 
not to exceed 15 minutes.

[[Page 352]]

    (iv) When the product style results in stratification or layering of 
the primary product in the containers, the positioning of containers in 
the retort shall be according to the scheduled process.
    (b) Equipment and procedures for pressure processing in water in 
still retorts--(1) Temperature-indicating device. Each retort shall be 
equipped with at least one temperature-indicating device that accurately 
indicates the temperature during processing. Each temperature-indicating 
device shall have a sensor and a display. Each temperature-indicating 
device and each reference device that is maintained by the processor 
shall be tested for accuracy against a reference device for which the 
accuracy is traceable to a National Institute of Standards and 
Technology (NIST), or other national metrology institute, standard 
reference device by appropriate standard procedures, upon installation 
and at least once a year thereafter, or more frequently if necessary, to 
ensure accuracy during processing. Each temperature-indicating device 
and each reference device that is maintained by the processor shall have 
a tag, seal, or other means of identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device 
and of a reference device that is maintained by the processor shall be 
established and maintained in accordance with Sec. 113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot be 
adjusted to the accurate calibrated reference device shall be repaired 
before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F 
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer 
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of 
graduated scale. A mercury-in-glass thermometer that has a divided 
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. In both horizontal and vertical 
retorts, the temperature-indicating device sensor shall be inserted 
directly into the retort shell or in a separate well or sleeve attached 
to the retort. The temperature-indicating device sensor shall be located 
so that it is beneath the surface of the water throughout the process 
and where there is adequate circulation to ensure accurate temperature 
measurement. On horizontal retorts, the temperature-indicating device 
sensor should be located in the side at the center of the retort. The 
temperature-indicating device--not the temperature-recording device--
shall be the reference instrument for indicating the processing 
temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Each temperature-recording device shall 
have a sensor and a mechanism for recording temperatures to a permanent 
record, such as a temperature-recording chart.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) of 
the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as data 
loggers, that record numbers or create other digital records may be 
used. Such a device shall record the temperature at intervals that will 
assure that the parameters of the process time and process temperature 
have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted with sufficient frequency to ensure agreement as nearly as 
possible with, but to

[[Page 353]]

be in no event higher than, the temperature-indicating device during 
processing. A means of preventing unauthorized changes in adjustment 
shall be provided. A lock or a notice from management posted at or near 
the temperature-recording device that provides a warning that only 
authorized persons are permitted to make adjustments is a satisfactory 
means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may be 
combined with the steam controller and may be a combination recorder-
controller. For a vertical retort equipped with a combination recorder-
controller, the temperature recorder-controller sensor 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. For a horizontal 
retort equipped with a combination recorder-controller, the temperature 
recorder-controller sensor 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 sensor. 
For all still retort systems that pressure process in water and are 
equipped with combination recorder-controllers, the temperature 
recorder-controller sensors shall be located where the recorded 
temperature is an accurate measurement of the scheduled process 
temperature and is not affected by the heating media.
    (3) Pressure gages. (i) Each retort should be equipped with a 
pressure gage that is accurate to 2 pounds per square inch (13.8 
kilopascals) or less.
    (ii) Each retort should have an adjustable pressure relief or 
control valve of a capacity sufficient to prevent an undesired increase 
in retort pressure when the water valve is wide open and should be 
installed in the overflow line.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. The steam 
controller may be combined with a temperature-recording device and, 
thus, may be a combination recorder-controller. Air-operated temperature 
controllers should have adequate filter systems to ensure a supply of 
clean, dry air.
    (5) Steam introduction. Steam shall be distributed in the bottom of 
the retort in a manner adequate to provide uniform heat distribution 
throughout the retort. In vertical retorts, uniform steam distribution 
can be achieved by any of several methods. In horizontal retorts, the 
steam distributor shall run the length of the bottom of the retort with 
perforations distributed uniformly along the upper part of the pipe.
    (6) Crate supports. A bottom crate support shall be used in vertical 
still retorts. Baffle plates shall not be used in the bottom of the 
retort. Centering guides should be installed so as to ensure that there 
is about a 1.5-inch (3.8 centimeters) clearance between the side wall of 
the crate and the retort wall.
    (7) Stacking equipment and position of containers. Crates, trays, 
gondolas, etc., for holding containers shall be made of strap iron, 
adequately perforated sheet metal, or other suitable material. When 
perforated sheet metal is used for the bottoms, the perforations should 
be approximately the equivalent of 1-inch (2.5 centimeters) holes on 2-
inch (5.1 centimeters) centers. If divider plates are used between the 
layers of containers, they should be perforated as stated in this 
paragraph. The positioning of containers in the retort, when specified 
in the scheduled process, shall be in accordance with that process. 
Dividers, racks, trays, or other means of positioning of flexible 
containers shall be designed and employed to ensure even circulation of 
heating medium around all containers in the retort.
    (8) Drain valve. A nonclogging, water-tight valve shall be used. A 
screen shall be installed or other suitable means shall be used on all 
drain openings to prevent clogging.
    (9) Air supply and controls. In both horizontal and vertical still 
retorts for pressure processing in water, a means shall be provided for 
introducing compressed air at the proper pressure and rate. The proper 
pressure shall be controlled by an automatic pressure control unit. A 
check valve shall be provided in the air supply line to prevent water 
from entering the system. Air or water circulation shall be maintained 
continuously during the come-up time

[[Page 354]]

and during processing and cooling periods. The adequacy of the air or 
water circulation for uniform heat distribution within the retort shall 
be established in accordance with procedures recognized by a competent 
processing authority and records shall be kept on file. 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.
    (10) Water level indicator. There shall be a means of determining 
the water level in the retort during operation, e.g., by using a sensor, 
gage, water glass, or petcock(s). Water shall cover the top layer of 
containers during the entire come-up time and processing periods and 
should cover the top layer of containers during the cooling periods. The 
operator shall check and record the water level at intervals sufficient 
to ensure its adequacy.
    (11) Water circulation. When a water circulating 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 and should have an aggregate area not greater than the 
cross-sectional area of the outlet line from the pump. The suction 
outlets shall be protected with nonclogging screens or other suitable 
means shall be used to keep debris from entering the circulating system. 
The pump shall be designed to provide proper flow on startup and during 
operation, such as with a bleeder or other suitable means to remove air 
during startup and with an appropriate device or design to prevent pump 
cavitation during operation. The pump shall be equipped with a signaling 
device to warn the operator when it is not running. Alternative methods 
for circulation of water in the retort may be used when established by a 
competent authority as adequate for even heat distribution.
    (12) Cooling water supply. In vertical retorts, the cooling water 
should be introduced at the top of the retort between the water and 
container levels. In horizontal retorts the cooling water should be 
introduced into the suction side of the pump. A check valve should be 
included in the cooling water line.
    (13) Retort headspace. The headspace necessary to control the air 
pressure should be maintained between the water level and the top of the 
retort shell.
    (14) Vertical and horizontal still retorts. Vertical and horizontal 
still retorts should follow the arrangements in the diagrams in this 
paragraph. Other installation and operating procedures that deviate from 
these arrangements may be used, as long as there is evidence in the form 
of heat distribution data or other suitable information, which shall be 
kept on file, which demonstrates that the heat distribution is adequate.

[[Page 355]]

[GRAPHIC] [TIFF OMITTED] TR03MR11.006

            Legend for Vertical and Horizontal Still Retorts

A--Water line.
B--Steam line.
C--Temperature control.
D--Overflow line.
E1--Drain line.
E2--Screens.
F--Check valves.

[[Page 356]]

G--Line from hot water storage.
H--Suction line and manifold.
I--Circulating pump.
J--Petcocks.
K--Recirculating line.
L--Steam distributor.
M--Temperature-controller sensor.
N--Temperature-indicating device sensor.
O--Water spreader.
P--Safety valve.
Q--Vent valve for steam processing.
R--Pressure gage.
S--Inlet air control.
T--Pressure control.
U--Air line.
V--To pressure control instrument.
W--To temperature control instrument.
X--Wing nuts.
Y1--Crate support.
Y2--Crate guides.
Z--Constant flow orifice valve.
Z1--Constant flow orifice valve used during come-up.
Z2--Constant flow orifice valve used during cook.

    (15) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the 
scheduled process, it shall be measured and recorded at intervals of 
sufficient frequency to ensure that the weight of the product does not 
exceed the maximum for the given container size specified in the 
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be 
observed and recorded at intervals of sufficient frequency to ensure 
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals 
not to exceed 15 minutes.
    (iv) When the product style results in stratification or layering of 
the primary product in the containers, the positioning of containers in 
the retort shall be according to the scheduled process.
    (c) Equipment and procedures for pressure processing in steam in 
continuous agitating retorts--(1) Temperature-indicating device. Each 
retort shall be equipped with at least one temperature-indicating device 
that accurately indicates the temperature during processing. Each 
temperature-indicating device shall have a sensor and a display. Each 
temperature-indicating device and each reference device that is 
maintained by the processor shall be tested for accuracy against a 
reference device for which the accuracy is traceable to a National 
Institute of Standards and Technology (NIST), or other national 
metrology institute, standard reference device by appropriate standard 
procedures, upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure accuracy during processing. Each 
temperature-indicating device and each reference device that is 
maintained by the processor shall have a tag, seal, or other means of 
identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device 
and of a reference device that is maintained by the processor shall be 
established and maintained in accordance with Sec. 113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot be 
adjusted to the accurate calibrated reference device shall be repaired 
before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F 
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer 
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of 
graduated scale. A mercury-in-glass thermometer that has a divided 
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The temperature-indicating device 
sensor shall be installed either within the retort shell or in external 
wells attached to the retort. External wells or pipes shall be connected 
to the retort through at least a \3/4\-inch (2 centimeters) diameter 
opening and equipped with a \1/16\-inch (1.5 millimeters) or larger 
bleeder opening so located as to provide a full flow of steam past the 
length of the temperature-indicating device sensor. The bleeders for 
external wells shall emit steam continuously during the entire

[[Page 357]]

processing period. The temperature-indicating device--not the 
temperature-recording device--shall be the reference instrument for 
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Each temperature-recording device shall 
have a sensor and a mechanism for recording temperatures to a permanent 
record, such as a temperature-recording chart. The temperature-recording 
device sensor shall be installed either within the retort shell or in a 
well attached to the shell. Each temperature-recording device sensor 
well shall have a \1/16\-inch (1.5 millimeters) or larger bleeder that 
emits steam continuously during the processing period.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) of 
the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as data 
loggers, that record numbers or create other digital records may be 
used. Such a device shall record the temperature at intervals that will 
assure that the parameters of the process time and process temperature 
have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted with sufficient frequency to ensure agreement as nearly as 
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized 
changes in adjustment shall be provided. A lock or a notice from 
management posted at or near the temperature-recording device that 
provides a warning that only authorized persons are permitted to make 
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may be 
combined with the steam controller and may be a recorder-controller.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or 
less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recorder-controller when combined with a temperature-recording 
device. A steam controller activated by the steam pressure of the retort 
is acceptable if it is carefully maintained mechanically so that it 
operates satisfactorily. Air-operated temperature controllers should 
have adequate filter systems to ensure a supply of clean, dry air.
    (5) Bleeders. Bleeders, except those for temperature-indicating 
device wells, shall be \1/8\-inch (3 millimeters) or larger and shall be 
wide open during the entire process, including the come-up time. 
Bleeders shall be located within approximately 1 foot (30.5 centimeters) 
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 
meters) apart along the top of the retort. All bleeders shall be 
arranged so that the operator can observe that they are functioning 
properly. The condensate bleeder shall be checked with sufficient 
frequency to ensure adequate removal of condensate or shall be equipped 
with an automatic alarm system(s) that would serve as a continuous 
monitor of condensate-bleeder functioning. Visual checks should be done 
at intervals of not more than 15 minutes. A record of such checks should 
be kept to show that the bleeder is functioning properly.
    (6) Venting and condensate removal. Vents shall be located in that 
portion of the retort opposite the steam inlet. Air shall be removed 
before processing is started. Heat distribution data or documentary 
proof from the manufacturer or from a competent processing authority, 
demonstrating that adequate venting is achieved, shall be kept on file. 
At the time steam is turned on,

[[Page 358]]

the drain should be opened for a time sufficient to remove steam 
condensate from the retort, and provision shall be made for continuing 
drainage of condensate during the retort operation. The condensate 
bleeder in the bottom of the shell serves as an indicator of continuous 
condensate removal.
    (7) Retort speed timing. The rotational speed of the retort shall be 
specified in the scheduled process. The speed shall be adjusted and 
recorded when the retort is started, at any time a speed change is made, 
and at intervals of sufficient frequency to ensure that the retort speed 
is maintained as specified in the scheduled process. These adjustments 
and recordings should be made every 4 hours or less. Alternatively, a 
recording tachometer may be used to provide a continuous record of the 
speed. A means of preventing unauthorized speed changes on retorts shall 
be provided. A lock or a notice from management posted at or near the 
speed adjustment device that provides a warning that only authorized 
persons are permitted to make adjustments is a satisfactory means of 
preventing unauthorized changes.
    (8) Emergency stops. If a retort jams or breaks down during 
processing operations, necessitating cooling the retort for repairs, the 
retort shall be operated in such a way that ensures that the product is 
commercially sterile, or the retort is to be cooled promptly and all 
containers either reprocessed, repacked and reprocessed, or discarded. 
When operated as a still retort, all containers shall be given a full 
still retort process before the retort is cooled. If, in such an 
emergency, a scheduled still process or another process established to 
ensure commercial sterility is to be used, it shall be made readily 
available to the retort operator.
    (i) Any containers in the retort intake valve or in transfer valves 
between cooker shells of a continuous retort at the time of breakdown 
shall either be reprocessed, repacked and reprocessed, or discarded.
    (ii) Both the time at which the reel stopped and the time the retort 
was used for a still retort process, if so used, shall be indicated on 
the temperature-recording device record and entered on the other 
production records required in this chapter. If the alternative 
procedure of prompt cooling is followed, the subsequent handling methods 
used for the containers in the retort at the time of stopping and 
cooling shall be entered on the production records.
    (9) Temperature drop. If the temperature of the continuous retort 
drops below the temperature specified in the scheduled process while 
containers are in the retort, the retort reel shall be stopped promptly. 
An automatic device should be used to stop the reel when the temperature 
drops below the specified process temperature. Before the reel is 
restarted, all containers in the retort shall be given a complete 
scheduled still retort process if the temperature drop was 10 [deg]F (5 
[deg]C) or more below the specified temperature, or alternatively, 
container entry to the retort shall be stopped and the reel restarted to 
empty the retort. The discharged containers shall be either reprocessed, 
repacked and reprocessed, or discarded. Both the time at which the reel 
stopped and the time the retort was used for a still retort process, if 
so used, shall be indicated on the temperature-recording device record 
and entered on the other production records required in this chapter. If 
the alternative procedure of emptying the retort is followed, the 
subsequent handling methods used for the containers in the retort at the 
time of the temperature drop shall be entered on the production records. 
If the temperature drop was less than 10 [deg]F (5 [deg]C), a scheduled 
authorized emergency still process approved by a qualified person(s) 
having expert knowledge of thermal processing requirements may be used 
before restarting the retort reel. Alternatively, container entry to the 
retort shall be stopped and an authorized emergency agitating process 
may be used before container entry to the retort is restarted. When 
emergency procedures are used, no containers may enter the retort and 
the process and procedures used shall be noted on the production 
records.
    (10) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors

[[Page 359]]

are within the limits specified in the scheduled process. The minimum 
headspace of containers, if specified in the scheduled process, shall be 
measured and recorded at intervals of sufficient frequency to ensure 
that the headspace is as specified in the scheduled process. The 
headspace of solder-tipped, lapseam (vent hole) cans may be measured by 
net weight determinations. The headspace of double seamed cans may also 
be measured by net weight determinations for homogenous liquids, taking 
into account the specific can end profile and other factors which affect 
the headspace, if proof of the accuracy of such measurements is 
maintained and the procedure and resultant headspace is in accordance 
with the scheduled process. When the product consistency is specified in 
the scheduled process, the consistency of the product shall be 
determined by objective measurements on the product taken from the 
filler before processing and recorded at intervals of sufficient 
frequency to ensure that the consistency is as specified in the 
scheduled process. Minimum closing machine vacuum in vacuum-packed 
products, maximum fill-in or drained weight, minimum net weight, and 
percent solids shall be as specified in the scheduled process for all 
products when deviations from such specifications may affect the 
scheduled process. All measurements and recordings of critical factors 
should be made at intervals not to exceed 15 minutes.
    (d) Equipment and procedures for pressure processing in steam in 
discontinuous agitating retorts--(1) Temperature-indicating device. Each 
retort shall be equipped with at least one temperature-indicating device 
that accurately indicates the temperature during processing. Each 
temperature-indicating device shall have a sensor and a display. Each 
temperature-indicating device and each reference device that is 
maintained by the processor shall be tested for accuracy against a 
reference device for which the accuracy is traceable to a National 
Institute of Standards and Technology (NIST), or other national 
metrology institute, standard reference device by appropriate standard 
procedures, upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure accuracy during processing. Each 
temperature-indicating device and each reference device that is 
maintained by the processor shall have a tag, seal, or other means of 
identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device 
and of a reference device that is maintained by the processor shall be 
established and maintained in accordance with Sec. 113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot be 
adjusted to the accurate calibrated reference device shall be repaired 
before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F 
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer 
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of 
graduated scale. A mercury-in-glass thermometer that has a divided 
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The temperature-indicating device 
sensor shall be installed either within the retort shell or in external 
wells attached to the retort. External wells or pipes shall be connected 
to the retort through at least a \3/4\-inch (2 centimeters) diameter 
opening and equipped with a \1/16\-inch (1.5 millimeters) or larger 
bleeder opening so located as to provide a full flow of steam past the 
length of the temperature-indicating device sensor. The bleeders for 
external wells shall emit steam continuously during the entire 
processing period. The temperature-indicating device--not the 
temperature-recording device--shall be the reference instrument for 
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Each temperature-recording device shall 
have a sensor and a mechanism for recording temperatures to a permanent 
record, such as a temperature-recording chart.

[[Page 360]]

The temperature-recording device sensor shall be installed either within 
the retort shell or in a well attached to the shell. Each temperature-
recording device sensor well shall have a \1/16\-inch (1.5 millimeters) 
or larger bleeder that emits steam continuously during the processing 
period.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) of 
the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as data 
loggers, that record numbers or create other digital records may be 
used. Such a device shall record the temperature at intervals that will 
assure that the parameters of the process time and process temperature 
have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted with sufficient frequency to ensure agreement as nearly as 
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized 
changes in adjustment shall be provided. A lock or a notice from 
management posted at or near the temperature-recording device that 
provides a warning that only authorized persons are permitted to make 
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may be 
combined with the steam controller and may be a recorder-controller.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or 
less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recorder-controller when combined with a temperature-recording 
device. A steam controller activated by the steam pressure of the retort 
is acceptable if it is mechanically maintained so that it operates 
satisfactorily. Air-operated temperature controllers should have 
adequate filter systems to ensure a supply of clean, dry air.
    (5) Bleeders. Bleeders, except those for temperature-indicating 
device wells, shall be \1/8\-inch (3 millimeters) or larger and shall be 
wide open during the entire process, including the come-up time. 
Bleeders shall be located within approximately 1 foot (30.5 centimeters) 
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 meters) apart along the top. Bleeders may be installed at positions 
other than those specified in this paragraph, as long as there is 
evidence in the form of heat distribution data that they accomplish 
adequate removal of air and circulation of heat within the retort. In 
retorts having top steam inlet and bottom venting, a bleeder shall be 
installed in the bottom of the retort to remove condensate. All bleeders 
shall be arranged in a way that enables the operator to observe that 
they are functioning properly.
    (6) Venting and condensate removal. The air in each retort shall be 
removed before processing is started. Heat distribution data or 
documentary proof from the manufacturer or from a competent processing 
authority, demonstrating that adequate venting is achieved, shall be 
kept on file. At the time steam is turned on, the drain should be opened 
for a time sufficient to remove steam condensate from the retort and 
provision should be made for continuing drainage of condensate during 
the retort operation.
    (7) Retort speed timing. The rotational speed of the retort shall be 
specified in the scheduled process. The speed shall be adjusted, as 
necessary, to ensure that the speed is as specified in the scheduled 
process. The rotational speed

[[Page 361]]

as well as the process time shall be recorded for each retort load 
processed. Alternatively, a recording tachometer may be used to provide 
a continuous record of the speed. A means of preventing unauthorized 
speed changes on retorts shall be provided. A lock or a notice from 
management posted at or near the speed-adjustment device that provides a 
warning that only authorized persons are permitted to make adjustments 
is a satisfactory means of preventing unauthorized changes.
    (8) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. The minimum headspace of 
containers in each retort load to be processed, if specified in the 
scheduled process, shall be measured and recorded at intervals of 
sufficient frequency to ensure that the headspace is as specified in the 
scheduled process. The headspace of solder-tipped, lap seam (vent hole) 
cans may be measured by net weight determinations. When the product 
consistency is specified in the scheduled process, the consistency of 
the product shall be determined by objective measurements on the product 
taken from the filler before processing and recorded at intervals of 
sufficient frequency to ensure that the consistency is as specified in 
the scheduled process. Minimum closing machine vacuum in vacuum-packed 
products, maximum fill-in or drained weight, minimum net weight, and 
percent solids shall be as specified in the scheduled process for all 
products for which deviations from such specifications may affect the 
scheduled process. All measurements and recordings of critical factors 
should be made at intervals not to exceed 15 minutes.
    (e) Equipment and procedures for pressure processing in water in 
discontinuous agitating retorts--(1) Temperature-indicating device. Each 
retort shall be equipped with at least one temperature-indicating device 
that accurately indicates the temperature during processing. Each 
temperature-indicating device shall have a sensor and a display. Each 
temperature-indicating device and each reference device that is 
maintained by the processor shall be tested for accuracy against a 
reference device for which the accuracy is traceable to a National 
Institute of Standards and Technology (NIST), or other national 
metrology institute, standard reference device by appropriate standard 
procedures, upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure accuracy during processing. Each 
temperature-indicating device and each reference device that is 
maintained by the processor shall have a tag, seal, or other means of 
identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device 
and of a reference device that is maintained by the processor shall be 
established and maintained in accordance with Sec. 113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot be 
adjusted to the accurate calibrated reference device shall be repaired 
before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F 
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer 
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of 
graduated scale. A mercury-in-glass thermometer that has a divided 
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. In both horizontal and vertical 
retorts, the temperature-indicating device sensor shall be inserted 
directly into the retort shell or in a separate well or sleeve attached 
to the retort. The temperature-indicating device sensor shall be located 
so that it is beneath the surface of the water throughout the process 
and where there is adequate circulation to ensure accurate temperature 
measurement. On horizontal retorts, the temperature-indicating device 
sensor should be located in the side at the center of the retort. The 
temperature-

[[Page 362]]

indicating device--not the temperature-recording device--shall be the 
reference instrument for indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Each temperature-recording device shall 
have a sensor and a mechanism for recording temperatures to a permanent 
record, such as a temperature-recording chart. The temperature-recording 
device sensor shall be installed either within the retort shell or in a 
well attached to the shell.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) of 
the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as data 
loggers, that record numbers or create other digital records may be 
used. Such a device shall record the temperature at intervals that will 
assure that the parameters of the process time and process temperature 
have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted with sufficient frequency to ensure agreement as nearly as 
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized 
changes in adjustment shall be provided. A lock or a notice from 
management posted at or near the temperature-recording device that 
provides a warning that only authorized persons are permitted to make 
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may be 
combined with the steam controller and may be a recorder-controller. 
Air-operated temperature controllers should have adequate filter systems 
to ensure a supply of clean, dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or 
less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recorder-controller when combined with a temperature-recording 
device. Air-operated temperature controllers should have adequate filter 
systems to ensure a supply of clean, dry air.
    (5) Retort speed timing. The rotational speed of the retort shall be 
specified in the scheduled process. The speed shall be adjusted, as 
necessary, to ensure that the speed is as specified in the scheduled 
process. The rotational speed as well as the process time shall be 
recorded for each retort load processed. Alternatively, a recording 
tachometer may be used to provide a continuous record of the speed. A 
means of preventing unauthorized speed changes shall be provided. A lock 
or a notice from management posted at or near the speed adjustment 
device that provides a warning that only authorized persons are 
permitted to make adjustment is a satisfactory means of preventing 
unauthorized changes.
    (6) Air supply and controls. When air is used to provide 
overpressure:
    (i) A means shall be provided for introducing compressed air at the 
proper pressure and rate. The proper pressure shall be controlled by an 
automatic pressure control unit. A check valve shall be provided in the 
air supply line to prevent water from entering the system.
    (ii) A water level indicator, e.g., sensor, gage, water glass, or 
petcock(s), shall be used for determining the water level in the retort 
during operation. Water shall cover the top layer of containers during 
the entire come-up time and processing periods and should also cover the 
top layer of containers during the cooling periods. The operator shall 
check and record the water level at intervals sufficient to ensure its 
adequacy.

[[Page 363]]

    (7) Water circulation. When a water circulating 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 and should have an aggregate area not greater than the 
cross-sectional area of the outlet line from the pump. The suction 
outlets shall be protected with nonclogging screens or other suitable 
means shall be used to keep debris from entering the circulating system. 
The pump shall be designed to provide proper flow on startup and during 
operation, such as with a bleeder or other suitable means to remove air 
during startup and with an appropriate device or design to prevent pump 
cavitation during operation. The pump shall be equipped with a signaling 
device to warn the operator when it is not running. Alternative methods 
for circulation of water in the retort may be used when established by a 
competent authority as adequate for even heat distribution.
    (8) Drain valve. A nonclogging, water-tight valve shall be used. A 
screen shall be installed or other suitable means shall be used on all 
drain openings to prevent clogging.
    (9) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. The minimum headspace of 
containers, if specified in the scheduled process, shall be measured and 
recorded at intervals of sufficient frequency to ensure that the 
headspace is as specified in the scheduled process. The headspace of 
solder-tipped, lap seam (vent hole) cans may be measured by net weight 
determinations. When the product consistency is specified in the 
scheduled process, the consistency of the product shall be determined by 
objective measurements on the product taken from the filler before 
processing and recorded at intervals of sufficient frequency to ensure 
that the consistency is as specified in the scheduled process. Minimum 
closing machine vacuum in vacuum-packed products, maximum fill-in or 
drained weight, minimum net weight, and percent solids shall be as 
specified in the scheduled process for all products when deviations from 
such specifications may affect the scheduled process. All measurements 
and recordings of critical factors should be made at intervals not to 
exceed 15 minutes.
    (f) Equipment and procedures for pressure processing in steam in 
hydrostatic retorts--(1) Temperature-indicating device. Each retort 
shall be equipped with at least one temperature-indicating device that 
accurately indicates the temperature during processing. Each 
temperature-indicating device shall have a sensor and a display. Each 
temperature-indicating device and each reference device that is 
maintained by the processor shall be tested for accuracy against a 
reference device for which the accuracy is traceable to a National 
Institute of Standards and Technology (NIST), or other national 
metrology institute, standard reference device by appropriate standard 
procedures, upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure accuracy during processing. Each 
temperature-indicating device and each reference device that is 
maintained by the processor shall have a tag, seal, or other means of 
identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device 
and of a reference device that is maintained by the processor shall be 
established and maintained in accordance with Sec. 113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot be 
adjusted to the accurate calibrated reference device shall be repaired 
before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F 
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer 
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of 
graduated scale. A mercury-in-glass

[[Page 364]]

thermometer that has a divided mercury column shall be considered 
defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The temperature-indicating device 
sensor shall be located in the steam dome near the steam-water 
interface. When the scheduled process specifies maintenance of 
particular temperatures in the hydrostatic water legs, a temperature-
indicating device sensor shall be located in each hydrostatic water leg 
in a position near the bottom temperature-recording device sensor. The 
temperature-indicating device--not the temperature-recording device--
shall be the reference instrument for indicating the processing 
temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Each temperature-recording device shall 
have a sensor and a mechanism for recording temperatures to a permanent 
record, such as a temperature-recording chart. The temperature-recording 
device sensor shall be installed either within the steam dome or in a 
well attached to the dome. Each temperature-recording device sensor well 
shall have a \1/16\-inch (1.5 millimeters) or larger bleeder that emits 
steam continuously during the processing period. Additional temperature-
recording device sensors shall be installed in the hydrostatic water 
legs in situations where the scheduled process specifies maintenance of 
particular temperatures in the hydrostatic water legs.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) of 
the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as data 
loggers, that record numbers or create other digital recordings may be 
used. Such a device shall record the temperature at intervals that will 
assure that the parameters of the process time and process temperature 
have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted with sufficient frequency to ensure agreement as nearly as 
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized 
changes in adjustment shall be provided. A lock or a notice from 
management posted at or near the temperature-recording device that 
provides a warning that only authorized persons are permitted to make 
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may be 
combined with the steam controller and may be a recorder-controller.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or 
less.
    (4) Recording of temperatures. Temperatures indicated by the 
temperature-indicating device or devices shall be entered on a suitable 
form during processing operations. Temperatures shall be recorded by an 
accurate temperature-recording device or devices at the following 
points:
    (i) In the steam chamber between the steam-water interface and the 
lowest container position.
    (ii) Near the top and the bottom of each hydrostatic water leg if 
the scheduled process specifies maintenance of particular temperatures 
in the legs.
    (5) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recorder-controller when combined with a temperature-recording 
device. A steam controller activated by the steam pressure of the retort 
is acceptable if it is carefully mechanically maintained so that it 
operates satisfactorily. Air-operated temperature controllers should 
have

[[Page 365]]

adequate filter systems to ensure a supply of clean, dry air.
    (6) Venting. Before the start of processing operations, the retort 
steam chamber or chambers shall be vented to ensure removal of air.
    (7) Bleeders. Bleeder openings \1/4\-inch (6 millimeters) or larger 
shall be located at the top of the steam chamber or chambers 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.
    (8) Retort speed. The speed of the container-conveyor chain shall be 
specified in the scheduled process and shall be determined and recorded 
at the start of processing and at intervals of sufficient frequency to 
ensure that the retort speed is maintained as specified. The speed 
should be determined and recorded every 4 hours. An automatic device 
should be used to stop the chain when the temperature drops below that 
specified in the scheduled process. A means of preventing unauthorized 
speed changes shall be provided. A lock or a notice from management 
posted at or near the speed-adjusting device that provides a warning 
that only authorized persons are permitted to make adjustments is a 
satisfactory means of preventing unauthorized changes.
    (9) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the 
scheduled process, it shall be measured and recorded at intervals of 
sufficient frequency to ensure that the weight of the product does not 
exceed the maximum for the given container size specified in the 
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be 
observed and recorded at intervals of sufficient frequency to ensure 
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals 
not to exceed 15 minutes.
    (g) Aseptic processing and packaging systems--(1) Product 
sterilizer--(i) Equipment--(A) Temperature-indicating device. Each 
product sterilizer shall be equipped with at least one temperature-
indicating device that accurately indicates the temperature during 
processing. Each temperature-indicating device shall have a sensor and a 
display. Each temperature-indicating device and each reference device 
that is maintained by the processor shall be tested for accuracy against 
a reference device for which the accuracy is traceable to a National 
Institute of Standards and Technology (NIST), or other national 
metrology institute, standard reference device by appropriate standard 
procedures, upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure accuracy during processing. Each 
temperature-indicating device and each reference device that is 
maintained by the processor shall have a tag, seal, or other means of 
identity.
    (1) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (2) Records of the accuracy of the temperature-indicating device and 
of a reference device that is maintained by the processor shall be 
established and maintained in accordance with Sec. 113.100(c) and (d).
    (3) A temperature-indicating device that is defective or cannot be 
adjusted to the accurate calibrated reference device shall be repaired 
before further use or replaced.
    (4) A temperature-indicating device shall be accurate to 1 [deg]F 
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer 
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of 
graduated scale. A mercury-in-glass thermometer that has a divided 
mercury column shall be considered defective.
    (5) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The temperature-indicating device--
not the temperature-recording device--shall be

[[Page 366]]

the reference instrument for indicating the processing temperature.
    (B) Temperature-recording device. Each product sterilizer shall have 
an accurate temperature-recording device. Each temperature-recording 
device shall have a sensor and a mechanism for recording temperatures to 
a permanent record, such as a temperature-recording chart. A 
temperature-recording device sensor shall be installed in the product at 
the holding-tube outlet between the holding tube and the inlet to the 
cooler. Additional temperature-recording device sensors shall be located 
at each point where temperature is specified as a critical factor in the 
scheduled process.
    (1) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the desired product sterilization temperature. 
Chart graduations shall not exceed 2 [deg]F (1 [deg]C) within a range of 
10 [deg]F (5 [deg]C) of the process temperature. Temperature-recording 
devices that create multipoint plottings of temperature readings shall 
record the temperature at intervals that will assure that the parameters 
of the process time and process temperature have been met.
    (2) Digital recordings. Temperature-recording devices, such as data 
loggers, that record numbers or create other digital recordings may be 
used. Such a device shall record the temperature at intervals that will 
assure that the parameters of the process time and process temperature 
have been met.
    (3) Adjustments. The temperature-recording device shall be adjusted 
with sufficient frequency to ensure agreement as nearly as possible 
with, but to be in no event higher than, the temperature-indicating 
device during processing. A means of preventing unauthorized changes in 
adjustment shall be provided. A lock or a notice from management posted 
at or near the temperature-recording device that provides a warning that 
only authorized persons are permitted to make adjustments is a 
satisfactory means of preventing unauthorized changes.
    (C) Temperature controller. An accurate temperature controller shall 
be installed and capable of ensuring that the desired product 
sterilization temperature is maintained. Air-operated temperature 
controllers should have adequate filter systems to ensure a supply of 
clean, dry air.
    (D) Product-to-product regenerators. When a product-to-product 
regenerator is used to heat the cold unsterilized product entering the 
sterilizer by means of a heat exchange system, it shall be designed, 
operated, and controlled so that the pressure of the sterilized product 
in the regenerator is greater than the pressure of any unsterilized 
product in the regenerator to ensure that any leakage in the regenerator 
is from the sterilized product into the unsterilized product.
    (E) Differential pressure recorder-controller. When a product-to-
product regenerator is used, it shall be equipped with an accurate 
differential pressure recorder-controller. The differential pressure 
recorder-controller shall be accurate to within 2 pounds per square inch 
(13.8 kilopascals). One pressure sensor shall be installed at the 
sterilized product regenerator outlet and the other pressure sensor 
shall be installed at the unsterilized product regenerator inlet. The 
sensor and recorder of the differential pressure recorder-controller 
shall be tested for accuracy against an accurate reference device upon 
installation and at least once every 3 months of operation thereafter, 
or more frequently if necessary, to ensure its accuracy.
    (1) Analog or graphical recordings. Differential pressure recorder-
controllers that create analog or graphical recordings may be used. 
Differential pressure recorder-controllers that record to charts shall 
be used only with the appropriate chart. The scale divisions of the 
chart shall not exceed 2 pounds per square inch (13.8 kilopascals) on a 
working scale of not more than 20 pounds per square inch per inch of 
scale (55 kilopascals per centimeter).
    (2) Digital recordings. Differential pressure recorder-controllers, 
such as data loggers, that record numbers or create other digital 
recordings may be

[[Page 367]]

used. Such differential pressure recorder-controllers shall record the 
differential pressure at intervals that will assure that the minimum 
differential pressure is maintained.
    (F) Flow control. A flow control device shall be located upstream 
from the holding tube and shall be operated to maintain the required 
rate of product flow. A means of preventing unauthorized flow 
adjustments shall be provided. A lock or a notice from management posted 
at or near the flow controlling device that provides a warning that only 
authorized persons are permitted to make adjustments is a satisfactory 
means of preventing unauthorized changes.
    (G) Product holding tube. The product-sterilizing holding tube shall 
be designed to give continuous holding of every particle of food for at 
least the minimum holding time specified in the scheduled process. The 
holding tube shall be designed so that no portion of the tube between 
the product inlet and the product outlet can be heated, and it must be 
sloped upward at least \1/4\-inch per foot (2.1 centimeters per meter).
    (H) Flow-diversion systems. If a processor elects to install a flow-
diversion system, it should be installed in the product piping located 
between the product cooler and the product filler or aseptic surge tank 
and should be designed to divert flow away from the filler or aseptic 
surge tank automatically. Controls and/or warning systems should be 
designed and installed with necessary sensors and actuators to operate 
whenever the sterilizing temperature in the holding tube or pressure 
differential in the product regenerator drops below specified limits. 
Flow-diversion systems should be designed and operated in accordance 
with recommendations of an aseptic processing and packaging authority.
    (I) Equipment downstream from the holding tube. Product coolers, 
aseptic surge tanks, or any other equipment downstream from the holding 
tube, with rotating or reciprocating shafts, valve stems, instrument 
connections, or other such points, are subject to potential entry of 
microorganisms into the product. Such locations in the system should be 
equipped with steam seals or other effective barriers at the potential 
access points. Appropriate means should be provided to permit the 
operator to monitor the performance of the seals or barriers during 
operations.
    (ii) Operation--(A) Startup. Before the start of aseptic processing 
operations the product sterilizer and all product-contact surfaces 
downstream shall be brought to a condition of commercial sterility.
    (B) Temperature drop in product-sterilizing holding tube. When 
product temperature in the holding tube drops below the temperature 
specified in the scheduled process, product flow should be diverted away 
from the filler or aseptic surge tank by means of a flow-diversion 
system. If for any reason product subjected to a temperature drop below 
the scheduled process is filled into containers, the product shall be 
segregated from product that received the scheduled process. The 
processing deviation shall be handled in accordance with Sec. 113.89. 
The product holding tube and any further system portions affected shall 
be returned to a condition of commercial sterility before product flow 
is resumed to the filler or to the aseptic surge tank.
    (C) Loss of proper pressures in the regenerator. When a regenerator 
is used, the product may lose sterility whenever the pressure of 
sterilized product in the regenerator is less than 1 pound per square 
inch (6.9 kilopascals) greater than the pressure of unsterilized product 
in the regenerator. In this case, product flow should be diverted away 
from the filler or aseptic surge tank by means of the flow-diversion 
system. If for any reason the product is filled into containers, the 
product shall be segregated from product that received the scheduled 
process. The processing deviation shall be handled in accordance with 
Sec. 113.89. Product flow to the filler or to the aseptic surge tank 
shall not be resumed until the cause of the improper pressure 
relationships in the regenerator has been corrected and the affected 
system(s) has been returned to a condition of commercial sterility.
    (D) Loss of sterile air pressure or other protection level in the 
aseptic surge tank. When an aseptic surge tank is used, conditions of 
commercial sterility may

[[Page 368]]

be lost when the sterile air overpressure or other means of protection 
drops below the scheduled process value. Product flow to and/or from the 
aseptic surge tank shall not be resumed until the potentially 
contaminated product in the tank is removed, and the aseptic surge tank 
has been returned to a condition of commercial sterility.
    (E) Records. Readings at the following points shall be observed and 
recorded at the start of aseptic packaging operations and at intervals 
of sufficient frequency to ensure that these values are as specified in 
the scheduled process: Temperature-indicating device in holding tube 
outlet; temperature-recording device in holding tube outlet; 
differential pressure recorder-controller, if a product-to-product 
regenerator is used; product flow rate as established by the flow 
control device or as determined by filling and closing rates and, if an 
aseptic surge tank is used, sterile air pressure or other protection 
means; and proper performance of steam seals or other similar devices. 
The measurements and recordings should be made at intervals not to 
exceed 1 hour.
    (2) Container sterilizing, filling, and closing operation--(i) 
Equipment--(A) Recording device. The container and closure sterilization 
system and product filling and closing system shall be instrumented to 
demonstrate that the required sterilization is being accomplished 
continuously. Recording devices shall be used to record, when 
applicable, the sterilization media flow rates, temperature, 
concentration, or other factors. When a batch system is used for 
container sterilization, the sterilization conditions shall be recorded.
    (B) Timing method(s). A method(s) shall be used either to give the 
retention time of containers, and closures if applicable, in the 
sterilizing environment specified in the scheduled process, or to 
control the sterilization cycle at the rate specified in the scheduled 
process. A means of preventing unauthorized speed changes must be 
provided. A lock or a notice from management posted at or near the speed 
adjusting device that provides a warning that only authorized persons 
are permitted to make adjustments is a satisfactory means of preventing 
unauthorized changes.
    (ii) Operation--(A) Startup. Before the start of packaging 
operations, both the container and closure sterilizing system and the 
product filling and closing system shall be brought to a condition of 
commercial sterility.
    (B) Loss of sterility. A system shall be provided to stop packaging 
operations, or alternatively to ensure segregation of any product 
packaged when the packaging conditions fall below scheduled processes. 
Compliance with this requirement may be accomplished by diverting 
product away from the filler, by preventing containers from entering the 
filler, or by other suitable means. In the event product is packaged 
under conditions below those specified in the scheduled process, all 
such product shall be segregated from product that received the 
scheduled process. The processing deviation shall be handled in 
accordance with Sec. 113.89. In the event of loss of sterility, the 
system(s) shall be returned to a condition of commercial sterility 
before resuming packaging operations.
    (C) Records. Observations and measurements of operating conditions 
shall be made and recorded at intervals of sufficient frequency to 
ensure that commercial sterility of the food product is being achieved; 
such measurements shall include the sterilization media flow rates, 
temperatures, the container and closure rates (if applicable) through 
the sterilizing system, and the sterilization conditions if a batch 
system is used for container sterilization. The measurements and 
recordings should be made at intervals not to exceed 1 hour.
    (3) Incubation. Incubation tests should be conducted on a 
representative sample of containers of product from each code; records 
of the test results should be maintained.
    (4) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. Such measurements and 
recordings should be done at intervals not to exceed 15 minutes.

[[Page 369]]

    (h) Equipment and procedures for flame sterilizers. The container 
conveyor speed shall be specified in the scheduled process. The 
container conveyor speed shall be measured and recorded at the start of 
operations and at intervals of sufficient frequency to ensure that the 
conveyor speed is as specified in the scheduled process. Such 
measurements and recordings should be done at 1-hour intervals. 
Alternatively, a recording tachometer may be used to provide a 
continuous record of the speed. A means of preventing changes in flame 
intensity and unauthorized speed changes on the conveyor shall be 
provided. A lock or a notice from management posted at or near the speed 
adjusting device that provides a warning that only authorized persons 
are permitted to make adjustments is a satisfactory means of preventing 
unauthorized changes. The surface temperature of at least one container 
from each conveyor channel shall be measured and recorded at the entry 
and at the end of the holding period at intervals of sufficient 
frequency to ensure that the temperatures specified in the scheduled 
process are maintained. Such measurements and recordings should be done 
at intervals not to exceed 15 minutes.
    (1) Process interruption. In the event of process interruption 
wherein the temperature of the product may have dropped, an authorized, 
scheduled emergency plan approved by a qualified person having expert 
knowledge of the process requirements may be used.
    (2) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) Equipment and procedures for thermal processing of foods wherein 
critical factors such as water activity are used in conjunction with 
thermal processing. The methods and controls used for the manufacture, 
processing, and packing of such foods shall be as established in the 
scheduled process and shall be operated or administered in a manner 
adequate to ensure that the product is safe. The time and temperature of 
processing and other critical factors specified in the scheduled process 
shall be measured with instruments having the accuracy and dependability 
adequate to ensure that the requirements of the scheduled process are 
met. All measurements shall be made and recorded at intervals of 
sufficient frequency to ensure that the critical factors are within the 
limits specified in the scheduled process.
    (j) Other systems. All systems, whether or not specifically 
mentioned in this part, for the thermal processing of low-acid foods in 
hermetically sealed containers shall conform to the applicable 
requirements of this part and the methods and controls used for the 
manufacture, processing, and packing of these foods shall be as 
established in the scheduled process. These systems shall be operated or 
administered in a manner adequate to ensure that commercial sterility is 
achieved. Critical factors specified in the scheduled process shall be 
measured and recorded at intervals of sufficient frequency to ensure 
that the critical factors are within the limits specified in the 
scheduled process.

[76 FR 11906, Mar. 3, 2011; 76 FR 81363, Dec. 28, 2011]



Subpart D_Control of Components, Food Product Containers, Closures, and 
                          In-Process Materials



Sec. 113.60  Containers.

    (a) Closures. Regular observations shall be maintained during 
production runs for gross closure defects. Any such defects shall be 
recorded and corrective action taken and recorded. At intervals of 
sufficient frequency to ensure proper closure, the operator, closure 
supervisor, or other qualified container closure inspection person shall 
visually examine either the top seam of a can randomly selected from 
each seaming head or the closure of any other type of container being 
used and shall record the observations made. For double-seam cans, each 
can should be examined for cutover or sharpness, skidding or 
deadheading, false seam, droop at the crossover or lap, and condition of 
inside of countersink wall for evidence of broken chuck. Such 
measurements

[[Page 370]]

and recordings should be made at intervals not to exceed 30 minutes. 
Additional visual closure inspections shall be made immediately 
following a jam in a closing machine, after closing machine adjustment, 
or after startup of a machine following a prolonged shutdown. All 
pertinent observations shall be recorded. When irregularities are found, 
the corrective action shall be recorded.
    (1) Teardown examinations for double-seam cans shall be performed by 
a qualified individual and the results therefrom shall be recorded at 
intervals of sufficient frequency on enough containers from each seaming 
station to ensure maintenance of seam integrity. Such examinations and 
recordings should be made at intervals not to exceed 4 hours. The 
results of the teardown examinations shall be recorded and the 
corrective action taken, if any, shall be noted.
    (i) Required and optional can seam measurements:
    (a) Micrometer measurement system:

------------------------------------------------------------------------
            Required                             Optional
------------------------------------------------------------------------
Cover hook                        Overlap (by calculation).
Body hook                         Countersink.
Width (length, height)            ......................................
Tightness (observation for        ......................................
 wrinkle)
Thickness                         ......................................
------------------------------------------------------------------------

    (b) Seam scope or projector:

------------------------------------------------------------------------
             Required                             Optional
------------------------------------------------------------------------
Body hook                          Width (length, height).
Overlap                            Cover hook.
Tightness (observation for         Countersink.
 wrinkle)
Thickness by micrometer            .....................................
------------------------------------------------------------------------

    (c) Can double seam terminology:

[[Page 371]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.376

    (1) ``Crossover'': The portion of a double seam at the lap.
    (2) ``Cutover'': A fracture, sharp bend, or break in the metal at 
the top of the inside portion of the double seam.

[[Page 372]]

    (3) ``Deadhead'': A seam which is incomplete due to chuck spinning 
in the countersink.
    (4) ``Droop'': Smooth projection of double seam below bottom of 
normal seam.
    (5) ``False seam'': A small seam breakdown where the cover hook and 
the body hook are not overlapped.
    (6) ``Lap'': Two thicknesses of material bonded together.
    (ii) Two measurements at different locations, excluding the side 
seam, shall be made for each double seam characteristic if a seam scope 
or seam projector is used. When a micrometer is used, three measurements 
shall be made at points approximately 120[deg] apart, excluding the side 
seam.
    (iii) Overlap length can be calculated by the following formula:


The theoretical overlap length = CH + BH + T - W, where

    CH = cover hook
    BH = body hook
    T = cover thickness, and
    W = seam width (height, length)

    (2) For glass containers with vacuum closures, capper efficiency 
must be checked by a measurement of the cold water vacuum. This shall be 
done before actual filling operations, and the results shall be 
recorded.
    (3) For closures other than double seams and glass containers, 
appropriate detailed inspections and tests shall be conducted by 
qualified personnel at intervals of sufficient frequency to ensure 
proper closing machine performance and consistently reliable hermetic 
seal production. Records of such tests shall be maintained.
    (b) Cooling water. Container cooling water shall be chlorinated or 
otherwise sanitized as necessary for cooling canals and for recirculated 
water supplies. There should be a measurable residual of the sanitizer 
employed at the water discharge point of the container cooler.
    (c) Coding. Each hermetically sealed container of low-acid processed 
food shall be marked with an identifying code that shall be permanently 
visible to the naked eye. When the container does not permit the code to 
be embossed or inked, the label may be legibly perforated or otherwise 
marked, if the label is securely affixed to the product container. The 
required identification shall identify in code the establishment where 
packed, the product contained therein, the year packed, the day packed, 
and the period during which packed. The packing period code shall be 
changed with sufficient frequency to enable ready identification of lots 
during their sale and distribution. Codes may be changed on the basis of 
one of the following: intervals of 4 to 5 hours; personnel shift 
changes; or batches, as long as the containers that constitute the batch 
do not extend over a period of more than one personnel shift.
    (d) Postprocess handling. Container handling equipment used in 
handling filled containers shall be designed, constructed, and operated 
to preserve the can seam or other container closure integrity. Container 
handling equipment, including automated and non-automated equipment, 
shall be checked with sufficient frequency and repaired or replaced as 
necessary to prevent damage to containers and container closures. When 
cans are handled on belt conveyors, the conveyors should be constructed 
to minimize contact by the belt with the double seam, i.e., cans should 
not be rolled on the double seam. All worn and frayed belting, can 
retarders, cushions, etc. should be replaced with new nonporous 
material. All tracks and belts that come into contact with the can seams 
should be thoroughly scrubbed and sanitized at intervals of sufficient 
frequency to avoid product contamination.

[44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11922, Mar. 3, 2011]



                Subpart E_Production and Process Controls



Sec. 113.81  Product preparation.

    (a) Before using raw materials and ingredients susceptible to 
microbiological contamination, the processor shall ensure that those 
materials and ingredients are suitable for use in processing low-acid 
food. Compliance with this requirement may be accomplished by receiving 
the raw materials and ingredients under a supplier's

[[Page 373]]

guarantee that they are suitable for use, by examining them for their 
microbiological condition, or by other acceptable means.
    (b) Blanching by heat, when required in the preparation of food for 
canning, should be effected by heating the food to the required 
temperature, holding it at this temperature for the required time, and 
then either rapidly cooling the food or passing it to subsequent 
processing without delay. Thermophilic growth and contamination in 
blanchers should be minimized by the use of adequate operating 
temperatures and by cleaning. If the blanched food product is washed 
before filling, potable water should be used.
    (c) The filling of containers, either mechanically or by hand, shall 
be controlled so as to ensure that the filling requirements specified in 
the scheduled process are met.
    (d) The exhausting of containers for the removal of air shall be 
controlled so as to meet the conditions for which the process was 
designed. Compliance with the requirement may be accomplished by heat 
exhausting, mechanical exhausting, hot brining, or steam injection.
    (e) When the maintenance of pH (above 4.6) of a normally low-acid 
food is a basis for a scheduled process, there shall be careful 
supervision to ensure that the equilibrium pH of the finished product 
meets that of the scheduled process. The methodology described in Sec. 
114.90 of this chapter should be used.
    (f) When the scheduled process sets forth critical factors to 
prevent the growth of microorganisms not destroyed by the thermal 
process, the factors shall be carefully controlled to ensure that the 
limits established in the scheduled process are not exceeded. When 
normally low-acid foods require sufficient solute to permit safe 
processing at low temperatures, such as in boiling water, there shall be 
careful supervision to ensure that the equilibrium water activity 
(aw) of the finished product meets that of the scheduled 
process. The scheduled thermal processes for foods having an 
aw greater than 0.85 and less than the aw that 
would allow the growth of spores of microorganisms of public health 
significance shall be sufficient to render the food free of 
microorganisms capable of reproducing in the food under normal 
nonrefrigerated conditions of storage and distribution.



Sec. 113.83  Establishing scheduled processes.

    Scheduled processes for low-acid foods shall be established by 
qualified persons having expert knowledge of thermal processing 
requirements for low-acid foods in hermetically sealed containers and 
having adequate facilities for making such determinations. The type, 
range, and combination of variations encountered in commercial 
production shall be adequately provided for in establishing the 
scheduled process. Variations include those that occur due to seasonal 
or growing fluctuations, variety differences, supplier processes, 
reprocessing, and mixing a batch of processed product with the same 
unprocessed product before it is processed. Critical factors, e.g., 
minimum headspace, consistency, maximum fill-in or drained weight, 
aw, etc., that may affect the scheduled process, shall be 
specified in the scheduled process. Acceptable scientific methods of 
establishing heat sterilization processes shall include, when necessary, 
but shall not be limited to, the use of microbial thermal death time 
data, process calculations based on product heat penetration data, and 
inoculated packs. Calculation shall be performed according to procedures 
recognized by competent processing authorities. If incubation tests are 
necessary for process confirmation, they shall include containers from 
test trials and from actual commercial production runs during the period 
of instituting the process. The incubation tests for confirmation of the 
scheduled processes should include the containers from the test trials 
and a number of containers from each of four or more actual commercial 
production runs. The number of containers from actual commercial 
production runs should be determined on the basis of recognized 
scientific methods to be of a size sufficient to ensure the adequacy of 
the process. Complete records covering all aspects of the establishment 
of the process and associated incubation tests shall be

[[Page 374]]

prepared and shall be permanently retained by the person or organization 
making the determination.

[76 FR 11922, Mar. 3, 2011]



Sec. 113.87  Operations in the thermal processing room.

    (a) Operating processes and retort venting procedures to be used for 
each product and container size being packed shall either be posted in a 
conspicuous place near the processing equipment or be made readily 
available to the retort or processing system operator and any duly 
authorized employee of the Food and Drug Administration. Scheduled 
processes must be made readily available to the supervisor and any duly 
authorized employee of the Food and Drug Administration.
    (b) A system for product traffic control in the retort room shall be 
established to prevent unretorted product from bypassing the retort 
process. Each retort basket, truck, car, or crate used to hold 
containers in a retort, or one or more containers therein, shall, if it 
contains any retorted food product, be plainly and conspicuously marked 
with a heat-sensitive indicator, or by other effective means that will 
indicate visually, to thermal processing personnel, those units that 
have been retorted. A visual check shall be performed to determine 
whether or not the appropriate change has occurred in the heat-sensitive 
indicator as a result of retorting for all retort baskets, trucks, cars, 
or crates, to ensure that each unit of product has been retorted. A 
record of these checks should be made.
    (c) The initial temperature of the contents of the containers to be 
processed shall be accurately determined and recorded with sufficient 
frequency to ensure that the temperature of the product is no lower than 
the minimum initial temperature specified in the scheduled process. For 
those operations that use water during the filling of the retort or 
during processing, provision shall be made to ensure that the water will 
not, before the start of each thermal process, lower the initial 
temperature of the product below that specified in the scheduled 
process. The temperature-indicating device used to determine the initial 
temperature shall be tested for accuracy against a reference device for 
which the accuracy is traceable to a National Institute of Standards and 
Technology (NIST), or other national metrology institute, standard 
reference device, by appropriate standard procedures, with sufficient 
frequency to ensure that initial temperature measurements are accurate. 
Records of the accuracy of the temperature-indicating device and of a 
reference device that is maintained by the processor shall be 
established and maintained in accordance with Sec. 113.100(c) and (d).
    (d) Timing devices used in recording thermal process time 
information shall be accurate to the extent needed to ensure that the 
processing time and venting time specified in the scheduled process are 
achieved. Pocket or wrist watches are not considered satisfactory for 
timing purposes. Digital clocks may be used if the operating process and 
the venting schedule have a 1-minute or greater safety factor over the 
scheduled process.
    (e) Clock times on temperature-recording device records shall 
reasonably correspond to the time of day on the processing records to 
provide correlation of these records.
    (f) The steam supply to the thermal processing system shall be 
adequate to the extent needed to ensure that sufficient steam pressure 
is maintained during thermal processing, regardless of other demands of 
steam by the plant.
    (g) If mufflers are used on bleeders or vent systems, evidence that 
the bleeders or vents are operated in a manner that does not 
significantly impede the removal of air shall be kept on file. This 
evidence may be in the form of heat distribution data or other 
satisfactory evidence such as a letter from the manufacturer, the 
designer, or a competent processing authority.

[44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11923, Mar. 3, 2011]



Sec. 113.89  Deviations in processing, venting, or control of critical
factors.

    Whenever any process is less than the scheduled process or when 
critical factors are out of control for any low-acid food or container 
system as disclosed

[[Page 375]]

from records by processor check or otherwise, the commerical processor 
of that low-acid food shall either fully reprocess that portion of the 
production involved, keeping full records of the reprocessing conditions 
or, alternatively, must set aside that portion of the product involved 
for further evaluation as to any potential public health significance. 
Such evaluation shall be made by a competent processing authority and 
shall be in accordance with procedures recognized by competent 
processing authorities as being adequate to detect any potential hazard 
to public health. Unless this evaluation demonstrates that the product 
had been given a thermal process that rendered it free of microorganisms 
of potential public health significance, the product set aside shall be 
either fully reprocessed to render it commercially sterile or destroyed. 
A record shall be made of the evaluation procedures used and the 
results. Either upon completion of full reprocessing and the attainment 
of commerical sterility or after the determination that no significant 
potential for public health hazard exists, that portion of the product 
involved may be shipped in normal distribution. Otherwise, the portion 
of the product involved shall be destroyed. All process deviations 
involving a failure to satisfy the minimum requirements of the scheduled 
process, including emergencies arising from a jam or breakdown of a 
continuous agitating retort necessitating cooling the retort for 
repairs, shall be recorded and made the subject of a separate file (or a 
log identifying the appropriate data) detailing those deviations and the 
actions taken.



                      Subpart F_Records and Reports



Sec. 113.100  Processing and production records.

    (a) Processing and production information shall be entered at the 
time it is observed by the retort or processing system operator, or 
other designated person, on forms that include the product, the code 
number, the date, the retort or processing system number, the size of 
container, the approximate number of containers per coding interval, the 
initial temperature, the actual processing time, the temperature-
indicating device and temperature-recording device readings, and other 
appropriate processing data. Closing machine vacuum in vacuum-packed 
products, maximum fill-in or drained weight, or other critical factors 
specified in the scheduled process shall also be recorded. In addition, 
the following records shall be maintained:
    (1) Still retorts. Time steam on; time temperature up to processing 
temperature; time steam off; venting time and temperature to which 
vented.
    (2) Agitating retorts. Functioning of condensate bleeder; retort 
speed; and, when specified in the scheduled process, headspace, 
consistency, maximum drained weight, minimum net weight, and percent 
solids.
    (3) Hydrostatic retorts. The temperature in the steam chamber 
between the steam-water interface and the lowest container position; 
speed of the container conveyor chain; and, when the scheduled process 
specifies maintenance of particular temperatures in the hydrostatic 
water legs, the temperatures near the top and the bottom of each 
hydrostatic water leg.
    (4) Aseptic processing and packaging systems. Product temperature in 
the holding tube outlet as indicated by the temperature-indicating 
device and the temperature-recording device; differential pressure as 
indicated by the differential pressure recorder-controller, if a 
product-to-product regenerator is used; product flow rate, as determined 
by the flow controlling device or by filling and closing rates; 
sterilization media flow rate or temperature or both; retention time of 
containers, and closures when applicable, in the sterilizing 
environment; and, when a batch system is used for container and/or 
closure sterilization, sterilization cycle times and temperatures.
    (5) Flame sterilizers. Container conveyor speed; surface temperature 
at the beginning and at the end of the holding period; nature of 
container.
    (6) Food preservation methods wherein critical factors such as water 
activity are used in conjunction with thermal processing. Product 
formulation and scheduled processes used, including the thermal process, 
its associated critical factors, as well as other critical factors, and 
results of aw determinations.

[[Page 376]]

    (7) Other systems. Critical factors specified in the formulation of 
the product or in the scheduled process.
    (b) Temperature-recording device records shall be identified by 
date, retort number, and other data as necessary, so they can be 
correlated with the record of lots processed. Each entry on the 
processing and production records shall be made by the retort or 
processing system operator, or other designated person, at the time the 
specific retort or processing system condition or operation occurs, and 
this retort or processing system operator or other designated person 
shall sign or initial each record form. Not later than 1 working day 
after the actual process, and before shipment or release for 
distribution, a representative of plant management who is qualified by 
suitable training or experience shall review all processing and 
production records for completeness and to ensure that the product 
received the scheduled process. The records, including temperature-
recording device records, shall be signed or initialed and dated by the 
reviewer.
    (c) Records of the accuracy of a temperature-indicating device shall 
include:
    (1) A reference to the tag, seal, or other means of identity used by 
the processor to identify the temperature-indicating device;
    (2) The name of the manufacturer of the temperature-indicating 
device;
    (3) The identity of the reference device, equipment, and procedures 
used for the accuracy test and to adjust the temperature-indicating 
device or, if an outside facility is used to conduct the accuracy test 
for the temperature-indicating device, a guarantee, certificate of 
accuracy, certificate of calibration, or other document from the 
facility that includes a statement or other documentation regarding the 
traceability of the accuracy to a National Institute of Standards and 
Technology (NIST) or other national metrology institute standard;
    (4) The identity of the person or facility that performed the 
accuracy test and adjusted or calibrated the temperature-indicating 
device;
    (5) The date and results of each accuracy test, including the amount 
of calibration adjustment; and
    (6) The date on or before which the next accuracy test must be 
performed.
    (d) Records of the accuracy of a reference device maintained by the 
processor shall include:
    (1) A reference to the tag, seal, or other means of identity used by 
the processor to identify the reference device;
    (2) The name of the manufacturer of the reference device;
    (3) The identity of the equipment and reference to procedures used 
for the accuracy test and to adjust or calibrate the reference device 
or, if an outside facility is used to conduct the accuracy test for the 
reference device, a guarantee, certificate of accuracy, certificate of 
calibration, or other document from the facility that includes a 
statement or other documentation regarding the traceability of the 
accuracy to a NIST or other national metrology institute standard;
    (4) The identity of the person or facility that performed the 
accuracy test and adjusted or calibrated the reference device;
    (5) The date and results of each accuracy test, including the amount 
of calibration adjustment; and
    (6) The date on or before which the next accuracy test must be 
performed.
    (e) Records of all container closure examinations shall specify the 
product code, the date and time of container closure inspections, the 
measurements obtained, and all corrective actions taken. Records shall 
be signed or initialed by the container closure inspector and reviewed 
by management with sufficient frequency to ensure that the containers 
are hermetically sealed. The records shall be signed or initialed and 
dated by the reviewer.
    (f) Records shall be maintained to identify the initial distribution 
of the finished product to facilitate, when necessary, the segregation 
of specific food lots that may have become contaminated or otherwise 
rendered unfit for their intended use.
    (g) Copies of all records provided for in this part, except those 
required under Sec. 113.83 establishing scheduled

[[Page 377]]

processes, shall be retained at the processing plant for a period of not 
less than 1 year from the date of manufacture, and at the processing 
plant or other reasonably accessible location for an additional 2 years. 
If, during the first year of the 3-year record-retention period, the 
processing plant is closed for a prolonged period between seasonal 
packs, the records may be transferred to some other reasonably 
accessible location at the end of the seasonal pack.
    (h) Records of this part may be maintained electronically, provided 
they are in compliance with part 11 of this chapter.

[44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11923, Mar. 3, 2011]



PART 114_ACIDIFIED FOODS--Table of Contents



                      Subpart A_General Provisions

Sec.
114.3 Definitions.
114.5 Current good manufacturing practices.
114.10 Personnel.

Subparts B-D [Reserved]

                Subpart E_Production and Process Controls

114.80 Processes and controls.
114.83 Establishing scheduled processes.
114.89 Deviations from scheduled procedures.
114.90 Methodology.

                      Subpart F_Records and Reports

114.100 Records.

    Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.

    Source: 44 FR 16235, Mar. 16, 1979, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 114.3  Definitions.

    For the purposes of this part, the following definitions apply.
    (a) Acid foods means foods that have a natural pH of 4.6 or below.
    (b) Acidified foods means low-acid foods to which acid(s) or acid 
food(s) are added; these foods include, but are not limited to, beans, 
cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical 
fruits, and fish, singly or in any combination. They have a water 
activity (aw) greater than 0.85 and have a finished 
equilibrium pH of 4.6 or below. These foods may be called, or may 
purport to be, ``pickles'' or ``pickled ___.'' Carbonated beverages, 
jams, jellies, preserves, acid foods (including such foods as 
standardized and nonstandardized food dressings and condiment sauces) 
that contain small amounts of low-acid food(s) and have a resultant 
finished equilibrium pH that does not significantly differ from that of 
the predominant acid or acid food, and foods that are stored, 
distributed, and retailed under refrigeration are excluded from the 
coverage of this part.
    (c) Lot means the product produced during a period indicated by a 
specific code.
    (d) Low-acid foods means any foods, other than alcoholic beverages, 
with a finished equilibrium pH greater than 4.6 and a water activity 
(aw) greater than 0.85. Tomatoes and tomato products having a 
finished equilibrium pH less than 4.7 are not classed as low-acid foods.
    (e) Scheduled process means the process selected by a processor as 
adequate for use under the conditions of manufacture for a food in 
achieving and maintaining a food that will not permit the growth of 
microorganisms having public health significance. It includes control of 
pH and other critical factors equivalent to the process established by a 
competent processing authority.
    (f) Shall is used to state mandatory requirements.
    (g) Should is used to state recommended or advisory procedures or to 
identify recommended equipment.
    (h) Water activity (aw) is a measure of the free moisture 
in a product and is the quotient of the water vapor pressure of the 
substance divided by the vapor pressure of pure water at the same 
temperature.

[44 FR 16235, Mar. 16, 1979, as amended at 61 FR 14245, Apr. 1, 1996]

[[Page 378]]



Sec. 114.5  Current good manufacturing practice.

    The criteria in Sec. Sec. 114.10, 114.80, 114.83, 114.89, and 
114.100, as well as the criteria in parts 110 and 117 of this chapter, 
apply in determining whether an article of acidified food is 
adulterated:
    (a) Within the meaning of section 402(a)(3) of the Federal Food, 
Drug, and Cosmetic Act in that it has been manufactured under such 
conditions that it is unfit for food; or
    (b) Within the meaning of section 402(a)(4) of the Federal Food, 
Drug, and Cosmetic Act in that 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.

[80 FR 56144, Sept. 17, 2015]



Sec. 114.10  Personnel.

    All operators of processing and packaging systems shall be under the 
operating supervisions of a person who has attended a school approved by 
the Commissioner for giving instruction in food-handling techniques, 
food-protection principles, personal hygiene and plant sanitation 
practices, pH controls and critical factors in acidification, and who 
has been identified by that school as having satisfactorily completed 
the prescribed course of instruction. The Commissioner will consider 
students who have satisfactorily completed the required portions of the 
courses presented under Sec. 108.35 and part 113 of this chapter before 
March 16, 1979, to be in compliance with the requirement of this 
section.

Subparts B-D [Reserved]



                Subpart E_Production and Process Controls



Sec. 114.80  Processes and controls.

    (a) Processing operations. The manufacturer shall employ appropriate 
quality control procedures to ensure that finished foods do not present 
a health hazard.
    (1) Acidified foods shall be so manufactured, processed, and 
packaged that a finished equilibrium pH value of 4.6 or lower is 
achieved within the time designated in the scheduled process and 
maintained in all finished foods. Manufacturing shall be in accordance 
with the scheduled process. Acidified foods shall be thermally processed 
to an extent that is sufficient to destroy the vegetative cells of 
microorganisms of public health significance and those of nonhealth 
significance capable of reproducing in the food under the conditions in 
which the food is stored, distributed, retailed and held by the user. 
Permitted preservatives may be used to inhibit reproduction of 
microorganisms of nonhealth significance (in lieu of thermal 
processing).
    (2) Sufficient control, including frequent testing and recording of 
results, shall be exercised so that the finished equilibrium pH values 
for acidified foods are not higher than 4.6. Measurement of acidity of 
foods in-process may be made by potentiometric methods, titratable 
acidity, or colorimetric methods. If the finished equilibrium pH of the 
food is above 4.0, the measurement of the finished equilibrium pH shall 
be by a potentiometric method, and the in-process measurements by 
titration or colorimetry shall be related to the finished equilibrium 
pH. If the finished equilibrium pH is 4.0 or below, then the measurement 
of acidity of the final product may be made by any suitable method. 
Special care should be taken when food ingredients have been subjected 
to lye, lime, or similar high pH materials.
    (3) Procedures for acidification to attain acceptable equilibrium pH 
levels in the final food include, but are not limited to, the following:
    (i) Blanching of the food ingredients in acidified aqueous 
solutions.
    (ii) Immersion of the blanched food in acid solutions. Although 
immersion of food in an acid solution is a satisfactory method for 
acidification, care must be taken to ensure that the acid concentration 
is properly maintained.
    (iii) Direct batch acidification, which can be achieved by adding a 
known amount of an acid solution to a specified amount of food during 
acidification.
    (iv) Direct addition of a predetermined amount of acid to individual 
containers during production. Liquid acids are generally more effective 
than

[[Page 379]]

solid or pelleted acids. Care must be taken to ensure that the proper 
amount of acid is added to each container.
    (v) Addition of acid foods to low-acid foods in controlled 
proportions to conform to specific formulations.
    (4) Testing and examinations of containers shall occur often enough 
to ensure that the container suitably protects the food from leakage or 
contamination.
    (b) Coding. Each container or product shall be marked with an 
identifying code permanently visible to the naked eye. If the container 
does not permit the code to be embossed or inked, the label may be 
legibly perforated or otherwise marked, as long as the label is securely 
affixed to the product container. The required identification shall 
specify in code the establishment where the product was packed, the 
product contained therein, and the year, day, and period during which it 
was packed. The packing period code shall be changed often enough to 
enable ready identification of lots during their sale and distribution. 
Codes may be changed periodically on one of the following bases: 
intervals of 4 to 5 hours; personnel shift changes; or batches, as long 
as the containers constituting the batch do not represent those 
processed during more than one personnel shift.



Sec. 114.83  Establishing scheduled processes.

    The scheduled process shall be established by a qualified person who 
has expert knowledge acquired through appropriate training and 
experience in the acidification and processing of acidified foods.



Sec. 114.89  Deviations from scheduled processes.

    Whenever any process operation deviates from the scheduled process 
for any acidified food and/or the equilibrium pH of the finished product 
is higher than 4.6, the commercial processor of the acidified food shall 
either: (a) Fully reprocess that portion of the food by a process 
established by a competent processing authority as adequate to ensure a 
safe product; (b) thermally process it as a low-acid food under part 113 
of this chapter; or (c) set aside that portion of the food involved for 
further evaluation as to any potential public health significance. The 
evaluation shall be made by a competent processing authority and shall 
be in accordance with procedures recognized by competent processing 
authorities as being adequate to detect any potential hazard to public 
health. Unless the evaluation demonstrates that the food has undergone a 
process that has rendered it safe, the food set aside shall either be 
fully reprocessed to render it safe, or be destroyed. A record shall be 
made of the procedures used in the evaluation and the results. Either 
upon completion of full reprocessing and the attainment of a safe food, 
or after the determination that no significant potential for public 
health hazard exists, that portion of the food involved may be shipped 
in normal distribution. Otherwise, the portion of the food involved 
shall be destroyed.



Sec. 114.90  Methodology.

    Methods that may be used to determine pH or acidity for acidified 
foods include, but are not limited to, the following:
    (a) Potentiometric method for the determination of pH--(1) 
Principles. The term ``pH'' is used to designate the intensity or degree 
of acidity. The value of pH, the logarithm of the reciprocal of the 
hydrogen ion concentration in solution, is determined by measuring the 
difference in potential between two electrodes immersed in a sample 
solution. A suitable system consists of a potentiometer, a glass 
electrode, and a reference electrode. A precise pH determination can be 
made by making an electromotive force (emf) measurement of a standard 
buffer solution whose pH is known, and then comparing that measurement 
to an emf measurement of a sample of the solution to be tested.
    (2) Instruments. The primary instrument for use in pH determination 
is the pH meter or potentiometer. For most work, an instrument with a 
direct-reading pH scale is necessary. Battery and line-operated 
instruments are available commercially. If the line voltage is unstable, 
line-operated instruments should be fitted with voltage regulators to 
eliminate drifting of

[[Page 380]]

meter-scale readings. Batteries should be checked frequently to ensure 
proper operation of battery operated instruments. An instrument using an 
expanded unit scale or a digital readout system is preferred since it 
allows more precise measurements.
    (3) Electrodes. The typical pH meter is equipped with a glass 
membrane electrode and a reference electrode or a single probe 
combination electrode. Various types of electrodes designed for specific 
uses are available. The most commonly used reference electrode is the 
calomel electrode, which incorporates a salt bridge filled with 
saturated potassium chloride solution.
    (i) Care and use of electrodes. Calomel electrodes should be kept 
filled with saturated potassium chloride solution or other solution 
specified by the manufacturer because they may become damaged if they 
are allowed to dry out. For best results, electrodes should be soaked in 
buffer solution, distilled or deionized water, or other liquid specified 
by the manufacturer for several hours before using and kept ready by 
storing with tips immersed in distilled water or in buffer solution used 
for standardization. Electrodes should be rinsed with water before 
immersing in the standard buffers and rinsed with water or the solution 
to be measured next between sample determinations. A lag in meter 
response may indicate aging effects or fouling of the electrodes, and 
cleaning and rejuvenation of the electrodes may be necessary and may be 
accomplished by placing the electrodes in 0.1 molar sodium hydroxide 
solution for 1 minute and then transferring them to 0.1 molar 
hydrochloric acid solution for 1 minute. The cycle should be repeated 
two times, ending with the electrodes in the acid solution. The 
electrodes should then be thoroughly rinsed with water and blotted with 
soft tissue before proceeding with the standardization.
    (ii) Temperature. To obtain accurate results, a uniform temperature 
should be maintained for the electrodes, the standard buffer solutions, 
and the samples. Tests should be made at a temperature between 20[deg] 
and 30 [deg]C, the optimum being 25 [deg]C. Any temperature 
determinations made without meter compensation may affect pH values. An 
automatic temperature compensator may be used.
    (iii) Accuracy. The accuracy of most pH meters is stated to be 
approximately 0.1 pH unit, and reproducibility is usually 0.05 pH unit or less. Some meters permit the expansion 
of any pH unit range to cover the entire scale and have an accuracy of 
approximately 0.01 pH unit and a reproducibility 
of 0.005 pH units.
    (4) General procedure for determining pH. When operating an 
instrument, the operator should use the manufacturer's instructions and 
should observe the following techniques for pH determinations:
    (i) Switch the instrument on and allow the electronic components to 
warm up and stabilize before proceeding.
    (ii) Standardize the instrument and electrodes with commercially 
prepared standard 4.0 pH buffer or with freshly prepared 0.05 molar 
potassium acid phthalate buffer solution prepared as outlined in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists'' (AOAC), 13th Ed. (1980), section 50.007(c), under ``Buffer 
Solutions for Calibration of pH Equipment--Official Final Action,'' 
which is incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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. Note 
the temperature of the buffer solution and set the temperature 
compensator control at the observed temperature (room temperature is 
near 25 [deg]C).
    (iii) Rinse the electrodes with water and blot, but do not wipe, 
with soft tissue.
    (iv) Immerse the tips in the buffer solution and take the pH 
reading, allowing about 1 minute for the meter to stabilize. Adjust the 
standardization control so that the meter reading corresponds to the pH 
of the known buffer (for example, 4.0) for the temperature observed. 
Rinse the electrodes with

[[Page 381]]

water and blot with soft tissue. Repeat procedure with fresh portions of 
buffer solution until the instrument remains in balance on two 
successive trials. To check the operation of the pH meter, check the pH 
reading using another standard buffer such as one having a pH of 7.0, or 
check it with freshly prepared 0.025 molar phosphate solution prepared 
as outlined in the AOAC, 13th Ed. (1980), section 50.007(e), which is 
incorporated by reference. The availability of this incorporation by 
reference is given in paragraph (a)(4)(ii) of this section. Expanded 
scale pH meters may be checked with pH 3.0 or pH 5.0 standard buffers. 
Buffers and instruments can be further checked by comparison with values 
obtained with a second properly standardized instrument.
    (v) Indicating electrodes may be checked for proper operation by 
first using an acid buffer and then a base buffer. First standardize the 
electrodes using a pH 4.0 buffer at or near 25 [deg]C. Standardization 
control should be adjusted so that the meter reads exactly 4.0. 
Electrodes should be rinsed with water, then blotted and immersed in a 
pH 9.18 borax buffer prepared as outlined in the AOAC, 13th Ed. (1980), 
section 50.007(f), which is incorporated by reference. The availability 
of this incorporation by reference is given in paragraph (a)(4)(ii) of 
this section. The pH reading should be within 0.3 
units of the 9.18 value.
    (vi) The pH meter can be tested for proper operation by shorting the 
glass and reference electrode inputs, thereby reducing the voltage to 
zero. In some meters this shorting is done by switching the instrument 
to standby, and in other instruments by use of a shorting strap. With 
the instrument shorted out, standardization control should be turned 
from one extreme to another. This operation should produce a deflection 
greater than 1.5 pH unit from center scale.
    (5) Determining pH on samples. (i) Adjust the temperature of the 
sample to room temperature (25 [deg]C), and set the temperature 
compensator control to the observed temperature. With some expanded 
scale instruments, the sample temperature must be the same as the 
temperature of the buffer solution used for the standardization.
    (ii) Rinse and blot the electrodes. Immerse the electrodes in the 
sample and take the pH reading, allowing 1 minute for the meter to 
stabilize. Rinse and blot the electrodes and repeat on a fresh portion 
of sample. Oil and grease from the samples may coat the electrodes; 
therefore, it is advisable to clean and standardize the instrument 
frequently. When oily samples cause fouling problems, it may become 
necessary to rinse the electrodes with ethyl ether.
    (iii) Determine two pH values on the well-mixed sample. These 
readings should agree with one another to indicate that the sample is 
homogeneous. Report values to the nearest 0.05 pH unit.
    (6) Preparation of samples. Some food products may consist of a 
mixture of liquid and solid components that differ in acidity. Other 
food products may be semisolid in character. The following are examples 
of preparation procedures for pH testing for each of these categories:
    (i) Liquid and solid component mixtures. Drain the contents of the 
container for 2 minutes on a U.S. standard No. 8 sieve (preferably 
stainless steel) inclined at a 17- to 20-degree angle. Record weight of 
the liquid and solid portions and retain each portion separately.
    (a) If the liquid contains sufficient oil to cause electrode 
fouling, separate the layers with a separatory funnel and retain the 
aqueous layer. The oil layer may be discarded. Adjust the temperature of 
the aqueous layer to 25 [deg]C and determine its pH.
    (b) Remove the drained solids from the sieve, blend to a uniform 
paste, adjust the temperature of the paste to 25 [deg]C and determine 
its pH.
    (c) Mix aliquots of solid and liquid fractions in the same ratio as 
found in the original container and blend to a uniform consistency. 
Adjust the temperature of the blend to 25 [deg]C and determine the 
equilibriated pH. Alternatively, blend the entire contents of the 
container to a uniform paste, adjust the temperature of the paste to 25 
[deg]C, and determine the equilibriated pH.

[[Page 382]]

    (ii) Marinated oil products. Separate the oil from the solid 
product. Blend the solid in a blender to a paste consistency; it may 
become necessary to add a small amount of distilled water to some 
samples to facilitate the blending. A small amount of added water will 
not alter the pH of most food products, but caution must be exercised 
concerning poorly buffered foods. No more than 20 milliliters of 
distilled water should be added to each 100 grams of product. Determine 
the pH by immersing electrodes in the prepared paste after adjusting the 
temperature to 25 [deg]C.
    (iii) Semisolid products. Food products of a semisolid consistency, 
such as puddings, potato salad, etc., may be blended to a paste 
consistency, and the pH may be determined on the prepared paste. If more 
fluidity is required, 10 to 20 milliliters of distilled water may be 
added to 100 grams of product. Adjust the temperature of the prepared 
paste to 25 [deg]C and determine its pH.
    (iv) Special product mixtures. For special product mixtures such as 
antipasto, pour off the oil, blend the remaining product to a paste, and 
determine the pH of the blended paste. If more fluidity is required, add 
10 to 20 milliliters of distilled water to each 100 grams of product and 
blend. Adjust the temperature of the prepared paste to 25 [deg]C and 
determine its pH.
    (7) Process pH determination. Obtain sample portions of material for 
pH determination.
    (i) For process liquids, adjust the temperature of the liquid to 25 
[deg]C and determine the pH by immersing the electrodes in the liquid.
    (ii) Drain solid materials on a sieve and blend to a workable paste. 
Adjust the temperature of the prepared paste to 25 [deg]C and determine 
its pH.
    (iii) If enough solid materials are available to make a paste, blend 
representative aliquots of liquid and solid materials to a workable 
paste. Adjust the temperature of the prepared paste to 25 [deg]C and 
determine the equilibrated pH. Alternatively, blend the entire contents 
of the container to a uniform paste, adjust the temperature of the paste 
to 25 [deg]C, and determine the equilibrated pH.
    (b) Colorimetric methods for the determination of pH. This method 
may be used in lieu of the potentiometric method if the pH is 4.0 or 
lower.
    (1) Principle. The colorimetric method for pH involves the use of 
indicator dyes in solutions that gradually change color over limited pH 
ranges. An indicator that has the greatest color change at approximately 
the pH of the sample being tested is selected. The pH is determined by 
the color of the indicator when exposed to the sample under test.
    (2) Indicator solutions. Most indicator solutions are prepared as a 
0.04 percent solution of the indicator dye in alcohol. In testing, a few 
drops of indicator solution are added to 10-milliliter portions of the 
sample solution. Colors should be compared using a bright background. 
Approximate determinations can be made on white porcelain spot plates, 
the test colors being compared thereon with a set of color standards. 
More accurate colorimetric tests can be made using a comparator block 
fitted with sets of tubes of standard indicator solutions of known pH.
    (3) Indicator paper. A paper tape treated with indicator dye is 
dipped into the sample solution. Depending upon the pH of the solution, 
the tape will change color and an approximate pH can be determined by 
comparison with a standard color chart.
    (c) Titratable acidity. Acceptable methods for determining 
titratable acidity are described in the AOAC, 13th Ed. (1980), section 
22.060, under ``Titratable Acidity--Official Final Action,'' for 
``Indicator Method,'' and section 22.061 for ``Glass Electrode Method--
Official Final Action,'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(a)(4)(ii) of this section. The procedure for preparing and 
standardizing the sodium hydroxide solution is described in the AOAC, 
13th Ed. (1980), sections 50.032-50.035, under ``Sodium Hydroxide--
Official Final Action'' by the ``Standard

[[Page 383]]

Potassium Hydroxide Phthalate Method,'' which is also incorporated by 
reference and available as set forth in paragraph (a)(4)(ii) of this 
section.

[44 FR 16235, Mar. 16, 1979, as amended at 47 FR 11822, Mar. 19, 1982; 
49 FR 5609, Feb. 14, 1984; 54 FR 24892, June 12, 1989; 63 FR 14035, Mar. 
24, 1998]



                      Subpart F_Records and Reports



Sec. 114.100  Records.

    (a) Records shall be maintained of examinations of raw materials, 
packaging materials, and finished products, and of suppliers' guarantees 
or certifications that verify compliance with Food and Drug 
Administration regulations and guidance documents or action levels.
    (b) Processing and production records showing adherence to scheduled 
processes, including records of pH measurements and other critical 
factors intended to ensure a safe product, shall be maintained and shall 
contain sufficient additional information such as product code, date, 
container size, and product, to permit a public health hazard evaluation 
of the processes applied to each lot, batch, or other portion of 
production.
    (c) All departures from scheduled processes having a possible 
bearing on public health or the safety of the food shall be noted and 
the affected portion of the product identified; these departures shall 
be recorded and made the subject of a separate file (or log identifying 
the appropriate data) delineating them, the action taken to rectify 
them, and the disposition of the portion of the product involved.
    (d) Records shall be maintained identifying initial distribution of 
the finished product to facilitate, when necessary, the segregation of 
specific food lots that may have become contaminated or otherwise unfit 
for their intended use.
    (e) Copies of all records provided for in paragraphs (b), (c), and 
(d) of this section shall be retained at the processing plant or other 
reasonably accessible location for a period of 3 years from the date of 
manufacture.

[44 FR 16235, Mar. 16, 1979, as amended at 65 FR 56479, Sept. 19, 2000]



PART 115_SHELL EGGS--Table of Contents



    Authority: 21 U.S.C. 342, 371; 42 U.S.C. 243, 264, 271.



Sec. 115.50  Refrigeration of shell eggs held for retail distribution.

    (a) For purposes of this section a ``retail establishment'' is an 
operation that stores, prepares, packages, serves, vends, or otherwise 
provides food for human consumption directly to consumers.
    (b) Except as provided in paragraph (c) of this section, all shell 
eggs, whether in intrastate or interstate commerce, held for retail 
distribution:
    (1) Shall promptly be placed under refrigeration as specified in 
paragraph (b)(2) of this section upon receipt at a retail establishment, 
except that, when short delays are unavoidable, the eggs shall be placed 
under refrigeration, as soon as reasonably possible; and
    (2) Shall be stored and displayed under refrigeration at an ambient 
temperature not greater than 7.2 [deg]C (45 [deg]F) while held at a 
retail establishment.
    (c) Shell eggs that have been specifically processed to destroy all 
viable Salmonella shall be exempt from the requirements of paragraph (b) 
of this section.
    (d) Under sections 311 and 361 of the Public Health Service Act (PHS 
Act), any State or locality that is willing and able to assist the 
agency in the enforcement of paragraph (b) of this section, and is 
authorized to inspect or regulate retail establishments, may, in its own 
jurisdiction, enforce paragraph (b) of this section through inspections 
under paragraph (f) of this section and through administrative 
enforcement remedies identified in paragraph (e) of this section until 
FDA notifies the State or locality in writing that such assistance is no 
longer needed. When providing assistance under paragraph (e) of this 
section, a State or locality may follow the hearing procedures set out 
in paragraphs (e)(2)(iii) through (e)(2)(iv) of this section, 
substituting, where necessary, appropriate State or local officials for 
designated FDA officials or may utilize State or local hearing 
procedures if such procedures satisfy due process.

[[Page 384]]

    (e) This section is established under authority of both the Federal 
Food, Drug, and Cosmetic Act (the act) and the PHS Act. Under the act, 
the agency can enforce the food adulteration provisions under 21 U.S.C. 
331, 332, 333, and 334. However, 42 U.S.C. 264 provides for the issuance 
of implementing enforcement regulations; therefore, FDA has established 
the following administrative enforcement procedures for the diversion or 
destruction of shell eggs and for informal hearings under the PHS Act:
    (1) Upon finding that any shell eggs have been held in violation of 
this section, an authorized FDA representative or a State or local 
representative in accordance with paragraph (d) of this section may 
order such eggs to be diverted, under the supervision of said 
representative, for processing in accordance with the Egg Products 
Inspection Act (EPIA) (21 U.S.C. 1031 et seq.) or destroyed by or under 
the supervision of an officer or employee of the FDA, or, if applicable, 
of the State or locality in accordance with the following procedures:
    (i) Order for diversion or destruction. Any division office of FDA 
or any State or local agency acting under paragraph (d) of this section, 
upon finding shell eggs held in violation of this section, may serve 
upon the person in whose possession such eggs are found a written order 
that such eggs be diverted, under the supervision of an officer or 
employee of the issuing entity, for processing in accordance with the 
EPIA (21 U.S.C. 1031 et seq.) or destroyed by or under the supervision 
of said division office, within 10 working days from the date of receipt 
of the order.
    (ii) Issuance of order. The order shall include the following 
information:
    (A) A statement that the shell eggs identified in the order are 
subject to diversion for processing in accordance with the EPIA or 
destruction;
    (B) A detailed description of the facts that justify the issuance of 
the order;
    (C) The location of the eggs;
    (D) A statement that these eggs shall not be sold, distributed, or 
otherwise disposed of or moved except as provided in paragraph (e)(1)(v) 
of this section;
    (E) Identification or description of the eggs;
    (F) The order number;
    (G) The date of the order;
    (H) The text of this entire section;
    (I) A statement that the order may be appealed by written appeal or 
by requesting an informal hearing;
    (J) The name and phone number of the person issuing the order; and
    (K) The location and telephone number of the office or agency and 
the name of its director.
    (iii) Approval of Division Director. An order, before issuance, 
shall be approved by the FDA Division Director in whose division the 
shell eggs are located. If prior written approval is not feasible, prior 
oral approval shall be obtained and confirmed by written memorandum as 
soon as possible.
    (iv) Labeling or marking of shell eggs under order. An FDA, State, 
or local agency representative issuing an order under paragraph (e)(1) 
of this section shall label or mark the shell eggs with official tags 
that include the following information:
    (A) A statement that the shell eggs are detained in accordance with 
regulations issued under section 361(a) of the PHS Act (42 U.S.C. 
264(a)).
    (B) A statement that the shell eggs shall not be sold, distributed 
or otherwise disposed of or moved except, after notifying the issuing 
entity in writing, to:
    (1) Divert them for processing in accordance with the EPIA or 
destroy them; or
    (2) Move them to an another location for holding pending appeal.
    (C) A statement that the violation of the order or the removal or 
alteration of the tag is punishable by fine or imprisonment or both 
(section 368 of the PHS Act, 42 U.S.C. 271).
    (D) The order number and the date of the order, and the name of the 
government representative who issued the order.
    (v) Sale or other disposition of shell eggs under order. After 
service of the order, the person in possession of the shell eggs that 
are the subject of the order shall not sell, distribute, or otherwise 
dispose of or move any eggs subject to the order unless and until the 
notice is withdrawn after an appeal except, after

[[Page 385]]

notifying FDA's division office or, if applicable, the State or local 
agency in writing, to:
    (A) Divert or destroy them as specified in paragraph (e)(1)(i) of 
this section; or
    (B) Move them to another location for holding pending appeal.
    (2) The person on whom the order for diversion or destruction is 
served may either comply with the order or appeal the order to an Office 
of Regulatory Affairs Program Director in accordance with the following 
procedures:
    (i) Appeal of a detention order. Any appeal shall be submitted in 
writing to FDA's Division Director in whose division the shell eggs are 
located within 5 working days of the issuance of the order. If the 
appeal includes a request for an informal hearing, the hearing shall be 
held within 5 working days after the appeal is filed or, if requested by 
the appellant, at a later date, which shall not be later than 20 
calendar days after the issuance of the order. The order may also be 
appealed within the same period of 5 working days by any other person 
having an ownership or proprietary interest in such shell eggs. The 
appellant of an order shall state the ownership or proprietary interest 
the appellant has in the shell eggs.
    (ii) Summary decision. A request for a hearing may be denied, in 
whole or in part and at any time after a request for a hearing has been 
submitted, if the Office of Regulatory Affairs Program Director or 
another FDA official senior to an FDA Division Director determines that 
no genuine and substantial issue of fact has been raised by the material 
submitted in connection with the hearing or from matters officially 
noticed. If the presiding FDA official determines that a hearing is not 
justified, written notice of the determination will be given to the 
parties explaining the reason for denial.
    (iii) Informal hearing. Appearance by any appellant at the hearing 
may be by mail or in person, with or without counsel. The informal 
hearing shall be conducted by the Office of Regulatory Affairs Program 
Director or another FDA official senior to an FDA Division Director, and 
a written summary of the proceedings shall be prepared by the presiding 
FDA official.
    (A) The presiding FDA official may direct that the hearing be 
conducted in any suitable manner permitted by law and this section. The 
presiding FDA official has the power to take such actions and make such 
rulings as are necessary or appropriate to maintain order and to conduct 
an informal, fair, expeditious, and impartial hearing, and to enforce 
the requirements concerning the conduct of hearings.
    (B) Employees of FDA will first give a full and complete statement 
of the action which is the subject of the hearing, together with the 
information and reasons supporting it, and may present oral or written 
information relevant to the hearing. The party requesting the hearing 
may then present oral or written information relevant to the hearing. 
All parties may conduct reasonable examination of any person (except for 
the presiding officer and counsel for the parties) who makes any 
statement on the matter at the hearing.
    (C) The hearing shall be informal in nature, and the rules of 
evidence do not apply. No motions or objections relating to the 
admissibility of information and views will be made or considered, but 
any party may comment upon or rebut any information and views presented 
by another party.
    (D) The party requesting the hearing may have the hearing 
transcribed, at the party's expense, in which case a copy of the 
transcript is to be furnished to FDA. Any transcript of the hearing will 
be included with the presiding FDA official's report of the hearing.
    (E) The presiding FDA official shall prepare a written report of the 
hearing. All written material presented at the hearing will be attached 
to the report. Whenever time permits, the presiding FDA official may 
give the parties the opportunity to review and comment on the report of 
the hearing.
    (F) The presiding FDA official shall include as part of the report 
of the hearing a finding on the credibility of witnesses (other than 
expert witnesses) whenever credibility is a material issue, and shall 
include a recommended decision, with a statement of reasons.
    (iv) Written appeal. If the appellant appeals the detention order 
but does not request a hearing, the presiding

[[Page 386]]

FDA official shall render a decision on the appeal affirming or revoking 
the detention within 5-working days after the receipt of the appeal.
    (v) Presiding FDA official's decision. If, based on the evidence 
presented at the hearing or by the appellant in a written appeal, the 
presiding FDA official finds that the shell eggs were held in violation 
of this section, he shall affirm the order that they be diverted, under 
the supervision of an officer or employee of FDA for processing under 
the EPIA or destroyed by or under the supervision of an officer or 
employee of FDA; otherwise, the presiding FDA official shall issue a 
written notice that the prior order is withdrawn. If the presiding FDA 
official affirms the order, he shall order that the diversion or 
destruction be accomplished within 10-working days from the date of the 
issuance of his decision. The presiding FDA official's decision shall be 
accompanied by a statement of the reasons for the decision. The decision 
of the presiding FDA official shall constitute final agency action, 
reviewable in the courts.
    (vi) No appeal. If there is no appeal of the order and the person in 
possession of the shell eggs that are subject to the order fails to 
divert or destroy them within 10 working days, or if the demand is 
affirmed by the presiding FDA official after an appeal and the person in 
possession of such eggs fails to divert or destroy them within 10 
working days, FDA's division office or appropriate State or local agency 
may designate an officer or employee to divert or destroy such eggs. It 
shall be unlawful to prevent or to attempt to prevent such diversion or 
destruction of the shell eggs by the designated officer or employee.
    (f) Inspection. Persons engaged in retail distribution of shell eggs 
shall permit authorized representatives of FDA to make at any reasonable 
time such inspection of the retail establishment in which shell eggs are 
being held, including inspection and sampling of such eggs and the 
equipment in which shell eggs are held and any records relating to such 
equipment or eggs, as may be necessary in the judgement of such 
representatives to determine compliance with the provisions of this 
section. Inspections may be made with or without notice and will 
ordinarily be made during regular business hours.
    (g) Preemption. No State or local governing entity shall establish 
or continue in effect any law, rule, regulation, or other requirement 
allowing refrigeration of unpasteurized shell eggs at retail 
establishments at any temperature greater than 7.2 [deg]C (45 [deg]F).

[65 FR 76112, Dec. 5, 2000, as amended at 82 FR 14145, Mar. 17, 2017; 85 
FR 16552, Mar. 24, 2020]



PART 117_CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, 
AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD--
Table of Contents



                      Subpart A_General Provisions

Sec.
117.1 Applicability and status.
117.3 Definitions.
117.4 Qualifications of individuals who manufacture, process, pack, or 
          hold food.
117.5 Exemptions.
117.7 Applicability of subparts C, D, and G of this part to a facility 
          solely engaged in the storage of unexposed packaged food.
117.8 Applicability of subpart B of this part to the off-farm packing 
          and holding of raw agricultural commodities
117.9 Records required for this subpart.

              Subpart B_Current Good Manufacturing Practice

117.10 Personnel.
117.20 Plant and grounds.
117.35 Sanitary operations.
117.37 Sanitary facilities and controls.
117.40 Equipment and utensils.
117.80 Processes and controls.
117.93 Warehousing and distribution.
117.95 Holding and distribution of human food by-products for use as 
          animal food.
117.110 Defect action levels.

      Subpart C_Hazard Analysis and Risk-Based Preventive Controls

117.126 Food safety plan.
117.130 Hazard analysis.
117.135 Preventive controls.
117.136 Circumstances in which the owner, operator, or agent in charge 
          of a manufacturing/processing facility is not required to 
          implement a preventive control.
117.137 Provision of assurances required under Sec. 117.136(a)(2), (3), 
          and (4).

[[Page 387]]

117.139 Recall plan.
117.140 Preventive control management components.
117.145 Monitoring.
117.150 Corrective actions and corrections.
117.155 Verification.
117.160 Validation.
117.165 Verification of implementation and effectiveness.
117.170 Reanalysis.
117.180 Requirements applicable to a preventive controls qualified 
          individual and a qualified auditor.
117.190 Implementation records required for this subpart.

                     Subpart D_Modified Requirements

117.201 Modified requirements that apply to a qualified facility.
117.206 Modified requirements that apply to a facility solely engaged in 
          the storage of unexposed packaged food.

         Subpart E_Withdrawal of a Qualified Facility Exemption

117.251 Circumstances that may lead FDA to withdraw a qualified facility 
          exemption.
117.254 Issuance of an order to withdraw a qualified facility exemption.
117.257 Contents of an order to withdraw a qualified facility exemption.
117.260 Compliance with, or appeal of, an order to withdraw a qualified 
          facility exemption.
117.264 Procedure for submitting an appeal.
117.267 Procedure for requesting an informal hearing.
117.270 Requirements applicable to an informal hearing.
117.274 Presiding officer for an appeal and for an informal hearing.
117.277 Timeframe for issuing a decision on an appeal.
117.280 Revocation of an order to withdraw a qualified facility 
          exemption.
117.284 Final agency action.
117.287 Reinstatement of a qualified facility exemption that was 
          withdrawn.

Subpart F_Requirements Applying to Records That Must Be Established and 
                               Maintained

117.301 Records subject to the requirements of this subpart.
117.305 General requirements applying to records.
117.310 Additional requirements applying to the food safety plan.
117.315 Requirements for record retention.
117.320 Requirements for official review.
117.325 Public disclosure.
117.330 Use of existing records.
117.335 Special requirements applicable to a written assurance.

                     Subpart G_Supply-Chain Program

117.405 Requirement to establish and implement a supply-chain program.
117.410 General requirements applicable to a supply-chain program.
117.415 Responsibilities of the receiving facility.
117.420 Using approved suppliers.
117.425 Determining appropriate supplier verification activities 
          (including determining the frequency of conducting the 
          activity).
117.430 Conducting supplier verification activities for raw materials 
          and other ingredients.
117.435 Onsite audit.
117.475 Records documenting the supply-chain program.

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 
374; 42 U.S.C. 243, 264, 271.

    Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 117 appear at 81 FR 
49896, July 29, 2016.



                      Subpart A_General Provisions



Sec. 117.1  Applicability and status.

    (a) The criteria and definitions in this part apply in determining 
whether a food is:
    (1) Adulterated within the meaning of:
    (i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in 
that the food has been manufactured under such conditions that it is 
unfit for food; or
    (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act 
in that the food 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; and
    (2) In violation of section 361 of the Public Health Service Act (42 
U.S.C. 264).
    (b) The operation of a facility that manufactures, processes, packs, 
or holds food for sale in the United States if the owner, operator, or 
agent in charge of such facility is required to comply with, and is not 
in compliance with, section 418 of the Federal Food, Drug, and Cosmetic 
Act or subpart C,

[[Page 388]]

D, E, F, or G of this part is a prohibited act under section 301(uu) of 
the Federal Food, Drug, and Cosmetic Act.
    (c) Food covered by specific current good manufacturing practice 
regulations also is subject to the requirements of those regulations.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3715, Jan. 22, 2016]



Sec. 117.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this part. The following definitions also apply:
    Acid foods or acidified foods means foods that have an equilibrium 
pH of 4.6 or below.
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    Affiliate means any facility that controls, is controlled by, or is 
under common control with another facility.
    Allergen cross-contact means the unintentional incorporation of a 
food allergen into a food.
    Audit means the systematic, independent, and documented examination 
(through observation, investigation, records review, discussions with 
employees of the audited entity, and, as appropriate, sampling and 
laboratory analysis) to assess an audited entity's food safety processes 
and procedures.
    Batter means a semifluid substance, usually composed of flour and 
other ingredients, into which principal components of food are dipped or 
with which they are coated, or which may be used directly to form bakery 
foods.
    Blanching, except for tree nuts and peanuts, means a prepackaging 
heat treatment of foodstuffs for an adequate time and at an adequate 
temperature to partially or completely inactivate the naturally 
occurring enzymes and to effect other physical or biochemical changes in 
the food.
    Calendar day means every day shown on the calendar.
    Correction means an action to identify and correct a problem that 
occurred during the production of food, without other actions associated 
with a corrective action procedure (such as actions to reduce the 
likelihood that the problem will recur, evaluate all affected food for 
safety, and prevent affected food from entering commerce).
    Critical control point means a point, step, or procedure in a food 
process at which control can be applied and is essential to prevent or 
eliminate a food safety hazard or reduce such hazard to an acceptable 
level.
    Defect action level means a level of a non-hazardous, naturally 
occurring, unavoidable defect at which FDA may regard a food product 
``adulterated'' and subject to enforcement action under section 
402(a)(3) of the Federal Food, Drug, and Cosmetic Act.
    Environmental pathogen means a pathogen capable of surviving and 
persisting within the manufacturing, processing, packing, or holding 
environment such that food may be contaminated and may result in 
foodborne illness if that food is consumed without treatment to 
significantly minimize the environmental pathogen. Examples of 
environmental pathogens for the purposes of this part include Listeria 
monocytogenes and Salmonella spp. but do not include the spores of 
pathogenic sporeforming bacteria.
    Facility means a domestic facility or a foreign facility that is 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act, in accordance with the requirements of part 1, subpart H 
of this chapter.
    Farm means farm as defined in Sec. 1.227 of this chapter.
    FDA means the Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act and includes raw materials and ingredients.
    Food allergen means a major food allergen as defined in section 
201(qq) of the Federal Food, Drug, and Cosmetic Act.
    Food-contact surfaces are those surfaces that contact human food and 
those surfaces from which drainage, or other transfer, onto the food or 
onto surfaces that contact the food ordinarily occurs during the normal 
course of operations. ``Food-contact surfaces'' includes utensils and 
food-contact surfaces of equipment.

[[Page 389]]

    Full-time equivalent employee is a term used to represent the number 
of employees of a business entity for the purpose of determining whether 
the business qualifies for the small business exemption. The number of 
full-time equivalent employees is determined by dividing the total 
number of hours of salary or wages paid directly to employees of the 
business entity and of all of its affiliates and subsidiaries by the 
number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 
weeks). If the result is not a whole number, round down to the next 
lowest whole number.
    Harvesting applies to farms and farm mixed-type facilities and means 
activities that are traditionally performed on farms for the purpose of 
removing raw agricultural commodities from the place they were grown or 
raised and preparing them for use as food. Harvesting is limited to 
activities performed on raw agricultural commodities, or on processed 
foods created by drying/dehydrating a raw agricultural commodity without 
additional manufacturing/processing, on a farm. Harvesting does not 
include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the Federal Food, Drug, 
and Cosmetic Act. Examples of harvesting include cutting (or otherwise 
separating) the edible portion of the raw agricultural commodity from 
the crop plant and removing or trimming part of the raw agricultural 
commodity (e.g., foliage, husks, roots or stems). Examples of harvesting 
also include cooling, field coring, filtering, gathering, hulling, 
shelling, sifting, threshing, trimming of outer leaves of, and washing 
raw agricultural commodities grown on a farm.
    Hazard means any biological, chemical (including radiological), or 
physical agent that has the potential to cause illness or injury.
    Hazard requiring a preventive control means a known or reasonably 
foreseeable hazard for which a person knowledgeable about the safe 
manufacturing, processing, packing, or holding of food would, based on 
the outcome of a hazard analysis (which includes an assessment of the 
severity of the illness or injury if the hazard were to occur and the 
probability that the hazard will occur in the absence of preventive 
controls), establish one or more preventive controls to significantly 
minimize or prevent the hazard in a food and components to manage those 
controls (such as monitoring, corrections or corrective actions, 
verification, and records) as appropriate to the food, the facility, and 
the nature of the preventive control and its role in the facility's food 
safety system.
    Holding means storage of food and also includes activities performed 
incidental to storage of a food (e.g., activities performed for the safe 
or effective storage of that food, such as fumigating food during 
storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed 
as a practical necessity for the distribution of that food (such as 
blending of the same raw agricultural commodity and breaking down 
pallets), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities 
could include warehouses, cold storage facilities, storage silos, grain 
elevators, and liquid storage tanks.
    Known or reasonably foreseeable hazard means a biological, chemical 
(including radiological), or physical hazard that is known to be, or has 
the potential to be, associated with the facility or the food.
    Lot means the food produced during a period of time and identified 
by an establishment's specific code.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating, 
extracting juice, formulating, freezing, grinding, homogenizing, 
irradiating, labeling, milling, mixing, packaging (including

[[Page 390]]

modified atmosphere packaging), pasteurizing, peeling, rendering, 
treating to manipulate ripening, trimming, washing, or waxing. For farms 
and farm mixed-type facilities, manufacturing/processing does not 
include activities that are part of harvesting, packing, or holding.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and 
microscopic parasites and includes species that are pathogens. The term 
``undesirable microorganisms'' includes those microorganisms that are 
pathogens, that subject food to decomposition, that indicate that food 
is contaminated with filth, or that otherwise may cause food to be 
adulterated.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or 
measurements to assess whether control measures are operating as 
intended.
    Packing means placing food into a container other than packaging the 
food and also includes re-packing and activities performed incidental to 
packing or re-packing a food (e.g., activities performed for the safe or 
effective packing or re-packing of that food (such as sorting, culling, 
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act.
    Pathogen means a microorganism of public health significance.
    Pest refers to any objectionable animals or insects including birds, 
rodents, flies, and larvae.
    Plant means the building or structure or parts thereof, used for or 
in connection with the manufacturing, processing, packing, or holding of 
human food.
    Preventive controls means those risk-based, reasonably appropriate 
procedures, practices, and processes that a person knowledgeable about 
the safe manufacturing, processing, packing, or holding of food would 
employ to significantly minimize or prevent the hazards identified under 
the hazard analysis that are consistent with the current scientific 
understanding of safe food manufacturing, processing, packing, or 
holding at the time of the analysis.
    Preventive controls qualified individual means a qualified 
individual who has successfully completed training in the development 
and application of risk-based preventive controls at least equivalent to 
that received under a standardized curriculum recognized as adequate by 
FDA or is otherwise qualified through job experience to develop and 
apply a food safety system.
    Qualified auditor means a person who is a qualified individual as 
defined in this part and has technical expertise obtained through 
education, training, or experience (or a combination thereof) necessary 
to perform the auditing function as required by Sec. 117.180(c)(2). 
Examples of potential qualified auditors include:
    (1) A government employee, including a foreign government employee; 
and
    (2) An audit agent of a certification body that is accredited in 
accordance with regulations in part 1, subpart M of this chapter.
    Qualified end-user, with respect to a food, means the consumer of 
the food (where the term consumer does not include a business); or a 
restaurant or retail food establishment (as those terms are defined in 
Sec. 1.227 of this chapter) that:
    (1) Is located:
    (i) In the same State or the same Indian reservation as the 
qualified facility that sold the food to such restaurant or 
establishment; or
    (ii) Not more than 275 miles from such facility; and
    (2) Is purchasing the food for sale directly to consumers at such 
restaurant or retail food establishment.

[[Page 391]]

    Qualified facility means (when including the sales by any 
subsidiary; affiliate; or subsidiaries or affiliates, collectively, of 
any entity of which the facility is a subsidiary or affiliate) a 
facility that is a very small business as defined in this part, or a 
facility to which both of the following apply:
    (1) During the 3-year period preceding the applicable calendar year, 
the average annual monetary value of the food manufactured, processed, 
packed or held at such facility that is sold directly to qualified end-
users (as defined in this part) during such period exceeded the average 
annual monetary value of the food sold by such facility to all other 
purchasers; and
    (2) The average annual monetary value of all food sold during the 3-
year period preceding the applicable calendar year was less than 
$500,000, adjusted for inflation.
    Qualified facility exemption means an exemption applicable to a 
qualified facility under Sec. 117.5(a).
    Qualified individual means a person who has the education, training, 
or experience (or a combination thereof) necessary to manufacture, 
process, pack, or hold clean and safe food as appropriate to the 
individual's assigned duties. A qualified individual may be, but is not 
required to be, an employee of the establishment.
    Quality control operation means a planned and systematic procedure 
for taking all actions necessary to prevent food from being adulterated.
    Raw agricultural commodity has the meaning given in section 201(r) 
of the Federal Food, Drug, and Cosmetic Act.
    Ready-to-eat food (RTE food) means any food that is normally eaten 
in its raw state or any other food, including a processed food, for 
which it is reasonably foreseeable that the food will be eaten without 
further processing that would significantly minimize biological hazards.
    Receiving facility means a facility that is subject to subparts C 
and G of this part and that manufactures/processes a raw material or 
other ingredient that it receives from a supplier.
    Rework means clean, unadulterated food that has been removed from 
processing for reasons other than insanitary conditions or that has been 
successfully reconditioned by reprocessing and that is suitable for use 
as food.
    Safe-moisture level is a level of moisture low enough to prevent the 
growth of undesirable microorganisms in the finished product under the 
intended conditions of manufacturing, processing, packing, and holding. 
The safe moisture level for a food is related to its water activity 
(aw). An aw will be considered safe for a food if 
adequate data are available that demonstrate that the food at or below 
the given aw will not support the growth of undesirable 
microorganisms.
    Sanitize means to adequately treat cleaned surfaces by a process 
that is effective in destroying vegetative cells of pathogens, and in 
substantially reducing numbers of other undesirable microorganisms, but 
without adversely affecting the product or its safety for the consumer.
    Significantly minimize means to reduce to an acceptable level, 
including to eliminate.
    Small business means, for purposes of this part, a business 
(including any subsidiaries and affiliates) employing fewer than 500 
full-time equivalent employees.
    Subsidiary means any company which is owned or controlled directly 
or indirectly by another company.
    Supplier means the establishment that manufactures/processes the 
food, raises the animal, or grows the food that is provided to a 
receiving facility without further manufacturing/processing by another 
establishment, except for further manufacturing/processing that consists 
solely of the addition of labeling or similar activity of a de minimis 
nature.
    Supply-chain-applied control means a preventive control for a hazard 
in a raw material or other ingredient when the hazard in the raw 
material or other ingredient is controlled before its receipt.
    Unexposed packaged food means packaged food that is not exposed to 
the environment.
    Validation means obtaining and evaluating scientific and technical 
evidence that a control measure, combination of control measures, or the 
food safety plan as a whole, when properly

[[Page 392]]

implemented, is capable of effectively controlling the identified 
hazards.
    Verification means the application of methods, procedures, tests and 
other evaluations, in addition to monitoring, to determine whether a 
control measure or combination of control measures is or has been 
operating as intended and to establish the validity of the food safety 
plan.
    Very small business means, for purposes of this part, a business 
(including any subsidiaries and affiliates) averaging less than 
$1,000,000, adjusted for inflation, per year, during the 3-year period 
preceding the applicable calendar year in sales of human food plus the 
market value of human food manufactured, processed, packed, or held 
without sale (e.g., held for a fee).
    Water activity (aw) is a measure of the free moisture in 
a food and is the quotient of the water vapor pressure of the substance 
divided by the vapor pressure of pure water at the same temperature.
    Written procedures for receiving raw materials and other ingredients 
means written procedures to ensure that raw materials and other 
ingredients are received only from suppliers approved by the receiving 
facility (or, when necessary and appropriate, on a temporary basis from 
unapproved suppliers whose raw materials or other ingredients are 
subjected to adequate verification activities before acceptance for 
use).
    You means, for purposes of this part, the owner, operator, or agent 
in charge of a facility.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3715, Jan. 22, 2016]



Sec. 117.4  Qualifications of individuals who manufacture, process,
pack, or hold food.

    (a) Applicability. (1) The management of an establishment must 
ensure that all individuals who manufacture, process, pack, or hold food 
subject to subparts B and F of this part are qualified to perform their 
assigned duties.
    (2) The owner, operator, or agent in charge of a facility must 
ensure that all individuals who manufacture, process, pack, or hold food 
subject to subpart C, D, E, F, or G of this part are qualified to 
perform their assigned duties.
    (b) Qualifications of all individuals engaged in manufacturing, 
processing, packing, or holding food. Each individual engaged in 
manufacturing, processing, packing, or holding food (including temporary 
and seasonal personnel) or in the supervision thereof must:
    (1) Be a qualified individual as that term is defined in Sec. 
117.3--i.e., have the education, training, or experience (or a 
combination thereof) necessary to manufacture, process, pack, or hold 
clean and safe food as appropriate to the individual's assigned duties; 
and
    (2) Receive training in the principles of food hygiene and food 
safety, including the importance of employee health and personal 
hygiene, as appropriate to the food, the facility and the individual's 
assigned duties.
    (c) Additional qualifications of supervisory personnel. 
Responsibility for ensuring compliance by individuals with the 
requirements of this part must be clearly assigned to supervisory 
personnel who have the education, training, or experience (or a 
combination thereof) necessary to supervise the production of clean and 
safe food.
    (d) Records. Records that document training required by paragraph 
(b)(2) of this section must be established and maintained.



Sec. 117.5  Exemptions.

    (a) Except as provided by subpart E of this part, subparts C and G 
of this part do not apply to a qualified facility. Qualified facilities 
are subject to the modified requirements in Sec. 117.201.
    (b) Subparts C and G of this part do not apply with respect to 
activities that are subject to part 123 of this chapter (Fish and 
Fishery Products) at a facility if you are required to comply with, and 
are in compliance with, part 123 of this chapter with respect to such 
activities.
    (c) Subparts C and G of this part do not apply with respect to 
activities that are subject to part 120 of this chapter (Hazard Analysis 
and Critical Control Point (HACCP) Systems) at a facility if you are 
required to comply with, and are in compliance with, part 120 of this 
chapter with respect to such activities.

[[Page 393]]

    (d)(1) Subparts C and G of this part do not apply with respect to 
activities that are subject to part 113 of this chapter (Thermally 
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) at 
a facility if you are required to comply with, and are in compliance 
with, part 113 of this chapter with respect to such activities.
    (2) The exemption in paragraph (d)(1) of this section is applicable 
only with respect to the microbiological hazards that are regulated 
under part 113 of this chapter.
    (e) Subparts C and G do not apply to any facility with regard to the 
manufacturing, processing, packaging, or holding of a dietary supplement 
that is in compliance with the requirements of part 111 of this chapter 
(Current Good Manufacturing Practice in Manufacturing, Packaging, 
Labeling, or Holding Operations for Dietary Supplements) and section 761 
of the Federal Food, Drug, and Cosmetic Act (Serious Adverse Event 
Reporting for Dietary Supplements).
    (f) Subparts C and G of this part do not apply to activities of a 
facility that are subject to section 419 of the Federal Food, Drug, and 
Cosmetic Act (Standards for Produce Safety).
    (g)(1) The exemption in paragraph (g)(3) of this section applies to 
packing or holding of processed foods on a farm mixed-type facility, 
except for processed foods produced by drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins, and drying/dehydrating fresh 
herbs to produce dried herbs), and packaging and labeling such 
commodities, without additional manufacturing/processing (such as 
chopping and slicing), the packing and holding of which are within the 
``farm'' definition in Sec. 1.227 of this chapter. Activities that are 
within the ``farm'' definition, when conducted on a farm mixed-type 
facility, are not subject to the requirements of subparts C and G of 
this part and therefore do not need to be specified in the exemption.
    (2) For the purposes of paragraphs (g)(3) and (h)(3) of this 
section, the following terms describe the foods associated with the 
activity/food combinations. Several foods that are fruits or vegetables 
are separately considered for the purposes of these activity/food 
combinations (i.e., coffee beans, cocoa beans, fresh herbs, peanuts, 
sugarcane, sugar beets, tree nuts, seeds for direct consumption) to 
appropriately address specific hazards associated with these foods and/
or processing activities conducted on these foods.
    (i) Dried/dehydrated fruit and vegetable products includes only 
those processed food products such as raisins and dried legumes made 
without additional manufacturing/processing beyond drying/dehydrating, 
packaging, and/or labeling.
    (ii) Other fruit and vegetable products includes those processed 
food products that have undergone one or more of the following 
processes: acidification, boiling, canning, coating with things other 
than wax/oil/resin, cooking, cutting, chopping, grinding, peeling, 
shredding, slicing, or trimming. Examples include flours made from 
legumes (such as chickpea flour), pickles, and snack chips made from 
potatoes or plantains. Examples also include dried fruit and vegetable 
products made with additional manufacturing/processing (such as dried 
apple slices; pitted, dried plums, cherries, and apricots; and sulfited 
raisins). This category does not include dried/dehydrated fruit and 
vegetable products made without additional manufacturing/processing as 
described in paragraph (g)(2)(i) of this section. This category also 
does not include products that require time/temperature control for 
safety (such as fresh-cut fruits and vegetables).
    (iii) Peanut and tree nut products includes processed food products 
such as roasted peanuts and tree nuts, seasoned peanuts and tree nuts, 
and peanut and tree nut flours.
    (iv) Processed seeds for direct consumption include processed food 
products such as roasted pumpkin seeds, roasted sunflower seeds, and 
roasted flax seeds.
    (v) Dried/dehydrated herb and spice products includes only processed 
food products such as dried intact herbs made without additional 
manufacturing/processing beyond drying/dehydrating, packaging, and/or 
labeling.
    (vi) Other herb and spice products includes those processed food 
products such as chopped fresh herbs, chopped or

[[Page 394]]

ground dried herbs (including tea), herbal extracts (e.g., essential 
oils, extracts containing more than 20 percent ethanol, extracts 
containing more than 35 percent glycerin), dried herb- or spice-infused 
honey, and dried herb- or spice-infused oils and/or vinegars. This 
category does not include dried/dehydrated herb and spice products made 
without additional manufacturing/processing beyond drying/dehydrating, 
packaging, and/or labeling as described in paragraph (g)(2)(v) of this 
section. This category also does not include products that require time/
temperature control for safety, such as fresh herb-infused oils.
    (vii) Grains include barley, dent- or flint-corn, sorghum, oats, 
rice, rye, wheat, amaranth, quinoa, buckwheat and oilseeds for oil 
extraction (such as cotton seed, flax seed, rapeseed, soybeans, and 
sunflower seed).
    (viii) Milled grain products include processed food products such as 
flour, bran, and corn meal.
    (ix) Baked goods include processed food products such as breads, 
brownies, cakes, cookies, and crackers. This category does not include 
products that require time/temperature control for safety, such as 
cream-filled pastries.
    (x) Other grain products include processed food products such as 
dried cereal, dried pasta, oat flakes, and popcorn. This category does 
not include milled grain products as described in paragraph (g)(2)(viii) 
of this section or baked goods as described in paragraph (g)(2)(ix) of 
this section.
    (3) Subparts C and G of this part do not apply to on-farm packing or 
holding of food by a small or very small business, and Sec. 117.201 
does not apply to on-farm packing or holding of food by a very small 
business, if the only packing and holding activities subject to section 
418 of the Federal Food, Drug, and Cosmetic Act that the business 
conducts are the following low-risk packing or holding activity/food 
combinations--i.e., packing (or re-packing) (including weighing or 
conveying incidental to packing or re-packing); sorting, culling, or 
grading incidental to packing or storing; and storing (ambient, cold and 
controlled atmosphere) of:
    (i) Baked goods (e.g., bread and cookies);
    (ii) Candy (e.g., hard candy, fudge, maple candy, maple cream, nut 
brittles, taffy, and toffee);
    (iii) Cocoa beans (roasted);
    (iv) Cocoa products;
    (v) Coffee beans (roasted);
    (vi) Game meat jerky;
    (vii) Gums, latexes, and resins that are processed foods;
    (viii) Honey (pasteurized);
    (ix) Jams, jellies, and preserves;
    (x) Milled grain products (e.g., flour, bran, and corn meal);
    (xi) Molasses and treacle;
    (xii) Oils (e.g., olive oil and sunflower seed oil);
    (xiii) Other fruit and vegetable products (e.g., flours made from 
legumes; pitted, dried fruits; sliced, dried apples; snack chips);
    (xiv) Other grain products (e.g., dried pasta, oat flakes, and 
popcorn);
    (xv) Other herb and spice products (e.g., chopped or ground dried 
herbs, herbal extracts);
    (xvi) Peanut and tree nut products (e.g., roasted peanuts and tree 
nut flours);
    (xvii) Processed seeds for direct consumption (e.g., roasted pumpkin 
seeds);
    (xviii) Soft drinks and carbonated water;
    (xix) Sugar;
    (xx) Syrups (e.g., maple syrup and agave syrup);
    (xxi) Trail mix and granola;
    (xxii) Vinegar; and
    (xxiii) Any other processed food that does not require time/
temperature control for safety (e..g., vitamins, minerals, and dietary 
ingredients (e.g., bone meal) in powdered, granular, or other solid 
form).
    (h)(1) The exemption in paragraph (h)(3) of this section applies to 
manufacturing/processing of foods on a farm mixed-type facility, except 
for manufacturing/processing that is within the ``farm'' definition in 
Sec. 1.227 of this chapter. Drying/dehydrating raw agricultural 
commodities to create a distinct commodity (such as drying/dehydrating 
grapes to produce raisins, and drying/dehydrating fresh herbs to produce 
dried herbs), and packaging

[[Page 395]]

and labeling such commodities, without additional manufacturing/
processing (such as chopping and slicing), are within the ``farm'' 
definition in Sec. 1.227 of this chapter. In addition, treatment to 
manipulate ripening of raw agricultural commodities (such as by treating 
produce with ethylene gas), and packaging and labeling the treated raw 
agricultural commodities, without additional manufacturing/processing, 
is within the ``farm'' definition. In addition, coating intact fruits 
and vegetables with wax, oil, or resin used for the purpose of storage 
or transportation is within the ``farm'' definition. Activities that are 
within the ``farm'' definition, when conducted on a farm mixed-type 
facility, are not subject to the requirements of subparts C and G of 
this part and therefore do not need to be specified in the exemption.
    (2) The terms in paragraph (g)(2) of this section describe certain 
foods associated with the activity/food combinations in paragraph (h)(3) 
of this section.
    (3) Subparts C and G of this part do not apply to on-farm 
manufacturing/processing activities conducted by a small or very small 
business for distribution into commerce, and Sec. 117.201 does not 
apply to on-farm manufacturing/processing activities conducted by a very 
small business for distribution into commerce, if the only 
manufacturing/processing activities subject to section 418 of the 
Federal Food, Drug, and Cosmetic Act that the business conducts are the 
following low-risk manufacturing/processing activity/food combinations:
    (i) Boiling gums, latexes, and resins;
    (ii) Chopping, coring, cutting, peeling, pitting, shredding, and 
slicing acid fruits and vegetables that have a pH less than 4.2 (e.g., 
cutting lemons and limes), baked goods (e.g., slicing bread), dried/
dehydrated fruit and vegetable products (e.g., pitting dried plums), 
dried herbs and other spices (e.g., chopping intact, dried basil), game 
meat jerky, gums/latexes/resins, other grain products (e.g., shredding 
dried cereal), peanuts and tree nuts, and peanut and tree nut products 
(e.g., chopping roasted peanuts);
    (iii) Coating dried/dehydrated fruit and vegetable products (e.g., 
coating raisins with chocolate), other fruit and vegetable products 
except for non-dried, non-intact fruits and vegetables (e.g., coating 
dried plum pieces, dried pitted cherries, and dried pitted apricots with 
chocolate are low-risk activity/food combinations but coating apples on 
a stick with caramel is not a low-risk activity/food combination), other 
grain products (e.g., adding caramel to popcorn or adding seasonings to 
popcorn provided that the seasonings have been treated to significantly 
minimize pathogens, peanuts and tree nuts (e.g., adding seasonings 
provided that the seasonings have been treated to significantly minimize 
pathogens), and peanut and tree nut products (e.g., adding seasonings 
provided that the seasonings have been treated to significantly minimize 
pathogens));
    (iv) Drying/dehydrating (that includes additional manufacturing or 
is performed on processed foods) other fruit and vegetable products with 
pH less than 4.2 (e.g., drying cut fruit and vegetables with pH less 
than 4.2), and other herb and spice products (e.g., drying chopped fresh 
herbs, including tea);
    (v) Extracting (including by pressing, by distilling, and by solvent 
extraction) dried/dehydrated herb and spice products (e.g., dried mint), 
fresh herbs (e.g., fresh mint), fruits and vegetables (e.g., olives, 
avocados), grains (e.g., oilseeds), and other herb and spice products 
(e.g., chopped fresh mint, chopped dried mint);
    (vi) Freezing acid fruits and vegetables with pH less than 4.2 and 
other fruit and vegetable products with pH less than 4.2 (e.g., cut 
fruits and vegetables);
    (vii) Grinding/cracking/crushing/milling baked goods (e.g., 
crackers), cocoa beans (roasted), coffee beans (roasted), dried/
dehydrated fruit and vegetable products (e.g., raisins and dried 
legumes), dried/dehydrated herb and spice products (e.g., intact dried 
basil), grains (e.g., oats, rice, rye, wheat), other fruit and vegetable 
products (e.g., dried, pitted dates), other grain products (e.g., dried 
cereal), other herb and spice products (e.g., chopped dried herbs), 
peanuts and tree nuts, and peanut and tree nut products (e.g., roasted 
peanuts);

[[Page 396]]

    (viii) Labeling baked goods that do not contain food allergens, 
candy that does not contain food allergens, cocoa beans (roasted), cocoa 
products that do not contain food allergens), coffee beans (roasted), 
game meat jerky, gums/latexes/resins that are processed foods, honey 
(pasteurized), jams/jellies/preserves, milled grain products that do not 
contain food allergens (e.g., corn meal) or that are single-ingredient 
foods (e.g., wheat flour, wheat bran), molasses and treacle, oils, other 
fruit and vegetable products that do not contain food allergens (e.g., 
snack chips made from potatoes or plantains), other grain products that 
do not contain food allergens (e.g., popcorn), other herb and spice 
products (e.g., chopped or ground dried herbs), peanut or tree nut 
products, (provided that they are single-ingredient, or are in forms in 
which the consumer can reasonably be expected to recognize the food 
allergen(s) without label declaration, or both (e.g., roasted or 
seasoned whole nuts, single-ingredient peanut or tree nut flours)), 
processed seeds for direct consumption, soft drinks and carbonated 
water, sugar, syrups, trail mix and granola (other than those containing 
milk chocolate and provided that peanuts and/or tree nuts are in forms 
in which the consumer can reasonably be expected to recognize the food 
allergen(s) without label declaration), vinegar, and any other processed 
food that does not require time/temperature control for safety and that 
does not contain food allergens (e.g., vitamins, minerals, and dietary 
ingredients (e.g., bone meal) in powdered, granular, or other solid 
form);
    (ix) Making baked goods from milled grain products (e.g., breads and 
cookies);
    (x) Making candy from peanuts and tree nuts (e.g., nut brittles), 
sugar/syrups (e.g., taffy, toffee), and saps (e.g., maple candy, maple 
cream);
    (xi) Making cocoa products from roasted cocoa beans;
    (xii) Making dried pasta from grains;
    (xiii) Making jams, jellies, and preserves from acid fruits and 
vegetables with a pH of 4.6 or below;
    (xiv) Making molasses and treacle from sugar beets and sugarcane;
    (xv) Making oat flakes from grains;
    (xvi) Making popcorn from grains;
    (xvii) Making snack chips from fruits and vegetables (e.g., making 
plantain and potato chips);
    (xviii) Making soft drinks and carbonated water from sugar, syrups, 
and water;
    (xix) Making sugars and syrups from fruits and vegetables (e.g., 
dates), grains (e.g., rice, sorghum), other grain products (e.g., malted 
grains such as barley), saps (e.g., agave, birch, maple, palm), sugar 
beets, and sugarcane;
    (xx) Making trail mix and granola from cocoa products (e.g., 
chocolate), dried/dehydrated fruit and vegetable products (e.g., 
raisins), other fruit and vegetable products (e.g., chopped dried 
fruits), other grain products (e.g., oat flakes), peanut and tree nut 
products, and processed seeds for direct consumption, provided that 
peanuts, tree nuts, and processed seeds are treated to significantly 
minimize pathogens;
    (xxi) Making vinegar from fruits and vegetables, other fruit and 
vegetable products (e.g., fruit wines, apple cider), and other grain 
products (e.g., malt);
    (xxii) Mixing baked goods (e.g., types of cookies), candy (e.g., 
varieties of taffy), cocoa beans (roasted), coffee beans (roasted), 
dried/dehydrated fruit and vegetable products (e.g., dried blueberries, 
dried currants, and raisins), dried/dehydrated herb and spice products 
(e.g., dried, intact basil and dried, intact oregano), honey 
(pasteurized), milled grain products (e.g., flour, bran, and corn meal), 
other fruit and vegetable products (e.g., dried, sliced apples and 
dried, sliced peaches), other grain products (e.g., different types of 
dried pasta), other herb and spice products (e.g., chopped or ground 
dried herbs, dried herb- or spice-infused honey, and dried herb- or 
spice-infused oils and/or vinegars), peanut and tree nut products, 
sugar, syrups, vinegar, and any other processed food that does not 
require time/temperature control for safety (e.g., vitamins, minerals, 
and dietary ingredients (e.g., bone meal) in powdered, granular, or 
other solid form);
    (xxiii) Packaging baked goods (e.g., bread and cookies), candy, 
cocoa beans (roasted), cocoa products, coffee beans (roasted), game meat 
jerky, gums/latexes/resins that are processed foods,

[[Page 397]]

honey (pasteurized), jams/jellies/preserves, milled grain products 
(e.g., flour, bran, corn meal), molasses and treacle, oils, other fruit 
and vegetable products (e.g., pitted, dried fruits; sliced, dried 
apples; snack chips), other grain products (e.g., popcorn), other herb 
and spice products (e.g., chopped or ground dried herbs), peanut and 
tree nut products, processed seeds for direct consumption, soft drinks 
and carbonated water, sugar, syrups, trail mix and granola, vinegar, and 
any other processed food that does not require time/temperature control 
for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., 
bone meal) in powdered, granular, or other solid form);
    (xxiv) Pasteurizing honey;
    (xxv) Roasting and toasting baked goods (e.g., toasting bread for 
croutons);
    (xxvi) Salting other grain products (e.g., soy nuts), peanut and 
tree nut products, and processed seeds for direct consumption; and
    (xxvii) Sifting milled grain products (e.g., flour, bran, corn 
meal), other fruit and vegetable products (e.g., chickpea flour), and 
peanut and tree nut products (e.g., peanut flour, almond flour).
    (i)(1) Subparts C and G of this part do not apply with respect to 
alcoholic beverages at a facility that meets the following two 
conditions:
    (i) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et 
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 
(26 U.S.C. 5001 et seq.) the facility is required to obtain a permit 
from, register with, or obtain approval of a notice or application from 
the Secretary of the Treasury as a condition of doing business in the 
United States, or is a foreign facility of a type that would require 
such a permit, registration, or approval if it were a domestic facility; 
and
    (ii) Under section 415 of the Federal Food, Drug, and Cosmetic Act 
the facility is required to register as a facility because it is engaged 
in manufacturing, processing, packing, or holding one or more alcoholic 
beverages.
    (2) Subparts C and G of this part do not apply with respect to food 
that is not an alcoholic beverage at a facility described in paragraph 
(i)(1) of this section, provided such food:
    (i) Is in prepackaged form that prevents any direct human contact 
with such food; and
    (ii) Constitutes not more than 5 percent of the overall sales of the 
facility, as determined by the Secretary of the Treasury.
    (j) Subparts C and G of this part do not apply to facilities that 
are solely engaged in the storage of raw agricultural commodities (other 
than fruits and vegetables) intended for further distribution or 
processing.
    (k)(1) Except as provided by paragraph (k)(2) of this section, 
subpart B of this part does not apply to any of the following:
    (i) ``Farms'' (as defined in Sec. 1.227 of this chapter);
    (ii) Fishing vessels that are not subject to the registration 
requirements of part 1, subpart H of this chapter in accordance with 
Sec. 1.226(f) of this chapter;
    (iii) Establishments solely engaged in the holding and/or 
transportation of one or more raw agricultural commodities;
    (iv) Activities of ``farm mixed-type facilities'' (as defined in 
Sec. 1.227 of this chapter) that fall within the definition of 
``farm''; or
    (v) Establishments solely engaged in hulling, shelling, drying, 
packing, and/or holding nuts (without additional manufacturing/
processing, such as roasting nuts).
    (2) If a ``farm'' or ``farm mixed-type facility'' dries/dehydrates 
raw agricultural commodities that are produce as defined in part 112 of 
this chapter to create a distinct commodity, subpart B of this part 
applies to the packaging, packing, and holding of the dried commodities. 
Compliance with this requirement may be achieved by complying with 
subpart B of this part or with the applicable requirements for packing 
and holding in part 112 of this chapter.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016]

[[Page 398]]



Sec. 117.7  Applicability of subparts C, D, and G of this part to a
facility solely engaged in the storage of unexposed packaged food.

    (a) Applicability of subparts C and G. Subparts C and G of this part 
do not apply to a facility solely engaged in the storage of unexposed 
packaged food.
    (b) Applicability of subpart D. A facility solely engaged in the 
storage of unexposed packaged food, including unexposed packaged food 
that requires time/temperature control to significantly minimize or 
prevent the growth of, or toxin production by, pathogens is subject to 
the modified requirements in Sec. 117.206 for any unexposed packaged 
food that requires time/temperature control to significantly minimize or 
prevent the growth of, or toxin production by, pathogens.



Sec. 117.8  Applicability of subpart B of this part to the off-farm
packing and holding of raw agricultural commodities.

    Except as provided by Sec. 117.5(k)(1), subpart B of this part 
applies to the off-farm packaging, packing, and holding of raw 
agricultural commodities. Compliance with this requirement for raw 
agricultural commodities that are produce as defined in part 112 of this 
chapter may be achieved by complying with subpart B of this part or with 
the applicable requirements for packing and holding in part 112 of this 
chapter.

[81 FR 3956, Jan. 25, 2016]



Sec. 117.9  Records required for this subpart.

    (a) Records that document training required by Sec. 117.4(b)(2) 
must be established and maintained.
    (b) The records that must be established and maintained are subject 
to the requirements of subpart F of this part.



              Subpart B_Current Good Manufacturing Practice



Sec. 117.10  Personnel.

    The management of the establishment must take reasonable measures 
and precautions to ensure the following:
    (a) Disease control. Any person who, by medical examination or 
supervisory observation, is shown to have, or appears to have, an 
illness, open lesion, including boils, sores, or infected wounds, or any 
other abnormal source of microbial contamination by which there is a 
reasonable possibility of food, food-contact surfaces, or food-packaging 
materials becoming contaminated, must be excluded from any operations 
which may be expected to result in such contamination until the 
condition is corrected, unless conditions such as open lesions, boils, 
and infected wounds are adequately covered (e.g., by an impermeable 
cover). Personnel must be instructed to report such health conditions to 
their supervisors.
    (b) Cleanliness. All persons working in direct contact with food, 
food-contact surfaces, and food-packaging materials must conform to 
hygienic practices while on duty to the extent necessary to protect 
against allergen cross-contact and against contamination of food. The 
methods for maintaining cleanliness include:
    (1) Wearing outer garments suitable to the operation in a manner 
that protects against allergen cross-contact and against the 
contamination of food, food-contact surfaces, or food-packaging 
materials.
    (2) Maintaining adequate personal cleanliness.
    (3) Washing hands thoroughly (and sanitizing if necessary to protect 
against contamination with undesirable microorganisms) in an adequate 
hand-washing facility before starting work, after each absence from the 
work station, and at any other time when the hands may have become 
soiled or contaminated.
    (4) Removing all unsecured jewelry and other objects that might fall 
into food, equipment, or containers, and removing hand jewelry that 
cannot be adequately sanitized during periods in which food is 
manipulated by hand. If such hand jewelry cannot be removed, it may be 
covered by material which can be maintained in an intact, clean, and 
sanitary condition and which effectively protects against the 
contamination by these objects of the food, food-

[[Page 399]]

contact surfaces, or food-packaging materials.
    (5) Maintaining gloves, if they are used in food handling, in an 
intact, clean, and sanitary condition.
    (6) Wearing, where appropriate, in an effective manner, hair nets, 
headbands, caps, beard covers, or other effective hair restraints.
    (7) Storing clothing or other personal belongings in areas other 
than where food is exposed or where equipment or utensils are washed.
    (8) Confining the following to areas other than where food may be 
exposed or where equipment or utensils are washed: eating food, chewing 
gum, drinking beverages, or using tobacco.
    (9) Taking any other necessary precautions to protect against 
allergen cross-contact and against contamination of food, food-contact 
surfaces, or food-packaging materials with microorganisms or foreign 
substances (including perspiration, hair, cosmetics, tobacco, chemicals, 
and medicines applied to the skin).



Sec. 117.20  Plant and grounds.

    (a) Grounds. The grounds about a food plant under the control of the 
operator must be kept in a condition that will protect against the 
contamination of food. The methods for adequate maintenance of grounds 
must include:
    (1) Properly storing equipment, removing litter and waste, and 
cutting weeds or grass within the immediate vicinity of the plant that 
may constitute an attractant, breeding place, or harborage for pests.
    (2) Maintaining roads, yards, and parking lots so that they do not 
constitute a source of contamination in areas where food is exposed.
    (3) Adequately draining areas that may contribute contamination to 
food by seepage, foot-borne filth, or providing a breeding place for 
pests.
    (4) Operating systems for waste treatment and disposal in an 
adequate manner so that they do not constitute a source of contamination 
in areas where food is exposed.
    (5) If the plant grounds are bordered by grounds not under the 
operator's control and not maintained in the manner described in 
paragraphs (a)(1) through (4) of this section, care must be exercised in 
the plant by inspection, extermination, or other means to exclude pests, 
dirt, and filth that may be a source of food contamination.
    (b) Plant construction and design. The plant must be suitable in 
size, construction, and design to facilitate maintenance and sanitary 
operations for food-production purposes (i.e., manufacturing, 
processing, packing, and holding). The plant must:
    (1) Provide adequate space for such placement of equipment and 
storage of materials as is necessary for maintenance, sanitary 
operations, and the production of safe food.
    (2) Permit the taking of adequate precautions to reduce the 
potential for allergen cross-contact and for contamination of food, 
food-contact surfaces, or food-packaging materials with microorganisms, 
chemicals, filth, and other extraneous material. The potential for 
allergen cross-contact and for contamination may be reduced by adequate 
food safety controls and operating practices or effective design, 
including the separation of operations in which allergen cross-contact 
and contamination are likely to occur, by one or more of the following 
means: location, time, partition, air flow systems, dust control 
systems, enclosed systems, or other effective means.
    (3) Permit the taking of adequate precautions to protect food in 
installed outdoor bulk vessels by any effective means, including:
    (i) Using protective coverings.
    (ii) Controlling areas over and around the vessels to eliminate 
harborages for pests.
    (iii) Checking on a regular basis for pests and pest infestation.
    (iv) Skimming fermentation vessels, as necessary.
    (4) Be constructed in such a manner that floors, walls, and ceilings 
may be adequately cleaned and kept clean and kept in good repair; that 
drip or condensate from fixtures, ducts and pipes does not contaminate 
food, food-contact surfaces, or food-packaging materials; and that 
aisles or working spaces are provided between equipment and walls and 
are adequately unobstructed and of adequate width to permit employees to 
perform their duties and to protect against contaminating food,

[[Page 400]]

food-contact surfaces, or food-packaging materials with clothing or 
personal contact.
    (5) Provide adequate lighting in hand-washing areas, dressing and 
locker rooms, and toilet rooms and in all areas where food is examined, 
manufactured, processed, packed, or held and where equipment or utensils 
are cleaned; and provide shatter-resistant light bulbs, fixtures, 
skylights, or other glass suspended over exposed food in any step of 
preparation or otherwise protect against food contamination in case of 
glass breakage.
    (6) Provide adequate ventilation or control equipment to minimize 
dust, odors and vapors (including steam and noxious fumes) in areas 
where they may cause allergen cross-contact or contaminate food; and 
locate and operate fans and other air-blowing equipment in a manner that 
minimizes the potential for allergen cross-contact and for contaminating 
food, food-packaging materials, and food-contact surfaces.
    (7) Provide, where necessary, adequate screening or other protection 
against pests.



Sec. 117.35  Sanitary operations.

    (a) General maintenance. Buildings, fixtures, and other physical 
facilities of the plant must be maintained in a clean and sanitary 
condition and must be kept in repair adequate to prevent food from 
becoming adulterated. Cleaning and sanitizing of utensils and equipment 
must be conducted in a manner that protects against allergen cross-
contact and against contamination of food, food-contact surfaces, or 
food-packaging materials.
    (b) Substances used in cleaning and sanitizing; storage of toxic 
materials. (1) Cleaning compounds and sanitizing agents used in cleaning 
and sanitizing procedures must be free from undesirable microorganisms 
and must be safe and adequate under the conditions of use. Compliance 
with this requirement must be verified by any effective means, including 
purchase of these substances under a letter of guarantee or 
certification or examination of these substances for contamination. Only 
the following toxic materials may be used or stored in a plant where 
food is processed or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and 
operation; and
    (iv) Those necessary for use in the plant's operations.
    (2) Toxic cleaning compounds, sanitizing agents, and pesticide 
chemicals must be identified, held, and stored in a manner that protects 
against contamination of food, food-contact surfaces, or food-packaging 
materials.
    (c) Pest control. Pests must not be allowed in any area of a food 
plant. Guard, guide, or pest-detecting dogs may be allowed in some areas 
of a plant if the presence of the dogs is unlikely to result in 
contamination of food, food-contact surfaces, or food-packaging 
materials. Effective measures must be taken to exclude pests from the 
manufacturing, processing, packing, and holding areas and to protect 
against the contamination of food on the premises by pests. The use of 
pesticides to control pests in the plant is permitted only under 
precautions and restrictions that will protect against the contamination 
of food, food-contact surfaces, and food-packaging materials.
    (d) Sanitation of food-contact surfaces. All food-contact surfaces, 
including utensils and food-contact surfaces of equipment, must be 
cleaned as frequently as necessary to protect against allergen cross-
contact and against contamination of food.
    (1) Food-contact surfaces used for manufacturing/processing, 
packing, or holding low-moisture food must be in a clean, dry, sanitary 
condition before use. When the surfaces are wet-cleaned, they must, when 
necessary, be sanitized and thoroughly dried before subsequent use.
    (2) In wet processing, when cleaning is necessary to protect against 
allergen cross-contact or the introduction of microorganisms into food, 
all food-contact surfaces must be cleaned and sanitized before use and 
after any interruption during which the food-contact surfaces may have 
become contaminated. Where equipment and utensils are used in a 
continuous production operation,

[[Page 401]]

the utensils and food-contact surfaces of the equipment must be cleaned 
and sanitized as necessary.
    (3) Single-service articles (such as utensils intended for one-time 
use, paper cups, and paper towels) must be stored, handled, and disposed 
of in a manner that protects against allergen cross-contact and against 
contamination of food, food-contact surfaces, or food-packaging 
materials.
    (e) Sanitation of non-food-contact surfaces. Non-food-contact 
surfaces of equipment used in the operation of a food plant must be 
cleaned in a manner and as frequently as necessary to protect against 
allergen cross-contact and against contamination of food, food-contact 
surfaces, and food-packaging materials.
    (f) Storage and handling of cleaned portable equipment and utensils. 
Cleaned and sanitized portable equipment with food-contact surfaces and 
utensils must be stored in a location and manner that protects food-
contact surfaces from allergen cross-contact and from contamination.



Sec. 117.37  Sanitary facilities and controls.

    Each plant must be equipped with adequate sanitary facilities and 
accommodations including:
    (a) Water supply. The water supply must be adequate for the 
operations intended and must be derived from an adequate source. Any 
water that contacts food, food-contact surfaces, or food-packaging 
materials must be safe and of adequate sanitary quality. Running water 
at a suitable temperature, and under pressure as needed, must be 
provided in all areas where required for the processing of food, for the 
cleaning of equipment, utensils, and food-packaging materials, or for 
employee sanitary facilities.
    (b) Plumbing. Plumbing must be of adequate size and design and 
adequately installed and maintained to:
    (1) Carry adequate quantities of water to required locations 
throughout the plant.
    (2) Properly convey sewage and liquid disposable waste from the 
plant.
    (3) Avoid constituting a source of contamination to food, water 
supplies, equipment, or utensils or creating an unsanitary condition.
    (4) Provide adequate floor drainage in all areas where floors are 
subject to flooding-type cleaning or where normal operations release or 
discharge water or other liquid waste on the floor.
    (5) Provide that there is not backflow from, or cross-connection 
between, piping systems that discharge waste water or sewage and piping 
systems that carry water for food or food manufacturing.
    (c) Sewage disposal. Sewage must be disposed of into an adequate 
sewerage system or disposed of through other adequate means.
    (d) Toilet facilities. Each plant must provide employees with 
adequate, readily accessible toilet facilities. Toilet facilities must 
be kept clean and must not be a potential source of contamination of 
food, food-contact surfaces, or food-packaging materials.
    (e) Hand-washing facilities. Each plant must provide hand-washing 
facilities designed to ensure that an employee's hands are not a source 
of contamination of food, food-contact surfaces, or food-packaging 
materials, by providing facilities that are adequate, convenient, and 
furnish running water at a suitable temperature.
    (f) Rubbish and offal disposal. Rubbish and any offal must be so 
conveyed, stored, and disposed of as to minimize the development of 
odor, minimize the potential for the waste becoming an attractant and 
harborage or breeding place for pests, and protect against contamination 
of food, food-contact surfaces, food-packaging materials, water 
supplies, and ground surfaces.



Sec. 117.40  Equipment and utensils.

    (a)(1) All plant equipment and utensils used in manufacturing, 
processing, packing, or holding food must be so designed and of such 
material and workmanship as to be adequately cleanable, and must be 
adequately maintained to protect against allergen cross-contact and 
contamination.
    (2) Equipment and utensils must be designed, constructed, and used 
appropriately to avoid the adulteration of food with lubricants, fuel, 
metal fragments, contaminated water, or any other contaminants.

[[Page 402]]

    (3) Equipment must be installed so as to facilitate the cleaning and 
maintenance of the equipment and of adjacent spaces.
    (4) Food-contact surfaces must be corrosion-resistant when in 
contact with food.
    (5) Food-contact surfaces must be made of nontoxic materials and 
designed to withstand the environment of their intended use and the 
action of food, and, if applicable, cleaning compounds, sanitizing 
agents, and cleaning procedures.
    (6) Food-contact surfaces must be maintained to protect food from 
allergen cross-contact and from being contaminated by any source, 
including unlawful indirect food additives.
    (b) Seams on food-contact surfaces must be smoothly bonded or 
maintained so as to minimize accumulation of food particles, dirt, and 
organic matter and thus minimize the opportunity for growth of 
microorganisms and allergen cross-contact.
    (c) Equipment that is in areas where food is manufactured, 
processed, packed, or held and that does not come into contact with food 
must be so constructed that it can be kept in a clean and sanitary 
condition.
    (d) Holding, conveying, and manufacturing systems, including 
gravimetric, pneumatic, closed, and automated systems, must be of a 
design and construction that enables them to be maintained in an 
appropriate clean and sanitary condition.
    (e) Each freezer and cold storage compartment used to store and hold 
food capable of supporting growth of microorganisms must be fitted with 
an indicating thermometer, temperature-measuring device, or temperature-
recording device so installed as to show the temperature accurately 
within the compartment.
    (f) Instruments and controls used for measuring, regulating, or 
recording temperatures, pH, acidity, water activity, or other conditions 
that control or prevent the growth of undesirable microorganisms in food 
must be accurate and precise and adequately maintained, and adequate in 
number for their designated uses.
    (g) Compressed air or other gases mechanically introduced into food 
or used to clean food-contact surfaces or equipment must be treated in 
such a way that food is not contaminated with unlawful indirect food 
additives.



Sec. 117.80  Processes and controls.

    (a) General. (1) All operations in the manufacturing, processing, 
packing, and holding of food (including operations directed to 
receiving, inspecting, transporting, and segregating) must be conducted 
in accordance with adequate sanitation principles.
    (2) Appropriate quality control operations must be employed to 
ensure that food is suitable for human consumption and that food-
packaging materials are safe and suitable.
    (3) Overall sanitation of the plant must be under the supervision of 
one or more competent individuals assigned responsibility for this 
function.
    (4) Adequate precautions must be taken to ensure that production 
procedures do not contribute to allergen cross-contact and to 
contamination from any source.
    (5) Chemical, microbial, or extraneous-material testing procedures 
must be used where necessary to identify sanitation failures or possible 
allergen cross-contact and food contamination.
    (6) All food that has become contaminated to the extent that it is 
adulterated must be rejected, or if appropriate, treated or processed to 
eliminate the contamination.
    (b) Raw materials and other ingredients. (1) Raw materials and other 
ingredients must be inspected and segregated or otherwise handled as 
necessary to ascertain that they are clean and suitable for processing 
into food and must be stored under conditions that will protect against 
allergen cross-contact and against contamination and minimize 
deterioration. Raw materials must be washed or cleaned as necessary to 
remove soil or other contamination. Water used for washing, rinsing, or 
conveying food must be safe and of adequate sanitary quality. Water may 
be reused for washing, rinsing, or conveying food if it does not cause 
allergen cross-contact or increase the level of contamination of the 
food.

[[Page 403]]

    (2) Raw materials and other ingredients must either not contain 
levels of microorganisms that may render the food injurious to the 
health of humans, or they must be pasteurized or otherwise treated 
during manufacturing operations so that they no longer contain levels 
that would cause the product to be adulterated.
    (3) Raw materials and other ingredients susceptible to contamination 
with aflatoxin or other natural toxins must comply with FDA regulations 
for poisonous or deleterious substances before these raw materials or 
other ingredients are incorporated into finished food.
    (4) Raw materials, other ingredients, and rework susceptible to 
contamination with pests, undesirable microorganisms, or extraneous 
material must comply with applicable FDA regulations for natural or 
unavoidable defects if a manufacturer wishes to use the materials in 
manufacturing food.
    (5) Raw materials, other ingredients, and rework must be held in 
bulk, or in containers designed and constructed so as to protect against 
allergen cross-contact and against contamination and must be held at 
such temperature and relative humidity and in such a manner as to 
prevent the food from becoming adulterated. Material scheduled for 
rework must be identified as such.
    (6) Frozen raw materials and other ingredients must be kept frozen. 
If thawing is required prior to use, it must be done in a manner that 
prevents the raw materials and other ingredients from becoming 
adulterated.
    (7) Liquid or dry raw materials and other ingredients received and 
stored in bulk form must be held in a manner that protects against 
allergen cross-contact and against contamination.
    (8) Raw materials and other ingredients that are food allergens, and 
rework that contains food allergens, must be identified and held in a 
manner that prevents allergen cross-contact.
    (c) Manufacturing operations. (1) Equipment and utensils and food 
containers must be maintained in an adequate condition through 
appropriate cleaning and sanitizing, as necessary. Insofar as necessary, 
equipment must be taken apart for thorough cleaning.
    (2) All food manufacturing, processing, packing, and holding must be 
conducted under such conditions and controls as are necessary to 
minimize the potential for the growth of microorganisms, allergen cross-
contact, contamination of food, and deterioration of food.
    (3) Food that can support the rapid growth of undesirable 
microorganisms must be held at temperatures that will prevent the food 
from becoming adulterated during manufacturing, processing, packing, and 
holding.
    (4) Measures such as sterilizing, irradiating, pasteurizing, 
cooking, freezing, refrigerating, controlling pH, or controlling 
aw that are taken to destroy or prevent the growth of 
undesirable microorganisms must be adequate under the conditions of 
manufacture, handling, and distribution to prevent food from being 
adulterated.
    (5) Work-in-process and rework must be handled in a manner that 
protects against allergen cross-contact, contamination, and growth of 
undesirable microorganisms.
    (6) Effective measures must be taken to protect finished food from 
allergen cross-contact and from contamination by raw materials, other 
ingredients, or refuse. When raw materials, other ingredients, or refuse 
are unprotected, they must not be handled simultaneously in a receiving, 
loading, or shipping area if that handling could result in allergen 
cross-contact or contaminated food. Food transported by conveyor must be 
protected against allergen cross-contact and against contamination as 
necessary.
    (7) Equipment, containers, and utensils used to convey, hold, or 
store raw materials and other ingredients, work-in-process, rework, or 
other food must be constructed, handled, and maintained during 
manufacturing, processing, packing, and holding in a manner that 
protects against allergen cross-contact and against contamination.
    (8) Adequate measures must be taken to protect against the inclusion 
of metal or other extraneous material in food.
    (9) Food, raw materials, and other ingredients that are adulterated:

[[Page 404]]

    (i) Must be disposed of in a manner that protects against the 
contamination of other food; or
    (ii) If the adulterated food is capable of being reconditioned, it 
must be:
    (A) Reconditioned (if appropriate) using a method that has been 
proven to be effective; or
    (B) Reconditioned (if appropriate) and reexamined and subsequently 
found not to be adulterated within the meaning of the Federal Food, 
Drug, and Cosmetic Act before being incorporated into other food.
    (10) Steps such as washing, peeling, trimming, cutting, sorting and 
inspecting, mashing, dewatering, cooling, shredding, extruding, drying, 
whipping, defatting, and forming must be performed so as to protect food 
against allergen cross-contact and against contamination. Food must be 
protected from contaminants that may drip, drain, or be drawn into the 
food.
    (11) Heat blanching, when required in the preparation of food 
capable of supporting microbial growth, must be effected by heating the 
food to the required temperature, holding it at this temperature for the 
required time, and then either rapidly cooling the food or passing it to 
subsequent manufacturing without delay. Growth and contamination by 
thermophilic microorganisms in blanchers must be minimized by the use of 
adequate operating temperatures and by periodic cleaning and sanitizing 
as necessary.
    (12) Batters, breading, sauces, gravies, dressings, dipping 
solutions, and other similar preparations that are held and used 
repeatedly over time must be treated or maintained in such a manner that 
they are protected against allergen cross-contact and against 
contamination, and minimizing the potential for the growth of 
undesirable microorganisms.
    (13) Filling, assembling, packaging, and other operations must be 
performed in such a way that the food is protected against allergen 
cross-contact, contamination and growth of undesirable microorganisms.
    (14) Food, such as dry mixes, nuts, intermediate moisture food, and 
dehydrated food, that relies principally on the control of aw 
for preventing the growth of undesirable microorganisms must be 
processed to and maintained at a safe moisture level.
    (15) Food, such as acid and acidified food, that relies principally 
on the control of pH for preventing the growth of undesirable 
microorganisms must be monitored and maintained at a pH of 4.6 or below.
    (16) When ice is used in contact with food, it must be made from 
water that is safe and of adequate sanitary quality in accordance with 
Sec. 117.37(a), and must be used only if it has been manufactured in 
accordance with current good manufacturing practice as outlined in this 
part.



Sec. 117.93  Warehousing and distribution.

    Storage and transportation of food must be under conditions that 
will protect against allergen cross-contact and against biological, 
chemical (including radiological), and physical contamination of food, 
as well as against deterioration of the food and the container.



Sec. 117.95  Holding and distribution of human food by-products
for use as animal food.

    (a) Human food by-products held for distribution as animal food 
without additional manufacturing or processing by the human food 
processor, as identified in Sec. 507.12 of this chapter, must be held 
under conditions that will protect against contamination, including the 
following:
    (1) Containers and equipment used to convey or hold human food by-
products for use as animal food before distribution must be designed, 
constructed of appropriate material, cleaned as necessary, and 
maintained to protect against the contamination of human food by-
products for use as animal food;
    (2) Human food by-products for use as animal food held for 
distribution must be held in a way to protect against contamination from 
sources such as trash; and
    (3) During holding, human food by-products for use as animal food 
must be accurately identified.
    (b) Labeling that identifies the by-product by the common or usual 
name must be affixed to or accompany human food by-products for use as 
animal food when distributed.

[[Page 405]]

    (c) Shipping containers (e.g., totes, drums, and tubs) and bulk 
vehicles used to distribute human food by-products for use as animal 
food must be examined prior to use to protect against contamination of 
the human food by-products for use as animal food from the container or 
vehicle when the facility is responsible for transporting the human food 
by-products for use as animal food itself or arranges with a third party 
to transport the human food by-products for use as animal food.

[80 FR 56337, Sept. 17, 2015]



Sec. 117.110  Defect action levels.

    (a) The manufacturer, processor, packer, and holder of food must at 
all times utilize quality control operations that reduce natural or 
unavoidable defects to the lowest level currently feasible.
    (b) The mixing of a food containing defects at levels that render 
that food adulterated with another lot of food is not permitted and 
renders the final food adulterated, regardless of the defect level of 
the final food. For examples of defect action levels that may render 
food adulterated, see the Defect Levels Handbook, which is accessible 
athttp://www.fda.gov/pchfrule and athttp://www.fda.gov.



      Subpart C_Hazard Analysis and Risk-Based Preventive Controls



Sec. 117.126  Food safety plan.

    (a) Requirement for a food safety plan. (1) You must prepare, or 
have prepared, and implement a written food safety plan.
    (2) The food safety plan must be prepared, or its preparation 
overseen, by one or more preventive controls qualified individuals.
    (b) Contents of a food safety plan. The written food safety plan 
must include:
    (1) The written hazard analysis as required by Sec. 117.130(a)(2);
    (2) The written preventive controls as required by Sec. 117.135(b);
    (3) The written supply-chain program as required by subpart G of 
this part;
    (4) The written recall plan as required by Sec. 117.139(a); and
    (5) The written procedures for monitoring the implementation of the 
preventive controls as required by Sec. 117.145(a);
    (6) The written corrective action procedures as required by Sec. 
117.150(a)(1); and
    (7) The written verification procedures as required by Sec. 
117.165(b).
    (c) Records. The food safety plan required by this section is a 
record that is subject to the requirements of subpart F of this part.

[80 FR 56145, Sept. 17, 2015, as amended at 84 FR 12491, Apr. 2, 2019]



Sec. 117.130  Hazard analysis.

    (a) Requirement for a hazard analysis. (1) You must conduct a hazard 
analysis to identify and evaluate, based on experience, illness data, 
scientific reports, and other information, known or reasonably 
foreseeable hazards for each type of food manufactured, processed, 
packed, or held at your facility to determine whether there are any 
hazards requiring a preventive control.
    (2) The hazard analysis must be written regardless of its outcome.
    (b) Hazard identification. The hazard identification must consider:
    (1) Known or reasonably foreseeable hazards that include:
    (i) Biological hazards, including microbiological hazards such as 
parasites, environmental pathogens, and other pathogens;
    (ii) Chemical hazards, including radiological hazards, substances 
such as pesticide and drug residues, natural toxins, decomposition, 
unapproved food or color additives, and food allergens; and
    (iii) Physical hazards (such as stones, glass, and metal fragments); 
and
    (2) Known or reasonably foreseeable hazards that may be present in 
the food for any of the following reasons:
    (i) The hazard occurs naturally;
    (ii) The hazard may be unintentionally introduced; or
    (iii) The hazard may be intentionally introduced for purposes of 
economic gain.
    (c) Hazard evaluation. (1)(i) The hazard analysis must include an 
evaluation of the hazards identified in paragraph (b) of this section to 
assess the severity of the illness or injury if the

[[Page 406]]

hazard were to occur and the probability that the hazard will occur in 
the absence of preventive controls.
    (ii) The hazard evaluation required by paragraph (c)(1)(i) of this 
section must include an evaluation of environmental pathogens whenever a 
ready-to-eat food is exposed to the environment prior to packaging and 
the packaged food does not receive a treatment or otherwise include a 
control measure (such as a formulation lethal to the pathogen) that 
would significantly minimize the pathogen.
    (2) The hazard evaluation must consider the effect of the following 
on the safety of the finished food for the intended consumer:
    (i) The formulation of the food;
    (ii) The condition, function, and design of the facility and 
equipment;
    (iii) Raw materials and other ingredients;
    (iv) Transportation practices;
    (v) Manufacturing/processing procedures;
    (vi) Packaging activities and labeling activities;
    (vii) Storage and distribution;
    (viii) Intended or reasonably foreseeable use;
    (ix) Sanitation, including employee hygiene; and
    (x) Any other relevant factors, such as the temporal (e.g., weather-
related) nature of some hazards (e.g., levels of some natural toxins).



Sec. 117.135  Preventive controls.

    (a)(1) You must identify and implement preventive controls to 
provide assurances that any hazards requiring a preventive control will 
be significantly minimized or prevented and the food manufactured, 
processed, packed, or held by your facility will not be adulterated 
under section 402 of the Federal Food, Drug, and Cosmetic Act or 
misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic 
Act.
    (2) Preventive controls required by paragraph (a)(1) of this section 
include:
    (i) Controls at critical control points (CCPs), if there are any 
CCPs; and
    (ii) Controls, other than those at CCPs, that are also appropriate 
for food safety.
    (b) Preventive controls must be written.
    (c) Preventive controls include, as appropriate to the facility and 
the food:
    (1) Process controls. Process controls include procedures, 
practices, and processes to ensure the control of parameters during 
operations such as heat processing, acidifying, irradiating, and 
refrigerating foods. Process controls must include, as appropriate to 
the nature of the applicable control and its role in the facility's food 
safety system:
    (i) Parameters associated with the control of the hazard; and
    (ii) The maximum or minimum value, or combination of values, to 
which any biological, chemical, or physical parameter must be controlled 
to significantly minimize or prevent a hazard requiring a process 
control.
    (2) Food allergen controls. Food allergen controls include 
procedures, practices, and processes to control food allergens. Food 
allergen controls must include those procedures, practices, and 
processes employed for:
    (i) Ensuring protection of food from allergen cross-contact, 
including during storage, handling, and use; and
    (ii) Labeling the finished food, including ensuring that the 
finished food is not misbranded under section 403(w) of the Federal 
Food, Drug, and Cosmetic Act.
    (3) Sanitation controls. Sanitation controls include procedures, 
practices, and processes to ensure that the facility is maintained in a 
sanitary condition adequate to significantly minimize or prevent hazards 
such as environmental pathogens, biological hazards due to employee 
handling, and food allergen hazards. Sanitation controls must include, 
as appropriate to the facility and the food, procedures, practices, and 
processes for the:
    (i) Cleanliness of food-contact surfaces, including food-contact 
surfaces of utensils and equipment;
    (ii) Prevention of allergen cross-contact and cross-contamination 
from insanitary objects and from personnel to food, food packaging 
material, and other food-contact surfaces and from raw product to 
processed product.
    (4) Supply-chain controls. Supply-chain controls include the supply-
chain

[[Page 407]]

program as required by subpart G of this part.
    (5) Recall plan. Recall plan as required by Sec. 117.139.
    (6) Other controls. Preventive controls include any other 
procedures, practices, and processes necessary to satisfy the 
requirements of paragraph (a) of this section. Examples of other 
controls include hygiene training and other current good manufacturing 
practices.



Sec. 117.136  Circumstances in which the owner, operator, or agent in 
charge of a manufacturing/processing facility is not required to 
implement a preventive control.
          

    (a) Circumstances. If you are a manufacturer/processor, you are not 
required to implement a preventive control when you identify a hazard 
requiring a preventive control (identified hazard) and any of the 
following circumstances apply:
    (1) You determine and document that the type of food (e.g., raw 
agricultural commodities such as cocoa beans, coffee beans, and grains) 
could not be consumed without application of an appropriate control.
    (2) You rely on your customer who is subject to the requirements for 
hazard analysis and risk-based preventive controls in this subpart to 
ensure that the identified hazard will be significantly minimized or 
prevented and you:
    (i) Disclose in documents accompanying the food, in accordance with 
the practice of the trade, that the food is ``not processed to control 
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject 
to the requirements of Sec. 117.137, that the customer has established 
and is following procedures (identified in the written assurance) that 
will significantly minimize or prevent the identified hazard.
    (3) You rely on your customer who is not subject to the requirements 
for hazard analysis and risk-based preventive controls in this subpart 
to provide assurance it is manufacturing, processing, or preparing the 
food in accordance with applicable food safety requirements and you:
    (i) Disclose in documents accompanying the food, in accordance with 
the practice of the trade, that the food is ``not processed to control 
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance that it is 
manufacturing, processing, or preparing the food in accordance with 
applicable food safety requirements.
    (4) You rely on your customer to provide assurance that the food 
will be processed to control the identified hazard by an entity in the 
distribution chain subsequent to the customer and you:
    (i) Disclose in documents accompanying the food, in accordance with 
the practice of the trade, that the food is ``not processed to control 
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject 
to the requirements of Sec. 117.137, that your customer:
    (A) Will disclose in documents accompanying the food, in accordance 
with the practice of the trade, that the food is ``not processed to 
control [identified hazard]''; and
    (B) Will only sell to another entity that agrees, in writing, it 
will:
    (1) Follow procedures (identified in a written assurance) that will 
significantly minimize or prevent the identified hazard (if the entity 
is subject to the requirements for hazard analysis and risk-based 
preventive controls in this subpart) or manufacture, process, or prepare 
the food in accordance with applicable food safety requirements (if the 
entity is not subject to the requirements for hazard analysis and risk-
based preventive controls in this subpart); or
    (2) Obtain a similar written assurance from the entity's customer, 
subject to the requirements of Sec. 117.137, as in paragraphs 
(a)(4)(ii)(A) and (B) of this section, as appropriate; or
    (5) You have established, documented, and implemented a system that 
ensures control, at a subsequent distribution step, of the hazards in 
the food you distribute and you document the implementation of that 
system.
    (b) Records. You must document any circumstance, specified in 
paragraph (a) of this section, that applies to you, including:
    (1) A determination, in accordance with paragraph (a) of this 
section, that

[[Page 408]]

the type of food could not be consumed without application of an 
appropriate control;
    (2) The annual written assurance from your customer in accordance 
with paragraph (a)(2) of this section;
    (3) The annual written assurance from your customer in accordance 
with paragraph (a)(3) of this section;
    (4) The annual written assurance from your customer in accordance 
with paragraph (a)(4) of this section; and
    (5) Your system, in accordance with paragraph (a)(5) of this 
section, that ensures control, at a subsequent distribution step, of the 
hazards in the food you distribute.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016]



Sec. 117.137  Provision of assurances required under 
Sec. 117.136(a)(2), (3), and (4).

    A facility that provides a written assurance under Sec. 
117.136(a)(2), (3), or (4) must act consistently with the assurance and 
document its actions taken to satisfy the written assurance.



Sec. 117.139  Recall plan.

    For food with a hazard requiring a preventive control:
    (a) You must establish a written recall plan for the food.
    (b) The written recall plan must include procedures that describe 
the steps to be taken, and assign responsibility for taking those steps, 
to perform the following actions as appropriate to the facility:
    (1) Directly notify the direct consignees of the food being 
recalled, including how to return or dispose of the affected food;
    (2) Notify the public about any hazard presented by the food when 
appropriate to protect public health;
    (3) Conduct effectiveness checks to verify that the recall is 
carried out; and
    (4) Appropriately dispose of recalled food--e.g., through 
reprocessing, reworking, diverting to a use that does not present a 
safety concern, or destroying the food.



Sec. 117.140  Preventive control management components.

    (a) Except as provided by paragraphs (b) and (c) of this section, 
the preventive controls required under Sec. 117.135 are subject to the 
following preventive control management components as appropriate to 
ensure the effectiveness of the preventive controls, taking into account 
the nature of the preventive control and its role in the facility's food 
safety system:
    (1) Monitoring in accordance with Sec. 117.145;
    (2) Corrective actions and corrections in accordance with Sec. 
117.150; and
    (3) Verification in accordance with Sec. 117.155.
    (b) The supply-chain program established in subpart G of this part 
is subject to the following preventive control management components as 
appropriate to ensure the effectiveness of the supply-chain program, 
taking into account the nature of the hazard controlled before receipt 
of the raw material or other ingredient:
    (1) Corrective actions and corrections in accordance with Sec. 
117.150, taking into account the nature of any supplier non-conformance;
    (2) Review of records in accordance with Sec. 117.165(a)(4); and
    (3) Reanalysis in accordance with Sec. 117.170.
    (c) The recall plan established in Sec. 117.139 is not subject to 
the requirements of paragraph (a) of this section.



Sec. 117.145  Monitoring.

    As appropriate to the nature of the preventive control and its role 
in the facility's food safety system:
    (a) Written procedures. You must establish and implement written 
procedures, including the frequency with which they are to be performed, 
for monitoring the preventive control; and
    (b) Monitoring. You must monitor the preventive controls with 
adequate frequency to provide assurance that they are consistently 
performed.
    (c) Records. (1) Requirement to document monitoring. You must 
document the monitoring of preventive controls in accordance with this 
section in records that are subject to verification in accordance with 
Sec. 117.155(a)(2) and

[[Page 409]]

records review in accordance with Sec. 117.165(a)(4)(i).
    (2) Exception records. (i) Records of refrigeration temperature 
during storage of food that requires time/temperature control to 
significantly minimize or prevent the growth of, or toxin production by, 
pathogens may be affirmative records demonstrating temperature is 
controlled or exception records demonstrating loss of temperature 
control.
    (ii) Exception records may be adequate in circumstances other than 
monitoring of refrigeration temperature.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016]



Sec. 117.150  Corrective actions and corrections.

    (a) Corrective action procedures. As appropriate to the nature of 
the hazard and the nature of the preventive control, except as provided 
by paragraph (c) of this section:
    (1) You must establish and implement written corrective action 
procedures that must be taken if preventive controls are not properly 
implemented, including procedures to address, as appropriate:
    (i) The presence of a pathogen or appropriate indicator organism in 
a ready-to-eat product detected as a result of product testing conducted 
in accordance with Sec. 117.165(a)(2); and
    (ii) The presence of an environmental pathogen or appropriate 
indicator organism detected through the environmental monitoring 
conducted in accordance with Sec. 117.165(a)(3).
    (2) The corrective action procedures must describe the steps to be 
taken to ensure that:
    (i) Appropriate action is taken to identify and correct a problem 
that has occurred with implementation of a preventive control;
    (ii) Appropriate action is taken, when necessary, to reduce the 
likelihood that the problem will recur;
    (iii) All affected food is evaluated for safety; and
    (iv) All affected food is prevented from entering into commerce, if 
you cannot ensure that the affected food is not adulterated under 
section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded 
under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
    (b) Corrective action in the event of an unanticipated food safety 
problem. (1) Except as provided by paragraph (c) of this section, you 
are subject to the requirements of paragraphs (b)(2) of this section if 
any of the following circumstances apply:
    (i) A preventive control is not properly implemented and a 
corrective action procedure has not been established;
    (ii) A preventive control, combination of preventive controls, or 
the food safety plan as a whole is found to be ineffective; or
    (iii) A review of records in accordance with Sec. 117.165(a)(4) 
finds that the records are not complete, the activities conducted did 
not occur in accordance with the food safety plan, or appropriate 
decisions were not made about corrective actions.
    (2) If any of the circumstances listed in paragraph (b)(1) of this 
section apply, you must:
    (i) Take corrective action to identify and correct the problem, 
reduce the likelihood that the problem will recur, evaluate all affected 
food for safety, and, as necessary, prevent affected food from entering 
commerce as would be done following a corrective action procedure under 
paragraphs (a)(2)(i) through (iv) of this section; and
    (ii) When appropriate, reanalyze the food safety plan in accordance 
with Sec. 117.170 to determine whether modification of the food safety 
plan is required.
    (c) Corrections. You do not need to comply with the requirements of 
paragraphs (a) and (b) of this section if:
    (1) You take action, in a timely manner, to identify and correct 
conditions and practices that are not consistent with the food allergen 
controls in Sec. 117.135(c)(2)(i) or the sanitation controls in Sec. 
117.135(c)(3)(i) or (ii); or
    (2) You take action, in a timely manner, to identify and correct a 
minor and isolated problem that does not directly impact product safety.
    (d) Records. All corrective actions (and, when appropriate, 
corrections) taken in accordance with this section must be documented in 
records. These records are subject to verification in

[[Page 410]]

accordance with Sec. 117.155(a)(3) and records review in accordance 
with Sec. 117.165(a)(4)(i).



Sec. 117.155  Verification.

    (a) Verification activities. Verification activities must include, 
as appropriate to the nature of the preventive control and its role in 
the facility's food safety system:
    (1) Validation in accordance with Sec. 117.160.
    (2) Verification that monitoring is being conducted as required by 
Sec. 117.140 (and in accordance with Sec. 117.145).
    (3) Verification that appropriate decisions about corrective actions 
are being made as required by Sec. 117.140 (and in accordance with 
Sec. 117.150).
    (4) Verification of implementation and effectiveness in accordance 
with Sec. 117.165; and
    (5) Reanalysis in accordance with Sec. 117.170.
    (b) Documentation. All verification activities conducted in 
accordance with this section must be documented in records.



Sec. 117.160  Validation.

    (a) You must validate that the preventive controls identified and 
implemented in accordance with Sec. 117.135 are adequate to control the 
hazard as appropriate to the nature of the preventive control and its 
role in the facility's food safety system.
    (b) The validation of the preventive controls:
    (1) Must be performed (or overseen) by a preventive controls 
qualified individual:
    (i)(A) Prior to implementation of the food safety plan; or
    (B) When necessary to demonstrate the control measures can be 
implemented as designed:
    (1) Within 90 calendar days after production of the applicable food 
first begins; or
    (2) Within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 90 calendar days 
after production of the applicable food first begins;
    (ii) Whenever a change to a control measure or combination of 
control measures could impact whether the control measure or combination 
of control measures, when properly implemented, will effectively control 
the hazards; and
    (iii) Whenever a reanalysis of the food safety plan reveals the need 
to do so;
    (2) Must include obtaining and evaluating scientific and technical 
evidence (or, when such evidence is not available or is inadequate, 
conducting studies) to determine whether the preventive controls, when 
properly implemented, will effectively control the hazards; and
    (c) You do not need to validate:
    (1) The food allergen controls in Sec. 117.135(c)(2);
    (2) The sanitation controls in Sec. 117.135(c)(3);
    (3) The recall plan in Sec. 117.139;
    (4) The supply-chain program in subpart G of this part; and
    (5) Other preventive controls, if the preventive controls qualified 
individual prepares (or oversees the preparation of) a written 
justification that validation is not applicable based on factors such as 
the nature of the hazard, and the nature of the preventive control and 
its role in the facility's food safety system.



Sec. 117.165  Verification of implementation and effectiveness.

    (a) Verification activities. You must verify that the preventive 
controls are consistently implemented and are effectively and 
significantly minimizing or preventing the hazards. To do so you must 
conduct activities that include the following, as appropriate to the 
facility, the food, and the nature of the preventive control and its 
role in the facility's food safety system:
    (1) Calibration of process monitoring instruments and verification 
instruments (or checking them for accuracy);
    (2) Product testing, for a pathogen (or appropriate indicator 
organism) or other hazard;
    (3) Environmental monitoring, for an environmental pathogen or for 
an appropriate indicator organism, if contamination of a ready-to-eat 
food with an environmental pathogen is a hazard requiring a preventive 
control, by collecting and testing environmental samples; and

[[Page 411]]

    (4) Review of the following records within the specified timeframes, 
by (or under the oversight of) a preventive controls qualified 
individual, to ensure that the records are complete, the activities 
reflected in the records occurred in accordance with the food safety 
plan, the preventive controls are effective, and appropriate decisions 
were made about corrective actions:
    (i) Records of monitoring and corrective action records within 7 
working days after the records are created or within a reasonable 
timeframe, provided that the preventive controls qualified individual 
prepares (or oversees the preparation of) a written justification for a 
timeframe that exceeds 7 working days; and
    (ii) Records of calibration, testing (e.g., product testing, 
environmental monitoring), supplier and supply-chain verification 
activities, and other verification activities within a reasonable time 
after the records are created; and
    (5) Other activities appropriate for verification of implementation 
and effectiveness.
    (b) Written procedures. As appropriate to the facility, the food, 
the nature of the preventive control, and the role of the preventive 
control in the facility's food safety system, you must establish and 
implement written procedures for the following activities:
    (1) The method and frequency of calibrating process monitoring 
instruments and verification instruments (or checking them for accuracy) 
as required by paragraph (a)(1) of this section.
    (2) Product testing as required by paragraph (a)(2) of this section. 
Procedures for product testing must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s) or other analyte(s);
    (iii) Specify the procedures for identifying samples, including 
their relationship to specific lots of product;
    (iv) Include the procedures for sampling, including the number of 
samples and the sampling frequency;
    (v) Identify the test(s) conducted, including the analytical 
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec. 
117.150(a)(1).
    (3) Environmental monitoring as required by paragraph (a)(3) of this 
section. Procedures for environmental monitoring must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s);
    (iii) Identify the locations from which samples will be collected 
and the number of sites to be tested during routine environmental 
monitoring. The number and location of sampling sites must be adequate 
to determine whether preventive controls are effective;
    (iv) Identify the timing and frequency for collecting and testing 
samples. The timing and frequency for collecting and testing samples 
must be adequate to determine whether preventive controls are effective;
    (v) Identify the test(s) conducted, including the analytical 
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec. 
117.150(a)(1).



Sec. 117.170  Reanalysis.

    (a) You must conduct a reanalysis of the food safety plan as a whole 
at least once every 3 years;
    (b) You must conduct a reanalysis of the food safety plan as a 
whole, or the applicable portion of the food safety plan:
    (1) Whenever a significant change in the activities conducted at 
your facility creates a reasonable potential for a new hazard or creates 
a significant increase in a previously identified hazard;
    (2) Whenever you become aware of new information about potential 
hazards associated with the food;
    (3) Whenever appropriate after an unanticipated food safety problem 
in accordance with Sec. 117.150(b); and
    (4) Whenever you find that a preventive control, combination of 
preventive controls, or the food safety plan as a whole is ineffective.
    (c) You must complete the reanalysis required by paragraphs (a) and 
(b) of this section and validate, as appropriate to the nature of the 
preventive control and its role in the facility's

[[Page 412]]

food safety system, any additional preventive controls needed to address 
the hazard identified:
    (1) Before any change in activities (including any change in 
preventive control) at the facility is operative; or
    (2) When necessary to demonstrate the control measures can be 
implemented as designed:
    (i) Within 90 calendar days after production of the applicable food 
first begins; or
    (ii) Within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 90-calendar days 
after production of the applicable food first begins.
    (d) You must revise the written food safety plan if a significant 
change in the activities conducted at your facility creates a reasonable 
potential for a new hazard or a significant increase in a previously 
identified hazard or document the basis for the conclusion that no 
revisions are needed.
    (e) A preventive controls qualified individual must perform (or 
oversee) the reanalysis.
    (f) You must conduct a reanalysis of the food safety plan when FDA 
determines it is necessary to respond to new hazards and developments in 
scientific understanding.



Sec. 117.180  Requirements applicable to a preventive controls 
qualified individual and a qualified auditor.

    (a) One or more preventive controls qualified individuals must do or 
oversee the following:
    (1) Preparation of the food safety plan (Sec. 117.126(a)(2));
    (2) Validation of the preventive controls (Sec. 117.160(b)(1));
    (3) Written justification for validation to be performed in a 
timeframe that exceeds the first 90 calendar days of production of the 
applicable food;
    (4) Determination that validation is not required (Sec. 
117.160(c)(5));
    (5) Review of records (Sec. 117.165(a)(4));
    (6) Written justification for review of records of monitoring and 
corrective actions within a timeframe that exceeds 7 working days;
    (7) Reanalysis of the food safety plan (Sec. 117.170(d)); and
    (8) Determination that reanalysis can be completed, and additional 
preventive controls validated, as appropriate to the nature of the 
preventive control and its role in the facility's food safety system, in 
a timeframe that exceeds the first 90 calendar days of production of the 
applicable food.
    (b) A qualified auditor must conduct an onsite audit (Sec. 
117.435(a)).
    (c)(1) To be a preventive controls qualified individual, the 
individual must have successfully completed training in the development 
and application of risk-based preventive controls at least equivalent to 
that received under a standardized curriculum recognized as adequate by 
FDA or be otherwise qualified through job experience to develop and 
apply a food safety system. Job experience may qualify an individual to 
perform these functions if such experience has provided an individual 
with knowledge at least equivalent to that provided through the 
standardized curriculum. This individual may be, but is not required to 
be, an employee of the facility.
    (2) To be a qualified auditor, a qualified individual must have 
technical expertise obtained through education, training, or experience 
(or a combination thereof) necessary to perform the auditing function.
    (d) All applicable training in the development and application of 
risk-based preventive controls must be documented in records, including 
the date of the training, the type of training, and the person(s) 
trained.



Sec. 117.190  Implementation records required for this subpart.

    (a) You must establish and maintain the following records 
documenting implementation of the food safety plan:
    (1) Documentation, as required by Sec. 117.136(b), of the basis for 
not establishing a preventive control in accordance with Sec. 
117.136(a);
    (2) Records that document the monitoring of preventive controls;
    (3) Records that document corrective actions;
    (4) Records that document verification, including, as applicable, 
those related to:
    (i) Validation;
    (ii) Verification of monitoring;

[[Page 413]]

    (iii) Verification of corrective actions;
    (iv) Calibration of process monitoring and verification instruments;
    (v) Product testing;
    (vi) Environmental monitoring;
    (vii) Records review; and
    (viii) Reanalysis;
    (5) Records that document the supply-chain program; and
    (6) Records that document applicable training for the preventive 
controls qualified individual and the qualified auditor.
    (b) The records that you must establish and maintain are subject to 
the requirements of subpart F of this part.



                     Subpart D_Modified Requirements



Sec. 117.201  Modified requirements that apply to a qualified facility.

    (a) Attestations to be submitted. A qualified facility must submit 
the following attestations to FDA:
    (1) An attestation that the facility is a qualified facility as 
defined in Sec. 117.3. For the purpose of determining whether a 
facility satisfies the definition of qualified facility, the baseline 
year for calculating the adjustment for inflation is 2011; and
    (2)(i) An attestation that you have identified the potential hazards 
associated with the food being produced, are implementing preventive 
controls to address the hazards, and are monitoring the performance of 
the preventive controls to ensure that such controls are effective; or
    (ii) An attestation that the facility is in compliance with State, 
local, county, tribal, or other applicable non-Federal food safety law, 
including relevant laws and regulations of foreign countries, including 
an attestation based on licenses, inspection reports, certificates, 
permits, credentials, certification by an appropriate agency (such as a 
State department of agriculture), or other evidence of oversight.
    (b) Procedure for submission. The attestations required by paragraph 
(a) of this section must be submitted to FDA by one of the following 
means:
    (1) Electronic submission. To submit electronically, go to http://
www.fda.gov/furls and follow the instructions. This Web site is 
available from wherever the Internet is accessible, including libraries, 
copy centers, schools, and Internet cafes. FDA encourages electronic 
submission.
    (2) Submission by mail. (i) You must use Form FDA 3942a. You may 
obtain a copy of this form by any of the following mechanisms:
    (A) Download it from http://www.fda.gov/pchfrule;
    (B) Write to the U.S. Food and Drug Administration (HFS-681), 5001 
Campus Dr., College Park, MD 20740; or
    (C) Request a copy of this form by phone at 1-800-216-7331 or 301-
575-0156.
    (ii) Send a paper Form FDA 3942a to the U.S. Food and Drug 
Administration (HFS-681), 5001 Campus Dr., College Park, MD 20740. We 
recommend that you submit a paper copy only if your facility does not 
have reasonable access to the Internet.
    (c) Frequency of determination of status and submission. (1) A 
facility must determine and document its status as a qualified facility 
on an annual basis no later than July 1 of each calendar year.
    (2) The attestations required by paragraph (a) of this section must 
be:
    (i) Submitted to FDA initially:
    (A) By December 17, 2018, for a facility that begins manufacturing, 
processing, packing, or holding food before September 17, 2018;
    (B) Before beginning operations, for a facility that begins 
manufacturing, processing, packing, or holding food after September 17, 
2018; or
    (C) By July 31 of the applicable calendar year, when the status of a 
facility changes from ``not a qualified facility'' to ``qualified 
facility'' based on the annual determination required by paragraph 
(c)(1) of this section; and
    (ii) Beginning in 2020, submitted to FDA every 2 years during the 
period beginning on October 1 and ending on December 31.
    (3) When the status of a facility changes from ``qualified 
facility'' to ``not a qualified facility'' based on the annual 
determination required by paragraph (c)(1) of this section, the facility 
must notify FDA of that change in status using Form 3942a by July 31 of 
the applicable calendar year.

[[Page 414]]

    (d) Timeframe for compliance with subparts C and G of this part when 
the facility status changes to ``not a qualified facility.'' When the 
status of a facility changes from ``qualified facility'' to ``not a 
qualified facility,'' the facility must comply with subparts C and G of 
this part no later than December 31 of the applicable calendar year 
unless otherwise agreed to by FDA and the facility.
    (e) Notification to consumers. A qualified facility that does not 
submit attestations under paragraph (a)(2)(i) of this section must 
provide notification to consumers as to the name and complete business 
address of the facility where the food was manufactured or processed 
(including the street address or P.O. box, city, state, and zip code for 
domestic facilities, and comparable full address information for foreign 
facilities), as follows:
    (1) If a food packaging label is required, the notification required 
by paragraph (e) of this section must appear prominently and 
conspicuously on the label of the food.
    (2) If a food packaging label is not required, the notification 
required by paragraph (e) of this section must appear prominently and 
conspicuously, at the point of purchase, on a label, poster, sign, 
placard, or documents delivered contemporaneously with the food in the 
normal course of business, or in an electronic notice, in the case of 
Internet sales.
    (f) Records. (1) A qualified facility must maintain those records 
relied upon to support the attestations that are required by paragraph 
(a) of this section.
    (2) The records that a qualified facility must maintain are subject 
to the requirements of subpart F of this part.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016]



Sec. 117.206  Modified requirements that apply to a facility solely
engaged in the storage of unexposed packaged food.

    (a) If a facility that is solely engaged in the storage of unexposed 
packaged food stores any such refrigerated packaged food that requires 
time/temperature control to significantly minimize or prevent the growth 
of, or toxin production by pathogens, the facility must conduct the 
following activities as appropriate to ensure the effectiveness of the 
temperature controls:
    (1) Establish and implement temperature controls adequate to 
significantly minimize or prevent the growth of, or toxin production by, 
pathogens;
    (2) Monitor the temperature controls with adequate frequency to 
provide assurance that the temperature controls are consistently 
performed;
    (3) If there is a loss of temperature control that may impact the 
safety of such refrigerated packaged food, take appropriate corrective 
actions to:
    (i) Correct the problem and reduce the likelihood that the problem 
will recur;
    (ii) Evaluate all affected food for safety; and
    (iii) Prevent the food from entering commerce, if you cannot ensure 
the affected food is not adulterated under section 402 of the Federal 
Food, Drug, and Cosmetic Act;
    (4) Verify that temperature controls are consistently implemented 
by:
    (i) Calibrating temperature monitoring and recording devices (or 
checking them for accuracy);
    (ii) Reviewing records of calibration within a reasonable time after 
the records are created; and
    (iii) Reviewing records of monitoring and corrective actions taken 
to correct a problem with the control of temperature within 7 working 
days after the records are created or within a reasonable timeframe, 
provided that the preventive controls qualified individual prepares (or 
oversees the preparation of) a written justification for a timeframe 
that exceeds 7 working days;
    (5) Establish and maintain the following records:
    (i) Records (whether affirmative records demonstrating temperature 
is controlled or exception records demonstrating loss of temperature 
control) documenting the monitoring of temperature controls for any such 
refrigerated packaged food;
    (ii) Records of corrective actions taken when there is a loss of 
temperature control that may impact the safety of any such refrigerated 
packaged food; and

[[Page 415]]

    (iii) Records documenting verification activities.
    (b) The records that a facility must establish and maintain under 
paragraph (a)(5) of this section are subject to the requirements of 
subpart F of this part.



         Subpart E_Withdrawal of a Qualified Facility Exemption



Sec. 117.251  Circumstances that may lead FDA to withdraw a qualified 
facility exemption.

    (a) FDA may withdraw a qualified facility exemption under Sec. 
117.5(a):
    (1) In the event of an active investigation of a foodborne illness 
outbreak that is directly linked to the qualified facility; or
    (2) If FDA determines that it is necessary to protect the public 
health and prevent or mitigate a foodborne illness outbreak based on 
conditions or conduct associated with the qualified facility that are 
material to the safety of the food manufactured, processed, packed, or 
held at such facility.
    (b) Before FDA issues an order to withdraw a qualified facility 
exemption, FDA:
    (1) May consider one or more other actions to protect the public 
health or mitigate a foodborne illness outbreak, including a warning 
letter, recall, administrative detention, suspension of registration, 
refusal of food offered for import, seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the 
facility, in writing, of circumstances that may lead FDA to withdraw the 
exemption, and provide an opportunity for the owner, operator, or agent 
in charge of the facility to respond in writing, within 15 calendar days 
of the date of receipt of the notification, to FDA's notification; and
    (3) Must consider the actions taken by the facility to address the 
circumstances that may lead FDA to withdraw the exemption.



Sec. 117.254  Issuance of an order to withdraw a qualified facility
exemption.

    (a) An FDA Division Director in whose division the qualified 
facility is located (or, in the case of a foreign facility, the Director 
of the Office of Compliance in the Center for Food Safety and Applied 
Nutrition), or an FDA official senior to either such Director, must 
approve an order to withdraw the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to 
withdraw the exemption after it has been approved in accordance with 
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner, 
operator, or agent in charge of the facility.
    (d) FDA must issue an order to withdraw the exemption in writing, 
signed and dated by the officer or qualified employee of FDA who is 
issuing the order.

[80 FR 56145, Sept. 17, 2015, as amended at 85 FR 16553, Mar. 24, 2020]



Sec. 117.257  Contents of an order to withdraw a qualified facility exemption.

    An order to withdraw a qualified facility exemption under Sec. 
117.5(a) must include the following information:
    (a) The date of the order;
    (b) The name, address, and location of the qualified facility;
    (c) A brief, general statement of the reasons for the order, 
including information relevant to one or both of the following 
circumstances that leads FDA to issue the order:
    (1) An active investigation of a foodborne illness outbreak that is 
directly linked to the facility; or
    (2) Conditions or conduct associated with a qualified facility that 
are material to the safety of the food manufactured, processed, packed, 
or held at such facility.
    (d) A statement that the facility must either:
    (1) Comply with subparts C and G of this part on the date that is 
120 calendar days after the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec. 117.264.

[[Page 416]]

    (e) A statement that a facility may request that FDA reinstate an 
exemption that was withdrawn by following the procedures in Sec. 
117.287;
    (f) The text of section 418(l) of the Federal Food, Drug, and 
Cosmetic Act and of this subpart;
    (g) A statement that any informal hearing on an appeal of the order 
must be conducted as a regulatory hearing under part 16 of this chapter, 
with certain exceptions described in Sec. 117.270;
    (h) The mailing address, telephone number, email address, fax 
number, and name of the FDA Division Director in whose division the 
facility is located (or, in the case of a foreign facility, the same 
information for the Director of the Office of Compliance in the Center 
for Food Safety and Applied Nutrition); and
    (i) The name and the title of the FDA representative who approved 
the order.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016; 
85 FR 16553, Mar. 24, 2020]



Sec. 117.260  Compliance with, or appeal of, an order to withdraw
a qualified facility exemption.

    (a) If you receive an order under Sec. 117.254 to withdraw a 
qualified facility exemption, you must either:
    (1) Comply with applicable requirements of this part within 120 
calendar days of the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec. 117.264.
    (b) Submission of an appeal, including submission of a request for 
an informal hearing, will not operate to delay or stay any 
administrative action, including enforcement action by FDA, unless the 
Commissioner of Food and Drugs, as a matter of discretion, determines 
that delay or a stay is in the public interest.
    (c) If you appeal the order, and FDA confirms the order:
    (1) You must comply with applicable requirements of this part within 
120 calendar days of the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; and
    (2) You are no longer subject to the modified requirements in Sec. 
117.201.



Sec. 117.264  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw a qualified facility exemption, 
you must:
    (1) Submit the appeal in writing to the FDA Division Director in 
whose division the facility is located (or, in the case of a foreign 
facility, the Director of the Office of Compliance in the Center for 
Food Safety and Applied Nutrition), at the mailing address, email 
address, or fax number identified in the order within 15 calendar days 
of the date of receipt of confirmation of the order; and
    (2) Respond with particularity to the facts and issues contained in 
the order, including any supporting documentation upon which you rely.
    (b) In a written appeal of the order withdrawing an exemption 
provided under Sec. 117.5(a), you may include a written request for an 
informal hearing as provided in Sec. 117.267.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016; 
85 FR 16553, Mar. 24, 2020]



Sec. 117.267  Procedure for requesting an informal hearing.

    (a) If you appeal the order, you:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with 
your written appeal submitted in accordance with Sec. 117.264 within 15 
calendar days of the date of receipt of the order.
    (b) A request for an informal hearing may be denied, in whole or in 
part, if the presiding officer determines that no genuine and 
substantial issue of material fact has been raised by the material 
submitted. If the presiding officer determines that a hearing is not 
justified, written notice of the determination will be given to you 
explaining the reason for the denial.

[[Page 417]]



Sec. 117.270  Requirements applicable to an informal hearing.

    If you request an informal hearing, and FDA grants the request:
    (a) The hearing will be held within 15 calendar days after the date 
the appeal is filed or, if applicable, within a timeframe agreed upon in 
writing by you and FDA.
    (b) The presiding officer may require that a hearing conducted under 
this subpart be completed within 1-calendar day, as appropriate.
    (c) FDA must conduct the hearing in accordance with part 16 of this 
chapter, except that:
    (1) The order withdrawing an exemption under Sec. Sec. 117.254 and 
117.257, rather than the notice under Sec. 16.22(a) of this chapter, 
provides notice of opportunity for a hearing under this section and is 
part of the administrative record of the regulatory hearing under Sec. 
16.80(a) of this chapter.
    (2) A request for a hearing under this subpart must be addressed to 
the FDA Division Director (or, in the case of a foreign facility, the 
Director of the Office of Compliance in the Center for Food Safety and 
Applied Nutrition) as provided in the order withdrawing an exemption.
    (3) Section 117.274, rather than Sec. 16.42(a) of this chapter, 
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a 
hearing under this subpart. The presiding officer must prepare a written 
report of the hearing. All written material presented at the hearing 
will be attached to the report. The presiding officer must include as 
part of the report of the hearing a finding on the credibility of 
witnesses (other than expert witnesses) whenever credibility is a 
material issue, and must include a proposed decision, with a statement 
of reasons. The hearing participant may review and comment on the 
presiding officer's report within 2-calendar days of issuance of the 
report. The presiding officer will then issue the final decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing under this subpart. The presiding officer's report of 
the hearing and any comments on the report by the hearing participant 
under Sec. 117.270(c)(4) are part of the administrative record.
    (6) No party shall have the right, under Sec. 16.119 of this 
chapter to petition the Commissioner of Food and Drugs for 
reconsideration or a stay of the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of 
an order withdrawing an exemption, the hearing must be conducted as a 
regulatory hearing under a regulation in accordance with part 16 of this 
chapter, except that Sec. 16.95(b) of this chapter does not apply to a 
hearing under this subpart. With respect to a regulatory hearing under 
this subpart, the administrative record of the hearing specified in 
Sec. Sec. 16.80(a)(1) through (3) and (a)(5) of this chapter and 
117.270(c)(5) constitutes the exclusive record for the presiding 
officer's final decision. For purposes of judicial review under Sec. 
10.45 of this chapter, the record of the administrative proceeding 
consists of the record of the hearing and the presiding officer's final 
decision.

[80 FR 56145, Sept. 17, 2015, as amended at 85 FR 16553, Mar. 24, 2020]



Sec. 117.274  Presiding officer for an appeal and for an informal
hearing.

    The presiding officer for an appeal, and for an informal hearing, 
must be an Office of Regulatory Affairs Program Director or another FDA 
official senior to an FDA Division Director.

[85 FR 16553, Mar. 24, 2020]



Sec. 117.277  Timeframe for issuing a decision on an appeal.

    (a) If you appeal the order without requesting a hearing, the 
presiding officer must issue a written report that includes a final 
decision confirming or revoking the withdrawal by the 10th calendar day 
after the appeal is filed.
    (b) If you appeal the order and request an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is held, 
the presiding officer must provide a 2-calendar day opportunity for the 
hearing participants to review and submit comments on the report of the 
hearing under Sec. 117.270(c)(4), and must issue a

[[Page 418]]

final decision within 10-calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer 
must issue a final decision on the appeal confirming or revoking the 
withdrawal within 10 calendar days after the date the appeal is filed.



Sec. 117.280  Revocation of an order to withdraw a qualified facility 
exemption.

    An order to withdraw a qualified facility exemption is revoked if:
    (a) You appeal the order and request an informal hearing, FDA grants 
the request for an informal hearing, and the presiding officer does not 
confirm the order within the 10-calendar days after the hearing, or 
issues a decision revoking the order within that time; or
    (b) You appeal the order and request an informal hearing, FDA denies 
the request for an informal hearing, and FDA does not confirm the order 
within the 10-calendar days after the appeal is filed, or issues a 
decision revoking the order within that time; or
    (c) You appeal the order without requesting an informal hearing, and 
FDA does not confirm the order within the 10-calendar days after the 
appeal is filed, or issues a decision revoking the order within that 
time.



Sec. 117.284  Final agency action.

    Confirmation of a withdrawal order by the presiding officer is 
considered a final agency action for purposes of 5 U.S.C. 702.



Sec. 117.287  Reinstatement of a qualified facility exemption that 
was withdrawn.

    (a) If the FDA Division Director in whose division your facility is 
located (or, in the case of a foreign facility, the Director of the 
Office of Compliance in the Center for Food Safety and Applied 
Nutrition) determines that a facility has adequately resolved any 
problems with the conditions and conduct that are material to the safety 
of the food manufactured, processed, packed, or held at the facility and 
that continued withdrawal of the exemption is not necessary to protect 
public health and prevent or mitigate a foodborne illness outbreak, the 
FDA Division Director in whose division your facility is located (or, in 
the case of a foreign facility, the Director of the Office of Compliance 
in the Center for Food Safety and Applied Nutrition) will, on his or her 
own initiative or on the request of a facility, reinstate the exemption.
    (b) You may ask FDA to reinstate an exemption that has been 
withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA Division Director in 
whose division your facility is located (or, in the case of a foreign 
facility, the Director of the Office of Compliance in the Center for 
Food Safety and Applied Nutrition); and
    (2) Present data and information to demonstrate that you have 
adequately resolved any problems with the conditions and conduct that 
are material to the safety of the food manufactured, processed, packed, 
or held at your facility, such that continued withdrawal of the 
exemption is not necessary to protect public health and prevent or 
mitigate a foodborne illness outbreak.
    (c) If your exemption was withdrawn under Sec. 117.251(a)(1) and 
FDA later determines, after finishing the active investigation of a 
foodborne illness outbreak, that the outbreak is not directly linked to 
your facility, FDA will reinstate your exemption under Sec. 117.5(a), 
and FDA will notify you in writing that your exempt status has been 
reinstated.
    (d) If your exemption was withdrawn under both Sec. 117.251(a)(1) 
and (2) and FDA later determines, after finishing the active 
investigation of a foodborne illness outbreak, that the outbreak is not 
directly linked to your facility, FDA will inform you of this finding, 
and you may ask FDA to reinstate your exemption under Sec. 117.5(a) in 
accordance with the requirements of paragraph (b) of this section.

[80 FR 56145, Sept. 17, 2015, as amended at 85 FR 16553, Mar. 24, 2020]

[[Page 419]]



Subpart F_Requirements Applying to Records That Must Be Established and 
                               Maintained



Sec. 117.301  Records subject to the requirements of this subpart.

    (a) Except as provided by paragraphs (b) and (c) of this section, 
all records required by this part are subject to all requirements of 
this subpart.
    (b) The requirements of Sec. 117.310 apply only to the written food 
safety plan.
    (c) The requirements of Sec. 117.305(b), (d), (e), and (f) do not 
apply to the records required by Sec. 117.201.



Sec. 117.305  General requirements applying to records.

    Records must:
    (a) Be kept as original records, true copies (such as photocopies, 
pictures, scanned copies, microfilm, microfiche, or other accurate 
reproductions of the original records), or electronic records;
    (b) Contain the actual values and observations obtained during 
monitoring and, as appropriate, during verification activities;
    (c) Be accurate, indelible, and legible;
    (d) Be created concurrently with performance of the activity 
documented;
    (e) Be as detailed as necessary to provide history of work 
performed; and
    (f) Include:
    (1) Information adequate to identify the plant or facility (e.g., 
the name, and when necessary, the location of the plant or facility);
    (2) The date and, when appropriate, the time of the activity 
documented;
    (3) The signature or initials of the person performing the activity; 
and
    (4) Where appropriate, the identity of the product and the lot code, 
if any.
    (g) Records that are established or maintained to satisfy the 
requirements of this part and that meet the definition of electronic 
records in Sec. 11.3(b)(6) of this chapter are exempt from the 
requirements of part 11 of this chapter. Records that satisfy the 
requirements of this part, but that also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.



Sec. 117.310  Additional requirements applying to the food safety 
plan.

    The owner, operator, or agent in charge of the facility must sign 
and date the food safety plan:
    (a) Upon initial completion; and
    (b) Upon any modification.



Sec. 117.315  Requirements for record retention.

    (a)(1) All records required by this part must be retained at the 
plant or facility for at least 2 years after the date they were 
prepared.
    (2) Records that a facility relies on during the 3-year period 
preceding the applicable calendar year to support its status as a 
qualified facility must be retained at the facility as long as necessary 
to support the status of a facility as a qualified facility during the 
applicable calendar year.
    (b) Records that relate to the general adequacy of the equipment or 
processes being used by a facility, including the results of scientific 
studies and evaluations, must be retained by the facility for at least 2 
years after their use is discontinued (e.g., because the facility has 
updated the written food safety plan (Sec. 117.126) or records that 
document validation of the written food safety plan (Sec. 117.155(b)));
    (c) Except for the food safety plan, offsite storage of records is 
permitted if such records can be retrieved and provided onsite within 24 
hours of request for official review. The food safety plan must remain 
onsite. Electronic records are considered to be onsite if they are 
accessible from an onsite location.
    (d) If the plant or facility is closed for a prolonged period, the 
food safety plan may be transferred to some other reasonably accessible 
location but must be returned to the plant or facility within 24 hours 
for official review upon request.



Sec. 117.320  Requirements for official review.

    All records required by this part must be made promptly available to 
a duly authorized representative of the Secretary of Health and Human 
Services for official review and copying upon oral or written request.

[[Page 420]]



Sec. 117.325  Public disclosure.

    Records obtained by FDA in accordance with this part are subject to 
the disclosure requirements under part 20 of this chapter.



Sec. 117.330  Use of existing records.

    (a) Existing records (e.g., records that are kept to comply with 
other Federal, State, or local regulations, or for any other reason) do 
not need to be duplicated if they contain all of the required 
information and satisfy the requirements of this subpart. Existing 
records may be supplemented as necessary to include all of the required 
information and satisfy the requirements of this subpart.
    (b) The information required by this part does not need to be kept 
in one set of records. If existing records contain some of the required 
information, any new information required by this part may be kept 
either separately or combined with the existing records.



Sec. 117.335  Special requirements applicable to a written assurance.

    (a) Any written assurance required by this part must contain the 
following elements:
    (1) Effective date;
    (2) Printed names and signatures of authorized officials;
    (3) The applicable assurance under:
    (i) Section 117.136(a)(2);
    (ii) Section 117.136(a)(3);
    (iii) Section 117.136(a)(4);
    (iv) Section 117.430(c)(2);
    (v) Section 117.430(d)(2); or
    (vi) Section 117.430(e)(2);
    (b) A written assurance required under Sec. 117.136(a)(2), (3), or 
(4) must include:
    (1) Acknowledgement that the facility that provides the written 
assurance assumes legal responsibility to act consistently with the 
assurance and document its actions taken to satisfy the written 
assurance; and
    (2) Provision that if the assurance is terminated in writing by 
either entity, responsibility for compliance with the applicable 
provisions of this part reverts to the manufacturer/processor as of the 
date of termination.



                     Subpart G_Supply-Chain Program



Sec. 117.405  Requirement to establish and implement a supply-chain
program.

    (a)(1) Except as provided by paragraphs (a)(2) and (3) of this 
section, the receiving facility must establish and implement a risk-
based supply-chain program for those raw materials and other ingredients 
for which the receiving facility has identified a hazard requiring a 
supply-chain-applied control.
    (2) A receiving facility that is an importer, is in compliance with 
the foreign supplier verification program requirements under part 1, 
subpart L of this chapter, and has documentation of verification 
activities conducted under Sec. 1.506(e) of this chapter (which 
provides assurance that the hazards requiring a supply-chain-applied 
control for the raw material or other ingredient have been significantly 
minimized or prevented) need not conduct supplier verification 
activities for that raw material or other ingredient.
    (3) The requirements in this subpart do not apply to food that is 
supplied for research or evaluation use, provided that such food:
    (i) Is not intended for retail sale and is not sold or distributed 
to the public;
    (ii) Is labeled with the statement ``Food for research or evaluation 
use'';
    (iii) Is supplied in a small quantity that is consistent with a 
research, analysis, or quality assurance purpose, the food is used only 
for this purpose, and any unused quantity is properly disposed of; and
    (iv) Is accompanied with documents, in accordance with the practice 
of the trade, stating that the food will be used for research or 
evaluation purposes and cannot be sold or distributed to the public.
    (b) The supply-chain program must be written.
    (c) When a supply-chain-applied control is applied by an entity 
other than the receiving facility's supplier (e.g., when a non-supplier 
applies controls to certain produce (i.e., produce covered by part 112 
of this chapter), because growing, harvesting, and packing activities 
are under different management), the receiving facility must:

[[Page 421]]

    (1) Verify the supply-chain-applied control; or
    (2) Obtain documentation of an appropriate verification activity 
from another entity, review and assess the entity's applicable 
documentation, and document that review and assessment.

[80 FR 56145, Sept. 17, 2015; 81 FR 3956, Jan. 25, 2016]

    Effective Date Note: At 80 FR 56145, Sept. 17, 2015, Sec. 117.405 
was added, effective Nov. 16, 2015, except for paragraph (a)(2). FDA 
will publish a document in the Federal Register announcing the effective 
date for this paragraph.



Sec. 117.410  General requirements applicable to a supply-chain 
program.

    (a) The supply-chain program must include:
    (1) Using approved suppliers as required by Sec. 117.420;
    (2) Determining appropriate supplier verification activities 
(including determining the frequency of conducting the activity) as 
required by Sec. 117.425;
    (3) Conducting supplier verification activities as required by 
Sec. Sec. 117.430 and 117.435;
    (4) Documenting supplier verification activities as required by 
Sec. 117.475; and
    (5) When applicable, verifying a supply-chain-applied control 
applied by an entity other than the receiving facility's supplier and 
documenting that verification as required by Sec. 117.475, or obtaining 
documentation of an appropriate verification activity from another 
entity, reviewing and assessing that documentation, and documenting the 
review and assessment as required by Sec. 117.475.
    (b) The following are appropriate supplier verification activities 
for raw materials and other ingredients:
    (1) Onsite audits;
    (2) Sampling and testing of the raw material or other ingredient;
    (3) Review of the supplier's relevant food safety records; and
    (4) Other appropriate supplier verification activities based on 
supplier performance and the risk associated with the raw material or 
other ingredient.
    (c) The supply-chain program must provide assurance that a hazard 
requiring a supply-chain-applied control has been significantly 
minimized or prevented.
    (d)(1) Except as provided by paragraph (d)(2) of this section, in 
approving suppliers and determining the appropriate supplier 
verification activities and the frequency with which they are conducted, 
the following must be considered:
    (i) The hazard analysis of the food, including the nature of the 
hazard controlled before receipt of the raw material or other 
ingredient, applicable to the raw material and other ingredients;
    (ii) The entity or entities that will be applying controls for the 
hazards requiring a supply-chain-applied control;
    (iii) Supplier performance, including:
    (A) The supplier's procedures, processes, and practices related to 
the safety of the raw material and other ingredients;
    (B) Applicable FDA food safety regulations and information relevant 
to the supplier's compliance with those regulations, including an FDA 
warning letter or import alert relating to the safety of food and other 
FDA compliance actions related to food safety (or, when applicable, 
relevant laws and regulations of a country whose food safety system FDA 
has officially recognized as comparable or has determined to be 
equivalent to that of the United States, and information relevant to the 
supplier's compliance with those laws and regulations); and
    (C) The supplier's food safety history relevant to the raw materials 
or other ingredients that the receiving facility receives from the 
supplier, including available information about results from testing raw 
materials or other ingredients for hazards, audit results relating to 
the safety of the food, and responsiveness of the supplier in correcting 
problems; and
    (iv) Any other factors as appropriate and necessary, such as storage 
and transportation practices.
    (2) Considering supplier performance can be limited to the 
supplier's compliance history as required by paragraph (d)(1)(iii)(B) of 
this section, if the supplier is:
    (i) A qualified facility as defined by Sec. 117.3;
    (ii) A farm that grows produce and is not a covered farm under part 
112 of

[[Page 422]]

this chapter in accordance with Sec. 112.4(a), or in accordance with 
Sec. Sec. 112.4(b) and 112.5; or
    (iii) A shell egg producer that is not subject to the requirements 
of part 118 of this chapter because it has less than 3,000 laying hens.
    (e) If the owner, operator, or agent in charge of a receiving 
facility determines through auditing, verification testing, document 
review, relevant consumer, customer or other complaints, or otherwise 
that the supplier is not controlling hazards that the receiving facility 
has identified as requiring a supply-chain-applied control, the 
receiving facility must take and document prompt action in accordance 
with Sec. 117.150 to ensure that raw materials or other ingredients 
from the supplier do not cause food that is manufactured or processed by 
the receiving facility to be adulterated under section 402 of the 
Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) 
of the Federal Food, Drug, and Cosmetic Act.



Sec. 117.415  Responsibilities of the receiving facility.

    (a)(1) The receiving facility must approve suppliers.
    (2) Except as provided by paragraphs (a)(3) and (4) of this section, 
the receiving facility must determine and conduct appropriate supplier 
verification activities, and satisfy all documentation requirements of 
this subpart.
    (3) An entity other than the receiving facility may do any of the 
following, provided that the receiving facility reviews and assesses the 
entity's applicable documentation, and documents that review and 
assessment:
    (i) Establish written procedures for receiving raw materials and 
other ingredients by the entity;
    (ii) Document that written procedures for receiving raw materials 
and other ingredients are being followed by the entity; and
    (iii) Determine, conduct, or both determine and conduct the 
appropriate supplier verification activities, with appropriate 
documentation.
    (4) The supplier may conduct and document sampling and testing of 
raw materials and other ingredients, for the hazard controlled by the 
supplier, as a supplier verification activity for a particular lot of 
product and provide such documentation to the receiving facility, 
provided that the receiving facility reviews and assesses that 
documentation, and documents that review and assessment.
    (b) For the purposes of this subpart, a receiving facility may not 
accept any of the following as a supplier verification activity:
    (1) A determination by its supplier of the appropriate supplier 
verification activities for that supplier;
    (2) An audit conducted by its supplier;
    (3) A review by its supplier of that supplier's own relevant food 
safety records; or
    (4) The conduct by its supplier of other appropriate supplier 
verification activities for that supplier within the meaning of Sec. 
117.410(b)(4).
    (c) The requirements of this section do not prohibit a receiving 
facility from relying on an audit provided by its supplier when the 
audit of the supplier was conducted by a third-party qualified auditor 
in accordance with Sec. Sec. 117.430(f) and 117.435.



Sec. 117.420  Using approved suppliers.

    (a) Approval of suppliers. The receiving facility must approve 
suppliers in accordance with the requirements of Sec. 117.410(d), and 
document that approval, before receiving raw materials and other 
ingredients received from those suppliers;
    (b) Written procedures for receiving raw materials and other 
ingredients. (1) Written procedures for receiving raw materials and 
other ingredients must be established and followed;
    (2) The written procedures for receiving raw materials and other 
ingredients must ensure that raw materials and other ingredients are 
received only from approved suppliers (or, when necessary and 
appropriate, on a temporary basis from unapproved suppliers whose raw 
materials or other ingredients are subjected to adequate verification 
activities before acceptance for use); and
    (3) Use of the written procedures for receiving raw materials and 
other ingredients must be documented.

[[Page 423]]



Sec. 117.425  Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity).

    Appropriate supplier verification activities (including the 
frequency of conducting the activity) must be determined in accordance 
with the requirements of Sec. 117.410(d).



Sec. 117.430  Conducting supplier verification activities for raw 
materials and other ingredients.

    (a) Except as provided by paragraph (c), (d), or (e) of this 
section, one or more of the supplier verification activities specified 
in Sec. 117.410(b), as determined under Sec. 117.410(d), must be 
conducted for each supplier before using the raw material or other 
ingredient from that supplier and periodically thereafter.
    (b)(1) Except as provided by paragraph (b)(2) of this section, when 
a hazard in a raw material or other ingredient will be controlled by the 
supplier and is one for which there is a reasonable probability that 
exposure to the hazard will result in serious adverse health 
consequences or death to humans:
    (i) The appropriate supplier verification activity is an onsite 
audit of the supplier; and
    (ii) The audit must be conducted before using the raw material or 
other ingredient from the supplier and at least annually thereafter.
    (2) The requirements of paragraph (b)(1) of this section do not 
apply if there is a written determination that other verification 
activities and/or less frequent onsite auditing of the supplier provide 
adequate assurance that the hazards are controlled.
    (c) If a supplier is a qualified facility as defined by Sec. 117.3, 
the receiving facility does not need to comply with paragraphs (a) and 
(b) of this section if the receiving facility:
    (1) Obtains written assurance that the supplier is a qualified 
facility as defined by Sec. 117.3:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
supplier is producing the raw material or other ingredient in compliance 
with applicable FDA food safety regulations (or, when applicable, 
relevant laws and regulations of a country whose food safety system FDA 
has officially recognized as comparable or has determined to be 
equivalent to that of the United States). The written assurance must 
include either:
    (i) A brief description of the preventive controls that the supplier 
is implementing to control the applicable hazard in the food; or
    (ii) A statement that the facility is in compliance with State, 
local, county, tribal, or other applicable non-Federal food safety law, 
including relevant laws and regulations of foreign countries.
    (d) If a supplier is a farm that grows produce and is not a covered 
farm under part 112 of this chapter in accordance with Sec. 112.4(a), 
or in accordance with Sec. Sec. 112.4(b) and 112.5, the receiving 
facility does not need to comply with paragraphs (a) and (b) of this 
section for produce that the receiving facility receives from the farm 
as a raw material or other ingredient if the receiving facility:
    (1) Obtains written assurance that the raw material or other 
ingredient provided by the supplier is not subject to part 112 of this 
chapter in accordance with Sec. 112.4(a), or in accordance with 
Sec. Sec. 112.4(b) and 112.5:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the farm 
acknowledges that its food is subject to section 402 of the Federal 
Food, Drug, and Cosmetic Act (or, when applicable, that its food is 
subject to relevant laws and regulations of a country whose food safety 
system FDA has officially recognized as comparable or has determined to 
be equivalent to that of the United States).
    (e) If a supplier is a shell egg producer that is not subject to the 
requirements of part 118 of this chapter because it has less than 3,000 
laying

[[Page 424]]

hens, the receiving facility does not need to comply with paragraphs (a) 
and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the shell eggs produced by the 
supplier are not subject to part 118 because the shell egg producer has 
less than 3,000 laying hens:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
shell egg producer acknowledges that its food is subject to section 402 
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that 
its food is subject to relevant laws and regulations of a country whose 
food safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States).
    (f) There must not be any financial conflicts of interests that 
influence the results of the verification activities listed in Sec. 
117.410(b) and payment must not be related to the results of the 
activity.



Sec. 117.435  Onsite audit.

    (a) An onsite audit of a supplier must be performed by a qualified 
auditor.
    (b) If the raw material or other ingredient at the supplier is 
subject to one or more FDA food safety regulations, an onsite audit must 
consider such regulations and include a review of the supplier's written 
plan (e.g., Hazard Analysis and Critical Control Point (HACCP) plan or 
other food safety plan), if any, and its implementation, for the hazard 
being controlled (or, when applicable, an onsite audit may consider 
relevant laws and regulations of a country whose food safety system FDA 
has officially recognized as comparable or has determined to be 
equivalent to that of the United States).
    (c)(1) The following may be substituted for an onsite audit, 
provided that the inspection was conducted within 1 year of the date 
that the onsite audit would have been required to be conducted:
    (i) The written results of an appropriate inspection of the supplier 
for compliance with applicable FDA food safety regulations by FDA, by 
representatives of other Federal Agencies (such as the United States 
Department of Agriculture), or by representatives of State, local, 
tribal, or territorial agencies; or
    (ii) For a foreign supplier, the written results of an inspection by 
FDA or the food safety authority of a country whose food safety system 
FDA has officially recognized as comparable or has determined to be 
equivalent to that of the United States.
    (2) For inspections conducted by the food safety authority of a 
country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent, the food that is the subject 
of the onsite audit must be within the scope of the official recognition 
or equivalence determination, and the foreign supplier must be in, and 
under the regulatory oversight of, such country.
    (d) If the onsite audit is solely conducted to meet the requirements 
of this subpart by an audit agent of a certification body that is 
accredited in accordance with regulations in part 1, subpart M of this 
chapter, the audit is not subject to the requirements in those 
regulations.

    Effective Date Note: At 80 FR 56145, Sept. 17, 2015, Sec. 117.435 
was added, effective Nov. 16, 2015, except for paragraph (d). FDA will 
publish a document in the Federal Register announcing the effective date 
for this paragraph.



Sec. 117.475  Records documenting the supply-chain program.

    (a) The records documenting the supply-chain program are subject to 
the requirements of subpart F of this part.
    (b) The receiving facility must review the records listed in 
paragraph (c) of this section in accordance with Sec. 117.165(a)(4).
    (c) The receiving facility must document the following in records as 
applicable to its supply-chain program:
    (1) The written supply-chain program;
    (2) Documentation that a receiving facility that is an importer is 
in compliance with the foreign supplier verification program 
requirements under part 1, subpart L of this chapter,

[[Page 425]]

including documentation of verification activities conducted under Sec. 
1.506(e) of this chapter;
    (3) Documentation of the approval of a supplier;
    (4) Written procedures for receiving raw materials and other 
ingredients;
    (5) Documentation demonstrating use of the written procedures for 
receiving raw materials and other ingredients;
    (6) Documentation of the determination of the appropriate supplier 
verification activities for raw materials and other ingredients;
    (7) Documentation of the conduct of an onsite audit. This 
documentation must include:
    (i) The name of the supplier subject to the onsite audit;
    (ii) Documentation of audit procedures;
    (iii) The dates the audit was conducted;
    (iv) The conclusions of the audit;
    (v) Corrective actions taken in response to significant deficiencies 
identified during the audit; and
    (vi) Documentation that the audit was conducted by a qualified 
auditor;
    (8) Documentation of sampling and testing conducted as a supplier 
verification activity. This documentation must include:
    (i) Identification of the raw material or other ingredient tested 
(including lot number, as appropriate) and the number of samples tested;
    (ii) Identification of the test(s) conducted, including the 
analytical method(s) used;
    (iii) The date(s) on which the test(s) were conducted and the date 
of the report;
    (iv) The results of the testing;
    (v) Corrective actions taken in response to detection of hazards; 
and
    (vi) Information identifying the laboratory conducting the testing;
    (9) Documentation of the review of the supplier's relevant food 
safety records. This documentation must include:
    (i) The name of the supplier whose records were reviewed;
    (ii) The date(s) of review;
    (iii) The general nature of the records reviewed;
    (iv) The conclusions of the review; and
    (v) Corrective actions taken in response to significant deficiencies 
identified during the review;
    (10) Documentation of other appropriate supplier verification 
activities based on the supplier performance and the risk associated 
with the raw material or other ingredient;
    (11) Documentation of any determination that verification activities 
other than an onsite audit, and/or less frequent onsite auditing of a 
supplier, provide adequate assurance that the hazards are controlled 
when a hazard in a raw material or other ingredient will be controlled 
by the supplier and is one for which there is a reasonable probability 
that exposure to the hazard will result in serious adverse health 
consequences or death to humans;
    (12) The following documentation of an alternative verification 
activity for a supplier that is a qualified facility:
    (i) The written assurance that the supplier is a qualified facility 
as defined by Sec. 117.3, before approving the supplier and on an 
annual basis thereafter; and
    (ii) The written assurance that the supplier is producing the raw 
material or other ingredient in compliance with applicable FDA food 
safety regulations (or, when applicable, relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States);
    (13) The following documentation of an alternative verification 
activity for a supplier that is a farm that supplies a raw material or 
other ingredient and is not a covered farm under part 112 of this 
chapter:
    (i) The written assurance that supplier is not a covered farm under 
part 112 of this chapter in accordance with Sec. 112.4(a), or in 
accordance with Sec. Sec. 112.4(b) and 112.5, before approving the 
supplier and on an annual basis thereafter; and
    (ii) The written assurance that the farm acknowledges that its food 
is subject to section 402 of the Federal Food, Drug, and Cosmetic Act 
(or, when applicable, that its food is subject to relevant laws and 
regulations of a country whose food safety system FDA has officially 
recognized as comparable or

[[Page 426]]

has determined to be equivalent to that of the United States);
    (14) The following documentation of an alternative verification 
activity for a supplier that is a shell egg producer that is not subject 
to the requirements established in part 118 of this chapter because it 
has less than 3,000 laying hens:
    (i) The written assurance that the shell eggs provided by the 
supplier are not subject to part 118 of this chapter because the 
supplier has less than 3,000 laying hens, before approving the supplier 
and on an annual basis thereafter; and
    (ii) The written assurance that the shell egg producer acknowledges 
that its food is subject to section 402 of the Federal Food, Drug, and 
Cosmetic Act (or, when applicable, that its food is subject to relevant 
laws and regulations of a country whose safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of 
the United States);
    (15) The written results of an appropriate inspection of the 
supplier for compliance with applicable FDA food safety regulations by 
FDA, by representatives of other Federal Agencies (such as the United 
States Department of Agriculture), or by representatives from State, 
local, tribal, or territorial agencies, or the food safety authority of 
another country when the results of such an inspection is substituted 
for an onsite audit;
    (16) Documentation of actions taken with respect to supplier non-
conformance;
    (17) Documentation of verification of a supply-chain-applied control 
applied by an entity other than the receiving facility's supplier; and
    (18) When applicable, documentation of the receiving facility's 
review and assessment of:
    (i) Applicable documentation from an entity other than the receiving 
facility that written procedures for receiving raw materials and other 
ingredients are being followed;
    (ii) Applicable documentation, from an entity other than the 
receiving facility, of the determination of the appropriate supplier 
verification activities for raw materials and other ingredients;
    (iii) Applicable documentation, from an entity other than the 
receiving facility, of conducting the appropriate supplier verification 
activities for raw materials and other ingredients;
    (iv) Applicable documentation, from its supplier, of:
    (A) The results of sampling and testing conducted by the supplier; 
or
    (B) The results of an audit conducted by a third-party qualified 
auditor in accordance with Sec. Sec. 117.430(f) and 117.435; and
    (v) Applicable documentation, from an entity other than the 
receiving facility, of verification activities when a supply-chain-
applied control is applied by an entity other than the receiving 
facility's supplier.

    Effective Date Note: At 80 FR 56145, Sept. 17, 2015, Sec. 117.475 
was added, effective Nov. 16, 2015, except for paragraph (c)(2). FDA 
will publish a document in the Federal Register announcing the effective 
date for this paragraph.



PART 118_PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS--
Table of Contents



Sec.
118.1 Persons covered by the requirements in this part.
118.3 Definitions.
118.4 Salmonella Enteritidis (SE) prevention measures.
118.5 Environmental testing for Salmonella Enteritidis (SE).
118.6 Egg testing for Salmonella Enteritidis (SE).
118.7 Sampling methodology for Salmonella Enteritidis (SE).
118.8 Testing methodology for Salmonella Enteritidis (SE).
118.9 Administration of the Salmonella Enteritidis (SE) prevention plan.
118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) 
          prevention plan.
118.11 Registration requirements for shell egg producers covered by the 
          requirements of this part.
118.12 Enforcement and compliance.

    Authority: 21 U.S.C. 321, 331-334, 342, 371, 381, 393; 42 U.S.C. 
243, 264, 271.

    Source: 74 FR 33095, July 9, 2009, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 118 appear at 81 FR 
49896, July 29, 2016.

[[Page 427]]



Sec. 118.1  Persons covered by the requirements in this part.

    (a) If you are a shell egg producer with 3,000 or more laying hens 
at a particular farm that does not sell all of your eggs directly to 
consumers and that produces shell eggs for the table market, you are 
covered by some or all of the requirements in this part, as follows:
    (1) If any of your eggs that are produced at a particular farm do 
not receive a treatment as defined in Sec. 118.3, you must comply with 
all of the requirements of this part for egg production on that farm.
    (2) If all of your eggs that are produced at the particular farm 
receive a treatment as defined in Sec. 118.3, you must comply only with 
the refrigeration requirements in Sec. 118.4(e) for production of eggs 
on that farm and with the registration requirements in Sec. 118.11.
    (b) If you transport or hold shell eggs for shell egg processing or 
egg products facilities, you must comply with the refrigeration 
requirements in Sec. 118.4(e). This section applies only to eggs from 
farms with 3,000 or more laying hens.



Sec. 118.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the FFDCA) (21 U.S.C. 321) are 
applicable to such terms when used in this part, except where they are 
redefined in this part. The following definitions also apply:
    Biosecurity means a program, including the limiting of visitors on 
the farm and in poultry houses, maintaining personnel and equipment 
practices that will protect against cross contamination from one poultry 
house to another, preventing stray poultry, wild birds, cats, and other 
animals from entering poultry houses, and not allowing employees to keep 
birds at home, to ensure that there is no introduction or transfer of 
Salmonella Enteritidis (SE) onto a farm or among poultry houses.
    Egg products facility means a USDA-inspected egg products plant 
where liquid, frozen, and/or dried egg products are produced.
    Farm means all poultry houses and grounds immediately surrounding 
the poultry houses covered under a single biosecurity program.
    Flock means all laying hens within one poultry house.
    Group means all laying hens of the same age within one poultry 
house.
    Induced molting means molting that is artificially initiated.
    Laying cycle means the period of time that a hen begins to produce 
eggs until it undergoes induced molting or is permanently taken out of 
production and the period of time that a hen produces eggs between 
successive induced molting periods or between induced molting and the 
time that the hen is permanently taken out of production.
    Molting means a life stage during which hens stop laying eggs and 
shed their feathers.
    Pest means any objectionable animal including, but not limited to, 
rodents, flies, and larvae.
    Positive flock means a flock that has had an egg test that was 
positive for SE. A flock is considered positive until that flock meets 
the egg testing requirements in Sec. 118.6(c) to return to table egg 
production.
    Positive poultry house means a poultry house from which there has 
been an environmental test that was positive for SE at any time during 
the life of a group in the poultry house until that house is cleaned and 
disinfected according to Sec. 118.4(d).
    Poultry house means a building, other structure, or separate section 
within a structure used to house poultry. For structures comprising more 
than one section containing poultry, each section that is separated from 
the other sections is considered a separate house.
    Producer means a person who owns and/or operates a poultry house 
containing laying hens which produce shell eggs for human consumption.
    Shell egg (or egg) means the egg of the domesticated chicken.
    Shell egg processing facility means a facility that processes (e.g., 
washes, grades, packs) shell eggs for the table egg market.
    Treatment (or treated) means a technology or process that achieves 
at least a 5-log destruction of SE for shell eggs, or the processing of 
egg products in accordance with the Egg Products Inspection Act.

[[Page 428]]



Sec. 118.4  Salmonella Enteritidis (SE) prevention measures.

    You must follow the SE prevention measures set forth in this 
section. In addition, you must have and implement a written SE 
prevention plan that is specific to each farm where you produce eggs and 
that includes, at a minimum, the following SE prevention measures:
    (a) Pullets. You must procure pullets that are SE monitored or raise 
pullets under SE monitored conditions. ``SE monitored'' means the 
pullets are raised under SE control conditions that prevent SE, 
including:
    (1) Procurement of chicks. Chicks are procured from SE-monitored 
breeder flocks that meet the National Poultry Improvement Plan's 
standards for ``U.S. S. Enteritidis Clean'' status (9 CFR 145.23(d)) or 
equivalent standard;
    (2) Environmental testing. (i) The pullet environment is tested for 
SE when pullets are 14 to 16 weeks of age;
    (ii) If the environmental test required in paragraph (a)(2)(i) of 
this section is negative, you do not need to perform any additional 
testing of those birds or their environment until the environmental test 
at 40 to 45 weeks of age specified in Sec. 118.5(a); and
    (iii) If the environmental test required in paragraph (a)(2)(i) of 
this section is positive, you must begin egg testing, as specified in 
Sec. 118.6, within 2 weeks of the start of egg laying.
    (3) Cleaning and disinfection. If the environmental test required in 
paragraph (a)(2) of this section is positive, the pullet environment is 
cleaned and disinfected, to include:
    (i) Removal of all visible manure;
    (ii) Dry cleaning the positive pullet house to remove dust, 
feathers, and old feed; and
    (iii) Following cleaning, disinfection of the positive pullet house 
with spray, aerosol, fumigation, or another appropriate disinfection 
method.
    (b) Biosecurity. As part of this program, you must take steps to 
ensure that there is no introduction or transfer of SE into or among 
poultry houses. Among such biosecurity measures you must, at a minimum:
    (1) Limit visitors on the farm and in the poultry houses;
    (2) Maintain practices that will protect against cross contamination 
when equipment is moved among poultry houses;
    (3) Maintain practices that will protect against cross contamination 
when persons move between poultry houses;
    (4) Prevent stray poultry, wild birds, cats, and other animals from 
entering poultry houses; and
    (5) Not allow employees to keep birds at home.
    (c) Rodents, flies, and other pest control. As part of this program, 
you must:
    (1) Monitor for rodents by visual inspection and mechanical traps or 
glueboards or another appropriate monitoring method and, when monitoring 
indicates unacceptable rodent activity within a poultry house, use 
appropriate methods to achieve satisfactory rodent control;
    (2) Monitor for flies by spot cards, Scudder grills, or sticky traps 
or another appropriate monitoring method and, when monitoring indicates 
unacceptable fly activity within a poultry house, use appropriate 
methods to achieve satisfactory fly control.
    (3) Remove debris within a poultry house and vegetation and debris 
outside a poultry house that may provide harborage for pests.
    (d) Cleaning and disinfection. You must clean and disinfect the 
poultry house according to these procedures before new laying hens are 
added to the house, if you have had an environmental test or an egg test 
that was positive for SE at any point during the life of a flock that 
was housed in the poultry house prior to depopulation. As part of the 
cleaning and disinfection procedures, you must:
    (1) Remove all visible manure;
    (2) Dry clean the positive poultry house to remove dust, feathers, 
and old feed; and
    (3) Following cleaning, disinfect the positive poultry house with 
spray, aerosol, fumigation, or another appropriate disinfection method.
    (e) Refrigeration. You must hold and transport eggs at or below 45 
[deg]F ambient temperature beginning 36 hours after time of lay. If the 
eggs are to be processed as table eggs and are not processed for the 
ultimate consumer within 36 hours from the time of lay

[[Page 429]]

and, therefore, are held and transported as required at or below 45 
[deg]F ambient temperature, then you may then hold them at room 
temperature for no more than 36 hours just prior to processing to allow 
an equilibration step to temper the eggs.



Sec. 118.5  Environmental testing for Salmonella Enteritidis (SE).

    (a) Environmental testing when laying hens are 40 to 45 weeks of 
age. As one indicator of the effectiveness of your SE prevention plan, 
you must perform environmental testing for SE (as described in 
Sec. Sec. 118.7 and 118.8) in a poultry house when any group of laying 
hens constituting the flock within the poultry house is 40 to 45 weeks 
of age.
    (1) If an environmental test at 40 to 45 weeks is negative and your 
laying hens do not undergo induced molting, then you do not need to 
perform any additional environmental testing within that poultry house, 
unless the poultry house contains more than one group of laying hens. If 
the poultry house contains more than one group of laying hens, then you 
must perform environmental testing on the poultry house when each group 
of laying hens is 40 to 45 weeks of age.
    (2) If the environmental test at 40 to 45 weeks is positive, then 
you must:
    (i) Review and make any necessary adjustments to your SE prevention 
plan to ensure that all measures are being properly implemented and
    (ii) Begin egg testing (described in Sec. 118.6), unless you divert 
eggs to treatment as defined in Sec. 118.3 for the life of the flock in 
that poultry house. Results of egg testing must be obtained within 10-
calendar days of receiving notification of the positive environmental 
test.
    (b) Environmental testing after an induced molting period. If you 
induce a molt in a flock or a group in a flock, you must perform 
environmental testing for SE in the poultry house at 4 to 6 weeks after 
the end of any molting process.
    (1) If an environmental test at 4 to 6 weeks after the end of the 
molting process is negative and none of your laying hens in that poultry 
house is molted again, then you do not need to perform any additional 
environmental testing in that poultry house. Each time a flock or group 
within the flock is molted, you must perform environmental testing in 
the poultry house at 4 to 6 weeks after the end of the molting process.
    (2) If the environmental test at 4 to 6 weeks after the end of a 
molting process is positive, then you must:
    (i) Review and make any necessary adjustments to your SE prevention 
plan to ensure that all measures are being properly implemented; and
    (ii) Begin egg testing (described in Sec. 118.6), unless you divert 
eggs to treatment as defined in Sec. 118.3 for the life of the flock in 
that poultry house. Results of egg testing, when conducted, must be 
available within 10-calendar days of receiving notification of the 
positive environmental test.



Sec. 118.6  Egg testing for Salmonella Enteritidis (SE).

    (a)(1) If the environmental test for pullets at 14 to 16 weeks of 
age required by Sec. 118.4(a) is positive, you must divert eggs to 
treatment (defined in Sec. 118.3) for the life of any flock or conduct 
egg testing within 2 weeks of the start of egg laying, as specified in 
paragraphs (b) through (e) of this section.
    (2) If you have an SE-positive environmental test at any time during 
the life of a flock, you must divert eggs to treatment (defined in Sec. 
118.3) for the life of the flock in that positive poultry house or 
conduct egg testing as specified in paragraphs (b) through (e) of this 
section.
    (b) Eggs must be sampled as described in Sec. 118.7 and tested 
using methodology as described in Sec. 118.8.
    (c) You must conduct four egg tests, using sampling and methodology 
in Sec. Sec. 118.7 and 118.8, on the flock in the positive poultry 
house at 2-week intervals. If all four tests are negative for SE, you 
are not required to do further egg testing.
    (d) If any of the four egg tests is positive for SE, you must 
divert, upon receiving notification of an SE-positive egg test, all eggs 
from that flock to treatment (defined in Sec. 118.3) until the 
conditions of paragraph (c) of this section are met.
    (e) If you have a positive egg test in a flock and divert eggs from 
that flock

[[Page 430]]

and later meet the negative test result requirements described in 
paragraph (c) of this section and return to table egg production, you 
must conduct one egg test per month on that flock, using sampling and 
methodology in Sec. Sec. 118.7 and 118.8, for the life of the flock.
    (1) If all the monthly egg tests in paragraph (e) of this section 
are negative for SE, you may continue to supply eggs to the table 
market.
    (2) If any of the monthly egg tests in paragraph (e) of this section 
is positive for SE, you must divert eggs from the positive flock to 
treatment for the life of the flock or until the conditions of paragraph 
(c) of this section are met.
    (f) If you are diverting eggs, the pallet, case, or other shipping 
container must be labeled and all documents accompanying the shipment 
must contain the following statement: ``Federal law requires that these 
eggs must be treated to achieve at least a 5-log destruction of 
Salmonella Enteritidis or processed as egg products in accordance with 
the Egg Products Inspection Act, 21 CFR 118.6(f).'' The statement must 
be legible and conspicuous.



Sec. 118.7  Sampling methodology for Salmonella Enteritidis (SE).

    (a) Environmental sampling. An environmental test must be done for 
each poultry house in accordance with Sec. 118.5 (a) and (b). Within 
each poultry house, you must sample the environment using a sampling 
plan appropriate to the poultry house layout.
    (b) Egg sampling. When you conduct an egg test required under Sec. 
118.6, you must collect and test the following number of eggs from the 
positive poultry house:
    (1) To meet the egg testing requirements of Sec. 118.6(c), you must 
collect and deliver for testing a minimum of 1,000 intact eggs 
representative of a day's production. The 1,000-egg sample must be 
tested according to Sec. 118.8. You must collect and test four 1,000-
egg samples at 2-week intervals for a total of 4,000 eggs.
    (2) To meet the monthly egg testing requirement of Sec. 118.6(e), 
you must collect and deliver for testing a minimum of 1,000 intact eggs 
representative of a day's production per month for the life of the 
flock. Eggs must be tested according to Sec. 118.8.



Sec. 118.8  Testing methodology for Salmonella Enteritidis (SE).

    (a) Testing of environmental samples for SE. Testing to detect SE in 
environmental samples must be conducted by the method entitled 
``Environmental Sampling and Detection of Salmonella in Poultry 
Houses,'' April 2008, or an equivalent method in accuracy, precision, 
and sensitivity in detecting SE. The April 2008 Environmental Sampling 
and Detection of Salmonella Web site is located at http://www.fda.gov/
Food/ScienceResearch/ LaboratoryMethods/ucm114716.htm, current as of 
June 26, 2009. The Director of the Federal Register approves the 
incorporation by reference of ``Environmental Sampling and Detection of 
Salmonella in Poultry Houses,'' April 2008, in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. FDA will request approval to incorporate by 
reference any updates to this Web site. FDA will change the date of the 
Web site in this paragraph with each update. You may obtain a copy from 
Division of Microbiology (HFS-710), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 301-436-2364, or you may examine a copy at the Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039, 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.
    (b) Testing of egg samples for SE. Testing to detect SE in egg 
samples must be conducted according to Chapter 5 of FDA's 
Bacteriological Analytical Manual (BAM), December 2007 Edition, or an 
equivalent method in accuracy, precision, and sensitivity in detecting 
SE. Chapter 5 of FDA's Bacteriological Analytical Manual, December 2007 
Edition, is located at http://www.fda.gov/Food/ScienceResearch/ 
LaboratoryMethods/ BacteriologicalAnalyticalManualBAM/

[[Page 431]]

ucm070149.htm, current as of June 26, 2009. The method is incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. FDA 
will request approval to incorporate by reference any updates to this 
Web site. FDA will change the date of the Web site in this paragraph 
with each update. You may obtain a copy from Division of Microbiology 
(HFS-710), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 301-436-2364, 
or you may examine a copy at the Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, 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.

[74 FR 33095, July 9, 2009, as amended at 81 FR 5590, Feb. 3, 2016]



Sec. 118.9  Administration of the Salmonella Enteritidis (SE) 
prevention plan.

    You must have one or more supervisory personnel, who do not have to 
be on-site employees, to be responsible for ensuring compliance with 
each farm's SE prevention plan. This person must have successfully 
completed training on SE prevention measures for egg production that is 
equivalent to that received under a standardized curriculum recognized 
by the Food and Drug Administration or must be otherwise qualified 
through job experience to administer the SE prevention measures. Job 
experience will qualify this person to perform these functions if it has 
provided knowledge at least equivalent to that provided through the 
standardized curriculum. This person is responsible for:
    (a) Development and implementation of an SE prevention plan that is 
appropriate for your specific farm and meets the requirements of Sec. 
118.4;
    (b) Reassessing and modifying the SE prevention plan as necessary to 
ensure that the requirements in Sec. 118.4 are met; and
    (c) Review of records created under Sec. 118.10. This person does 
not need to have performed the monitoring or created the records.



Sec. 118.10  Recordkeeping requirements for the Salmonella Enteritidis
(SE) prevention plan.

    (a) Records: You must maintain the following records documenting 
your SE prevention measures:
    (1) A written SE prevention plan required by Sec. 118.4;
    (2) Documentation that pullets were ``SE monitored'' or were raised 
under ``SE monitored'' conditions, including environmental testing 
records for pullets, as required by Sec. 118.4(a)(2);
    (3) Records documenting compliance with the SE prevention measures, 
as follows:
    (i) Biosecurity measures;
    (ii) Rodent and other pest control measures;
    (iii) Cleaning and disinfection procedures performed at 
depopulation, when applicable;
    (iv) Refrigeration requirements;
    (v) Environmental and egg sampling procedures, when applicable, 
performed under Sec. 118.7;
    (vi) Results of SE testing, when applicable, performed under Sec. 
118.8 as required in Sec. Sec. 118.4(a)(2), 118.5, and 118.6;
    (vii) Diversion of eggs, if applicable, as required in Sec. 118.6; 
and
    (viii) Eggs at a particular farm being given a treatment as defined 
in Sec. 118.3, if you are a producer complying with the requirements of 
this section as described in Sec. 118.1(a)(2).
    (4) Records of review and of modifications of the SE prevention plan 
and corrective actions taken.
    (b) General requirements for records maintained by shell egg 
producers. All records required by Sec. 118.10(a) must include:
    (1) Your name and the location of your farm,
    (2) The date and time of the activity that the record reflects,
    (3) The signature or initials of the person performing the operation 
or creating the record. The written SE prevention plan must be dated and 
carry the signature(s) (not initials) of the person(s) who administers 
the plan as described in Sec. 118.9, and

[[Page 432]]

    (4) Data and information reflecting compliance activities must be 
entered on records at the time the activity is performed or observed, 
and the records must contain the actual values observed, if applicable.
    (c) Length of time records must be retained. You must retain all 
records required by this part at your place of business, unless stored 
offsite under Sec. 118.10(d), for 1 year after the flock to which they 
pertain has been taken permanently out of production.
    (d) Offsite storage of records. You may store the records required 
by this part, except for the written SE prevention plan, offsite. You 
must be able to retrieve and provide the records at your place of 
business within 24 hours of request for official review. Electronic 
records are considered to be onsite if they are accessible from an 
onsite location.
    (e) Official review of records. You must have all records required 
by this part available for official review and copying at reasonable 
times.
    (f) Public disclosure of records. Records required by this part are 
subject to the disclosure requirements under part 20 of this chapter.



Sec. 118.11  Registration requirements for shell egg producers 
covered by the requirements of this part.

    (a) Shell egg producers covered under Sec. 118.1(a) are required to 
register their farms with FDA within 30 days of becoming an egg producer 
or, if already an egg producer, by each farm's applicable compliance 
date.
    (b) Shell egg producers may register their farms by any of the 
following means:
    (1) Electronic registration. To register electronically, you must 
register at http://www.access.fda.gov, which will be available for 
registration 24 hours a day, 7 days a week beginning May 10, 2010. This 
Web site is available from wherever the Internet is accessible, 
including libraries, copy centers, schools, and Internet cafes.
    (i) An individual authorized by the owner or operator of a farm, 
such as an agent in charge, may also register a farm electronically.
    (ii) FDA strongly encourages electronic registration for the benefit 
of both FDA and the registrant.
    (iii) Once you complete your electronic registration, FDA will 
automatically provide you with an electronic confirmation of 
registration and a permanent registration number.
    (iv) You will be considered registered once FDA electronically 
transmits your confirmation and registration number.
    (2) Registration by mail or by fax. If, for example, you do not have 
reasonable access to the Internet through any of the methods described 
in paragraph (b)(1) of this section, an individual authorized by the 
owner or operator of a farm, such as an agent in charge, may register by 
mail or fax.
    (i) You must register using FDA Form No. 3733. You may obtain a copy 
of this form by writing to the U.S. Food and Drug Administration, 5600 
Fishers Lane (HFS-681), Rockville, MD 20857, or by requesting the form 
by phone at 1-800-216-7331 or 301-575-0156.
    (ii) When you receive the form, you must fill it out completely and 
legibly and either mail it to the address in paragraph (b)(2)(i) of this 
section or fax it to the number on the form.
    (iii) If any required information on the form is incomplete or 
illegible when FDA receives it, FDA will return the form to you for 
revision, provided that your mailing address or fax number is legible 
and valid. When returning a registration form for revision, FDA will use 
the means by which the form was received by the agency (i.e., by mail or 
fax).
    (iv) FDA will enter complete and legible mailed and faxed 
registration submissions into its registration system, along with CD-ROM 
submissions, as soon as practicable, in the order FDA receives them.
    (v) FDA will then mail to the address or fax to the fax number on 
the registration form a copy of the registration as entered, 
confirmation of registration, and your registration number. When 
responding to a registration submission, FDA will use the means by which 
the registration was received by the agency (i.e., by mail or fax).
    (vi) If any information you previously submitted was incorrect at 
the

[[Page 433]]

time of submission, you must immediately update your facility's 
registration. If any information you previously submitted that was 
correct at the time of submission subsequently changes, you must update 
your facility's registration within 60 calendar days.
    (vii) Your facility is considered registered once FDA enters your 
facility's registration data into the registration system and the system 
generates a registration number.
    (3) Registration by CD-ROM for multiple submissions. If, for 
example, you do not have reasonable access to the Internet through any 
of the methods provided under paragraph (b)(1) of this section, you may 
register by CD-ROM.
    (i) Registrants submitting their registrations in CD-ROM format must 
use ISO 9660 (CD-R or CD-RW) data format.
    (ii) These files must be submitted on a portable document format 
(PDF) rendition of the registration form (FDA Form No. 3733) and be 
accompanied by one signed copy of the certification statement that 
appears on the registration form.
    (iii) Each submission on the CD-ROM must contain the same preferred 
mailing address in the appropriate block on FDA Form No. 3733.
    (iv) A CD-ROM may contain registrations for as many facilities as 
needed up to the CD-ROM's capacity.
    (v) The registration on the CD-ROM for each separate facility must 
have a unique file name up to 32 characters long, the first part of 
which may be used to identify the parent company.
    (vi) You must mail the CD-ROM to the U.S. Food and Drug 
Administration, 5600 Fishers Lane (HFS-681), Rockville, MD 20857.
    (vii) If FDA receives a CD-ROM that does not comply with these 
specifications, it will return the CD-ROM to the submitter unprocessed.
    (viii) FDA will enter CD-ROM submissions that comply with these 
specifications into its registration system, along with the complete and 
legible mailed and faxed submissions, as soon as practicable, in the 
order FDA receives them.
    (ix) For each facility on the CD-ROM, FDA will mail to the preferred 
mailing address a copy of the registration(s) as entered, confirmation 
of registration, and each facility's assigned registration number.
    (x) If any information you previously submitted was incorrect at the 
time of submission, you must immediately update your facility's 
registration. If any information you previously submitted that was 
correct at the time of submission subsequently changes, you must update 
your facility's registration within 60 calendar days.
    (xi) Your facility is considered registered once FDA enters your 
facility's registration data into the registration system and the system 
generates a registration number.
    (c) No registration fee is required.
    (d) You must submit all registration information in the English 
language. All information must be submitted using the Latin (Roman) 
alphabet.
    (e) Each registrant must submit the following information through 
one of the methods described in paragraph (b) of this section:
    (1) The name, full address, and phone number of the farm; and
    (2) The average or usual number of layers of each house and number 
of poultry houses on the farm.
    (3) A statement in which the shell egg producer certifies that the 
information submitted is true and accurate. If the individual submitting 
the form is not the shell egg producer in charge of the farm, the 
registration must also include a statement in which the individual 
certifies that the information submitted is true and accurate, certifies 
that he/she is authorized to submit registration, and identifies by 
name, address, and telephone number, the individual who authorized 
submission of the registration. Each registration must include the name 
of the individual registering the farm submitting the registration, and 
the individual's signature (for paper and CD-ROM options).
    (f) Registered egg producers must submit an update to a registration 
within 60-calendar days of any change to any of the information 
previously submitted by any of the means as provided in Sec. 118.11(b).
    (g) Registered egg producers must notify FDA within 120 days of 
ceasing egg production by completing sections 1b,

[[Page 434]]

1c, and 2 of Form 3733. This notification is not required if you are a 
seasonal egg producer or you temporarily cease operation due to labor 
disputes, fire, natural disasters, or other temporary conditions.

[74 FR 33095, July 9, 2009, as amended at 75 FR 18751, Apr. 13, 2010]



Sec. 118.12  Enforcement and compliance.

    (a) Authority. This part is established under authority of the 
Public Health Service Act (the PHS Act). Under the FFDCA, the Food and 
Drug Administration (FDA) can enforce the food adulteration provisions 
under 21 U.S.C. 331 through 334 and 342. Under the PHS Act (42 U.S.C. 
264), FDA has the authority to make and enforce regulations for the 
control of communicable diseases. FDA has established the following 
administrative enforcement procedures for the diversion or destruction 
of shell eggs and for informal hearings under the PHS Act:
    (1) Upon a finding that any shell eggs have been produced or held in 
violation of this part, an authorized FDA representative or a State or 
local representative in accordance with paragraph (c) of this section 
may order such eggs to be diverted, under the supervision of said 
representative, for processing in accordance with the Egg Products 
Inspection Act (EPIA) (21 U.S.C. 1031 et seq.) or by a treatment that 
achieves at least a 5-log destruction of SE or destroyed by or under the 
supervision of an officer or employee of FDA, or, if applicable, of the 
State or locality in accordance with the following procedures:
    (i) Order for diversion or destruction under the PHS Act. Any 
division office of FDA or any State or locality acting under paragraph 
(c) of this section, upon finding shell eggs that have been produced or 
held in violation of this part, may serve a written order upon the 
person in whose possession the eggs are found requiring that the eggs be 
diverted, under the supervision of an officer or employee of the issuing 
entity, for processing in accordance with the EPIA (21 U.S.C. 1031 et 
seq.) or by a treatment that achieves at least a 5-log destruction of SE 
or destroyed by or under the supervision of the issuing entity, within 
10 working days from the date of receipt of the order, unless, under 
paragraph (a)(2)(iii) of this section, a hearing is held, in which case 
the eggs must be diverted or destroyed consistent with the decision of 
the Office of Regulatory Affairs Program Director or another FDA 
official senior to an FDA Division Director under paragraph (a)(2)(v) of 
this section. The order must include the following information:
    (A) A statement that the shell eggs identified in the order are 
subject to diversion for processing in accordance with the EPIA or by a 
treatment that achieves at least a 5-log destruction of SE or 
destruction;
    (B) A detailed description of the facts that justify the issuance of 
the order;
    (C) The location of the eggs;
    (D) A statement that these eggs must not be sold, distributed, or 
otherwise disposed of or moved except as provided in paragraph 
(a)(1)(iv) of this section;
    (E) Identification or description of the eggs;
    (F) The order number;
    (G) The date of the order;
    (H) The text of this entire section;
    (I) A statement that the order may be appealed by written appeal or 
by requesting an informal hearing;
    (J) The name and phone number of the person issuing the order; and
    (K) The location and telephone number of the office or agency 
issuing the order and the name of its Director.
    (ii) Approval of Division Director. An order, before issuance, must 
be approved by FDA's Division Director. If prior written approval is not 
feasible, prior oral approval must be obtained and confirmed by written 
memorandum as soon as possible.
    (iii) Labeling or marking of shell eggs under order. An FDA, State, 
or local representative issuing an order under paragraph (a)(1)(i) of 
this section must label or mark the shell eggs with official tags that 
include the following information:
    (A) A statement that the shell eggs are detained in accordance with 
regulations issued under section 361(a) of the PHS Act (42 U.S.C. 
264(a)).
    (B) A statement that the shell eggs must not be sold, distributed or 
otherwise disposed of or moved except, after

[[Page 435]]

notifying the issuing entity in writing, to:
    (1) Divert them for processing in accordance with the EPIA or by a 
treatment that achieves at least a 5-log destruction of SE or destroy 
them or
    (2) Move them to another location for holding pending appeal.
    (C) A statement that the violation of the order or the removal or 
alteration of the tag is punishable by fine or imprisonment or both 
(section 368 of the PHS Act (42 U.S.C. 271)).
    (D) The order number and the date of the order, and the name of the 
government representative who issued the order.
    (iv) Sale or other disposition of shell eggs under order. After 
service of the order, the person in possession of the shell eggs that 
are the subject of the order must not sell, distribute, or otherwise 
dispose of or move any eggs subject to the order unless and until 
receiving a notice that the order is withdrawn after an appeal except, 
after notifying FDA's division office or, if applicable, the State or 
local representative, in writing, to:
    (A) Divert or destroy them as specified in paragraph (a)(1)(i) of 
this section, or
    (B) Move them to another location for holding pending appeal.
    (2) The person on whom the order for diversion or destruction is 
served may either comply with the order or appeal the order to an Office 
of Regulatory Affairs Program Director in accordance with the following 
procedures:
    (i) Appeal of a detention order. Any appeal must be submitted in 
writing to FDA's Division Director in whose division the shell eggs are 
located within 5 working days of the issuance of the order. If the 
appeal includes a request for an informal hearing, the hearing must be 
held within 5 working days after the appeal is filed or, if requested by 
the appellant, at a later date, which must not be later than 20 calendar 
days after the issuance of the order. The order may also be appealed 
within the same period of 5 working days by any other person having an 
ownership or proprietary interest in such shell eggs. The appellant of 
an order must state the ownership or proprietary interest the appellant 
has in the shell eggs.
    (ii) Summary decision. A request for a hearing may be denied, in 
whole or in part and at any time after a request for a hearing has been 
submitted, if the Office of Regulatory Affairs Program Director or 
another FDA official senior to an FDA Division Director determines that 
no genuine and substantial issue of fact has been raised by the material 
submitted in connection with the hearing or from matters officially 
noticed. If the presiding FDA official determines that a hearing is not 
justified, written notice of the determination will be given to the 
parties explaining the reason for denial.
    (iii) Informal hearing. Appearance by any appellant at the hearing 
may be by mail or in person, with or without counsel. The informal 
hearing must be conducted by the Office of Regulatory Affairs Program 
Director or another FDA official senior to an FDA Division Director, and 
a written summary of the proceedings must be prepared by the presiding 
FDA official.
    (A) The presiding FDA official may direct that the hearing be 
conducted in any suitable manner permitted by law and by this section. 
The presiding FDA official has the power to take such actions and make 
such rulings as are necessary or appropriate to maintain order and to 
conduct an informal, fair, expeditious, and impartial hearing, and to 
enforce the requirements concerning the conduct of hearings.
    (B) Employees of FDA will first give a full and complete statement 
of the action that is the subject of the hearing, together with the 
information and reasons supporting it, and may present oral or written 
information relevant to the hearing. The party requesting the hearing 
may then present oral or written information relevant to the hearing. 
All parties may conduct reasonable examination of any person (except for 
the presiding officer and counsel for the parties) who makes any 
statement on the matter at the hearing.
    (C) The hearing shall be informal in nature, and the rules of 
evidence do not apply. No motions or objections relating to the 
admissibility of information and views will be made or considered, but 
any party may comment upon or rebut any information and views presented 
by another party.

[[Page 436]]

    (D) The party requesting the hearing may have the hearing 
transcribed, at the party's expense, in which case a copy of the 
transcript is to be furnished to FDA. Any transcript of the hearing will 
be included with the presiding FDA official's report of the hearing.
    (E) The presiding FDA official must prepare a written report of the 
hearing. All written material presented at the hearing will be attached 
to the report. Whenever time permits, the presiding FDA official may 
give the parties the opportunity to review and comment on the report of 
the hearing.
    (F) The presiding FDA official must include as part of the report of 
the hearing a finding on the credibility of witnesses (other than expert 
witnesses) whenever credibility is a material issue, and must include a 
recommended decision, with a statement of reasons.
    (iv) Written appeal. If the appellant appeals the detention order 
but does not request a hearing, the presiding FDA official must render a 
decision on the appeal affirming or revoking the detention order within 
5-working days after the receipt of the appeal.
    (v) Presiding FDA official's decision. If, based on the evidence 
presented at the hearing or by the appellant in a written appeal, the 
presiding FDA official finds that the shell eggs were produced or held 
in violation of this section, he must affirm the order that they be 
diverted, under the supervision of an officer or employee of FDA for 
processing under the EPIA or by a treatment that achieves at least a 5-
log destruction of SE or destroyed by or under the supervision of an 
officer or employee of FDA; otherwise, the presiding FDA official must 
issue a written notice that the prior order is withdrawn. If the 
presiding FDA official affirms the order, he must order that the 
diversion or destruction be accomplished within 10-working days from the 
date of the issuance of his decision. The presiding FDA official's 
decision must be accompanied by a statement of the reasons for the 
decision. The decision of the presiding FDA official constitutes final 
agency action, subject to judicial review.
    (vi) No appeal. If there is no appeal of the order and the person in 
possession of the shell eggs that are subject to the order fails to 
divert or destroy them within 10 working days, or if the demand is 
affirmed by the presiding FDA official after an appeal and the person in 
possession of such eggs fails to divert or destroy them within 10 
working days, FDA's division office or, if applicable, the State or 
local representative may designate an officer or employee to divert or 
destroy such eggs. It shall be unlawful to prevent or to attempt to 
prevent such diversion or destruction of the shell eggs by the 
designated officer or employee.
    (b) Inspection. Persons engaged in production of shell eggs must 
permit authorized representatives of FDA to make, at any reasonable 
time, an inspection of the egg production establishment in which shell 
eggs are being produced. Such inspection includes the inspection and 
sampling of shell eggs and the environment, the equipment related to 
production of shell eggs, the equipment in which shell eggs are held, 
and examination and copying of any records relating to such equipment or 
eggs, as may be necessary in the judgment of such representatives to 
determine compliance with the provisions of this section. Inspections 
may be made with or without notice and will ordinarily be made during 
regular business hours.
    (c) State and local cooperation. Under sections 311 and 361 of the 
Public Health Service Act, any State or locality that is willing and 
able to assist the agency in the enforcement of Sec. Sec. 118.4 through 
118.10, and is authorized to inspect or regulate egg production 
establishments, may, in its own jurisdiction, enforce Sec. Sec. 118.4 
through 118.10 through inspections under paragraph (b) of this section 
and through administrative enforcement remedies specified in paragraph 
(a) of this section unless FDA notifies the State or locality in writing 
that such assistance is no longer needed. A state or locality may 
substitute, where necessary, appropriate State or local officials for 
designated FDA officials in this section. When providing assistance 
under paragraph (a) of this section, a State or locality may follow the 
hearing procedures set out in paragraphs (a)(2)(iii) through (a)(2)(v) 
of this section, or may

[[Page 437]]

utilize comparable State or local hearing procedures if such procedures 
satisfy due process.
    (d) Preemption. No State or local governing entity shall establish, 
or continue in effect any law, rule, regulation, or other requirement 
regarding prevention of SE in shell eggs during production, storage, or 
transportation that is less stringent than those required by this part.

[74 FR 33095, July 9, 2009, as amended at 82 FR 14146, Mar. 17, 2017; 85 
FR 16554, Mar. 24, 2020]



PART 119_DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT 
OR UNREASONABLE RISK--Table of Contents



    Authority: 21 U.S.C. 321, 342, 343, 371.



Sec. 119.1  Dietary supplements containing ephedrine alkaloids.

    Dietary supplements containing ephedrine alkaloids present an 
unreasonable risk of illness or injury under conditions of use 
recommended or suggested in the labeling, or if no conditions of use are 
recommended or suggested in the labeling, under ordinary conditions of 
use. Therefore, dietary supplements containing ephedrine alkaloids are 
adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and 
Cosmetic Act.

[69 FR 6853, Feb. 11, 2004]



PART 120_HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
--Table of Contents



                      Subpart A_General Provisions

Sec.
120.1 Applicability.
120.3 Definitions.
120.5 Current good manufacturing practice.
120.6 Sanitation standard operating procedures.
120.7 Hazard analysis.
120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
120.9 Legal basis.
120.10 Corrective actions.
120.11 Verification and validation.
120.12 Records.
120.13 Training.
120.14 Application of requirements to imported products.

                      Subpart B_Pathogen Reduction

120.20 General.
120.24 Process controls.
120.25 Process verification for certain processors.

    Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 
393; 42 U.S.C. 241, 242l, 264.

    Source: 66 FR 6197, Jan. 19, 2001, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 120.1  Applicability.

    (a) Any juice sold as such or used as an ingredient in beverages 
shall be processed in accordance with the requirements of this part. 
Juice means the aqueous liquid expressed or extracted from one or more 
fruits or vegetables, purees of the edible portions of one or more 
fruits or vegetables, or any concentrates of such liquid or puree. The 
requirements of this part shall apply to any juice regardless of whether 
the juice, or any of its ingredients, is or has been shipped in 
interstate commerce (as defined in section 201(b) of the Federal Food, 
Drug, and Cosmetic Act, 21 U.S.C. 321(b)). Raw agricultural ingredients 
of juice are not subject to the requirements of this part. Processors 
should apply existing agency guidance to minimize microbial food safety 
hazards for fresh fruits and vegetables in handling raw agricultural 
products.
    (b) The regulations in this part shall be effective January 22, 
2002. However, by its terms, this part is not binding on small and very 
small businesses until the dates listed in paragraphs (b)(1) and (b)(2) 
of this section.
    (1) For small businesses employing fewer than 500 persons the 
regulations in this part are binding on January 21, 2003.
    (2) For very small businesses that have either total annual sales of 
less than $500,000, or if their total annual sales are greater than 
$500,000 but their total food sales are less than $50,000; or the person 
claiming this exemption employed fewer than an average of 100 full-time 
equivalent employees and fewer than 100,000 units of juice were sold in 
the United States, the regulations are binding on January 20, 2004.

[[Page 438]]



Sec. 120.3  Definitions.

    The definitions of terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act, Sec. 101.9(j)(18)(vi) of this chapter, and parts 110 
and 117 of this chapter are applicable to such terms when used in this 
part, except that the definitions and terms in parts 110 and 117 do not 
govern such terms where such terms are redefined in this part and except 
that the terms facility, hazard, and manufacturing/processing in parts 
110 and 117 do not govern such terms where used in this part. The 
following definitions shall also apply:
    (a) Cleaned means washed with water of adequate sanitary quality.
    (b) Control means to prevent, eliminate, or reduce.
    (c) Control measure means any action or activity to prevent, reduce 
to acceptable levels, or eliminate a hazard.
    (d) Critical control point means a point, step, or procedure in a 
food process at which a control measure can be applied and at which 
control is essential to reduce an identified food hazard to an 
acceptable level.
    (e) Critical limit means the maximum or minimum value to which a 
physical, biological, or chemical parameter must be controlled at a 
critical control point to prevent, eliminate, or reduce to an acceptable 
level the occurrence of the identified food hazard.
    (f) Culled means separation of damaged fruit from undamaged fruit. 
For processors of citrus juices using treatments to fruit surfaces to 
comply with Sec. 120.24, culled means undamaged, tree-picked fruit that 
is U.S. Department of Agriculture choice or higher quality.
    (g) Food hazard means any biological, chemical, or physical agent 
that is reasonably likely to cause illness or injury in the absence of 
its control.
    (h) Importer means either the U.S. owner or consignee at the time of 
entry of a food product into the United States, or the U.S. agent or 
representative of the foreign owner or consignee at the time of entry 
into the United States. The importer is responsible for ensuring that 
goods being offered for entry into the United States are in compliance 
with all applicable laws. For the purposes of this definition, the 
importer is ordinarily not the custom house broker, the freight 
forwarder, the carrier, or the steamship representative.
    (i) Monitor means to conduct a planned sequence of observations or 
measurements to assess whether a process, point, or procedure is under 
control and to produce an accurate record for use in verification.
    (j)(1) Processing means activities that are directly related to the 
production of juice products.
    (2) For purposes of this part, processing does not include:
    (i) Harvesting, picking, or transporting raw agricultural 
ingredients of juice products, without otherwise engaging in processing; 
and
    (ii) The operation of a retail establishment.
    (k) Processor means any person engaged in commercial, custom, or 
institutional processing of juice products, either in the United States 
or in a foreign country, including any person engaged in the processing 
of juice products that are intended for use in market or consumer tests.
    (l) Retail establishment is an operation that provides juice 
directly to the consumers and does not include an establishment that 
sells or distributes juice to other business entities as well as 
directly to consumers. ``Provides'' includes storing, preparing, 
packaging, serving, and vending.
    (m) Shall is used to state mandatory requirements.
    (n) Shelf-stable product means a product that is hermetically sealed 
and, when stored at room temperature, should not demonstrate any 
microbial growth.
    (o) Should is used to state recommended or advisory procedures or to 
identify recommended equipment.
    (p) Validation means that element of verification focused on 
collecting and evaluating scientific and technical information to 
determine whether the HACCP plan, when properly implemented, will 
effectively control the identified food hazards.
    (q) Verification means those activities, other than monitoring, that 
establish the validity of the HACCP plan and that the system is 
operating according to the plan.

[66 FR 6197, Jan. 19, 2001, as amended at 80 FR 56167, Sept. 17, 2015]

[[Page 439]]



Sec. 120.5  Current good manufacturing practice.

    Except as provided by Sec. 117.5(c), parts 110 and 117 of this 
chapter apply in determining whether the facilities, methods, practices, 
and controls used to process juice are safe, and whether the food has 
been processed under sanitary conditions.

[80 FR 56167, Sept. 17, 2015]



Sec. 120.6  Sanitation standard operating procedures.

    (a) Sanitation controls. Each processor shall have and implement a 
sanitation standard operating procedure (SSOP) that addresses sanitation 
conditions and practices before, during, and after processing. The SSOP 
shall address:
    (1) Safety of the water that comes into contact with food or food 
contact surfaces or that is used in the manufacture of ice;
    (2) Condition and cleanliness of food contact surfaces, including 
utensils, gloves, and outer garments;
    (3) Prevention of cross contamination from insanitary objects to 
food, food packaging material, and other food contact surfaces, 
including utensils, gloves, and outer garments, and from raw product to 
processed product;
    (4) Maintenance of hand washing, hand sanitizing, and toilet 
facilities;
    (5) Protection of food, food packaging material, and food contact 
surfaces from adulteration with lubricants, fuel, pesticides, cleaning 
compounds, sanitizing agents, condensate, and other chemical, physical, 
and biological contaminants;
    (6) Proper labeling, storage, and use of toxic compounds;
    (7) Control of employee health conditions that could result in the 
microbiological contamination of food, food packaging materials, and 
food contact surfaces; and
    (8) Exclusion of pests from the food plant.
    (b) Monitoring. The processor shall monitor the conditions and 
practices during processing with sufficient frequency to ensure, at a 
minimum, conformance with those conditions and practices specified in 
part 110 of this chapter and in subpart B of part 117 of this chapter 
that are appropriate both to the plant and to the food being processed. 
Each processor shall correct, in a timely manner, those conditions and 
practices that are not met.
    (c) Records. Each processor shall maintain SSOP records that, at a 
minimum, document the monitoring and corrections prescribed by paragraph 
(b) of this section. These records are subject to the recordkeeping 
requirements of Sec. 120.12.
    (d) Relationship to Hazard Analysis and Critical Control Point 
(HACCP) plan. Sanitation standard operating procedure controls may be 
included in the HACCP plan required under Sec. 120.8(b). However, to 
the extent that they are implemented in accordance with this section, 
they need not be included in the HACCP plan.

[66 FR 6197, Jan. 19, 2001, as amended at 80 FR 56167, Sept. 17, 2015]



Sec. 120.7  Hazard analysis.

    (a) Each processor shall develop, or have developed for it, a 
written hazard analysis to determine whether there are food hazards that 
are reasonably likely to occur for each type of juice processed by that 
processor and to identify control measures that the processor can apply 
to control those hazards. The written hazard analysis shall consist of 
at least the following:
    (1) Identification of food hazards;
    (2) An evaluation of each food hazard identified to determine if the 
hazard is reasonably likely to occur and thus, constitutes a food hazard 
that must be addressed in the HACCP plan. A food hazard that is 
reasonably likely to occur is one for which a prudent processor would 
establish controls because experience, illness data, scientific reports, 
or other information provide a basis to conclude that there is a 
reasonable possibility that, in the absence of those controls, the food 
hazard will occur in the particular type of product being processed. 
This evaluation shall include an assessment of the severity of the 
illness or injury if the food hazard occurs;
    (3) Identification of the control measures that the processor can 
apply to control the food hazards identified as reasonably likely to 
occur in paragraph (a)(2) of this section;

[[Page 440]]

    (4) Review of the current process to determine whether modifications 
are necessary; and
    (5) Identification of critical control points.
    (b) The hazard analysis shall include food hazards that can be 
introduced both within and outside the processing plant environment, 
including food hazards that can occur before, during, and after harvest. 
The hazard analysis shall be developed by an individual or individuals 
who have been trained in accordance with Sec. 120.13 and shall be 
subject to the recordkeeping requirements of Sec. 120.12.
    (c) In evaluating what food hazards are reasonably likely to occur, 
consideration should be given, at a minimum, to the following:
    (1) Microbiological contamination;
    (2) Parasites;
    (3) Chemical contamination;
    (4) Unlawful pesticides residues;
    (5) Decomposition in food where a food hazard has been associated 
with decomposition;
    (6) Natural toxins;
    (7) Unapproved use of food or color additives;
    (8) Presence of undeclared ingredients that may be allergens; and
    (9) Physical hazards.
    (d) Processors should evaluate product ingredients, processing 
procedures, packaging, storage, and intended use; facility and equipment 
function and design; and plant sanitation, including employee hygiene, 
to determine the potential effect of each on the safety of the finished 
food for the intended consumer.
    (e) HACCP plans for juice need not address the food hazards 
associated with microorganisms and microbial toxins that are controlled 
by the requirements of part 113 or part 114 of this chapter. A HACCP 
plan for such juice shall address any other food hazards that are 
reasonably likely to occur.



Sec. 120.8  Hazard Analysis and Critical Control Point (HACCP) plan.

    (a) HACCP plan. Each processor shall have and implement a written 
HACCP plan whenever a hazard analysis reveals one or more food hazards 
that are reasonably likely to occur during processing, as described in 
Sec. 120.7. The HACCP plan shall be developed by an individual or 
individuals who have been trained in accordance with Sec. 120.13 and 
shall be subject to the recordkeeping requirements of Sec. 120.12. A 
HACCP plan shall be specific to:
    (1) Each location where juice is processed by that processor; and
    (2) Each type of juice processed by the processor. The plan may 
group types of juice products together, or group types of production 
methods together, if the food hazards, critical control points, critical 
limits, and procedures required to be identified and performed by 
paragraph (b) of this section are essentially identical, provided that 
any required features of the plan that are unique to a specific product 
or method are clearly delineated in the plan and are observed in 
practice.
    (b) The contents of the HACCP plan. The HACCP plan shall, at a 
minimum:
    (1) List all food hazards that are reasonably likely to occur as 
identified in accordance with Sec. 120.7, and that thus must be 
controlled for each type of product;
    (2) List the critical control points for each of the identified food 
hazards that is reasonably likely to occur, including as appropriate:
    (i) Critical control points designed to control food hazards that 
are reasonably likely to occur and could be introduced inside the 
processing plant environment; and
    (ii) Critical control points designed to control food hazards 
introduced outside the processing plant environment, including food 
hazards that occur before, during, and after harvest;
    (3) List the critical limits that shall be met at each of the 
critical control points;
    (4) List the procedures, and the frequency with which they are to be 
performed, that will be used to monitor each of the critical control 
points to ensure compliance with the critical limits;
    (5) Include any corrective action plans that have been developed in 
accordance with Sec. 120.10(a), and that are to be followed in response 
to deviations from critical limits at critical control points;

[[Page 441]]

    (6) List the validation and verification procedures, and the 
frequency with which they are to be performed, that the processor will 
use in accordance with Sec. 120.11; and
    (7) Provide for a recordkeeping system that documents the monitoring 
of the critical control points in accordance with Sec. 120.12. The 
records shall contain the actual values and observations obtained during 
monitoring.
    (c) Sanitation. Sanitation controls may be included in the HACCP 
plan. However, to the extent that they are monitored in accordance with 
Sec. 120.6, they are not required to be included in the HACCP plan.



Sec. 120.9  Legal basis.

    Failure of a processor to have and to implement a Hazard Analysis 
and Critical Control Point (HACCP) system that complies with Sec. Sec. 
120.6, 120.7, and 120.8, or otherwise to operate in accordance with the 
requirements of this part, shall render the juice products of that 
processor adulterated under section 402(a)(4) of the Federal Food, Drug, 
and Cosmetic Act. Whether a processor's actions are consistent with 
ensuring the safety of juice will be determined through an evaluation of 
the processor's overall implementation of its HACCP system.



Sec. 120.10  Corrective actions.

    Whenever a deviation from a critical limit occurs, a processor shall 
take corrective action by following the procedures set forth in 
paragraph (a) or paragraph (b) of this section.
    (a) Processors may develop written corrective action plans, which 
become part of their HACCP plans in accordance with Sec. 120.8(b)(5), 
by which processors predetermine the corrective actions that they will 
take whenever there is a deviation from a critical limit. A corrective 
action plan that is appropriate for a particular deviation is one that 
describes the steps to be taken and assigns responsibility for taking 
those steps, to ensure that:
    (1) No product enters commerce that is either injurious to health or 
is otherwise adulterated as a result of the deviation; and
    (2) The cause of the deviation is corrected.
    (b) When a deviation from a critical limit occurs, and the processor 
does not have a corrective action plan that is appropriate for that 
deviation, the processor 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 or obtain a review to determine the acceptability of the 
affected product for distribution. The review shall be performed by an 
individual or individuals who have adequate training or experience to 
perform such review;
    (3) Take corrective action, when necessary, with respect to the 
affected product to ensure that no product enters commerce that is 
either injurious to health or is otherwise adulterated as a result of 
the deviation;
    (4) Take corrective action, when necessary, to correct the cause of 
the deviation; and
    (5) Perform or obtain timely verification in accordance with Sec. 
120.11, by an individual or individuals who have been trained in 
accordance with Sec. 120.13, to determine whether modification of the 
HACCP plan is required to reduce the risk of recurrence of the 
deviation, and to modify the HACCP plan as necessary.
    (c) All corrective actions taken in accordance with this section 
shall be fully documented in records that are subject to verification in 
accordance with Sec. 120.11(a)(1)(iv)(B) and the recordkeeping 
requirements of Sec. 120.12.



Sec. 120.11  Verification and validation.

    (a) Verification. Each processor shall verify that the Hazard 
Analysis and Critical Control Point (HACCP) system is being implemented 
according to design.
    (1) Verification activities shall include:
    (i) A review of any consumer complaints that have been received by 
the processor to determine whether such complaints relate to the 
performance of the HACCP plan or reveal previously unidentified critical 
control points;
    (ii) The calibration of process monitoring instruments;

[[Page 442]]

    (iii) At the option of the processor, the performance of periodic 
end-product or in-process testing; except that processors of citrus 
juice that rely in whole or in part on surface treatment of fruit shall 
perform end-product testing in accordance with Sec. 120.25.
    (iv) A review, including signing and dating, by an individual who 
has been trained in accordance with Sec. 120.13, of the records that 
document:
    (A) The monitoring of critical control points. The purpose of this 
review shall be, at a minimum, to ensure that the records are complete 
and to verify that the records document values that are within the 
critical limits. This review shall occur within 1 week (7 days) of the 
day that the records are made;
    (B) The taking of corrective actions. The purpose of this review 
shall be, at a minimum, to ensure that the records are complete and to 
verify that appropriate corrective actions were taken in accordance with 
Sec. 120.10. This review shall occur within 1 week (7 days) of the day 
that the records are made; and
    (C) The calibrating of any process monitoring instruments used at 
critical control points and the performance of any periodic end-product 
or in-process testing that is part of the processor's verification 
activities. The purpose of these reviews shall be, at a minimum, to 
ensure that the records are complete and that these activities occurred 
in accordance with the processor's written procedures. These reviews 
shall occur within a reasonable time after the records are made; and
    (v) The following of procedures in Sec. 120.10 whenever any 
verification procedure, including the review of consumer complaints, 
establishes the need to take a corrective action; and
    (vi) Additional process verification if required by Sec. 120.25.
    (2) Records that document the calibration of process monitoring 
instruments, in accordance with paragraph (a)(1)(iv)(B) of this section, 
and the performance of any periodic end-product and in-process testing, 
in accordance with paragraph (a)(1)(iv)(C) of this section, are subject 
to the recordkeeping requirements of Sec. 120.12.
    (b) Validation of the HACCP plan. Each processor shall validate that 
the HACCP plan is adequate to control food hazards that are reasonably 
likely to occur; this validation shall occur at least once within 12 
months after implementation and at least annually thereafter or whenever 
any changes in the process occur that could affect the hazard analysis 
or alter the HACCP plan in any way. Such changes may include changes in 
the following: Raw materials or source of raw materials; product 
formulation; processing methods or systems, including computers and 
their software; packaging; finished product distribution systems; or the 
intended use or consumers of the finished product. The validation shall 
be performed by an individual or individuals who have been trained in 
accordance with Sec. 120.13 and shall be subject to the recordkeeping 
requirements of Sec. 120.12. The HACCP plan shall be modified 
immediately whenever a validation reveals that the plan is no longer 
adequate to fully meet the requirements of this part.
    (c) Validation of the hazard analysis. Whenever a juice processor 
has no HACCP plan because a hazard analysis has revealed no food hazards 
that are reasonably likely to occur, the processor shall reassess the 
adequacy of that hazard analysis whenever there are any changes in the 
process that could reasonably affect whether a food hazard exists. Such 
changes may include changes in the following: Raw materials or source of 
raw materials; product formulation; processing methods or systems, 
including computers and their software; packaging; finished product 
distribution systems; or the intended use or intended consumers of the 
finished product. The validation of the hazard analysis shall be 
performed by an individual or individuals who have been trained in 
accordance with Sec. 120.13, and, records documenting the validation 
shall be subject to the recordkeeping requirements of Sec. 120.12.



Sec. 120.12  Records.

    (a) Required records. Each processor shall maintain the following 
records documenting the processor's Hazard Analysis and Critical Control 
Point (HACCP) system:
    (1) Records documenting the implementation of the sanitation 
standard

[[Page 443]]

operating procedures (SSOP's) (see Sec. 120.6);
    (2) The written hazard analysis required by Sec. 120.7;
    (3) The written HACCP plan required by Sec. 120.8;
    (4) Records documenting the ongoing application of the HACCP plan 
that include:
    (i) Monitoring of critical control points and their critical limits, 
including the recording of actual times, temperatures, or other 
measurements, as prescribed in the HACCP plan; and
    (ii) Corrective actions, including all actions taken in response to 
a deviation; and
    (5) Records documenting verification of the HACCP system and 
validation of the HACCP plan or hazard analysis, as appropriate.
    (b) General requirements. All records required by this part shall 
include:
    (1) The name of the processor or importer and the location of the 
processor or importer, if the processor or importer has more than one 
location;
    (2) The date and time of the activity that the record reflects, 
except that records required by paragraphs (a)(2), (a)(3), and (a)(5) of 
this section need not include the time;
    (3) The signature or initials of the person performing the operation 
or creating the record; and
    (4) Where appropriate, the identity of the product and the 
production code, if any. Processing and other information shall be 
entered on records at the time that it is observed. The records shall 
contain the actual values and observations obtained during monitoring.
    (c) Documentation. (1) The records in paragraphs (a)(2) and (a)(3) 
of this section shall be signed and dated by the most responsible 
individual onsite at the processing facility or by a higher level 
official of the processor. These signatures shall signify that these 
records have been accepted by the firm.
    (2) The records in paragraphs (a)(2) and (a)(3) of this section 
shall be signed and dated:
    (i) Upon initial acceptance;
    (ii) Upon any modification; and
    (iii) Upon verification and validation in accordance with Sec. 
120.11.
    (d) Record retention. (1) All records required by this part shall be 
retained at the processing facility or at the importer's place of 
business in the United States for, in the case of perishable or 
refrigerated juices, at least 1 year after the date that such products 
were prepared, and for, in the case of frozen, preserved, or shelf 
stable products, 2 years or the shelf life of the product, whichever is 
greater, after the date that the products were prepared.
    (2) Offsite storage of processing records required by paragraphs 
(a)(1) and (a)(4) of this section is permitted after 6 months following 
the date that the monitoring occurred, if such records can be retrieved 
and provided onsite within 24 hours of request for official review. 
Electronic records are considered to be onsite if they are accessible 
from an onsite location and comply with paragraph (g) of this section.
    (3) If the processing facility is closed for a prolonged period 
between seasonal packs, the records may be transferred to some other 
reasonably accessible location at the end of the seasonal pack but shall 
be immediately returned to the processing facility for official review 
upon request.
    (e) Official review. All records required by this part shall be 
available for review and copying at reasonable times.
    (f) Public disclosure. (1) All records required by this part are not 
available for public disclosure unless they have been previously 
disclosed to the public, as defined in Sec. 20.81 of this chapter, or 
unless they relate to a product or ingredient that has been abandoned 
and no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec. 20.61 of this chapter.
    (2) Records required to be maintained by this part are subject to 
disclosure to the extent that they are otherwise publicly available, or 
that disclosure could not reasonably be expected to cause a competitive 
hardship, such as generic type HACCP plans that reflect standard 
industry practices.
    (g) Records maintained on computers. The maintenance of computerized 
records, in accordance with part 11 of this chapter, is acceptable.

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Sec. 120.13  Training.

    (a) Only an individual who has met the requirements of paragraph (b) 
of this section shall be responsible for the following functions:
    (1) Developing the hazard analysis, including delineating control 
measures, as required by Sec. 120.7.
    (2) Developing a Hazard Analysis and Critical Control Point (HACCP) 
plan that is appropriate for a specific processor, in order to meet the 
requirements of Sec. 120.8;
    (3) Verifying and modifying the HACCP plan in accordance with the 
corrective action procedures specified in Sec. 120.10(b)(5) and the 
validation activities specified in Sec. Sec. 120.11(b) and (c); and 
120.7;
    (4) Performing the record review required by Sec. 120.11(a)(1)(iv).
    (b) The individual performing the functions listed in paragraph (a) 
of this section shall have successfully completed training in the 
application of HACCP principles to juice processing at least equivalent 
to that received under standardized curriculum recognized as adequate by 
the Food and Drug Administration, or shall be otherwise qualified 
through job experience to perform these functions. Job experience may 
qualify an individual to perform these functions if such experience has 
provided knowledge at least equivalent to that provided through the 
standardized curriculum. The trained individual need not be an employee 
of the processor.



Sec. 120.14  Application of requirements to imported products.

    This section sets forth specific requirements for imported juice.
    (a) Importer requirements. Every importer of juice shall either:
    (1) Obtain the juice from a country that has an active memorandum of 
understanding (MOU) or similar agreement with the Food and Drug 
Administration, that covers the food and documents the equivalency or 
compliance of the inspection system of the foreign country with the U.S. 
system, accurately reflects the relationship between the signing 
parties, and is functioning and enforceable in its entirety; or
    (2) Have and implement written procedures for ensuring that the 
juice that such importer receives for import into the United States was 
processed in accordance with the requirements of this part. The 
procedures shall provide, at a minimum:
    (i) Product specifications that are designed to ensure that the 
juice is not adulterated under section 402 of the Federal Food, Drug, 
and Cosmetic Act because it may be injurious to health or because it may 
have been processed under insanitary conditions; and
    (ii) Affirmative steps to ensure that the products being offered for 
entry were processed under controls that meet the requirements of this 
part. These steps may include any of the following:
    (A) Obtaining from the foreign processor the Hazard Analysis and 
Critical Control Point (HACCP) plan and prerequisite program of the 
standard operating procedure records required by this part that relate 
to the specific lot of food being offered for import;
    (B) Obtaining either a continuing or lot specific certificate from 
an appropriate foreign government inspection authority or competent 
third party certifying that the imported food has been processed in 
accordance with the requirements of this part;
    (C) Regularly inspecting the foreign processor's facilities to 
ensure that the imported food is being processed in accordance with the 
requirements of this part;
    (D) Maintaining on file a copy, in English, of the foreign 
processor's hazard analysis and HACCP plan, and a written guarantee from 
the foreign processor that the imported food is processed in accordance 
with the requirements of this part;
    (E) Periodically testing the imported food, and maintaining on file 
a copy, in English, of a written guarantee from the foreign processor 
that the imported food is processed in accordance with the requirements 
of this part; or
    (F) Other such verification measures as appropriate that provide an 
equivalent level of assurance of compliance with the requirements of 
this part.
    (b) Competent third party. An importer may hire a competent third 
party to assist with or perform any or all of the

[[Page 445]]

verification activities specified in paragraph (a)(2) of this section, 
including writing the importer's verification procedures on the 
importer's behalf.
    (c) Records. The importer shall maintain records, in English, that 
document the performance and results of the affirmative steps specified 
in paragraph (a)(2)(ii) of this section. These records shall be subject 
to the applicable provisions of Sec. 120.12.
    (d) Determination of compliance. The importer shall provide evidence 
that all juice offered for entry into the United States has been 
processed under conditions that comply with this part. If assurances do 
not exist that an imported juice has been processed under conditions 
that are equivalent to those required of domestic processors under this 
part, the product will appear to be adulterated and will be denied 
entry.



                      Subpart B_Pathogen Reduction



Sec. 120.20  General.

    This subpart augments subpart A of this part by setting forth 
specific requirements for process controls.



Sec. 120.24  Process controls.

    (a) In order to meet the requirements of subpart A of this part, 
processors of juice products shall include in their Hazard Analysis and 
Critical Control Point (HACCP) plans control measures that will 
consistently produce, at a minimum, a 5 log (i.e., 10\5\) reduction, for 
a period at least as long as the shelf life of the product when stored 
under normal and moderate abuse conditions, in the pertinent 
microorganism. For the purposes of this regulation, the ``pertinent 
microorganism'' is the most resistant microorganism of public health 
significance that is likely to occur in the juice. The following juice 
processors are exempt from this paragraph:
    (1) A juice processor that is subject to the requirements of part 
113 or part 114 of this chapter; and
    (2) A juice processor using a single thermal processing step 
sufficient to achieve shelf-stability of the juice or a thermal 
concentration process that includes thermal treatment of all 
ingredients, provided that the processor includes a copy of the thermal 
process used to achieve shelf-stability or concentration in its written 
hazard analysis required by Sec. 120.7.
    (b) All juice processors shall meet the requirements of paragraph 
(a) of this section through treatments that are applied directly to the 
juice, except that citrus juice processors may use treatments to fruit 
surfaces, provided that the 5-log reduction process begins after culling 
and cleaning as defined in Sec. 120.3(a) and (f) and the reduction is 
accomplished within a single production facility.
    (c) All juice processors shall meet the requirements of paragraphs 
(a) and (b) of this section and perform final product packaging within a 
single production facility operating under current good manufacturing 
practices. Processors claiming an exemption under paragraph (a)(1) or 
(a)(2) of this section shall also process and perform final product 
packaging of all juice subject to the claimed exemption within a single 
production facility operating under current good manufacturing 
practices.



Sec. 120.25  Process verification for certain processors.

    Each juice processor that relies on treatments that do not come into 
direct contact with all parts of the juice to achieve the requirements 
of Sec. 120.24 shall analyze the finished product for biotype I 
Escherichia coli as follows:
    (a) One 20 milliliter (mL) sample (consisting of two 10 mL 
subsamples) for each 1,000 gallons of juice produced shall be sampled 
each production day. If less than 1,000 gallons of juice is produced per 
day, the sample must be taken for each 1,000 gallons produced but not 
less than once every 5 working days that the facility is producing that 
juice. Each subsample shall be taken by randomly selecting a package of 
juice ready for distribution to consumers.
    (b) If the facility is producing more than one type of juice covered 
by this section, processors shall take subsamples according to paragraph 
(a) of this section for each of the covered juice products produced.
    (c) Processors shall analyze each subsample for the presence of E. 
coli by the

[[Page 446]]

method entitled ``Analysis for Escherichia coli in Citrus Juices--
Modification of AOAC Official Method 992.30'' or another method that is 
at least equivalent to this method in terms of accuracy, precision, and 
sensitivity in detecting E. coli. This method is designed to detect the 
presence or absence of E. coli in a 20 mL sample of juice (consisting of 
two 10 mL subsamples). The method is as follows:
    (1) Sample size. Total-20 mL of juice; perform analysis using two 10 
mL aliquots.
    (2) Media. Universal Preenrichment Broth (Difco, Detroit, MI), EC 
Broth (various manufacturers).
    (3) Method. ColiComplete (AOAC Official Method 992.30--modified).
    (4) Procedure. Perform the following procedure two times:
    (i) Aseptically inoculate 10 mL of juice into 90 mL of Universal 
Preenrichment Broth (Difco) and incubate at 35 [deg]C for 18 to 24 
hours.
    (ii) Next day, transfer 1 mL of preenriched sample into 10 mL of EC 
Broth, without durham gas vials. After inoculation, aseptically add a 
ColiComplete SSD disc into each tube.
    (iii) Incubate at 44.5 [deg]C for 18 to 24 hours.
    (iv) Examine the tubes under longwave ultra violet light (366 nm). 
Fluorescent tubes indicate presence of E. coli.
    (v) MUG positive and negative controls should be used as reference 
in interpreting fluorescence reactions. Use an E. coli for positive 
control and 2 negative controls--a MUG negative strain and an 
uninoculated tube media.
    (d) If either 10 mL subsample is positive for E. coli, the 20 mL 
sample is recorded as positive and the processor shall:
    (1) Review monitoring records for the control measures to attain the 
5-log reduction standard and correct those conditions and practices that 
are not met. In addition, the processor may choose to test the sample 
for the presence of pathogens of concern.
    (2) If the review of monitoring records or the additional testing 
indicates that the 5-log reduction standard was not achieved (e.g., a 
sample is found to be positive for the presence of a pathogen or a 
deviation in the process or its delivery is identified), the processor 
shall take corrective action as set forth in Sec. 120.10.
    (e) If two samples in a series of seven tests are positive for E. 
coli, the control measures to attain the 5-log reduction standard shall 
be deemed to be inadequate and the processor shall immediately:
    (1) Until corrective actions are completed, use an alternative 
process or processes that achieve the 5-log reduction after the juice 
has been expressed;
    (2) Perform a review of the monitoring records for control measures 
to attain the 5-log reduction standard. The review shall be sufficiently 
extensive to determine that there are no trends towards loss of control;
    (i) If the conditions and practices are not being met, correct those 
that do not conform to the HACCP plan; or
    (ii) If the conditions and practices are being met, the processor 
shall validate the HACCP plan in relation to the 5-log reduction 
standard; and
    (3) Take corrective action as set forth in Sec. 120.10. Corrective 
actions shall include ensuring no product enters commerce that is 
injurious to health as set forth in Sec. 120.10(a)(1).



PART 121_MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL 
ADULTERATION--Table of Contents



                      Subpart A_General Provisions

Sec.
121.1 Applicability.
121.3 Definitions.
121.4 Qualifications of individuals who perform activities under subpart 
          C of this part.
121.5 Exemptions.

Subpart B [Reserved]

                     Subpart C_Food Defense Measures

121.126 Food defense plan.
121.130 Vulnerability assessment to identify significant vulnerabilities 
          and actionable process steps.
121.135 Mitigation strategies for actionable process steps.
121.138 Mitigation strategies management components.
121.140 Food defense monitoring.
121.145 Food defense corrective actions.
121.150 Food defense verification.

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121.157 Reanalysis.

Subpart D_Requirements Applying to Records That Must Be Established and 
                               Maintained

121.301 Records subject to the requirements of this subpart.
121.305 General requirements applying to records.
121.310 Additional requirements applying to the food defense plan.
121.315 Requirements for record retention.
121.320 Requirements for official review.
121.325 Public disclosure.
121.330 Use of existing records.

                          Subpart E_Compliance

121.401 Compliance.

    Authority: 21 U.S.C. 331, 342, 350g, 350(i), 371, 374.

    Source: 81 FR 34219, May 27, 2016, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 121.1  Applicability.

    This part applies to the owner, operator or agent in charge of a 
domestic or foreign food facility that manufactures/processes, packs, or 
holds food for consumption in the United States and is required to 
register under section 415 of the Federal Food, Drug, and Cosmetic Act, 
unless one of the exemptions in Sec. 121.5 applies.



Sec. 121.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act are applicable to such terms when 
used in this part. The following definitions also apply:
    Actionable process step means a point, step, or procedure in a food 
process where a significant vulnerability exists and at which mitigation 
strategies can be applied and are essential to significantly minimize or 
prevent the significant vulnerability.
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practices.
    Affiliate means any facility that controls, is controlled by, or is 
under common control with another facility.
    Calendar day means every day as shown on the calendar.
    Contaminant means, for purposes of this part, any biological, 
chemical, physical, or radiological agent that may be added to food to 
intentionally cause illness, injury, or death.
    Facility means a domestic facility or a foreign facility that is 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act, in accordance with the requirements of part 1, subpart H 
of this chapter.
    Farm means farm as defined in Sec. 1.227 of this chapter.
    FDA means the Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act and includes raw materials and ingredients.
    Food defense means, for purposes of this part, the effort to protect 
food from intentional acts of adulteration where there is an intent to 
cause wide scale public health harm.
    Food defense monitoring means to conduct a planned sequence of 
observations or measurements to assess whether mitigation strategies are 
operating as intended.
    Food defense verification means the application of methods, 
procedures, and other evaluations, in addition to food defense 
monitoring, to determine whether a mitigation strategy or combination of 
mitigation strategies is or has been operating as intended according to 
the food defense plan.
    Full-time equivalent employee is a term used to represent the number 
of employees of a business entity for the purpose of determining whether 
the business qualifies as a small business. The number of full-time 
equivalent employees is determined by dividing the total number of hours 
of salary or wages paid directly to employees of the business entity and 
of all of its affiliates and subsidiaries by the number of hours of work 
in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). If the result is not 
a whole number, round down to the next lowest whole number.
    Holding means storage of food and also includes activities performed 
incidental to storage of food (e.g., activities performed for the safe 
or effective

[[Page 448]]

storage of that food, such as fumigating food during storage, and 
drying/dehydrating raw agricultural commodities when the drying/
dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed 
as a practical necessity for the distribution of that food (such as 
blending of the same raw agricultural commodity and breaking down 
pallets), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities 
could include warehouses, cold storage facilities, storage silos, grain 
elevators, and liquid storage tanks.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating, 
extracting juice, formulating, freezing, grinding, homogenizing, 
irradiating, labeling, milling, mixing, packaging (including modified 
atmosphere packaging), pasteurizing, peeling, rendering, treating to 
manipulate ripening, trimming, washing, or waxing. For farms and farm 
mixed-type facilities, manufacturing/processing does not include 
activities that are part of harvesting, packing, or holding.
    Mitigation strategies mean those risk-based, reasonably appropriate 
measures that a person knowledgeable about food defense would employ to 
significantly minimize or prevent significant vulnerabilities identified 
at actionable process steps, and that are consistent with the current 
scientific understanding of food defense at the time of the analysis.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
    Packing means placing food into a container other than packaging the 
food and also includes re-packing and activities performed incidental to 
packing or re-packing a food (e.g., activities performed for the safe or 
effective packing or re-packing of that food (such as sorting, culling, 
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act.
    Qualified individual means a person who has the education, training, 
or experience (or a combination thereof) necessary to perform an 
activity required under subpart C of this part, as appropriate to the 
individual's assigned duties. A qualified individual may be, but is not 
required to be, an employee of the establishment.
    Significant vulnerability means a vulnerability that, if exploited, 
could reasonably be expected to cause wide scale public health harm. A 
significant vulnerability is identified by a vulnerability assessment 
conducted by a qualified individual, that includes consideration of the 
following: (1) Potential public health impact (e.g., severity and scale) 
if a contaminant were added, (2) degree of physical access to the 
product, and (3) ability of an attacker to successfully contaminate the 
product. The assessment must consider the possibility of an inside 
attacker.
    Significantly minimize means to reduce to an acceptable level, 
including to eliminate.
    Small business means, for purposes of this part, a business 
(including any subsidiaries and affiliates) employing fewer than 500 
full-time equivalent employees.
    Subsidiary means any company which is owned or controlled directly 
or indirectly by another company.
    Very small business means, for purposes of this part, a business 
(including

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any subsidiaries and affiliates) averaging less than $10,000,000, 
adjusted for inflation, per year, during the 3-year period preceding the 
applicable calendar year in sales of human food plus the market value of 
human food manufactured, processed, packed, or held without sale (e.g., 
held for a fee).
    Vulnerability means the susceptibility of a point, step, or 
procedure in a facility's food process to intentional adulteration.
    You means, for purposes of this part, the owner, operator, or agent 
in charge of a facility.



Sec. 121.4  Qualifications of individuals who perform activities under
subpart C of this part.

    (a) Applicability. You must ensure that each individual who performs 
activities required under subpart C of this part is a qualified 
individual as that term is defined in Sec. 121.3.
    (b) Qualifications of individuals assigned to an actionable process 
step. Each individual assigned to an actionable process step (including 
temporary and seasonal personnel) or in the supervision thereof must:
    (1) Be a qualified individual as that term is defined in Sec. 
121.3--i.e., have the appropriate education, training, or experience (or 
a combination thereof) necessary to properly implement the mitigation 
strategy or combination of mitigation strategies at the actionable 
process step; and
    (2) Receive training in food defense awareness.
    (c) Qualifications of individuals for certain activities described 
in paragraph (c)(3) of this section. Each individual assigned to certain 
activities described in paragraph (c)(3) of this section must:
    (1) Be a qualified individual as that term is defined in Sec. 
121.3--i.e., have the appropriate education, training, or experience (or 
a combination thereof) necessary to properly perform the activities; and
    (2) Have successfully completed training for the specific function 
at least equivalent to that received under a standardized curriculum 
recognized as adequate by FDA or be otherwise qualified through job 
experience to conduct the activities. Job experience may qualify an 
individual to perform these functions if such experience has provided an 
individual with knowledge at least equivalent to that provided through 
the standardized curriculum. This individual may be, but is not required 
to be, an employee of the facility.
    (3) One or more qualified individuals must do or oversee:
    (i) The preparation of the food defense plan as required in Sec. 
121.126;
    (ii) The conduct of a vulnerability assessment as required in Sec. 
121.130;
    (iii) The identification and explanation of the mitigation 
strategies as required in Sec. 121.135; and
    (iv) Reanalysis as required in Sec. 121.157.
    (d) Additional qualifications of supervisory personnel. 
Responsibility for ensuring compliance by individuals with the 
requirements of this part must be clearly assigned to supervisory 
personnel with a combination of education, training, and experience 
necessary to supervise the activities under this subpart.
    (e) Records. Training required by paragraphs (b)(2) and (c)(2) of 
this section must be documented in records, and must:
    (1) Include the date of training, the type of training, and the 
persons trained; and
    (2) Be established and maintained in accordance with the 
requirements of subpart D of this part.



Sec. 121.5  Exemptions.

    (a) This part does not apply to a very small business, except that a 
very small business must, upon request, provide for official review 
documentation sufficient to show that the facility meets this exemption. 
Such documentation must be retained for 2 years.
    (b) This part does not apply to the holding of food, except the 
holding of food in liquid storage tanks.
    (c) This part does not apply to the packing, re-packing, labeling, 
or re-labeling of food where the container that directly contacts the 
food remains intact.
    (d) This part does not apply to activities of a farm that are 
subject to section 419 of the Federal Food, Drug, and Cosmetic Act 
(Standards for Produce Safety).

[[Page 450]]

    (e)(1) This part does not apply with respect to alcoholic beverages 
at a facility that meets the following two conditions:
    (i) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et 
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 
(26 U.S.C. 5001 et seq.) the facility is required to obtain a permit 
from, register with, or obtain approval of a notice or application from 
the Secretary of the Treasury as a condition of doing business in the 
United States, or is a foreign facility of a type that would require 
such a permit, registration, or approval if it were a domestic facility; 
and
    (ii) Under section 415 of the Federal Food, Drug, and Cosmetic Act 
the facility is required to register as a facility because it is engaged 
in manufacturing, processing, packing, or holding one or more alcoholic 
beverages.
    (2) This part does not apply with respect to food that is not an 
alcoholic beverage at a facility described in paragraph (e)(1) of this 
section, provided such food:
    (i) Is in prepackaged form that prevents any direct human contact 
with such food; and
    (ii) Constitutes not more than 5 percent of the overall sales of the 
facility, as determined by the Secretary of the Treasury.
    (f) This part does not apply to the manufacturing, processing, 
packing, or holding of food for animals other than man.
    (g) This part does not apply to on-farm manufacturing, processing, 
packing, or holding of the following foods on a farm mixed-type 
facility, when conducted by a small or very small business if such 
activities are the only activities conducted by the business subject to 
section 418 of the Federal Food, Drug, and Cosmetic Act.
    (1) Eggs (in-shell, other than raw agricultural commodities, e.g., 
pasteurized); and
    (2) Game meats (whole or cut, not ground or shredded, without 
secondary ingredients).

Subpart B--Reserved



                     Subpart C_Food Defense Measures



Sec. 121.126  Food defense plan.

    (a) Requirement for a food defense plan. You must prepare, or have 
prepared, and implement a written food defense plan.
    (b) Contents of a food defense plan. The written food defense plan 
must include:
    (1) The written vulnerability assessment, including required 
explanations, to identify significant vulnerabilities and actionable 
process steps as required by Sec. 121.130(c);
    (2) The written mitigation strategies, including required 
explanations, as required by Sec. 121.135(b);
    (3) The written procedures for the food defense monitoring of the 
implementation of the mitigation strategies as required by Sec. 
121.140(a);
    (4) The written procedures for food defense corrective actions as 
required by Sec. 121.145(a)(1); and
    (5) The written procedures for food defense verification as required 
by Sec. 121.150(b).
    (c) Records. The food defense plan required by this section is a 
record that is subject to the requirements of subpart D of this part.



Sec. 121.130  Vulnerability assessment to identify significant 
vulnerabilities and actionable process steps.

    (a) Requirement for a vulnerability assessment. You must conduct or 
have conducted a vulnerability assessment for each type of food 
manufactured, processed, packed, or held at your facility using 
appropriate methods to evaluate each point, step, or procedure in your 
food operation to identify significant vulnerabilities and actionable 
process steps. Appropriate methods must include, at a minimum, an 
evaluation of:
    (1) The potential public health impact (e.g., severity and scale) if 
a contaminant were added;
    (2) The degree of physical access to the product; and
    (3) The ability of an attacker to successfully contaminate the 
product.
    (b) Inside attacker. The assessment must consider the possibility of 
an inside attacker.

[[Page 451]]

    (c) Written vulnerability assessment. Regardless of the outcome, the 
vulnerability assessment must be written and must include an explanation 
as to why each point, step, or procedure either was or was not 
identified as an actionable process step.



Sec. 121.135  Mitigation strategies for actionable process steps.

    (a) You must identify and implement mitigation strategies at each 
actionable process step to provide assurances that the significant 
vulnerability at each step will be significantly minimized or prevented 
and the food manufactured, processed, packed, or held by your facility 
will not be adulterated under section 402 of the Federal Food, Drug, and 
Cosmetic Act. For each mitigation strategy implemented at each 
actionable process step, you must include a written explanation of how 
the mitigation strategy sufficiently minimizes or prevents the 
significant vulnerability associated with the actionable process step.
    (b) Mitigation strategies and accompanying explanations must be 
written.



Sec. 121.138  Mitigation strategies management components.

    Mitigation strategies required underSec. 121.135 are subject to the 
following mitigation strategies management components as appropriate to 
ensure the proper implementation of the mitigation strategies, taking 
into account the nature of each such mitigation strategy and its role in 
the facility's food defense system:
    (a) Food defense monitoring in accordance with Sec. 121.140;
    (b) Food defense corrective actions in accordance with Sec. 
121.145; and
    (c) Food defense verification in accordance with Sec. 121.150.



Sec. 121.140  Food defense monitoring.

    As appropriate to the nature of the mitigation strategy and its role 
in the facility's food defense system:
    (a) Written procedures. You must establish and implement written 
procedures, including the frequency with which they are to be performed, 
for food defense monitoring of the mitigation strategies.
    (b) Food defense monitoring. You must monitor the mitigation 
strategies with adequate frequency to provide assurances that they are 
consistently performed.
    (c) Records--(1) Requirement to document food defense monitoring. 
You must document the monitoring of mitigation strategies in accordance 
with this section in records that are subject to verification in 
accordance with Sec. 121.150(a)(1) and records review in accordance 
with Sec. 121.150(a)(3)(i).
    (2) Exception records. Records may be affirmative records 
demonstrating the mitigation strategy is functioning as intended. 
Exception records demonstrating the mitigation strategy is not 
functioning as intended may be adequate in some circumstances.



Sec. 121.145  Food defense corrective actions.

    (a) Food defense corrective action procedures. As appropriate to the 
nature of the actionable process step and the nature of the mitigation 
strategy:
    (1) You must establish and implement written food defense corrective 
action procedures that must be taken if mitigation strategies are not 
properly implemented.
    (2) The food defense corrective action procedures must describe the 
steps to be taken to ensure that:
    (i) Appropriate action is taken to identify and correct a problem 
that has occurred with implementation of a mitigation strategy; and
    (ii) Appropriate action is taken, when necessary, to reduce the 
likelihood that the problem will recur.
    (b) Records. All food defense corrective actions taken in accordance 
with this section must be documented in records that are subject to food 
defense verification in accordance with Sec. 121.150(a)(2) and records 
review in accordance with Sec. 121.150(a)(3)(i).



Sec. 121.150  Food defense verification.

    (a) Food defense verification activities. Food defense verification 
activities must include, as appropriate to the nature of the mitigation 
strategy and its role in the facility's food defense system:

[[Page 452]]

    (1) Verification that food defense monitoring is being conducted as 
required by Sec. 121.138 (and in accordance with Sec. 121.140);
    (2) Verification that appropriate decisions about food defense 
corrective actions are being made as required by Sec. 121.138 (and in 
accordance with Sec. 121.145);
    (3) Verification that mitigation strategies are properly implemented 
and are significantly minimizing or preventing the significant 
vulnerabilities. To do so, you must conduct activities that include the 
following, as appropriate to the facility, the food, and the nature of 
the mitigation strategy and its role in the facility's food defense 
system:
    (i) Review of the food defense monitoring and food defense 
corrective actions records within appropriate timeframes to ensure that 
the records are complete, the activities reflected in the records 
occurred in accordance with the food defense plan, the mitigation 
strategies are properly implemented, and appropriate decisions were made 
about food defense corrective actions; and
    (ii) Other activities appropriate for verification of proper 
implementation of mitigation strategies; and
    (4) Verification of reanalysis in accordance with Sec. 121.157.
    (b) Written procedures. You must establish and implement written 
procedures, including the frequency for which they are to be performed, 
for verification activities conducted according to Sec. 
121.150(a)(3)(ii).
    (c) Documentation. All verification activities conducted in 
accordance with this section must be documented in records.



Sec. 121.157  Reanalysis.

    (a) You must conduct a reanalysis of the food defense plan, as a 
whole at least once every 3 years;
    (b) You must conduct a reanalysis of the food defense plan as a 
whole, or the applicable portion of the food defense plan:
    (1) Whenever a significant change made in the activities conducted 
at your facility creates a reasonable potential for a new vulnerability 
or a significant increase in a previously identified vulnerability;
    (2) Whenever you become aware of new information about potential 
vulnerabilities associated with the food operation or facility;
    (3) Whenever you find that a mitigation strategy, a combination of 
mitigation strategies, or the food defense plan as a whole is not 
properly implemented; and
    (4) Whenever FDA requires reanalysis to respond to new 
vulnerabilities, credible threats to the food supply, and developments 
in scientific understanding including, as appropriate, results from the 
Department of Homeland Security biological, chemical, radiological, or 
other terrorism risk assessment.
    (c) You must complete such reanalysis required by paragraphs (a) and 
(b) of this section and implement any additional mitigation strategies 
needed to address the significant vulnerabilities identified, if any:
    (1) Before any change in activities (including any change in 
mitigation strategy) at the facility is operative;
    (2) When necessary within 90-calendar days after production; and
    (3) Within a reasonable timeframe, providing a written justification 
is prepared for a timeframe that exceeds 90 days after production of the 
applicable food first begins.
    (d) You must revise the written food defense plan if a significant 
change in the activities conducted at your facility creates a reasonable 
potential for a new vulnerability or a significant increase in a 
previously identified vulnerability or document the basis for the 
conclusion that no revisions are needed.



Subpart D_Requirements Applying to Records That Must Be Established and 
                               Maintained



Sec. 121.301  Records subject to the requirements of this subpart.

    (a) Except as provided by paragraph (b) of this section, all records 
required by subpart C of this part are subject to all requirements of 
this subpart.
    (b) The requirements of Sec. 121.310 apply only to the written food 
defense plan.

[[Page 453]]



Sec. 121.305  General requirements applying to records.

    Records must:
    (a) Be kept as original records, true copies (such as photocopies, 
pictures, scanned copies, microfilm, microfiche, or other accurate 
reproductions of the original records), or electronic records;
    (b) Contain the actual values and observations obtained during food 
defense monitoring;
    (c) Be accurate, indelible, and legible;
    (d) Be created concurrently with performance of the activity 
documented;
    (e) Be as detailed as necessary to provide history of work 
performed; and
    (f) Include:
    (1) Information adequate to identify the facility (e.g., the name, 
and when necessary, the location of the facility);
    (2) The date and, when appropriate, the time of the activity 
documented;
    (3) The signature or initials of the person performing the activity; 
and
    (4) Where appropriate, the identity of the product and the lot code, 
if any.
    (g) Records that are established or maintained to satisfy the 
requirements of this part and that meet the definition of electronic 
records in Sec. 11.3(b)(6) of this chapter are exempt from the 
requirements of part 11 of this chapter. Records that satisfy the 
requirements of this part, but that also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.



Sec. 121.310  Additional requirements applying to the food defense
plan.

    The owner, operator, or agent in charge of the facility must sign 
and date the food defense plan:
    (a) Upon initial completion; and
    (b) Upon any modification.



Sec. 121.315  Requirements for record retention.

    (a)(1) All records required by this part must be retained at the 
facility for at least 2 years after the date they were prepared.
    (2) Records that a facility relies on during the 3-year period 
preceding the applicable calendar year to support its status as exempt 
as a very small business must be retained at the facility as long as 
necessary to support the status of a facility as a very small business 
during the applicable calendar year.
    (b) The food defense plan must be retained for at least 2 years 
after its use is discontinued.
    (c) Except for the food defense plan, offsite storage of records is 
permitted if such records can be retrieved and provided onsite within 24 
hours of request for official review. The food defense plan must remain 
onsite. Electronic records are considered to be onsite if they are 
accessible from an onsite location.
    (d) If the facility is closed for a prolonged period, the food 
defense plan may be transferred to some other reasonably accessible 
location but must be returned to the facility within 24 hours for 
official review upon request.



Sec. 121.320  Requirements for official review.

    All records required by this part must be made promptly available to 
a duly authorized representative of the Secretary of Health and Human 
Services for official review and copying upon oral or written request.



Sec. 121.325  Public disclosure.

    Records required by this part will be protected from public 
disclosure to the extent allowable under part 20 of this chapter.



Sec. 121.330  Use of existing records.

    (a) Existing records (e.g., records that are kept to comply with 
other Federal, State, or local regulations, or for any other reason) do 
not need to be duplicated if they contain all of the required 
information and satisfy the requirements of this subpart. Existing 
records may be supplemented as necessary to include all of the required 
information and satisfy the requirements of this subpart.
    (b) The information required by this part does not need to be kept 
in one set of records. If existing records contain some of the required 
information, any new information required by this part may be kept 
either separately or combined with the existing records.

[[Page 454]]



                          Subpart E_Compliance



Sec. 121.401  Compliance.

    (a) The operation of a facility that manufactures, processes, packs, 
or holds food for sale in the United States if the owner, operator, or 
agent in charge of such facility is required to comply with, and is not 
in compliance with, section 418 of the Federal Food, Drug, and Cosmetic 
Act or subparts C or D of this part is a prohibited act under section 
301(uu) of the Federal Food, Drug, and Cosmetic Act.
    (b) The failure to comply with section 420 of the Federal Food, 
Drug, and Cosmetic Act or subparts C or D of this part is a prohibited 
act under section 301(ww) of the Federal Food, Drug, and Cosmetic Act.



PART 123_FISH AND FISHERY PRODUCTS--Table of Contents



                      Subpart A_General Provisions

Sec.
123.3 Definitions.
123.5 Current good manufacturing practice.
123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) 
          plan.
123.7 Corrective actions.
123.8 Verification.
123.9 Records.
123.10 Training.
123.11 Sanitation control procedures.
123.12 Special requirements for imported products.

          Subpart B_Smoked and Smoke-Flavored Fishery Products

123.15 General.
123.16 Process controls.

                    Subpart C_Raw Molluscan Shellfish

123.20 General.
123.28 Source controls.

    Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 
393; 42 U.S.C. 241, 241l, 264.

    Source: 60 FR 65197, Dec. 18, 1995, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 123.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the act) and in parts 110 and 117 
of this chapter are applicable to such terms when used in this part, 
except that the definitions and terms in parts 110 and 117 do not govern 
such terms where such terms are redefined in this part and except that 
the terms facility, hazard, and manufacturing/processing in parts 110 
and 117 do not govern such terms where used in this part. The following 
definitions shall also apply:
    (a) Certification number means a unique combination of letters and 
numbers assigned by a shellfish control authority to a molluscan 
shellfish processor.
    (b) Critical control point means a point, step, or procedure in a 
food process at which control can be applied, and a food safety hazard 
can as a result be prevented, eliminated, or reduced to acceptable 
levels.
    (c) Critical limit means the maximum or minimum value to which a 
physical, biological, or chemical parameter 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.
    (d) Fish means fresh or saltwater finfish, crustaceans, other forms 
of aquatic animal life (including, but not limited to, alligator, frog, 
aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of 
such animals) other than birds or mammals, and all mollusks, where such 
animal life is intended for human consumption.
    (e) Fishery product means any human food product in which fish is a 
characterizing ingredient.
    (f) Food safety hazard means any biological, chemical, or physical 
property that may cause a food to be unsafe for human consumption.
    (g) Importer means either the U.S. owner or consignee at the time of 
entry into the United States, or the U.S. agent or representative of the 
foreign owner or consignee at the time of entry into the United States, 
who is responsible for ensuring that goods being offered for entry into 
the United States are in compliance with all laws affecting the 
importation. For the purposes of this definition, ordinarily the 
importer is not the custom house broker, the freight forwarder, the 
carrier, or the steamship representative.

[[Page 455]]

    (h) Molluscan shellfish means any edible species of fresh or frozen 
oysters, clams, mussels, or scallops, or edible portions of such 
species, except when the product consists entirely of the shucked 
adductor muscle.
    (i) Preventive measure means physical, chemical, or other factors 
that can be used to control an identified food safety hazard.
    (j) Process-monitoring instrument means an instrument or device used 
to indicate conditions during processing at a critical control point.
    (k)(1) Processing means, with respect to fish or fishery products: 
Handling, storing, preparing, heading, eviscerating, shucking, freezing, 
changing into different market forms, manufacturing, preserving, 
packing, labeling, dockside unloading, or holding.
    (2) The regulations in this part do not apply to:
    (i) Harvesting or transporting fish or fishery products, without 
otherwise engaging in processing.
    (ii) Practices such as heading, eviscerating, or freezing intended 
solely to prepare a fish for holding on board a harvest vessel.
    (iii) The operation of a retail establishment.
    (l) Processor means any person engaged in commercial, custom, or 
institutional processing of fish or fishery products, either in the 
United States or in a foreign country. A processing includes any person 
engaged in the production of foods that are to be used in market or 
consumer tests.
    (m) Scombroid toxin-forming species means tuna, bluefish, mahi mahi, 
and other species, whether or not in the family Scombridae, in which 
significant levels of histamine may be produced in the fish flesh by 
decarboxylation of free histidine as a result of exposure of the fish 
after capture to temperatures that permit the growth of mesophilic 
bacteria.
    (n) Shall is used to state mandatory requirements.
    (o) Shellfish control authority means a Federal, State, or foreign 
agency, or sovereign tribal government, legally responsible for the 
administration of a program that includes activities such as 
classification of molluscan shellfish growing areas, enforcement of 
molluscan shellfish harvesting controls, and certification of molluscan 
shellfish processors.
    (p) Shellstock means raw, in-shell molluscan shellfish.
    (q) Should is used to state recommended or advisory procedures or to 
identify recommended equipment.
    (r) Shucked shellfish means molluscan shellfish that have one or 
both shells removed.
    (s) Smoked or smoke-flavored fishery products means the finished 
food prepared by:
    (1) Treating fish with salt (sodium chloride), and
    (2) Subjecting it to the direct action of smoke from burning wood, 
sawdust, or similar material and/or imparting to it the flavor of smoke 
by a means such as immersing it in a solution of wood smoke.
    (t) Tag means a record of harvesting information attached to a 
container of shellstock by the harvester or processor.

[60 FR 65197, Dec. 18, 1995, as amended at 80 FR 56167, Sept. 17, 2015]



Sec. 123.5  Current good manufacturing practice.

    (a) Except as provided by Sec. 117.5(b), parts 110 and 117 of this 
chapter apply in determining whether the facilities, methods, practices, 
and controls used to process fish and fishery products are safe, and 
whether these products have been processed under sanitary conditions.
    (b) The purpose of this part is to set forth requirements specific 
to the processing of fish and fishery products.

[60 FR 65197, Dec. 18, 1995, as amended at 80 FR 56167, Sept. 17, 2015]



Sec. 123.6  Hazard analysis and Hazard Analysis Critical Control Point
(HACCP) plan.

    (a) Hazard analysis. Every processor shall conduct, or have 
conducted for it, a hazard analysis to determine whether there are food 
safety hazards that are reasonably likely to occur for each kind of fish 
and fishery product processed by that processor and to identify the 
preventive measures that the processor can apply to control those 
hazards. Such food safety hazards can be introduced both within and 
outside the

[[Page 456]]

processing plant environment, including food safety hazards that can 
occur before, during, and after harvest. A food safety hazard that is 
reasonably likely to occur is one for which a prudent processor would 
establish controls because experience, illness data, scientific reports, 
or other information provide a basis to conclude that there is a 
reasonable possibility that it will occur in the particular type of fish 
or fishery product being processed in the absence of those controls.
    (b) The HACCP plan. Every processor shall have and implement a 
written HACCP plan whenever a hazard analysis reveals one or more food 
safety hazards that are reasonably likely to occur, as described in 
paragraph (a) of this section. A HACCP plan shall be specific to:
    (1) Each location where fish and fishery products are processed by 
that processor; and
    (2) Each kind of fish and fishery product processed by the 
processor. The plan may group kinds of fish and fishery products 
together, or group kinds of production methods together, 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 identical for all fish and fishery products so grouped or for all 
production methods so grouped.
    (c) The contents of the HACCP plan. The HACCP plan shall, at a 
minimum:
    (1) List the food safety hazards that are reasonably likely to 
occur, as identified in accordance with paragraph (a) of this section, 
and that thus must be controlled for each fish and fishery product. 
Consideration should be given to whether any food safety hazards are 
reasonably likely to occur as a result of the following:
    (i) Natural toxins;
    (ii) Microbiological contamination;
    (iii) Chemical contamination;
    (iv) Pesticides;
    (v) Drug residues;
    (vi) Decomposition in scombroid toxin-forming species or in any 
other species where a food safety hazard has been associated with 
decomposition;
    (vii) Parasites, where the processor has knowledge or has reason to 
know that the parasite-containing fish or fishery product will be 
consumed without a process sufficient to kill the parasites, or where 
the processor represents, labels, or intends for the product to be so 
consumed;
    (viii) Unapproved use of direct or indirect food or color additives; 
and
    (ix) Physical hazards;
    (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 processing plant environment; and
    (ii) Critical control points designed to control food safety hazards 
introduced outside the processing plant environment, including food 
safety hazards that occur before, during, and after harvest;
    (3) List the critical limits that must be met at each of the 
critical control points;
    (4) List the procedures, and frequency thereof, that will be used to 
monitor each of the critical control points to ensure compliance with 
the critical limits;
    (5) Include any corrective action plans that have been developed in 
accordance with Sec. 123.7(b), to be followed in response to deviations 
from critical limits at critical control points;
    (6) List the verification procedures, and frequency thereof, that 
the processor will use in accordance with Sec. 123.8(a);
    (7) 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.
    (d) Signing and dating the HACCP plan. (1) The HACCP plan shall be 
signed and dated, either by the most responsible individual onsite at 
the processing facility or by a higher level official of the processor. 
This signature shall signify that the HACCP plan has been accepted for 
implementation by the firm.
    (2) The HACCP plan shall be dated and signed:
    (i) Upon initial acceptance;
    (ii) Upon any modification; and
    (iii) Upon verification of the plan in accordance with Sec. 
123.8(a)(1).

[[Page 457]]

    (e) Products subject to other regulations. For fish and fishery 
products that are subject to the requirements of part 113 or 114 of this 
chapter, the HACCP plan need not list the food safety hazard associated 
with the formation of Clostridium botulinum toxin in the finished, 
hermetically sealed container, nor list the controls to prevent that 
food safety hazard. A HACCP plan for such fish and fishery products 
shall address any other food safety hazards that are reasonably likely 
to occur.
    (f) Sanitation. Sanitation controls may be included in the HACCP 
plan. However, to the extent that they are monitored in accordance with 
Sec. 123.11(b) they need not be included in the HACCP plan, and vice 
versa.
    (g) Legal basis. Failure of a processor to have and implement a 
HACCP plan that complies with this section whenever a HACCP plan is 
necessary, otherwise operate in accordance with the requirements of this 
part, shall render the fish or fishery products of that processor 
adulterated under section 402(a)(4) of the act. Whether a processor's 
actions are consistent with ensuring the safety of food will be 
determined through an evaluation of the processors overall 
implementation of its HACCP plan, if one is required.



Sec. 123.7  Corrective actions.

    (a) Whenever a deviation from a critical limit occurs, a processor 
shall take corrective action either by:
    (1) Following a corrective action plan that is appropriate for the 
particular deviation, or
    (2) Following the procedures in paragraph (c) of this section.
    (b) Processors may develop written corrective action plans, which 
become part of their HACCP plans in accordance with Sec. 123.6(c)(5), 
by which they predetermine the corrective actions that they will take 
whenever there is a deviation from a critical limit. A corrective action 
plan that is appropriate for a particular deviation is one that 
describes the steps to be taken and assigns responsibility for taking 
those steps, to ensure that:
    (1) No product enters commerce that is either injurious to health or 
is otherwise adulterated as a result of the deviation; and
    (2) The cause of the deviation is corrected.
    (c) When a deviation from a critical limit occurs and the processor 
does not have a corrective action plan that is appropriate for that 
deviation, the processor shall:
    (1) Segregate and hold the affected product, at least until the 
requirements of paragraphs (c)(2) and (c)(3) of this section are met;
    (2) Perform or obtain a review to determine the acceptability of the 
affected product for distribution. The review shall be performed by an 
individual or individuals who have adequate training or experience to 
perform such a review. Adequate training may or may not include training 
in accordance with Sec. 123.10;
    (3) Take corrective action, when necessary, with respect to the 
affected product to ensure that no product enters commerce that is 
either injurious to health or is otherwise adulterated as a result of 
the deviation;
    (4) Take corrective action, when necessary, to correct the cause of 
the deviation;
    (5) Perform or obtain timely reassessment by an individual or 
individuals who have been trained in accordance with Sec. 123.10, to 
determine whether the HACCP plan needs to be modified to reduce the risk 
of recurrence of the deviation, and modify the HACCP plan as necessary.
    (d) All corrective actions taken in accordance with this section 
shall be fully documented in records that are subject to verification in 
accordance with Sec. 123.8(a)(3)(ii) and the recordkeeping requirements 
of Sec. 123.9.



Sec. 123.8  Verification.

    (a) Overall verification. Every processor shall verify that the 
HACCP plan is adequate to control food safety hazards that are 
reasonably likely to occur, and that the plan is being effectively 
implemented. Verification shall include, at a minimum:
    (1) Reassessment of the HACCP plan. A reassessment of the adequacy 
of the HACCP plan whenever any changes occur that could affect the 
hazard analysis or alter the HACCP plan in any way or at least annually. 
Such changes may include changes in the following:

[[Page 458]]

Raw materials or source of raw materials, product formulation, 
processing methods or systems, finished product distribution systems, or 
the intended use or consumers of the finished product. The reassessment 
shall be performed by an individual or individuals who have been trained 
in accordance with Sec. 123.10. The HACCP plan shall be modified 
immediately whenever a reassessment reveals that the plan is no longer 
adequate to fully meet the requirements of Sec. 123.6(c).
    (2) Ongoing verification activities. Ongoing verification activities 
including:
    (i) A review of any consumer complaints that have been received by 
the processor to determine whether they relate to the performance of 
critical control points or reveal the existence of unidentified critical 
control points;
    (ii) The calibration of process-monitoring instruments; and,
    (iii) At the option of the processor, the performing of periodic 
end-product or in-process testing.
    (3) Records review. A review, including signing and dating, by an 
individual who has been trained in accordance with Sec. 123.10, of the 
records that document:
    (i) The monitoring of critical control points. The purpose of this 
review shall be, at a minimum, to ensure that the records are complete 
and to verify that they document values that are within the critical 
limits. This review shall occur within 1 week of the day that the 
records are made;
    (ii) The taking of corrective actions. The purpose of this review 
shall be, at a minimum, to ensure that the records are complete and to 
verify that appropriate corrective actions were taken in accordance with 
Sec. 123.7. This review shall occur within 1 week of the day that the 
records are made; and
    (iii) The calibrating of any process control instruments used at 
critical control points and the performing of any periodic end-product 
or in-process testing that is part of the processor's verification 
activities. The purpose of these reviews shall be, at a minimum, to 
ensure that the records are complete, and that these activities occurred 
in accordance with the processor's written procedures. These reviews 
shall occur within a reasonable time after the records are made.
    (b) Corrective actions. Processors shall immediately follow the 
procedures in Sec. 123.7 whenever any verification procedure, including 
the review of a consumer complaint, reveals the need to take a 
corrective action.
    (c) Reassessment of the hazard analysis. Whenever a processor does 
not have a HACCP plan because a hazard analysis has revealed no food 
safety hazards that are reasonably likely to occur, the processor shall 
reassess the adequacy of that hazard analysis whenever there are any 
changes that could reasonably affect whether a food safety hazard now 
exists. Such changes may include, but are not limited to changes in: Raw 
materials or source of raw materials, product formulation, processing 
methods or systems, finished product distribution systems, or the 
intended use or consumers of the finished product. The reassessment 
shall be performed by an individual or individuals who have been trained 
in accordance with Sec. 123.10.
    (d) Recordkeeping. The calibration of process-monitoring 
instruments, and the performing of any periodic end-product and in-
process testing, in accordance with paragraphs (a)(2)(ii) through (iii) 
of this section shall be documented in records that are subject to the 
recordkeeping requirements of Sec. 123.9.



Sec. 123.9  Records.

    (a) General requirements. All records required by this part shall 
include:
    (1) The name and location of the processor or importer;
    (2) The date and time of the activity that the record reflects;
    (3) The signature or initials of the person performing the 
operation; and
    (4) Where appropriate, the identity of the product and the 
production code, if any. Processing and other information shall be 
entered on records at the time that it is observed.
    (b) Record retention. (1) All records required by this part shall be 
retained at the processing facility or importer's place of business in 
the United States for at least 1 year after the date they were prepared 
in the case of refrigerated products and for at least 2 years

[[Page 459]]

after the date they were prepared in the case of frozen, preserved, or 
shelf-stable products.
    (2) Records that relate to the general adequacy of equipment or 
processes being used by a processor, including the results of scientific 
studies and evaluations, shall be retained at the processing facility or 
the importer's place of business in the United States for at least 2 
years after their applicability to the product being produced at the 
facility.
    (3) If the processing facility is closed for a prolonged period 
between seasonal packs, or if record storage capacity is limited on a 
processing vessel or at a remote processing site, the records may be 
transferred to some other reasonably accessible location at the end of 
the seasonal pack but shall be immediately returned for official review 
upon demand.
    (c) 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 at reasonable times.
    (d) Public disclosure. (1) Subject to the limitations in paragraph 
(d)(2) of this section, all plans and records required by this part are 
not available for public disclosure unless they have been previously 
disclosed to the public as defined in Sec. 20.81 of this chapter or 
they relate to a product or ingredient that has been abandoned and they 
no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec. 20.61 of this chapter.
    (2) However, these records and plans may be subject to disclosure to 
the extent that they are otherwise publicly available, or that 
disclosure could not reasonably be expected to cause a competitive 
hardship, such as generic-type HACCP plans that reflect standard 
industry practices.
    (e) Tags. Tags as defined in Sec. 123.3(t) are not subject to the 
requirements of this section unless they are used to fulfill the 
requirements of Sec. 123.28(c).
    (f) Records maintained on computers. The maintenance of records on 
computers is acceptable, provided that appropriate controls are 
implemented to ensure the integrity of the electronic data and 
signatures.



Sec. 123.10  Training.

    At a minimum, the following functions shall be performed by an 
individual who has successfully completed training in the application of 
HACCP principles to fish and fishery product processing at least 
equivalent to that received under standardized curriculum recognized as 
adequate by the U.S. Food and Drug Administration or who is otherwise 
qualified through job experience to perform these functions. Job 
experience will qualify an individual to perform these functions if it 
has provided knowledge at least equivalent to that provided through the 
standardized curriculum.
    (a) Developing a HACCP plan, which could include adapting a model or 
generic-type HACCP plan, that is appropriate for a specific processor, 
in order to meet the requirements of Sec. 123.6(b);
    (b) Reassessing and modifying the HACCP plan in accordance with the 
corrective action procedures specified in Sec. 123.7(c)(5), the HACCP 
plan in accordance with the verification activities specified in Sec. 
123.8(a)(1), and the hazard analysis in accordance with the verification 
activities specified in Sec. 123.8(c); and
    (c) Performing the record review required by Sec. 123.8(a)(3); The 
trained individual need not be an employee of the processor.



Sec. 123.11  Sanitation control procedures.

    (a) Sanitation SOP. Each processor should have and implement a 
written sanitation standard operating procedure (herein referred to as 
SSOP) or similar document that is specific to each location where fish 
and fishery products are produced. The SSOP should specify how the 
processor will meet those sanitation conditions and practices that are 
to be monitored in accordance with paragraph (b) of this section.
    (b) Sanitation monitoring. Each processor shall monitor the 
conditions and practices during processing with sufficient frequency to 
ensure, at a minimum, conformance with those conditions and practices 
specified in part 110 of this chapter and in subpart B of part 117 of 
this chapter that are both appropriate to the plant and the food being 
processed and relate to the following:

[[Page 460]]

    (1) Safety of the water that comes into contact with food or food 
contact surfaces, or is used in the manufacture of ice;
    (2) Condition and cleanliness of food contact surfaces, including 
utensils, gloves, and outer garments;
    (3) Prevention of cross-contamination from insanitary objects to 
food, food packaging material, and other food contact surfaces, 
including utensils, gloves, and outer garments, and from raw product to 
cooked product;
    (4) Maintenance of hand washing, hand sanitizing, and toilet 
facilities;
    (5) Protection of food, food packaging material, and food contact 
surfaces from adulteration with lubricants, fuel, pesticides, cleaning 
compounds, sanitizing agents, condensate, and other chemical, physical, 
and biological contaminants;
    (6) Proper labeling, storage, and use of toxic compounds;
    (7) Control of employee health conditions that could result in the 
microbiological contamination of food, food packaging materials, and 
food contact surfaces; and
    (8) Exclusion of pests from the food plant.
    The processor shall correct in a timely manner, those conditions and 
practices that are not met.
    (c) Sanitation control records. Each processor shall maintain 
sanitation control records that, at a minimum, document the monitoring 
and corrections prescribed by paragraph (b) of this section. These 
records are subject to the requirements of Sec. 123.9.
    (d) Relationship to HACCP plan. Sanitation controls may be included 
in the HACCP plan, required by Sec. 123.6(b). However, to the extent 
that they are monitored in accordance with paragraph (b) of this section 
they need not be included in the HACCP plan, and vice versa.

[60 FR 65197, Dec. 18, 1995, as amended at 80 FR 56167, Sept. 17, 2015]



Sec. 123.12  Special requirements for imported products.

    This section sets forth specific requirements for imported fish and 
fishery products.
    (a) Importer verification. Every importer of fish or fishery 
products shall either:
    (1) Obtain the fish or fishery product from a country that has an 
active memorandum of understanding (MOU) or similar agreement with the 
Food and Drug Administration, that covers the fish or fishery product 
and documents the equivalency or compliance of the inspection system of 
the foreign country with the U.S. system, accurately reflects the 
current situation between the signing parties, and is functioning and 
enforceable in its entirety; or
    (2) Have and implement written verification procedures for ensuring 
that the fish and fishery products that they offer for import into the 
United States were processed in accordance with the requirements of this 
part. The procedures shall list at a minimum:
    (i) Product specifications that are designed to ensure that the 
product is not adulterated under section 402 of the Federal Food, Drug, 
and Cosmetic Act because it may be injurious to health or have been 
processed under insanitary conditions, and,
    (ii) Affirmative steps that may include any of the following:
    (A) Obtaining from the foreign processor the HACCP and sanitation 
monitoring records required by this part that relate to the specific lot 
of fish or fishery products being offered for import;
    (B) Obtaining either a continuing or lot-by-lot certificate from an 
appropriate foreign government inspection authority or competent third 
party certifying that the imported fish or fishery product is or was 
processed in accordance with the requirements of this part;
    (C) Regularly inspecting the foreign processor's facilities to 
ensure that the imported fish or fishery product is being processed in 
accordance with the requirements of this part;
    (D) Maintaining on file a copy, in English, of the foreign 
processor's HACCP plan, and a written guarantee from the foreign 
processor that the imported fish or fishery product is processed in 
accordance with the requirements of the part;

[[Page 461]]

    (E) Periodically testing the imported fish or fishery product, and 
maintaining on file a copy, in English, of a written guarantee from the 
foreign processor that the imported fish or fishery product is processed 
in accordance with the requirements of this part or,
    (F) Other such verification measures as appropriate that provide an 
equivalent level of assurance of compliance with the requirements of 
this part.
    (b) Competent third party. An importer may hire a competent third 
party to assist with or perform any or all of the verification 
activities specified in paragraph (a)(2) of this section, including 
writing the importer's verification procedures on the importer's behalf.
    (c) Records. The importer shall maintain records, in English, that 
document the performance and results of the affirmative steps specified 
in paragraph (a)(2)(ii) of this section. These records shall be subject 
to the applicable provisions of Sec. 123.9.
    (d) Determination of compliance. There must be evidence that all 
fish and fishery products offered for entry into the United States have 
been processed under conditions that comply with this part. If 
assurances do not exist that the imported fish or fishery product has 
been processed under conditions that are equivalent to those required of 
domestic processors under this part, the product will appear to be 
adulterated and will be denied entry.



          Subpart B_Smoked and Smoke-Flavored Fishery Products



Sec. 123.15  General.

    This subpart augments subpart A of this part by setting forth 
specific requirements for processing smoked and smoke-flavored fishery 
products.



Sec. 123.16  Process controls.

    In order to meet the requirements of subpart A of this part, 
processors of smoked and smoke-flavored fishery products, except those 
subject to the requirements of part 113 or 114 of this chapter, shall 
include in their HACCP plans how they are controlling the food safety 
hazard associated with the formation of toxin by Clostridium botulinum 
for at least as long as the shelf life of the product under normal and 
moderate abuse conditions.



                    Subpart C_Raw Molluscan Shellfish



Sec. 123.20  General.

    This subpart augments subpart A of this part by setting forth 
specific requirements for processing fresh or frozen molluscan 
shellfish, where such processing does not include a treatment that 
ensures the destruction of vegetative cells of microorganisms of public 
health concern.



Sec. 123.28  Source controls.

    (a) In order to meet the requirements of subpart A of this part as 
they apply to microbiological contamination, chemical contamination, 
natural toxins, and related food safety hazards, processors shall 
include in their HACCP plans how they are controlling the origin of the 
molluscan shellfish they process to ensure that the conditions of 
paragraphs (b), (c), and (d) of this section are met.
    (b) Processors shall only process molluscan shellfish harvested from 
growing waters approved for harvesting by a shellfish control authority. 
In the case of molluscan shellfish harvested from U.S. Federal waters, 
the requirements of this paragraph will be met so long as the shellfish 
have not been harvested from waters that have been closed to harvesting 
by an agency of the Federal government.
    (c) To meet the requirements of paragraph (b) of this section, 
processors who receive shellstock shall accept only shellstock from a 
harvester that is in compliance with such licensure requirements as may 
apply to the harvesting of molluscan shellfish or from a processor that 
is certified by a shellfish control authority, and that has a tag 
affixed to each container of shellstock. The tag shall bear, at a 
minimum, the information required in Sec. 1240.60(b) of this chapter. 
In place of the tag, bulk shellstock shipments may be accompanied by a 
bill of lading or similar shipping document that contains the 
information required in Sec. 1240.60(b) of this chapter. Processors 
shall maintain records that document

[[Page 462]]

that all shellstock have met the requirements of this section. These 
records shall document:
    (1) The date of harvest;
    (2) The location of harvest by State and site;
    (3) The quantity and type of shellfish;
    (4) The date of receipt by the processor; and
    (5) The name of the harvester, the name or registration number of 
the harvester's vessel, or an identification number issued to the 
harvester by the shellfish control authority.
    (d) To meet the requirements of paragraph (b) of this section, 
processors who receive shucked molluscan shellfish shall accept only 
containers of shucked molluscan shellfish that bear a label that 
complies with Sec. 1240.60(c) of this chapter. Processors shall 
maintain records that document that all shucked molluscan shellfish have 
met the requirements of this section. These records shall document:
    (1) The date of receipt;
    (2) The quantity and type of shellfish; and
    (3) The name and certification number of the packer or repacker of 
the product.



PART 129_PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER--
Table of Contents



                      Subpart A_General Provisions

Sec.
129.1 Current good manufacturing practice.
129.3 Definitions.

                   Subpart B_Buildings and Facilities

129.20 Plant construction and design.
129.35 Sanitary facilities.
129.37 Sanitary operations.

                           Subpart C_Equipment

129.40 Equipment and procedures.

Subpart D [Reserved]

                Subpart E_Production and Process Controls

129.80 Processes and controls.

    Authority: 21 U.S.C. 342, 348, 371, 374; 42 U.S.C. 264.

    Source: 42 FR 14355, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 129.1  Current good manufacturing practice.

    The applicable criteria in parts 110 and 117 of this chapter, as 
well as the criteria in Sec. Sec. 129.20, 129.35, 129.37, 129.40, and 
129.80 shall apply in determining whether the facilities, methods, 
practices, and controls used in the processing, bottling, holding, and 
shipping of bottled drinking water are in conformance with or are 
operated or administered in conformity with good manufacturing practice 
to assure that bottled drinking water is safe and that it has been 
processed, bottled, held, and transported under sanitary conditions.

[80 FR 56167, Sept. 17, 2015]



Sec. 129.3  Definitions.

    For the purposes of this part, the following definitions apply:
    (a) Approved source when used in reference to a plant's product 
water or operations water means a source of water and the water 
therefrom, whether it be from a spring, artesian well, drilled well, 
municipal water supply, or any other source, that has been inspected and 
the water sampled, analyzed, and found to be of a safe and sanitary 
quality according to applicable laws and regulations of State and local 
government agencies having jurisdiction. The presence in the plant of 
current certificates or notifications of approval from the government 
agency or agencies having jurisdiction constitutes approval of the 
source and the water supply.
    (b) Bottled drinking water means all water which is sealed in 
bottles, packages, or other containers and offered for sale for human 
consumption, including bottled mineral water.
    (c) Lot means a collection of primary containers or unit packages of 
the same size, type, and style produced under conditions as nearly 
uniform as possible and designated by a common container code or 
marking.
    (d) Multiservice containers means containers intended for use more 
than one time.
    (e) Nontoxic materials means materials for product water contact 
surfaces

[[Page 463]]

utilized in the transporting, processing, storing, and packaging of 
bottled drinking water, which are free of substances which may render 
the water injurious to health or which may adversely affect the flavor, 
color, odor, or bacteriological quality of the water.
    (f) Operations water means water which is delivered under pressure 
to a plant for container washing, hand washing, plant and equipment 
cleanup and for other sanitary purposes.
    (g) Primary container means the immediate container in which the 
product water is packaged.
    (h) Product water means processed water used by a plant for bottled 
drinking water.
    (i) Shall and should. ``Shall'' refers to mandatory requirements and 
``should'' refers to recommended or advisory procedures or equipment.
    (j) Shipping case means a container in which one or more primary 
containers of the product are held.
    (k) Single-service container means a container intended for one time 
usage only.
    (l) Unit package means a standard commercial package of bottled 
drinking water, which may consist of one or more containers.

[42 FR 14355, Mar. 6, 1977, as amended at 44 FR 12175, Mar. 6, 1979]



                   Subpart B_Buildings and Facilities



Sec. 129.20  Plant construction and design.

    (a) The bottling room shall be separated from other plant operations 
or storage areas by tight walls, ceilings, and self-closing doors to 
protect against contamination. Conveyor openings shall not exceed the 
size required to permit passage of containers.
    (b) If processing operations are conducted in other than a sealed 
system under pressure, adequate protection shall be provided to preclude 
contamination of the water and the system.
    (c) Adequate ventilation shall be provided to minimize condensation 
in processing rooms, bottling rooms, and in container washing and 
sanitizing areas.
    (d) The washing and sanitizing of containers for bottled drinking 
water shall be performed in an enclosed room. The washing and sanitizing 
operation shall be positioned within the room so as to minimize any 
possible post-sanitizing contamination of the containers before they 
enter the bottling room.
    (e) Rooms in which product water is handled, processed, or held or 
in which containers, utensils, or equipment are washed or held shall not 
open directly into any room used for domestic household purposes.



Sec. 129.35  Sanitary facilities.

    Each plant shall provide adequate sanitary facilities including, but 
not limited to, the following:
    (a) Product water and operations water--(1) Product water. The 
product water supply for each plant shall be from an approved source 
properly located, protected, and operated and shall be easily 
accessible, adequate, and of a safe, sanitary quality which shall be in 
conformance at all times with the applicable laws and regulations of the 
government agency or agencies having jurisdiction.
    (2) Operations water. If different from the product water supply, 
the operations water supply shall be obtained from an approved source 
properly located, protected, and operated and shall be easily 
accessible, adequate, and of a safe, sanitary quality which shall be in 
conformance at all times with the applicable laws and regulations of the 
government agency or agencies having jurisdiction.
    (3) Product water and operations water from approved sources. (i) 
Samples of source water from each source in use by the plant are to be 
taken and analyzed by the plant as often as necessary, but at a minimum 
frequency of once each year for chemical contaminants and once every 4 
years for radiological contaminants. Additionally, source water obtained 
from other than a public water system is to be sampled and analyzed for 
total coliform at least once each week. If any coliform organisms are 
detected, follow-up testing must be conducted to determine whether any 
of the coliform organisms are Escherichia coli. This sampling is in 
addition to any performed by government agencies having jurisdiction. 
Source water found to contain E. coli is not considered water of a safe, 
sanitary quality as required for use in bottled

[[Page 464]]

water by paragraph (a)(1) of this section. Before a bottler can use 
source water from a source that has tested positive for E. coli, the 
bottler must take appropriate measures to rectify or otherwise eliminate 
the cause of E. coli contamination of that source in a manner sufficient 
to prevent its reoccurrence. A source previously found to contain E. 
coli will be considered negative for E. coli after five samples 
collected over a 24-hour period from the same sampling site that 
originally tested positive for E. coli are tested and found to be E. 
coli negative. Records of approval of the source water by government 
agencies having jurisdiction, records of sampling and analyses for which 
the plant is responsible, and records describing corrective measures 
taken in response to a finding of E. coli are to be maintained on file 
at the plant.
    (ii) Test and sample methods shall be those recognized and approved 
by the government agency or agencies having jurisdiction over the 
approval of the water source, and shall be consistent with the minimum 
requirements set forth in Sec. 165.110(b) of this chapter.
    (iii) Analysis of the sample may be performed for the plant by 
competent commercial laboratories (e.g., Environmental Protection Agency 
(EPA) and State-certified laboratories).
    (4) Source water testing exemptions. (i) Firms that use a public 
water system for source water may substitute public water system testing 
results, or certificates showing full compliance with all provisions of 
EPA National Primary and Secondary Drinking Water Regulations pertaining 
to chemical contaminants (40 CFR parts 141 and 143), for the testing 
requirements of Sec. 129.35(a)(3).
    (ii) Firms that do not use a public water system as the source of 
their water may reduce the frequency of their testing of that source, as 
well as the number of chemical contaminants for which they test the 
source water, if they can document that such reduction is consistent 
with a State-issued waiver under EPA regulations (40 CFR parts 141 and 
143).
    (iii) Firms that do not use a public water system as the source of 
their water and whose source water has not been treated with a chlorine-
based disinfectant or ozone do not have to test their source water for 
the residual disinfectants and DBP's listed in Sec. 
165.110(b)(4)(iii)(H) of this chapter. Firms that do not use a public 
water system as the source of their water but whose source water has 
been treated with a chlorine-based disinfectant or ozone must test their 
source water for the residual disinfectants and the DBP's listed in 
Sec. 165.110(b)(4)(iii)(H) that are likely to result from such 
treatment.
    (iv) The finished bottled water must comply with bottled water 
quality standards (Sec. 165.110(b) of this chapter) and section 
402(a)(1) and (a)(3) of the Federal Food, Drug, and Cosmetic Act dealing 
with adulterated foods.
    (b) Air under pressure. Whenever air under pressure is directed at 
product water or a product water-contact surface, it shall be free of 
oil, dust, rust, excessive moisture, and extraneous materials; shall not 
affect the bacteriological quality of the water; and should not 
adversely affect the flavor, color, or odor of the water.
    (c) Locker and lunchrooms. When employee locker and lunchrooms are 
provided, they shall be separate from plant operations and storage areas 
and shall be equipped with self-closing doors. The rooms shall be 
maintained in a clean and sanitary condition and refuse containers 
should be provided. Packaging or wrapping material or other processing 
supplies shall not be stored in locker or lunchrooms.

[42 FR 14355, Mar. 15, 1977, as amended at 44 FR 12175, Mar. 6, 1979; 60 
FR 57123, Nov. 13, 1995; 66 FR 16865, Mar. 28, 2001; 74 FR 25664, May 
29, 2009]



Sec. 129.37  Sanitary operations.

    (a) The product water-contact surfaces of all multiservice 
containers, utensils, pipes, and equipment used in the transportation, 
processing, handling, and storage of product water shall be clean and 
adequately sanitized. All product water-contact surfaces shall be 
inspected by plant personnel as often as necessary to maintain the 
sanitary condition of such surfaces and to assure they are kept free of 
scale, evidence of oxidation, and other residue. The presence of any 
unsanitary condition, scale, residue, or oxidation shall

[[Page 465]]

be immediately remedied by adequate cleaning and sanitizing of that 
product water-contact surface prior to use.
    (b) After cleaning, all multiservice containers, utensils, and 
disassembled piping and equipment shall be transported and stored in 
such a manner as to assure drainage and shall be protected from 
contamination.
    (c) Single-service containers and caps or seals shall be purchased 
and stored in sanitary closures and kept clean therein in a clean, dry 
place until used. Prior to use they shall be examined, and as necessary, 
washed, rinsed, and sanitized and shall be handled in a sanitary manner.
    (d) Filling, capping, closing, sealing, and packaging of containers 
shall be done in a sanitary manner so as to preclude contamination of 
the bottled drinking water.



                           Subpart C_Equipment



Sec. 129.40  Equipment and procedures.

    (a) Suitability. (1) All plant equipment and utensils shall be 
suitable for their intended use. This includes all collection and 
storage tanks, piping, fittings, connections, bottle washers, fillers, 
cappers, and other equipment which may be used to store, handle, 
process, package, or transport product water.
    (2) All product water contact surfaces shall be constructed of 
nontoxic and nonabsorbant material which can be adequately cleaned and 
sanitized and is in compliance with section 409 of the act.
    (b) Design. Storage tanks shall be of the type that can be closed to 
exclude all foreign matter and shall be adequately vented.

Subpart D [Reserved]



                Subpart E_Production and Process Controls



Sec. 129.80  Processes and controls.

    (a) Treatment of product water. All treatment of product water by 
distillation, ion-exchanging, filtration, ultraviolet treatment, reverse 
osmosis, carbonation, mineral addition, or any other process shall be 
done in a manner so as to be effective in accomplishing its intended 
purpose and in accordance with section 409 of the Federal Food, Drug, 
and Cosmetic Act. All such processes shall be performed in and by 
equipment and with substances which will not adulterate the bottled 
product. A record of the type and date of physical inspections of such 
equipment, conditions found, and the performance and effectiveness of 
such equipment shall be maintained by the plant. Product water samples 
shall be taken after processing and prior to bottling by the plant and 
analyzed as often as is necessary to assure uniformity and effectiveness 
of the processes performed by the plant. The methods of analysis shall 
be those approved by the government agency or agencies having 
jurisdiction.
    (b) Containers. (1) Multiservice primary containers shall be 
adequately cleaned, sanitized, and inspected just prior to being filled, 
capped, and sealed. Containers found to be unsanitary or defective by 
the inspection shall be reprocessed or discarded. All multiservice 
primary containers shall be washed, rinsed, and sanitized by mechanical 
washers or by any other method giving adequate sanitary results. 
Mechanical washers shall be inspected as often as is necessary to assure 
adequate performance. Records of physical maintenance, inspections and 
conditions found, and performance of the mechanical washer shall be 
maintained by the plant.
    (2) Multiservice shipping cases shall be maintained in such 
condition as to assure they will not contaminate the primary container 
or the product water. Adequate dry or wet cleaning procedures shall be 
performed as often as necessary to maintain the cases in satisfactory 
condition.
    (c) Cleaning and sanitizing solutions. Cleaning and sanitizing 
solutions utilized by the plant shall be sampled and tested by the plant 
as often as is necessary to assure adequate performance in the cleaning 
and sanitizing operations. Records of these tests shall be maintained by 
the plant.
    (d) Sanitizing operations. Sanitizing operations, including those 
performed by chemical means or by any other means such as circulation of 
live steam

[[Page 466]]

or hot water, shall be adequate to effect sanitization of the intended 
product water-contact surfaces and any other critical area. The plant 
should maintain a record of the intensity of the sanitizing agent and 
the time duration that the agent was in contact with the surface being 
sanitized. The following times and intensities shall be considered a 
minimum:
    (1) Steam in enclosed system: At least 170 [deg]F for at least 15 
minutes or at least 200 [deg]F for at least 5 minutes.
    (2) Hot water in enclosed system: At least 170 [deg]F for at least 
15 minutes or at least 200 [deg]F for at least 5 minutes.
    (3) Chemical sanitizers shall be equivalent in bactericidal action 
to a 2-minute exposure of 50 parts per million of available chlorine at 
57 [deg]F when used as an immersion or circulating solution. Chemical 
sanitizers applied as a spray or fog shall have as a minimum 100 parts 
per million of available chlorine at 57 [deg]F or its equivalent in 
bactericidal action.
    (4) 0.1 part per million ozone water solution in an enclosed system 
for at least 5 minutes.
    (5) When containers are sanitized using a substance other than one 
provided for in Sec. 178.1010 of this chapter, such substance shall be 
removed from the surface of the container by a rinsing procedure. The 
final rinse, prior to filling the container with product water, shall be 
performed with a disinfected water rinse free of pathogenic bacteria or 
by an additional sanitizing procedure equivalent in bactericidal action 
to that required in paragraph (d)(3) of this section.
    (e) Unit package production code. Each unit package from a batch or 
segment of a continuous production run of bottled drinking water shall 
be identified by a production code. The production code shall identify a 
particular batch or segment of a continuous production run and the day 
produced. The plant shall record and maintain information as to the kind 
of product, volume produced, date produced, lot code used, and the 
distribution of the finished product to wholesale and retail outlets.
    (f) Filling, capping, or sealing. During the process of filling, 
capping or sealing either single-service or multiservice containers, the 
performance of the filler, capper or sealer shall be monitored and the 
filled containers visually or electronically inspected to assure they 
are sound, properly capped or sealed, and coded and labeled. Containers 
which are not satisfactory shall be reprocessed or rejected. Only 
nontoxic containers and closures shall be used. All containers and 
closures shall be sampled and inspected to ascertain that they are free 
from contamination. At least once each 3 months, a bacteriological swab 
and/or rinse count should be made from at least four containers and 
closures selected just prior to filling and sealing. No more than one of 
the four samples may exceed more than one bacteria per milliliter of 
capacity or one colony per square centimeter of surface area. All 
samples shall be free of coliform organisms. The procedure and apparatus 
for these bacteriological tests shall be in conformance with those 
recognized by the government agency or agencies having jurisdiction. 
Tests shall be performed either by qualified plant personnel or a 
competent commercial laboratory.
    (g) Compliance procedures. A quality standard for bottled drinking 
water is established in Sec. 165.110(b) of this chapter. To assure that 
the plant's production of bottled drinking water complies with the 
applicable standards, laws, and regulations of the government agency or 
agencies having jurisdiction, the plant will analyze product samples as 
follows:
    (1) For bacteriological purposes, take and analyze at least once a 
week for total coliform a representative sample from a batch or segment 
of a continuous production run for each type of bottled drinking water 
produced during a day's production. The representative sample shall 
consist of primary containers of product or unit packages of product. If 
any coliform organisms are detected, follow-up testing must be conducted 
to determine whether any of the coliform organisms are E. coli.
    (2) For chemical, physical, and radiological purposes, take and 
analyze at least annually a representative sample from a batch or 
segment of a continuous production run for each type of bottled drinking 
water produced during a day's production. The representtive

[[Page 467]]

sample(s) consists of primary containers of product of unit packages of 
product.
    (3) Analyze such samples by methods approved by the government 
agency or agencies having jurisdiction. The plant shall maintain records 
of date of sampling, type of product sampled, production code, and 
results of the analysis.
    (h) Record retention. All records required by Sec. Sec. 129.1, 
129.20, 129.35, 129.37, 129.40, and 129.80 shall be maintained at the 
plant for not less than 2 years. Plants shall also retain, on file at 
the plant, current certificates or notifications of approval issued by 
the government agency or agencies approving the plant's source and 
supply of product water and operations water. All required documents 
shall be available for official review at reasonable times.

[42 FR 14355, Mar. 15, 1977, as amended at 44 FR 12175, Mar. 6, 1979; 60 
FR 57124, Nov. 13, 1995; 74 FR 25665, May 29, 2009]



PART 130_FOOD STANDARDS: GENERAL--Table of Contents



                      Subpart A_General Provisions

Sec.
130.3 Definitions and interpretations.
130.5 Procedure for establishing a food standard.
130.6 Review of Codex Alimentarius food standards.
130.8 Conformity to definitions and standards of identity.
130.9 Sulfites in standardized food.
130.10 Requirements for foods named by use of a nutrient content claim 
          and a standardized term.
130.11 Label designations of ingredients for standardized foods.
130.12 General methods for water capacity and fill of containers.
130.14 General statements of substandard quality and substandard fill of 
          container.
130.17 Temporary permits for interstate shipment of experimental packs 
          of food varying from the requirements of definitions and 
          standards of identity.

             Subpart B_Food Additives in Standardized Foods

130.20 Food additives proposed for use in foods for which definitions 
          and standards of identity are established.

    Authority: 21 U.S.C. 321, 336, 341, 343, 371.

    Editorial Note: Nomenclature changes to part 130 appear at 81 FR 
49896, July 29, 2016.



                      Subpart A_General Provisions



Sec. 130.3  Definitions and interpretations.

    (a) The definitions and interpretations of terms contained in 
section 201 of the act shall be applicable also to such terms when used 
in regulations promulgated under the act.
    (b) If a regulation prescribing a definition and standard of 
identity for a food has been promulgated under section 401 of the act 
and the name therein specified for the food is used in any other 
regulation under section 401 or any other provision of the act, such 
name means the food which conforms to such definition and standard, 
except as otherwise specifically provided in such other regulation.
    (c) No provision of any regulation prescribing a definition and 
standard of identity or standard of quality or fill of container under 
section 401 of the act shall be construed as in any way affecting the 
concurrent applicability of the general provisions of the act and the 
regulations thereunder relating to adulteration and misbranding. For 
example, all regulations under section 401 contemplate that the food and 
all articles used as components or ingredients thereof shall not be 
poisonous or deleterious and shall be clean, sound, and fit for food. A 
provision in such regulations for the use of coloring or flavoring does 
not authorize such use under circumstances or in a manner whereby damage 
or inferiority is concealed or whereby the food is made to appear better 
or of greater value than it is.
    (d) Safe and suitable means that the ingredient:
    (1) Performs an appropriate function in the food in which it is 
used.
    (2) Is used at a level no higher than necessary to achieve its 
intended purpose in that food.
    (3) Is not a food additive or color additive as defined in section 
201 (s) or (t) of the Federal Food, Drug, and Cosmetic Act as used in 
that food, or is a food additive or color additive as so defined and is 
used in conformity with regulations established pursuant to section 409 
or 721 of the act.
    (e) Section 403(i) of the act requires the listing of all 
ingredients in standardized foods. All ingredients must be

[[Page 468]]

listed in accordance with the requirements of part 101 of this chapter, 
except that where a definition and standard of identity has specific 
labeling provisions for optional ingredients, optional ingredients may 
be declared in accordance with those provisions.

[42 FR 14357, Mar. 15, 1977, as amended at 58 FR 2876, Jan. 6, 1993]



Sec. 130.5  Procedure for establishing a food standard.

    (a) The procedure for establishing a food standard under section 401 
of the act shall be governed by part 10 of this chapter.
    (b) Any petition for a food standard shall show that the proposal, 
if adopted, would promote honesty and fair dealing in the interest of 
consumers.
    (c) Any petition for a food standard shall assert that the 
petitioner commits himself to substantiate the information in the 
petition by evidence in a public hearing, if such a hearing becomes 
necessary.
    (d) If a petitioner fails to appear, or to substantiate the 
information in his petition, at a public hearing on the matter, the 
Commissioner may either (1) withdraw the regulation and terminate the 
proceeding or (2) if he concludes that it is in accordance with the 
requirements of section 401 of the act, continue the proceeding and 
introduce evidence to substantiate such information.

[42 FR 14357, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]



Sec. 130.6  Review of Codex Alimentarius food standards.

    (a) All food standards adopted by the Codex Alimentarius Commission 
will be reviewed by the Food and Drug Administration and will be 
accepted without change, accepted with change, or not accepted.
    (b) Review of Codex standards will be accomplished in one of the 
following three ways:
    (1) Any interested person may petition the Commissioner to adopt a 
Codex standard, with or without change, by proposing a new standard or 
an appropriate amendment of an existing standard, pursuant to section 
401 of the act. Any such petition shall specify any deviations from the 
Codex standard, and the reasons for any such deviations. The 
Commissioner shall publish such a petition in the Federal Register as a 
proposal, with an opportunity for comment, if reasonable grounds are 
provided in the petition. Any published proposal shall state any 
deviations from the Codex standard and the stated reasons therefor.
    (2) The Commissioner may on his own initiative propose by 
publication in the Federal Register the adoption of a Codex standard, 
with or without change, through a new standard or an appropriate 
amendment to an existing standard, pursuant to section 401 of the act. 
Any such proposal shall specify any deviations from the Codex standard, 
and the reasons for any such deviations.
    (3) Any Codex standard not handled under paragraph (b) (1) or (2) of 
this section may be published in the Federal Register for review and 
informal comment. Interested persons shall be requested to comment on 
the desirability and need for the standard, on the specific provisions 
of the standard, on additional or different provisions that should be 
included in the standard, and on any other pertinent points. After 
reviewing all such comments, the Commissioner either shall publish a 
proposal to establish a food standard pursuant to section 401 of the act 
covering the food involved, or shall publish a notice terminating 
consideration of such a standard.
    (c) All interested persons are encouraged to confer with different 
interest groups (consumers, industry, the academic community, 
professional organizations, and others) in formulating petitions or 
comments pursuant to paragraph (b) of this section. All such petitions 
or comments are requested to include a statement of any meetings and 
discussions that have been held with other interest groups. Appropriate 
weight will be given by the Commissioner to petitions or comments that 
reflect a consensus of different interest groups.



Sec. 130.8  Conformity to definitions and standards of identity.

    In the following conditions, among others, a food does not conform 
to the

[[Page 469]]

definition and standard of identity therefor:
    (a) If it contains an ingredient for which no provision is made in 
such definition and standard, unless such ingredient is an incidental 
additive introduced at a nonfunctional and insignificant level as a 
result of its deliberate and purposeful addition to another ingredient 
permitted by the terms of the applicable standard and the presence of 
such incidental additive in unstandardized foods has been exempted from 
label declaration as provided in Sec. 101.100 of this chapter.
    (b) If it fails to contain any one or more ingredients required by 
such definition and standard;
    (c) If the quantity of any ingredient or component fails to conform 
to the limitation, if any, prescribed therefor by such definition and 
standard.



Sec. 130.9  Sulfites in standardized food.

    (a) Any standardized food that contains a sulfiting agent or 
combination of sulfiting agents that is functional and provided for in 
the applicable standard or that is present in the finished food at a 
detectable level is misbranded unless the presence of the sulfiting 
agent or agents is declared on the label of the food. A detectable 
amount of sulfiting agent is 10 parts per million or more of the sulfite 
in the finished food. The level of sulfite in the finished food will be 
determined using sections 20.123 through 20.125, ``Sulfurous Acid 
(Total) in Food Modified Monier-Williams Method Final Action'' in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 14th ed. (1984), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, and the refinements 
of the ``Total Sulfurous Acid'' procedure in the ``Monier-Williams 
Procedure (with Modifications) for Sulfites in Foods,'' which is 
appendix A to part 101 of this chapter. A copy of sections 20.123 
through 20.125 of the ``Official Methods of Analysis of the Association 
of Official Analytical Chemists'' is available from AOAC INTERNATIONAL, 
481 North Frederick Ave., suite 500, Gaithersburg, MD 20877 , or 
available for 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) Any standardized food that, as a result of actions that are 
consistent with current good manufacturing practice, contains an 
indirectly added sulfiting agent that has no functional effect in the 
food and that would, in the absence of Sec. 101.100(a)(4) of this 
chapter, be considered to be an incidental additive for purposes of 
Sec. 130.8, conforms to the applicable definition and standard of 
identity if the presence of the sulfiting agent is declared on the label 
of the food.

[58 FR 2876, Jan. 6, 1993, as amended at 63 FR 14035, Mar. 24, 1998]



Sec. 130.10  Requirements for foods named by use of a nutrient content
claim and a standardized term.

    (a) Description. The foods prescribed by this general definition and 
standard of identity are those foods that substitute (see Sec. 
101.13(d) of this chapter) for a standardized food defined in parts 131 
through 169 of this chapter and that use the name of that standardized 
food in their statement of identity but that do not comply with the 
standard of identity because of a deviation that is described by an 
expressed nutrient content claim that has been defined by FDA 
regulation. The nutrient content claim shall comply with the 
requirements of Sec. 101.13 of this chapter and with the requirements 
of the regulations in part 101 of this chapter that define the 
particular nutrient content claim that is used. The food shall comply 
with the relevant standard in all other respects except as provided in 
paragraphs (b), (c), and (d) of this section.
    (b) Nutrient addition. Nutrients shall be added to the food to 
restore nutrient levels so that the product is not nutritionally 
inferior, as defined in Sec. 101.3(e)(4) of this chapter, to the 
standardized food as defined in parts 131 through 169 of this chapter. 
The addition of nutrients shall be reflected in the ingredient 
statement.
    (c) Performance characteristics. Deviations from noningredient 
provisions of the standard of identity (e.g., moisture

[[Page 470]]

content, food solids content requirements, or processing conditions) are 
permitted in order that the substitute food possesses performance 
characteristics similar to those of the standardized food. Deviations 
from ingredient and noningredient provisions of the standard must be the 
minimum necessary to qualify for the nutrient content claim while 
maintaining similar performance characteristics as the standardized 
food, or the food will be deemed to be adulterated under section 402(b) 
of the act. The performance characteristics (e.g., physical properties, 
flavor characteristics, functional properties, shelf life) of the food 
shall be similar to those of the standardized food as produced under 
parts 131 through 169 of this chapter, except that if there is a 
significant difference in performance characteristics that materially 
limits the uses of the food compared to the uses of the standardized 
food, the label shall include a statement informing the consumer of such 
difference (e.g., if appropriate, ``not recommended for cooking''). Such 
statement shall comply with the requirements of Sec. 101.13(d) of this 
chapter. The modified product shall perform at least one of the 
principal functions of the standardized product substantially as well as 
the standardized product.
    (d) Other ingredients. (1) Ingredients used in the product shall be 
those ingredients provided for by the standard as defined in parts 131 
through 169 of this chapter and in paragraph (b) of this section, except 
that safe and suitable ingredients may be used to improve texture, add 
flavor, prevent syneresis, extend shelf life, improve appearance, or add 
sweetness so that the product is not inferior in performance 
characteristics to the standardized food defined in parts 131 through 
169 of this chapter.
    (2) An ingredient or component of an ingredient that is specifically 
required by the standard (i.e., a mandatory ingredient) as defined in 
parts 131 through 169 of this chapter, shall not be replaced or 
exchanged with a similar ingredient from another source unless the 
standard, as defined in parts 131 through 169 of this chapter, provides 
for the addition of such ingredient (e.g., vegetable oil shall not 
replace milkfat in light sour cream).
    (3) An ingredient or component of an ingredient that is specifically 
prohibited by the standard as defined in parts 131 through 169 of this 
chapter, shall not be added to a substitute food under this section.
    (4) An ingredient that is specifically required by the standard as 
defined in parts 131 through 169 of this chapter, shall be present in 
the product in a significant amount. A significant amount of an 
ingredient or component of an ingredient is at least that amount that is 
required to achieve the technical effect of that ingredient in the food.
    (5) Water and fat analogs may be added to replace fat and calories 
in accordance with Sec. 130.10(c), (d)(1), and (d)(2).
    (e) Nomenclature. The name of a substitute food that complies with 
all parts of this regulation is the appropriate expressed nutrient 
content claim and the applicable standardized term.
    (f) Label declaration. (1) Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
part 101 of this chapter and part 130.
    (2) Ingredients not provided for, and ingredients used in excess of 
those levels provided for, by the standard as defined in parts 131 
through 169 of this chapter, shall be identified as such with an 
asterisk in the ingredient statement, except that ingredients added to 
restore nutrients to the product as required in paragraph (b) of this 
section shall not be identified with an asterisk. The statement 
``*Ingredient(s) not in regular ___'' (fill in name of the traditional 
standardized food) or ``*Ingredient(s) in excess of amount permitted in 
regular ___'' (fill in name of the traditional standardized food) or 
both as appropriate shall immediately follow the ingredient statement in 
the same type size.

[58 FR 2446, Jan. 6, 1993]

[[Page 471]]



Sec. 130.11  Label designations of ingredients for standardized foods.

    Some definitions and standards of identity for foods set forth below 
require that designated optional ingredients such as spices, flavorings, 
colorings, emulsifiers, flavor enhancers, stabilizers, preservatives, 
and sweeteners be declared in a specified manner on the label wherever 
the name of the standardized food appears on the label so conspicuously 
as to be easily seen under customary conditions of purchase. Such 
requirements shall apply to a manufacturer, packer, or distributor of a 
standardized food only if the words or statements on the label of the 
standardized food significantly differentiate between two or more foods 
that comply with the same standard by describing the optional forms or 
varieties, the packing medium, or significant characterizing ingredients 
present in the food.

[58 FR 2876, Jan. 6, 1993]



Sec. 130.12  General methods for water capacity and fill of containers.

    For the purposes of regulations promulgated under section 401 of the 
act:
    (a) The term general method for water capacity of containers means 
the following method:
    (1) In the case of a container with lid attached by double seam, cut 
out the lid without removing or altering the height of the double seam.
    (2) Wash, dry, and weigh the empty container.
    (3) Fill the container with distilled water at 68 [deg]F to \3/16\ 
inch vertical distance below the top level of the container, and weigh 
the container thus filled.
    (4) Subtract the weight found in paragraph (a)(2) of this section 
from the weight found in paragraph (a)(3) of this section. The 
difference shall be considered to be the weight of water required to 
fill the container.


In the case of a container with lid attached otherwise than by double 
seam, remove the lid and proceed as directed in paragraphs (a) (2) to 
(4) of this section, except that under paragraph (a)(3) of this section, 
fill the container to the level of the top thereof.
    (b) The term general method for fill of containers means the 
following method:
    (1) In the case of a container with lid attached by double seam, cut 
out the lid without removing or altering the height of the double seam.
    (2) Measure the vertical distance from the top level of the 
container to the top level of the food.
    (3) Remove the food from the container; wash, dry, and weigh the 
container.
    (4) Fill the container with water to \3/16\ inch vertical distance 
below the top level of the container. Record the temperature of the 
water, weigh the container thus filled, and determine the weight of the 
water by subtracting the weight of the container found in paragraph 
(b)(3) of this section.
    (5) Maintaining the water at the temperature recorded in paragraph 
(b)(4) of this section, draw off water from the container as filled in 
paragraph (b)(4) of this section to the level of the food found in 
paragraph (b)(2) of this section, weigh the container with remaining 
water, and determine the weight of the remaining water by subtracting 
the weight of the container found in paragraph (b)(3) of this section.
    (6) Divide the weight of water found in paragraph (b)(5) of this 
section by the weight of water found in paragraph (b)(4) of this 
section, and multiply by 100. The result shall be considered to be the 
percent of the total capacity of the container occupied by the food.


In the case of a container with lid attached otherwise than by double 
seam, remove the lid and proceed as directed in paragraphs (b) (2) to 
(6) of this section, except that under paragraph (b)(4) of this section, 
fill the container to the level of the top thereof.



Sec. 130.14  General statements of substandard quality and substandard
fill of container.

    For the purposes of regulations promulgated under section 401 of the 
act:
    (a) The term general statement of substandard quality means the 
statement ``Below Standard in Quality Good Food--Not High Grade'' 
printed in two lines of Cheltenham bold condensed caps. The words 
``Below Standard in Quality'' constitute the first line, and the second 
immediately follows. If the

[[Page 472]]

quantity of the contents of the container is less than 1 pound, the type 
of the first line is 12-point, and of the second, 8-point. If such 
quantity is 1 pound or more, the type of the first line is 14-point, and 
of the second, 10-point. Such statement is enclosed within lines, not 
less than 6 points in width, forming a rectangle. Such statement, with 
enclosing lines, is on a strongly contrasting, uniform background, and 
is so placed as to be easily seen when the name of the food or any 
pictorial representation thereof is viewed, wherever such name or 
representation appears so conspicuously as to be easily seen under 
customary conditions of purchase.
    (b) The term general statement of substandard fill means the 
statement ``Below Standard in Fill'' printed in Cheltenham bold 
condensed caps. If the quantity of the contents of the container is less 
than 1 pound, the statement is in 12-point type; if such quantity is 1 
pound or more, the statement is in 14-point type. Such statement is 
enclosed within lines, not less than 6 points in width, forming a 
rectangle; but if the statement specified in paragraph (a) of this 
section is also used, both statements (one following the other) may be 
enclosed within the same rectangle. Such statement or statements, with 
enclosing lines, are on a strongly contrasting, uniform background, and 
are so placed as to be easily seen when the name of the food or any 
pictorial representation thereof is viewed, wherever such name or 
representation appears so conspicuously as to be easily seen under 
customary conditions of purchase.



Sec. 130.17  Temporary permits for interstate shipment of experimental
packs of food varying from the requirements of definitions and 
standards of identity.

    (a) The Food and Drug Administration recognizes that before 
petitions to amend food standards can be submitted, appropriate 
investigations of potential advances in food technology sometimes 
require tests in interstate markets of the advantages to and acceptance 
by consumers of experimental packs of food varying from applicable 
definitions and standards of identity prescribed under section 401 of 
the act.
    (b) It is the purpose of the Food and Drug Administration to permit 
such tests when it can be ascertained that the sole purpose of the tests 
is to obtain data necessary for reasonable grounds in support of a 
petition to amend food standards, that the tests are necessary to the 
completion or conclusiveness of an otherwise adequate investigation, and 
that the interests of consumers are adequately safeguarded; permits for 
such tests shall normally be for a period not to exceed 15 months. The 
Food and Drug Administration, or good cause shown by the applicant, may 
provide for a longer test market period. The Food and Drug 
Administration will therefore refrain from recommending regulatory 
proceedings under the act on the charge that a food does not conform to 
an applicable standard, if the person who introduces or causes the 
introduction of the food into interstate commerce holds an effective 
permit from the Food and Drug Administration providing specifically for 
those variations in respect to which the food fails to conform to the 
applicable definition and standard of identity. The test period will 
begin on the date the person holding an effective permit from the Food 
and Drug Administration introduces or causes the introduction of the 
food covered by the permit into interstate commerce but not later than 3 
months after notice of the issuance of the permit is published in the 
Federal Register. The Food and Drug Administration shall be notified in 
writing of the date on which the test period begins as soon as it is 
determined.
    (c) Any person desiring a permit may file with the Team Leader, 
Conventional Foods Team, Division of Standards and Labeling Regulations, 
Office of Nutritional Products, Labeling and Dietary Supplements, Center 
for Food Safety and Applied Nutrition (HFS-822), 5001 Campus Dr., 
College Park, MD 20740, a written application in triplicate containing 
as part thereof the following:
    (1) Name and address of the applicant.
    (2) A statement of whether or not the applicant is regularly engaged 
in producing the food involved.

[[Page 473]]

    (3) A reference to the applicable definition and standard of 
identity (citing applicable section of regulations).
    (4) A full description of the proposed variation from the standard.
    (5) The basis upon which the food so varying is believed to be 
wholesome and nondeleterious.
    (6) The amount of any new ingredient to be added; the amount of any 
ingredient, required by the standard, to be eliminated; any change of 
concentration not contemplated by the standard; or any change in name 
that would more appropriately describe the new product under test. If 
such new ingredient is not a commonly known food ingredient, a 
description of its properties and basis for concluding that it is not a 
deleterious substance.
    (7) The purpose of effecting the variation.
    (8) A statement of how the variation is of potential advantage to 
consumers. The statement shall include the reasons why the applicant 
does not consider the data obtained in any prior investigations which 
may have been conducted sufficient to support a petition to amend the 
standard.
    (9) The proposed label (or an accurate draft) to be used on the food 
to be market tested. The label shall conform in all respects to the 
general requirements of the act and shall provide a means whereby the 
consumer can distinguish between the food being tested and such food 
complying with the standard.
    (10) The period during which the applicant desires to introduce such 
food into interstate commerce, with a statement of the reasons 
supporting the need for such period. If a period longer than 15 months 
is requested, a detailed explanation of why a 15-month period is 
inadequate shall be provided.
    (11) The probable amount of such food that will be distributed. The 
amount distributed should be limited to the smallest number of units 
reasonably required for a bona fide market test. Justification for the 
amount requested shall be included.
    (12) The areas of distribution.
    (13) The address at which such food will be manufactured.
    (14) A statement of whether or not such food has been or is to be 
distributed in the State in which it was manufactured.
    (15) If it has not been or is not to be so distributed, a statement 
showing why.
    (16) If it has been or is to be so distributed, a statement of why 
it is deemed necessary to distribute such food in other States.
    (d) The Food and Drug Administration may require the applicant to 
furnish samples of the food varying from the standard and to furnish 
such additional information as may be deemed necessary for action on the 
application.
    (e) If the Food and Drug Administration concludes that the variation 
may be advantageous to consumers and will not result in failure of the 
food to conform to any provision of the act except section 403(g), a 
permit shall be issued to the applicant for interstate shipment of such 
food. The terms and conditions of the permit shall be those set forth in 
the application with such modifications, restrictions, or qualifications 
as the Food and Drug Administration may deem necessary and state in the 
permit.
    (f) The terms and conditions of the permit may be modified at the 
discretion of the Food and Drug Administration or upon application of 
the permittee during the effective period of the permit.
    (g) The Food and Drug Administration may revoke a permit for cause, 
which shall include but not be limited to the following:
    (1) That the permittee has introduced a food into interstate 
commerce contrary to the terms and conditions of the permit.
    (2) That the application for a permit contains an untrue statement 
of a material fact.
    (3) That the need therefor no longer exists.
    (h) During the period within which any permit is effective, it shall 
be deemed to be included within the terms of any guaranty or undertaking 
otherwise effective pursuant to the provisions of section 303(c) of the 
act.
    (i) If an application is made for an extension of the permit, it 
shall be accompanied by a description of experiments conducted under the 
permit,

[[Page 474]]

tentative conclusions reached, and reasons why further experimental 
shipments are considered necessary. The application for an extension 
shall be filed not later than 3 months prior to the expiration date of 
the permit and shall be accompanied by a petition to amend the affected 
food standard. If the Food and Drug Administration concludes that it 
will be in the interest of consumers to issue an extension of the time 
period for the market test, a notice will be published in the Federal 
Register stating that fact. The notice will include an invitation to all 
interested persons to participate in the market test under the same 
conditions that applied to the initial permit holder, including labeling 
and the amount to be distributed, except that the designated area of 
distribution shall not apply. The extended market test period shall not 
begin prior to the publication of a notice in the Federal Register 
granting the extension and shall terminate either on the effective date 
of an affirmative order ruling on the proposal or 30 days after a 
negative order ruling on the proposal, whichever the case may be. Any 
interested person who accepts the invitation to participate in the 
extended market test shall notify the Food and Drug Administration in 
writing of that fact, the amount to be distributed, and the area of 
distribution; and along with such notification, he shall submit the 
labeling under which the food is to be distributed.
    (j) Notice of the granting or revocation of any permit shall be 
published in the Federal Register.
    (k) All applications for a temporary permit, applications for an 
extension of a temporary permit, and related records are available for 
public disclosure when the notice of a permit or extension thereof is 
published in the Federal Register. Such disclosure shall be in 
accordance with the rules established in part 20 of this chapter.
    (l) Any person who contests denial, modification, or revocation of a 
temporary permit shall have an opportunity for a regulatory hearing 
before the Food and Drug Administration pursuant to part 16 of this 
chapter.

[42 FR 14357, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
46 FR 37500, July 21, 1981; 54 FR 24892, June 12, 1989; 59 FR 15051, 
Mar. 31, 1994; 66 FR 17359, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001]



             Subpart B_Food Additives in Standardized Foods



Sec. 130.20  Food additives proposed for use in foods for which
definitions and standards of identity are established.

    (a) Where a petition is received for the issuance or amendment of a 
regulation establishing a definition and standard of identity for a food 
under section 401 of the act, which proposes the inclusion of a food 
additive in such definition and standard of identity, the provisions of 
the regulations in part 171 of this chapter shall apply with respect to 
the information that must be submitted with respect to the food 
additive. Since section 409(b)(5) of the act requires that the 
Commissioner publish notice of a petition for the establishment of a 
food additive regulation within 30 days after filing, notice of a 
petition relating to a definition and standard of identity shall also be 
published within that time limitation if it includes a request, so 
designated, for the establishment of a regulation pertaining to a food 
additive.
    (b) If a petition for a definition and standard of identity contains 
a proposal for a food additive regulation, and the petitioner fails to 
designate it as such, the Commissioner, upon determining that the 
petition includes a proposal for a food additive regulation, shall so 
notify the petitioner and shall thereafter proceed in accordance with 
the regulations in part 171 of this chapter.



PART 131_MILK AND CREAM--Table of Contents



                      Subpart A_General Provisions

Sec.
131.3 Definitions.
131.25 Whipped cream products containing flavoring or sweetening.

[[Page 475]]

     Subpart B_Requirements for Specific Standardized Milk and Cream

131.110 Milk.
131.111 Acidified milk.
131.112 Cultured milk.
131.115 Concentrated milk.
131.120 Sweetened condensed milk.
131.125 Nonfat dry milk.
131.127 Nonfat dry milk fortified with vitamins A and D.
131.130 Evaporated milk.
131.147 Dry whole milk.
131.149 Dry cream.
131.150 Heavy cream.
131.155 Light cream.
131.157 Light whipping cream.
131.160 Sour cream.
131.162 Acidified sour cream.
131.170 Eggnog.
131.180 Half-and-half.
131.200 Yogurt.
131.203 Lowfat yogurt.
131.206 Nonfat yogurt.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14360, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 131 appear at 63 FR 
14035, Mar. 24, 1998.



                      Subpart A_General Provisions



Sec. 131.3  Definitions.

    (a) Cream means the liquid milk product high in fat separated from 
milk, which may have been adjusted by adding thereto: Milk, concentrated 
milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry 
milk. Cream contains not less than 18 percent milkfat.
    (b) Pasteurized when used to describe a dairy product means that 
every particle of such product shall have been heated in properly 
operated equipment to one of the temperatures specified in the table of 
this paragraph and held continuously at or above that temperature for 
the specified time (or other time/temperature relationship which has 
been demonstrated to be equivalent thereto in microbial destruction):

------------------------------------------------------------------------
               Temperature                              Time
------------------------------------------------------------------------
145 [deg]F \1\...........................  30 minutes
161 [deg]F \1\...........................  15 seconds
191 [deg]F...............................  1 second
204 [deg]F...............................  0.05 second
212 [deg]F...............................  0.01 second
------------------------------------------------------------------------
\1\ If the dairy ingredient has a fat content of 10 percent or more, or
  if it contains added sweeteners, the specified temperature shall be
  increased by 5 [deg]F.

    (c) Ultra-pasteurized when used to describe a dairy product means 
that such product shall have been thermally processed at or above 280 
[deg]F for at least 2 seconds, either before or after packaging, so as 
to produce a product which has an extended shelf life under refrigerated 
conditions.



Sec. 131.25  Whipped cream products containing flavoring or sweetening.

    The unqualified name ``whipped cream'' should not be applied to any 
product other than one made by whipping the cream that complies with the 
standards of identity for whipping cream (Sec. Sec. 131.150 and 131.157 
of this chapter). If flavoring and/or sweetening is added, the resulting 
product is a flavored and/or sweetened whipped cream, and should be so 
identified.



     Subpart B_Requirements for Specific Standardized Milk and Cream



Sec. 131.110  Milk.

    (a) Description. Milk is the lacteal secretion, practically free 
from colostrum, obtained by the complete milking of one or more healthy 
cows. Milk that is in final package form for beverage use shall have 
been pasteurized or ultrapasteurized, and shall contain not less than 
8\1/4\ percent milk solids not fat and not less than 3\1/4\ percent 
milkfat. Milk may have been adjusted by separating part of the milkfat 
therefrom, or by adding thereto cream, concentrated milk, dry whole 
milk, skim milk, concentrated skim milk, or nonfat dry milk. Milk may be 
homogenized.
    (b) Vitamin addition (Optional). (1) If added, vitamin A shall be 
present in such quantity that each quart of the food contains not less 
than 2000 International Units thereof within limits of good 
manufacturing practice.
    (2) If added, vitamin D shall be present in such quantity that each

[[Page 476]]

quart of the food contains 400 International Units thereof within limits 
of good manufacturing practice.
    (c) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Carriers for vitamins A and D.
    (2) Characterizing flavoring ingredients (with or without coloring, 
nutritive sweetener, emulsifiers, and stabilizers) as follows:
    (i) Fruit and fruit juice (including concentrated fruit and fruit 
juice).
    (ii) Natural and artificial food flavorings.
    (d) Methods of analysis. Referenced methods are from ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), which is incorporated by reference. Copies 
may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877, or may be examined 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.
    (1) Milkfat content--``Fat, Roese-Gottlieb Method--Official Final 
Action,'' section 16.059.
    (2) Milk solids not fat content--Calculated by subtracting the milk 
fat content from the total solids content as determined by the method 
``Total Solids, Method I--Official Final Action,'' section 16.032.
    (3) Vitamin D content--``Vitamin D--Official Final Action,'' 
sections 43.195-43.208.
    (e) Nomenclature. The name of the food is ``milk''. The name of the 
food shall be accompanied on the label by a declaration indicating the 
presence of any characterizing flavoring, as specified in Sec. 101.22 
of this chapter.
    (1) The following terms shall accompany the name of the food 
wherever it appears on the principal display panel or panels of the 
label in letters not less than one-half the height of the letters used 
in such name:
    (i) If vitamins are added, the phrase ``vitamin A'' or ``vitamin A 
added'', or ``vitamin D'' or ``vitamin D added'', or ``vitamin A and D'' 
or ``vitamins A and D added'', as is appropriate. The word ``vitamin'' 
may be abbreviated ``vit.''.
    (ii) The word ``ultra-pasteurized'' if the food has been ultra-
pasteurized.
    (2) The following terms may appear on the label:
    (i) The word ``pasteurized'' if the food has been pasteurized.
    (ii) The word ``homogenized'' if the food has been homogenized.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982; 
49 FR 10090, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 
6, 1993]



Sec. 131.111  Acidified milk.

    (a) Description. Acidified milk is the food produced by souring one 
or more of the optional dairy ingredients specified in pargaph (c) of 
this section with one or more of the acidifying ingredients specified in 
paragraph (d) of this section, with or without the addition of 
characterizing microbial organisms. One or more of the other optional 
ingredients specified in paragraphs (b) and (e) of this section may also 
be added. When one or more of the ingredients specified in paragraph 
(e)(1) of this section are used, they shall be included in the souring 
process. All ingredients used are safe and suitable. Acidified milk 
contains not less than 3.25 percent milkfat and not less than 8.25 
percent milk solids not fat and has a titratable acidity of not less 
than 0.5 percent, expressed as lactic acid. The food may be homogenized 
and shall be pasteurized or ultra-pasteurized prior to the addition of 
the microbial culture and, when applicable, the addition of flakes or 
granules of butterfat or milkfat.
    (b) Vitamin addition (optional). (1) If added, vitamin A shall be 
present in such quantity that each 946 milliliters (quart) of the food 
contains not less than 2,000 International Units thereof, within limits 
of good manufacturing practice.
    (2) If added, vitamin D shall be present in such quantity that each 
946 milliliters (quart) of the food contains

[[Page 477]]

400 International Units thereof, within limits of good manufacturing 
practice.
    (c) Optional dairy ingredients. Cream, milk, partially skimmed milk, 
or skim milk, used alone or in combination.
    (d) Optional acidifying ingredients. Acetic acid, adipic acid, 
citric acid, fumaric acid, glucono-delta- lactone, hydrochloric acid, 
lactic acid, malic acid, phosphoric acid, succinic acid, and tartaric 
acid.
    (e) Other optional ingredients. (1) Concentrated skim milk, nonfat 
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or 
whey modified by partial or complete removal of lactose and/or minerals, 
to increase the nonfat solids content of the food: Provided, That the 
ratio of protein to total nonfat solids of the food, and the protein 
efficiency ratio of all protein present, shall not be decreased as a 
result of adding such ingredients.
    (2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or 
cane; invert sugar (in paste or sirup form); brown sugar; refiner's 
sirup; molasses (other than blackstrap); high fructose corn sirup; 
fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup; 
malt extract, dried malt extract; malt sirup, dried malt sirup; honey; 
maple sugar; or any of the sweeteners listed in part 168 of this 
chapter, except table sirup.
    (3) Flavoring ingredients.
    (4) Color additives that do not impart a color simulalting that of 
milkfat or butterfat.
    (5) Stabilizers.
    (6) Butterfat or milkfat, which may or may not contain color 
additives, in the form of flakes or granules.
    (7) Aroma- and flavor-producing microbial culture.
    (8) Salt.
    (9) Citric acid, in a maximum amount of 0.15 percent by weight of 
the milk used, or an equivalent amount of sodium citrate, as a flavor 
precursor.
    (f) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies are available from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or 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.
    (1) Milkfat content--As determined by the method prescribed in 
section 16.059, ``Roese-Gottlieb Method (Reference Method) (11)--
Official Final Action,'' under the heading ``Fat.''
    (2) Milk solids not fat content--Calculated by subtracting the 
milkfat content from the total solids content as determined by the 
method prescribed in section 16.032, ``Method I--Official Final 
Action,'' under the heading ``Total Solids.''
    (3) Titratable acidity--As determined by the method prescribed in 
section 16.023, ``Acidity (2)--Official Final Action,'' or by an 
equivalent potentiometric method.
    (g) Nomenclature. The name of the food is ``acidified milk''. The 
full name of the food shall appear on the principal display panel of the 
label in type of uniform size, style, and color. The name of the food 
shall be accompanied by a declaration indicating the presence of any 
characterizing flavoring as specified in Sec. 101.22 of this chapter, 
and may be accompanied by a declaration such as a traditional name of 
the food or the generic name of the organisms used, thereby indicating 
the presence of the characterizing microbial organisms or ingredients 
when used, e.g., ``acidified kefir milk'', ``acidified acidophilus 
milk'', or when characterizing ingredients such as those in paragraphs 
(e) (6), (7), (8), and (9) of this section are used, the food may be 
named ``acidified buttermilk''.
    (1) The following terms shall accompany the name of the food 
wherever it appears on the principal display panel or panels of the 
label in letters not less than one-half of the height of the letters 
used in such name:
    (i) The phrase ``vitamin A'' or ``vitamin A added'', or ``vitamin 
D'' or ``vitamin D added'', or ``vitamins A and D added'', as 
appropriate. The word ``vitamin'' may be abbreviated ``vit.''.
    (ii) The word ``sweetened'' if nutritive carbohydrate sweetener is 
added

[[Page 478]]

without the addition of characterizing flavoring.
    (2) The term ``homogenized'' may appear on the label if the dairy 
ingredients used are homogenized.
    (h) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[46 FR 9934, Jan. 30, 1981, as amended at 47 FR 11822, Mar. 19, 1982; 47 
FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24892, June 
12, 1989; 58 FR 2890, Jan. 6, 1993]



Sec. 131.112  Cultured milk.

    (a) Description. Cultured milk is the food produced by culturing one 
or more of the optional dairy ingredients specified in paragraph (c) of 
this section with characterizing microbial organisms. One or more of the 
other optional ingredients specified in paragraphs (b) and (d) of this 
section may also be added. When one or more of the ingredients specified 
in paragraph (d)(1) of this section are used, they shall be included in 
the culturing process. All ingredients used are safe and suitable. 
Cultured milk contains not less than 3.25 percent milkfat and not less 
than 8.25 percent milk solids not fat and has a titratable acidity of 
not less than 0.5 percent, expressed as lactic acid. The food may be 
homogenized and shall be pasteurized or ultra-pasteurized prior to the 
addition to the microbial culture, and when applicable, the addition of 
flakes or granules of butterfat or milkfat.
    (b) Vitamin addition (optional). (1) If added, vitamin A shall be 
present in such quantity that each 946 milliliters (quart) of the food 
contains not less than 2,000 International Units thereof, within limits 
of good manufacturing practice.
    (2) If added, vitamin D shall be present in such quantity that each 
946 milliliters (quart) of the food contains 400 International Units 
thereof, within limits of good manufacturing practice.
    (c) Optional dairy ingredients. Cream, milk, partially skimmed milk, 
or skim milk, used alone or in combination.
    (d) Other optional ingredients. (1) Concentrated skim milk, nonfat 
dry milk, buttermilk, whey, lactose, lact al bum ins, lactoglobulins, or 
whey modified by partial or complete removal of lactose and/or minerals, 
to increase the nonfat solids content of the food: Provided, That the 
ratio of protein to total nonfat solids of the food, and the protein 
efficiency ratio of all protein present, shall not be decreased as a 
result of adding such ingredients.
    (2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or 
cane; invert sugar (in paste or sirup form); brown sugar; refiner's 
sirup; molasses (other than blackstrap); high fructose corn sirup; 
fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup; 
malt extract, dried malt extract; malt sirup, dried malt sirup; honey; 
maple sugar; or any of the sweeteners listed in part 168 of this 
chapter, except table sirup.
    (3) Flavoring ingredients.
    (4) Color additives that do not impart a color simulating that of 
milkfat or butterfat.
    (5) Stabilizers.
    (6) Butterfat or milkfat, which may or may not contain color 
additives, in the form of flakes or granules.
    (7) Aroma- and flavor-producing microbial culture.
    (8) Salt.
    (9) Citric acid, in a maximum amount of 0.15 percent by weight of 
the milk used, or an equivalent amount of sodium citrate, as a flavor 
precursor.
    (e) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or 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.
    (1) Milkfat content--section 16.059, ``Roese-Gottlieb Method 
(Reference Method) (11)--Official Final Action,'' under the heading 
``Fat.''
    (2) Milk solids not fat content--Calculated by subtracting the 
milkfat content from the total solids content as

[[Page 479]]

determined by the method prescribed in section 16.032, ``Method I--
Official Final Action,'' under the heading ``Total Solids.''
    (3) Titratable acidity--As determined by the methods prescribed in 
section 16.023 ``Acidity (2)--Official Final Action,'' or by an 
equivalent potentiometric method.
    (f) Nomenclature. The name of the food is ``cultured milk''. The 
full name of the food shall appear on the principal display panel in 
type of uniform size, style, and color. The name of the food shall be 
accompanied by a declaration indicating the presence of any 
characterizing flavoring as specified in Sec. 101.22 of this chapter, 
and may be accompanied by a declaration such as a traditional name of 
the food or the generic name of the organisms used, thereby indicating 
the presence of the characterizing microbial organisms or ingredients, 
e.g., ``kefir cultured milk'', ``acidophilus cultured milk'', or when 
characterizing ingredients such as those in paragraphs (d) (6), (7), 
(8), and (9) of this section, and lactic acid-producing organisms are 
used the food may be named ``cultured buttermilk''.
    (1) The following terms shall accompany the name of the food 
wherever it appears on the principal display panel or panels of the 
label in letters not less than one-half of the height of the letters 
used in such name:
    (i) The phrase ``vitamin A'' or ``vitamin A added'', or ``vitamin 
D'' or ``vitamin D added'', or ``vitamin A and D added'', as 
appropriate. The word ``vitamin'' may be abbreviated ``vit.''.
    (ii) The word ``sweetened'' if nutritive carbohydrate sweetener is 
added without the addition of characterizing flavoring.
    (2) The term ``homogenized'' may appear on the label if the dairy 
ingredients used are homogenized.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[46 FR 9934, Jan. 30, 1981, as amended at 47 FR 11822, Mar. 19, 1982; 47 
FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24892, June 
12, 1989; 58 FR 2890, Jan. 6, 1993]



Sec. 131.115  Concentrated milk.

    (a) Description. Concentrated milk is the liquid food obtained by 
partial removal of water from milk. The milkfat and total milk solids 
contents of the food are not less than 7.5 and 25.5 percent, 
respectively. It is pasteurized, but is not processed by heat so as to 
prevent spoilage. It may be homogenized.
    (b) Vitamin addition (Optional). If added, vitamin D shall be 
present in such quantity that each fluid ounce of the food contains 25 
International Units thereof, within limits of good manufacturing 
practice.
    (c) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (1) Carrier for vitamin D.
    (2) Characterizing flavoring ingredients, with or without coloring, 
as follows:
    (i) Fruit and fruit juice, including concentrated fruit and fruit 
juice.
    (ii) Natural and artificial food flavoring.
    (d) Methods of analysis. Referenced methods are from ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), which is incorporated by reference. Copies 
may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877, or may be examined 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.
    (1) Milkfat content--``Fat--Official Final Action,'' section 16.172.
    (2) Total milk solids--``Total Solids--Official Final Action,'' 
section 16.169.
    (3) Vitamin D content--``Vitamin D in Milk--Official Final Action,'' 
sections 43.195-43.208.
    (e) Nomenclature. The name of the food is ``Concentrated milk'' or 
alternatively ``Condensed milk''. If the food contains added vitamin D, 
the phrase ``vitamin D'' or ``vitamin D added'' shall accompany the name 
of the food wherever it appears on the principal display panel or panels 
of the label in letters not less than one-half the

[[Page 480]]

height of the letters used in such name. The word ``homogenized'' may 
appear on the label if the food has been homogenized. The name of the 
food shall include a declaration of the presence of any characterizing 
flavoring, as specified in Sec. 101.22 of this chapter.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982; 
48 FR 13024, Mar. 29, 1983; 49 FR 10090, Mar. 19, 1984; 54 FR 24892, 
June 12, 1989; 58 FR 2890, Jan. 6, 1993]



Sec. 131.120  Sweetened condensed milk.

    (a) Description. Sweetened condensed milk is the food obtained by 
partial removal of water only from a mixture of milk and safe and 
suitable nutritive carbohydrate sweeteners. The finished food contains 
not less than 8 percent by weight of milkfat, and not less than 28 
percent by weight of total milk solids. The quantity of nutritive 
carbohydrate sweetener used is sufficient to prevent spoilage. The food 
is pasteurized and may be homogenized.
    (b) Optional ingredients. The following safe and suitable 
characterizing flavoring ingredients, with or without coloring and 
nutritive carbohydrate sweeteners, may be used:
    (1) Fruit and fruit juice, including concentrated fruit and fruit 
juice.
    (2) Natural and artificial food flavoring.
    (c) Methods of analysis. The milkfat content is determined by the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980), section 16.185, 
under ``Fat--Official Final Action,'' which is incorporated by 
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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.
    (d) Nomenclature. The name of the food is ``Sweetened condensed 
milk.'' The word ``homogenized'' may appear on the label if the food has 
been homogenized. The name of the food shall include a declaration of 
the presence of any characterizing flavoring, as specified in Sec. 
101.22 of this chapter.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[43 FR 21670, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982; 49 
FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 
1993]



Sec. 131.125  Nonfat dry milk.

    (a) Description. Nonfat dry milk is the product obtained by removal 
of water only from pasteurized skim milk. It contains not more than 5 
percent by weight of moisture, and not more than 1\1/2\ percent by 
weight of milkfat unless otherwise indicated.
    (b) Optional ingredients. Safe and suitable characterizing flavoring 
ingredients (with or without coloring and nutritive carbohydrate 
sweetener) as follows:
    (1) Fruit and fruit juice, including concentrated fruit and fruit 
juice.
    (2) Natural and artificial food flavorings.
    (c) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
examined 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.
    (1) Milkfat content--``Fat in Dried Milk--Official Final Action,'' 
sections 16.199-16.200.
    (2) Moisture content--``Moisture--Official Final Action,'' section 
16.192.
    (d) Nomenclature. The name of the food is ``Nonfat dry milk''. If 
the fat

[[Page 481]]

content is over 1\1/2\ percent by weight, the name of the food on the 
principal display panel or panels shall be accompanied by the statement 
``Contains _% milkfat'', the blank to be filled in with the percentage 
to the nearest one-tenth of 1 percent of fat contained, within limits of 
good manufacturing practice. The name of the food shall include a 
declaration of the presence of any characterizing flavoring, as 
specified in Sec. 101.22 of this chapter.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 43 FR 19836, May 9, 1978; 47 
FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 
12, 1989; 58 FR 2890, Jan. 6, 1993]



Sec. 131.127  Nonfat dry milk fortified with vitamins A and D.

    (a) Description. Nonfat dry milk fortified with vitamins A and D 
conforms to the standard of identity for nonfat dry milk, except that 
vitamins A and D are added as prescribed by paragraph (b) of this 
section.
    (b) Vitamin addition. (1) Vitamin A is added in such quantity that, 
when prepared according to label directions, each quart of the 
reconstituted product contains 2000 International Units thereof.
    (2) Vitamin D is added in such quantity that, when prepared 
according to label directions, each quart of the reconstituted product 
contains 400 International Units thereof.
    (3) The requirements of this paragraph will be deemed to have been 
met if reasonable overages, within limits of good manufacturing 
practice, are present to ensure that the required levels of vitamins are 
maintained throughout the expected shelf life of the food under 
customary conditions of distribution.
    (c) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (1) Carriers for vitamins A and D.
    (2) Characterizing flavoring ingredients, with or without coloring 
and nutritive carbohydrate sweetener, as follows:
    (i) Fruit and fruit juice, including concentrated fruit and fruit 
juice.
    (ii) Natural and artificial food flavorings.
    (d) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
examined 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.
    (1) Milkfat content--``Fat in Dried Milk--Official Final Action,'' 
sections 16.199-16.200.
    (2) Moisture content--``Moisture--Official Final Action,'' section 
16.192.
    (3) Vitamin D content--``Vitamin D--Official Final Action,'' 
sections 43.195-43.208.
    (e) Nomenclature. The name of the food is ``Nonfat dry milk 
fortified with vitamins A and D''. If the fat content is over 1\1/2\ 
percent by weight, the name of the food on the principal display panel 
or panels shall be accompanied by the statement ``Contains _% milkfat'', 
the blank to be filled in to the nearest one-tenth of 1 percent with the 
percentage of fat contained within limits of good manufacturing 
practice. The name of the food shall include a declaration of the 
presence of any characterizing flavoring, as specified in Sec. 101.22 
of this chapter.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 43 FR 19836, May 9, 1978; 43 
FR 29769, July 11, 1978; 43 FR 36622, Aug. 18, 1978; 47 FR 11823, Mar. 
19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 
2890, Jan. 6, 1993]

[[Page 482]]



Sec. 131.130  Evaporated milk.

    (a) Description. Evaporated milk is the liquid food obtained by 
partial removal of water only from milk. It contains not less than 6.5 
percent by weight of milkfat, not less than 16.5 percent by weight of 
milk solids not fat, and not less than 23 percent by weight of total 
milk solids. Evaporated milk contains added vitamin D as prescribed by 
paragraph (b) of this section. It is homogenized. It is sealed in a 
container and so processed by heat, either before or after sealing, as 
to prevent spoilage.
    (b) Vitamin addition. (1) Vitamin D shall be present in such 
quantity that each fluid ounce of the food contains 25 International 
Units thereof within limits of good manufacturing practice.
    (2) Addition of vitamin A is optional, If added, vitamin A shall be 
present in such quantity that each fluid ounce of the food contains not 
less than 125 International Units thereof within limits of good 
maufacturing practice.
    (c) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Carriers for vitamins A and D.
    (2) Emulsifiers.
    (3) Stabilizers, with or without dioctyl sodium sulfosuccinate (when 
permitted by and complying with the provisions of Sec. 172.810 of this 
chapter) as a solubilizing agent.
    (4) Characterizing flavoring ingredients, with or without coloring 
and nutritive carbohydrate sweeteners, as follows:
    (i) Fruit and fruit juice, including concentrated fruit and fruit 
juice.
    (ii) Natural and artificial food flavoring.
    (d) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
examined 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.
    (1) Milkfat content--``Fat--Official Final Action,'' section 16.172.
    (2) Total milk solids--``Total Solids--Official Final Action,'' 
section 16.169.
    (3) Vitamin D content--``Vitamin D in Milk--Official Final Action,'' 
sections 43.195-43.208.
    (e) Nomenclature. The name of the food is ``Evaporated milk.'' The 
phrase ``vitamin D'' or ``vitamin D added'', or ``vitamins A and D'' or 
``vitamins A and D added'', as is appropriate, shall immediately precede 
or follow the name of the food wherever it appears on the principal 
display panel or panels of the label in letters not less than one-half 
the height of the letters used in such name. The name of the food shall 
include a declaration of a the presence of any characterizing flavoring, 
as specified in Sec. 101.22 of this chapter.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[43 FR 21670, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982; 49 
FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 
1993; 59 FR 17691, Apr. 14, 1994]



Sec. 131.147  Dry whole milk.

    (a) Description. Dry whole milk is the product obtained by removal 
of water only from pasteurized milk, as defined in Sec. 131.110(a), 
which may have been homogenized. Alternatively, dry whole milk may be 
obtained by blending fluid, condensed, or dried nonfat milk with liquid 
or dried cream or with fluid, condensed, or dried milk, as appropriate, 
provided the resulting dry whole milk is equivalent in composition to 
that obtained by the method described in the first sentence of this 
paragraph. It contains the lactose, milk proteins, milkfat, and milk 
minerals in the same relative proportions as the milk from which it was 
made. It contains not less than 26 percent but less than 40 percent by 
weight of milkfat on an as is basis. It contains not more than 5 percent 
by weight of moisture on a milk solids not fat basis.
    (b) Vitamin addition. (1) Addition of vitamin A is optional. If 
added, vitamin A shall be present in such quantity

[[Page 483]]

that, when prepared according to label directions, each quart of the 
reconstituted product shall contain not less than 2,000 International 
Units thereof.
    (2) Addition of vitamin D is optional. If added, vitamin D shall be 
present in such quantity that, when prepared according to label 
directions, each quart of the reconstituted product shall contain 400 
International Units thereof.
    (3) The requirements of this paragraph will be met if reasonable 
overages, within limits of good manufacturing practice, are present to 
ensure that the required levels of vitamins are maintained throughout 
the expected shelf life of the food under customary conditions of 
distribution.
    (c) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (1) Carriers for vitamins A and D.
    (2) Emulsifiers.
    (3) Stabilizers.
    (4) Anticaking agents.
    (5) Antioxidants.
    (6) Characterizing flavoring ingredients (with or without coloring 
and nutritive carbohydrate sweetener) as follows:
    (i) Fruit and fruit juice, including concentrated fruit and fruit 
juice.
    (ii) Natural and artificial food flavoring.
    (d) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
examined 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.
    (1) Milkfat content--``Fat in Dried Milk--Official Final Action,'' 
sections 16.199-16.200.
    (2) Moisture content--``Moisture--Official Final Action,'' section 
16.192.
    (3) Vitamin D content--``Vitamin D--Official Final Action,'' 
sections 43.195-43.208.
    (e) Nomenclature. The name of the food is ``Dry whole milk.'' The 
name of the food shall appear on the principal display panel of the 
label in type of uniform size, style, and color. The name of the food 
shall be accompanied by a declaration indicating the presence of any 
characterizing flavoring as specified in Sec. 101.22 of this chapter. 
The following phrases in type size not less than one-half the height of 
the type size used in such name shall accompany the name of the food 
wherever it appears on the principal display panel or panels.
    (1) The phrase ``Contains _% milkfat'', the blank to be filled in 
with the whole number closest to the actual fat content of the food.
    (2) If vitamins are ``added'', the phrase ``vitamin A'', or 
``vitamin A added'', or ``vitamin D'', or ``vitamin D added'', or 
``vitamins A and D'', or ``vitamins A and D added'', as appropriate. The 
word ``vitamin'' may be abbreviated ``vit.''
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[43 FR 19836, May 9, 1978, as amended at 47 FR 11824, Mar. 19, 1982; 49 
FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 
1993]



Sec. 131.149  Dry cream.

    (a) Description. Dry cream is the product obtained by removal of 
water only from pasteurized milk or cream or a mixture thereof, which 
may have been homogenized. Alternatively, dry cream may be obtained by 
blending dry milks as defined in Sec. Sec. 131.125(a) and 131.147(a) 
with dry cream as appropriate: Provided, That the resulting product is 
equivalent in composition to that obtained by the method described in 
the first sentence of this paragraph. It contains not less than 40 
percent but less than 75 percent by weight of milkfat on an as is basis. 
It contains not more than 5 percent by weight of moisture on a milk 
solids not fat basis.
    (b) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (1) Emulsifiers.
    (2) Stabilizers.

[[Page 484]]

    (3) Anticaking agents.
    (4) Antioxidants.
    (5) Nutritive carbohydrate sweeteners.
    (6) Characterizing flavoring ingredients, with or without coloring, 
as follows:
    (i) Fruit and fruit juice, including concentrated fruit and fruit 
juice.
    (ii) Natural and artificial food flavoring.
    (c) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
examined 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.
    (1) Milkfat content--``Fat in Dried Milk--Official Final Action,'' 
sections 16.199-16.200.
    (2) Moisture content--``Moisture--Official Final Action,'' section 
16.192.
    (d) Nomenclature. The name of the food is ``Dry cream.'' The name of 
the food shall appear on the principal display panel of the label in 
type of uniform size, style, and color. The name of the food shall be 
accompanied by a declaration indicating the presence of any 
characterizing flavoring as specified in Sec. 101.22 of this chapter. 
The following terms shall accompany the name of the food wherever it 
appears on the principal display panel or panels of the label, in 
letters not less than one-half of the height of the letters used in such 
name:
    (1) The phrase ``Contains _% milkfat'', the blank to be filled in 
with the whole number closest to the actual fat content of the food.
    (2) The word ``sweetened'' if no characterizing flavoring 
ingredients are used but nutritive carbohydrate sweetener is added.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[43 FR 19836, May 9, 1978, as amended at 44 FR 3965, Jan. 19, 1979; 47 
FR 11824, Mar. 19, 1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10092, Mar. 
19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993; 61 FR 
59002, Nov. 20, 1996]



Sec. 131.150  Heavy cream.

    (a) Description. Heavy cream is cream which contains not less than 
36 percent milkfat. It is pasteurized or ultra-pasteurized, and may be 
homogenized.
    (b) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (1) Emulsifiers.
    (2) Stabilizers.
    (3) Nutritive sweeteners.
    (4) Characterizing flavoring ingredients (with or without coloring) 
as follows:
    (i) Fruit and fruit juice (including concentrated fruit and fruit 
juice).
    (ii) Natural and artificial food flavoring.
    (c) Methods of analysis. The milkfat content is determined by the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980), sections 16.156 and 
16.059, under ``Fat, Roese-Gottlieb Method--Official Final Action,'' 
which is incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (d) Nomenclature. (1) The name of the food is ``Heavy cream'' or 
alternatively ``Heavy whipping cream''. The name of the food shall be 
accompanied on the label by a declaration indicating the presence of any 
characterizing flavoring, as specified in Sec. 101.22 of this chapter. 
The following terms shall accompany the name of the food wherever it 
appears on the principal display panel or panels of the label in letters 
not less than one-half the height of the letters used in such name:

[[Page 485]]

    (i) The word ``ultra-pasteurized'' if the food has been ultra-
pasteurized.
    (ii) The word ``sweetened'' if no characterizing flavoring 
ingredients are used, but nutritive sweetener is added.
    (2) The following terms may appear on the label:
    (i) The word ``pasteurized'' if the food has been pasteurized.
    (ii) The word ``homogenized'' if the food has been homogenized.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982; 
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 
6, 1993]



Sec. 131.155  Light cream.

    (a) Description. Light cream is cream which contains not less than 
18 percent but less than 30 percent milkfat. It is pasteurized or ultra-
pasteurized, and may be homogenized.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Stabilizers.
    (2) Emulsifiers.
    (3) Nutritive sweeteners.
    (4) Characterizing flavoring ingredients (with or without coloring) 
as follows:
    (i) Fruit and fruit juice (including concentrated fruit and fruit 
juice).
    (ii) Natural and artificial food flavoring.
    (c) Methods of analysis. The milkfat content is determined by the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980), sections 16.156 and 
16.059, under ``Fat, Roese-Gottlieb Method--Official Final Action,'' 
which is incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (d) Nomenclature. The name of the food is ``Light cream'', or 
alternatively ``Coffee cream'' or ``Table cream''. The name of the food 
shall be accompanied on the label by a declaration indicating the 
presence of any characterizing flavoring, as specified in Sec. 101.22 
of this chapter.
    (1) The following terms shall accompany the name of the food 
wherever it appears on the principal display panel or panels of the 
label in letters not less than one-half the height of the letters used 
in such name:
    (i) The word ``ultra-pasteurized'' if the food has been ultra-
pasteurized.
    (ii) The word ``sweetened'' if no characterizing flavoring 
ingredients are used, but nutritive sweetener is added.
    (2) The following terms may appear on the label:
    (i) The word ``pasteurized'' if the food has been pasteurized.
    (ii) The word ``homogenized'' if the food has been homogenized.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982; 
49 FR 10092, Mar. 1, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 
6, 1993]



Sec. 131.157  Light whipping cream.

    (a) Description. Light whipping cream is cream which contains not 
less than 30 percent but less than 36 percent milkfat. It is pasteurized 
or ultra-pasteurized, and may be homogenized.
    (b) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (1) Emulsifiers.
    (2) Stabilizers.
    (3) Nutritive sweeteners.
    (4) Characterizing flavoring ingredients (with or without coloring) 
as follows:
    (i) Fruit and fruit juice (including concentrated fruit and fruit 
juice).
    (ii) Natural and artificial food flavoring.
    (c) Methods of analysis. The milkfat content is determined by the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980),

[[Page 486]]

sections 16.156 and 16.059, under ``Fat, Roese-Gottlieb Method--Official 
Final Action,'' which is incorporated by reference. Copies may be 
obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined 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.
    (d) Nomenclature. The name of the food is ``Light whipping cream'' 
or alternatively ``Whipping cream''. The name of the food shall be 
accompanied on the label by a declaration indicating the presence of any 
characterizing flavoring, as specified in Sec. 101.22 of this chapter.
    (1) The following terms shall accompany the name of the food 
wherever it appears on the principal display panel or panels of the 
label in letters not less than one-half the height of the letters used 
in such name:
    (i) The word ``ultra-pasteurized'' if the food has been ultra-
pasteurized.
    (ii) The word ``sweetened'' if no characterizing flavoring 
ingredients are used, but nutritive sweetener is added.
    (2) The following terms may appear on the label:
    (i) The word ``pasteurized'' if the food has been pasteurized.
    (ii) The word ``homogenized'' if the food has been homogenized.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982; 
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 
6, 1993]



Sec. 131.160  Sour cream.

    (a) Description. Sour cream results from the souring, by lactic acid 
producing bacteria, of pasteurized cream. Sour cream contains not less 
than 18 percent milkfat; except that when the food is characterized by 
the addition of nutritive sweeteners or bulky flavoring ingredients, the 
weight of the milkfat is not less than 18 percent of the remainder 
obtained by subtracting the weight of such optional ingredients from the 
weight of the food; but in no case does the food contain less than 14.4 
percent milkfat. Sour cream has a titratable acidity of not less than 
0.5 percent, calculated as lactic acid.
    (b) Optional ingredients. (1) Safe and suitable ingredients that 
improve texture, prevent syneresis, or extend the shelf life of the 
product.
    (2) Sodium citrate in an amount not more than 0.1 percent may be 
added prior to culturing as a flavor precursor.
    (3) Rennet.
    (4) Safe and suitable nutritive sweeteners.
    (5) Salt.
    (6) Flavoring ingredients, with or without safe and suitable 
coloring, as follows:
    (i) Fruit and fruit juice (including concentrated fruit and fruit 
juice).
    (ii) Safe and suitable natural and artificial food flavoring.
    (c) Methods of analysis. Referenced methods in paragraph (c) (1) and 
(2) of this section are from ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (1) Milkfat content--``Fat--Official Final Action,'' section 16.172.
    (2) Titratable acidity--``Acidity--Official Final Action,'' section 
16.023.
    (d) Nomenclature. The name of the food is ``Sour cream'' or 
alternatively ``Cultured sour cream''. The full name of the food shall 
appear on the principal display panel of the label in type of uniform 
size, style, and color. The name of the food shall be accompanied by a 
declaration indicating the presence of any flavoring that characterizes 
the product, as specified in Sec. 101.22 of this chapter. If nutritive 
sweetener in an amount sufficient to characterize the food is added 
without addition of

[[Page 487]]

characterizing flavoring, the name of the food shall be preceded by the 
word ``sweetened''.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982; 
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 
6, 1993]



Sec. 131.162  Acidified sour cream.

    (a) Description. Acidified sour cream results from the souring of 
pasteurized cream with safe and suitable acidifiers, with or without 
addition of lactic acid producing bacteria. Acidified sour cream 
contains not less than 18 percent milkfat; except that when the food is 
characterized by the addition of nutritive sweeteners or bulky flavoring 
ingredients, the weight of milkfat is not less than 18 percent of the 
remainder obtained by subtracting the weight of such optional 
ingredients from the weight of the food; but in no case does the food 
contain less than 14.4 percent milkfat. Acidified sour cream has a 
titratable acidity of not less than 0.5 percent, calculated as lactic 
acid.
    (b) Optional ingredients. (1) Safe and suitable ingredients that 
improve texture, prevent syneresis, or extend the shelf life of the 
product.
    (2) Rennet.
    (3) Safe and suitable nutritive sweeteners.
    (4) Salt.
    (5) Flavoring ingredients, with or without safe and suitable 
coloring, as follows:
    (i) Fruit and fruit juice, including concentrated fruit and fruit 
juice.
    (ii) Safe and suitable natural and artificial food flavoring.
    (c) Methods of analysis. Referenced methods in paragraphs (c) (1) 
and (2) of this section are from ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (1) Milkfat content--``Fat--Official Final Action,'' section 16.172.
    (2) Titratable acidity--``Acidity--Official Final Action,'' section 
16.023.
    (d) Nomenclature. The name of the food is ``Acidified sour cream''. 
The full name of the food shall appear on the principal display panel of 
the label in type of uniform size, style, and color. The name of the 
food shall be accompanied by a declaration indicating the presence of 
any flavoring that characterizes the product, as specified in Sec. 
101.22 of this chapter. If nutritive sweetener in an amount sufficient 
to characterize the food is added without addition of characterizing 
flavoring, the name of the food shall be preceded by the word 
``sweetened''.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19, 1982; 
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 
6, 1993]



Sec. 131.170  Eggnog.

    (a) Description. Eggnog is the food containing one or more of the 
optional dairy ingredients specified in paragraph (b), one or more of 
the optional egg yolk-containing ingredients specified in paragraph (c) 
of this section, and one or more of the optional nutritive carbohydrate 
sweeteners specified in paragraph (d) of this section. One or more of 
the optional ingredients specified in paragraph (e) of this section may 
also be added. All ingredients used are safe and suitable. Eggnog 
contains not less than 6 percent milkfat and not less than 8.25 percent 
milk solids not fat. The egg yolk solids content is not less than 1 
percent by weight of the finished food. The food shall be pasteurized or 
ultra-pasteurized and may be homogenized. Flavoring ingredients and 
color additives may be added after the food is pasteurized or ultra-
pasteurized.

[[Page 488]]

    (b) Optional dairy ingredients. Cream, milk, partially skimmed milk, 
or skim milk, used alone or in combination.
    (c) Egg yolk-containing ingredients. Liquid egg yolk, frozen egg 
yolk, dried egg yolk, liquid whole eggs, frozen whole eggs, dried whole 
eggs, or any one or more of the foregoing ingredients with liquid egg 
white or frozen egg white.
    (d) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or 
cane; invert sugar (in paste or sirup form); brown sugar; refiner's 
sirup; molasses (other than blackstrap); high fructose corn sirup; 
fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup; 
malt extract, dried malt extract; malt sirup, dried malt sirup; honey; 
maple sugar; or any of the sweeteners listed in part 168 of this 
chapter, except table sirup.
    (e) Other optional ingredients. (1) Concentrated skim milk, nonfat 
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or 
whey modified by partial or complete removal of lactose and/or minerals, 
to increase the nonfat solids content of the food: Provided, That the 
ratio of protein to total nonfat solids of the food, and the protein 
efficiency ratio of all protein present shall not be decreased as a 
result of adding such ingredients.
    (2) Salt.
    (3) Flavoring ingredients.
    (4) Color additives that do not impart a color simulating that of 
egg yolk, milkfat, or butterfat.
    (5) Stabilizers.
    (f) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies are available from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or 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.
    (1) Milkfat content--As determined by the method prescribed in 
section 16.059, ``Roese-Gottlieb Method (Reference Method) (11)--
Official Final Action,'' under the heading ``Fat.''
    (2) Milk solids not fat content--Calculated by subtracting the 
milkfat content from the total solids content as determined by the 
method prescribed in section 16.032, ``Method I--Official Final 
Action,'' under the heading ``Total Solids.''
    (g) Nomenclature. The name of the food is ``eggnog''. The name of 
the food shall be accompanied by a declaration indicating the presence 
of any characterizing flavoring as specified in Sec. 101.22 of this 
chapter. If the food is ultra-pasteurized, the phrase ``ultra-
pasteurized'' shall accompany the name of the food wherever it appears 
on the label in letters not less than one-half of the height of the 
letters used in the name. The following terms may accompany the name of 
the food on the label:
    (1) The word ``pasteurized'' if the food has been pasteurized.
    (2) The word ``homogenized'' if the food has been homogenized.
    (h) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[46 FR 9938, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47 
FR 41524, Sept. 21, 1982; 47 FR 49638, Nov. 2, 1982; 48 FR 24869, June 
3, 1983; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]



Sec. 131.180  Half-and-half.

    (a) Description. Half-and-half is the food consisting of a mixture 
of milk and cream which contains not less than 10.5 percent but less 
than 18 percent milkfat. It is pasteurized or ultra-pasteurized, and may 
be homogenized.
    (b) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (1) Emulsifiers.
    (2) Stabilizers.
    (3) Nutritive sweeteners.
    (4) Characterizing flavoring ingredients (with or without coloring) 
as follows:
    (i) Fruit and fruit juice (including concentrated fruit and fruit 
juice).
    (ii) Natural and artificial food flavoring.

[[Page 489]]

    (c) Methods of analysis. The milkfat content is determined by the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980), in sections 16.156 
and 16.059, under ``Fat, Roese-Gottlieb Method--Official Final Action,'' 
which is incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, 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.
    (d) Nomenclature. The name of the food is ``Half-and-half''. The 
name of the food shall be accompanied on the label by a declaration 
indicating the presence of any characterizing flavoring, as specified in 
Sec. 101.22 of this chapter.
    (1) The following terms shall accompany the name of the food 
wherever it appears on the principal display panel or panels of the 
label in letters not less than one-half the height of the letters used 
in such name:
    (i) The word ``ultra-pasteurized'' if the food has been ultra-
pasteurized.
    (ii) The word ``sweetened'' if no characterizing flavor ingredients 
are used, but nutritive sweetener is added.
    (2) The following terms may appear on the label:
    (i) The word ``pasteurized'' if the food has been pasteurized.
    (ii) The word ``homogenized'' if the food has been homogenized.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19, 1982; 
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 
6, 1993]



Sec. 131.200  Yogurt.

    (a) Description. Yogurt is the food produced by culturing one or 
more of the optional dairy ingredients specified in paragraph (c) of 
this section with a characterizing bacterial culture that contains the 
lactic acid-producing bacteria, Lactobacillus bulgaricus and 
Streptococcus thermophilus. One or more of the other optional 
ingredients specified in paragraphs (b) and (d) of this section may also 
be added. When one or more of the ingredients specified in paragraph 
(d)(1) of this section are used, they shall be included in the culturing 
process. All ingredients used are safe and suitable. Yogurt, before the 
addition of bulky flavors, contains not less than 3.25 percent milkfat 
and not less than 8.25 percent milk solids not fat, and has a titratable 
acidity of not less than 0.9 percent, expressed as lactic acid. The food 
may be homogenized and shall be pasteurized or ultra-pasteurized prior 
to the addition of the bacterial culture. Flavoring ingredients may be 
added after pasteurization or ultra-pasteurization. To extend the shelf 
life of the food, yogurt may be heat treated after culturing is 
completed, to destroy viable microorganisms.
    (b) Vitamin addition (optional). (1) If added, vitamin A shall be 
present in such quantity that each 946 milliliters (quart) of the food 
contains not less than 2,000 International Units thereof, within limits 
of current good manufacturing practice.
    (2) If added, vitamin D shall be present in such quantity that each 
946 milliliters (quart) of the food contains 400 International Units 
thereof, within limits of current good manufacturing practice.
    (c) Optional dairy ingredients. Cream, milk, partially skimmed milk, 
or skim milk, used alone or in combination.
    (d) Other optional ingredients. (1) Concentrated skim milk, nonfat 
dry milk, buttermilk, whey, lactose, lact al bum ins, lacto globulins, 
or whey modified by partial or complete removal of lactose and/or 
minerals, to increase the nonfat solids content of the food: Provided, 
That the ratio of protein to total nonfat solids of the food, and the 
protein efficiency ratio of all protein present shall not be decreased 
as a result of adding such ingredients.
    (2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or 
cane; invert sugar (in paste or sirup form); brown sugar; refiner's 
sirup; molasses (other than blackstrap); high fructose

[[Page 490]]

corn sirup; fructose; fructose sirup; maltose; maltose sirup, dried 
maltose sirup; malt extract, dried malt extract; malt sirup, dried malt 
sirup; honey; maple sugar; or any of the sweeteners listed in part 168 
of this chapter, except table sirup.
    (3) Flavoring ingredients.
    (4) Color additives.
    (5) Stabilizers.
    (e) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies are available from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or 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.
    (1) Milkfat content--As determined by the method prescribed in 
section 16.059 ``Roese-Gottlieb Method (Reference Method) (11)--Official 
Final Action,'' under the heading ``Fat.''
    (2) Milk solids not fat content--Calculated by subtracting the 
milkfat content from the total solids content as determined by the 
method prescribed in section 16.032, ``Method I--Official Final 
Action,'' under the heading ``Total Solids.''
    (3) Titratable acidity--As determined by the method prescribed in 
section 16.023, ``Acidity (2)--Official Final Action,'' or by an 
equivalent potentiometric method.
    (f) Nomenclature. The name of the food is ``yogurt''. The name of 
the food shall be accompanied by a declaration indicating the presence 
of any characterizing flavoring as specified in Sec. 101.22 of this 
chapter.
    (1) The following terms shall accompany the name of the food 
wherever it appears on the principal display panel or panels of the 
label in letters not less than one-half of the height of the letters 
used in such name:
    (i) The word ``sweetened'' if nutritive carbohydrate sweetener is 
added without the addition of characterizing flavor.
    (ii) The parenthetical phrase ``(heat-treated after culturing)'' 
shall follow the name of the food if the dairy ingredients have been 
heat-treated after culturing.
    (iii) The phrase ``vitamin A'' or ``vitamin A added'', or ``vitamin 
D'' or ``vitamin D added'', or ``vitamins A and D added'', as 
appropriate. The word ``vitamin'' may be abbreviated ``vit''.
    (2) The term ``homogenized'' may appear on the label if the dairy 
ingredients used are homogenized.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[46 FR 9939, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47 
FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June 
12, 1989; 58 FR 2891, Jan. 6, 1993]



Sec. 131.203  Lowfat yogurt.

    (a) Description. Lowfat yogurt is the food produced by culturing one 
or more of the optional dairy ingredients specified in paragraph (c) of 
this section with a characterizing bacterial culture that contains the 
lactic acid-producing bacteria, Lactobacillus bulgaricus and 
Streptococcus thermophilus. One or more of the other optional 
ingredients specified in paragraphs (b) and (d) of this section may also 
be added. When one or more of the ingredients specified in paragraph 
(d)(1) of this section are used, they shall be included in the culturing 
process. All ingredients used are safe and suitable. Lowfat yogurt, 
before the addition of bulky flavors, contains not less than 0.5 percent 
nor more than 2 percent milkfat and not less than 8.25 percent milk 
solids not fat, and has a titratable acidity of not less than 0.9 
percent, expressed as lactic acid. The food may be homogenized and shall 
be pasteurized or ultra-pasteurized prior to the addition of the 
bacterial culture. Flavoring ingredients may be added after 
pasteurization or ultra-pasteurization. To extend the shelf life of the 
food, lowfat yogurt may be heat treated after culturing is completed, to 
destroy viable microorganisms.

[[Page 491]]

    (b) Vitamin addition (optional). (1) If added, vitamin A shall be 
present in such quantity that each 946 milliliters (quart) of the food 
contains not less than 2,000 International Units thereof, within limits 
of current good manufacturing practice.
    (2) If added, vitamin D shall be present in such quantity that each 
946 milliliters (quart) of the food contains 400 International Units 
thereof, within limits of current good manufacturing practice.
    (c) Optional dairy ingredients. Cream, milk, partially skimmed milk, 
or skim milk, used alone or in combination.
    (d) Other optional ingredients. (1) Concentrated skim milk, nonfat 
dry milk, buttermilk, whey, lactose, lact al bum ins, lactoglobulins, or 
whey modified by partial or complete removal of lactose and/or minerals, 
to increase the nonfat solids content of the food: Provided, That the 
ratio of protein to total nonfat solids of the food, and the protein 
efficiency ratio of all protein present shall not be decreased as a 
result of adding such ingredients.
    (2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or 
cane; invert sugar (in paste or sirup form); brown sugar; refiner's 
sirup; molasses (other than blackstrap); high fructose corn sirup; 
fructose; fructose sirup; maltose, maltose sirup, dried maltose sirup; 
malt extract, dried malt extract; malt sirup, dried malt sirup; honey; 
maple sugar; or any of the sweeteners listed in part 168 of this 
chapter, except table sirup.
    (3) Flavoring ingredients.
    (4) Color additives.
    (5) Stabilizers.
    (e) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies are available from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877 or 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.
    (1) Milkfat content--As determined by the method prescribed in 
section 16.059 ``Roese-Gottlieb Method (Reference Method) (11)--Official 
Final Action,'' under the heading ``Fat.''
    (2) Milk solids not fat content--Calculated by subtracting the 
milkfat content from the total solids content as determined by the 
method prescribed in section 16.032, ``Method I--Official Final 
Action,'' under the heading ``Total Solids.''
    (3) Titratable acidity--As determined by the method prescribed in 
section 16.023, ``Acidity (2)--Official Final Action,'' or by an 
equivalent po ten tio metric method.
    (f) Nomenclature. The name of the food is ``lowfat yogurt''. The 
full name of the food shall appear on the principal display panel of the 
label in type of uniform size, style, and color. The name of the food 
shall be accompanied by a declaration indicating the presence of any 
characterizing flavoring as specified in Sec. 101.22 of this chapter.
    (1) The following terms shall accompany the name of the food 
wherever it appears on the principal display panel or panels of the 
label in letters not less than one-half of the height of the letters 
used in such name.
    (i) The phrase ``_% milkfat'', the blank to be filled in with the 
fraction \1/2\ or multiple thereof closest to the actual fat content of 
the food.
    (ii) The word ``sweetened'' if nutritive carbohydrate sweetener is 
added without the addition of characterizing flavoring.
    (iii) The parenthetical phrase ``(heat-treated after culturing)'' 
shall follow the name of the food if the dairy ingredients have been 
heat-treated after culturing.
    (iv) The phrase ``vitamin A'' or ``vitamin A added'', or ``vitamin 
D'' or ``vitamin D added'', or ``vitamins A and D added'', as 
appropriate. The word ``vitamin'' may be abbreviated ``vit''.
    (2) The term ``homogenized'' may appear on the label if the dairy 
ingredients used are homogenized.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the

[[Page 492]]

applicable sections of parts 101 and 130 of this chapter.

[46 FR 9939, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47 
FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June 
12, 1989; 58 FR 2891, Jan. 6, 1993]



Sec. 131.206  Nonfat yogurt.

    (a) Description. Nonfat yogurt is the food produced by culturing one 
or more of the optional dairy ingredients specified in paragraph (c) of 
this section with a characterizing bacterial culture that contains the 
lactic acid-producing bacteria, Lactobacillus bulgaricus and 
Streptococcus thermophilus. One or more of the other optional 
ingredients specified in paragraphs (b) and (d) of this section may also 
be added. When one or more of the ingredients specified in paragraph 
(d)(1) of this section are used, they shall be included in the culturing 
process. All ingredients used are safe and suitable. Nonfat yogurt, 
before the addition of bulky flavors, contains less than 0.5 percent 
milkfat and not less than 8.25 percent milk solids not fat, and has a 
titratable acidity of not less than 0.9 percent, expressed as lactic 
acid. The food may be homogenized and shall be pasteurized or ultra-
pasteurized prior to the addition of the bacterial culture. Flavoring 
ingredients may be added after pasteurization or ultra-pasteurization. 
To extend the shelf life of the food, nonfat yogurt may be heat treated 
after culturing is completed, to destroy viable microorganisms.
    (b) Vitamin addition (optional). (1) If added, vitamin A shall be 
present in such quantity that each 946 milliliters (quart) of the food 
contains not less than 2,000 International Units thereof, within limits 
of good manufacturing practice.
    (2) If added, vitamin D shall be present in such quantity that each 
946 milliliters (quart) of the food contains 400 International Units 
thereof, within limits of good manufacturing practice.
    (c) Optional dairy ingredients. Cream, milk, partially skimmed milk, 
or skim milk, used alone or in combination.
    (d) Other optional ingredients. (1) Concentrated skim milk, nonfat 
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or 
whey modified by partial or complete removal of lactose and/or minerals, 
to increase the nonfat solids content of the food: Provided, That the 
ratio of protein to total nonfat solids of the food, and the protein 
efficiency ratio of all protein present shall not be decreased as a 
result of adding such ingredients.
    (2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or 
cane; invert sugar (in paste or sirup form); brown sugar; refiner's 
sirup; molasses (other than blackstrap); high fructose corn sirup; 
fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup; 
malt extract, dired malt extract; malt sirup, dried malt sirup; honey; 
maple sugar; or any of the sweeteners listed in part 168 of this 
chapter, except table sirup.
    (3) Flavoring ingredients.
    (4) Color additives.
    (5) Stabilizers.
    (e) Methods of analysis. The following referenced methods of 
analysis are from ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated 
by reference. Copies are available from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or 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.
    (1) Milkfat content--As determined by the method prescribed in 
section 16.059, ``Roese-Gottlieb Method (Reference Method) (11)--
Official Final Action,'' under the heading ``Fat.''
    (2) Milk solids not fat content--Calculated by subtracting the 
milkfat content from the total solids content as determined by the 
method prescribed in section 16.032, ``Method I--Official Final 
Action,'' under the heading ``Total Solids.''
    (3) Titratable acidity--As determined by the method prescribed in 
section 16.023, ``Acidity (2)--Official Final Action,'' or by an 
equivalent potentiometric method.
    (f) Nomenclature. The name of the food is ``nonfat yogurt''. The 
full name

[[Page 493]]

of the food shall appear on the principal display panel of the label in 
type of uniform size, style, and color. The name of the food shall be 
accompanied by a declaration indicating the presence of any 
characterizing flavoring as specified in Sec. 101.22 of this chapter.
    (1) The following terms shall accompany the name of the food 
wherever it appears on the principal display panel or panels of the 
label in letters not less than one-half of the height of the letters 
used in such name:
    (i) The word ``sweetened'' if nutritive carbohydrate sweetener is 
added without the addition of characterizing flavoring.
    (ii) The parenthetical phrase ``(heat-treated after culturing)'' 
shall follow the name of the food if the dairy ingredients have been 
heat-treated after culturing.
    (iii) The phrase ``vitamin A'' or ``vitamin A added'', or ``vitamin 
D'' or ``vitamin D added'', or ``vitamins A and D added'', as 
appropriate. The word ``vitamin'' may be abbreviated ``vit''.
    (2) The term ``homogenized'' may appear on the label if the dairy 
ingredients used are homogenized.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[46 FR 9940, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47 
FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June 
12, 1989; 58 FR 2891, Jan. 6, 1993]



PART 133_CHEESES AND RELATED CHEESE PRODUCTS--Table of Contents



                      Subpart A_General Provisions

Sec.
133.3 Definitions.
133.5 Methods of analysis.
133.10 Notice to manufacturers, packers, and distributors of pasteurized 
          blended cheese, pasteurized process cheese, cheese food, 
          cheese spread, and related foods.

  Subpart B_Requirements for Specific Standardized Cheese and Related 
                                Products

133.102 Asiago fresh and asiago soft cheese.
133.103 Asiago medium cheese.
133.104 Asiago old cheese.
133.106 Blue cheese.
133.108 Brick cheese.
133.109 Brick cheese for manufacturing.
133.111 Caciocavallo siciliano cheese.
133.113 Cheddar cheese.
133.114 Cheddar cheese for manufacturing.
133.116 Low sodium cheddar cheese.
133.118 Colby cheese.
133.119 Colby cheese for manufacturing.
133.121 Low sodium colby cheese.
133.123 Cold-pack and club cheese.
133.124 Cold-pack cheese food.
133.125 Cold-pack cheese food with fruits, vegetables, or meats.
133.127 Cook cheese, koch kaese.
133.128 Cottage cheese.
133.129 Dry curd cottage cheese.
133.133 Cream cheese.
133.134 Cream cheese with other foods.
133.136 Washed curd and soaked curd cheese.
133.137 Washed curd cheese for manufacturing.
133.138 Edam cheese.
133.140 Gammelost cheese.
133.141 Gorgonzola cheese.
133.142 Gouda cheese.
133.144 Granular and stirred curd cheese.
133.145 Granular cheese for manufacturing.
133.146 Grated cheeses.
133.147 Grated American cheese food.
133.148 Hard grating cheeses.
133.149 Gruyere cheese.
133.150 Hard cheeses.
133.152 Limburger cheese.
133.153 Monterey cheese and monterey jack cheese.
133.154 High-moisture jack cheese.
133.155 Mozzarella cheese and scamorza cheese.
133.156 Low-moisture mozzarella and scamorza cheese.
133.157 Part-skim mozzarella and scamorza cheese.
133.158 Low-moisture part-skim mozzarella and scamorza cheese.
133.160 Muenster and munster cheese.
133.161 Muenster and munster cheese for manufacturing.
133.162 Neufchatel cheese.
133.164 Nuworld cheese.
133.165 Parmesan and reggiano cheese.
133.167 Pasteurized blended cheese.
133.168 Pasteurized blended cheese with fruits, vegetables, or meats.
133.169 Pasteurized process cheese.
133.170 Pasteurized process cheese with fruits, vegetables, or meats.
133.171 Pasteurized process pimento cheese.
133.173 Pasteurized process cheese food.
133.174 Pasteurized process cheese food with fruits, vegetables, or 
          meats.
133.175 Pasteurized cheese spread.
133.176 Pasteurized cheese spread with fruits, vegetables, or meats.
133.178 Pasteurized neufchatel cheese spread with other foods.
133.179 Pasteurized process cheese spread.

[[Page 494]]

133.180 Pasteurized process cheese spread with fruits, vegetables, or 
          meats.
133.181 Provolone cheese.
133.182 Soft ripened cheeses.
133.183 Romano cheese.
133.184 Roquefort cheese, sheep's milk blue-mold, and blue-mold cheese 
          from sheep's milk.
133.185 Samsoe cheese.
133.186 Sap sago cheese.
133.187 Semisoft cheeses.
133.188 Semisoft part-skim cheeses.
133.189 Skim milk cheese for manufacturing.
133.190 Spiced cheeses.
133.191 Part-skim spiced cheeses.
133.193 Spiced, flavored standardized cheeses.
133.195 Swiss and emmentaler cheese.
133.196 Swiss cheese for manufacturing.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.



                      Subpart A_General Provisions



Sec. 133.3  Definitions.

    (a) Milk means the lacteal secretion, practically free from 
colostrum, obtained by the complete milking of one or more healthy cows, 
which may be clarified and may be adjusted by separating part of the fat 
therefrom; concentrated milk, reconstituted milk, and dry whole milk. 
Water, in a sufficient quantity to reconstitute concentrated and dry 
forms, may be added.
    (b) Nonfat milk means skim milk, concentrated skim milk, 
reconstituted skim milk, and nonfat dry milk. Water, in a sufficient 
quantity to reconstitute concentrated and dry forms, may be added.
    (c) Cream means cream, reconstituted cream, dry cream, and plastic 
cream. Water, in a sufficient quantity to reconstitute concentrated and 
dry forms, may be added.
    (d) Pasteurized when used to describe a dairy ingredient means that 
every particle of such ingredient shall have been heated in properly 
operated equipment to one of the temperatures specified in the table of 
this paragraph and held continuously at or above that temperature for 
the specified time (or other time/temperature relationship which has 
been demonstrated to be equivalent thereto in microbial destruction):

------------------------------------------------------------------------
                 Temperature                             Time
------------------------------------------------------------------------
145 [deg]F\1\...............................  30 min.
161 [deg]F\1\...............................  15 s.
191 [deg]F..................................  1 s.
204 [deg]F..................................  0.05 s.
212 [deg]F..................................  0.01 s.
------------------------------------------------------------------------
\1\ If the dairy ingredient has a fat content of 10 percent or more, the
  specified temperature shall be increased by 5 [deg]F.

    (e) Ultrapasteurized when used to describe a dairy ingredient means 
that such ingredient shall have been thermally processed at or above 280 
[deg]F for at least 2 seconds.

[48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983]



Sec. 133.5  Methods of analysis.

    Moisture, milkfat, and phosphatase levels in cheeses will be 
determined by the following methods of analysis from ``Official Methods 
of Analysis of the Association of Official Analytical Chemists,'' 13th 
ed., 1980, which is incorporated by reference (copies are available from 
the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877, or 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):
    (a) Moisture content--section 16.233 ``Method I (52)--Official Final 
Action'', under the heading ``Moisture''.
    (b) Milkfat content--section 16.255 ``Fat (60)--Official Final 
Action''.
    (c) Phenol equivalent value--section 16.275 ``Reagents'', section 
16.276 ``Sampling'', and section 16.277 ``Determination'', under the 
heading ``Residual Phosphatase (27) Official Final Action''.
    (d) Milkfat in solids (fat on a dry basis)--Subtract the percent of 
moisture found from 100; divide the remainder into the percent milkfat 
found. The quotient, multiplied by 100, shall be considered to be the 
percent of milkfat contained in the solids.

[48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 54 
FR 24893, June 12, 1989; 63 FR 14035, Mar. 24, 1998]

[[Page 495]]



Sec. 133.10  Notice to manufacturers, packers, and distributors of 
pasteurized blended cheese, pasteurized process cheese, cheese food,
cheese spread, and related foods.
          

    (a) Definitions and standards of identity have recently been 
promulgated under the authority of the Federal Food, Drug, and Cosmetic 
Act for a number of foods made in part from cheese, including 
pasteurized process cheese; pasteurized process cheese with fruits, 
vegetables, or meats; pasteurized blended cheese; pasteurized process 
cheese food; pasteurized process cheese spread, and related foods. These 
standards prescribe the name for each such food. The act requires that 
this name appear on the label. Many of these names consist of several 
words. In the past it has been the practice of some manufacturers to 
subordinate the words ``pasteurized,'' ``blended,'' ``process,'' 
``food,'' and ``spread'' to give undue prominence to the word ``cheese'' 
and to words naming the variety of cheese involved.
    (b) When placing the names of these foods on labels so as to comply 
with the requirements of section 403 (a), (f), and (g) of the act, all 
the words forming the name specified by a definition and standard of 
identity should be given equal prominence. This can readily be 
accomplished by printing the specified name of the food in letters of 
the same size, color, and style of type, and with the same background.
    (c) Where the names of optional ingredients are required to appear 
on the label, the designations of all such ingredients should be given 
equal prominence. The names of the optional ingredients should appear 
prominently and conspicuously but should not be displayed with greater 
prominence than the name of the food. The word ``contains'' may precede 
the names of the optional ingredients, and when so used will not be 
considered as intervening printed matter between name of food and name 
of optional ingredients required to be placed on the label.
    (d) Where a manufacturer elects to include a label statement of fat 
and moisture content, the declaration should be on the basis of the food 
as marketed. A fat declaration on a moisture-free basis is likely to be 
misleading, and should not be used in labeling.



  Subpart B_Requirements for Specific Standardized Cheese and Related 
                                Products



Sec. 133.102  Asiago fresh and asiago soft cheese.

    (a) Asiago fresh cheese, asiago soft cheese, is the food prepared 
from milk and other ingredients specified in this section, by the 
procedure set forth in paragraph (b) of this section, or by another 
procedure which produces a finished cheese having the same physical and 
chemical properties as the cheese produced when the procedure set forth 
in paragraph (b) of this section is used. It contains not more than 45 
percent of moisture, and its solids contain not less than 50 percent of 
milkfat, as determined by the methods prescribed in Sec. 133.5 (a), 
(b), and (d). It is cured for not less than 60 days.
    (b) Milk which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid 
producing bacteria, present in such milk or added thereto. Harmless 
artificial blue or green coloring in a quantity which neutralizes any 
natural yellow coloring in the curd may be added. Sufficient rennet, or 
other safe and suitable milk-clotting enzyme that produces equivalent 
curd formation, or both, with or without purified calcium chloride in a 
quantity not more than 0.02 percent (calculated as anhydrous calcium 
chloride) of the weight of the milk, is added to set the milk to a 
semisolid mass. The mass is cut, stirred, and heated to promote and 
regulate separation of the whey from the curd. The whey is drained off. 
When the curd is sufficiently firm it is removed from the kettle or vat, 
further drained for a short time, packed into hoops, and pressed. The 
pressed curd is salted in brine and cured in a well-ventilated room. 
During curing the surface of the cheese is occasionally rubbed with a 
vegetable oil. A harmless preparation of enzymes of animal or plant 
origin capable of aiding in the curing or development of flavor of 
asiago fresh cheese may be added during the procedure in such quantity 
that the weight

[[Page 496]]

of the solids of such preparation is not more than 0.1 percent of the 
weight of the milk used.
    (c)(1) For the purposes of this section, the word ``milk'' means 
cow's milk, which may be adjusted by separating part of the fat 
therefrom or by adding thereto one or more of the following: Cream, skim 
milk, concentrated skim milk, nonfat dry milk, water in a quantity 
sufficient to reconstitute any concentrated skim milk or nonfat dry milk 
used.
    (2) Such milk may be bleached by the use of benzoyl peroxide or a 
mixture of benzoyl peroxide with potassium alum, calcium sulfate, and 
magnesium carbonate; but the weight of the benzoyl peroxide is not more 
than 0.002 percent of the weight of the milk bleached, and the weight of 
the potassium alum, calcium sulfate, and magnesium carbonate, singly or 
combined, is not more than six times the weight of the benzoyl peroxide 
used. If milk is bleached in this manner, sufficient vitamin A is added 
to the curd to compensate for the vitamin A or its precursors destroyed 
in the bleaching process, and artificial coloring is not used.
    (d) Safe and suitable antimycotic agent(s), the cumulative levels of 
which shall not exceed current good manufacturing practice, may be added 
to the surface of the cheese.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that enzymes of animal, plant, 
or microbial origin may be declared as ``enzymes''.

[42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49013, Oct. 24, 1983; 
49 FR 10093, Mar. 19, 1984; 58 FR 2891, Jan. 6, 1993]



Sec. 133.103  Asiago medium cheese.

    Asiago medium cheese conforms to the definition and standard of 
identity and is subject to the requirements for label statement of 
ingredients prescribed by Sec. 133.102 for asiago fresh cheese, except 
that it contains not more than 35 percent moisture, its solids contain 
not less than 45 percent of milkfat, and it is cured for not less than 6 
months.

[58 FR 2892, Jan. 6, 1993]



Sec. 133.104  Asiago old cheese.

    Asiago old cheese conforms to the definition and standard of 
identity and is subject to the requirements for label statement of 
ingredients prescribed by Sec. 133.102 for asiago fresh cheese, except 
that it contains not more than 32 percent moisture, its solids contain 
not less than 42 percent of milk fat, and it is cured for not less than 
1 year.

[58 FR 2892, Jan. 6, 1993]



Sec. 133.106  Blue cheese.

    (a) Description. (1) Blue cheese is the food prepared by the 
procedure set forth in paragraph (a)(2), of this section, or by any 
other procedure which produces a finished cheese having the same 
physical and chemical properties. It is characterized by the presence of 
bluish-green mold, Penicillium roque fortii, throughout the cheese. The 
minimum milkfat content is 50 percent by weight of the solids and the 
maximum moisture content is 46 percent by weight, as determined by the 
methods described in Sec. 133.5. The dairy ingredients used may be 
pasteurized. Blue cheese is at least 60 days old.
    (2) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be homogenized, bleached, warmed, and is 
subjected to the action of a lactic acid-producing bacterial culture. 
One or more of the clotting enzymes specified in paragraph (b)(2) of 
this section is added to set the dairy ingredients to a semisolid mass. 
The mass is cut into smaller portions and allowed to stand for a time. 
The mixed curd and whey is placed in forms permitting further drainage. 
While the curd is being placed in forms, spores of the mold Penicillium 
roque fortii are added. The forms are turned several times during 
drainage. When sufficiently drained, the shaped curd is removed from the 
forms and salted with dry salt or brine. Perforations are then made in 
the shaped curd, and it is held at a temperature of approximately 50 
[deg]F. at 90 to 95 percent relative humidity, until the characteristic 
mold growth has developed. During storage the surface of the cheese may 
be scraped to remove surface growth of undesirable microorganisms. 
Antimycotics may be applied to the

[[Page 497]]

surface of the whole cheese. One or more of the other optional 
ingredients specified in paragraph (b)(3) of this section may be added 
during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Blue or green color in an amount 
to neutralize the natural yellow color of the curd.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iv) Antimycotic agents, applied to the surface of slices or cuts in 
consumer-sized packages or to the surface of the bulk cheese during 
curing.
    (v) Benzoyl peroxide or a mixture of benzoyl peroxide with potassium 
alum, calcium sulfate, and magnesium carbonate used to bleach the dairy 
ingredients. The weight of the benzoyl peroxide is not more than 0.002 
percent of the weight of the milk being bleached, and the weight of the 
potassium alum, calcium sulfate, and magnesium carbonate, singly or 
combined, is not more than six times the weight of the benzoyl peroxide 
used. If milk is bleached in this manner, vitamin A is added to the curd 
in such quantity as to compensate for the vitamin A or its precursors 
destroyed in the bleaching process, and artificial coloring is not used.
    (vi) Vegetable fats or oils, which may be hydrogenated, used as a 
coating for the rind.
    (c) Nomenclature. The name of the food is ``blue cheese.''
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[48 FR 2742, Jan. 21, 1983, as amended at 54 FR 32052, Aug. 4, 1989; 58 
FR 2892, Jan. 6, 1993]



Sec. 133.108  Brick cheese.

    (a) Description. (1) Brick cheese is the food prepared from dairy 
ingredients and other ingredients specified in this section by the 
procedure set forth in paragraph (a)(3) of this section, or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. The minimum milkfat content is 50 percent by weight 
of the solids and the maximum moisture content is 44 percent by weight, 
as determined by the methods described in Sec. 133.5. If the dairy 
ingredients used are not pasteurized, the cheese is cured at a 
temperature of not less than 35 [deg]F for at least 60 days.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of brick cheese is not more than 5 micrograms as 
determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section is brought to a temperature of about 88 [deg]F 
and subjected to the action of a lactic acid-producing bacterial 
culutre. One or more of the clotting enzymes specified in paragraph 
(b)(2) of this section is added to set the dairy ingredients to a 
semisolid mass. The mass is cut into cubes with sides approximately \3/
8\ inch long, and stirred and heated so that the temperature rises 
slowly to about 96 [deg]F. The stirring is continued until the curd is 
sufficiently firm. Part of the whey is then removed, and the mixture 
diluted with water or salt brine to control the acidity. The curd is 
transferred to forms, and drained. During drainage it is pressed and 
turned. After drainage the curd is salted, and the biological curing 
agents characteristic of brick cheese are applied to the surface. The 
cheese is then cured to develop the characteristics of brick cheese. One 
or more of the other optional ingredients specified

[[Page 498]]

in paragraph (b)(3) of this section may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iv) Antimycotic agents, the cumulative level of which shall not 
exceed current good manufacturing practice, may be added to the surface 
of the cheese.
    (c) Nomenclature. The name of the food is ``brick cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[54 FR 32052, Aug. 4, 1989; 54 FR 35756, Aug. 29, 1989, as amended at 58 
FR 2892, Jan. 6, 1993; 58 FR 17105, Apr. 1, 1993]



Sec. 133.109  Brick cheese for manufacturing.

    Brick cheese for manufacturing conforms to the definition and 
standard of identity for brick cheese prescribed by Sec. 133.108, 
except that the dairy ingredients are not pasteurized and curing is not 
required.

[54 FR 32053, Aug. 4, 1989]



Sec. 133.111  Caciocavallo siciliano cheese.

    (a) Caciocavallo siciliano cheese is the food prepared from cow's 
milk or sheep's milk or goat's milk or mixtures of two or all of these 
and other ingredients specified in this section, by the procedure set 
forth in paragraph (b) of this section, or by another procedure which 
produces a finished cheese having the same physical and chemical 
properties as the cheese produced when the procedure set forth in 
paragraph (b) of this section is used. It has a stringy texture, and is 
made in oblong shapes. It contains not more than 40 percent of moisture, 
and its solids contain not less than 42 percent milkfat as determined by 
the methods prescribed in Sec. 133.5 (a), (b), and (d). It is cured for 
not less than 90 days at a temperature of not less than 35 [deg]F.
    (b) Milk, which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria, present in such milk or added thereto. Harmless 
artificial blue or green coloring in a quantity which neutralizes any 
natural yellow coloring in the curd may be added. Sufficient rennet, 
rennet paste, extract of rennet paste, or other safe and suitable milk-
clotting enzyme that produces equivalent curd formation, singly or in 
any combination (with or without purified calcium chloride in a quantity 
not more than 0.02 percent, calculated as anhydrous calcium chloride, of 
the weight of the milk) is added to set the milk to a semisolid mass. 
The mass is cut, stirred, and heated so as to promote and regulate the 
separation of whey from curd. The whey is drained off, and the curd is 
removed to another vat containing hot whey, in which it is soaked for 
several hours. This whey is withdrawn, the curd is allowed to mat, and 
is cut into blocks. These are washed in hot whey until the desired 
elasticity is obtained. The curd is removed from the vat, drained, 
pressed into oblong forms, dried, and salted in brine, and cured. It may 
be paraffined. A harmless preparation of enzymes of animal or plant 
origin capable of aiding in the curing or development of flavor of 
caciocavallo siciliano cheese may be added during the procedure, in such 
quantity that the weight of the solids of such preparation is not more 
than 0.1 percent of the weight of the milk used.

[[Page 499]]

    (c)(1) For the purposes of this section, the word ``milk'' means 
cow's milk or goat's milk or sheep's milk or mixtures of two or all of 
these. Such milk may be adjusted by separating part of the fat therefrom 
or (in the case of cow's milk) by adding one or more of the following: 
Cream, skim milk, concentrated skim milk, nonfat dry milk; (in the case 
of goat's milk) the corresponding products from goat's milk; (in the 
case of sheep's milk) the corresponding products from sheep's milk; 
water in a quantity sufficient to reconstitute any such concentrated or 
dried products used.
    (2) Such milk may be bleached by the use of benzoyl peroxide or a 
mixture of benzoyl peroxide with potassium alum, calcium sulfate, and 
magnesium carbonate; but the weight of the benzoyl peroxide is not more 
than 0.002 percent of the weight of the milk bleached, and the weight of 
the potassium alum, calcium sulfate, and magnesium carbonate, singly or 
combined, is not more than six times the weight of the benzoyl peroxide 
used. If milk is bleached in this manner, sufficient vitamin A is added 
to the curd to compensate for the vitamin A or its precursors destroyed 
in the bleaching process, and artificial coloring is not used.
    (d) Safe and suitable antimycotic agent(s), the cumulative levels of 
which shall not exceed current good manufacturing practice, may be added 
to the cheese during the kneading and stretching process and/or applied 
to the surface of the cheese.
    (e) When caciocavallo siciliano cheese is made solely from cow's 
milk, the name of such cheese is ``Caciocavallo siciliano cheese''. When 
made from sheep's milk or goat's milk or mixtures of these, or one or 
both of these with cow's milk, the name is followed by the words ``made 
from ___'', the blank being filled in with the name or names of the 
milks used, in order of predominance by weight.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that enzymes of animal, plant, 
or microbial origin may be declared as ``enzymes''.

[42 FR 14366, Mar. 15, 1977, as amended at 42 FR 39102, Aug. 2, 1977; 48 
FR 49013, Oct. 24, 1983; 49 FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, 
1993]



Sec. 133.113  Cheddar cheese.

    (a) Description. (1) Cheddar cheese is the food prepared by the 
procedure set forth in paragraph (a)(3) of this section, or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. The minimum milkfat content is 50 percent by weight 
of the solids, and the maximum moisture content is 39 percent by weight, 
as determined by the methods described in Sec. 133.5. If the dairy 
ingredients used are not pasteurized, the cheese is cured at a 
temperature of not less than 35 [deg]F for at least 60 days.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of cheddar cheese is not more than 3 micrograms as 
determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed, treated with hydrogen peroxide/
catalase, and is subjected to the action of a lactic acid-producing 
bacterial culture. One or more of the clotting enzymes specified in 
paragraph (b)(2) of this section is added to set the dairy ingredients 
to a semisolid mass. The mass is so cut, stirred, and heated with 
continued stirring, as to promote and regulate the separation of whey 
and curd. The whey is drained off, and the curd is matted into a 
cohesive mass. The mass is cut into slabs, which are so piled and 
handled as to promote the drainage of whey and the development of 
acidity. The slabs are then cut into pieces, which may be rinsed by 
sprinkling or pouring water over them, with free and continuous 
drainage; but the duration of such rinsing is so limited that only the 
whey on the surface of such pieces is removed. The curd is salted, 
stirred, further drained, and pressed into forms. One or more of the 
other optional ingredients specified in paragraph (b)(3) of this section 
may be added during the procedure.

[[Page 500]]

    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial orgin, used in curing 
or flavor development.
    (iv) Antimycotic agents, applied to the surface of slices or cuts in 
consumer-sized packages.
    (v) Hydrogen peroxide, followed by a sufficient quantity of catalase 
preparation to eliminate the hydrogen peroxide. The weight of the 
hydrogen peroxide shall not exceed 0.05 percent of the weight of the 
milk and the weight of the catalase shall not exceed 20 parts per 
million of the weight of the milk treated.
    (c) Nomenclature. The name of the food is ``cheddar cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order or 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 58 
FR 2892, Jan. 6, 1993]



Sec. 133.114  Cheddar cheese for manufacturing.

    Cheddar cheese for manufacturing conforms to the definition and 
standard of identity prescribed for cheddar cheese by Sec. 133.113, 
except that the milk is not pasteurized, curing is not required, and the 
provisions of paragraph (b)(3)(iv) of that section do not apply.

[48 FR 2743, Jan. 21, 1983]



Sec. 133.116  Low sodium cheddar cheese.

    Low sodium cheddar cheese is the food prepared from the same 
ingredients and in the same manner prescribed in Sec. 133.113 for 
cheddar cheese and complies with all the provisions of Sec. 133.113, 
including the requirements for label statement of ingredients, except 
that:
    (a) It contains not more than 96 milligrams of sodium per pound of 
finished food.
    (b) The name of the food is ``low sodium cheddar cheese''. The 
letters in the words ``low sodium'' shall be of the same size and style 
of type as the letters in the words ``cheddar cheese'', wherever such 
words appear on the label.
    (c) If a salt substitute is used, the label shall bear the statement 
``___ added as a salt substitute'', the blank being filled in with the 
common name or names of the ingredient or ingredients used as a salt 
substitute.

[48 FR 2743, Jan. 21, 1983, as amended at 85 FR 72907, Nov. 16, 2020]



Sec. 133.118  Colby cheese.

    (a) Colby cheese is the food prepared from milk and other 
ingredients specified in this section, by the procedure set forth in 
paragraph (b) of this section, or by another procedure which produces a 
finished cheese having the same physical and chemical properties as the 
cheese produced when the procedure set forth in paragraph (b) of this 
section is used. It contains not more than 40 percent of moisture, and 
its solids contain not less than 50 percent of milkfat, as determined by 
the methods prescribed in Sec. 133.5 (a), (b), and (d). If the milk 
used is not pasteurized, the cheese so made is cured at a temperature of 
not less than 35 [deg]F for not less than 60 days.
    (b) Milk, which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria, present in such milk or added thereto. Harmless 
artificial coloring may be added. Sufficient rennet, or other safe and 
suitable milk-clotting enzyme that produces equivalent curd formation, 
or both, with or without purified calcium chloride in a quantity

[[Page 501]]

not more than 0.02 percent (calculated as anhydrous calcium chloride) of 
the weight of the milk, is added to set the milk to a semisolid mass. 
The mass is so cut, stirred, and heated with continued stirring, as to 
promote and regulate the separation of whey and curd. A part of the whey 
is drained off, and the curd is cooled by adding water, the stirring 
being continued so as to prevent the pieces of curd from matting. The 
curd is drained, salted, stirred, further drained, and pressed into 
forms. A harmless preparation of enzymes of animal or plant origin 
capable of aiding in the curing or development of flavor of colby cheese 
may be added during the procedure, in such quantity that the weight of 
the solids of such preparation is not more than 0.1 percent of the 
weight of the milk used.
    (c) For the purposes of this section:
    (1) The word ``milk'' means cow's milk, which may be adjusted by 
separating part of the fat therefrom or by adding thereto one or more of 
the following: Cream, skim milk, concentrated skim milk, nonfat dry 
milk, water, in a quantity sufficient to reconstitute any concentrated 
skim milk or nonfat dry milk used.
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a temperature of not less than 143 [deg]F for a period of not 
less than 30 minutes, or for a time and at a temperature equivalent 
thereto in phosphatase destruction. Colby cheese shall be deemed not to 
have been made from pasteurized milk if 0.25 gram shows a phenol 
equivalent of more than 3 micrograms when tested by the method 
prescribed in Sec. 133.5(c).
    (3) During the cheesemaking process the milk may be treated with 
hydrogen peroxide/catalase as provided in Sec. 133.113(a)(3).
    (d)(1) Colby cheese in the form of slices or cuts may have added to 
it a clear aqueous solution prepared by condensing or precipitating wood 
smoke in water.
    (2) Colby cheese in the form of slices or cuts in consumer-sized 
packages may contain an optional mold-inhibiting ingredient consisting 
of sorbic acid, potassium sorbate, sodium sorbate, or any combination of 
two or more of these, in an amount not to exceed 0.3 percent by weight 
calculated as sorbic acid.
    (e)(1) If colby cheese has added to it a clear aqueous solution 
prepared by condensing or precipitating wood smoke in water as provided 
in paragraph (d)(1) of this section, the name of the food is immediately 
followed by the words ``with added smoke flavoring'' with all words in 
this phrase of the same type size, style, and color without intervening 
written, printed, or graphic matter.
    (2) If colby cheese in sliced or cut form contains an optional mold-
inhibiting ingredient as specified in paragraph (d)(2) of this section, 
the label shall bear the statement ``___ added to retard mold growth'' 
or ``___ added as a preservative'', the blank being filled in with the 
common name or names of the mold-inhibiting ingredient or ingredients 
used.
    (3) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statement specified in paragraph (e)(2) of this section, 
showing the optional ingredient used, shall immediately and 
conspicuously precede or follow such name, without intervening written, 
printed, or graphic matter except for the statement ``with added smoke 
flavoring,'' as set forth in paragraph (e)(1) of this section.
    (f) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter, except that enzymes of animal, plant, or microbial origin 
may be declared as ``enzymes''.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10093, Mar. 19, 1984; 
58 FR 2892, Jan. 6, 1993]



Sec. 133.119  Colby cheese for manufacturing.

    Colby cheese for manufacturing conforms to the definition and 
standard of identity prescribed for colby cheese by Sec. 133.118, 
except that the milk is not pasteurized, curing is not required, and the 
provisions of paragraph (d) of that section do not apply.

[[Page 502]]



Sec. 133.121  Low sodium colby cheese.

    Low sodium colby cheese is the food prepared from the same 
ingredients and in the same manner prescribed in Sec. 133.118 for colby 
cheese and complies with all the provisions of Sec. 133.118, including 
the requirements for label statement of ingredients, except that:
    (a) Salt is not used. Any safe and suitable ingredient or 
combination of ingredients that contains no sodium and that is 
recognized as a salt substitute may be used.
    (b) Sodium sorbate is not used.
    (c) It contains not more than 96 milligrams of sodium per pound of 
finished food.
    (d) The name of the food is ``low sodium colby cheese''. The letters 
in the words ``low sodium'' shall be of the same size and style of type 
as the letters in the words ``colby cheese'', wherever such words appear 
on the label.
    (e) If a salt substitute as provided for in paragraph (a) of this 
section is used, the label shall bear the statement ``___ added as a 
salt substitute'', the blank being filled in with the common name or 
names of the ingredient or ingredients used as a salt substitute.

[42 FR 14366, Mar. 15, 1977, as amended at 58 FR 2892, Jan. 6, 1993; 85 
FR 72907, Nov. 16, 2020]



Sec. 133.123  Cold-pack and club cheese.

    (a)(1) Cold-pack cheese, club cheese, is the food prepared by 
comminuting, without the aid of heat, one or more cheeses of the same or 
two or more varieties, except cream cheese, neufchatel cheese, cottage 
cheese, lowfat cottage cheese, cottage cheese dry curd, hard grating 
cheese, semisoft part-skim cheese, part-skim spiced cheese and skim milk 
cheese for manufacturing, into a homogeneous plastic mass. One or more 
of the optional ingredients designated in paragraph (c) of this section 
may be used.
    (2) All cheeses used in a cold-pack cheese are made from pasteurized 
milk or are held for not less than 60 days at a temperature of not less 
than 35 [deg]F before being comminuted.
    (3)(i) The moisture content of a cold-pack cheese made from a single 
variety of cheese is not more than the maximum moisture content 
prescribed by the definition and standard of identity, if any there be, 
for the variety of cheese used. If there is no applicable definition and 
standard of identity, or if such standard contains no provision as to 
maximum moisture content, no water is used in the preparation of the 
cold-pack cheese.
    (ii) The fat content of the solids of a cold-pack cheese made from a 
single variety of cheese is not less than the minimum prescribed by the 
definition and standard of identity, if any there be, for the variety of 
cheese used, but in no case is less than 47 percent, except that the fat 
content of the solids of cold-pack swiss cheese is not less than 43 
percent, and the fat content of the solids of cold-pack gruyere cheese 
is not less than 45 percent.
    (4)(i) The moisture content of a cold-pack cheese made from two or 
more varieties of cheese is not more than the arithmetical average of 
the maximum moisture contents prescribed by the definitions and 
standards of identity, if any there be, for the varieties of cheese 
used, but in no case is the moisture content more than 42 percent, 
except that the moisture content of a cold-pack cheese made from two or 
more of the varieties cheddar cheese, washed curd cheese, colby cheese, 
and granular cheese is not more than 39 percent.
    (ii) The fat content of the solids of a cold-pack cheese made from 
two or more varieties of cheese is not less than the arithmetical 
average of the minimum percent of fat prescribed by the definitions and 
standards of identity, if any there be, for the varieties of cheese 
used, but in no case is less than 47 percent, except that the fat 
content of the solids of a cold-pack cheese made from swiss cheese and 
gruyere cheese is not less than 45 percent.
    (5) Moisture and fat are determined by the methods prescribed in 
Sec. 133.5(a), (b), and (d).
    (6) The weight of each variety of cheese in a cold-pack cheese made 
from two varieties of cheese is not less than 25 percent of the total 
weight of both, except that the weight of blue cheese, nuworld cheese, 
roquefort cheese, or gorgonzola cheese is not less than 10 percent of 
the total weight of both, and the weight of limburger cheese is not less 
than 5 percent of the total weight

[[Page 503]]

of both. The weight of each variety of cheese in a cold-pack cheese made 
from three or more varieties of cheese is not less than 15 percent of 
the total weight of all, except that the weight of blue cheese, nuworld 
cheese, roquefort cheese, or gorgonzola cheese is not less than 5 
percent of the total weight of all, and the weight of limburger cheese 
is not less than 3 percent of the total weight of all. These limits do 
not apply to the quantity of cheddar cheese, washed curd cheese, colby 
cheese, and granular cheese in mixtures which are designated as 
``American cheese'' as prescribed in paragraph (d)(2) of this section. 
Such mixtures are considered as one variety of cheese for the purpose of 
this paragraph (a)(6).
    (b) Cold-pack cheese may be smoked, or the cheese or cheeses from 
which it is made may be smoked, before comminuting and mixing, or it may 
contain substances prepared by condensing or precipitating wood smoke.
    (c) The optional ingredients referred to in paragraph (a) of this 
section are:
    (1) An acidifying agent consisting of one or any mixture of two or 
more of the following: A vinegar, lactic acid, citric acid, acetic acid, 
and phosphoric acid, in such quantity that the pH of the finished cold-
pack cheese is not below 4.5. For the purposes of this section vinegar 
is considered to be acetic acid.
    (2) Water.
    (3) Salt.
    (4) Harmless artificial coloring.
    (5) Spices or flavorings, other than any which singly or in 
combination with other ingredients simulate the flavor of a cheese of 
any age or variety.
    (6) Cold-pack cheese in consumer-sized packages may contain an 
optional mold-inhibiting ingredient consisting of sorbic acid, potassium 
sorbate, sodium sorbate, or any combination of two or more of these, in 
an amount not to exceed 0.3 percent by weight, calculated as sorbic acid 
or consisting of not more than 0.3 percent by weight of sodium 
propionate, calcium propionate, or a combination of sodium propionate 
and calcium propionate.
    (d)(1) The name of a cold-pack cheese for which a definition and 
standard of identity is prescribed by this section is ``Cold-pack ___ 
cheese'', ``___ cold-pack cheese'' or ``___ club cheese'', the blanks 
being filled in with the name or names of the varieties of cheese used, 
in order of predominance by weight.
    (2) If the cold-pack cheese is made of cheddar cheese, washed curd 
cheese, colby cheese, or granular cheese or any mixture of two or more 
of these, it may be designated ``Cold-pack American cheese''; or when 
cheddar cheese, washed curd cheese, colby cheese, granular cheese, or 
any mixture of two or more of these is combined with other varieties of 
cheese in the cheese ingredient any of such cheeses or such mixture may 
be designated as ``American cheese''.
    (3) The full name of the food shall appear on the principal display 
panel of the label in type of uniform size, style, and color. Wherever 
any word or statement emphasizing the name of any ingredient appears on 
the label (other than in an ingredient statement as specified in 
paragraph (f) of this section) so conspicuously as to be easily seen 
under customary conditions of purchase, the full name of the food shall 
immediately and conspicuously precede or follow such word or statement 
in type of at least the same size as the type used in such word or 
statement.
    (e) The name of the food shall include a declaration of any 
flavoring, including smoke and substances prepared by condensing or 
precipitating wood smoke, that characterizes the product as specified in 
Sec. 101.22 of this chapter and a declaration of any spice that 
characterizes the product.
    (f) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter, except that cheddar cheese, washed curd cheese, colby 
cheese, granular cheese, or any mixture of two or more of these, may be 
designated as ``American cheese''.
    (1) Artificial coloring need not be declared.
    (2) If the cheese ingredient contains cheddar cheese, washed curd 
cheese, colby cheese, granular cheese, or any mixture of two or more of 
these, such

[[Page 504]]

cheese or such mixture may be designated as ``American cheese''.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10093, Mar. 19, 1984; 
58 FR 2892, Jan. 6, 1993]



Sec. 133.124  Cold-pack cheese food.

    (a)(1) Cold-pack cheese food is the food prepared by comminuting and 
mixing, without the aid of heat, one or more of the optional cheese 
ingredients prescribed in paragraph (c) of this section with one or more 
of the optional dairy ingredients prescribed in paragraph (d) of this 
section, into a homogeneous plastic mass. One or more of the optional 
ingredients specified in paragraph (e) of this section may be used.
    (2) All cheeses used in a cold-pack cheese food are made from 
pasteurized milk, or are held for not less than 60 days at a temperature 
of not less than 35 [deg]F before being comminuted.
    (3) The moisture content of a cold-pack cheese food is not more than 
44 percent, and the fat content is not less than 23 percent.
    (4) Moisture and fat are determined by the methods prescribed in 
Sec. 133.5 (a), (b), and (d), except that in determining moisture the 
loss in weight which occurs in drying for 5 hours, under the conditions 
prescribed in such method, is taken as the weight of moisture.
    (5) The weight of the cheese ingredient prescribed by paragraph 
(a)(1) of this section constitutes not less than 51 percent of the 
weight of the finished cold-pack cheese food.
    (6) The weight of each variety of cheese in the cold-pack cheese 
food made with two varieties of cheese is not less than 25 percent of 
the total weight of both, except that the weight of blue cheese, nuworld 
cheese, roquefort cheese, gorgonzola cheese, or limburger cheese is not 
less than 10 percent of the total weight of both. The weight of each 
variety of cheese in the cold-pack cheese food made with three or more 
varieties of cheese is not less than 15 percent of the total weight of 
all, except that the weight of blue cheese, nuworld cheese, roquefort 
cheese, gorgonzola cheese, or limburger cheese is not less than 5 
percent of the total weight of all. These limits do not apply to the 
quantity of cheddar cheese, washed curd cheese, colby cheese, and 
granular cheese in mixtures which are designated as ``American cheese'' 
as prescribed in paragraph (h)(5) of this section. Such mixtures are 
considered as one variety of cheese for the purposes of this paragraph 
(a)(6).
    (b) Cold-pack cheese food may be smoked, or the cheese or cheeses 
from which it is made may be smoked, before comminuting and mixing, or 
it may contain substances prepared by condensing or precipitating wood 
smoke.
    (c) The optional cheese ingredients referred to in paragraph (a) of 
this section are: One or more cheeses of the same or two or more 
varieties, except that cream cheese, neufchatel cheese, cottage cheese, 
creamed cottage cheese, cook cheese, and skim-milk cheese for 
manufacturing are not used, and except that semisoft part-skim cheese, 
part-skim spiced cheese, and hard grating cheese may not be used, alone 
or in combination with each other, as the cheese ingredient.
    (d) The optional dairy ingredients referred to in paragraph (a) of 
this section are: Cream, milk, skim milk, buttermilk, cheese whey, any 
of the foregoing from which part of the water has been removed, 
anhydrous milkfat, dehydrated cream, skim milk cheese for manufacturing, 
and albumin from cheese whey. All optional dairy ingredients used in 
cold-pack cheese food are pasteurized or made from products that have 
been pasteurized.
    (e) The other optional ingredients referred to in paragraph (a) of 
this section are:
    (1) An acidifying agent consisting of one or any mixture of two or 
more of the following: A vinegar, lactic acid, citric acid, acetic acid, 
and phosphoric acid, in such quantity that the pH of the finished cold-
pack cheese food is not below 4.5.
    (2) Water.
    (3) Salt.
    (4) Harmless artificial coloring.
    (5) Spices or flavorings, other than any which singly or in 
combination with other ingredients simulate the flavor of cheese of any 
age or variety.
    (6) A sweetening agent consisting of one or any mixture of two or 
more of the following: Sugar, dextrose, corn

[[Page 505]]

sugar, corn sirup, corn sirup solids, glucose sirup, glucose sirup 
solids, maltose, malt sirup, and hydrolyzed lactose, in a quantity 
necessary for seasoning.
    (7) Cold-pack cheese food in consumer-sized packages may contain an 
optional mold-inhibiting ingredient consisting of sorbic acid, potassium 
sorbate, sodium sorbate, or any combination of two or more of these, in 
an amount not to exceed 0.3 percent by weight, calculated as sorbic acid 
or consisting of not more than 0.3 percent by weight of sodium 
propionate, calcium propionate, or a combination of sodium propionate 
and calcium propionate.
    (8) In the preparation of cold-pack cheese food, guar gum or xanthan 
gum, or both, may be used, but the total quantity of such ingredient or 
combination is not to exceed 0.3 percent of the weight of the finished 
food. When one or both such optional ingredients is used, dioctyl sodium 
sulfosuccinate complying with the requirements of Sec. 172.810 of this 
chapter may be used in a quantity not in excess of 0.5 percent by weight 
of such ingredient or ingredients.
    (f) The name of the food is ``cold-pack cheese food''. The full name 
of the food shall appear on the principal display panel of the label in 
type of uniform size, style, and color. Wherever any word or statement 
emphasizing the name of (other than in an ingredient statement any 
ingredient appears on the label as specified in paragraph (h) of this 
section) so conspicuously as to be easily seen under customary 
conditions of purchase, the full name of the food shall immediately and 
conspicuously precede or follow such word or statement in type of at 
least the same size as the type used in such word or statement.
    (g) The name of the food shall include a declaration of any 
flavoring, including smoke and substances prepared by condensing or 
precipitating wood smoke, that characterizes the product as specified in 
Sec. 101.22 of this chapter and a declaration of any spice that 
characterizes the product.
    (h) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter, except that cheddar cheese, washed curd cheese, colby 
cheese, granular cheese, or any mixture of two or more of these, may be 
designated as ``American cheese''.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10093, Mar. 19, 1984; 
58 FR 2892, Jan. 6, 1993]



Sec. 133.125  Cold-pack cheese food with fruits, vegetables, or meats.

    (a) Cold-pack cheese food with fruits, vegetables, or meats or 
mixtures of these is the food which conforms to the definition and 
standard of identity, and is subject to the requirements for label 
declaration of ingredients, prescribed for cold pack cheese food by 
Sec. 133.124, except that:
    (1) Its milk fat content is not less than 22 percent.
    (2) It contains one or any mixture of two or more of the following: 
Any properly prepared fresh, cooked, canned, or dried vegetable; any 
properly prepared cooked or canned meat.
    (3) When the added fruits, vegetables, or meats contain fat, the 
method prescribed for the determination of fat by Sec. 133.5(b) and (d) 
is not applicable.
    (b) The name of a cold-pack cheese food with fruits, vegetables or 
meats is ``Cold-pack cheese food with ___'', the blank being filled in 
with the common or usual name or names of the fruits, vegetables, or 
meats used, in order of predominance by weight.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10093, Mar. 19, 1984; 
58 FR 2892, Jan. 6, 1993]



Sec. 133.127  Cook cheese, koch kaese.

    (a) Description. (1) Cook cheese, koch kaese, is the food prepared 
by the procedure set forth in paragraph (a)(3) of this section or by any 
other procedure which produces a finished cheese having the same 
physical and chemical properties. The maximum moisture content is 80 
percent by weight, as determined by the method described in Sec. 133.5. 
The dairy ingredients used may be pasteurized.
    (2) The phenol equivalent value of 0.25 gram of cook cheese is not 
more than 3 micrograms as determined by the method described in Sec. 
133.5.

[[Page 506]]

    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of a 
lactic acid-producing bacterial culture. One or more of the clotting 
enzymes specified in paragraph (b)(2) of this section is added to set 
the dairy ingredients to a semisolid mass. The mass is cut, stirred, and 
heated with continued stirring, so as to separate the curd and whey. The 
whey is drained from the curd and the curd is cured for 2 or 3 days. It 
is then heated to a temperature of not less than 180 [deg]F until the 
hot curd will drop from a ladle with a consistency like that of honey. 
The hot cheese is filled into packages and cooled. One or more of the 
other optional ingredients specified in paragraph (b)(3) of this section 
may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Nonfat milk as defined in Sec. 133.3.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Calcium chloride in an amount 
not more than 0.02 percent (calculated as anhydrous calcium chloride) of 
the weight of the dairy ingredients, used as a coagulation aid.
    (ii) Culture of white mold.
    (iii) Pasteurized cream.
    (iv) Caraway seed.
    (v) Salt.
    (c) Nomenclature. The name of the food is ``cook cheese'' or, 
alternatively, ``koch kaese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130, except that enzymes of animal, plant, or microbial 
origin may be declared as ``enzymes''.

[54 FR 32053, Aug. 4, 1989, as amended at 55 FR 51409, Dec. 14, 1990; 58 
FR 2892, Jan. 6, 1993]



Sec. 133.128  Cottage cheese.

    (a) Cottage cheese is the soft uncured cheese prepared by mixing 
cottage cheese dry curd with a creaming mixture as provided in paragraph 
(b) of this section. The milkfat content is not less than 4 percent by 
weight of the finished food, within limits of good manufacturing 
practice. The finished food contains not more than 80 percent of 
moisture, as determined by the method prescribed in Sec. 133.129(a).
    (b) The creaming mixture is prepared from safe and suitable 
ingredients including, but not limited to, milk or substances derived 
from milk. Any ingredients used that are not derived from milk shall 
serve a useful function other than building the total solids content of 
the finished food, and shall be used in a quantity not greater than is 
reasonably required to accomplish their intended effect. The creaming 
mixture shall be pasteurized; however, heat labile ingredients, such as 
bacterial starters, may be added following pasteurization.
    (c) The name of the food consists of the following two phrases which 
shall appear together:
    (1) The words ``cottage cheese'' which shall appear in type of the 
same size and style.
    (2) The statement ``not less than _ percent milkfat'' or ``_ percent 
milkfat minimum'', the blank being filled in with the whole number that 
is closest to, but does not exceed, the actual fat content of the 
product. This statement of fat content shall appear in letters not less 
than one-half of the height of the letters in the phrase specified in 
paragraph (c)(1) of this section, but in no case less than one-eighth of 
an inch in height.
    (d) When the optional process described in Sec. 133.129(b)(1) (ii) 
or (iii) is used to make the cottage cheese dry curd used in cottage 
cheese, the label shall bear the statement ``Directly set'' or ``Curd 
set by direct acidification''. Wherever the name of the food appears on 
the label so conspicuously as to be seen under customary conditions of 
purchase, the statement specified in this paragraph, showing the 
optional process used, shall immediately and conspicuously precede or 
follow such name without intervening written, printed, or graphic 
matter.
    (e) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections

[[Page 507]]

of parts 101 and 130 of this chapter, except that milk-clotting enzymes 
may be declared by the word ``enzymes''.

[42 FR 14366, Mar. 15, 1977, as amended at 58 FR 2892, Jan. 6, 1993]



Sec. 133.129  Dry curd cottage cheese.

    (a) Cottage cheese dry curd is the soft uncured cheese prepared by 
the procedure set forth in paragraph (b) of this section. The finished 
food contains less than 0.5 percent milkfat. It contains not more than 
80 percent of moisture, as determined by the method prescribed in Sec. 
133.5(a).
    (b)(1) One or more of the dairy ingredients specified in paragraph 
(b)(2) of this section is pasteurized; calcium chloride may be added in 
a quantity of not more than 0.02 percent (calculated as anhydrous 
calcium chloride) of the weight of the mix; thereafter one of the 
following methods is employed:
    (i) Harmless lactic-acid-producing bacteria, with or without rennet 
and/or other safe and suitable milk-clotting enzyme that produces 
equivalent curd formation, are added and it is held until it becomes 
coagulated. The coagulated mass may be cut; it may be warmed; it may be 
stirred; it is then drained. The curd may be washed with water and 
further drained; it may be pressed, chilled, worked, seasoned with salt; 
or
    (ii) Food grade phosphoric acid, lactic acid, citric acid, or 
hydrochloric acid, with or without rennet and/or other safe and suitable 
milk-clotting enzyme that produces equivalent curd formation, is added 
in such amount as to reach a pH of between 4.5 and 4.7; coagulation to a 
firm curd is achieved while heating to a maximum of 120 [deg]F without 
agitation during a continuous process. The coagulated mass may be cut; 
it may be warmed; it may be stirred; it is then drained. The curd is 
washed with water, stirred, and further drained. It may be pressed, 
chilled, worked, seasoned with salt.
    (iii) Food grade acids as provided in paragraph (b)(1)(ii) of this 
section, D-Glucono-delta-lactone with or without rennet, and/or other 
safe and suitable milk clotting enzyme that produces equivalent curd 
formation, are added in such amounts as to reach a final pH value in the 
range of 4.5-4.8, and it is held until it becomes coagulated. The 
coagulated mass may be cut; it may be warmed; it may be stirred; it is 
then drained. The curd is then washed with water, and further drained. 
It may be pressed, chilled, worked, and seasoned with salt.
    (2) The dairy ingredients referred to in paragraph (b)(1) of this 
section are sweet skim milk, concentrated skim milk, and nonfat dry 
milk. If concentrated skim milk or nonfat dry milk is used, water may be 
added in a quantity not in excess of that removed when the skim milk was 
concentrated or dried.
    (3) For the purposes of this section the term ``skim milk'' means 
the milk of cows from which the milk fat has been separated, and 
``concentrated skim milk'' means skim milk from which a portion of the 
water has been removed by evaporation.
    (c) The name of the food consists of the following two phrases which 
shall appear together:
    (1) The words ``cottage cheese dry curd'' or alternatively ``dry 
curd cottage cheese'' which shall all appear in type of the same size 
and style.
    (2) The words ``less than \1/2\% milkfat'' which shall all appear in 
letters not less than one-half of the height of the letters in the 
phrase specified in paragraph (c)(1) of this section, but in no case 
less than one-eighth of an inch in height.
    (d) When either of the optional processes described in paragraph 
(b)(1) (ii) or (iii) of this section is used to make cottage cheese dry 
curd, the label shall bear the statement ``Directly set'' or ``Curd set 
by direct acidification''. Wherever the name of the food appears on the 
label so conspicuously as to be seen under customary conditions of 
purchase, the statement specified in this paragraph, showing the 
optional process used, shall immediately and conspicuously precede or 
follow such name without intervening written, printed, or graphic 
matter.
    (e) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections

[[Page 508]]

of parts 101 and 130 of this chapter, except that milk-clotting enzymes 
may be declared by the word ``enzymes''.

[42 FR 14366, Mar. 15, 1977, as amended at 47 FR 11826, Mar. 19, 1982; 
49 FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, 1993]



Sec. 133.133  Cream cheese.

    (a) Description. (1) Cream cheese is the soft, uncured cheese 
prepared by the procedure set forth in paragraph (a)(2) of this section, 
or by any other procedure which produces a finished cheese having the 
same physical and chemical properties. The minimum milkfat content is 33 
percent by weight of the finished food, and the maximum moisture content 
is 55 percent by weight, as determined by the methods described in Sec. 
133.5. The dairy ingredients used are pasteurized.
    (2) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be homogenized and is subjected to the action 
of lactic acid-producing bacterial culture. One or more of the clotting 
enzymes specified in paragraph (b)(2) of this section is added to 
coagulate the dairy ingredients. The coagulated mass may be warmed and 
stirred and it is drained. The moisture content may be adjusted with one 
or more of the optional ingredients specified in paragraph (b)(3)(ii) of 
this section. The curd may be pressed, chilled, and worked and it may be 
heated until it becomes fluid. It may then be homogenized or otherwise 
mixed. One or more of the optional dairy ingredients specified in 
paragraph (b)(1) and the other optional ingredients specified in 
paragraph (b)(3) of this section may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Salt.
    (ii) Cheese whey, concentrated cheese whey, dried cheese whey, or 
reconstituted cheese whey prepared by addition of water to concentrated 
cheese whey or dried cheese whey.
    (iii) Stabilizers, in a total amount not to exceed 0.5 percent of 
the weight of the finished food, with or without the addition of dioctyl 
sodium sulfosuccinate in a maximum amount of 0.5 percent of the weight 
of the stabilizer(s) used.
    (c) Nomenclature. The name of the food is ``cream cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial original may be declared 
as ``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[54 FR 32053, Aug. 4, 1989, as amended at 58 FR 2892, Jan. 6, 1993]



Sec. 133.134  Cream cheese with other foods.

    (a) Description. Cream cheese with other foods is the class of foods 
prepared by mixing, with or without the aid of heat, cream cheese with 
one or a mixture of two or more types of foods (except other cheeses) 
listed in paragraph (b)(1) of this section, in an amount sufficient to 
differentiate the mixture from cream cheese. One or more of the other 
optional ingredients in paragraph (b)(2) of this section may be used. 
The maximum moisture content of the mixture is 60 percent by weight. The 
minimum milkfat is 33 percent by weight of the cream cheese and in no 
case less than 27 percent of the finished food. The moisture and fat 
contents will be determined by the methods described in Sec. 133.5, 
except that the method for determination of fat content is not 
applicable when the added food contains fat.
    (b) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (1) Foods. Properly prepared fresh, cooked, canned, or dried fruits 
or vegetables; cooked or canned meats, relishes, pickles, or other 
suitable foods.
    (2) Other optional ingredients. (i) Stabilizers, in a total amount 
not to exceed 0.8 percent, with or without the

[[Page 509]]

addition of dioctyl sodium sulfosuccinate in a maximum amount of 0.5 
percent of the weight of the stabilizer(s) used.
    (ii) Coloring.
    (c) Nomenclature. The name of the food is ``cream cheese with ___'' 
or, alternatively, ``cream cheese and ___'', the blank being filled in 
with the name of the foods used in order of predominance by weight.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[54 FR 32053, Aug. 4, 1989, as amended at 58 FR 2893, Jan. 6, 1993]



Sec. 133.136  Washed curd and soaked curd cheese.

    (a) Description. (1) Washed curd, soaked curd cheese is the food 
prepared by the procedure set forth in paragraph (a)(3) of this section 
or by any other procedure which produces a finished cheese having the 
same physical and chemical properties. The minimum milkfat content is 50 
percent by weight of the solids and the maximum moisture content is 42 
percent by weight, as determined by the methods described in Sec. 
133.5. If the dairy ingredients used are not pasteurized, the cheese is 
cured at a temperature of not less than 35 [deg]F for at least 60 days.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of washed curd cheese is not more than 3 micrograms 
as determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed, treated with hydrogen peroxide/
catalase, and is subjected to the action of a lactic acid-producing 
bacterial culture. One or more of the clotting enzymes specified in 
paragraph (b)(2) of this section is added to set the dairy ingredients 
to a semisolid mass. The mass is so cut, stirred, and heated with 
continued stirring, as to promote and regulate the separation of whey 
and curd. The whey is drained off, and the curd is matted into a 
cohesive mass. The mass is cut into slabs, which are so piled and 
handled as to promote the drainage of whey and the development of 
acidity. The slabs are then cut into pieces, cooled in water, and soaked 
therein until the whey is partly extracted and water is absorbed. The 
curd is drained, salted, stirred, and pressed into forms. One or more of 
the other optional ingredients specified in paragraph (b)(3) of this 
section may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iv) Antimycotic agents, the cumulative levels of which shall not 
exceed current good manufacturing practice, may be added to the surface 
of the cheese.
    (v) Hydrogen peroxide, followed by a sufficient quantity of catalase 
preparation to eliminate the hydrogen peroxide. The weight of the 
hydrogen peroxide shall not exceed 0.05 percent of the weight of the 
dairy ingredients and the weight of the catalase shall not exeed 20 
parts per million of the weight of dairy ingredients treated.
    (c) Nomenclature. The name of the food is ``washed curd cheese'' or, 
alternatively, ``soaked curd cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:

[[Page 510]]

    (1) Enzymes of animal, plant or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[54 FR 32054, Aug. 4, 1989, as amended at 58 FR 2893, Jan. 6, 1993]



Sec. 133.137  Washed curd cheese for manufacturing.

    Washed curd cheese for manufacturing conforms to the definition and 
standard of identity prescribed for washed curd cheese by Sec. 133.136, 
except that the dairy ingredients are not pasteurized and curing is not 
required.

[54 FR 32054, Aug. 4, 1989]



Sec. 133.138  Edam cheese.

    (a) Description. (1) Edam cheese is the food prepared by the 
procedure set forth in paragraph (a)(3) of this section or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. The minimum milkfat content is 40 percent by weight 
of the solids and the maximum moisture content is 45 percent by weight, 
as determined by the methods described in Sec. 133.5. If the dairy 
ingredients used are not pasturized, the cheese is cured at a 
temperature of not less than than 35 [deg]F for at least 60 days.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of edam cheese is not more than 3 micrograms, as 
determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of a 
lactic acid-producing bacterial culture. One or more of the clotting 
enzymes specified in paragraph (b)(2) of this section is added to set 
the dairy ingredients to a semisolid mass. After coagulation the mass is 
cut into small cube-shaped pieces with sides approximately three-
eighths-inch long. The mass is stirred and heated to about 90 [deg]F. 
and so handled by further stirring, heating, dilution with water or salt 
brine, and salting as to promote and regulate the separation of curd and 
whey. When the desired curd is obtained, it is transferred to forms 
permitting drainage of whey. During drainage the curd is pressed and 
turned. After drainage the curd is removed from the forms and is salted 
and cured. One or more of the other optional ingredients specified in 
paragraph (b)(3) of this section may be added during the procedures.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iv) Antimycotic agents, the cumulative levels of which shall not 
exceed current good manufacturing practice, may be added to the surface 
of the cheese.
    (c) Nomenclature. The name of the food is ``edam cheese.''
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat,'' as appropriate.

[48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 55 
FR 6795, Feb. 27, 1990; 58 FR 2893, Jan. 6, 1993]



Sec. 133.140  Gammelost cheese.

    (a) Description. (1) Gammelost cheese is the food prepared from 
nonfat milk, as defined in Sec. 133.3, by the procedure set forth in 
paragraph (a)(2) of this section, or by any other procedure which

[[Page 511]]

produces a finished cheese having the same physical and chemical 
properties. The maximum moisture content is 52 percent by weight, as 
determined by the methods described in Sec. 133.5.
    (2) The dairy ingredients are subjected to the action of a lactic 
acid-producing bacterial culture. The development of acidity is 
continued until the dairy ingredients coagulate to a semisolid mass. The 
mass is stirred and heated until a temperature of about 145 [deg]F is 
reached, and is held at that temperature for at least 30 minutes. The 
whey is drained off and the curd removed and placed in forms and 
pressed. The shaped curd is placed in whey and heated for 3 or 4 hours, 
and may again be pressed. It is then stored under conditions suitable 
for curing.
    (b) Nomenclature. The name of the food is ``gammelost cheese''.
    (c) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[54 FR 32054, Aug. 4, 1989, as amended at 58 FR 2893, Jan. 6, 1993]



Sec. 133.141  Gorgonzola cheese.

    (a) Description. (1) Gorgonzola cheese is the food prepared by the 
procedure set forth in paragraph (a)(2) of this section or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. It is characterized by the presence of bluish-green 
mold, Penicillium roque fortii, throughout the cheese. The minimum 
milkfat content is 50 percent by weight of the solids and the maximum 
moisture content is 42 percent by weight, as determined by the methods 
described in Sec. 133.5. The dairy ingredients used may be pasteurized. 
Gorgonzola cheese is at least 90 days old.
    (2) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of a 
lactic acid-producing bacterial culture. One or more of the clotting 
enzymes specified in paragraph (b)(2) of this section is added to set 
the dairy ingredients to a semisolid mass. The mass is cut into smaller 
portions and allowed to stand for a time. The mixed curd and whey is 
placed into forms permitting further drainage. While being placed in 
forms, spores of the mold Penicillium roque fortii are added. The forms 
are turned several times during drainage. When sufficiently drained, the 
shaped curd is removed from the forms and salted with dry salt or brine. 
Perforations are then made in the shaped curd and it is held at a 
temperature of approximately 50 [deg]F at 90 to 95 percent relative 
humidity, until the characteristic mold growth has developed. During 
storage, the surface of the cheese may be scraped to remove surface 
growth of undesirable microorganisms. One or more of the other optional 
ingredients specified in paragraph (b)(3) of this section may be added 
during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, or corresponding products of goat origin, used alone or in 
combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Blue or green color in an amount 
to neutralize the natural yellow color of the curd.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iv) Antimycotic agents, the cumulative levels of which shall not 
exceed current good manufacturing practice, may be added to the surface 
of the cheese.
    (v) Benzoyl peroxide, or a mixture of benzoyl peroxide with 
potassium alum, calcium sulfate, and magnesium carbonate used to bleach 
the dairy ingredients. The weight of the benzoyl peroxide is not more 
than 0.002 percent of the weight of the dairy ingredients being 
bleached, and the weight of the potassium alum, calcium sulfate, and 
magnesium carbonate, singly or combined, is not more than six times the 
weight of the benzoyl peroxide used. If the dairy ingredients are 
bleached in

[[Page 512]]

this manner, vitamin A is added to the curd in such quantity as to 
compensate for the vitamin A or its precursors destroyed in the 
bleaching process, and artificial coloring is not used.
    (vi) Vegetable fats or oil which may be hydrogenated, used as a 
coating for the rind.
    (c) Nomenclature. The name of the food is ``gorgonzola cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate; ``milkfat from goat's milk 
and nonfat goat's milk'', etc.

[54 FR 32054, Aug. 4, 1989, as amended at 58 FR 2893, Jan. 6, 1993]



Sec. 133.142  Gouda cheese.

    Gouda cheese conforms to the definition and standard of identity and 
complies with the requirements for label declaration of ingredients 
prescribed for edam cheese by Sec. 133.138, except that the minimum 
milkfat content is 46 percent by weight of the solids, as determined by 
the methods described in Sec. 133.5 and the maximum moisture content is 
45 percent by weight.

[48 FR 2744, Jan. 21, 1983]



Sec. 133.144  Granular and stirred curd cheese.

    (a) Description. (1) Granular cheese, stirred curd cheese is the 
food prepared by the procedure set forth in paragraph (a)(3) of this 
section or by any other procedure which produces a finished cheese 
having the same physical and chemical properties. The minimum milkfat 
content is 50 percent by weight of the solids and the maximum moisture 
content is 39 percent by weight as determined by the methods described 
in Sec. 133.5. If the dairy ingredients used are not pasteurized, the 
cheese is cured at a temperature of not less than 35 [deg]F for at least 
60 days.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of granular cheese is not more than 3 micrograms as 
determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed, treated with hydrogen peroxide/
catalase, and is subjected to the action of a lactic acid-producing 
bacterial culture. One or more of the clotting enzymes specified in 
paragraph (b)(2) of this section is added to set the dairy ingredients 
to a semisolid mass. The mass is so cut, stirred, and heated with 
continued stirring, as to promote and regulate the separation of whey 
and curd. A part of the whey is drained off. The curd is then 
alternately stirred and drained to prevent matting and to remove whey 
from curd. The curd is then salted, stirred, drained, and pressed into 
forms. One or more of the other optional ingredients specified in 
paragraph (b)(3) of this section may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) by weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iv) Antimycotic agents, the cumulative levels of which shall not 
exceed current good manufacturing practice, may be added to the surface 
of the cheese.
    (v) Hydrogen peroxide, followed by a sufficient quantity of catalase 
preparation to eliminate the hydrogen peroxide. The weight of the 
hydrogen peroxide shall not exceed 0.05 percent of the weight of the 
dairy ingredients and

[[Page 513]]

the weight of the catalase shall not exceed 20 parts per million of the 
weight of the dairy ingredients treated.
    (c) Nomenclature. The name of the food is ``granular cheese'' or, 
alternatively, ``stirred curd cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[54 FR 32055, Aug. 4, 1989, as amended at 58 FR 2893, Jan. 6, 1993]



Sec. 133.145  Granular cheese for manufacturing.

    Granular cheese for manufacturing conforms to the definition and 
standard of identity prescribed for granular cheese by Sec. 133.144, 
except that the dairy ingredients are not pasteurized and curing is not 
required.

[54 FR 32056, Aug. 4, 1989]



Sec. 133.146  Grated cheeses.

    (a) Description. Grated cheeses is the class of foods prepared by 
grinding, grating, shredding, or otherwise comminuting cheese of one 
variety or a mixture of two or more varieties. The cheese varieties that 
may be used are those for which there are definitions and standards of 
identity, except that cream cheese, neufchatel cheese, cottage cheese, 
creamed cottage cheese, cook cheese, and skim milk cheese for 
manufacturing may not be used. All cheese ingredients used are either 
made from pasteurized milk or held at a temperature of not less than 35 
[deg]F for at least 60 days. Moisture may be removed from the cheese 
ingredients in the manufacture of the finished food, but no moisture is 
added. One or more of the optional ingredients specified in paragraph 
(c) of this section may be used.
    (b) Composition. (1) Each cheese ingredient used is present at a 
minimum level of 2 percent of the weight of the finished food.
    (2) When one variety of cheese is used, the minimum milkfat content 
of the food is not more than 1 percent lower than the minimum prescribed 
by the standard of identity for that cheese.
    (3) When two or more varieties of cheese are used, the minimum 
milkfat content is not more than 1 percent below the arithmetical 
average of the minimum fat content percentages prescribed by the 
standards of identity for the varieties of cheese used, and in no case 
is the milkfat content less than 31 percent.
    (4) Milkfat and moisture contents are determined by the methods 
described in Sec. 133.5.
    (c) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Antimycotics.
    (2) Anticaking agents.
    (3) Spices.
    (4) Flavorings other than those which, singly or in combination with 
other ingredients, simulate the flavor of cheese of any age or variety.
    (d) Nomenclature. (1) The name of the food is ``grated cheese'' or 
``grated cheeses'', as appropriate. The name of the food shall be 
accompanied by a declaration of the specific variety of cheese(s) used 
in the food and by a declaration indicating the presence of any added 
spice or flavoring.
    (2) Any cheese varietal names used in the name of the food are those 
specified by applicable standards of identity, except that the 
designation ``American cheese'' may be used for cheddar, washed curd, 
colby, or granular cheese or for any mixture of these cheeses.
    (3) The following terms may be used in place of the name of the food 
to describe specific types of grated cheese:
    (i) If only one variety of cheese is used, the name of the food is 
``grated ___ cheese'', the name of the cheese filling the blank.
    (ii) If only parmesan and romano cheeses are used and each is 
present at a level of not less than 25 percent by weight of the finished 
food, the name of the food is ``grated ___ and ___ cheese'', the blanks 
being filled with

[[Page 514]]

the names ``parmesan'' and ``romano'' in order of predominance by 
weight. The name ``reggiano'' may be used for ``parmesan''.
    (iii) If a mixture of cheese varieties (not including parmesan or 
romano) is used and each variety is present at a level of not less than 
25 percent of the weight of the finished food, the name of the food is 
``grated ___ cheese'', the blank being filled in with the names of the 
varieties in order of predominance by weight.
    (iv) If a mixture of cheese varieties in which one or more varieties 
(not including parmesan or romano) are each present at a level of not 
less than 25 percent by weight of the finished food, and one or more 
other varieties (which may include parmesan and romano cheese) are each 
present at a level of not less than 2 percent but in the aggregate not 
more than 10 percent of the weight of the finished food, the name of the 
food is ``grated ___ cheese with other grated cheese'' or ``grated ___ 
cheese with other grated cheeses'', as appropriate, the blank being 
filled in with the name or names of those cheese varieties present at 
levels of not less than 25 percent by weight of the finished food in 
order of predominance, in letters not more than twice as high as the 
letters in the phrase ``with other grated cheese(s)''.
    (4) The following terms may be used in place of ``grated'' to 
describe alternative forms of cheese:
    (i) ``Shredded'', if the particles of cheese are in the form of 
cylinders, shreds, or strings.
    (ii) ``Chipped'' or ``chopped'', if the particles of cheese are in 
the form of chips.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', ``milkfat from goat's milk and nonfat 
goat's milk'', ``milkfat from sheep's milk and nonfat sheep's milk'', 
etc., as appropriate.

[54 FR 32056, Aug. 4, 1989; 54 FR 35756, Aug. 29, 1989, as amended at 58 
FR 2893, Jan. 6, 1993]



Sec. 133.147  Grated American cheese food.

    (a)(1) Grated American cheese food is the food prepared by mixing, 
with or without the aid of heat, one or more of the optional cheese 
ingredients prescribed in paragraph (b) of this section with one or more 
of the optional ingredients prescribed in paragraph (c) of this section, 
into a uniformly blended, partially dehydrated, powdered, or granular 
mixture.
    (2) Grated American cheese food contains not less than 23 percent of 
milkfat, as determined by the method prescribed in Sec. 133.5(b).
    (b) The optional cheese ingredients referred to in paragraph (a) of 
this section are cheddar cheese, washed curd cheese, colby cheese, and 
granular cheese.
    (c) The other optional ingredients referred to in paragraph (a) of 
this section are:
    (1) Nonfat dry milk.
    (2) Dried whey.
    (3) An emulsifying agent consisting of one or any mixture of two or 
more of the emulsifying ingredients named in Sec. 133.173(e)(1), in 
such quantity that the weight of the solids thereof is not more than 3 
percent of the weight of the grated American cheese food.
    (4) An acidifying agent consisting of one or more of the acid-
reacting ingredients named in Sec. 133.173(e)(2).
    (5) Salt.
    (6) Artificial coloring.
    (d) The name of the food is ``Grated American cheese food''. The 
full name of the food shall appear on the principal display panel of the 
label in type of uniform size, style, and color. Wherever any word or 
statement emphasizing the name of any ingredient appears on the label 
(other than in an ingredient statement as specified in paragraph (e) of 
this section) so conspicuously as to be easily seen under customary 
conditions of purchase, the full name of the food shall immediately and 
conspicuously precede or follow such word or statement in type of at

[[Page 515]]

least the same size as the type used in such word or statement.
    (e) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter, except that cheddar cheese, washed curd cheese, colby 
cheese, granular cheese, or any mixture of two or more of these may be 
designated ``American cheese''.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10094, Mar. 19, 1984; 
58 FR 2893, Jan. 6, 1993]



Sec. 133.148  Hard grating cheeses.

    (a) The cheeses for which definitions and standards of identity are 
prescribed by this section are hard grating cheeses for which 
specifically applicable definitions and standards of identity are not 
prescribed by other sections of this part. They are made from milk and 
the other ingredients specified in this section, by the procedure set 
forth in paragraph (b) of this section. They contain not more than 34 
percent of moisture, and their solids contain not less than 32 percent 
of milkfat, as determined by the methods prescribed in Sec. 133.5 (a), 
(b), and (d). Hard grating cheeses are cured for not less than 6 months.
    (b) Milk, which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria or other harmless flavor-producing bacteria, present 
in such milk or added thereto. Sufficient rennet, rennet paste, extract 
of rennet paste, or other safe and suitable milk-clotting enzyme that 
produces equivalent curd formation, singly or in any combination (with 
or without purified calcium chloride in a quantity not more than 0.02 
percent, calculated as anhydrous calcium chloride, of the weight of the 
milk) is added to set the milk to a semisolid mass. Harmless artificial 
coloring may be added. The mass is cut into small particles, stirred, 
and heated. The curd is separated from the whey, drained, shaped into 
forms, pressed, salted, and cured. The rind may be colored or rubbed 
with vegetable oil or both. A harmless preparation of enzymes of animal 
or plant origin capable of aiding in the curing or development of flavor 
of hard grating cheese may be added during the procedure, in such 
quantity that the weight of the solids of such preparation is not more 
than 0.1 percent of the weight of the milk used.
    (c) For the purposes of this section, the word ``milk'' means cow's 
milk or goat's milk or sheep's milk or mixtures of two or all of these. 
Such milk may be adjusted by separating part of the fat therefrom or (in 
the case of cow's milk) by adding one or more of the following: Cream, 
skim milk, concentrated skim milk, nonfat dry milk; (in the case of 
goat's milk) the corresponding products from goat's milk; (in the case 
of sheep's milk) the corresponding products from sheep's milk; water in 
a quantity sufficient to reconstitute any such concentrated or dried 
products used.
    (d) Safe and suitable antimycotic agent(s), the cumulative levels of 
which shall not exceed current good manufacturing practice, may be added 
to the surface of the cheese.
    (e) The name of each hard grating cheese for which a definition and 
standard of identity is prescribed by this section is ``Hard grating 
cheese'', preceded or followed by:
    (1) The specific common or usual name of such hard grating cheese, 
if any such name has become generally recognized therefor; or
    (2) If no such specific common or usual name has become generally 
recognized therefor, an arbitrary or fanciful name that is not false or 
misleading in any particular.
    (3) When milk other than cow's milk is used, in whole or in part, 
the statement ``made from ___'', the blank being filled in with the name 
or names of the milk used, in order of predominance by weight.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) When milk other than cow's milk is used, in whole or in part, 
the common or usual name of each such milk ingredient shall be declared 
in order of predominance by weight; and

[[Page 516]]

    (2) Enzymes of the animal, plant, or microbial origin may be 
declared as ``enzymes''.

[42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49013, Oct. 24, 1983; 
49 FR 10094, Mar. 19, 1984; 58 FR 2893, Jan. 6, 1993]



Sec. 133.149  Gruyere cheese.

    (a) Description. (1) Gruyere cheese is the food prepared by the 
procedure set forth in paragraph (a)(3) of this section or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. It contains small holes or eyes. It has a mild 
flavor, due in part to the growth of surface-curing agents. The minimum 
milkfat content is 45 percent by weight of the solids and the maximum 
moisture content is 39 percent by weight, as determined by the methods 
described in Sec. 133.5. The dairy ingredients used may be pasteurized. 
The cheese is at least 90 days old.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of gruyere cheese is not more than 3 micrograms as 
determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of 
lactic acid-producing and propionic acid-producing bacterial cultures. 
One or more of the clotting enzymes specified in paragraph (b)(2) of 
this section is added to set the dairy ingredients to a semisolid mass. 
The mass is cut into particles similar in size to wheat kernels. For 
about 30 minutes the particles are alternately stirred and allowed to 
settle. The temperature is raised to about 126 [deg]F. Stirring is 
continued until the curd becomes firm. The curd is transferred to hoops 
or forms, and pressed until the desired shape and firmness are obtained. 
The cheese is surface-salted while held at a temperature of 48[deg] to 
54 [deg]F for a few days. It is soaked for 1 day in a saturated salt 
solution. It is then held for 3 weeks in a salting cellar and wiped 
every 2 days with brine cloth to insure growth of biological curing 
agents on the rind. It is then removed to a heating room and held at 
progressively higher temperatures, finally reaching 65 [deg]F with a 
relative humidity of 85 to 90 percent, for several weeks, during which 
time small holes, or so-called eyes, form. The cheese is then stored at 
a lower temperature for further curing. One or more of the other 
optional ingredients specified in paragraph (b)(3) of this section may 
be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Calcium chloride in an amount 
not more than 0.02 percent (calculated as anhydrous calcium chloride) of 
the weight of the dairy ingredients, used as a coagulation aid.
    (ii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iii) Antimycotic agents, applied to the surface of slices or cuts 
in consumer-sized packages.
    (c) Nomenclature. The name of the food is ``gruyere cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[48 FR 2744, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 58 
FR 2893, Jan. 6, 1993]



Sec. 133.150  Hard cheeses.

    (a) The cheeses for which definitions and standards of identity are 
prescribed by this section are hard cheeses for which specifically 
applicable definitions and standards of identity are not prescribed by 
other sections of this part. They are made from milk and the other 
ingredients specified in this section, by the procedure set forth in 
paragraph (b) of this section. They contain not more than 39 percent of 
moisture, and their solids contain not less

[[Page 517]]

than 50 percent of milkfat, as determined by the methods prescribed in 
Sec. 133.5 (a), (b), and (d). If the milk used is not pasteurized, the 
cheese so made is cured at a temperature of not less than 35 [deg]F for 
not less than 60 days.
    (b) Milk, which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria, with or without other harmless flavor-producing 
bacteria, present in such milk or added thereto. Harmless artificial 
coloring may be added. Sufficient rennet, rennet paste, extract of 
rennet paste, or other safe and suitable milk-clotting enzyme that 
produces equivalent curd formation, singly or in any combination (with 
or without purified calcium chloride in a quantity not more than 0.02 
percent, calculated as anhydrous calcium chloride, of the weight of the 
milk) is added to set the milk to a semisolid mass. The mass is cut into 
small particles, stirred, and heated. The curd is separated from the 
whey, drained, and shaped into forms, and may be pressed. The curd is 
salted at some stage of the manufacturing process. The shaped curd may 
be cured. The rind may be coated with paraffin or rubbed with vegetable 
oil. A harmless preparation of enzymes of animal or plant origin capable 
of aiding in the curing or development of flavor of hard cheese may be 
added during the procedure, in such quantity that the weight of the 
solids of such preparation is not more than 0.1 percent of the weight of 
the milk used. Harmless flavor-producing microorganisms may be added, 
and curing may be conducted under suitable conditions for the 
development of biological curing agents.
    (c) For the purposes of this section:
    (1) The word ``milk'' means cow's milk or goat's milk or sheep's 
milk or mixtures of two or all of these. Such milk may be adjusted by 
separating part of the fat therefrom, or (in the case of cow's milk) by 
adding one or more of the following: Cream, skim milk, concentrated skim 
milk, nonfat dry milk; (in the case of goat's milk) the corresponding 
products from goat's milk; (in the case of sheep's milk) the 
corresponding products from sheep's milk; water in a quantity sufficient 
to reconstitute any concentrated or dried products used.
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a temperature of not less than 143 [deg]F for a period of not 
less than 30 minutes, or for a time and at a temperature equivalent 
thereto in phosphatase destruction. A hard cheese shall be deemed not to 
have been made from pasteurized milk if 0.25 gram shows a phenol 
equivalent of more than 3 micrograms when tested by the method 
prescribed in Sec. 133.5(c).
    (d) Safe and suitable antimycotic agent(s), the cumulative levels of 
which shall not exceed current good manufacturing practice, may be added 
to the surface of the cheese.
    (e) The name of each hard cheese for which a definition and standard 
of identity is prescribed by this section is ``Hard cheese'', preceded 
or followed by:
    (1) The specific common or unusual name of such hard cheese, if any 
such name has become generally recognized therefor; or
    (2) If no such specific common or usual name has become generally 
recognized, therefor, an arbitrary or fanciful name that is not false or 
misleading in any particular.
    (3) When milk other than cow's milk is used, in whole or in part, 
the statement ``made from ___'', the blank being filled in with the name 
or names of the milk used, in order of predominance by weight.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) When milk other than cow's milk is used, in whole or in part, 
the common or usual name of each such milk ingredient shall be declared 
in order of predominance by weight; and
    (2) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''.

[42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49013, Oct. 24, 1983; 
49 FR 10094, Mar. 19, 1984; 58 FR 2893, Jan. 6, 1993]

[[Page 518]]



Sec. 133.152  Limburger cheese.

    (a) Description. (1) Limburger cheese is the food prepared by one of 
the procedures set forth in paragraph (a)(3) of this section, or by any 
other procedure which produces a finished cheese having the same 
physical and chemical properties. The minimum milkfat content is 50 
percent by weight of the solids and the maximum moisture content is 50 
percent by weight, as determined by the methods described in Sec. 
133.5. If the dairy ingredients used are not pasteurized, the cheese is 
cured at a temperature of not less than 35 [deg]F for at least 60 days.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of limburger cheese is not more than 4 micrograms as 
determined by the method described in Sec. 133.5.
    (3) One of the following procedures may be followed for producing 
limburger cheese:
    (i) One or more of the dairy ingredients, unpasteurized, specified 
in paragraph (b)(1) of this section is warmed to about 92 [deg]F and 
subjected to the action of a lactic acid-producing bacterial culture. 
One or more of the clotting enzymes specified in paragraph (b)(2) of 
this section is added to set the dairy ingredients to a semisolid mass. 
The mass is cut into cubes with sides approximately one-half inch long. 
After a few minutes the mass is stirred and heated, gradually raising 
the temperature to 96[deg] to 98 [deg]F. The curd is then allowed to 
settle, most of the whey is drained off, and the remaining curd and whey 
dipped into molds. During drainage the curd may be pressed. It is turned 
at regular intervals. After drainage the curd is cut into pieces of 
desired size and dry-salted at intervals for 24 to 48 hours. The cheese 
is then cured with frequent applications of a weak brine solution to the 
surface, until the proper growth of surface-curing organisms is 
obtained. It is then wrapped and held in storage for development of as 
much additional flavor as is desired. One or more of the other optional 
ingredients specified in paragraph (b)(3) of this section may be added 
during the procedure.
    (ii) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section is pasteurized, brought to a temperature of 
89[deg] to 90 [deg]F. after pasteurization, and is subjected to the 
action of a lactic acid-producing bacterial culture. The procedure is 
then the same as in paragraph (a)(3)(i) of this section, except that 
heating is to 94 [deg]F. After most of the whey is drained off, salt 
brine at a temperature of 66[deg] to 70 [deg]F is added, so that the pH 
of the curd is about 4.8. The mixed curd, whey, and brine is dipped into 
molds, and the remaining procedure specified in paragraph (a)(3)(i) of 
this section is followed.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) by weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (c) Nomenclature. The name of the food is ``limburger cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[48 FR 2744, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 58 
FR 2893, Jan. 6, 1993]



Sec. 133.153  Monterey cheese and monterey jack cheese.

    (a) Description. (1) Monterey cheese, monterey jack cheese is the 
food prepared by the procedure set forth in paragraph (a)(3) of this 
section, or by any other procedure which produces a

[[Page 519]]

finished cheese having the same physical and chemical properties. The 
minimum milkfat content is 50 percent by weight of the solids, and the 
maximum moisture content is 44 percent by weight, as determined by the 
methods described in Sec. 133.5. The dairy ingredients used are 
pasteurized.
    (2) The phenol equivalent of 0.25 gram of monterey cheese is not 
more than 3 micrograms, as determined by the method described in Sec. 
133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section is subjected to the action of a lactic acid-
producing bacterial culture. One or more of the clotting enzymes 
specified in paragraph (b)(2) of this section is added to set the dairy 
ingredients to a semisolid mass. The mass is so cut, stirred, and heated 
with continued stirring, as to promote and regulate the separation of 
whey and curd. Part of the whey is drained off, and water or salt brine 
may be added. The curd is drained and placed in a muslin or sheeting 
cloth, formed into a ball, and pressed; or the curd is placed in a 
cheese hoop and pressed. Later, the cloth bandage is removed, and the 
cheese may be covered with a suitable coating. One or more of the other 
optional ingredients specified in paragraph (b)(3) of this section may 
be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Calcium chloride in an amount 
not more than 0.02 percent (calculated as anhydrous calcium chloride) by 
weight of the dairy ingredients, used as a coagulation aid.
    (ii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iii) Salt.
    (iv) Antimycotic agents, the cumulative levels of which shall not 
exceed current good manufacturing practice, may be added to the surface 
of the cheese.
    (v) Vegetable oil, with or without rice flour sprinkled on the 
surface, used as a coating for the rind.
    (c) Nomenclature. The name of the food is ``monterey cheese'' or 
alternatively, ``monterey jack cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes'', and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[54 FR 32056, Aug. 4, 1989, as amended at 58 FR 2893, Jan. 6, 1993]



Sec. 133.154  High-moisture jack cheese.

    High-moisture jack cheese conforms to the definition and standard of 
identity and is subject to the requirement for label statement of 
ingredients prescribed for monterey cheese by Sec. 133.153, except that 
its moisture content is more than 44 percent but less than 50 percent.

[58 FR 2893, Jan. 6, 1993]



Sec. 133.155  Mozzarella cheese and scamorza cheese.

    (a) Description. (1) Mozzarella cheese, scamorza cheese is the food 
prepared from dairy ingredients and other ingredients specified in this 
section by the procedure set forth in paragraph (a)(3) of this section, 
or by any other procedure which produces a finished cheese having the 
same physical and chemical properties. It may be molded into various 
shapes. The minimum milkfat content is 45 percent by weight of the 
solids, and the moisture content is more than 52 percent but not more 
than 60 percent by weight as determined by the methods described in 
Sec. 133.5. The dairy ingredients are pasteurized.
    (2) The phenol equivalent value of 0.25 gram of mozzarella cheese is 
not more than 3 micrograms as determined by the method described in 
Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of

[[Page 520]]

this section is warmed to approximately 88 [deg]F (31.1 [deg]C) and 
subjected to the action of a lactic acid-producing bacterial culture. 
One or more of the clotting enzymes specified in paragraph (b)(2) of 
this section is added to set the dairy ingredients to a semisolid mass. 
The mass is cut, and it may be stirred to facilitate separation of whey 
from the curd. The whey is drained, and the curd may be washed with cold 
water and the water drained off. The curd may be collected in bundles 
for further drainage and for ripening. The curd may be iced, it may be 
held under refrigeration, and it may be permitted to warm to room 
temperature and ripen further. The curd may be cut. It is immersed in 
hot water or heated with steam and is kneaded and stretched until smooth 
and free of lumps. It is then cut and molded. The molded curd is firmed 
by immersion in cold water and drained. One or more of the other 
optional ingredients specified in paragraph (b)(3) of this section may 
be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Cow's milk, nonfat milk, or cream, as defined 
in Sec. 133.3, or the corresponding products of water buffalo origin, 
except that cow's milk products are not combined with water buffalo 
products.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Vinegar.
    (ii) Coloring to mask any natural yellow color in the curd.
    (iii) Salt.
    (iv) Antimycotics, the cumulative levels of which shall not exceed 
current good manufacturing practice, may be added to the cheese during 
the kneading and stretching process and/or applied to the surface of the 
cheese.
    (c) Nomenclature. The name of the food is ``mozzarella cheese'' or, 
alternatively, ``scamorza cheese''. When the food is made with water 
buffalo milk, the name of the food is accompanied by the phrase ``made 
with water buffalo milk''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', ``milkfat from water buffalo milk and 
nonfat buffalo milk'' or ``nonfat water buffalo milk and milkfat from 
water buffalo milk,'' as appropriate.

[53 FR 3743, Feb. 9, 1988, as amended at 58 FR 2893, Jan. 6, 1993]



Sec. 133.156  Low-moisture mozzarella and scamorza cheese.

    (a) Description. (1) Low-moisture mozzarella cheese, low-moisture 
scamorza cheese is the food prepared from dairy ingredients and other 
ingredients specified in this section by the procedure set forth in 
paragraph (a)(3) of this section, or by any other procedure which 
produces a finished cheese having the same physical and chemical 
properties. It may be molded into various shapes. The minimum milkfat 
content is 45 percent by weight of the solids and the moisture content 
is more than 45 percent but not more than 52 percent by weight as 
determined by the methods described in Sec. 133.5. The dairy 
ingredients are pasteurized.
    (2) The phenol equivalent value of 0.25 gram of low-moisture 
mozzarella cheese is not more than 3 micrograms as determined by the 
method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of a 
lactic acid-producing bacterial culture. One or more of the clotting 
enzymes specified in paragraph (b)(2) of this action is added to set the 
dairy ingredients to a semisolid mass. The mass is cut, stirred, and 
allowed to stand. It may be reheated and again stirred. The whey is 
drained and the curd may be cut and piled to promote further separation 
of whey. It may be washed with cold water and the water drained off. The 
curd may be collected in bundles for further drainage and for ripening. 
The

[[Page 521]]

curd may be iced, it may be held under refrigeration, and it may be 
permitted to warm to room temperature and ripen further. The curd may be 
cut. It is immersed in hot water or heated with steam and is kneaded and 
stretched until smooth and free of lumps. It is then cut and molded. In 
molding, the curd is kept sufficiently warm to cause proper sealing of 
the surface. The molded curd is firmed by immersion in cold water and 
drained. One or more of the other optional ingredients specified in 
paragraph (b)(3) of this section may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Cow's milk, nonfat milk, or cream, as defined 
in Sec. 133.3, or the corresponding products of water buffalo origin, 
except that cow's milk products are not combined with water buffalo 
products.
    (2) Clotting enzymes. Rennet and/or clotting enzymes of animal, 
plant, or microbial origin.
    (3) Other optional ingredients. (i) Vinegar.
    (ii) Coloring to mask any natural yellow color in the curd.
    (iii) Salt.
    (iv) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (v) Antimycotics, the cumulative levels of which shall not exceed 
current good manufacturing practices, may be added to the cheese during 
the kneading and stretching process and/or applied to the surface of the 
cheese.
    (c) Nomenclature. The names of the food is ``low-moisture mozzarella 
cheese'' or, alternatively, ``low-moisture scamorza cheese''. When the 
food is made with water buffalo milk, the name of the food is 
accompanied by the phrase ``made with water buffalo milk''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', ``milkfat from water buffalo milk and 
nonfat water buffalo milk'' or ``nonfat water buffalo) The dairy 
ingredients may be declared, in descending order of predominance, by the 
use of the terms ``milkfat and nonfat milk'' or ``nonfat milk and 
milkfat'', ``milkfat from water buffalo milk and nonfat water buffalo 
milk'' or ``nonfat water buffalo milk and milkfat from water buffalo 
milk'', as appropriate.

[53 FR 3743, Feb. 9, 1988, as amended at 58 FR 2893, Jan. 6, 1993]



Sec. 133.157  Part-skim mozzarella and scamorza cheese.

    Part-skim mozzarella cheese, part-skim scamorza cheese conforms to 
the definition and standard of identity as prescribed for mozzarella 
cheese by Sec. 133.155, except that its milk fat content, calculated on 
the solids basis, is less than 45 percent but not less than 30 percent.



Sec. 133.158  Low-moisture part-skim mozzarella and scamorza cheese.

    Low-moisture part-skim mozzarella cheese and low-moisture part-skim 
scamorza cheese conform to the definition and standard of identity and 
comply with the requirements for label declaration of ingredients 
prescribed for low-moisture mozzarella cheese and low-moisture scamorza 
cheese by Sec. 133.156, except that their milkfat content, calculated 
on the solids basis, is less than 45 percent but not less than 30 
percent.

[58 FR 2894, Jan. 6, 1993]



Sec. 133.160  Muenster and munster cheese.

    (a) Description. (1) Muenster cheese, munster cheese, is the food 
prepared by the procedure set forth in paragraph (a)(3) of this section 
or by any other procedure which produces a finished cheese having the 
same physical and chemical properties. The minimum milkfat content is 50 
percent by weight

[[Page 522]]

of the solids and the maximum moisture content is 46 percent by weight, 
as determined by the methods decribed in Sec. 133.5. The dairy 
ingredients used are pasteurized.
    (2) The phenol equivalent of 0.25 gram of muenster cheese is not 
more than 3 micrograms, as determined by the methods described in Sec. 
133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of a 
harmless lactic acid-producing bacterial culture. One or more of the 
clotting enzymes specified in paragraph (b)(2) of this section is added 
to set the dairy ingredients to a semisolid mass. After coagulation the 
mass is divided into small portions, stirred, and heated, with or 
without dilution with water or salt brine, so as to promote and regulate 
the separation of whey and curd. The curd is transferred to forms 
permitting drainage of the whey. During drainage the curd may be pressed 
and turned. After drainage the curd is removed from the forms and is 
salted. One or more of the other optional ingredients specified in 
paragraph (b)(3) of this section may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin used in curing 
or flavor development.
    (iv) Antimycotic agents, the cumulative levels of which shall not 
exceed current good manufacturing practice, may be added to the surface 
of the cheese.
    (v) Vegetable oil, used as a coating for the rind.
    (c) Nomenclature. The name of the food is ``muenster cheese'' or, 
alternatively, ``munster cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[54 FR 32057, Aug. 4, 1989; 54 FR 35756, Aug. 29, 1989, as amended at 58 
FR 2894, Jan. 6, 1993]



Sec. 133.161  Muenster and munster cheese for manufacturing.

    Muenster cheese for manufacturing conforms to the definition and 
standard of identity for muenster cheese prescribed by Sec. 133.160, 
except that the dairy ingredients are not pasteurized.

[54 FR 32057, Aug. 4, 1989]



Sec. 133.162  Neufchatel cheese.

    (a) Description. (1) Neufchatel cheese is the soft uncured cheese 
prepared by the procedure set forth in paragraph (a)(2) of this section 
or by any other procedure which produces a finished cheese having the 
same physical and chemical properties. The milkfat content is not less 
than 20 percent but less than 33 percent by weight of the finished food 
and the maximum moisture content is 65 percent by weight, as determined 
by the methods described in Sec. 133.5. The dairy ingredients used are 
pasteurized.
    (2) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section is subjected to the action of a harmless lactic 
acid-producing bacterial culture, with or without one or more of the 
clotting enzymes specified in paragraph (b)(2) of this section. The 
mixture is held until the dairy ingredients coagulate. The coagulated 
mass may be warmed and stirred and it is drained. The moisture content 
may be adjusted with one of the optional ingredients in paragraph 
(b)(3)(ii) of this section. The curd may be pressed,

[[Page 523]]

chilled, worked, and heated until it becomes fluid. It may then be 
homogenized or otherwise mixed. One or more of the dairy ingredients 
specified in paragraph (b)(1) of this section or the other optional 
ingredients specified in paragraph (b)(3) of this section may be added 
during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Salt.
    (ii) Cheese whey, concentrated cheese whey, dried cheese whey, or 
reconstituted cheese whey prepared by addition of water to concentrated 
cheese whey or dried cheese whey.
    (iii) Stabilizers, in a total amount not to exceed 0.5 percent of 
the weight of the finished food, with or without the addition of dioctyl 
sodium sulfosuccinate in a maximum amount of 0.5 percent of the weight 
of the stabilizer(s) used.
    (c) Nomenclature. The name of the food is ``neufchatel cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[54 FR 32057, Aug. 4, 1989, as amended at 58 FR 2894, Jan. 6, 1993]



Sec. 133.164  Nuworld cheese.

    (a) Description. (1) Nuworld cheese is the food prepared by the 
procedure set forth in paragraph (a)(2) of this section or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. It is characterized by the presence of creamy-white 
mold, a white mutant of Penicillium roquefortii, throughout the cheese. 
The minimum milkfat content is 50 percent by weight of the solids and 
the maximum moisture content is 46 percent by weight, as determined by 
the methods described in Sec. 133.5. The dairy ingredients used may be 
pasteurized. Nuworld cheese is at least 60 days old.
    (2) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of a 
lactic acid-producing bacterial culture. One or more of the clotting 
enzymes specified in paragraph (b)(2) of this section is added to set 
the dairy ingredients to a semisolid mass. The mass is cut into smaller 
portions and allowed to stand for a time. The mixed curd and whey is 
placed into forms permitting further drainage. While being placed in 
forms, spores of a white mutant of the mold Penicillium roquefortii are 
added. The forms are turned several times during drainage. When 
sufficiently drained, the shaped curd is removed from the forms and 
salted with dry salt or brine. Perforations are then made in the shaped 
curd and it is held at a temperature of approximately 50 [deg]F at 90 to 
95 percent relative humidity, until the characteristic mold growth has 
developed. During storage, the surface of the cheese may be scraped to 
remove surface growth of undesirable microorganisms. One or more of the 
other optional ingredients specified in paragraph (b)(3) of this section 
may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Blue or green color in an amount 
to neutralize the natural yellow color of the curd.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.

[[Page 524]]

    (c) Nomenclature. The name of the food is ``nuworld cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[54 FR 32058, Aug. 4, 1989, as amended at 58 FR 2894, Jan. 6, 1993]



Sec. 133.165  Parmesan and reggiano cheese.

    (a) Parmesan cheese, reggiano cheese, is the food prepared from milk 
and other ingredients specified in this section, by the procedure set 
forth in paragraph (b) of this section, or by another procedure which 
produces a finished cheese having the same physical and chemical 
properties as the cheese produced when the procedure set forth in 
paragraph (b) of this section is used. It is characterized by a granular 
texture and a hard and brittle rind. It grates readily. It contains not 
more than 32 percent of moisture, and its solids contain not less than 
32 percent of milkfat, as determined by the methods prescribed in Sec. 
133.5 (a), (b), and (d). It is cured for not less than 10 months.
    (b) Milk, which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria, present in such milk or added thereto. Sufficient 
rennet, or other safe and suitable milk-clotting enzyme that produces 
equivalent curd formation, or both, with or without purified calcium 
chloride in a quantity not more than 0.02 percent (calculated as 
anhydrous calcium chloride) of the weight of the milk, is added to set 
the milk to a semisolid mass. Harmless artificial coloring may be added. 
The mass is cut into pieces no larger than wheat kernels, heated, and 
stirred until the temperature reaches between 115 [deg]F and 125 [deg]F. 
The curd is allowed to settle and is then removed from the kettle or 
vat, drained for a short time, placed in hoops, and pressed. The pressed 
curd is removed and salted in brine, or dry-salted. The cheese is cured 
in a cool, ventilated room. The rind of the cheese may be coated or 
colored. A harmless preparation of enzymes of animal or plant origin 
capable of aiding in the curing or development of flavor of parmesan 
cheese may be added during the procedure, in such quantity that the 
weight of the solids of such preparation is not more than 0.1 percent of 
the weight of the milk used.
    (c)(1) For the purposes of this section, the word ``milk'' means 
cow's milk, which may be adjusted by separating part of the fat 
therefrom or by adding thereto one or more of the following: Cream, skim 
milk, concentrated skim milk, nonfat dry milk, water in a quantity 
sufficient to reconstitute any concentrated skim milk or nonfat dry milk 
used.
    (2) Such milk may be bleached by the use of benzoyl peroxide or a 
mixture of benzoyl peroxide with potassium alum, calcium sulfate, and 
magnesium carbonate; but the weight of the benzoyl peroxide is not more 
than 0.002 percent of the weight of the milk bleached, and the weight of 
the potassium alum, calcium sulfate, and magnesium carbonate, singly or 
combined, is not more than six times the weight of the benzoyl peroxide 
used. If milk is bleached in this manner, sufficient vitamin A is added 
to the curd to compensate for the vitamin A or its precursors destroyed 
in the bleaching process, and artificial coloring is not used.
    (d) Safe and suitable antimycotic agent(s), the cumulative levels of 
which shall not exceed current good manufacturing practice may be added 
to the surface of the cheese.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that enzymes of animal, plant, 
or microbial origin may be declared as ``enzymes''.

[42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49014, Oct. 24, 1983; 
49 FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, 1993]

[[Page 525]]



Sec. 133.167  Pasteurized blended cheese.

    Pasteurized blended cheese conforms to the definition and standard 
of identity, and is subject to the requirements for label statement of 
ingredients, prescribed for pasteurized process cheese by Sec. 133.169, 
except that:
    (a) In mixtures of two or more cheeses, cream cheese or neufchatel 
cheese may be used.
    (b) None of the ingredients prescribed or permitted for pasteurized 
process cheese by Sec. 133.169 (c) and (d)(1) is used.
    (c) In case of mixtures of two or more cheeses containing cream 
cheese or neufchatel cheese, the moisture content is not more than the 
arithmetical average of the maximum moisture contents prescribed by the 
definitions and standards of identity for the varieties of cheeses 
blended, for which such limits have been prescribed.
    (d) The word ``process'' is replaced by the word ``blended'' in the 
name prescribed by Sec. 133.169(e).

[42 FR 14366, Mar. 15, 1977, as amended at 58 FR 2894, Jan. 6, 1993]



Sec. 133.168  Pasteurized blended cheese with fruits, vegetables, or meats.

    (a) Pasteurized blended cheese with fruits, vegetables, or meats, or 
mixtures of these is the food which conforms to the definition and 
standard of identity, and is subject to the requirements for label 
statement of ingredients, prescribed for pasteurized blended cheese by 
Sec. 133.167, except that:
    (1) Its moisture content may be 1 percent more, and the milk fat 
content of its solids may be 1 percent less, than the limits prescribed 
by Sec. 133.167 for moisture and milk fat in the corresponding 
pasteurized blended cheese.
    (2) It contains one or any mixture of two or more of the following: 
Any properly prepared cooked, canned, or dried fruit; any properly 
prepared cooked, canned, or dried vegetable; any properly prepared 
cooked or canned meat.
    (3) When the added fruits, vegetables, or meats contain fat, the 
method prescribed for the determination of fat by Sec. 133.5(b) is not 
applicable.
    (b) The name of a pasteurized blended cheese with fruits, 
vegetables, or meats is the name prescribed by Sec. 133.167 for the 
applicable pasteurized blended cheese, followed by the term ``with 
___'', the blank being filled in with the common or usual name or names 
of the fruits, vegetables, or meats used, in order of predominance by 
weight.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1977; 
58 FR 2894, Jan. 6, 1993]



Sec. 133.169  Pasteurized process cheese.

    (a)(1) Pasteurized process cheese is the food prepared by 
comminuting and mixing, with the aid of heat, one or more cheeses of the 
same or two or more varieties, except cream cheese, neufchatel cheese, 
cottage cheese, lowfat cottage cheese, cottage cheese dry curd, cook 
cheese, hard grating cheese, semisoft part-skim cheese, part-skim spiced 
cheese, and skim milk cheese for manufacturing with an emulsifying agent 
prescribed by paragraph (c) of this section into a homogeneous plastic 
mass. One or more of the optional ingredients designated in paragraph 
(d) of this section may be used.
    (2) During its preparation, pasteurized process cheese is heated for 
not less than 30 seconds at a temperature of not less than 150 [deg]F. 
When tested for phosphatase by the method prescribed in Sec. 133.5(c), 
the phenol equivalent of 0.25 gram of pasteurized process cheese is not 
more than 3 micrograms.
    (3)(i) The moisture content of a pasteurized process cheese made 
from a single variety of cheese is not more than 1 percent greater than 
the maximum moisture content prescribed by the definition and standard 
of identity, if any there be, for the variety of cheese used; but in no 
case is more than 43 percent, except that the moisture content of 
pasteurized process washed curd cheese or pasteurized process colby 
cheese is not more than 40 percent; the moisture content of pasteurized 
process swiss cheese or pasteurized process gruyere cheese is not more 
than 44 percent; and the moisture content of pasteurized process 
limburger cheese is not more than 51 percent.
    (ii) The fat content of the solids of a pasteurized process cheese 
made from a single variety of cheese is not less than the minimum 
prescribed by the definition and standard of identity, if any

[[Page 526]]

there be, for the variety of cheese used, but in no case is less than 47 
percent; except that the fat content of the solids of pasteurized 
process swiss cheese is not less than 43 percent, and the fat content of 
the solids of pasteurized process gruyere cheese is not less than 45 
percent.
    (4)(i) The moisture content of a pasteurized process cheese made 
from two or more varieties of cheese is not more than 1 percent greater 
than the arithmetical average of the maximum moisture contents 
prescribed by the definitions and standards of identity, if any there 
be, for the varieties of cheese used; but in no case is the moisture 
content more than 43 percent, except that the moisture content of a 
pasteurized process cheese made from two or more of the varieties 
cheddar cheese, washed curd cheese, colby cheese, and granular cheese is 
not more than 40 percent, and the moisture content of a mixture of swiss 
cheese and gruyere cheese is not more than 44 percent.
    (ii) The fat content of the solids of a pasteurized process cheese 
made from two or more varieties of cheese is not less than the 
arithmetical average of the minimum fat contents prescribed by the 
definitions and standards of identity, if any there be, for the 
varieties of cheese used, but in no case is less than 47 percent, except 
that the fat content of the solids of a pasteurized process gruyere 
cheese made from a mixture of swiss cheese and gruyere cheese is not 
less than 45 percent.
    (5) Moisture and fat are determined by the methods prescribed in 
Sec. 133.5(a), (b), and (d).
    (6) The weight of each variety of cheese in a pasteurized process 
cheese made from two varieties of cheese is not less than 25 percent of 
the total weight of both, except that the weight of blue cheese, nuworld 
cheese, roquefort cheese, or gorgonzola cheese is not less than 10 
percent of the total weight of both, and the weight of limburger cheese 
is not less than 5 percent of the total weight of both. The weight of 
each variety of cheese in a pasteurized process cheese made from three 
or more varieties of cheese is not less than 15 percent of the total 
weight of all, except that the weight of blue cheese, nuworld cheese, 
roquefort cheese, or gorgonzola cheese is not less than 5 percent of the 
total weight of all, and the weight of limburger cheese is not less than 
3 percent of the total weight of all. These limits do not apply to the 
quantity of cheddar cheese, washed curd cheese, colby cheese and 
granular cheese in mixtures which are designated as ``American cheese'' 
as prescribed in paragraph (e)(2)(ii) of this section. Such mixtures are 
considered as one variety of cheese for the purposes of this paragraph 
(a)(6).
    (7) For the purposes of this section, cheddar cheese for 
manufacturing, washed curd cheese for manufacturing, colby cheese for 
manufacturing, granular cheese for manufacturing, brick cheese for 
manufacturing, muenster cheese for manufacturing, and swiss cheese for 
manufacturing are considered as cheddar cheese, washed curd cheese, 
colby cheese, granular cheese, brick cheese, muenster cheese, and swiss 
cheese, respectively.
    (b) Pasteurized process cheese may be smoked, or the cheese or 
cheeses from which it is made may be smoked, before comminuting and 
mixing, or it may contain substances prepared by condensing or 
precipitating wood smoke.
    (c) The emulsifying agent referred to in paragraph (a) of this 
section is one or any mixture of two or more of the following: 
Monosodium phosphate, disodium phosphate, dipotassium phosphate, 
trisodium phosphate, sodium metaphosphate (sodium hexametaphosphate), 
sodium acid pyrophosphate, tetrasodium pyrophosphate, sodium aluminum 
phosphate, sodium citrate, potassium citrate, calcium citrate, sodium 
tartrate, and sodium potassium tartrate, in such quantity that the 
weight of the solids of such emulsifying agent is not more than 3 
percent of the weight of the pasteurized process cheese.
    (d) The optional ingredients referred to in paragraph (a) of this 
section are:
    (1) An acidifying agent consisting of one or any mixture of two or 
more of the following: A vinegar, lactic acid, citric acid, acetic acid, 
and phosphoric acid, in such quantity that the pH of the pasteurized 
process cheese is not below 5.3.

[[Page 527]]

    (2) Cream, anhydrous milkfat, dehydrated cream, or any combination 
of two or more of these, in such quantity that the weight of the fat 
derived therefrom is less than 5 percent of the weight of the 
pasteurized process cheese.
    (3) Water.
    (4) Salt.
    (5) Harmless artificial coloring.
    (6) Spices or flavorings, other than any which singly or in 
combination with other ingredients simulate the flavor of a cheese of 
any age or variety.
    (7) Pasteurized process cheese in the form of slices or cuts in 
consumer-sized packages may contain an optional mold-inhibiting 
ingredient consisting of not more than 0.2 percent by weight of sorbic 
acid, potassium sorbate, sodium sorbate, or any combination of two or 
more of these, or consisting of not more than 0.3 percent by weight of 
sodium propionate, calcium propionate, or a combination of sodium 
propionate and calcium propionate.
    (8) Pasteurized process cheese in the form of slices or cuts in 
consumer-sized packages may contain lecithin as an optional anti-
sticking agent in an amount not to exceed 0.03 percent by weight of the 
finished product.
    (9) Safe and suitable enzyme modified cheese.
    (e) The name of a pasteurized process cheese for which a definition 
and standard of identity is prescribed by this section is as follows:
    (1) In case it is made from a single variety of cheese, its name is 
``Pasteurized process ___ cheese'', the blank being filled in with the 
name of the variety of cheese used.
    (2) In case it is made from two or more varieties of cheese, its 
name is ``Pasteurized process ___ and ___ cheese'', or ``Pasteurized 
process ___ blended with ___ cheese'', or ``Pasteurized process blend of 
___ and ___ cheese'', the blanks being filled in with the names of the 
varieties of cheeses used, in order of predominance by weight; except 
that:
    (i) In case it is made from gruyere cheese and swiss cheese, and the 
weight of gruyere cheese is not less than 25 percent of the weight of 
both, it may be designated ``Pasteurized process gruyere cheese''; and
    (ii) In case it is made of cheddar cheese, washed curd cheese, colby 
cheese, or granular cheese or any mixture of two or more of these, it 
may be designated ``Pasteurized process American cheese''; or when 
cheddar cheese, washed curd cheese, colby cheese, granular cheese, or 
any mixture of two or more of these is combined with other varieties of 
cheese in the cheese ingredient, any of such cheeses or such mixture may 
be designated as ``American cheese''.


The full name of the food shall appear on the principal display panel of 
the label in type of uniform size, style, and color. Wherever any word 
or statement emphasizing the name of any ingredient appears on the label 
(other than in an ingredient statement as specified in paragraph (g) of 
this section) so conspicuously as to be easily seen under customary 
conditions of purchase, the full name of the food shall immediately and 
conspicuously precede or follow such word or statement in type of at 
least the same size as the type used in such word or statement.
    (f) The name of the food shall include a declaration of any 
flavoring, including smoke and substances prepared by condensing or 
precipitating wood smoke, that characterizes the product as specified in 
Sec. 101.22 of this chapter and a declaration of any spice that 
characterizes the product.
    (g) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter, except that cheddar cheese, washed curd cheese, colby 
cheese, granular cheese, or any mixture of two or more of these may be 
designated as ``American cheese''.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1984; 
58 FR 2894, Jan. 6, 1993]



Sec. 133.170  Pasteurized process cheese with fruits, vegetables,
or meats.

    (a) Unless a definition and standard of identity specifically 
applicable is established by another section of this part, a pasteurized 
process cheese with fruits, vegetables, or meats, or mixtures of these 
is a food which conforms to the definition and standard of identity, and 
is subject to the requirements

[[Page 528]]

for label statement of ingredients, prescribed for pasteurized process 
cheese by Sec. 133.169, except that:
    (1) Its moisture content may be 1 percent more, and the milk fat 
content of its solids may be 1 percent less than the limits prescribed 
by Sec. 133.169 for moisture and fat in the corresponding pasteurized 
process cheese.
    (2) It contains one or any mixture of two or more of the following: 
Any properly prepared cooked, canned, or dried fruit; any properly 
prepared cooked, canned, or dried vegetable; any properly prepared 
cooked or canned meat.
    (3) When the added fruits, vegetables, or meats contain fat, the 
method prescribed for the determination of fat by Sec. 133.5(b) is not 
applicable.
    (b) The name of a pasteurized process cheese with fruits, 
vegetables, or meats is the name prescribed by Sec. 133.169 for the 
applicable pasteurized process cheese, followed by the term ``with 
___'', the blank being filled in with the common or usual name or names 
of the fruits, vegetables, or meats used, in order of predominance by 
weight.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1984; 
58 FR 2894, Jan. 6, 1993]



Sec. 133.171  Pasteurized process pimento cheese.

    Pasteurized process pimento cheese is the food which conforms to the 
definition and standard of identity for pasteurized process cheese with 
fruits, vegetables, or meats, and is subject to the requirement for 
label statement of ingredients, except that:
    (a) Its moisture content is not more than 41 percent, and the fat 
content of its solids is not less than 49 percent.
    (b) The cheese ingredient is cheddar cheese, washed curd cheese, 
colby cheese, granular cheese or any mixture of two or more of these in 
any proportion.
    (c) For the purposes of this section, cheddar cheese for 
manufacturing, washed curd cheese for manufacturing, colby cheese for 
manufacturing, and granular cheese for manufacturing shall be considered 
as cheddar cheese, washed curd cheese, colby cheese, and granular 
cheese, respectively.
    (d) The only fruit, vegetable, or meat ingredient is pimentos in 
such quantity that the weight of the solids thereof is not less than 0.2 
percent of the weight of the finished pasteurized process pimento 
cheese.
    (e) The optional ingredients designated in Sec. 133.169(b) and 
(d)(6) are not used.

[42 FR 14366, Mar. 15, 1977, as amended at 58 FR 2894, Jan. 6, 1993]



Sec. 133.173  Pasteurized process cheese food.

    (a)(1) A pasteurized process cheese food is the food prepared by 
comminuting and mixing, with the aid of heat, one or more of the 
optional cheese ingredients prescribed in paragraph (c) of this section, 
with one or more of the optional dairy ingredients prescribed in 
paragraph (d) of this section, into a homogeneous plastic mass. One or 
more of the optional ingredients specified in paragraph (e) of this 
section may be used.
    (2) During its preparation, a pasteurized process cheese food is 
heated for not less than 30 seconds, at a temperature of not less than 
150 [deg]F. When tested for phosphatase by the method prescribed in 
Sec. 133.5(c), the phenol equivalent of 0.25 gram of pasteurized 
process cheese food is not more than 3 micrograms.
    (3) The moisture content of a pasteurized process cheese food is not 
more than 44 percent, and the fat content is not less than 23 percent.
    (4) Moisture and fat are determined by the methods prescribed in 
Sec. 133.5(a) and (b), except that in determining moisture the loss in 
weight which occurs in drying for 5 hours, under the conditions 
prescribed in such method, is taken as the weight of the moisture.
    (5) The weight of the cheese ingredient prescribed by paragraph 
(a)(1) of this section constitutes not less than 51 percent of the 
weight of the finished pasteurized process cheese food.
    (6) The weight of each variety of cheese in a pasteurized process 
cheese food made with two varieties of cheese is not less than 25 
percent of the total weight of both, except that the weight of blue 
cheese, nuworld cheese, roquefort cheese, gorgonzola cheese, or 
limburger cheese is not less than 10 percent of the total weight of 
both. The weight of each variety of cheese in a

[[Page 529]]

pasteurized process cheese food made with three or more varieties of 
cheese is not less than 15 percent of the total weight of all, except 
that the weight of blue cheese, nuworld cheese, roquefort cheese, 
gorgonzola cheese, or limburger cheese is not less than 5 percent of the 
total weight of all. These limits do not apply to the quantity of 
cheddar cheese, washed curd cheese, colby cheese, and granular cheese in 
mixtures which are designated as ``American cheese'' as prescribed in 
paragraph (h)(5) of this section. Such mixtures are considered as one 
variety of cheese for the purposes of this subparagraph.
    (7) For the purposes of this section, cheddar cheese for 
manufacturing, washed curd cheese for manufacturing, colby cheese for 
manufacturing, granular cheese for manufacturing, brick cheese for 
manufacturing, muenster cheese for manufacturing, and swiss cheese for 
manufacturing are considered as cheddar cheese, washed curd cheese, 
colby cheese, granular cheese, brick cheese, muenster cheese, and swiss 
cheese, respectively.
    (b) Pasteurized process cheese food may be smoked, or the cheese or 
cheeses from which it is made may be smoked, before comminuting and 
mixing, or it may contain substances prepared by condensing or 
precipitating wood smoke.
    (c) The optional cheese ingredients referred to in paragraph (a) of 
this section are one or more cheeses of the same or two or more 
varieties, except cream cheese, neufchatel cheese, cottage cheese, 
creamed cottage cheese, cook cheese, and skim-milk cheese for 
manufacturing, and except that hard grating cheese, semisoft part skim 
cheese, and part-skim spiced cheese are not used alone or in combination 
with each other as the cheese ingredient.
    (d) The optional dairy ingredients referred to in paragraph (a) of 
this section are cream, milk, skim milk, buttermilk, cheese whey, any of 
the foregoing from which part of the water has been removed, anhydrous 
milkfat, dehydrated cream, albumin from cheese whey, and skim milk 
cheese for manufacturing.
    (e) The other optional ingredients referred to in paragraph (a) of 
this section are:
    (1) An emulsifying agent consisting of one or any mixture of two or 
more of the following: Monosodium phosphate, disodium phosphate, 
dipotassium phosphate, trisodium phosphate, sodium metaphosphate (sodium 
hexa meta phos phate), sodium acid pyro phos phate, tetra sodium pyro 
phos phate, sodium aluminum phosphate, sodium citrate, potassium 
citrate, calcium citrate, sodium tartrate, and sodium potassium 
tartrate, in such quantity that the weight of the solids of such 
emulsifying agent is not more than 3 percent of the weight of the 
pasteurized process cheese food.
    (2) An acidifying agent consisting of one or any mixture of two or 
more of the following: A vinegar, lactic acid, citric acid, acetic acid, 
and phosphoric acid in such quantity that the pH of the pasteurized 
process cheese food is not below 5.0.
    (3) Water.
    (4) Salt.
    (5) Harmless artificial coloring.
    (6) Spices or flavorings other than any which singly or in 
combination with other ingredients simulate the flavor of cheese of any 
age or variety.
    (7) Pasteurized process cheese food in the form of slices or cuts in 
consumer-sized packages may contain an optional mold-inhibiting 
ingredient consisting of not more than 0.2 percent by weight of sorbic 
acid, potassium sorbate, sodium sorbate, or any combination of two or 
more of these, or consisting of not more than 0.3 percent by weight of 
sodium propionate, calcium propionate, or a combination of sodium 
propionate and calcium propionate.
    (8) Pasteurized process cheese food in the form of slices or cuts in 
consumer-sized packages may contain lecithin as an optional anti-
sticking agent in an amount not to exceed 0.03 percent by weight of the 
finished product.
    (9) Safe and suitable enzyme modified cheese.
    (f) The name of the food is ``Pasteurized process cheese food''. The 
full name of the food shall appear on the principal display panel of the 
label in type of uniform size, style, and color. Wherever any word or 
statement emphasizing the name of any ingredient appears on the label 
(other than in an ingredient statement as specified in

[[Page 530]]

paragraph (h) of this section) so conspicuously as to be easily seen 
under customary conditions of purchase, the full name of the food shall 
immediately and conspicuously precede or follow such word or statement 
in type of at least the same size as the type used in such word or 
statement.
    (g) The name of the food shall include a declaration of any 
flavoring, including smoke and substances prepared by condensing or 
precipitating wood smoke, that characterizes the product as specified in 
Sec. 101.22 of this chapter and a declaration of any spice that 
characterizes the product.
    (h) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter, except that cheddar cheese, washed curd cheese, colby 
cheese, granular cheese, or any mixture of two or more of these may be 
designated as ``American cheese''.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1984; 
58 FR 2894, Jan. 6, 1993]



Sec. 133.174  Pasteurized process cheese food with fruits,
vegetables, or meats.

    (a) Pasteurized process cheese food with fruits, vegetables, or 
meats, or mixtures of these is the food which conforms to the definition 
and standard of identity, and is subject to the requirements for label 
statement of ingredients, prescribed for pasteurized process cheese food 
by Sec. 133.173, except that:
    (1) Its milk fat content is not less than 22 percent.
    (2) It contains one or any mixture of two or more of the following: 
Any properly prepared cooked, canned, or dried fruit; any properly 
prepared cooked, canned, or dried vegetable; any properly prepared 
cooked or canned meat.
    (3) When the added fruits, vegetables, or meats contain fat, the 
method prescribed for the determination of fat by Sec. 133.5(b) is not 
applicable.
    (b) The name of a pasteurized process cheese food with fruits, 
vegetables, or meats is ``Pasteurized process cheese food with ___'', 
the blank being filled in with the common or usual name or names of the 
fruits, vegetables, or meats used, in order of predominance by weight.
    (c) If the only vegetable ingredient is pimento, and no meat or 
fruit ingredient is used, the weight of the solids of such pimentos is 
not less than 0.2 percent of the weight of the finished food. The name 
of this food is ``Pimento pasteurized process cheese food'' or 
``Pasteurized process pimento cheese food''.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1984; 
58 FR 2894, Jan. 6, 1993]



Sec. 133.175  Pasteurized cheese spread.

    Pasteurized cheese spread is the food which conforms to the 
definition and standard of identity, and is subject to the requirements 
for label statement of ingredients, prescribed for pasteurized process 
cheese spread by Sec. 133.179, except that no emulsifying agent as 
prescribed by Sec. 133.179(e) is used.

[58 FR 2894, Jan. 6, 1993]



Sec. 133.176  Pasteurized cheese spread with fruits, vegetables,
or meats.

    (a) Pasteurized cheese spread with fruits, vegetables, or meats, or 
mixtures of these is a food which conforms to the definition and 
standard of identity, and is subject to the requirements for label 
statement of ingredients, prescribed for pasteurized cheese spread by 
Sec. 133.175, except that:
    (1) It contains one or any mixture of two or more of the following: 
Any properly prepared cooked, canned, or dried fruit; any properly 
prepared cooked, canned, or dried vegetable; any properly prepared 
cooked or canned meat.
    (2) When the added fruits, vegetables, or meats contain fat, the 
method prescribed for the determination of fat by Sec. 133.5(b) is not 
applicable.
    (b) The name of a pasteurized cheese spread with fruits, vegetables, 
or meats is ``Pasteurized cheese spread with ___'', the blank being 
filled in with the name or names of the fruits, vegetables, or meats 
used, in order of predominance by weight.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1984; 
58 FR 2894, Jan. 6, 1993]

[[Page 531]]



Sec. 133.178  Pasteurized neufchatel cheese spread with other foods.

    (a)(1) Pasteurized neufchatel cheese spread with other foods is the 
class of foods each of which is prepared by mixing, with the aid of 
heat, neufchatel cheese with one or a mixture of two or more properly 
prepared foods (except other cheeses), such as fresh, cooked, canned, or 
dried fruits or vegetables; cooked or canned meats; relishes, pickles or 
other foods suitable for blending with neufchatel cheese. It may contain 
one or any mixture of two or more of the optional ingredients named in 
paragraph (b) of this section. The amount of the added food or foods 
must be sufficient to so differentiate the blend that it does not 
simulate neufchatel cheese. It is spreadable at 70 [deg]F.
    (2) During its preparation the mixture is heated for not less than 
30 seconds at a temperature of not less than 150 [deg]F. When tested for 
phosphatase by the method prescribed in Sec. 133.5(c), the phenol 
equivalent of 0.25 gram of such food is not more than 3 micrograms.
    (3)(i) No water other than that contained in the ingredients used is 
added to this food, but the moisture content in no case is more than 65 
percent.
    (ii) The milk fat is not less than 20 percent by weight of the 
finished food.
    (b) The optional ingredients referred to in paragraph (a) of this 
section are:
    (1)(i) One or any mixture of two or more of the following: Gum 
karaya, gum tragacanth, carob bean gum, gelatin, algin (sodium 
alginate), propylene glycol alginate, guar gum, sodium 
carboxymethylcellulose (cellulose gum), carrageenan, oat gum, or xanthan 
gum. The total quantity of any such substances, including that contained 
in the neufchatel cheese, is not more than 0.8 percent by weight of the 
finished food.
    (ii) When one or more of the optional ingredients in paragraph 
(b)(1)(i) of this section are used, dioctyl sodium sulfosuccinate 
complying with the requirements of Sec. 172.810 of this chapter may be 
used in a quantity not in excess of 0.5 percent by weight of such 
ingredients.
    (2) Artificial coloring, unless such addition conceals damage or 
inferiority or makes the finished food appear better or of greater value 
than it is.
    (3) An acidifying agent consisting of one or a mixture of two or 
more of the following: A vinegar, acetic acid, lactic acid, citric acid, 
phosphoric acid.
    (4) A sweetening agent consisting of one or a mixture of two or more 
of the following: Sugar, dextrose, corn sirup, corn sirup solids, 
glucose sirup, glucose sirup solids, maltose, malt sirup, hydrolyzed 
lactose.
    (5) Cream, milk, skim milk, buttermilk, cheese whey, any of the 
foregoing from which part of the water has been removed, anhydrous 
milkfat, dehydrated cream, and albumin from cheese whey.
    (c) The name of the food is ``pasteurized Neufchatel cheese spread 
with ___'' or ``pasteurized Neufchatel cheese spread and ___'', the 
blank being filled in with the common names of the foods added, in order 
of predominance by weight. The full name of the food shall appear on the 
principal display panel of the label in type of uniform size, style, and 
color. Wherever any word or statement emphasizing the name of any 
ingredient appears on the label (other than in an ingredient statement 
as specified in paragraph (d) of this section) so conspicuously as to be 
easily seen under customary conditions of purchase, the full name of the 
food shall immediately and conspicuously precede or follow such word or 
statement in type of at least the same size as the type used in such 
word or statement.
    (d) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1984; 
58 FR 2894, Jan. 6, 1993]



Sec. 133.179  Pasteurized process cheese spread.

    (a)(1) Pasteurized process cheese spread is the food prepared by 
comminuting and mixing, with the aid of heat, one or more of the 
optional cheese ingredients prescribed in paragraph (c) of this section, 
with or without one or more of the optional dairy ingredients prescribed 
in paragraph (d) of this section, with one or more of the emulsifying 
agents prescribed in paragraph (e) of this section, and with or

[[Page 532]]

without one or more of the optional ingredients prescribed by paragraph 
(f) of this section, into a homogeneous plastic mass, which is 
spreadable at 70 [deg]F.
    (2) During its preparation, a pasteurized process cheese spread is 
heated for not less than 30 seconds at a temperature of not less than 
150 [deg]F. When tested for phosphatase by the method prescribed in 
Sec. 133.5(c), the phenol equivalent of 0.25 gram of pasteurized 
process cheese spread is not more than 3 micrograms.
    (3) The moisture content of a pasteurized process cheese spread is 
more than 44 percent but not more than 60 percent, and the milk fat 
content is not less than 20 percent.
    (4) Moisture and fat are determined by the methods prescribed in 
Sec. 133.5(a) and (b), except that in determining moisture the loss in 
weight which occurs in drying for 5 hours, under the conditions 
prescribed in such method, is taken as the weight of the moisture.
    (5) The weight of the cheese ingredient referred to in paragraph 
(a)(1) of this section constitutes not less than 51 percent of the 
weight of the pasteurized process cheese spread.
    (6) The weight of each variety of cheese in a pasteurized process 
cheese spread made with two varieties of cheese is not less than 25 
percent of the total weight of both, except that the weight of blue 
cheese, nuworld cheese, roquefort cheese, gorgonzola cheese, or 
limburger cheese is not less than 10 percent of the total weight of 
both. The weight of each variety of cheese in a pasteurized process 
cheese spread made with three or more varieties of cheese is not less 
than 15 percent of the total weight of all, except that the weight of 
blue cheese, nuworld cheese, roquefort cheese, gorgonzola cheese, or 
limburger cheese is not less than 5 percent of the total weight of all. 
These limits do not apply to the quantity of cheddar cheese, washed curd 
cheese, colby cheese, and granular cheese in mixtures which are 
designated as ``American cheese'' as prescribed in paragraph (i)(5) of 
this section. Such mixtures are considered as one variety of cheese for 
the purposes of this paragraph (a)(6).
    (7) For the purposes of this section, cheddar cheese for 
manufacturing, washed curd cheese for manufacturing, colby cheese for 
manufacturing, granular cheese for manufacturing, brick cheese for 
manufacturing, muenster cheese for manufacturing, and swiss cheese for 
manufacturing are considered as cheddar cheese, washed curd cheese, 
colby cheese, granular cheese, brick cheese, muenster cheese, and swiss 
cheese, respectively.
    (b) Pasteurized process cheese spread may be smoked, or the cheese 
or cheeses from which it is made may be smoked, before comminuting and 
mixing, or it may contain substances prepared by condensing or 
precipitating wood smoke.
    (c) The optional cheese ingredients referred to in paragraph (a) of 
this section are one or more cheeses of the same or two or more 
varieties, except that skim-milk cheese for manufacturing may not be 
used, and except that cream cheese, neufchatel cheese, cottage cheese, 
creamed cottage cheese, cook cheese, hard grating cheese, semisoft part-
skim cheese, and part-skim spiced cheese are not used, alone or in 
combination with each other, as the cheese ingredient.
    (d) The optional dairy ingredients referred to in paragraph (a) of 
this section are cream, milk, skim milk, buttermilk, cheese whey, any of 
the foregoing from which part of the water has been removed, anhydrous 
milkfat, dehydrated cream, albumin from cheese whey, and skim milk 
cheese for manufacturing.
    (e) The emulsifying agents prescribed in paragraph (a) of this 
section are one or any mixture of two or more of the following: 
Monosodium phosphate, disodium phosphate, dipotassium phosphate, 
trisodium phosphate, sodium metaphosphate (sodium hexa meta phos phate), 
sodium acid pyro phos phate, tetra sodium pyro phos phate, sodium 
aluminum phosphate, sodium citrate, potassium citrate, calcium citrate, 
sodium tartrate, and sodium potassium tartrate, in such quantity that 
the weight of the solids of such emulsifying agent is not more than 3 
percent of the weight of the pasteurized process cheese spread.
    (f) The other optional ingredients referred to in paragraph (a) of 
this section are:

[[Page 533]]

    (1)(i) One or any mixture of two or more of the following: Carob 
bean gum, gum karaya, gum tragacanth, guar gum, gelatin, sodium carb oxy 
methyl cellulose (cellulose gum), car ra geenan, oat gum, algin (sodium 
alginate), pro pylene glycol alginate, or xanthan gum. The total weight 
of such substances is not more than 0.8 percent of the weight of the 
finished food.
    (ii) When one or more of the optional ingredients in paragraph 
(f)(1)(i) of this section are used, dioctyl sodium sulfosuccinate 
complying with the requirements of Sec. 172.810 of this chapter may be 
used in a quantity not in excess of 0.5 percent by weight of such 
ingredients.
    (2) An acidifying agent consisting of one or any mixture of two or 
more of the following: A vinegar, lactic acid, citric acid, acetic acid, 
and phosphoric acid, in such quantity that the pH of the pasteurized 
process cheese spread is not below 4.0.
    (3) A sweetening agent consisting of one or any mixture of two or 
more of the following: Sugar, dextrose, corn sugar, corn sirup, corn 
sirup solids, glucose sirup, glucose sirup solids, maltose, malt sirup, 
and hydrolyzed lactose, in a quantity necessary for seasoning.
    (4) Water.
    (5) Salt.
    (6) Harmless artificial coloring.
    (7) Spices or flavorings other than any which singly or in 
combination with other ingredients simulates the flavor of a cheese of 
any age or variety.
    (8) Pasteurized process cheese spread in consumer-sized packages may 
contain an optional mold-inhibiting ingredient consisting of sorbic 
acid, potassium sorbate, sodium sorbate, or any combination of two or 
more of these, in an amount not to exceed 0.2 percent by weight, 
calculated as sorbic acid or consisting of not more than 0.3 percent by 
weight of sodium propionate, calcium propionate, or a combination of 
sodium propionate and calcium propionate.
    (9) Pasteurized process cheese spread in consumer-sized packages may 
contain lecithin as an optional anti-sticking agent in an amount not to 
exceed 0.03 percent by weight of the finished product.
    (10) Safe and suitable enzyme modified cheese.
    (11) Nisin preparation in an amount which results in not more than 
250 parts per million nisin in the food.
    (g) The name of the food is ``pasteurized process cheese spread''. 
The full name of the food shall appear on the principal display panel of 
the label in type of uniform size, style, and color. Wherever any word 
or statement emphasizing the name of any ingredient appears on the label 
(other than in an ingredient statement as specified in paragraph (i) of 
this section) so conspicuously as to be easily seen under customary 
conditions of purchase, the full name of the food shall immediately and 
conspicuously precede or follow such word or statement in type of at 
least the same size as the type used in such word or statement.
    (h) The name of the food shall include a declaration of any 
flavoring, including smoke and substances prepared by condensing or 
precipitating wood smoke, that characterizes the product as specified in 
Sec. 101.22 of this chapter and a declaration of any spice that 
characterizes the product.
    (i) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter, except that cheddar cheese, washed curd cheese, colby 
cheese, granular cheese, or any mixture of two or more of these may be 
designated as ``American cheese''.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1984; 
54 FR 6121, Feb. 8, 1989; 54 FR 22741, May 26, 1989; 58 FR 2895, Jan. 6, 
1993]



Sec. 133.180  Pasteurized process cheese spread with fruits, 
vegetables, or meats.

    (a) Pasteurized process cheese spread with fruits, vegetables, or 
meats, or mixtures of these is a food which conforms to the definition 
and standard of identity, and is subject to the requirements for label 
statement of ingredients, prescribed for pasteurized process cheese 
spread by Sec. 133.179, except that:
    (1) It contains one or any mixture of two or more of the following: 
Any properly prepared cooked, canned, or dried fruit; any properly 
prepared cooked,

[[Page 534]]

canned, or dried vegetable; any properly prepared cooked or canned meat.
    (2) When the added fruits, vegetables, or meats contain fat, the 
method prescribed for the determination of fat by Sec. 133.5(b) is not 
applicable.
    (b) The name of a pasteurized process cheese spread with fruits, 
vegetables, or meats is ``Pasteurized process cheese spread with ___'', 
the blank being filled in with the name or names of the fruits, 
vegetables, or meats used, in order of predominance by weight.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1984; 
58 FR 2895, Jan. 6, 1993]



Sec. 133.181  Provolone cheese.

    (a) Description. (1) Provolone, a pasta filata or stretched curd-
type cheese, is the food prepared by the procedure set forth in 
paragraph (a)(3) of this section, or by any other method which produces 
a finished cheese having the same physical and chemical properties. It 
has a stringy texture. The minimum milkfat content is 45 percent by 
weight of the solids, as determined by the methods described in Sec. 
133.5 and the maximum moisture content is 45 percent by weight. If the 
dairy ingredients used are not pasteurized, the cheese is cured at a 
temperature of not less than 35 [deg]F for at least 60 days.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of provolone cheese is not more than 3 micrograms as 
determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be bleached, warmed, and is subjected to the 
action of a lactic acid-producing bacterial culture. One or more of the 
clotting enzymes specified in paragraph (b)(2) of this section is added 
to set the dairy ingredients to a semisolid mass. The mass is cut, 
stirred, and heated so as to promote and regulate the separation of whey 
from the curd. The whey is drained off, and the curd is matted and cut, 
immersed in hot water, and kneaded and stretched until it is smooth and 
free from lumps. Antimycotics may be added to the curd during the 
kneading and stretching process. Then it is cut and molded. During the 
molding the curd is kept sufficiently warm to cause proper sealing of 
the surface. The molded curd is then firmed by immersion in cold water, 
salted in brine, and dried. It is given some additional curing. 
Provolone cheese may be smoked, and one or more of the other optional 
ingredients specified in paragraph (b)(3) of this section may be added 
during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Blue or green color in an amount 
to neutralize the natural yellow color of the curd.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) by weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iv) Safe and suitable antimycotic agent(s), the cumulative levels 
of which shall not exceed current good manufacturing practice, may be 
added to the cheese during the kneading and stretching process and/or 
applied to the surface of the cheese.
    (v) Benzoyl peroxide or a mixture of benzoyl peroxide with potassium 
alum, calcium sulfate, and magnesium carbonate used to bleach the dairy 
ingredients. The weight of the benzoyl peroxide is not more than 0.002 
percent of the weight of the milk being bleached, and the weight of the 
potassium alum, calcium sulfate, and magnesium carbonate, singly or 
combined, is not more than six times the weight of the benzoyl peroxide 
used. If milk is bleached in this manner, vitamin A is added to the curd 
in such quantity as to compensate for the vitamin A or its precursors 
destroyed in the bleaching process, and artificial coloring is not used.
    (c) Nomenclature. (1) The name of the food is ``provolone cheese''. 
The name of the food may include the common name of the shape of the 
cheese, such as ``salami provolone''.

[[Page 535]]

    (2) One of the following terms, in letters not less than one-half 
the height of the letters used in the name of the food, shall accompany 
the name of the food wherever it appears on the principal display panel 
or panels:
    (i) ``Smoked'' if the food has been smoked.
    (ii) ``Not smoked'' if the food has not been smoked.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[48 FR 2745, Jan. 21, 1983, as amended at 48 FR 49014, Oct. 24, 1983; 58 
FR 2895, Jan. 6, 1993]



Sec. 133.182  Soft ripened cheeses.

    (a) The cheeses for which definitions and standards of identity are 
prescribed by this section are soft ripened cheeses for which 
specifically applicable definitions and standards of identity are not 
prescribed by other sections of this part. They are made from milk and 
other ingredients specified in this section, by the procedure set forth 
in paragraph (b) of this section. Their solids contain not less than 50 
percent of milkfat, as determined by the methods prescribed in Sec. 
133.5(a), (b), and (d). If the milk used is not pasteurized, the cheese 
so made is cured at a temperature of not less than 35 [deg]F for not 
less than 60 days.
    (b) Milk, which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria or other harmless flavor-producing bacteria, present 
in such milk or added thereto. Sufficient rennet, rennet paste, extract 
of rennet paste, or other safe and suitable milk-clotting enzyme that 
produces equivalent curd formation, singly or in any combination (with 
or without purified calcium chloride in a quantity not more than 0.02 
percent, calculated as anhydrous calcium chloride, of the weight of the 
milk) is added to set the milk to a semisolid mass. Harmless artificial 
coloring may be added. After coagulation the mass is so treated as to 
promote and regulate the separation of whey and curd. Such treatment may 
include one or more of the following: Cutting, stirring, heating, 
dilution with water or brine. The whey, or part of it, is drained off, 
and the curd is collected and shaped. It may be placed in forms, and may 
be pressed. Harmless flavor-producing microorganisms may be added. It is 
cured under conditions suitable for development of biological curing 
agents on the surface of the cheese, and the curing is conducted so that 
the cheese cures from the surface toward the center. Salt may be added 
during the procedure. A harmless preparation of enzymes of animal or 
plant origin capable of aiding in the curing or development of flavor of 
soft ripened cheeses may be added, in such quantity that the weight of 
the solids of such preparation is not more than 0.1 percent of the 
weight of the milk used.
    (c) For the purposes of this section:
    (1) The word ``milk'' means cow's milk or goat's milk or sheep's 
milk or mixtures of two or all of these. Such milk may be adjusted by 
separating part of the fat therefrom or (in the case of cow's milk) by 
adding one or more of the following: Cream, skim milk, concentrated skim 
milk, nonfat dry milk; (in the case of goat's milk) the corresponding 
products from goat's milk; (in the case of sheep's milk) the 
corresponding products from sheep's milk; water, in a quantity 
sufficient to reconstitute any such concentrated or dried products used.
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a temperature of not less than 143 [deg]F for a period of not 
less than 30 minutes, or for a time and at a temperature equivalent 
thereto in phosphatase destruction.
    (d) The name of each soft ripened cheese for which a definition and 
standard of identity is prescribed by this section is ``Soft ripened 
cheese'', preceded or followed by:
    (1) The specific common or usual name of such soft ripened cheese, 
if any

[[Page 536]]

such name has become generally recognized therefor; or
    (2) If no such specific common or usual name has become generally 
recognized therefor, an arbitrary or fanciful name which is not false or 
misleading in any particular.
    (e) When milk other than cow's milk is used in whole or in part, the 
name of the cheese includes the statement ``made from ___'', the blank 
being filled in with the name or names of the milk used, in order of 
predominance by weight.
    (f) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19, 1984; 
58 FR 2895, Jan. 6, 1993]



Sec. 133.183  Romano cheese.

    (a) Romano cheese is the food prepared from cow's milk or sheep's 
milk or goat's milk or mixtures of two or all of these and other 
ingredients specified in this section, by the procedure set forth in 
paragraph (b) of this section, or by another procedure which produces a 
finished cheese having the same physical and chemical properties as the 
cheese produced when the procedure set forth in paragraph (b) of this 
section is used. It grates readily, and has a granular texture and a 
hard and brittle rind. It contains not more than 34 percent of moisture, 
and its solids contain not less than 38 percent of milkfat, as 
determined by the methods prescribed in Sec. 133.5(a), (b), and (d). It 
is cured for not less than 5 months.
    (b) Milk, which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria present in such milk or added thereto. Harmless 
artificial blue or green coloring in a quantity which neutralizes any 
natural yellow coloring in the curd may be added. Rennet, rennet paste, 
extract of rennet paste, or other safe and suitable milk-clotting enzyme 
that produces equivalent curd formation, singly or in any combination 
(with or without purified calcium chloride in a quantity not more than 
0.02 percent, calculated as anhydrous calcium chloride, of the weight of 
the milk) is added to set the milk to be a semisolid mass. The mass is 
cut into particles no larger than corn kernels, stirred, and heated to a 
temperature of about 120 [deg]F. The curd is allowed to settle to the 
bottom of the kettle or vat, and is then removed and drained for a short 
time, packed in forms or hoops, and pressed. The pressed curd is salted 
by immersing in brine for about 24 hours and is then removed from the 
brine and the surface allowed to dry. It is then alternately rubbed with 
salt and washed at intervals. It may be perforated with needles. It is 
finally drycured. During curing it is turned and scraped. The surface 
may be rubbed with vegetable oil. A harmless preparation of enzymes of 
animal or plant origin capable of aiding in the curing or development of 
flavor of romano cheese may be added during the procedure, in such 
quantity that the weight of the solids of such preparation is not more 
than 0.1 percent of the weight of the milk used.
    (c)(1) For the purposes of this section, the word ``milk'' means 
cow's milk or goat's milk or sheep's milk or mixtures of two or all of 
these. Such milk may be adjusted by separating part of the fat therefrom 
or (in the case of cow's milk) by adding one or more of the following: 
Cream, skim milk, concentrated skim milk, nonfat dry milk; (in the case 
of goat's milk) the corresponding products from goat's milk; (in the 
case of sheep's milk) the corresponding products from sheep's milk; 
water in a quantity sufficient to reconstitute any such concentrated or 
dried products used.
    (2) Such milk may be bleached by the use of benzoyl peroxide or a 
mixture of benzoyl peroxide with potassium alum, calcium sulfate, and 
magnesium carbonate; but the weight of the benzoyl peroxide is not more 
than 0.002 percent of the weight of the milk bleached, and the weight of 
the potassium alum, calcium, sulfate, and magnesium carbonate, singly or 
combined, is not more than six times the weight of the benzoyl peroxide 
used. If milk is bleached in this manner, sufficient vitamin A is added 
to the curd to compensate for the vitamin A or its precursors destroyed 
in the bleaching process, and artificial coloring is not used.

[[Page 537]]

    (d) Safe and suitable antimycotic agent(s), the cumulative levels of 
which shall not exceed current good manufacturing practice, may be added 
to the surface of the cheese.
    (e) When romano cheese is made solely from cow's milk, the name of 
such cheese is ``Romano cheese made from cow's milk'', and may be 
preceded by the word ``Vaccino'' (or ``Vacchino''); when made solely 
from sheep's milk, the name is ``Romano cheese made from sheep's milk'', 
and may be preceded by the word ``Pecorino''; when made solely from 
goat's milk, the name is ``Romano cheese made from goat's milk'', and 
may be preceded by the word ``Caprino''; and when a mixture of two or 
all of the milks specified in this section is used, the name of the 
cheese is ``Romano cheese made from ___'', the blank being filled in 
with the names of the milks used, in order of predominance by weight.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) When milk other than cow's milk is used, in whole or in part, 
the common or usual name of each such milk ingredient shall be declared 
in order of predominance by weight; and
    (2) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''.

[42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49014, Oct. 24, 1983; 
49 FR 10095, Mar. 19, 1984; 58 FR 2895, Jan. 6, 1993]



Sec. 133.184  Roquefort cheese, sheep's milk blue-mold, and blue-mold
cheese from sheep's milk.

    (a) Description. (1) Roquefort cheese, sheep's milk blue-mold 
cheese, blue-mold cheese from sheep's milk, is the food prepared by the 
procedure set forth in paragraph (a)(2) of this section or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. It is characterized by the presence of bluish-green 
mold, Penicillium roque fortii, throughout the cheese. The minimum 
milkfat content is 50 percent by weight of the solids and the maximum 
moisture content is 45 percent by weight, as determined by the methods 
described in Sec. 133.5. The dairy ingredients used may be pasteurized. 
Roquefort cheese is at least 60 days old.
    (2) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of a 
lactic acid-producing bacterial culture. One or more of the clotting 
enzymes specified in paragraph (b)(2) of this section is added to set 
the dairy ingredients to a semisolid mass. The mass is cut into smaller 
portions and allowed to stand for a time. The mixed curd and whey is 
placed into forms permitting further drainage. While being placed in 
forms, spores of the mold Penicillium roquefortii are added. The forms 
are turned several times during drainage. When sufficiently drained, the 
shaped curd is removed from the forms and salted with dry salt or brine. 
Perforations are then made in the shaped curd and it is held at a 
temperature of approximately 50 [deg]F at 90 to 95 percent relative 
humidity, until the characteristic mold growth has developed. During 
storage, the surface of the cheese may be scraped to remove surface 
growth of undesirable microorganisms. One or more of the other optional 
ingredients specified in paragraph (b)(3) of this section may be added 
during the procedure.
    (b) Operational ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Forms of milk, nonfat milk, or cream, as 
defined in Sec. 133.3, of sheep origin, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. Enzymes of animal, plant, or 
microbial origin, used in curing or flavor development.
    (c) Nomenclature. The name of the food is ``roquefort cheese'', or 
alternatively, ``sheep's milk blue-mold cheese'' or ``blue-mold cheese 
from sheep's milk.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:

[[Page 538]]

    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat from sheep's milk and 
nonfat sheep's milk'' or ``nonfat sheep's milk and milkfat from sheep's 
milk'', as appropriate.

[54 FR 32058, Aug. 4, 1989, as amended at 58 FR 2895, Jan. 6, 1993]



Sec. 133.185  Samsoe cheese.

    (a) Description. (1) Samsoe cheese is the food prepared by the 
procedure set forth in paragraph (a)(3) of this section or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. It has a small amount of eye formation of 
approximately uniform size of about five-sixteenths inch (8 
millimeters). The minimum milkfat content is 45 percent by weight of the 
solids and the maximum moisture content is 41 percent by weight, as 
determined by the methods described in Sec. 133.5. The dairy 
ingredients used may be pasteurized. Samsoe cheese is cured at not less 
than 35 [deg]F for at least 60 days.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of samsoe cheese is not more than 3 micrograms as 
determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of a 
lactic acid-producing bacterial culture. One or more of the clotting 
enzymes specified in paragraph (b)(2) of this section is added to set 
the dairy ingredients to a semisolid mass. After coagulation the mass is 
cut into small cube-shaped pieces with sides approximately three-eighths 
inch (1 centimeter). The mass is stirred and heated to about 102 [deg]F, 
and so handled by further stirring, heating, dilution with water, and 
salting as to promote and regulate the separation of curd and whey. When 
the desired curd is obtained, it is transferred to forms permitting 
drainage of whey. During drainage, the curd is pressed. After drainage, 
the curd is removed from the forms and is further salted by immersing in 
a concentrated salt solution for about 3 days. The curd is then cured at 
a temperature of from 60[deg] to 70 [deg]F for 3 to 5 weeks to obtain 
the desired eye formation. Further curing is conducted at a lower 
temperature. One or more of the other optional ingredients specified in 
paragraph (b)(3) of this section may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) by weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iv) Antimycotic agents, applied to the surface of slices or cuts in 
consumer-sized packages.
    (c) Nomenclature. The name of the food is ``samsoe cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[48 FR 2745, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 58 
FR 2895, Jan. 6, 1993]



Sec. 133.186  Sap sago cheese.

    (a) Description. (1) Sap sago cheese is the food prepared by the 
procedure set forth in paragraph (a)(2) of this section or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. The cheese is pale green in color and has the shape 
of a truncated cone. The

[[Page 539]]

maximum moisture content is 38 percent by weight, as determined by the 
method described in Sec. 133.5. Sap sago cheese is not less than 5 
months old.
    (2) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section is allowed to become sour, and is heated to 
boiling temperature, with stirring. Sufficient sour whey is added to 
precipitate the casein. The curd is removed, spread out in boxes, and 
pressed, and while under pressure is allowed to drain and ferment. It is 
ripened for not less than 5 weeks. The ripened curd is dried and ground; 
salt and dried clover of the species Melilotus coerulea are added. The 
mixture is shaped into truncated cones and ripened. The optional 
ingredient in paragraph (b)(2) of this section may be added during this 
procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Nonfat milk, as defined in Sec. 133.3.
    (2) Other optional ingredients. Buttermilk.
    (c) Nonmenclature. The name of the food is ``sap sago cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[54 FR 32058, Aug. 4, 1989, as amended at 58 FR 2895, Jan. 6, 1993]



Sec. 133.187  Semisoft cheeses.

    (a) The cheeses for which definitions and standards of identity are 
prescribed by this section are semisoft cheeses for which specifically 
applicable definitions and standards of identity are not prescribed by 
other sections of this part. They are made from milk and other 
ingredients specified in this section, by the procedure set forth in 
paragraph (b) of this section. They contain more than 39 percent, but 
not more than 50 percent, of moisture, and their solids contain not less 
than 50 percent of milkfat, as determined by the methods prescribed in 
Sec. 133.5 (a), (b), and (d). If the milk used is not pasteurized, the 
cheese so made is cured at a temperature of not less than 35 [deg]F for 
not less than 60 days.
    (b) Milk, which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria or other harmless flavor-producing bacteria, present 
in such milk or added thereto. Sufficient rennet, rennet paste, extract 
of rennet paste, or other safe and suitable milk-clotting enzyme that 
produces equivalent curd formation, singly or in any combination (with 
or without purified calcium chloride in a quantity not more than 0.02 
percent, calculated as anhydrous calcium chloride, of the weight of the 
milk) is added to set the milk to a semisolid mass. Harmless artificial 
coloring may be added. After coagulation the mass is so treated as to 
promote and regulate the separation of whey and curd. Such treatment may 
include one or more of the following: cutting, stirring, heating, 
dilution with water or brine. The whey, or part of it, is drained off, 
and the curd is collected and shaped. It may be placed in forms, and may 
be pressed. Harmless flavor-producing microorganisms may be added. It 
may be cured in a manner to promote the growth of biological curing 
agents. Salt may be added during the procedure. A harmless preparation 
of enzymes of animal or plant origin capable of aiding in the curing or 
development of flavor of semisoft cheese may be added, in such quantity 
that the weight of the solids of such preparation is not more than 0.1 
percent of the weight of the milk used.
    (c) For the purposes of this section:
    (1) The word ``milk'' means cow's milk or goat's milk or sheep's 
milk or mixtures of two or all of these. Such milk may be adjusted by 
separating part of the fat therefrom, or (in the case of cow's milk) by 
adding one or more of the following: Cream, skim milk, concentrated skim 
milk, nonfat dry milk; (in the case of goat's milk) the corresponding 
products from goat's milk; (in the case of sheep's milk) the 
corresponding products from sheep's milk; water in a quantity sufficient 
to reconstitute any concentrated or dried products used.
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a temperature of not less than 143 [deg]F for a period of not 
less than 30 minutes, or

[[Page 540]]

for a time and at a temperature equivalent thereto in phosphatase 
destruction. A semisoft cheese shall be deemed not to have been made 
from pasteurized milk if 0.25 gram shows a phenol equivalent of more 
than 5 micrograms when tested by the method prescribed in Sec. 
133.5(c).
    (d) Semisoft cheeses in the form of slices or cuts in consumer-sized 
packages may contain an optional mold-inhibiting ingredient consisting 
of sorbic acid, potassium sorbate, sodium sorbate, or any combination of 
two or more of these, in an amount not to exceed 0.3 percent by weight, 
calculated as sorbic acid.
    (e) The name of each semisoft cheese for which a definition and 
standard of identity is prescribed by this section is ``Semisoft 
cheese'', preceded or followed by:
    (1) The specific common or usual name of such semisoft cheese, if 
any such name has become generally recognized therefor; or
    (2) If no such specific common or usual name has become generally 
recognized therefor, an arbitrary or fanciful name which is not false or 
misleading in any particular.
    (f)(1) When milk other than cow's milk is used in whole or in part, 
the name of the cheese includes the statement ``made from ___'', the 
blank being filled in with the name or names of the milk used, in order 
of predominance by weight.
    (2) If semisoft cheese in sliced or cut form contains an optional 
mold-inhibiting ingredient as specified in paragraph (d) of this 
section, the label shall bear the statement ``___ added to retard mold 
growth'' or ``___ added as a preservative'', the blank being filled in 
with the common name or names of the mold-inhibiting ingredient or 
ingredients used.
    (3) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the words and statements prescribed by this section, showing 
the optional ingredient used, shall immediately and conspicuously 
precede or follow such name, without intervening written, printed, or 
graphic matter.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10096, Mar. 19, 1984; 
58 FR 2895, Jan. 6, 1993]



Sec. 133.188  Semisoft part-skim cheeses.

    (a) The cheeses for which definitions and standards of identity are 
prescribed by this section are semisoft part-skim cheeses for which 
specifically applicable definitions and standards of identity are not 
prescribed by other sections of this part. They are made from partly 
skimmed milk and other ingredients specified in this section, by the 
procedure set forth in paragraph (b) of this section. They contain not 
more than 50 percent of moisture, and their solids contain not less than 
45 percent, but less than 50 percent, of milkfat, as determined by the 
methods set forth in Sec. 133.5 (a), (b), and (d). If the milk used is 
not pasteurized, the cheese so made is cured at a temperature of not 
less than 35 [deg]F, for not less than 60 days.
    (b) Milk, which may be pasteurized or clarified or both, and which 
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria or other harmless flavor-producing bacteria, present 
in such milk or added thereto. Sufficient rennet, rennet paste, extract 
of rennet paste, or other safe and suitable milk-clotting enzyme that 
produces equivalent curd formation singly or in any combination (with or 
without purified calcium chloride in a quantity not more than 0.02 
percent, calculated as anhydrous calcium chloride, of the weight of the 
milk) is added to set the milk to a semisolid mass. Harmless artificial 
coloring may be added. After coagulation the mass is so treated as to 
promote and regulate the separation of whey and curd. Such treatment may 
include one or more of the following: Cutting, stirring, heating, 
dilution with water or brine. The whey, or part of it, is drained off, 
and the curd is collected and shaped. It may be placed in forms, and it 
may be pressed. Harmless flavor-producing microorganisms may be added. 
It may be cured in a manner

[[Page 541]]

to promote the growth of biological curing agents. Salt may be added 
during the procedure. A harmless preparation of enzymes of animal or 
plant origin capable of aiding in the curing or development of flavor of 
semisoft part-skim cheese may be added in such quantity that the weight 
of the solids of such preparation is not more than 0.1 percent of the 
weight of the milk used.
    (c) For the purposes of this section:
    (1) The word ``milk'' means cow's milk or goat's milk or sheep's 
milk or mixtures of two or all of these. Such milk may be adjusted by 
separating part of the fat therefrom or (in the case of cow's milk) by 
adding one or more of the following: Cream, skim milk, concentrated skim 
milk, nonfat dry milk; (in the case of goat's milk) the corresponding 
products from goat's milk; (in the case of sheep's milk) the 
corresponding products from sheep's milk; water in a quantity sufficient 
to reconstitute any such concentrated or dried products used.
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a temperature of not less than 143 [deg]F for a period of not 
less than 30 minutes, or for a time and at a temperature equivalent 
thereto in phosphatase destruction. A semisoft part-skim cheese shall be 
deemed not to have been made from pasteurized milk if 0.25 gram shows a 
phenol equivalent of more than 5 micrograms when tested by the method 
prescribed in Sec. 133.5(c).
    (d) Semisoft part-skim cheeses in the form of slices or cuts in 
consumer-sized packages may contain an optional mold-inhibiting 
ingredient consisting of sorbic acid, potassium sorbate, sodium sorbate, 
or any combination of two or more of these, in an amount not to exceed 
0.3 percent by weight, calculated as sorbic acid.
    (e) The name of each semisoft part-skim cheese for which a 
definition and standard of identity is prescribed by this section is 
``Semisoft part-skim cheese,'' preceded or followed by:
    (1) The specific common or usual name of such semisoft cheese, if 
any such name has become generally recognized therefor; or
    (2) If no such specific common or usual name has become generally 
recognized therefor, an arbitrary or fanciful name which is not false or 
misleading in any particular.
    (f)(1) When milk other than cow's milk is used in whole or in part, 
the name of the cheese includes the statement ``made from ___'', the 
blank being filled in with the name or names of the milk used, in order 
of predominance by weight.
    (2) If semi-soft part-skim cheese in sliced or cut form contains an 
optional mold-inhibiting ingredient as specified in paragraph (d) of 
this section, the label shall bear the statement ``___ added to retard 
mold growth'' or ``___ added as a preservative'', the blank being filled 
in with the common name or names of the mold-inhibiting ingredient or 
ingredients used.
    (3) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the words and statements prescribed by this section, showing 
the optional ingredient used, shall immediately and conspicuously 
precede or follow such name, without intervening written, printed, or 
graphic matter.
    (g) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter.

[42 FR 14366, Mar. 19, 1977, as amended at 49 FR 10096, Mar. 19, 1984; 
58 FR 2895, Jan. 6, 1993]



Sec. 133.189  Skim milk cheese for manufacturing.

    (a) Skim milk cheese for manufacturing is the food prepared from 
skim milk and other ingredients specified in this section, by the 
procedure set forth in paragraph (b) of this section, or by another 
procedure which produces a finished cheese having the same physical and 
chemical properties as the cheese produced when the procedure set forth 
in paragraph (b) of this section is used. It contains not more than 50 
percent of moisture, as determined by the method prescribed in Sec. 
133.5 (a). It is coated with blue-colored paraffin or other tightly 
adhering coating, colored blue.
    (b) Skim milk or the optional dairy ingredients specified in 
paragraph (c)

[[Page 542]]

of this section, which may be pasteurized, and which may be warmed, are 
subjected to the action of harmless lactic-acid-producing bacteria, 
present in such milk or added thereto. Harmless artificial coloring may 
be added. Sufficient rennet, or other safe and suitable milk-clotting 
enzyme that produces equivalent curd formation, or both, with or without 
purified calcium chloride in a quantity not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the skim 
milk, is added to set the skim milk to a semisolid mass. The mass is so 
cut, stirred, and heated with continued stirring, as to promote and 
regulate the separation of whey and curd. The whey is drained off, and 
the curd is matted into a cohesive mass. Proteins from the whey may be 
incorporated. The mass is cut into slabs which are so piled and handled 
as to promote the drainage of whey and the development of acidity. The 
slabs are then cut into pieces, which may be rinsed by pouring or 
sprinkling water over them, with free and continuous drainage; but the 
duration of such rinsing is so limited that only the whey on the surface 
of such pieces is removed. The curd is salted, stirred, further drained, 
and pressed into forms. A harmless preparation of enzymes of animal or 
plant origin capable of aiding in the curing or development of flavor of 
skim milk cheese for manufacturing may be added during the procedure, in 
such quantity that the weight of the solids of such preparation is not 
more than 0.1 percent of the weight of the milk used.
    (c) The optional dairy ingredients referred to in paragraph (b) of 
this section are: Skim milk or concentrated skim milk or nonfat dry milk 
or a mixture of any two or more of these, with water in a quantity not 
in excess of that sufficient to reconstitute any concentrated skim milk 
or nonfat dry milk used.
    (d) For the purposes of this section, ``skim milk'' means cow's milk 
from which the milk fat has been separated.
    (e) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of parts 101 and 130 of 
this chapter.

[42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10096, Mar. 19, 1984; 
58 FR 2895, Jan. 6, 1993]



Sec. 133.190  Spiced cheeses.

    (a) Description. (1) Spiced cheeses are cheeses for which 
specifically applicable definitions and standards of identity are not 
prescribed by other sections of this part. The food is prepared by the 
procedure set forth in paragraph (a)(3) of this section or by any other 
procedure which produces a finished cheese having the same physical and 
chemical properties. The minimum milkfat content is 50 percent by weight 
of the solids, as determined by the method described in Sec. 133.5. The 
food contains spices, in a minimum amount of 0.015 ounce per pound of 
cheese, and may contain spice oils. If the dairy ingredients are not 
pasteurized, the cheese is cured at a temperature of not less than 35 
[deg]F for at least 60 days.
    (2) The phenol equivalent of 0.25 gram of spiced cheese is not more 
than 3 micrograms, as determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be warmed and is subjected to the action of a 
harmless lactic acid-producing bacterial culture. One or more of the 
clotting enzymes specified in paragraph (b)(2) of this section is added 
to set the dairy ingredients to a semisolid mass. The mass is divided 
into smaller portions and so handled by stirring, heating, and diluting 
with water or salt brine as to promote and regulate the separation of 
whey and curd. The whey is drained off. The curd is removed and may be 
further drained. The curd is then shaped into forms, and may be pressed. 
At some time during the procedure, spices are added so as to be evenly 
distributed throughout the finished cheese. One or more of the other 
optional ingredients specified in paragraph (b)(3) of this section may 
be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, or

[[Page 543]]

corresponding products of goat or sheep origin, used alone or in 
combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) of the weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Salt.
    (iv) Spice oils which do not, alone or in combination with other 
ingredients, simulate the flavor of cheese of any age or variety.
    (v) Enzymes of animal, plant, or microbial origin, used in curing or 
flavor development.
    (vi) Antimycotic agents, applied to the surface of slices or cuts in 
consumer-sized packages.
    (c) Nomenclature. The name of the food is ``spiced cheese''. The 
following terms shall accompany the name of the food, as appropriate:
    (1) The specific common or usual name of the spiced cheese, if any 
such name has become generally recognized; or
    (2) An arbitrary or fanciful name that is not false or misleading in 
any particular.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', or ``milkfat from goat's milk and nonfat 
goat's milk'', etc., as appropriate.

[54 FR 32059, Aug. 4, 1989, as amended at 58 FR 2895, Jan. 6, 1993]



Sec. 133.191  Part-skim spiced cheeses.

    Part-skim spiced cheeses conform to the definition and standard of 
identity, and are subject to the requirements for label statement of 
ingredients prescribed for spiced cheeses by Sec. 133.190, except that 
their solids contain less than 50 percent, but not less than 20 percent, 
of milkfat.

[58 FR 2895, Jan. 6, 1993]



Sec. 133.193  Spiced, flavored standardized cheeses.

    (a) Except as otherwise provided for herein and in applicable 
sections in this part, a spiced or flavored standardized cheese conforms 
to the applicable definitions, standard of identity and requirements for 
label statement of ingredients prescribed for that specific natural 
cheese variety promulgated pursuant to section 401 of the Federal Food, 
Drug, and Cosmetic Act. In addition a spiced and/or flavored 
standardized cheese shall contain one or more safe and suitable spices 
and/or flavorings, in such proportions as are reasonably required to 
accomplish their intended effect: Provided, That, no combination of 
ingredients shall be used to simulate the flavor of cheese of any age or 
variety.
    (b) The name of a spiced or flavored standardized cheese shall 
include in addition to the varietal name of the natural cheese, a 
declaration of any flavor and/or spice that characterizes the food, in 
the manner prescribed in Sec. 101.22 of this chapter.

[42 FR 14366, Mar. 15, 1977, as amended at 58 FR 2895, Jan. 6, 1993]



Sec. 133.195  Swiss and emmentaler cheese.

    (a) Description. (1) Swiss cheese, emmentaler cheese, is the food 
prepared by the procedure set forth in paragraph (a)(3) of this section, 
or by any other procedure which produces a finished cheese having the 
same physical and chemical properties. It has holes or eyes developed 
throughout the cheese. The minimum milkfat content is 43 percent by 
weight of the solids and the maximum moisture content is 41 percent by 
weight, as determined by the methods described in Sec. 133.5. The dairy 
ingredients used may be pasteurized. Swiss cheese is at least 60 days 
old.
    (2) If pasteurized dairy ingredients are used, the phenol equivalent 
value of 0.25 gram of swiss cheese is not more

[[Page 544]]

than 3 micrograms as determined by the method described in Sec. 133.5.
    (3) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section may be bleached, warmed, or treated with hydrogen 
peroxide/catalase, and is subjected to the action of lactic acid-
producing and propionic acid-producing bacterial cultures. One or more 
of the clotting enzymes specified in paragraph (b)(2) of this section is 
added to set the dairy ingredients to a semisolid mass. The mass is cut 
into particles similar in size to wheat kernels. For about 30 minutes 
the particles are alternately stirred and allowed to settle. The 
temperature is raised to about 126 [deg]F. Stirring is continued until 
the curd becomes firm. The acidity of the whey at this point, calculated 
as lactic acid, does not exceed 0.13 percent. The curd is transferred to 
hoops or forms and pressed until the desired shape and firmness are 
obtained. The cheese is then salted by immersing it in a saturated salt 
solution for about 3 days. It is then held at a temperature of about 
50[deg] to 60 [deg]F. for a period of 5 to 10 days, after which it is 
held at a temperature of about 75 [deg]F. until it is approximately 30 
days old, or until the so-called eyes form. Salt, or a solution of salt 
in water, is added to the surface of the cheese at some time during the 
curing process. The cheese is then stored at a lower temperature for 
further curing. One or more of the optional ingredients specified in 
paragraph (b)(3) of this section may be added during the procedure.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 
Sec. 133.3, used alone or in combination.
    (2) Clotting enzymes. Rennet and/or other clotting enzymes of 
animal, plant, or microbial origin.
    (3) Other optional ingredients. (i) Coloring.
    (ii) Calcium chloride in an amount not more than 0.02 percent 
(calculated as anhydrous calcium chloride) by weight of the dairy 
ingredients, used as a coagulation aid.
    (iii) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (iv) Antimycotic agents, the cumulative levels of which shall not 
exceed good manufacturing practice, may be added to the surface of the 
cheese.
    (v) Benzoyl peroxide or a mixture of benzoyl peroxide with potassium 
alum, calcium sulfate, and magnesium carbonate used to bleach the dairy 
ingredients. The weight of the benzoyl peroxide is not more than 0.002 
percent of the weight of the milk being bleached, and the weight of the 
potassium alum, calcium sulfate, and magnesium carbonate, singly or 
combined, is not more than six times the weight of the benzoyl peroxide 
used. If milk is bleached in this manner, vitamin A is added to the curd 
in such quantity as to compensate for the vitamin A or its precursors 
destroyed in the bleaching process, and artificial coloring is not used.
    (vi) Hydrogen peroxide, followed by a sufficient quantity of 
catalase preparation to eliminate the hydrogen peroxide. The weight of 
the hydrogen peroxide shall not exceed 0.05 percent of the weight of the 
milk and the weight of the catalase shall not exceed 20 parts per 
million of the weight of the milk treated.
    (c) Nomenclature. The name of the food is ``swiss cheese'', or 
alternatively, ``emmentaler cheese''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) Enzymes of animal, plant, or microbial origin may be declared as 
``enzymes''; and
    (2) The dairy ingredients may be declared, in descending order of 
predominance, by the use of the terms ``milkfat and nonfat milk'' or 
``nonfat milk and milkfat'', as appropriate.

[48 FR 2746, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 55 
FR 6795, Feb. 27, 1990; 58 FR 2895, Jan. 6, 1993]



Sec. 133.196  Swiss cheese for manufacturing.

    Swiss cheese for manufacturing conforms to the definition and 
standard of identity prescribed for swiss cheese by Sec. 133.195, 
except that the holes, or eyes, have not developed throughout the entire 
cheese.

[55 FR 6795, Feb. 27, 1990]

[[Page 545]]



PART 135_FROZEN DESSERTS--Table of Contents



                      Subpart A_General Provisions

Sec.
135.3 Definitions.

    Subpart B_Requirements for Specific Standardized Frozen Desserts

135.110 Ice cream and frozen custard.
135.115 Goat's milk ice cream.
135.130 Mellorine.
135.140 Sherbet.
135.160 Water ices.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.



                      Subpart A_General Provisions



Sec. 135.3  Definitions.

    For the purposes of this part, a pasteurized mix is one in which 
every particle of the mix has been heated in properly operated equipment 
to one of the temperatures specified in the table in this section and 
held continuously at or above that temperature for the specified time 
(or other time/temperature relationship which has been demonstrated to 
be equivalent thereto in microbial destruction):

------------------------------------------------------------------------
                 Temperature                             Time
------------------------------------------------------------------------
155 [deg]F..................................  30 min.
175 [deg]F..................................  25 sec.
------------------------------------------------------------------------


[42 FR 19132, Apr. 12, 1977]



    Subpart B_Requirements for Specific Standardized Frozen Desserts



Sec. 135.110  Ice cream and frozen custard.

    (a) Description. (1) Ice cream is a food produced by freezing, while 
stirring, a pasteurized mix consisting of one or more of the optional 
dairy ingredients specified in paragraph (b) of this section, and may 
contain one or more of the optional caseinates specified in paragraph 
(c) of this section subject to the conditions hereinafter set forth, one 
or more of the optional hydrolyzed milk proteins as provided for in 
paragraph (d) of this section subject to the conditions hereinafter set 
forth, and other safe and suitable nonmilk-derived ingredients; and 
excluding other food fats, except such as are natural components of 
flavoring ingredients used or are added in incidental amounts to 
accomplish specific functions. Ice cream is sweetened with safe and 
suitable sweeteners and may be characterized by the addition of 
flavoring ingredients.
    (2) Ice cream contains not less than 1.6 pounds of total solids to 
the gallon, and weighs not less than 4.5 pounds to the gallon. Ice cream 
contains not less than 10 percent milkfat, nor less than 10 percent 
nonfat milk solids, except that when it contains milkfat at 1 percent 
increments above the 10 percent minimum, it may contain the following 
milkfat-to-nonfat milk solids levels:

------------------------------------------------------------------------
                                                                Minimum
                                                                percent
                       Percent milkfat                          nonfat
                                                                 milk
                                                                solids
------------------------------------------------------------------------
10..........................................................          10
11..........................................................           9
12..........................................................           8
13..........................................................           7
14..........................................................           6
------------------------------------------------------------------------


Except that when one or more bulky flavors are used, the weights of 
milkfat and total milk solids are not less than 10 percent and 20 
percent, respectively, of the remainder obtained by subtracting the 
weight of the bulky flavors from the weight of the finished food; but in 
no case is the weight of milkfat or total milk solids less than 8 
percent and 16 percent, respectively, of the weight of the finished 
food. Except in the case of frozen custard, ice cream contains less than 
1.4 percent egg yolk solids by weight of the food, exclusive of the 
weight of any bulky flavoring ingredients used. Frozen custard shall 
contain 1.4 percent egg yolk solids by weight of the finished food: 
Provided, however, That when bulky flavors are added the egg yolk solids 
content of frozen custard may be reduced in proportion to the amount by 
weight of the bulky flavors added, but in no case is the content of egg 
yolk solids in the finished food less than 1.12 percent. A product 
containing egg yolk solids in excess of 1.4 percent, the maximum set 
forth in this paragraph for ice cream, may be marketed if labeled as 
specified by paragraph (e)(1) of this section.

[[Page 546]]

    (3) When calculating the minimum amount of milkfat and nonfat milk 
solids required in the finished food, the solids of chocolate or cocoa 
used shall be considered a bulky flavoring ingredient. In order to make 
allowance for additional sweetening ingredients needed when certain 
bulky ingredients are used, the weight of chocolate or cocoa solids used 
may be multiplied by 2.5; the weight of fruit or nuts used may be 
multiplied by 1.4; and the weight of partially or wholly dried fruits or 
fruit juices may be multiplied by appropriate factors to obtain the 
original weights before drying and this weight may be multiplied by 1.4.
    (b) Optional dairy ingredients. The optional dairy ingredients 
referred to in paragraph (a) of this section are: Cream; dried cream; 
plastic cream (sometimes known as concentrated milkfat); butter; butter 
oil; milk; concentrated milk; evaporated milk; sweetened condensed milk; 
superheated condensed milk; dried milk; skim milk; concentrated skim 
milk; evaporated skim milk; condensed skim milk; superheated condensed 
skim milk; sweetened condensed skim milk; sweetened condensed part-skim 
milk; nonfat dry milk; sweet cream buttermilk; condensed sweet cream 
buttermilk; dried sweet cream buttermilk; skim milk, that may be 
concentrated, and from which part or all of the lactose has been removed 
by a safe and suitable procedure; skim milk in concentrated or dried 
form that has been modified by treating the concentrated skim milk with 
calcium hydroxide and disodium phosphate; and whey and those modified 
whey products (e.g., reduced lactose whey, reduced minerals whey, and 
whey protein concentrate) that have been determined by FDA to be 
generally recognized as safe (GRAS) for use in this type of food. Water 
may be added, or water may be evaporated from the mix. The sweet cream 
buttermilk and the concentrated sweet cream buttermilk or dried sweet 
cream buttermilk, when adjusted with water to a total solids content of 
8.5 percent, has a titratable acidity of not more than 0.17 percent, 
calculated as lactic acid. The term ``milk'' as used in this section 
means cow's milk. Any whey and modified whey products used contribute, 
singly or in combination, not more than 25 percent by weight of the 
total nonfat milk solids content of the finished food. The modified skim 
milk, when adjusted with water to a total solids content of 9 percent, 
is substantially free of lactic acid as determined by titration with 
0.1N NaOH, and it has a Ph value in the range of 8.0 to 8.3.
    (c) Optional caseinates. The optional caseinates referred to in 
paragraph (a) of this section that may be added to ice cream mix 
containing not less than 20 percent total milk solids are: Casein 
prepared by precipitation with gums, ammonium caseinate, calcium 
caseinate, potassium caseinate, and sodium caseinate. Caseinate may be 
added in liquid or dry form, but must be free of excess alkali.
    (d) Optional hydrolyzed milk proteins. One or more of the optional 
hydrolyzed milk proteins referred to in paragraph (a) of this section 
may be added as stabilizers at a level not to exceed 3 percent by weight 
of ice cream mix containing not less that 20 percent total milk solids, 
provided that any whey and modified whey products used contribute, 
singly or in combination, not more than 25 percent by weight of the 
total nonfat milk solids content of the finished food. Further, when 
hydrolyzed milk proteins are used in the food, the declaration of these 
ingredients on the food label shall comply with the requirements of 
Sec. 102.22 of this chapter.
    (e) Methods of analysis. The fat content shall be determined by the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980), sections 16.287 and 
16.059, under ``Fat, Roese-Gottlieb Method--Official Final Action,'' 
which is incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (f) Nomenclature. (1) The name of the food is ``ice cream''; except 
that when

[[Page 547]]

the egg yolk solids content of the food is in excess of that specified 
for ice cream by paragraph (a) of this section, the name of the food is 
``frozen custard'' or ``french ice cream'' or ``french custard ice 
cream''.
    (2)(i) If the food contains no artificial flavor, the name on the 
principal display panel or panels of the label shall be accompanied by 
the common or usual name of the characterizing flavor, e.g., 
``vanilla'', in letters not less than one-half the height of the letters 
used in the words ``ice cream''.
    (ii) If the food contains both a natural characterizing flavor and 
an artificial flavor simulating it, and if the natural flavor 
predominates, the name on the principal display panel or panels of the 
label shall be accompanied by the common name of the characterizing 
flavor, in letters not less than one-half the height of the letters used 
in the words ``ice cream'', followed by the word ``flavored'', in 
letters not less than one-half the height of the letters in the name of 
the characterizing flavor, e.g., ``Vanilla flavored'', or ``Peach 
flavored'', or ``Vanilla flavored and Strawberry flavored''.
    (iii) If the food contains both a natural characterizing flavor and 
an artificial flavor simulating it, and if the artificial flavor 
predominates, or if artificial flavor is used alone the name on the 
principal display panel or panels of the label shall be accompanied by 
the common name of the characterizing flavor in letters not less than 
one-half the height of the letters used in the words ``ice cream'', 
preceded by ``artificial'' or ``artificially flavored'', in letters not 
less than one-half the height of the letters in the name of the 
characterizing flavor, e.g., ``artificial Vanilla'', or ``artifically 
flavored Strawberry'' or ``artificially flavored Vanilla and 
artificially flavored Strawberry''.
    (3)(i) If the food is subject to the requirements of paragraph 
(f)(2)(ii) of this section or if it contains any artificial flavor not 
simulating the characterizing flavor, the label shall also bear the 
words ``artificial flavor added'' or ``artificial ___ flavor added'', 
the blank being filled with the common name of the flavor simulated by 
the artificial flavor in letters of the same size and prominence as the 
words that precede and follow it.
    (ii) Wherever the name of the characterizing flavor appears on the 
label so conspicuously as to be easily seen under customary conditions 
of purchase, the words prescribed by this paragraph shall immediately 
and conspicuously precede or follow such name, in a size reasonably 
related to the prominence of the name of the characterizing flavor and 
in any event the size of the type is not less than 6-point on packages 
containing less than 1 pint, not less than 8-point on packages 
containing at least 1 pint but less than one-half gallon, not less than 
10-point on packages containing at least one-half gallon but less than 1 
gallon, and not less than 12-point on packages containing 1 gallon or 
over: Provided, however, That where the characterizing flavor and a 
trademark or brand are presented together, other written, printed, or 
graphic matter that is a part of or is associated with the trademark or 
brand, may intervene if the required words are in such relationship with 
the trademark or brand as to be clearly related to the characterizing 
flavor: And provided further, That if the finished product contains more 
than one flavor of ice cream subject to the requirements of this 
paragraph, the statements required by this paragraph need appear only 
once in each statement of characterizing flavors present in such ice 
cream, e.g., ``Vanilla flavored, Chocolate, and Strawberry flavored, 
artificial flavors added''.
    (4) If the food contains both a natural characterizing flavor and an 
artificial flavor simulating the characterizing flavor, any reference to 
the natural characterizing flavor shall, except as otherwise authorized 
by this paragraph, be accompanied by a reference to the artificial 
flavor, displayed with substantially equal prominence, e.g., 
``strawberry and artificial strawberry flavor''.
    (5) An artificial flavor simulating the characterizing flavor shall 
be deemed to predominate:
    (i) In the case of vanilla beans or vanilla extract used in 
combination with vanillin if the amount of vanillin used

[[Page 548]]

is greater than 1 ounce per unit of vanilla constituent, as that term is 
defined in Sec. 169.3(c) of this chapter.
    (ii) In the case of fruit or fruit juice used in combination with 
artificial fruit flavor, if the quantity of the fruit or fruit juice 
used is such that, in relation to the weight of the finished ice cream, 
the weight of the fruit or fruit juice, as the case may be (including 
water necessary to reconstitute partially or wholly dried fruits or 
fruit juices to their original moisture content) is less than 2 percent 
in the case of citrus ice cream, 6 percent in the case of berry or 
cherry ice cream, and 10 percent in the case of ice cream prepared with 
other fruits.
    (iii) In the case of nut meats used in combination with artificial 
nut flavor, if the quantity of nut meats used is such that, in relation 
to the finished ice cream the weight of the nut meats is less than 2 
percent.
    (iv) In the case of two or more fruits or fruit juices, or nut 
meats, or both, used in combination with artificial flavors simulating 
the natural flavors and dispersed throughout the food, if the quantity 
of any fruit or fruit juice or nut meat is less than one-half the 
applicable percentage specified in paragraph (e)(5) (ii) or (iii) of 
this section. For example, if a combination ice cream contains less than 
5 percent of bananas and less than 1 percent of almonds it would be 
``artificially flavored banana-almond ice cream''. However, if it 
contains more than 5 percent of bananas and more than 1 percent of 
almonds it would be ``banana-almond flavored ice cream''.
    (6) If two or more flavors of ice cream are distinctively combined 
in one package, e.g., ``Neapolitan'' ice cream, the applicable 
provisions of this paragraph shall govern each flavor of ice cream 
comprising the combination.
    (7) Until September 14, 1998, when safe and suitable sweeteners 
other than nutritive carbohydrate sweeteners are used in the food, their 
presence shall be declared by their common or usual name on the 
principal display panel of the label as part of the statement of 
identity in letters that shall be no less than one-half the size of the 
type used in the term ``ice cream'' but in any case no smaller than one-
sixteenth of an inch. If the food purports to be or is represented for 
special dietary use, it shall bear labeling in accordance with the 
requirements of part 105 of this chapter.
    (g) Label declaration. Each of the ingredients used shall be 
declared on the label as required by the applicable sections of parts 
101 and 130 of this chapter, except that the sources of milkfat or milk 
solids not fat may be declared in descending order of predominance 
either by the use of all the terms ``milkfat and nonfat milk'' when one 
or any combination of two or more of the ingredients listed in Sec. 
101.4(b)(3), (b)(4), (b)(8), and (b)(9) of this chapter are used or, 
alternatively, as permitted in Sec. 101.4 of this chapter. Under 
section 403(k) of the Federal Food, Drug, and Cosmetic Act, artificial 
color need not be declared in ice cream, except as required by Sec. 
101.22(c) or (k) of this chapter. Voluntary declaration of all colors 
used in ice cream and frozen custard is recommended.

[43 FR 4598, Feb. 3, 1978, as amended at 45 FR 63838, Sept. 26, 1980; 46 
FR 44433, Sept. 4, 1981; 47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 
19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, Jan. 6, 1993; 59 FR 
47079, Sept. 14, 1994; 63 FR 14035, Mar. 24, 1998; 63 FR 14818, Mar. 27, 
1998]



Sec. 135.115  Goat's milk ice cream.

    (a) Description. Goat's milk ice cream is the food prepared in the 
same manner prescribed in Sec. 135.110 for ice cream, and complies with 
all the provisions of Sec. 135.110, except that the only optional dairy 
ingredients that may be used are those in paragraph (b) of this section; 
caseinates and hydrolyzed milk proteins may not be used; and paragraphs 
(f)(1) and (g) of Sec. 135.110 shall not apply.
    (b) Optional dairy ingredients. The optional dairy ingredients 
referred to in paragraph (a) of this section are goat's skim milk, 
goat's milk, and goat's cream. These optional dairy ingredients may be 
used in liquid, concentrated, and/or dry form.
    (c) Nomenclature. (1) The name of the food is ``goat's milk ice 
cream'' or, alternatively, ``ice cream made with goat's milk'', except 
that when the egg yolk solids content of the food is in excess of that 
specified for ice cream in paragraph (a) of Sec. 135.110, the name of

[[Page 549]]

the food is ``goat's milk frozen custard'' or, alternatively, ``frozen 
custard made with goat's milk'', or ``goat's milk french ice cream'', 
or, alternatively, ``french ice cream made with goat's milk'', or 
``goat's milk french custard ice cream'', or, alternatively, ``french 
custard ice cream made with goat's milk''.
    (2) Until September 14, 1998, when safe and suitable sweeteners 
other than nutritive carbohydrate sweeteners are used in the food, their 
presence shall be declared by their common or usual name on the 
principal display panel of the label as part of the statement of 
identity in letters that shall be no less than one-half the size of the 
type used in the term ``goat's milk ice cream'' but in any case no 
smaller than one-sixteenth of an inch. If the food purports to be or is 
represented for special dietary use, it shall bear labeling in 
accordance with the requirements of part 105 of this chapter.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[47 FR 41526, Sept. 21, 1982, as amended at 58 FR 2896, Jan. 6, 1993; 59 
FR 47080, Sept. 14, 1994]



Sec. 135.130  Mellorine.

    (a) Description. (1) Mellorine is a food produced by freezing, while 
stirring, a pasteurized mix consisting of safe and suitable ingredients 
including, but not limited to, milk-derived nonfat solids and animal or 
vegetable fat, or both, only part of which may be milkfat. Mellorine is 
sweetened with nutritive carbohydrate sweetener and is characterized by 
the addition of flavoring ingredients.
    (2) Mellorine contains not less than 1.6 pounds of total solids to 
the gallon, and weighs not less than 4.5 pounds to the gallon. Mellorine 
contains not less than 6 percent fat and 2.7 percent protein having a 
protein efficiency ratio (PER) not less than that of whole milk protein 
(108 percent of casein) by weight of the food, exclusive of the weight 
of any bulky flavoring ingredients used. In no case shall the fat 
content of the finished food be less than 4.8 percent or the protein 
content be less than 2.2 percent. The protein to meet the minimum 
protein requirements shall be provided by milk solids, not fat and/or 
other milk-derived ingredients.
    (3) When calculating the minimum amount of milkfat and protein 
required in the finished food, the solids of chocolate or cocoa used 
shall be considered a bulky flavoring ingredient. In order to make 
allowance for additional sweetening ingredients needed when certain 
bulky ingredients are used, the weight of chocolate or cocoa solids used 
may be multiplied by 2.5; the weight of fruit or nuts used may be 
multiplied by 1.4; and the weight of partially or wholly dried fruits or 
fruit juices may be multiplied by appropriate factors to obtain the 
original weights before drying and this weight may be multiplied by 1.4.
    (b) Fortification. Vitamin A is present in a quantity which will 
ensure that 40 international units (IU) are available for each gram of 
fat in mellorine, within limits of good manufacturing practice.
    (c) Methods of analysis. Fat and protein content, and the PER shall 
be determined by following the methods contained in ``Official Methods 
of Analysis of the Association of Official Analytical Chemists,'' 13th 
Ed. (1980), which is incorporated by reference. Copies may be obtained 
from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877, or may be examined 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.
    (1) Fat content shall be determined by the method: ``Fat, Roese-
Gottlieb Method--Official Final Action,'' section 16.287.
    (2) Protein content shall be determined by one of the following 
methods: ``Nitrogen--Official Final Action,'' Kjeldahl Method, section 
16.285, or Dye Binding Method, section 16.286.
    (3) PER shall be determined by the method: ``Biological Evaluation 
of Protein Quality--Official Final Action,'' sections 43.212-43.216.

[[Page 550]]

    (d) Nomenclature. The name of the food is ``mellorine''. The name of 
the food on the label shall be accompanied by a declaration indicating 
the presence of characterizing flavoring in the same manner as is 
specified in Sec. 135.110(c).
    (e) Label declaration. Each of the ingredients used shall be 
declared on the label as required by the applicable sections of parts 
101 and 130 of this chapter, except that sources of milkfat or milk 
solids not fat may be declared in descending order of predominance 
either by the use of the terms ``milkfat and nonfat milk'' when one or 
any combination of two or more of the ingredients listed in Sec. 
101.4(b)(3), (b)(4), (b)(8), and (b)(9) of this chapter are used, or 
alternatively as permitted in Sec. 101.4 of this chapter.

[42 FR 19137, Apr. 12, 1977, as amended at 47 FR 11826, Mar. 19, 1982; 
49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 135.140  Sherbet.

    (a) Description. (1) Sherbet is a food produced by freezing, while 
stirring, a pasteurized mix consisting of one or more of the optional 
dairy ingredients specified in paragraph (b) of this section, and may 
contain one or more of the optional caseinates specified in paragraph 
(c) of this section subject to the conditions hereinafter set forth, and 
other safe and suitable nonmilk-derived ingredients; and excluding other 
food fats, except such as are added in small amounts to accomplish 
specific functions or are natural components of flavoring ingredients 
used. Sherbet is sweetened with nutritive carbohydrate sweeteners and is 
characterized by the addition of one or more of the characterizing fruit 
ingredients specified in paragraph (d) of this section or one or more of 
the nonfruit-characterizing ingredients specified in paragraph (e) of 
this section.
    (2) Sherbet weighs not less than 6 pounds to the gallon. The milkfat 
content is not less than 1 percent nor more than 2 percent, the nonfat 
milk-derived solids content not less than 1 percent, and the total milk 
or milk-derived solids content is not less than 2 percent nor more than 
5 percent by weight of the finished food. Sherbet that is characterized 
by a fruit ingredient shall have a titratable acidity, calculated as 
lactic acid, of not less than 0.35 percent.
    (b) Optional dairy ingredients. The optional dairy ingredients 
referred to in paragraph (a) of this section are: Cream, dried cream, 
plastic cream (sometimes known as concentrated milkfat), butter, butter 
oil, milk, concentrated milk, evaporated milk, superheated condensed 
milk, sweetened condensed milk, dried milk, skim milk, concentrated skim 
milk, evaporated skim milk, condensed skim milk, sweetened condensed 
skim milk, sweetened condensed part-skim milk, nonfat dry milk, sweet 
cream buttermilk, condensed sweet cream buttermilk, dried sweet cream 
buttermilk, skim milk that has been concentrated and from which part of 
the lactose has been removed by crystallization, and whey and those 
modified whey products (e.g., reduced lactose whey, reduced minerals 
whey, and whey protein concentrate) that have been determined by FDA to 
be generally recognized as safe (GRAS) for use in this type of food. 
Water may be added, or water may be evaporated from the mix. The sweet 
cream buttermilk and the concentrated sweet cream buttermilk or dried 
sweet cream buttermilk, when adjusted with water to a total solids 
content of 8.5 percent, has a titratable acidity of not more than 0.17 
percent calculated as lactic acid. The term ``milk'' as used in this 
section means cow's milk.
    (c) Optional caseinates. The optional caseinates referred to in 
paragraph (a) of this section which may be added to sherbet mix are: 
Casein prepared by precipitation with gums, ammonium caseinate, calcium 
caseinate, potassium caseinate, and sodium caseinate. Caseinates may be 
added in liquid or dry form, but must be free of excess alkali, such 
caseinates are not considered to be milk solids.
    (d) Optional fruit-characterizing ingredients. The optional fruit-
characterizing ingredients referred to in paragraph (a) of this section 
are any mature fruit or the juice of any mature fruit. The fruit or 
fruit juice used may be fresh, frozen, canned, concentrated, or 
partially or wholly dried. The fruit may be thickened with pectin or 
other

[[Page 551]]

optional ingredients. The fruit is prepared by the removal of pits, 
seeds, skins, and cores, where such removal is usual in preparing that 
kind of fruit for consumption as fresh fruit. The fruit may be screened, 
crushed, or otherwise comminuted. It may be acidulated. In the case of 
concentrated fruit or fruit juices, from which part of the water is 
removed, substances contributing flavor volatilized during water removal 
may be condensed and reincorporated in the concentrated fruit or fruit 
juice. In the case of citrus fruits, the whole fruit, including the peel 
but excluding the seeds, may be used, and in the case of citrus juice or 
concentrated citrus juices, cold-pressed citrus oil may be added thereto 
in an amount not exceeding that which would have been obtained if the 
whole fruit had been used. The quantity of fruit ingredients used is 
such that, in relation to the weight of the finished sherbet, the weight 
of fruit or fruit juice, as the case may be (including water necessary 
to reconstitute partially or wholly dried fruits or fruit juices to 
their original moisture content), is not less than 2 percent in the case 
of citrus sherbets, 6 percent in the case of berry sherbets, and 10 
percent in the case of sherbets prepared with other fruits. For the 
purpose of this section, tomatoes and rhubarb are considered as kinds of 
fruit.
    (e) Optional nonfruit characterizing ingredients. The optimal 
nonfruit characterizing ingredients referred to in paragraph (a) of this 
section include but are not limited to the following:
    (1) Ground spice or infusion of coffee or tea.
    (2) Chocolate or cocoa, including sirup.
    (3) Confectionery.
    (4) Distilled alcoholic beverage, including liqueurs or wine, in an 
amount not to exceed that required for flavoring the sherbet.
    (5) Any natural or artificial food flavoring (except any having a 
characteristic fruit or fruit-like flavor).
    (f) Nomenclature. (1) The name of each sherbet is as follows:
    (i) The name of each fruit sherbet is ``___ sherbet'', the blank 
being filled in with the common name of the fruit or fruits from which 
the fruit ingredients used are obtained. When the names of two or more 
fruits are included, such names shall be arranged in order of 
predominance, if any, by weight of the respective fruit ingredients 
used.
    (ii) The name of each nonfruit sherbet is ``___ sherbet'', the blank 
being filled in with the common or usual name or names of the 
characterizing flavor or flavors; for example, ``peppermint'', except 
that if the characterizing flavor used is vanilla, the name of the food 
is ``___ sherbet'', the blank being filled in as specified by Sec. 
135.110(e) (2) and (5)(i).
    (2) When the optional ingredients, artificial flavoring, or 
artificial coloring are used in sherbet, they shall be named on the 
label as follows:
    (i) If the flavoring ingredient or ingredients consists exclusively 
of artificial flavoring, the label designation shall be ``artificially 
flavored''.
    (ii) If the flavoring ingredients are a combination of natural and 
artificial flavors, the label designation shall be ``artificial and 
natural flavoring added''.
    (iii) The label shall designate artificial coloring by the statement 
``artificially colored'', ``artificial coloring added'', ``with added 
artificial coloring'', or ``___, an artificial color added'', the blank 
being filled in with the name of the artificial coloring used.
    (g) Characterizing flavor(s). Wherever there appears on the label 
any representation as to the characterizing flavor or flavors of the 
food and such flavor or flavors consist in whole or in part of 
artificial flavoring, the statment required by paragraph (f)(2) (i) and 
(ii) of this section, as appropriate, shall immediately and 
conspicuously precede or follow such representation, without intervening 
written, printed, or graphic matter (except that the word ``sherbet'' 
may intervene) in a size reasonably related to the prominence of the 
name of the characterizing flavor and in any event the size of the type 
is not less than 6-point on packages containing less than 1 pint, not 
less than 8-point on packages containing at least 1 pint but less than 
one-half gallon, not less than 10-point on packages containing at least 
one-half gallon but less than 1 gallon,

[[Page 552]]

and not less than 12-point on packages containing 1 gallon or over.
    (h) Display of statements required by paragraph (f)(2). Except as 
specified in paragraph (g) of this section, the statements required by 
paragraph (f)(2) of this section shall be set forth on the principal 
display panel or panels of the label with such prominence and 
conspicuousness as to render them likely to be read and understood by 
the ordinary individual under customary conditions of purchase and use.
    (i) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[43 FR 4599, Feb. 3, 1978, as amended at 46 FR 44434, Sept. 4, 1981; 58 
FR 2896, Jan. 6, 1993]



Sec. 135.160  Water ices.

    (a) Description. Water ices are the foods each of which is prepared 
from the same ingredients and in the same manner prescribed in Sec. 
135.140 for sherbets, except that the mix need not be pasteurized, and 
complies with all the provisions of Sec. 135.140 (including the 
requirements for label statement of ingredients), except that no milk or 
milk-derived ingredient and no egg ingredient, other than egg white, is 
used.
    (b) Nomenclature. The name of the food is ``___ ice'', the blank 
being filled in, in the same manner as specified in Sec. 135.140(f)(1) 
(i) and (ii), as appropriate.

[42 FR 19132, Apr. 12, 1977, as amended 58 FR 2876, Jan. 6, 1993]



PART 136_BAKERY PRODUCTS--Table of Contents



                      Subpart A_General Provisions

Sec.
136.3 Definitions.

    Subpart B_Requirements for Specific Standardized Bakery Products

136.110 Bread, rolls, and buns.
136.115 Enriched bread, rolls, and buns.
136.130 Milk bread, rolls, and buns.
136.160 Raisin bread, rolls, and buns.
136.180 Whole wheat bread, rolls, and buns.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.



                      Subpart A_General Provisions



Sec. 136.3  Definitions.

    For purposes of this part, the following definitions apply:
    (a) The word bread when used in the name of the food means the unit 
weighs one-half pound or more after cooling.
    (b) The words rolls and buns when used in the name of the food mean 
the unit weighs less than one-half pound after cooling.



    Subpart B_Requirements for Specific Standardized Bakery Products



Sec. 136.110  Bread, rolls, and buns.

    (a) Bread, white bread, and rolls, white rolls, or buns, and white 
buns are the foods produced by baking mixed yeast-leavened dough 
prepared from one or more of the farinaceous ingredients listed in 
paragraph (c)(1) of this section and one or more of the moistening 
ingredients listed in paragraphs (c) (2), (6), (7), and (8) of this 
section and one or more of the leavening agents provided for by 
paragraph (c)(3) of this section. The food may contain additional 
ingredients as provided for by paragraph (c) of this section. Each of 
the finished foods contains not less than 62 percent total solids as 
determined by the method prescribed in paragraph (d) of this section.
    (b) All ingredients from which the food is fabricated shall be safe 
and suitable.
    (c) The following optional ingredients are provided for:
    (1) Flour, bromated flour, phosphated flour, or a combination of two 
or more of these. The potassium bromate in any bromated flour used and 
the monocalcium phosphate in any phosphated flour used are deemed to be 
additional optional ingredients in the bread, rolls, or buns. All 
ingredients in any flour, bromated flour, or phosphated flour used are 
deemed to be optional ingredients of the bread, rolls, or buns prepared 
therefrom.
    (2) Water.
    (3) Yeast--any type which produces the necessary leavening effect.
    (4) Salt.

[[Page 553]]

    (5) Shortening, in which or in conjunction with which may be used 
one or any combination of two or more of the following:
    (i) Lecithin, hydroxylated lecithin complying with the provisions of 
part 172 of this chapter, either of which may include related 
phosphatides derived from the corn oil or soybean oil from which such 
ingredients were obtained.
    (ii) Mono- and diglycerides of fat-forming fatty acids, diacetyl 
tartaric acid esters of mono- and diglycerides of fat-forming fatty 
acids, propylene glycol mono- and diesters of fat-forming fatty acids, 
and other ingredients that perform a similar function.
    (6) Milk and/or other dairy products in such quantity and 
composition as not to meet the requirements for milk and/or other dairy 
products prescribed for milk bread by Sec. 136.130. Whenever nonfat 
milk solids in any form are used, carrageenan or salts of carrageenan 
complying with the provisions of part 172 of this chapter may be used in 
a quantity not in excess of 0.8 percent by weight of such nonfat milk 
solids.
    (7) Egg products.
    (8) Nutritive carbohydrate sweeteners.
    (9) Enzyme active preparations.
    (10) Lactic-acid-producing bacteria.
    (11) Nonwheat flours, nonwheat meals, nonwheat grits, wheat and 
nonwheat starches, any of which may be wholly or in part dextrinized, 
dextrinized wheat flour, or any combination of 2 or more of these, if 
the total quantity is not more than 3 parts for each 100 parts by weight 
of flour used.
    (12) Ground dehulled soybeans which may be heat-treated, and from 
which oil may be removed, but which retain enzymatic activity, if the 
quantity is not more than 0.5 part for each 100 parts by weight of flour 
used.
    (13) Yeast nutrients and calcium salts, if the total quantity of 
such ingredients, with the exception of monocalcium phosphate and 
calcium propionate, is not more than 0.25 part for each 100 parts by 
weight of flour used. The quantity of monocalcium phosphate, including 
any quantity in the flour used, is not more than 0.75 part for each 100 
parts by weight of flour used. Any calcium propionate used as a 
preservative in bread, rolls, or buns is not subject to the limitation 
prescribed in this paragraph.
    (14)(i) Potassium bromate, calcium bromate, potassium iodate, 
calcium iodate, calcium peroxide, or any combination of 2 or more of 
these if the total quantity, including the potassium bromate in any 
bromated flour used, is not more than 0.0075 part for each 100 parts by 
weight of flour used.
    (ii) Azodicarbonamide, if the total quantity, including any quantity 
in the flour used, is not more than 0.0045 part for each 100 parts by 
weight of flour used.
    (15) Dough strengtheners and other dough conditioners not listed or 
referred to in this paragraph, if the total quantities of such 
ingredients or combination is not more than 0.5 part for each 100 parts 
by weight of flour used.
    (16) Spices, spice oil, and spice extract.
    (17) Coloring may not be added as such or as part of another 
ingredient except as permitted by paragraph (c)(16) of this section and 
except that coloring which may be present in butter or margarine if the 
intensity of the butter or margarine color does not exceed ``medium 
high'' (MH) when viewed under diffused light (7400 Kelvin) against the 
Munsell Butter Color Comparator. The MH designation corresponds to the 
Munsell renotation of 3.8Y7.9/7.6.
    (18) Other ingredients that do not change the basic identity or 
adversely affect the physical and nutritional characteristics of the 
food.
    (d) Total solids are determined by the method prescribed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), section 14.091(a), which is incorporated by 
reference, except that if the baked unit weighs 454 grams (1 pound) or 
more, one entire unit is used for the determination; if the baked unit 
weighs less than 454 grams, enough units to weigh 454 grams or more are 
used. Copies of the material incorporated by reference may be obtained 
from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877, or may be examined at the National Archives and

[[Page 554]]

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.
    (e)(1) The name of the food is ``bread'', ``white bread'', 
``rolls'', ``white rolls'', ``buns'', ``white buns'', as applicable. 
When the food contains not less than 2.56 percent by weight of whole egg 
solids, the name of the food may be ``egg bread'', ``egg rolls'', or 
``egg buns'', as applicable, accompanied by the statement ``Contains __ 
medium-sized egg(s) per pound'' in the manner prescribed by Sec. 
102.5(c)(3) of this chapter, the blank to be filled in with the number 
which represents the whole egg content of the food expressed to the 
nearest one-fifth egg but not greater than the amount actually present. 
For the purpose of this regulation, whole egg solids are the edible 
contents of eggs calculated on a moisture-free basis and exclusive of 
any nonegg solids which may be present in standardized and other 
commercial egg products. One medium-sized egg is equivalent to 0.41 
ounce of whole egg solids.
    (2) When the label bears any representation, other than in the 
ingredient listing, of the presence of egg in the food, e.g., the word 
egg or any phonetic equivalent spelling of the word egg, or a picture of 
an egg, the food shall contain not less than 2.56 percent of whole egg 
solids.
    (f) Label declaration. Each of the ingredients used shall be 
declared on the label as required by the applicable sections of parts 
101 and 130 of this chapter.

[42 FR 14400, Mar. 15, 1977, as amended at 43 FR 47177, Oct. 13, 1978; 
47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 19, 1984; 49 FR 13692, 
Apr. 6, 1984; 54 FR 24894, June 12, 1989; 58 FR 2877, Jan. 6, 1993; 63 
FR 14035, Mar. 24, 1998]



Sec. 136.115  Enriched bread, rolls, and buns.

    (a) Each of the foods enriched bread, enriched rolls, and enriched 
buns conforms to the definition and standard of identity and is subject 
to the requirements for label statement of ingredients prescribed for 
bread, rolls or buns by Sec. 136.110, except that:
    (1) Each such food contains in each pound 1.8 milligrams of thiamin, 
1.1 milligrams of riboflavin, 15 milligrams of niacin, 0.43 milligrams 
of folic acid, and 12.5 milligrams of iron.
    (2) Each such food may contain added calcium in such quantity that 
the total calcium content is 600 milligrams per pound. If insufficient 
calcium is added to meet the 600-milligram level per pound of the 
finished food, no claim may be made on the label for calcium as a 
nutrient except as a part of nutrition labeling.
    (3) The requirements of paragraphs (a) (1) and (2) of this section 
will be deemed to have been met if reasonable overages of the vitamins 
and minerals, within the limits of good manufacturing practice, are 
present to ensure that the required levels of the vitamins and minerals 
are maintained throughout the expected shelf life of the food under 
customary conditions of distribution and storage. The quantitative 
content of the following vitamins shall be calculated in terms of the 
following chemically identifiable reference forms:

------------------------------------------------------------------------
                                            Reference form
                             -------------------------------------------
           Vitamin                                Empirical    Molecular
                                    Name           formula       weight
------------------------------------------------------------------------
Thiamine....................  Thiamine         C12H17ClN4        337.28
                               chloride         OS[middot]HCl
                               hydrochloride.
Riboflavin..................  Riboflavin.....  C17H20N4O6        376.37
Niacin......................  Niacin.........  C6H5NO2           123.11
------------------------------------------------------------------------

    (4) Each such food may also contain wheat germ or partly defatted 
wheat germ, but the total quantity thereof, including any wheat germ or 
partly defatted wheat germ in any enriched flour used, shall not be more 
than 5 percent of the flour ingredient.
    (5) Enriched flour may be used, in whole or in part, instead of 
flour. As used in this section, the term ``enriched flour'' includes 
enriched bromated flour.
    (6) The limitation prescribed by Sec. 136.110(c)(6) on the quantity 
and composition of milk and/or other dairy products does not apply.
    (7) The vitamins and minerals added to the food for enrichment 
purposes

[[Page 555]]

may be supplied by any safe and suitable substances. Niacin equivalents 
as derived from tryptophan content shall not be used in determining 
total niacin content.
    (b) The name of the food is ``enriched bread'', ``enriched rolls'', 
or ``enriched buns'', as applicable. When the food contains not less 
than 2.56 percent by weight of whole egg solids, the name of the food 
may be ``enriched egg bread'', ``enriched egg rolls'', or ``enriched egg 
buns'', as applicable, accompanied by the statement ``Contains _ medium-
sized egg(s) per pound'' in the manner prescribed by Sec. 102.5(c)(3) 
of this chapter, the blank to be filled in with the number which 
represents the whole egg content of the food expressed to the nearest 
one-fifth egg but not greater than the amount actually present. For the 
purpose of this regulation, whole egg solids are the edible contents of 
eggs calculated on a moisture-free basis and exclusive of any non-egg 
solids which may be present in standardized and other commercial egg 
products. One medium-sized egg is equivalent to 0.41 ounce of whole egg 
solids. When the food complies with the requirements for milk and/or 
other dairy products content in Sec. 136.130 for milk bread, the name 
of the food may be ``enriched milk bread'', ``enriched milk rolls'', or 
``enriched milk buns'', as applicable. When the food complies with the 
requirements for both enriched egg bread and enriched milk bread in this 
section, the name of the food may be ``enriched milk and egg bread'', 
``enriched milk and egg rolls'', or ``enriched milk and egg buns'', as 
applicable accompanied by the statement ``Contains _ medium-sized egg(s) 
per pound'' in the manner prescribed by Sec. 102.5(c)(3) of this 
chapter, the blank to be filled in with the number which represents the 
whole egg content of the food expressed to the nearest one-fifth egg but 
no greater than the amount actually present. For purposes of this 
regulation, whole egg solids are the edible contents of eggs calculated 
on a moisture-free basis and exclusive of any non-egg solids which may 
be present in standardized or other commercial egg products. One medium-
sized egg is equivalent to 0.41 ounce of whole egg solids.

[42 FR 14400, Mar. 15, 1977, as amended at 43 FR 38578, Aug. 29, 1978; 
46 FR 43413, Aug. 28, 1981; 61 FR 8796, Mar. 5, 1996; 61 FR 14245, Apr. 
1, 1996]



Sec. 136.130  Milk bread, rolls, and buns.

    (a) Each of the foods milk bread, milk rolls, and milk buns conforms 
to the definition and standard of identity and is subject to the 
requirements for label statement of ingredients prescribed for bread, 
rolls or buns by Sec. 136.110 except that:
    (1) The only moistening ingredient permitted in the preparation of 
the dough is milk or, as an alternative, a combination of dairy products 
in such a proportion that the weight of the nonfat milk solids is not 
more than 2.3 times and not less than 1.2 times the weight of the 
milkfat therein, with or without water, in a quantity that provides not 
less than 8.2 parts milk solids for each 100 parts by weight of flour.
    (2) No buttermilk, buttermilk product, cheese whey, cheese whey 
product, or milk protein is used.
    (b) The name of the food is ``milk bread'', ``milk rolls'', ``milk 
buns'', as applicable.



Sec. 136.160  Raisin bread, rolls, and buns.

    (a) Each of the foods raisin bread, raisin rolls, and raisin buns 
conforms to the definition and standard of identity and is subject to 
the requirements for label statement of ingredients prescribed for 
bread, rolls or buns by Sec. 136.110, except that:
    (1) Not less than 50 parts by weight of seeded or seedless raisins 
are used for each 100 parts by weight of flour used.
    (2) Water extract of raisins may be used, but not to replace 
raisins.
    (3) The baked units may bear icing or frosting.
    (4) The limitation prescribed by Sec. 136.110(c)(6) on the quantity 
and composition of milk and/or other dairy products does not apply.
    (5) The total solids are determined by the method prescribed in 
Sec. 136.110(d), except that section 14.091(b) of ``Official Methods of 
Analysis of the Association of Official Analytical Chemists,'' 13th Ed. 
(1980), which is incorporated by reference, will apply. Copies

[[Page 556]]

may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877, or may be examined 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 name of the food is ``raisin bread'', ``raisin rolls'', 
``raisin buns'', as applicable. When the food contains not less than 
2.56 percent by weight of whole egg solids, the name of the food may be 
``raisin and egg bread'', ``raisin and egg rolls'', or ``raisin and egg 
buns'', as applicable, accompanied by the statement ``Contains _ medium-
sized egg(s) per pound'' in the manner prescribed by Sec. 102.5(c)(3) 
of this chapter, the blank to be filled in with the number which 
represents the whole egg content of the food expressed to the nearest 
one-fifth egg but not greater than the amount actually present. For 
purposes of this regulation, whole egg solids are the edible contents of 
eggs calculated on a moisture-free basis and exclusive of any nonegg 
solids which may be present in standardized and other commercial egg 
products. One medium-sized egg is equivalent to 0.41 ounce of whole egg 
solids.

[42 FR 14400, Mar. 15, 1977, as amended at 47 FR 11826, Mar. 19, 1982; 
49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 63 FR 14035, 
Mar. 24, 1998]



Sec. 136.180  Whole wheat bread, rolls, and buns.

    (a) Each of the foods whole wheat bread, graham bread, entire wheat 
bread, whole wheat rolls, graham rolls, entire wheat rolls, whole wheat 
buns, graham buns, and entire wheat buns conforms to the definition and 
standard of identity and is subject to the label statement of 
ingredients prescribed for bread, rolls and buns by Sec. 136.110, 
except that:
    (1) The dough is made from the optional ingredient whole wheat 
flour, bromated whole wheat flour, or a combination of these. No flour, 
bromated flour, or phosphated flour is used. The potassium bromate in 
any bromated whole wheat flour used is deemed to be an additional 
optional ingredient in the whole wheat bread, whole wheat rolls, or 
whole wheat buns.
    (2) The limitation prescribed by Sec. 136.110(c)(6) on the quantity 
and composition of milk and/or other dairy products does not apply.
    (b) The name of the food is ``whole wheat bread'', ``graham bread'', 
``entire wheat bread'', ``whole wheat rolls'', ``graham rolls'', 
``entire wheat rolls'', ``whole wheat buns'', ``graham buns'', ``entire 
wheat buns'', as applicable.



PART 137_CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents



Subpart A [Reserved]

   Subpart B_Requirements for Specific Standardized Cereal Flours and 
                            Related Products

Sec.
137.105 Flour.
137.155 Bromated flour.
137.160 Enriched bromated flour.
137.165 Enriched flour.
137.170 Instantized flours.
137.175 Phosphated flour.
137.180 Self-rising flour.
137.185 Enriched self-rising flour.
137.190 Cracked wheat.
137.195 Crushed wheat.
137.200 Whole wheat flour.
137.205 Bromated whole wheat flour.
137.211 White corn flour.
137.215 Yellow corn flour.
137.220 Durum flour.
137.225 Whole durum flour.
137.250 White corn meal.
137.255 Bolted white corn meal.
137.260 Enriched corn meals.
137.265 Degerminated white corn meal.
137.270 Self-rising white corn meal.
137.275 Yellow corn meal.
137.280 Bolted yellow corn meal.
137.285 Degerminated yellow corn meal.
137.290 Self-rising yellow corn meal.
137.300 Farina.
137.305 Enriched farina.
137.320 Semolina.
137.350 Enriched rice.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14402, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 137 appear at 63 FR 
14035, Mar. 24, 1998.

Subpart A [Reserved]

[[Page 557]]



   Subpart B_Requirements for Specific Standardized Cereal Flours and 
                            Related Products



Sec. 137.105  Flour.

    (a) Flour, white flour, wheat flour, plain flour, is the food 
prepared by grinding and bolting cleaned wheat, other than durum wheat 
and red durum wheat. To compensate for any natural deficiency of 
enzymes, malted wheat, malted wheat flour, malted barley flour, or any 
combination of two or more of these, may be used; but the quantity of 
malted barley flour so used is not more than 0.75 percent. Harmless 
preparations of [alpha]-amylase obtained from Aspergillus oryzae, alone 
or in a safe and suitable carrier, may be used. When tested for 
granulation as prescribed in paragraph (c)(4) of this section, not less 
than 98 percent of the flour passes through a cloth having openings not 
larger than those of woven wire cloth designated ``212 [micro]m (No. 
70)'' complying with the specifications for such cloth set forth in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists'' (AOAC), 13th Ed. (1980), Table 1, ``Nominal Dimensions of 
Standard Test Sieves (U.S.A. Standard Series),'' under the heading 
``Definitions of Terms and Explanatory Notes,'' which is incorporated by 
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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. The flour is freed from 
bran coat, or bran coat and germ, to such extent that the percent of ash 
therein, calculated to a moisture-free basis, is not more than the sum 
of \1/20\ of the percent of protein therein, calculated to a moisture-
free basis, plus 0.35. Its moisture content is not more than 15 percent. 
It may contain ascorbic acid in a quantity not to exceed 200 parts per 
million as a dough conditioner. Unless such addition conceals damage or 
inferiority or makes the flour appear to be better or of greater value 
than it is, one or any combination of two or more of the following 
optional bleaching ingredients may be added in a quantity not more than 
sufficient for bleaching or, in case such ingredient has an artificial 
aging effect, in a quantity not more than sufficient for bleaching and 
such artificial aging effect:
    (1) Oxides of nitrogen.
    (2) Chlorine.
    (3) Nitrosyl chloride.
    (4) Chlorine dioxide.
    (5) One part by weight of benzoyl peroxide mixed with not more than 
six parts by weight of one or any mixture of two or more of the 
following: potassium alum, calcium sulfate, magnesium carbonate, sodium 
aluminum sulfate, dicalcium phosphate, tricalcium phosphate, starch, 
calcium carbonate.
    (6) Acetone peroxides complying with the provisions of Sec. 172.802 
of this chapter.
    (7) Azodicarbonamide (complying with the requirements of Sec. 
172.806 of this chapter, including the quantitative limit of not more 
than 45 parts per million).
    (b)(1) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (2) When ascorbic acid is added, the label shall bear the statement 
``Ascorbic acid added as a dough conditioner''. When the optional 
ingredient [alpha]-amylase obtained from Aspergillus oryzae'' is used, 
it may alternatively be declared in the list of ingredients as ``Fungal 
alpha-amylase,'' ``Fungal [alpha]-amylase'', ``Enzyme'', or ``Enzyme 
added for improved baking''. When any optional bleaching ingredient is 
used, the label shall bear the word ``Bleached''. Wherever the name of 
the food appears on the label so conspicuously as to be easily seen 
under customary conditions of purchase, the word ``Bleached'' shall 
immediately and conspicuously precede or follow such name, without 
intervening written, printed, or graphic matter; except that where such 
name is a part of a trademark or brand, other written, printed, or 
graphic matter, which is also a part of such trademark or brand, may so 
intervene if the word

[[Page 558]]

``Bleached'' is in such juxtaposition with such trademark or brand as to 
be conspicuoulsy related to such name.
    (c) For the purposes of this section:
    (1) Ash is determined by the method prescribed in the AOAC, 13th Ed. 
(1980), section 14.006, ``Direct Method--Official Final Action,'' under 
the heading ``Ash (5),'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(a) of this section. Ash is calculated to a moisture-free basis by 
subtracting the percent of moisture in the flour from 100, dividing the 
remainder into the percent of ash, and multiplying the quotient by 100.
    (2) Protein is 5.7 times the nitrogen as determined by the method 
prescribed in section 2.057, ``Improved Kjeldahl Methods for Nitrate-
Free Samples (20)--Official Final Action,'' AOAC, 13th Ed. (1980), which 
is incorporated by reference. The availability of this incorporation by 
reference is given in paragraph (a) of this section. Protein is 
calculated to a moisture-free basis by subtracting the percent of 
moisture in the flour from 100, dividing the remainder into the percent 
of protein, and multiplying the quotient by 100.
    (3) Moisture is determined by the method prescribed in the AOAC, 
13th Ed. (1980), sections 14.002 and 14.003, ``Vacuum Oven Method (2)--
Official Final Action,'' under the heading ``Total Solids Moisture, 
Indirect Method,'' which is incorporated by reference. The availability 
of this incorporation by reference is given in paragraph (a) of this 
section.
    (4) Granulation is determined as follows: Use No. 70 sieve complying 
with the specifications for ``Nominal Dimensions of Standard Test Sieves 
(U.S.A. Standard Series)'' prescribed in paragraph (a) of this section. 
Attach bottom pan to sieve in Ro-Tap sifter (or an equivalent sifter). 
Place half of a rubber ball or other sieving aid in the sieve. Pour 100 
grams of the sample in the sieve and turn on the sifter with knocker. 
Sift exactly 5 minutes. Weigh the residue on the No. 70 sieve and 
convert to percentage.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 
47 FR 24693, June 8, 1982; 47 FR 43363, Oct. 1, 1982; 49 FR 10097, Mar. 
19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2877, Jan. 6, 1993]



Sec. 137.155  Bromated flour.

    Bromated flour conforms to the definition and standard of identity, 
and is subject to the requirements for label statement of ingredients, 
prescribed for flour by Sec. 137.105, except that potassium bromate is 
added in a quantity not exceeding 50 parts to each million parts of the 
finished bromated flour, and is added only to flours whose baking 
qualities are improved by such addition.

[57 FR 2877, Jan. 6, 1993]



Sec. 137.160  Enriched bromated flour.

    Enriched bromated flour conforms to the definition and standard of 
identity, and is subject to the requirements for label statement of 
ingredients, prescribed for enriched flour by Sec. 137.165, except that 
potassium bromate is added in a quantity not exceeding 50 parts to each 
million parts of the finished enriched bromated flour, and is added only 
to enriched flours whose baking qualities are improved by such addition.

[58 FR 2877, Jan. 6, 1993]



Sec. 137.165  Enriched flour.

    Enriched flour conforms to the definition and standard of identity, 
and is subject to the requirements for label statement of ingredients, 
prescribed for flour by Sec. 137.105, except that:
    (a) It contains in each pound 2.9 milligrams of thiamin, 1.8 
milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of 
folic acid, and 20 milligrams of iron.
    (b) It may contain added calcium in such quantity that the total 
calcium content is 960 milligrams per pound. Enriched flour may be 
acidified with monocalcium phosphate within the limits prescribed by 
Sec. 137.175 for phosphated flour, but, if insufficient additional 
calcium is present to meet the 960 milligram level, no claim may

[[Page 559]]

be made on the label for calcium as a nutrient;
    (c) The requirement of paragraphs (a) and (b) of this section will 
be deemed to have been met if reasonable overages of the vitamins and 
minerals, within the limits of good manufacturing practice, are present 
to insure that the required levels of the vitamins and minerals are 
maintained throughout the expected shelf life of the food under 
customary conditions of distribution and storage. The quantitative 
content of the following vitamins shall be calculated in terms of the 
following chemically identifiable reference forms:

------------------------------------------------------------------------
                                            Reference form
                             -------------------------------------------
           Vitamin                                Empirical    Molecular
                                    Name           formula       weight
------------------------------------------------------------------------
Thiamine....................  Thiamine         C12H17ClN4OS[m    337.28
                               chloride         iddot]HCl
                               hydrochloride.
Riboflavin..................  Riboflavin.....  C17H20N4O6        376.37
Niacin......................  Niacin.........  C6H5NO2           123.11
------------------------------------------------------------------------

    (d) It may contain not more than 5 percent by weight of wheat germ 
or partly defatted wheat germ;
    (e) In determining whether the ash content complies with the 
requirements of this section, ash resulting from any added iron or salts 
of iron or calcium or wheat germ is excluded in calculating ash content.
    (f) All ingredients from which the food is fabricated shall be safe 
and suitable. The vitamins and minerals added to the food for enrichment 
purposes may be supplied by any safe and suitable substance. Niacin 
equivalents as derived from tryptophan content shall not be used in 
determining total niacin content.

[42 FR 14402, Mar. 15, 1977, as amended at 43 FR 38578, Aug. 29, 1978; 
46 FR 43414, Aug. 28, 1981; 58 FR 2877, Jan. 6, 1993; 61 FR 8796, Mar. 
5, 1996]



Sec. 137.170  Instantized flours.

    (a) Instantized flours, instant blending flours, and quick-mixing 
flours, are the foods each of which conforms to the definition and 
standard of identity and is subject to the requirement for label 
statement of ingredients prescribed for the corresponding kind of flour 
by Sec. Sec. 137.105, 137.155, 137.160, 137.165, 137.175, 137.180, and 
137.185, except that each such flour has been made by one of the 
optional procedures set forth in paragraph (b) of this section, and is 
thereby made readily pourable. Such flours will all pass through a No. 
20 mesh U.S. standard sieve (840-micron opening), and not more than 20 
percent will pass through a 200 mesh U.S standard sieve (74-micron 
opening).
    (b) The optional procedures referred to in paragraph (a) of this 
section are:
    (1) A selective grinding and bolting procedure or other milling 
procedure, whereby controlled techniques are used to obtain a food too 
fine to meet the granulation specification prescribed in Sec. 
137.300(a) for farina.
    (2) An agglomerating procedure, whereby flour that originally meets 
the granulation specification prescribed in Sec. 137.105(a) has been 
modified by further processing, so that a number of the individual flour 
particles have been combined into agglomerates conforming to the 
granulation specifications set out in paragraph (a) of this section.
    (c) The name of each product covered by this section is the name 
prescribed by the definition and standard of identity for the 
corresponding kind of flour as referred to in paragraph (a) of this 
section, preceded immediately and conspicuously by the words 
``Instantized'', ``Instant blending'', or ``Quick-mixing''.

[42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2877, Jan. 6, 1993]



Sec. 137.175  Phosphated flour.

    Phosphated flour, phosphated white flour, and phosphated wheat 
flour, conform to the definition and standard of identity, and are 
subject to the requirements for label declaration of ingredients, 
prescribed for flour by Sec. 137.105, except that:
    (a) Monocalcium phosphate is added in a quantity not less than 0.25 
percent and not more than 0.75 percent of the weight of the finished 
phosphated flour; and
    (b) In determining whether the ash content complies with the 
requirements of this section allowance is

[[Page 560]]

made for the added monocalcium phosphate.

[42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2877, Jan. 6, 1993]



Sec. 137.180  Self-rising flour.

    (a) Self-rising flour, self-rising white flour, self-rising wheat 
flour, is an intimate mixture of flour, sodium bicarbonate, and one or 
more of the acid-reacting substances monocalcium phosphate, sodium acid 
pyrophosphate, and sodium aluminum phosphate. It is seasoned with salt. 
When it is tested by the method prescribed in paragraph (c) of this 
section not less than 0.5 percent of carbon dioxide is evolved. The 
acid-reacting substance is added in sufficient quantity to neutralize 
the sodium bicarbonate. The combined weight of such acid-reacting 
substance and sodium bicarbonate is not more than 4.5 parts to each 100 
parts of flour used. Subject to the conditions and restrictions 
prescribed by Sec. 137.105(a), the bleaching ingredients specified in 
such section may be added as optional ingredients. If the flour used in 
making the self-rising flour is bleached, the optional bleaching 
ingredient used therein (see Sec. 137.105(a)) is also an optional 
ingredient of the self-rising flour.
    (b) Label declaration. Each of the ingredients used in the food, 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (c) The method referred to in paragraph (a) of this section is the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists'' (AOAC), 13th Ed. (1980), section 
8.002, ``Reagent (Displacement soln.),'' and section 8.003, ``Chittick 
apparatus,'' under the heading ``Total Carbon Dioxide (1)--Official 
Final Action,'' which is incorporated by reference. Copies may be 
obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined 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.The following procedure is substituted for the 
procedure specified in the AOAC, under section 8.004, ``Determination'':
    (1) Weigh 17 grams of the official sample into flask A, add 15-20 
glass beads (4-6 mm. diameter), and connect this flask with the 
apparatus (fig. 22). Open stopcock C and by means of the leveling bulb E 
bring the displacement solution to the 25 cc. graduation above the zero 
mark. (This 25 cc. is a partial allowance for the volume of acid to be 
used in the decomposition.) Allow the apparatus to stand 1-2 minutes to 
insure that the temperature and pressure within the apparatus are the 
same as those of the room. Close the stopcock, lower the leveling bulb 
somewhat to reduce the pressure within the apparatus, and slowly run 
into the decomposition flask from burette F 45 cc. of sulfuric acid (1 + 
5). To prevent the liberated carbon dioxide from escaping through the 
acid burette into the air, keep the displacement solution in the 
leveling bulb at all times during the decomposition at a lower level 
than that in the gas-measuring tube. Rotate and then vigorously agitate 
the decomposition flask for three minutes to mix the contents 
intimately. Allow to stand for 10 minutes to bring to equilibrium. 
Equalize the pressure in the measuring tube by means of the leveling 
bulb and read the volume of gas from the zero point on the tube. Deduct 
20 cc. from this reading (this 20 cc. together with previous allowance 
of 25 cc. compensates for the 45 cc. acid used in the decomposition). 
Observe the temperature of the air surrounding the apparatus and also 
the barometric pressure and multiply the number of mL of gas evolved by 
the factor given in section 52.007, ``Correction factors for gasometric 
determination of carbon dioxide,'' AOAC, 13th Ed. (1980), which is 
incorporated by reference (the availability of this incorporation by 
reference is given in paragraph (c) of this section), for the 
temperature and pressure observed. Divide the corrected reading by 100 
to obtain the apparent percent by weight of carbon dioxide in the 
official sample.
    (2) Correct the apparent percent of carbon dioxide to compensate for 
varying atmospheric conditions by immediately assaying a synthetic 
sample by

[[Page 561]]

the same method in the same apparatus.
    (3) Prepare the synthetic sample with 16.2 grams of flour, 0.30 gram 
of monocalcium phosphate, 0.30 gram of salt, and a sufficient quantity 
of sodium bicarbonate U.S.P. (dried over sulfuric acid) to yield the 
amount of carbon dioxide recovered in assay of official sample. 
Determine this quantity by multiplying weight of carbon dioxide 
recovered in assay of official sample by 1.91.
    (4) Divide the weight of carbon dioxide recovered from synthetic 
sample by weight of carbon dioxide contained in sodium bicarbonate used.
    (5) Divide the quotient into the apparent percent of carbon dioxide 
in official sample to obtain percent of carbon dioxide evolved from the 
official sample.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 
49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2877, Jan. 
6, 1993]



Sec. 137.185  Enriched self-rising flour.

    Enriched self-rising flour conforms to the definition and standard 
of identity, and is subject to the requirements for label statement of 
ingredients, prescribed for self-rising flour by Sec. 137.180, except 
that:
    (a) It contains in each pound 2.9 milligrams of thiamin, 1.8 
milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of 
folic acid, and 20 milligrams of iron.
    (b) It contains added calcium in such quantity that the total 
calcium content is 960 milligrams per pound. If a calcium compound is 
added for technical purposes to give self-rising characteristics to the 
flour, the amount of calcium per pound of flour may exceed 960 
milligrams provided that the excess is no greater than necessary to 
accomplish the intended effect. However, if such calcium is insufficient 
to meet the 960-milligram level, no claim may be made on the label for 
calcium as a nutrient.
    (c) The requirements of paragraphs (a) and (b) of this section will 
be deemed to have been met if reasonable overages of the vitamins and 
minerals, within the limits of good manufacturing practice, are present 
to insure that the required levels of the vitamins and minerals are 
maintained throughout the expected shelf life of the food under 
customary conditions of distribution and storage. The quantitative 
content of the following vitamins shall be calculated in terms of the 
following chemically identifiable reference forms:

------------------------------------------------------------------------
                                            Referemce form
                             -------------------------------------------
           Vitamin                                Empirical    Molecular
                                    Name           formula       weight
------------------------------------------------------------------------
Thiamine....................  Thiamine         C12H17ClN4OS[m    337.28
                               chloride         iddot]HCl
                               hydrochloride.
Riboflavin..................  Riboflavin.....  C17H20N4O6        376.37
Niacin......................  Niacin.........  C6H5NO2           123.11
------------------------------------------------------------------------

    (d) It may contain not more than 5 percent by weight of wheat germ 
or partly defatted wheat germ;
    (e) When calcium is added as dicalcium phosphate, such dicalcium 
phosphate is also considered to be an acid-reacting substance;
    (f) When calcium is added as carbonate, the method set forth in 
Sec. 137.180(c) does not apply as a test for carbon dioxide evolved; 
but in such case the quantity of carbon dioxide evolved under ordinary 
conditions of use of the enriched self-rising flour is not less than 0.5 
percent of the weight thereof;
    (g) All ingredients from which the food is fabricated shall be safe 
and suitable. The vitamins and minerals added to the food for enrichment 
purposes may be supplied by any safe and suitable substances. Niacin 
equivalents as derived from tryptophan content shall not be used in 
determining total niacin content.

[42 FR 14402, Mar. 15, 1977, as amended at 43 FR 38578, Aug. 29, 1978; 
46 FR 43414, Aug. 28, 1981; 58 FR 2877, Jan. 6, 1993; 61 FR 8796, Mar. 
5, 1996]



Sec. 137.190  Cracked wheat.

    Cracked wheat is the food prepared by so cracking or cutting into 
angular fragments cleaned wheat other than durum wheat and red durum 
wheat that, when tested by the method prescribed in Sec. 137.200(c)(2), 
not less than 90 percent passes through a No. 8 sieve and not more than 
20 percent passes through a No. 20 sieve. The proportions

[[Page 562]]

of the natural constituents of such wheat, other than moisture, remain 
unaltered. Cracked wheat contains not more than 15 percent of the 
moisture as determined by the method prescribed in ``Official Methods of 
Analysis of the Association of Official Analytical Chemists,'' 13th Ed. 
(1980), section 7.002 under ``Preparation of Sample--Official Final 
Action,'' and section 7.003 under ``Moisture--Official Final Action. I. 
Drying in Vacuo at 95-100[deg] (2),'' which is incorporated by 
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 
49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989]



Sec. 137.195  Crushed wheat.

    Crushed wheat, coarse ground wheat, is the food prepared by so 
crushing cleaned wheat other than durum wheat and red durum wheat that, 
when tested by the method prescribed in Sec. 137.200(c)(2), 40 percent 
or more passes through a No. 8 sieve and less than 50 percent passes 
through a No. 20 sieve. The proportions of the natural constituents of 
such wheat, other than moisture, remain unaltered. Crushed wheat 
contains not more than 15 percent of moisture as determined by the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980), section 7.002 under 
``Preparation of Sample--Official Final Action,'' and section 7.003 
under ``Moisture--Official Final Action. I. Drying in Vacuo at 95-
100[deg] (2),'' which is incorporated by reference. Copies may be 
obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined 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.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 
49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989]



Sec. 137.200  Whole wheat flour.

    (a) Whole wheat flour, graham flour, entire wheat flour is the food 
prepared by so grinding cleaned wheat, other than durum wheat and red 
durum wheat, that when tested by the method prescribed in paragraph 
(c)(2) of this section, not less than 90 percent passes through a 2.36 
mm (No. 8) sieve and not less than 50 percent passes through a 850 
[micro]m (No. 20) sieve. The proportions of the natural constituents of 
such wheat, other than moisture, remain unaltered. To compensate for any 
natural deficiency of enzymes, malted wheat, malted wheat flour, malted 
barley flour, or any combination of two or more of these, may be used; 
but the quantity of malted barley flour so used is not more than 0.75 
percent. It may contain harmless preparations of [alpha]-amylase 
obtained from Aspergillus oryzae, alone or in a safe and suitable 
carrier. The moisture content of whole wheat flour is not more than 15 
percent. It may contain ascorbic acid in a quantity not to exceed 200 
parts per million as a dough conditioner. Unless such addition conceals 
damage or inferiority or makes the whole wheat flour appear to be better 
or of greater value than it is, the optional bleaching ingredient 
azodicarbonamide (complying with the requirements of Sec. 172.806 of 
this chapter, including the quantitative limit of not more than 45 parts 
per million) or chlorine dioxide, or chlorine, or a mixture of nitrosyl 
chloride and chlorine, may be added in a quantity not more than 
sufficient for bleaching and artificial aging effects.
    (b)(1) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (2) When ascorbic acid is added, the label shall bear the statement 
``Ascorbic acid added as a dough conditioner''. When the optional 
ingredient ``[alpha]''-amylase obtained from Aspergillus oryzae'' is 
used, it may alternatively be declared in the list of ingredients as

[[Page 563]]

``Fungal alpha-amylase,'' ``Fungal [alpha]-amylase'', ``Enzyme'', or 
``Enzyme added for improved baking''. When any optional bleaching 
ingredient is used, the label shall bear the word ``Bleached''. Wherever 
the name of the food appears on the label so conspicuously as to be 
easily seen under customary conditions of purchase, the word 
``Bleached'' shall immediately and conspicuously precede or follow such 
name, without intervening written, printed, or graphic matter; except 
that where such name is a part of a trademark or brand, other written, 
printed or graphic matter, which is also a part of such trademark or 
brand, may so intervene if the word ``Bleached'' is in such 
juxtaposition with such trademark or brand as to be conspicuously 
related to such name.
    (c) For the purposes of this section:
    (1) Moisture is determined by the method prescribed in ``Official 
Methods of Analysis of the Association of Official Analytical Chemists'' 
(AOAC), 13th Ed. (1980), section 14.002. ``Vacuum Oven Method--Official 
Final Action,'' and section 14.003, ``Determination,'' which is 
incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (2) The method referred to in paragraph (a) of this section is as 
follows: Use No. 8 and No. 20 sieves, having standard 8-inch full-height 
frames, complying with the specifications set forth in the AOAC, Table 
1, ``Nominal Dimensions of Standard Test Sieves (U.S.A. Standard 
Series),'' under the heading ``Definitions of Terms and Explanatory 
Notes,'' which is incorporated by reference. The availability of this 
incorporation by reference is given in paragraph (c)(1) of this section. 
Fit a No. 8 sieve into a No. 20 sieve. Attach bottom pan to the No. 20 
sieve. Pour 100 gm. of the sample into the No. 8 sieve. Attach cover and 
hold the assembly in a slightly inclined position with one hand. Shake 
the sieves by striking the sides against the other hand with an upward 
stroke, at the rate of about 150 times per minute. Turn the sieves about 
one-sixth of a revolution each time in the same direction, after each 25 
strokes. Continue shaking for 2 minutes. Weigh the material which fails 
to pass through the No. 8 sieve and the material which passes through 
the No. 20 sieve.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 
47 FR 24693, June 8, 1982; 47 FR 43364, Oct. 1, 1982; 49 FR 10097, Mar. 
19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2877, Jan. 6, 1993]



Sec. 137.205  Bromated whole wheat flour.

    Bromated whole wheat flour conforms to the definition and standard 
of identity, and is subject to the requirements for label statement of 
ingredients, prescribed for whole wheat flour by Sec. 137.200, except 
that potassium bromate is added in a quantity not exceeding 75 parts to 
each million parts of finished bromated whole wheat flour.

[58 FR 2877, Jan. 6, 1993]



Sec. 137.211  White corn flour.

    (a) White corn flour is the food prepared by so grinding and bolting 
cleaned white corn that when tested by the method prescribed in 
paragraph (b)(2) of this section, not less than 98 percent passes 
through a No. 50 sieve and not less than 50 percent passes through No. 
70 woven-wire cloth. Its moisture content is not more than 15 percent. 
In its preparation, part of the ground corn may be removed, but in any 
such case, the content (on a moisture-free basis) of neither the crude 
fiber nor fat in the finished white corn flour exceeds the content (on a 
moisture-free basis) of such substance in the cleaned corn from which it 
was ground.
    (b)(1) For the purpose of this section, moisture, fat, and crude 
fiber are determined by methods therefore referred to in Sec. 
137.250(b)(1).
    (2) The method referred to in paragraph (a) of this section is as 
follows: Weigh 5 grams of sample into a tared truncated metal cone (top 
diameter 5 centimeters, bottom diameter 2 centimeters, height 4 
centimeters), fitted at

[[Page 564]]

bottom with 70-mesh wire cloth complying with the specifications for No. 
70 wire cloth in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), Table 1, ``Nominal 
Dimensions of Standard Test Sieves (U.S.A. Standard Series),'' under the 
heading ``Definitions of Terms and Explanatory Notes,'' which is 
incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.Attach 
cone to a suction flask. Wash with 150 ml. of petroleum ether applied in 
a small stream without suction, while gently stirring the sample with a 
small glass rod. Apply suction for 2 minutes after washing is completed, 
then shake the cone for 2 minutes with a vigorous horizontal motion, 
striking the side against the hand, and then weigh. The decrease in 
weight of sample, calculated as percent by weight of sample shall be 
considered the percent passing through No. 70 wire cloth. Transfer the 
residue from cone to a No. 50 sieve having a standard 20.3 centimeter 
(8-inch) diameter full-height frame, complying with the specifications 
for wire cloth and sieve frame in ``Nominal Dimensions of Standard Test 
Sieves (U.S.A. Standard Series).'' Shake for 2 minutes with a vigorous 
horizontal motion, striking the side against the hand; remove and weigh 
the residue; calculate the weight of residue as percent by weight of 
sample, and subtract from 100 percent to obtain the percent of sample 
passing through the No. 50 sieve.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 
49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989]



Sec. 137.215  Yellow corn flour.

    Yellow corn flour conforms to the definition and standard of 
identity prescribed by Sec. 137.211 for white corn flour except that 
cleaned yellow corn is used instead of clean white corn.



Sec. 137.220  Durum flour.

    (a) Durum flour is the food prepared by grinding and bolting cleaned 
durum wheat. When tested for granulation as prescribed in Sec. 
137.105(c)(4), not less than 98 percent of such flour passes through the 
No. 70 sieve. It is freed from bran coat, or bran coat and germ, to such 
extent that the percent of ash therein, calculated to a moisture-free 
basis, is not more than 1.5 percent. Its moisture content is not more 
than 15 percent.
    (b) For the purpose of this section, ash, moisture, and granulation 
are determined by the methods prescribed in Sec. 137.105(c).



Sec. 137.225  Whole durum flour.

    Whole durum wheat flour conforms to the definition and standard of 
identity, and is subject to the requirements for label statement of 
ingredients, prescribed for whole wheat flour by Sec. 137.200, except 
that cleaned durum wheat, instead of cleaned wheat other than durum 
wheat and red durum wheat, is used in its preparation.

[58 FR 2877, Jan. 6, 1993]



Sec. 137.250  White corn meal.

    (a) White corn meal is the food prepared by so grinding cleaned 
white corn that when tested by the method prescribed in paragraph (b)(2) 
of this section not less than 95 percent passes through a No. 12 sieve, 
not less than 45 percent through a No. 25 sieve, but not more than 35 
percent through a No. 72 grits gauze. Its moisture content is not more 
than 15 percent. In its preparation coarse particles of the ground corn 
may be separated and discarded, or reground and recombined with all or 
part of the material from which they were separated, but in any such 
case the crude fiber content of the finished corn meal is not less than 
1.2 percent and not more than that of the cleaned corn from which it was 
ground, and its fat content does not differ more than 0.3 percent from 
that of such corn. The contents of crude fiber and fat in all the 
foregoing provisions relating thereto are on a moisture-free basis.

[[Page 565]]

    (b)(1) For the purposes of this section, moisture, fat, and crude 
fiber content will be determined by the following methods of analysis 
from ``Official Methods of Analysis of the Association of Official 
Analytical Chemists,'' 13th Ed. (1980), which is incorporated by 
reference (copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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):
    (i) Moisture content--sections 14.062 and 14.063 (Official Final 
Action).
    (ii) Fat content--sections 14.062 and 14.067 (Official Final 
Action).
    (iii) Crude fiber content--sections 14.062 and 14.065 (Official 
Final Action).
    (2) The method referred to in paragraph (a) of this section is as 
follows: Use No. 12 and No. 25 sieves, having standard 20.3 centimeter 
(8-inch) diameter full-height frames, complying with the specifications 
for wire cloth and sieve frames in ``Nominal Dimensions of Standard Test 
Sieves (U.S.A. Standard Series)'' prescribed in Sec. 137.105(a), which 
is incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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. A 
sieve with frame of the same dimensions as the Nos. 12 and 25 and fitted 
with 72 XXX grits gauze is used as the third sieve. It is referred to 
hereafter as the No. 72 sieve. The 72 XXX grits gauze has openings 
equivalent in size with those of No. 70 woven-wire cloth, complying with 
specifications for such cloth contained in such ``Standard 
Specifications for Sieves.'' Attach bottom pan to No. 72 sieve. Fit the 
No. 25 sieve into the No. 72 sieve and the No. 12 sieve into the No. 25 
sieve. Pour 100 grams of sample into the No. 12 sieve, attach cover and 
hold the assembly in a slightly inclined position and shake the assembly 
of sieves by striking the sides against one hand with an upward stroke, 
at the rate of about 150 times per minute. Turn the assembly of sieves 
about one-sixth of a revolution, each time in the same direction, after 
each 25 strokes. Continue shaking for 2 minutes. Weigh separately the 
material remaining on each sieve and in the pan, and calculate each 
weight as percent of sample. Sometimes when meals are tested, fine 
particles clog the sieve openings. If any sieve is clogged by fine 
material smaller than its openings, empty the contents onto a piece of 
paper. Remove the entrapped material on the bottom of the sieve by a 
hair brush and add to the sieve below. In like manner, clean the 
adhering material from inside the sieve and add to the material on the 
paper. Return mixture on the paper to the sieve, reassemble the sieves, 
and shake in the same manner as before for 1 minute. Repeat cleaning 
procedure if necessary until a 5-gram or less loss in weight occurs in 
any sieve during a 1-minute shaking. The percent of sample passing 
through No. 12 sieve shall be determined by subtracting from 100 
percent, the percent of material remaining on the No. 12 sieve. The 
percent passing through a No. 25 sieve shall be determined by adding the 
percents remaining on the No. 72 sieve and the percent in pan. The 
percent in the pan shall be considered as the percent passing through a 
No. 72 XXX grits gauze.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982; 
49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989]



Sec. 137.255  Bolted white corn meal.

    (a) Bolted white corn meal is the food prepared by so grinding and 
sifting cleaned white corn that:
    (1) Its crude fiber content is less than 1.2 percent but its fat 
content is not less than 2.25 percent; and
    (2) When tested by the method prescribed in Sec. 137.250(b)(2), 
except that a No. 20 standard sieve is used instead of the No. 12 sieve, 
not less than 95 percent passes through a No. 20 sieve, not less than 45 
percent through a No. 25 sieve, but not more than 25 percent

[[Page 566]]

through No. 72 XXX grits gauze. Its moisture content is not more than 15 
percent. In its preparation particles of ground corn which contain germ 
may be separated, reground, and recombined with all or part of the 
material from which it was separated, but in any such case the fat 
content of the finished bolted white corn meal does not exceed by more 
than 0.3 percent the fat content of the cleaned corn from which it was 
ground. The contents of crude fiber and fat in all the foregoing 
provisions relating thereto are on a moisture-free basis.
    (b) For the purposes of this section, moisture, fat and crude fiber 
are determined by the methods therefor referred to in Sec. 
137.250(b)(1).



Sec. 137.260  Enriched corn meals.

    (a) Enriched corn meals are the foods, each of which conforms to the 
definition and standard of identity prescribed for a kind of corn meal 
by Sec. Sec. 137.250, 137.255, 137.265, 137.270, 137.275, 137.280, 
137.285, and 137.290, except that:
    (1) It contains in each pound not less than 2.0 milligrams (mg) and 
not more than 3.0 mg of thiamin, not less than 1.2 mg and not more than 
1.8 mg of riboflavin, not less than 16 mg and not more than 24 mg of 
niacin or niacinamide, not less than 0.7 mg and not more than 1.0 mg of 
folic acid, and not less than 13 mg and not more than 26 mg of iron 
(Fe);
    (2) It may contain in each pound not less than 250 U.S.P. units and 
not more than 1,000 U.S.P. units of vitamin D; and
    (3) It may contain in each pound not less than 500 milligrams and 
not more than 750 milligrams of calcium (Ca); Provided, however, That 
enriched self-rising corn meals shall contain in each pound not more 
than 1,750 milligrams of calcium (Ca). Iron and calcium may be added 
only in forms which are harmless and assimilable. The substances 
referred to in this paragraph (a)(3) and in paragraphs (a) (1) and (2) 
of this section may be added in a harmless carrier which does not impair 
the enriched corn meal; such carrier is used only in the quantity 
necessary to effect an intimate and uniform admixture of such substances 
with the kind of corn meal used. Dried yeast in quantities not exceeding 
1.5 percent by weight of the finished food may be used.
    (b) The name of each kind of enriched corn meal is the word 
``Enriched'' followed by the name of the kind of corn meal used which is 
prescribed in the definition and standard of identity therefor.
    (c) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993; 61 
FR 8796, Mar. 5, 1996]



Sec. 137.265  Degerminated white corn meal.

    (a) Degerminated white corn meal, degermed white corn meal, is the 
food prepared by grinding cleaned white corn and removing bran and germ 
so that:
    (1) On a moisture-free basis, its crude fiber content is less than 
1.2 percent and its fat content is less than 2.25 percent; and
    (2) When tested by the method prescribed in Sec. 137.250(b)(2), 
except that a No. 20 standard sieve is used instead of a No. 12 sieve, 
not less than 95 percent passes through a No. 20 sieve, not less than 45 
percent through a No. 25 sieve, but not more than 25 percent through No. 
72 XXX grits gauze. Its moisture content is not more than 15 percent.
    (b) For the purposes of this section, moisture, fat and crude fiber 
are determined by methods therefor referred to in Sec. 137.250(b)(1).



Sec. 137.270  Self-rising white corn meal.

    (a) Self-rising white corn meal is an intimate mixture of white corn 
meal, sodium bicarbonate, and one or both of the acid-reacting 
substances monocalcium phosphate and sodium aluminum phosphate. It is 
seasoned with salt. When it is tested by the method prescribed in 
paragraph (b) of this section, not less than 0.5 percent of carbon 
dioxide is evolved. The acid-reacting substance is added in sufficient 
quantity to neutralize the sodium bicarbonate. The combined weight of 
such acid-reacting substance and sodium bicarbonate is not more than 4.5 
parts to each 100 parts of white corn meal used.

[[Page 567]]

    (b) The method referred to in paragraph (a) of this section is the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists'' (AOAC), 13th Ed. (1980), section 
8.002, ``Reagent (Displacement soln.),'' and section 8.003, ``Chittick 
apparatus,'' under the heading ``Total Carbon Dioxide (1)--Official 
Final Action,'' which is incorporated by reference. Copies may be 
obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined 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. The following procedure is substituted for the 
procedure specified in the AOAC, under section 8.004, ``Determination'':
    (1) Weigh 17 grams of the official sample into flask A, add 15-20 
glass beads (4-6 mm. diameter), and connect this flask with the 
apparatus (fig. 25). Open stopcock C and by means of the leveling bulk E 
bring the displacement solution to the 25 cc. graduation above the zero 
mark. (This 25 cc. is a partial allowance for the volume of acid to be 
used in the decomposition.) Allow the apparatus to stand 1-2 minutes to 
insure that the temperature and pressure within the apparatus are the 
same as those of the room. Close the stopcock, lower the leveling bulb 
somewhat to reduce the pressure within the apparatus, and slowly run 
into the decomposition flask from burette F 45 cc. of sulfuric acid (1 + 
5). To prevent the liberated carbon dioxide from escaping through the 
acid burette into the air keep the displacement solution in the leveling 
bulb at all times during the decomposition at a lower level than that in 
the gas-measuring tube. Rotate and then vigorously agitate the 
decomposition flask for 3 minutes to mix the contents intimately. Allow 
to stand for 10 minutes to bring to equilibrium. Equalize the pressure 
in the measuring tube by means of the leveling bulb and read the volume 
of gas from the zero point on the tube. Deduct 20 cc. from this reading 
(this 20 cc. together with previous allowance of 25 cc. compensates for 
the 45 cc. acid used in the decomposition). Observe the temperature of 
the air surrounding the apparatus and also the barometric pressure and 
multiply the number of mL of gas evolved by the factor given in the 
AOAC, 13th Ed. (1980), section 52.007 under Reference Tables for the 
temperature and pressure observed, which is incorporated by reference. 
The availability of this incorporation by reference is given in 
paragraph (b) of this section. Divide the corrected reading by 100 to 
obtain the apparent percent by weight of carbon dioxide in the official 
sample.
    (2) Correct the apparent percent of carbon dioxide to compensate for 
varying atmospheric conditions by immediately assaying a synthetic 
sample by the same method in the same apparatus.
    (3) Prepare the synthetic sample with 16.2 grams of corn meal, 0.30 
gram of monocalcium phosphate, 0.30 gram of salt, and a sufficient 
quantity of sodium bicarbonate U.S.P. (dried over sulfuric acid) to 
yield the amount of carbon dioxide recovered in assay of official 
sample. Determine this quantity by multiplying weight of carbon dioxide 
recovered in assay of official sample by 1.91.
    (4) Divide the weight of carbon dioxide recovered from synthetic 
sample by weight of carbon dioxide contained in sodium bicarbonate used.
    (5) Divide the quotient into the apparent percent of carbon dioxide 
in official sample to obtain percent of carbon dioxide evolved from the 
official sample.
    (c) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982; 
49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 
6, 1993]



Sec. 137.275  Yellow corn meal.

    Yellow corn meal conforms to the definition and standard of identity 
prescribed by Sec. 137.250 for white corn meal except that cleaned 
yellow corn is used instead of cleaned white corn.

[[Page 568]]



Sec. 137.280  Bolted yellow corn meal.

    Bolted yellow corn meal conforms to the definition and standard of 
identity prescribed by Sec. 137.255 for bolted white corn meal except 
that cleaned yellow corn is used instead of cleaned white corn.



Sec. 137.285  Degerminated yellow corn meal.

    Degerminated yellow corn meal, degermed yellow corn meal, conforms 
to the definition and standard of identity prescribed by Sec. 137.265 
for degerminated white corn meal except that cleaned yellow corn is used 
instead of cleaned white corn.



Sec. 137.290  Self-rising yellow corn meal.

    Self-rising yellow corn meal conforms to the definition and standard 
of identity prescribed by Sec. 137.270 for self-rising white corn meal 
except that yellow corn meal is used instead of white corn meal.



Sec. 137.300  Farina.

    (a) Farina is the food prepared by grinding and bolting cleaned 
wheat, other than durum wheat and red durum wheat, to such fineness 
that, when tested by the method prescribed in paragraph (b)(2) of this 
section, it passes through a No. 20 sieve, but not more than 3 percent 
passes through a No. 100 sieve. It is freed from bran coat, or bran coat 
and germ, to such extent that the percent of ash therein, calculated to 
a moisture-free basis, is not more than 0.6 percent. Its moisture 
content is not more than 15 percent.
    (b) For the purposes of this section:
    (1) Ash and moisture are determined by the methods therefor referred 
to in Sec. 137.105(c).
    (2) The method referred to in paragraph (a) of this section is as 
follows: Use No. 20 and No. 100 sieves, having standard 20.3 centimeter 
(8-inch) full-height frames, complying with the specifications for such 
cloth set forth in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), Table 1, ``Nominal 
Dimensions of Standard Test Sieves (U.S.A. Standard Series),'' under the 
heading ``Definitions of Terms and Explanatory Notes,'' which is 
incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be 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. Fit a No. 20 sieve into 
a No. 100 sieve. Attach bottom pan to the No. 100 sieve. Pour 100 grams 
of the sample into the No. 20 sieve. Attach cover and hold the assembly 
in a slightly inclined position with one hand. Shake the sieves by 
striking the sides against the other hand with an upward stroke, at the 
rate of about 150 times per minute. Turn the sieves about one-sixth of a 
revolution, each time in the same direction, after each 25 strokes. 
Continue shaking for 2 minutes. Weigh the material which fails to pass 
through the No. 20 sieve and the material which passes through the No. 
100 sieve.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982; 
49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989]



Sec. 137.305  Enriched farina.

    (a) Enriched farina conforms to the definition and standard of 
identity prescribed for farina by Sec. 137.300, except that:
    (1) It contains in each pound not less than 2.0 milligrams (mg) and 
not more than 2.5 mg of thiamin, not less than 1.2 mg and not more than 
1.5 mg of riboflavin, not less than 16.0 mg and not more than 20.0 mg of 
niacin or niacinamide, not less than 0.7 mg and not more than 0.87 mg of 
folic acid, and not less than 13.0 mg of iron (Fe).
    (2) Vitamin D may be added in such quantity that each pound of the 
finished enriched farina contains not less than 250 U.S.P. units of the 
optional ingredient vitamin D.
    (3) Calcium may be added in such quantity that each pound of the 
finished enriched farina contains not less than 500 milligrams of the 
optional ingredient calcium (Ca).
    (4) It may contain not more than 8 percent by weight of the optional 
ingredient wheat germ or partly defatted wheat germ.

[[Page 569]]

    (5)(i) It may contain not less than 0.5 percent and not more than 1 
percent by weight of the optional ingredient disodium phosphate; or
    (ii) It may be treated with one of the proteinase enzymes papain or 
pepsin to reduce substantially the time required for cooking. In such 
treatment papain or pepsin, in an amount not to exceed 0.1 percent by 
weight, is added to the farina, which is moistened, warmed, and 
subsequently heated sufficiently to inactivate the enzyme and to dry the 
product to comply with the limit for moisture prescribed by Sec. 
137.300(a).
    (6) In determining whether the ash content complies with the 
requirements of this section allowance is made for ash resulting from 
any added iron or salts of iron or calcium, or from any added disodium 
phosphate, or from any added wheat germ or partly defatted wheat germ.


Iron and calcium may be added only in forms which are harmless and 
assimilable. Dried irradiated yeast may be used as a source of vitamin 
D. The substances referred to in paragraphs (a) (1) and (2) of this 
section may be added in a harmless carrier which does not impair the 
enriched farina; such carrier is used only in the quantity necessary to 
effect an intimate and uniform admixture of such substances with the 
farina.
    (b)(1) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (2)(i) When the optional ingredient disodium phosphate is used, the 
label shall bear the statement ``Disodium phosphate added for quick 
cooking''.
    (ii) When the proteinase enzyme treatment is used, the label shall 
bear the statement ``Enzyme treated for quicker cooking''.
    (3) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statements prescribed by paragraph (b)(2) of this section 
shall immediately and conspicuously precede or follow such name without 
intervening written, printed, or graphic matter; except that where the 
name of the food is a part of a trademark or brand, then other written, 
printed, or graphic matter that is also a part of the trademark or brand 
may so intervene, if such statement is in such juxtaposition with the 
trademark or brand as to be conspicuously related to the name of the 
food.

[42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993; 61 
FR 8796, Mar. 5, 1996]



Sec. 137.320  Semolina.

    (a) Semolina is the food prepared by grinding and bolting cleaned 
durum wheat to such fineness that, when tested by the method prescribed 
in Sec. 137.300(b)(2), it passes through a No. 20 sieve, but not more 
than 3 percent passes through a No. 100 sieve. It is freed from bran 
coat, or bran coat and germ, to such extent that the percent of ash 
therein, calculated to a moisture-free basis, is not more than 0.92 
percent. Its moisture content is not more than 15 percent.
    (b) For the purpose of this section, ash and moisture are determined 
by the methods therefor referred to in Sec. 137.105(c).



Sec. 137.350  Enriched rice.

    (a) The foods for which definitions and standards of identity are 
prescribed by this section are forms of milled rice (except rice coated 
with talc and glucose and known as coated rice), to which nutrients have 
been added so that each pound of the rice contains:
    (1) Not less than 2.0 milligrams (mg) and not more than 4.0 mg of 
thiamin, not less than 1.2 mg and not more than 2.4 mg of riboflavin, 
not less than 16 mg and not more than 32 mg of niacin or niacinamide, 
not less than 0.7 mg and not more than 1.4 mg of folic acid, and not 
less than 13 mg and not more than 26 mg of iron (Fe).
    (2) Each pound may contain not less than 250 U.S.P. units and not 
more than 1,000 U.S.P. units of vitamin D.
    (3) Each pound may contain not less than 500 milligrams and not more 
than 1,000 milligrams of calcium (Ca). Calcium carbonate derived from 
the use of this substance in milling rice, when present in quantities 
that furnish less than 500 milligrams of calcium (Ca) per pound, is 
considered a normal ingredient of the milled rice used and not an 
optional ingredient of the enriched rice unless such enriched rice is 
labeled to

[[Page 570]]

show it contains the optional ingredient calcium. Iron and calcium may 
be added only in forms that are harmless and assimilable. The vitamins 
referred to in paragraphs (a) (1) and (2) of this section may be 
combined with harmless substances to render them insoluble in water, if 
the water-insoluble products are assimilable.
    (4) In the case of enriched parboiled rice, butylated hydroxytoluene 
may be added as an optional ingredient in an amount not to exceed 0.0033 
percent by weight of the finished food.
    (b) The substances referred to in paragraphs (a) (1), (2), and (3) 
of this section may be added in a harmless carrier. Such carrier is used 
only in the quantity necessary to effect an intimate and uniform mixture 
of such substances with the rice.
    (c) Unless the label of the food bears the statement ``To retain 
vitamins do not rinse before or drain after cooking'' immediately 
preceding or following the name of the food and in letters not less than 
one-fourth the point size of type used for printing the name of the food 
(but in no case less than 8-point type) and the label bears no cooking 
directions calling for washing or draining or unless the food is 
precooked and it is packaged in consumer packages which are 
conspicuously and prominently labeled with directions for preparation 
which, if followed, will avoid washing away or draining off enriching 
ingredients, the substances named in paragraphs (a) (1), (2), and (3) of 
this section shall be present in such quantity or in such form that when 
the enriched rice is washed as prescribed in paragraph (e) of this 
section, the washed rice contains not less than 85 percent of the 
minimum quantities of the substances named in paragraph (a)(1) of this 
section, as required for enriched rice; and in case any optional 
ingredients named in paragraphs (a) (2) and (3) of this section are 
used, the washed rice also contains not less than 85 percent of the 
minimum quantity specified for the substance or substances used.
    (d) The name specified for each food for which a definition and 
standard of identity is prescribed by this section is the common name of 
the kind of milled rice to which the enriching substances are added, 
preceded by the word ``enriched'' as, for example, ``Enriched rice'' or 
``Enriched parboiled rice''.
    (e) The method referred to in paragraph (c) of this section is as 
follows: Mix the contents of one or more containers and transfer \1/2\ 
pound thereof to a 4-liter flask containing 2 liters of distilled water 
at room temperature (but not below 20 [deg]C). Stopper the flask and 
swirl it moderately for \1/2\ minute so that the rice is in motion and 
in uniform suspension. Allow the rice to settle for \1/2\ minute, then 
pour off 1,600 milliliters of the water, together with any floating and 
suspended matter, and discard. To the contents of the flask, add 1,600 
milliliters of distilled water and 20 milliliters of 10 N hydrochloric 
acid. Agitate vigorously and wash down the sides of the flask with 150 
milliliters of 0.1 N hydrochloric acid. In order to avoid excess foaming 
during the extraction, heat the mixture slowly to about 100 [deg]C, 
agitate if necessary, and maintain at this temperature until air is 
expelled. Again wash down the sides of the flask with 150 milliliters of 
0.1 N hydrochloric acid. Heat the mixture in an autoclave at 120 [deg]C 
to 123 [deg]C for 30 minutes, remove and cool to room temperature. 
Dilute the mixture with distilled water so that the total volume is 
2,500 milliliters. Swirl the flask, and while the solids are in uniform 
suspension pour off about 250 milliliters of the mixture for later 
determination of iron (and calcium, if this is to be determined). With 
filter paper that has been shown not to adsorb thiamine, riboflavin, or 
niacin, filter enough of the remaining mixture for determination of 
thiamine, riboflavin, and niacin. (In the case of a mixture difficult to 
filter, centrifuging or filtering through fritted glass, or both, using 
a suitable analytical filter-aid, may be substituted for, or may 
precede, filtering through paper.) Dilute an aliquot of filtrate with 
0.1 N hydrochloric acid, so that each milliliter contains about 0.2 
microgram of thiamine, and determine thiamine by the ``Rapid 
Fluorometric Method--Official Final Action,'' in section 43.034 of 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists'' (AOAC), 13th Ed. (1980), which is incorporated by reference. 
Copies may

[[Page 571]]

be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined 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.With a suitable aliquot determine riboflavin by the 
method prescribed in section 43.041(a) by the ``Fluorometric Method--
Official Final Action,'' AOAC, 13th Ed. (1980), beginning with the third 
sentence of the second paragraph, ``Adjust, with vigorous agitation * * 
*.'' Determine niacin in a 200-milliliter aliquot of the filtrate by the 
``Colorimetric Method--Official Final Action,'' in section 43.045, AOAC, 
13th Ed. (1980), beginning with the sixth sentence of the first 
paragraph, ``Adjust to pH 4.5 with * * *.'' Evaporate to dryness a 100-
milliliter aliquot of the nonfiltered material withdrawn while 
agitating, and determine iron using the method ``Iron--Official Final 
Action,'' in sections 14.011, 14.012, and 14.013, AOAC, 13th Ed. (1980), 
and, if required, determine calcium as directed in section 14.014 under 
the heading ``Calcium--Official Final Action,'' AOAC, 13th Ed. (1980).
    (f) When the optional ingredient specified in paragraph (a)(4) of 
this section is added, the statement ``Butylated hydroxytoluene added as 
a preservative'' shall be placed on the label prominently and with such 
conspicuousness (as compared with other words, statements, designs, or 
devices in the label) as to render it likely to be read and understood 
by the ordinary individual under customary conditions of purchase.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    Note: The Order of the Commissioner of Food and Drugs appearing at 
23 FR 1170, Feb. 25, 1958, amending paragraphs (a)(1) and (c) provides 
in part as follows: The regulations in Sec. 137.350 (formerly Sec. 
15.525) are stayed insofar as they require each pound of the food to 
contain not less than 1.2 milligrams and not more than 2.4 milligrams of 
riboflavin. This stay shall continue until final action is taken 
disposing of the objections, after public hearing thereon.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982; 
49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 
6, 1993; 61 FR 8796, Mar. 5, 1996]



PART 139_MACARONI AND NOODLE PRODUCTS--Table of Contents



Subpart A [Reserved]

  Subpart B_Requirements for Specific Standardized Macaroni and Noodle 
                                Products

Sec.
139.110 Macaroni products.
139.115 Enriched macaroni products.
139.117 Enriched macaroni products with fortified protein.
139.120 Milk macaroni products.
139.121 Nonfat milk macaroni products.
139.122 Enriched nonfat milk macaroni products.
139.125 Vegetable macaroni products.
139.135 Enriched vegetable macaroni products.
139.138 Whole wheat macaroni products.
139.140 Wheat and soy macaroni products.
139.150 Noodle products.
139.155 Enriched noodle products.
139.160 Vegetable noodle products.
139.165 Enriched vegetable noodle products.
139.180 Wheat and soy noodle products.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14409, Mar. 15, 1977, unless otherwise noted.

Subpart A [Reserved]



  Subpart B_Requirements for Specific Standardized Macaroni and Noodle 
                                Products



Sec. 139.110  Macaroni products.

    (a) Macaroni products are the class of food each of which is 
prepared by drying formed units of dough made from semolina, durum 
flour, farina, flour, or any combination of two or more of these, with 
water and with or without one or more of the optional ingredients 
specified in paragraphs (a) (1) to (6), inclusive, of this section.
    (1) Egg white, frozen egg white, dried egg white, or any two or all 
of these, in such quantity that the solids thereof are not less than 0.5 
percent and not

[[Page 572]]

more than 2.0 percent of the weight of the finished food.
    (2) Disodium phosphate, in a quantity not less than 0.5 percent and 
not more than 1.0 percent of the weight of the finished food.
    (3) Onions, celery, garlic, bay leaf, or any two or more of these, 
in a quantity which seasons the food.
    (4) Salt, in a quantity which seasons the food.
    (5) Gum gluten, in such quantity that the protein content of the 
finished food is not more than 13 percent by weight. The finished 
macaroni product contains not less than 87 percent of total solids as 
determined by the method prescribed in ``Official Methods of Analysis of 
the Association of Official Analytical Chemists,'' 13th Ed. (1980), in 
section 14.133, under the heading ``Vacuum Oven Method--Official Final 
Action,'' which is incorporated by reference. Copies may be obtained 
from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877, or may be examined 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.
    (6) Concentrated glyceryl monostearate (containing not less than 90 
percent monoester), in a quantity not exceeding 2 percent by weight of 
the finished food.
    (b) Macaroni is the macaroni product the units of which are tube-
shaped and more than 0.11 inch but not more than 0.27 inch in diameter.
    (c) Spaghetti is the macaroni product the units of which are tube-
shaped or cord-shaped (not tubular) and more than 0.06 inch but not more 
than 0.11 inch in diameter.
    (d) Vermicelli is the macaroni product the units of which are cord-
shaped (not tubular) and not more than 0.06 inch in diameter.
    (e) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Macaroni product''; or 
alternatively, the name is ``Macaroni'', ``Spaghetti'', or 
``Vermicelli'', as the case may be, when the units of the food are of 
the shapes and sizes specified in paragraph (b), (c), or (d), 
respectively, of this section.
    (f)(1) When disodium phosphate is used the label shall bear the 
statement ``Disodium phosphate added for quick cooking''.
    (2) When any ingredient specified in paragraph (a)(3) of this 
section is used the label shall bear the statement ``Seasoned with 
___'', the blank being filled in with the common name of the ingredient; 
or in the case of bay leaves the statement ``Spiced'', ``Spice added'', 
or ``Spiced with bay leaves''.
    (3) When the ingredient specified in paragraph (a)(6) of this 
section is used, the label shall bear the statement ``Glyceryl 
monostearate added'' or the statement ``With added glyceryl 
monostearate''.
    (4) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the words and statements prescribed in this section, showing 
the optional ingredients used, shall immediately and conspicuously 
precede or follow, or in part precede and in part follow, such name, 
without intervening written, printed, or graphic matter.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982; 
49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 139.115  Enriched macaroni products.

    (a) Description. Enriched macaroni products are the class of food 
each of which conforms to the definition and standard of identity and is 
subject to the requirements for label statement of ingredients, 
prescribed for macaroni products by Sec. 139.110(a), (f), and (g), 
except that:
    (1) Each such food contains in each pound not less than 4.0 
milligrams (mg) and not more than 5.0 mg of thiamin, not less than 1.7 
mg and not more than 2.2 mg of riboflavin, not less than 27 mg and not 
more than 34 mg of niacin or niacinamide, not less than 0.9 mg and not 
more than 1.2 mg of folic acid, and

[[Page 573]]

not less than 13 mg and not more than 16.5 mg of iron (Fe);
    (2) Each such food may also contain as an optional ingredient added 
vitamin D in such quantity that each pound of the finished food contains 
not less than 250 U.S.P. units and not more than 1000 U.S.P. units of 
vitamin D.
    (3) Each such food may also contain as an optional ingredient added 
calcium in such quantity that each pound of the finished food contains 
not less than 500 mg. and not more than 625 mg. of calcium (Ca);
    (4) Each such food may also contain as an optional ingredient partly 
defatted wheat germ but the amount thereof does not exceed 5 percent of 
the weight of the finished food;
    (5) Each such food may be supplied, wholly or in part, with the 
prescribed quantity of any substance referred to in paragraphs (a) (1), 
(2), and (3) of this section through the use of dried yeast, dried 
torula yeast, partly defatted wheat germ, enriched farina, or enriched 
flour, or through the direct additions of any of the substances 
prescribed in paragraphs (a) (1), (2), and (3) of this section.


Iron and calcium may be added only in forms which are harmless and 
assimilable. The substances referred to in paragraphs (a) (1) and (2) of 
this section may be added in a harmless carrier which does not impair 
the enriched macaroni product, such carrier being used only in the 
quantity reasonably necessary to effect an intimate and uniform 
distribution of such substances in the finished enriched macaroni 
product.
    (b) Enriched macaroni is the enriched macaroni product the units of 
which conform to the specifications of shape and size prescribed for 
macaroni by Sec. 139.110(b).
    (c) Enriched spaghetti is the enriched macaroni product the units of 
which conform to the specifications of shape and size prescribed for 
spaghetti by Sec. 139.110(c).
    (d) Enriched vermicelli is the enriched macaroni product the units 
of which conform to the specifications of shape and size prescribed for 
vermicelli by Sec. 139.110(d).
    (e) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Enriched Macaroni product''; 
or alternatively, the name is ``Enriched macaroni'', ``Enriched 
spaghetti'', or ``Enriched vermicelli'', as the case may be, when the 
units of the food comply with the requirements of paragraphs (b), (c), 
or (d) respectively of this section.

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993; 61 
FR 8797, Mar. 5, 1996]



Sec. 139.117  Enriched macaroni products with fortified protein.

    (a)(1) Each of the foods for which a standard of identity is 
prescribed by this section is produced by drying formed units of dough 
made with one or more of the milled wheat ingredients designated in 
Sec. Sec. 139.110(a) and 139.138(a), and other ingredients to enable 
the finished food to meet the protein requirements set out in paragraph 
(a)(2)(i) of this section. Edible protein sources, including food grade 
flours or meals made from nonwheat cereals or from oilseeds, may be 
used. Vitamin and mineral enrichment nutrients are added to bring the 
food into conformity with the requirements of paragraph (b) of this 
section. Safe and suitable ingredients, as provided for in paragraph (c) 
of this section, may be added. The proportion of the milled wheat 
ingredient is larger than the proportion of any other ingredient used.
    (2) Each such finished food, when tested by the methods described in 
the cited sections of ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference (copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.), 
meets the following specifications:
    (i) The protein content (N x 6.25) is not less than 20 percent by 
weight (on a 13 percent moisture basis) as determined by the method in 
section 14.142. The protein quality is not less than 95 percent that of 
casein as determined on

[[Page 574]]

the cooked food by the method in sections 43.212 through 43.216 of the 
official methods.
    (ii) The total solids content is not less than 87 percent by weight 
as determined by the method in section 14.133 of the official methods.
    (b)(1) Each food covered by this section contains in each pound 5 
milligrams of thiamin, 2.2 milligrams of riboflavin, 34 milligrams of 
niacin or niacinamide, and 16.5 milligrams of iron.
    (2) Each pound of such food may also contain 625 milligrams of 
calcium.
    (3) Iron and calcium may be added only in forms which are harmless 
and assimilable. The enrichment nutrients may be added in a harmless 
carrier used only in a quantity necessary to effect a uniform 
distribution of the nutrients in the finished food. The requirements of 
paragraphs (b) (1) and (2) of this section shall be deemed to have been 
met if reasonable overages, within the limits of good manufacturing 
practice, are present to assure that the prescribed levels of the 
vitamins and mineral(s) are maintained throughout the expected shelf 
life of the food under customary conditions of distribution.
    (c) The safe and suitable ingredients referred to in paragraph (a) 
of this section are ingredients that serve a useful purpose, e.g., to 
fortify the protein or facilitate production of the food, but they do 
not include color additives, artificial flavorings, artificial 
sweeteners, chemical preservatives, or starches. Ingredients deemed 
suitable for use by this paragraph are added in amounts that are not in 
excess of those reasonably required to achieve their intended purposes. 
Ingredients are deemed to be safe if they are not food additives within 
the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic 
Act, or in case they are food additives, if they are used in conformity 
with regulations established pursuant to section 409 of the act.
    (d)(1) The name of any food covered by this section is ``Enriched 
Wheat ___ Macaroni Product--with Fortified Protein'', the blank being 
filled in with appropriate word(s) such as ``Soy'' to show the source of 
any flours or meals used that were made from nonwheat cereals or from 
oilseeds. In lieu of the words ``Macaroni Product'' the word 
``Macaroni'', ``Spaghetti'', or ``Vermicelli'', as appropriate, may be 
used if the units conform in shape and size to the requirements of Sec. 
139.110 (b), (c), or (d).
    (2) When any ingredient, not designated in the part of the name 
prescribed in paragraph (d)(1) of this section, is added in such 
proportion as to contribute 10 percent or more of the quantity of 
protein contained in the finished food, the name shall include the 
statement ``Made with ___'', the blank being filled in with the name of 
each such ingredient, e.g., ``Made with nonfat milk''.
    (3) When, in conformity with paragraph (d) (1) or (2) of this 
section, two or more ingredients are listed in the name, their 
designations shall be arranged in descending order of predominance by 
weight.
    (4) In the case of a food made to comply with another section of 
this part, but which also meets the compositional requirements of this 
section, it may alternatively bear the name set out in that other 
section.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 
49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]

    Effective Date Note: Section 139.117 was stayed in its entirety at 
43 FR 11695, Mar. 21, 1978.



Sec. 139.120  Milk macaroni products.

    (a) Milk macaroni products are the class of food, each of which 
conforms to the definition and standard of identity and is subject to 
the requirements for label statement of ingredients prescribed for 
macaroni products by Sec. 139.110(a), (f)(2), (f)(3), and (g), except 
that:
    (1) Milk is used as the sole moistening ingredient in preparing the 
dough; or in lieu of milk one or more of the milk ingredients specified 
in paragraph (f) of this section is used, with or without water, in such 
quantity that the weight of milk solids therein is not less than 3.8 
percent of the weight of

[[Page 575]]

the finished milk macaroni product; and
    (2) None of the optional ingredients permitted by Sec. 139.110(a) 
(1) and (2) is used. When the optional ingredient gum gluten (Sec. 
139.110(a)(5)) is added, the quantity is such that the protein derived 
therefrom, together with the protein derived from semolina, durum flour, 
farina, flour, or any combination of these used, does not exceed 13 
percent of the weight of the finished food.
    (b) Milk macaroni is the milk macaroni product the units of which 
conform to the specifications of shape and size prescribed for macaroni 
by Sec. 139.110(b).
    (c) Milk spaghetti is the milk macaroni product the units of which 
conform to the specifications of shape and size prescribed for spaghetti 
by Sec. 139.110(c).
    (d) Milk vermicelli is the milk macaroni product the units of which 
conform to the specifications of shape and size prescribed for 
vermicelli by Sec. 139.110(d).
    (e) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Milk Macaroni Product''; or 
alternatively, the name is ``Milk macaroni'', ``Milk spaghetti'', or 
``Milk vermicelli'', as the case may be, when the units of the food 
comply with the requirements of paragraph (b), (c), or (d), 
respectively, of this section.
    (f) The milk ingredients referred to in paragraph (a)(1) of this 
section are concentrated milk, evaporated milk, dried milk, and a 
mixture of butter with skim milk, concentrated skim milk, evaporated 
skim milk, nonfat dry milk (dried skim milk), or any two or more of 
these, in such proportion that the weight of nonfat milk solids in such 
mixture is not more than 2.275 times the weight of milk fat therein.

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993]



Sec. 139.121  Nonfat milk macaroni products.

    (a) Each of the macaroni products made with nonfat milk for which a 
definition and standard of identity is prescribed by this section 
conforms to the definition and standard of identity, and is subject to 
the requirements for label statement of ingredients, prescribed for 
macaroni products by Sec. 139.110(a), (f)(2), (f)(3), (f)(4), and (g), 
except that:
    (1)(i) In preparing the dough, nonfat dry milk or concentrated skim 
milk, or a mixture of these, is used in an amount such that the finished 
macaroni product made with nonfat milk contains by weight not less than 
12 percent and not more than 25 percent of milk solids-not-fat. 
Carrageenan or salts of carrageenan conforming to the requirements of 
Sec. Sec. 172.620 and 172.626 of this chapter may be used in a quantity 
not in excess of 0.833 percent by weight of the milk solids-not-fat 
used.
    (ii) When the ingredient carrageenan or the salts of carrageenan 
specified in paragraph (a)(1)(i) of this section is used, the label 
shall bear the statement, ``Carrageenan added'' or ``Salts of 
carrageenan added'' or the statement ``With added carrageenan'' or 
``With added salts of carrageenan'', in the manner further prescribed by 
Sec. 139.110(f)(4).
    (2) None of the optional ingredients permitted by Sec. 139.110(a) 
(1), (2), and (5) are used.
    (b) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Macaroni products made with 
nonfat milk'' or, alternatively, the name is ``Macaroni made with nonfat 
milk'', ``Spaghetti made with nonfat milk'' or ``Vermicelli made with 
nonfat milk'', as the case may be when the units of the food conform to 
the specifications of shape and size prescribed by Sec. 139.110 (b), 
(c), or (d), respectively.

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993]



Sec. 139.122  Enriched nonfat milk macaroni products.

    (a) Each of the enriched macaroni products made with nonfat milk for 
which a definition and standard of identity is prescribed by this 
section conforms to the definition and standard of identity, and is 
subject to the requirements for label statement of ingredients, 
prescribed for macaroni products by Sec. 139.110(a), (f)(2), (f)(3), 
(f)(4), and (g), except that:
    (1)(i) In preparing the dough, nonfat dry milk or concentrated skim 
milk, or a mixture of these, is used in an

[[Page 576]]

amount such that the finished enriched macaroni product made with nonfat 
milk contains by weight not less than 12 percent and not more than 25 
percent of milk solids-not-fat. Carrageenan or the salts of carrageenan 
conforming to the requirements of Sec. 172.620 and Sec. 172.626 of 
this chapter may be used in a quantity not in excess of 0.833 percent by 
weight of the milk solids-not-fat used.
    (ii) When the ingredient carrageenan or the salts of carrageenan 
specified in paragraph (a)(1)(i) of this section is used, the label 
shall bear the statement, ``Carrageenan added'' or ``Salts of 
carrageenan added'' or the statement ``With added carrageenan'' or 
``With added salts of carrageenan'', in the manner further prescribed by 
Sec. 139.110(f)(4).
    (2) None of the optional ingredients permitted by Sec. 139.110(a) 
(1), (2), and (5) are used.
    (3) Each such food contains in each pound not less than 4.0 
milligrams (mg) and not more than 5.0 mg of thiamin, not less than 1.7 
mg and not more than 2.2 mg of riboflavin, not less than 27 mg and not 
more than 34 mg of niacin or niacinamide, not less than 0.9 mg and not 
more than 1.2 mg of folic acid, and not less than 13 mg and not more 
than 16.5 mg of iron (Fe). These substances may be added through direct 
addition or wholly or in part through the use of dried yeast, dried 
torula yeast, partly defatted wheat germ (as provided for in paragraph 
(a)(4) of this section), enriched farina, or enriched flour. They may be 
added in a harmless carrier, such carrier being used only in the 
quantity reasonably necessary to effect an intimate and uniform 
distribution of such substances in the finished food. Iron may be added 
only in a form that is harmless and assimilable.
    (4) Each such food may also contain as an optional ingredient partly 
defatted wheat germ, but the amount thereof does not exceed 5 percent by 
weight of the finished food.
    (b) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Enriched macaroni product 
made with nonfat milk'' or, alternatively, the name is ``Enriched 
macaroni made with nonfat milk'', ``Enriched spaghetti made with nonfat 
milk'', or ``Enriched vermicelli made with nonfat milk,'' as the case 
may be when the units of the food conform to the specifications of shape 
and size prescribed by Sec. 139.110 (b), (c), or (d), respectively.

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993]



Sec. 139.125  Vegetable macaroni products.

    (a) Vegetable macaroni products are the class of food each of which 
conforms to the definition and standard of identity and is subject to 
the requirements for label statement of ingredients prescribed for 
macaroni products by Sec. 139.110(a), (f)(2), (f)(3), and (g), except 
that:
    (1) Tomato (of any red variety), artichoke, beet, carrot, parsley, 
or spinach is added in such quantity that the solids thereof are not 
less than 3 percent by weight of the finished vegetable macaroni product 
(the vegetable used may be fresh, canned, dried, or in the form of puree 
or paste); and
    (2) None of the optional ingredients permitted by Sec. 139.110(a) 
(1) and (2) is used. When the optional ingredient gum gluten (Sec. 
139.110(a)(5)) is added, the quantity is such that the protein derived 
therefrom, together with the protein derived from the semolina, durum 
flour, farina, flour or any combination of these used, does not exceed 
13 percent of the weight of the finished food.
    (b) Vegetable macaroni is the vegetable macaroni product the units 
of which conform to the specifications of shape and size prescribed for 
macaroni by Sec. 139.110(b).
    (c) Vegetable spaghetti is the vegetable macaroni product the units 
of which conform to the specifications of shape and size prescribed for 
spaghetti by Sec. 139.110(c).
    (d) Vegetable vermicelli is the vegetable macaroni product, the 
units of which conform to the specifications of shape and size 
prescribed for vermicelli by Sec. 139.110(d).
    (e) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``___ macaroni product'', the 
blank being filled in with the name whereby the

[[Page 577]]

vegetable used is designated in paragraph (a) of this section; or 
alternatively, the name is ``___ macaroni'', ``___ spaghetti'', or ``___ 
vermicelli'', as the case may be, when the units of the food comply with 
the requirements of paragraph (b), (c), or (d) of this section, 
respectively, the blank in each instance being filled in with the name 
whereby the vegetable used is designated in paragraph (a) of this 
section.

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993]



Sec. 139.135  Enriched vegetable macaroni products.

    (a) Each of the macaroni products for which a definition and 
standard of identity is prescribed by this section conforms to the 
definition and standard of identity and is subject to the requirements 
for label statement of ingredients prescribed for macaroni products by 
Sec. 139.110(a), (f), and (g), and in addition is enriched to meet the 
requirements prescribed for enriched macaroni products by Sec. 139.115 
and contains a vegetable ingredient in compliance with the requirements 
prescribed for vegetable macaroni products by Sec. 139.125.
    (b) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Enriched ___ macaroni 
product'', or, alternatively, the name is ``Enriched ___ macaroni'', 
``Enriched ___ spaghetti'', or ``Enriched ___ vermicelli'', when the 
units comply with the shape and size requirements prescribed for 
macaroni, spaghetti, or vermicelli in Sec. 139.110 (b), (c), or (d). 
The blank in each instance is filled in with the name of the vegetable 
used, as specified in Sec. 139.125(a). For example, the name of an 
enriched macaroni product containing the prescribed amount of spinach 
and made in units not conforming in shape and size to the requirements 
for macaroni, spaghetti, or vermicelli is ``Enriched spinach macaroni 
product''.

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993]



Sec. 139.138  Whole wheat macaroni products.

    (a) Whole wheat macaroni products are the class of food each of 
which conforms to the definition and standard of identity and is subject 
to the requirements for label statement of ingredients, prescribed for 
macaroni products by Sec. 139.110(a), (f)(2), (f)(3), and (g), except 
that:
    (1) Whole wheat flour or whole durum wheat flour or both are used as 
the sole wheat ingredient; and
    (2) None of the optional ingredients permitted by Sec. 139.110(a) 
(1), (2), and (5) is used.
    (b) Whole wheat macaroni is the whole wheat macaroni product the 
units of which conform to the specifications of shape and size 
prescribed for macaroni by Sec. 139.110(b).
    (c) Whole wheat spaghetti is the whole wheat macaroni product the 
units of which conform to the specifications of shape and size 
prescribed for spaghetti by Sec. 139.110(c).
    (d) Whole wheat vermicelli is the whole wheat macaroni product the 
units of which conform to the specifications of shape and size 
prescribed for vermicelli by Sec. 139.110(d).
    (e) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Whole wheat macaroni 
product''; or alternatively, the name is ``Whole wheat macaroni'', 
``Whole wheat spaghetti'', or ``Whole wheat vermicelli'', as the case 
may be, when the units of the food comply with the requirements of 
paragraph (b), (c), or (d), respectively, of this section.

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993]



Sec. 139.140  Wheat and soy macaroni products.

    (a) Wheat and soy macaroni products are the class of food each of 
which conforms to the definition and standard of identity and is subject 
to the requirements for label statement of ingredients, prescribed for 
macaroni products by Sec. 139.110(a), (f)(2), (f)(3), and (g), except 
that:
    (1) Soy flour is added in a quantity not less than 12.5 percent of 
the combined weight of the wheat and soy ingredients used (the soy flour 
used is

[[Page 578]]

made from heat-processed, dehulled soybeans, with or without the removal 
of fat therefrom); and
    (2) None of the optional ingredients permitted by Sec. 139.110(a) 
(1) and (2) is used. When the optional ingredient gum gluten (Sec. 
139.110(a)(5)) is added, the quantity is such that the protein derived 
therefrom, together with the protein derived from semolina, durum flour, 
farina, flour or any combination of these used, does not exceed 13 
percent of the weight of the finished food.
    (b) Wheat and soy macaroni is the wheat and soy macaroni product the 
units of which conform to the specifications of shape and size 
prescribed for macaroni by Sec. 139.110(b).
    (c) Wheat and soy spaghetti is the wheat and soy macaroni product 
the units of which conform to the specifications of shape and size 
prescribed for spaghetti by Sec. 139.110(c).
    (d) Wheat and soy vermicelli is the wheat and soy macaroni product 
the units of which conform to the specifications of shape and size 
prescribed for vermicelli by Sec. 139.110(d).
    (e) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Wheat and soy macaroni 
product'', ``Wheat and soybean macaroni product'', ``___ and soy 
macaroni product'', or ``___ and soybean macaroni product'', the blank 
in each instance being filled in with the name whereby the wheat 
ingredient used is designated in Sec. 139.110(a); or alternatively, the 
name is ``Wheat and soy macaroni'', ``Wheat and soybean macaroni'', 
``___ and soy macaroni'', or ``___ and soybean macaroni'' when the units 
of the food comply with the requirements of paragraph (b) of this 
section; or ``Wheat and soy spaghetti'', ``Wheat and soybean 
spaghetti'', ``___ and soy spaghetti'', or ``___ and soybean spaghetti'' 
when such units comply with the requirements of paragraph (c) of this 
section; or ``Wheat and soy vermicelli'', ``Wheat and soybean 
vermicelli'', ``___ and soy vermicelli'', or ``___ and soybean 
vermicelli'' when such units comply with the requirements of paragraph 
(d) of this section, the blank in each instance being filled in with the 
name whereby the wheat ingredient used is designated in Sec. 
139.110(a).

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993]



Sec. 139.150  Noodle products.

    (a) Noodle products are the class of food each of which is prepared 
by drying formed units of dough made from semolina, durum flour, farina, 
flour, or any combination of two or more of these, with liquid eggs, 
frozen eggs, dried eggs, egg yolks, frozen yolks, dried yolks, or any 
combination of two or more of these, with or without water and with or 
without one or more of the optional ingredients specified in paragraphs 
(a) (1) to (4) of this section inclusive:
    (1) Onions, celery, garlic, bay leaf, or any two or more of these, 
in a quantity which seasons the food.
    (2) Salt, in a quantity which seasons the food.
    (3) Gum gluten, in such quantity that the protein derived therefrom, 
together with the protein derived from semolina, durum flour, farina, 
flour or any combination of these used, does not exceed 13 percent of 
the weight of the finished food.
    (4) Concentrated glyceryl monostearate (containing not less than 90 
percent monoester) in a quantity not exceeding 3 percent by weight of 
the finished food.
    The finished noodle product contains not less than 87 percent of 
total solids as determined by the method prescribed in ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), in section 14.133, under the heading 
``Vacuum Oven Method--Official Final Action,'' which is incorporated by 
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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. The total solids of 
noodle products contains not less than 5.5 percent by weight of the 
solids of egg, or egg yolk.

[[Page 579]]

    (b) Noodles, egg noodles, is the noodle product the units of which 
are ribbon-shaped.
    (c) Egg macaroni is the noodle product the units of which are tube-
shaped and more than 0.11 inch but not more than 0.27 inch in diameter.
    (d) Egg spaghetti is the noodle product the units of which are tube-
shaped or cord-shaped (not tubular) and more than 0.06 inch but not more 
than 0.11 inch in diameter.
    (e) Egg vermicelli is the noodle product the units of which are 
cord-shaped (not tubular) and not more than 0.06 inch in diameter.
    (f) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Noodle product'' or ``Egg 
noodle product''; or alternatively, the name is ``Noodles'' or ``Egg 
noodles'', ``Egg macaroni'', ``Egg spaghetti'', or ``Egg vermicelli'', 
as the case may be, when the units of the food are of the shapes and 
sizes specified in paragraph (b), (c), (d), or (e), respectively, of 
this section.
    (g)(1) When any ingredient specified in paragraph (a)(1) of this 
section is used, the label of the noodle product shall bear the 
statement ``Seasoned with ___'', the blank being filled in with the 
common name of the ingredient; or in the case of bay leaves, the 
statement ``Spiced'', ``Spice added'', or ``Spiced with bay leaves''.
    (2) When the ingredient specified in paragraph (a)(4) of this 
section is used, the label shall bear the statement ``Glyceryl 
monostearate added'' or the statement ``With added glyceryl 
monostearate''.
    (h) Wherever the name of the food appears on such label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the words and statements prescribed in this section, showing 
the ingredients used shall immediately and conspicuously precede or 
follow, or in part precede and in part follow, such name without 
intervening written, printed, or other graphic matter.
    (i) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 
49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2879, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 139.155  Enriched noodle products.

    (a) Enriched noodle products are the class of food each of which 
conforms to the definition and standard of identity, and is subject to 
the requirements for label statement of ingredients, prescribed for 
noodle products by Sec. 139.150 (a), (g), and (i), except that:
    (1) Each such food contains in each pound not less than 4 milligrams 
(mg) and not more than 5 mg of thiamin, not less than 1.7 mg and not 
more than 2.2 mg of riboflavin, not less than 27 mg and not more than 34 
mg of niacin or niacinamide, not less than 0.9 mg and not more than 1.2 
mg of folic acid, and not less than 13 mg and not more than 16.5 mg of 
iron (Fe);
    (2) Each such food may also contain as an optional ingredient added 
vitamin D in such quantity that each pound of the finished food contains 
not less than 250 U.S.P. units and not more than 1000 U.S.P. units of 
vitamin D;
    (3) Each such food may also contain as an optional ingredient added 
calcium in such quantity that each pound of the finished food contains 
not less than 500 mg. and not more than 625 mg. of calcium (Ca);
    (4) Each such food may also contain as an optional ingredient partly 
defatted wheat germ, but the amount thereof does not exceed 5 percent of 
the weight of the finished food;
    (5) Each such food may be supplied, wholly or in part, with the 
prescribed quantity of any substance referred to in paragraphs (a) (1), 
(2), and (3) of this section through the use of dried yeast, dried 
torula yeast, partly defatted wheat germ, enriched farina, or enriched 
flour, or through the direct additions of any of the substances 
prescribed in paragraphs (a) (1), (2), and (3) of this section.


Iron and calcium may be added only in forms which are harmless and 
assimilable. The substances referred to in paragraphs (a) (1) and (2) of 
this section may be added in a harmless carrier which does not impair 
the enriched

[[Page 580]]

noodle product, such carrier being used only in the quantity reasonably 
necessary to effect an intimate and uniform distribution of such 
substances in the finished enriched noodle product.
    (b) Enriched noodles, enriched egg noodles are the enriched noodle 
products the units of which conform to the specifications of shape and 
size prescribed for noodles in Sec. 139.150(b).
    (c) Enriched egg macaroni is the enriched noodle product the units 
of which conform to the specifications of shape and size prescribed for 
egg macaroni in Sec. 139.150(c).
    (d) Enriched egg spaghetti is the enriched noodle product the units 
of which conform to the specifications of shape and size prescribed for 
egg spaghetti in Sec. 139.150(d).
    (e) Enriched egg vermicelli is the enriched noodle product the units 
of which conform to the specifications of shape and size prescribed for 
egg vermicelli in Sec. 139.150(e).
    (f) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Enriched noodle product'' or 
``Enriched egg noodle product''; or alternatively, the name is 
``Enriched noodles'', or ``Enriched egg noodles'', ``Enriched egg 
macaroni'', ``Enriched egg spaghetti'', or ``Enriched egg vermicelli'', 
as the case may be, when the units of the food comply with the 
requirements of paragraph (b), (c), (d), or (e) respectively of this 
section.

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993]



Sec. 139.160  Vegetable noodle products.

    (a) Vegetable noodle products are the class of food each of which 
conforms to the definition and standard of identity, and is subject to 
the requirements for label statement of ingredients, prescribed for 
noodle products by Sec. 139.150(a), (g), and (i), except that tomato 
(of any red variety), artichoke, beet, carrot, parsley, or spinach is 
added in such quantity that the solids thereof are not less than 3 
percent by weight of the finished vegetable noodle product (the 
vegetable used may be fresh, canned, dried, or in the form of puree or 
paste).
    (b) Vegetable noodles, vegetable egg noodles, is the vegetable 
noodle product the units of which are ribbon-shaped.
    (c) Vegetable egg macaroni is the vegetable noodle product the units 
of which conform to the specifications of shape and size prescribed for 
egg macaroni by Sec. 139.150(c).
    (d) Vegetable egg spaghetti is the vegetable noodle product the 
units of which conform to the specifications of shape and size 
prescribed for egg spaghetti by Sec. 139.150(d).
    (e) Vegetable egg vermicelli is the vegetable noodle product the 
units of which conform to the specifications of shape and size 
prescribed for egg vermicelli by Sec. 139.150(e).
    (f) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``___ noodle product'' or 
``___ egg noodle product'', the blank being filled in with the name 
whereby the vegetable used is designated in paragraph (a) of this 
section; or alternatively, the name is ``___ noodles'' or ``___ egg 
noodles'', ``___ egg macaroni'', ``___ egg spaghetti'', or ``___ egg 
vermicelli'', as the case may be, when the units of the food comply with 
the requirements of paragraph (b), (c), (d), or (e) of this section, 
respectively, the blank in each instance being filled in with the name 
whereby the vegetable is designated in paragraph (a) of this section.

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993]



Sec. 139.165  Enriched vegetable noodle products.

    (a) Each of the noodle products for which a definition and standard 
of identity is prescribed by this section conforms to the definition and 
standard of identity and is subject to the requirements for label 
declaration of ingredients prescribed for noodle products by Sec. 
139.150 (a), (g), (h), and (i), and in addition is enriched to meet the 
requirements prescribed for enriched noodle products by Sec. 139.155 
and, except as hereinafter provided, contains a vegetable ingredient in 
compliance with the requirements prescribed for vegetable noodle 
products by Sec. 139.160. Because they are apt to impart an egg-yolk 
color, carrots are not used in enriched vegetable noodle products.

[[Page 581]]

    (b) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Enriched ___ noodle 
product'', ``Enriched ___ egg noodle product'', or, alternatively, the 
name is ``Enriched ___ noodles'', or ``Enriched ___ egg noodles'', 
``Enriched ___ egg macaroni'', ``Enriched ___ egg spaghetti'', or 
``Enriched ___ egg vermicelli'', when the units comply with the size and 
shape requirements for noodles, macaroni, spaghetti, or vermicelli in 
Sec. 139.150 (b), (c), (d), or (e). The blank in each instance is 
filled in with the name of the vegetable used, as specified in Sec. 
139.160(a).

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993]



Sec. 139.180  Wheat and soy noodle products.

    (a) Wheat and soy noodle products are the class of food each of 
which conforms to the definition and standard of identity and is subject 
to the requirements for label statement of ingredients prescribed for 
noodle products by Sec. 139.150(a), (g), and (i), except that soy flour 
is added in a quantity not less than 12.5 percent of the combined weight 
of the wheat and soy ingredients used (the soy flour used is made from 
heat-processed, dehulled soybeans, with or without the removal of fat 
therefrom).
    (b) Wheat and soy noodles, wheat and soy egg noodles, is the wheat 
and soy noodle product the units of which are ribbon-shaped.
    (c) Wheat and soy egg macaroni is the wheat and soy noodle product 
the units of which conform to the specifications of shape and size 
prescribed for egg macaroni by Sec. 139.150(c).
    (d) Wheat and soy egg spaghetti is the wheat and soy noodle product 
the units of which conform to the specifications of shape and size 
prescribed for egg spaghetti by Sec. 139.150(d).
    (e) Wheat and soy egg vermicelli is the wheat and soy noodle product 
the units of which conform to the specifications of shape and size 
prescribed for egg vermicelli by Sec. 139.150(e).
    (f) The name of each food for which a definition and standard of 
identity is prescribed by this section is ``Wheat and soy noodle 
product'', ``Wheat and soy egg noodle product'', ``Wheat and soybean 
noodle product'', ``Wheat and soybean egg noodle product'', ``___ and 
soy noodle product'', ``___ and soy egg noodle product'', ``___ and 
soybean noodle product'', or ``___ and soybean egg noodle product'', the 
blank in each instance being filled in with the name whereby the wheat 
ingredient used is designated in Sec. 139.150(a); or alternatively, the 
name is ``Wheat and soy noodles'', ``Wheat and soy egg noodles'', 
``Wheat and soybean noodles'', ``Wheat and soybean egg noodles'', ``___ 
and soy noodles'', ``___ and soy egg noodles'', ``___ and soybean 
noodles'', or ``___ and soybean egg noodles'' when the units of the food 
comply with the requirements of paragraph (b) of this section; or 
``Wheat and soy egg macaroni'', ``Wheat and soybean egg macaroni'', 
``___ and soy egg macaroni'', or ``___ and soybean egg macaroni'' when 
such units comply with the requirements of paragraph (c) of this 
section; or ``Wheat and soy egg spaghetti'', ``Wheat and soybean egg 
spaghetti'', ``___ and soy egg spaghetti'', or ``___ and soybean egg 
spaghetti'' when such units comply with the requirements of paragraph 
(d) of this section; or ``Wheat and soy egg vermicelli'', ``Wheat and 
soybean egg vermicelli'', ``___ and soy egg vermicelli'', or ``___ and 
soybean egg vermicelli'', when such units comply with the requirements 
of paragraph (e) of this section, the blank in each instance being 
filled in with the name whereby the wheat ingredient used is designated 
in Sec. 139.150(a).

[42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993]



PART 145_CANNED FRUITS--Table of Contents



                      Subpart A_General Provisions

Sec.
145.3 Definitions.

     Subpart B_Requirements for Specific Standardized Canned Fruits

145.110 Canned applesauce.
145.115 Canned apricots.
145.116 Artificially sweetened canned apricots.
145.120 Canned berries.

[[Page 582]]

145.125 Canned cherries.
145.126 Artificially sweetened canned cherries.
145.130 Canned figs.
145.131 Artificially sweetened canned figs.
145.134 Canned preserved figs.
145.135 Canned fruit cocktail.
145.136 Artificially sweetened canned fruit cocktail.
145.140 Canned seedless grapes.
145.145 Canned grapefruit.
145.170 Canned peaches.
145.171 Artificially sweetened canned peaches.
145.175 Canned pears.
145.176 Artificially sweetened canned pears.
145.180 Canned pineapple.
145.181 Artificially sweetened canned pineapple.
145.185 Canned plums.
145.190 Canned prunes.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14414, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 145.3  Definitions.

    For the purposes of this part:
    (a) The term corn sirup means a clarified, concentrated aqueous 
solution of the products obtained by the incomplete hydrolysis of 
cornstarch, and includes dried corn sirup. The solids of corn sirup and 
of dried corn sirup contain not less than 40 percent by weight of 
reducing sugars calculated as anhydrous dextrose.
    (b) The term dextrose means the hydrated or anhydrous, refined 
monosaccharide obtained from hydrolyzed starch.
    (c) The term dried glucose sirup means the product obtained by 
drying ``glucose sirup.''
    (d) The term glucose sirup means a clarified, concentrated, aqueous 
solution of the products obtained by the incomplete hydrolysis of any 
edible starch. The solids of glucose sirup contain not less than 40 
percent by weight of reducing sugars calculated as anhydrous dextrose.
    (e) The term invert sugar sirup means an aqueous solution of 
inverted or partly inverted, refined or partly refined sucrose, the 
solids of which contain not more than 0.3 percent by weight of ash, and 
which is colorless, odorless, and flavorless, except for sweetness.
    (f) The term sugar means refined sucrose.
    (g) The terms edible organic acid and edible organic salt refer to 
any edible organic acid and any edible organic salt added for the 
purpose of flavor enhancement that either is not a food additive as 
defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act 
or, if it is a food additive as so defined, is used in conformity with 
regulations established pursuant to section 409 of the act.
    (h) The term water means, in addition to water, any mixture of water 
and fruit juice in which the fruit juice(s) is less than 50 percent of 
such mixture, including any water contributed by the use of liquid 
nutritive carbohydrate sweeteners.
    (i) The term fruit juice(s) and water means any mixture of fruit 
juice as herein defined and water, including any water contributed by 
the use of liquid nutritive carbohydrate sweeteners, in which the fruit 
juice(s) is 50 percent, or more, of such mixture except that water used 
in preparing equivalent single strength juice(s) from concentrate(s) 
shall not be considered to be a mixture of fruit juice and water.
    (j) The term fruit juice(s) means single strength expressed juice(s) 
of sound, mature fruit(s). It may be fresh, frozen, canned, or made from 
concentrate(s). However, if it is made from concentrate(s), the juice(s) 
shall be reconstituted with water to not less than the soluble solids 
that such fruit juice had before concentration. Fruit juice(s) may be 
used singly or in combination. If a fruit juice(s) is used which is 
regulated by a standard of identity of this chapter, it shall conform to 
the compositional requirements prescribed by such standard prior to the 
addition of any sweetener which may be used.
    (k) The term clarified juice means the liquid expressed wholly or in 
part from fruit peelings, fruit shells, fruit cores, or from the fruit 
flesh or parts thereof, which is clarified and may be further refined or 
concentrated.
    (l) The term solid pack means the product contains practically all 
fruit with only the very little free flowing liquid that is expressed 
from the fruit

[[Page 583]]

and to which no packing media have been added.
    (m) The procedure for determining the densities of the packing media 
means the following: The density of the packing medium, when measured 15 
days or more after packing, or the density of the blended homogenized 
slurry of the comminuted entire contents of the container, when measured 
less than 15 days after canning, is determined according to ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), which is incorporated by reference, section 
31.\6\F011 (Solids) ``By Means of the Refractometer--Official Final 
Action'' (and sections 52.012 and 52.015) with result expressed as 
percent by weight of sucrose (degrees Brix) with correction for 
temperature to the equivalent at 20 [deg]C, but without correction for 
invert sugar or other substances. Copies of the material incorporated by 
reference may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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.
    (n) The procedure for determining drained weight is as follows: Tilt 
the opened container so as to distribute the contents evenly over the 
meshes of a circular sieve which has previously been weighed. The 
diameter of the sieve is 20.3 centimeters (8 inches) if the quantity of 
contents of the container is less than 1.4 kilograms (3 pounds) and 30.5 
centimeters (12 inches) if such quantity is 1.4 kilograms (3 pounds) or 
more. The bottom of the sieve is woven-wire cloth which complies with 
the specifications for the No. 8 sieve set forth in the ``Definitions of 
Terms and Explanatory Notes'' of the ``Official Methods of Analysis of 
the Association of Official Analytical Chemists,'' 13th Ed. (1980), 
which is incorporated by reference. The availability of this 
incorporation by reference is given in paragraph (m) of this section. 
Carefully invert by hand all fruits having cups or cavities if they fall 
on the sieve with cups or cavities up. Cups or cavities in soft products 
may be drained by tilting sieve. Without further shifting the material 
on the sieve, incline the sieve at an angle of 17[deg] to 20[deg] to 
facilitate drainage. Two minutes after the drainage begins, weigh the 
sieve and drained fruit. The weight so found, less the weight of the 
sieve, shall be considered to be the weight of the drained fruit.
    (o) Compliance means the following: Unless otherwise provided in a 
standard, a lot of canned fruits shall be deemed in compliance for the 
following factors, to be determined by the sampling and acceptance 
procedure as provided in paragraph (p) of this section, namely:
    (1) Packing medium density. A lot shall be deemed to be in 
compliance for packing medium density based on the average sucrose value 
for all samples analyzed according to the sampling plans, but no 
container may have a sucrose value lower than that of the next lower 
category or 2 percent by weight sucrose (degrees Brix) lower if no lower 
category exists.
    (2) Quality. The quality of a lot shall be considered acceptable 
when the number of defectives does not exceed the acceptance number in 
the sampling plans.
    (3) Fill of container. A lot shall be deemed to be in compliance for 
fill of container (packing medium and fruit ingredient) when the number 
of defectives does not exceed the acceptance number (c) in the sampling 
plans.
    (4) Drained weight. A lot shall be deemed to be in compliance for 
drained weight based on the average value of all samples analyzed 
according to the sampling plans. The sample unit shall be the entire 
contents of the container.
    (p) The sampling and acceptance procedure means the following:
    (1) Definitions--(i) Lot. A collection of primary containers or 
units of the same size, type, and style manufactured or packed under 
similar conditions and handled as a single unit of trade.
    (ii) Lot size. The number of primary containers or units in the lot.
    (iii) Sample size. The total number of sample units drawn for 
examination from a lot.

[[Page 584]]

    (iv) Sample unit. A container, a portion of the contents of a 
container, or a composite mixture of product from small containers that 
is sufficient for the examination or testing as a single unit.
    (v) Defective. Any sample unit shall be regarded as defective when 
the sample unit does not meet the criteria set forth in the standards.
    (vi) Acceptance number (c). The maximum number of defective sample 
units permitted in the sample in order to consider the lot as meeting 
the specified requirements.
    (vii) Acceptable quality level (AQL). The maximum percent of 
defective sample units permitted in a lot that will be accepted 
approximately 95 percent of the time.
    (2) Sampling plans:

------------------------------------------------------------------------
                                                      Size in container
           Lot size (primary containers)           ---------------------
                                                      n \1\      c \2\
------------------------------------------------------------------------
             net weight equal to or less than 1 kg (2.2 lb)
------------------------------------------------------------------------
4,800 or less.....................................         13          2
4,801 to 24,000...................................         21          3
24,001 to 48,000..................................         29          4
48,001 to 84,000..................................         48          6
84,001 to 144,000.................................         84          9
144,001 to 240,000................................        126         13
Over 240,000......................................        200         19
------------------------------------------------------------------------
 net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
------------------------------------------------------------------------
2,400 or less.....................................         13          2
2,401 to 15,000...................................         21          3
15,001 to 24,000..................................         29          4
24,001 to 42,000..................................         48          6
42,001 to 72,000..................................         84          9
72,001 to 120,000.................................        126         13
Over 120,000......................................        200         19
------------------------------------------------------------------------
                 net weight greater than 4.5 kg (10 lb)
------------------------------------------------------------------------
600 or less.......................................         13          2
601 to 2,000......................................         21          3
2,001 to 7,200....................................         29          4
7,201 to 15,000...................................         48          6
15,001 to 24,000..................................         84          9
24,001 to 42,000..................................        126         13
Over 42,000.......................................        200         19
------------------------------------------------------------------------
\1\ n = number of primary containers in sample.
\2\ c = acceptance number.


[42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 
49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 63 FR 14035, 
Mar. 24, 1998]



     Subpart B_Requirements for Specific Standardized Canned Fruits



Sec. 145.110  Canned applesauce.

    (a) Identity--(1) Definition. Canned applesauce is the food prepared 
from comminuted or chopped apples (Malus domestica Borkhausen), which 
may or may not be peeled and cored, and which may have added thereto one 
or more of the optional ingredients specified in paragraph (a)(2) of 
this section. The apple ingredient is heated and, in accordance with 
good manufacturing practices, bruised apple particles, peel, seed, core 
material, carpel tissue, and other coarse, hard, or extraneous materials 
are removed. The food is sealed in containers. It is so processed by 
heat, either before or after sealing, as to prevent spoilage. The 
soluble solids content, measured by refractometer and expressed as 
percent sucrose (degrees Brix) with correction for temperature to the 
equivalent at 20 [deg]C (68 [deg]F), is not less than 9 percent 
(exclusive of the solids of any added optional nutritive carbohydrate 
sweeteners) as determined by the method prescribed in ``Official Methods 
of Analysis of the Association of Official Analytical Chemists,'' 13th 
Ed. (1980), section 22.024, ``Soluble Solids by Refractometer in Fresh 
and Canned Fruits, Jams, Marmalades, and Preserves--Official First 
Action,'' which is incorporated by reference, but without correction for 
invert sugar or other substances. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (2) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (i) Water.
    (ii) Apple juice.
    (iii) Salt.
    (iv) Any organic acid added for the purpose of acidification. 
(Organic acids

[[Page 585]]

generally recognized as having a preservative effect are not permitted 
in applesauce except as provided for in paragraph (a)(2)(viii) of this 
section.)
    (v) Nutritive carbohydrate sweeteners.
    (vi) Spices.
    (vii) Natural and artificial flavoring.
    (viii) Either of the following:
    (a) Erythorbic acid or ascorbic acid as an antioxidant preservative 
in an amount not to exceed 150 parts per million; or
    (b) Ascorbic acid (vitamin C) in a quantity such that the total 
vitamin C in each 113 g (4 ounces) by weight of the finished food 
amounts to 60 mg. This requirement will be deemed to have been met if a 
reasonable overage of the vitamin, within limits of good manufacturing 
practice, is present to insure that the required level is maintained 
throughout the expected shelf life of the food under customary 
conditions of distribution.
    (ix) Color additives in such quantity as to distinctly characterize 
the food unless such addition conceals damage or inferiority or makes 
the finished food appear better or of greater value than it is.
    (3) Nomenclature. The name of the food is ``applesauce''. The name 
of the food shall include a declaration indicating the presence of any 
flavoring that characterizes the product as specified in Sec. 101.22 of 
this chapter and a declaration of any spice that characterizes the 
product. If a nutritive sweetener as provided for in paragraph (a)(2)(v) 
of this section is added and the soluble solids content of the finished 
food is not less than 16.5 percent as determined by the method referred 
to in paragraph (a)(1) of this section, the name may include the word 
``sweetened''. If no such sweetener is added, the name may include the 
word ``unsweetened''.
    (4) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter. However, when ascorbic acid (vitamin 
C) is added as provided for in paragraph (a)(2)(viii)(b) of this 
section, after the application of heat to the apples, preservative 
labeling requirements do not apply.
    (b) [Reserved]
    (c) Fill of container. (1) The standard of fill of container for 
canned applesauce is a fill of not less than 90 percent of the total 
capacity of the container, as determined by the general method for fill 
of containers prescribed in Sec. 130.12(b) of this chapter; except that 
in the case of glass containers having a total capacity of 192 ml (6\1/
2\ fluid ounces) or less, the fill is not less than 85 percent.
    (2) Sampling and acceptance procedure: A lot will be deemed to fall 
below the standard of fill when the number of ``defectives'' exceeds the 
acceptance number ``c'' in the sampling plans prescribed in paragraph 
(c)(2)(ii) of this section.
    (i) Definitions of terms to be used in the sampling plans in 
paragraph (c)(2)(ii) of this section are as follows:
    (a) Lot. A collection of primary containers or units of the same 
size, type, and style manufactured or packed under similar conditions 
and handled as a single unit of trade.
    (b) Lot size. The number of primary containers or units in the lot.
    (c) Sample size ``n.'' The total number of sample units drawn for 
examination from a lot as indicated in paragraph (c)(2)(ii) of this 
section.
    (d) Sample unit. A container, the entire contents of a container, a 
portion of the contents of a container, or a composite mixture of 
product from small containers that is sufficient for examination or 
testing as a single unit.
    (e) Defective. A container that falls below the requirement for 
minimum fill prescribed in paragraph (c)(1) of this section is 
considered a ``defective.''
    (f) Acceptable number ``c.'' The maximum number of defective sample 
units permitted in the sample in order to consider the lot as meeting 
the specified requirements.
    (g) Acceptable quality level (AQL). The maximum percent of defective 
sample units permitted in a lot that will be accepted approximately 95 
percent of the time.
    (ii) Sampling and acceptance:

[[Page 586]]



                   Acceptable quality level (AQL) 6.5
------------------------------------------------------------------------
                                                      Size of container
           Lot size (primary containers)           ---------------------
                                                      n \1\      c \2\
------------------------------------------------------------------------
             net weight equal to or less than 1 kg (2.2 lb)
------------------------------------------------------------------------
4,800 or less.....................................         13          2
4,801 to 24,000...................................         21          3
24,001 to 48,000..................................         29          4
48,001 to 84,000..................................         48          6
84,001 to 144,000.................................         84          9
144,001 to 240,000................................        126         13
Over 240,000......................................        200         19
------------------------------------------------------------------------
 net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
------------------------------------------------------------------------
2,400 or less.....................................         13          2
2,401 to 15,000...................................         21          3
15,001 to 24,000..................................         29          4
24,001 to 42,000..................................         48          6
42,001 to 72,000..................................         84          9
72,001 to 120,000.................................        126         13
Over 120,000......................................        200         19
------------------------------------------------------------------------
                 net weight greater than 4.5 kg (10 lb)
------------------------------------------------------------------------
600 or less.......................................         13          2
601 to 2,000......................................         21          3
2,001 to 7,200....................................         29          4
7,201 to 15,000...................................         48          6
15,001 to 24,000..................................         84          9
24,001 to 42,000..................................        126         13
Over 42,000.......................................        200         19
------------------------------------------------------------------------
\1\ n = number of primary containers in sample.
\2\ c = acceptance number.

    (3) If canned applesauce falls below the standard of fill of 
container prescribed in paragraph (c)(1) of this section, the label 
shall bear the general statement of substandard fill specified in Sec. 
130.14(b) of this chapter, in the manner and form therein specified.

[42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 
49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2879, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 145.115  Canned apricots.

    (a) Identity--(1) Ingredients. Canned apricots is the food prepared 
from mature apricots of one of the optional styles specified in 
paragraph (a)(2) of this section, which may be packed as solid pack or 
in one of the optional packing media specified in paragraph (a)(3) of 
this section. Such food may also contain one, or any combination of two 
or more of the following safe and suitable optional ingredients:
    (i) Natural and artificial flavors.
    (ii) Spice.
    (iii) Vinegar, lemon juice, or organic acids.
    (iv) Apricot pits, except in the cases of unpeeled whole apricots 
and peeled whole apricots, in a quantity not more than 1 apricot pit to 
each 227 grams (8 ounces) of finished canned apricots.
    (v) Apricot kernels, except in the cases of unpeeled whole apricots 
and peeled whole apricots, and except when optional ingredient under 
paragraph (a)(4) of this section is used.
    (vi) Ascorbic acid in an amount no greater than necessary to 
preserve color.


Such food is sealed in a container and before or after sealing is so 
processed by heat as to prevent spoilage.
    (2) Optional styles of the apricot ingredient. The optional styles 
of the apricot ingredient referred to in paragraph (a) of this section 
are peeled or unpeeled:
    (i) Whole.
    (ii) Halves.
    (iii) Quarters.
    (iv) Slices.
    (v) Pieces or irregular pieces.


Each such ingredient, except in the cases of unpeeled whole apricots and 
peeled whole apricots, is pitted.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section, as defined in Sec. 145.3 are:
    (a) Water.
    (b) Fruit juice(s) and water.
    (c) Fruit juice(s).


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.3.
    (ii) When a sweetener is added as a part of any such liquid packing 
medium, the density range of the resulting packing medium expressed as 
percent by weight of sucrose (degrees Brix) as determined by the 
procedure prescribed in Sec. 145.3(m) shall be designated by the 
appropriate name for the respective density ranges, namely:
    (a) When the density of the solution is 10 percent or more but less 
than 16

[[Page 587]]

percent, the medium shall be designated as ``slightly sweetened water''; 
or ``extra light sirup''; ``slightly sweetened fruit juice(s) and 
water''; or ``slightly sweetened fruit juice(s)'', as the case may be.
    (b) When the density of the solution is 16 percent or more but less 
than 21 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'', as the case may be.
    (c) When the density of the solution is 21 percent or more but less 
than 25 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (d) When the density of the solution is 25 percent or more but not 
more than 40 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened fruit juice(s) and water''; or 
``extra heavily sweetened fruit juice(s)'', as the case may be.
    (4) Labeling requirements. (i) The name of the food is ``apricots''. 
The name of the food shall also include a declaration of any flavoring 
that characterizes the product as specified in Sec. 101.22 of this 
chapter and a declaration of any spice or seasoning that characterizes 
the product; for example, ``Spice Added'', or in lieu of the word 
``Spice'', the common name of the spice, ``Seasoned with Vinegar'' or 
``Seasoned with Apricot Kernels''. When two or more of the optional 
ingredients specified in paragraphs (a)(1) (ii) through (iv), inclusive, 
of this section are used, such words may be combined as for example, 
``Seasoned with Cider Vinegar, Cloves, Cinnamon Oil and Apricot 
Kernels''.
    (ii) The style of the apricot ingredient as provided in paragraph 
(a)(2) of this section and the name of the packing medium as used in 
paragraphs (a)(3)(i) and (ii) of this section, preceded by ``In'' or 
``Packed in'' or the words ``solid pack'', where applicable, shall be 
included as part of the name or in close proximity to the name of the 
food, except that pieces or irregular pieces shall be designated 
``Pieces'', ``Irregular pieces'', or ``Mixed pieces of irregular sizes 
and shapes''. The style of the apricot ingredient shall be preceded or 
followed by ``Unpeeled'' or ``Peeled'', as the case may be. ``Halves'' 
may be alternatively designated ``Halved'', ``Quarters'' as 
``Quartered'' and ``Slices'' as ``Sliced''. When the packing medium is 
prepared with a sweetener(s) which imparts a taste, flavor or other 
characteristic to the finished food in addition to sweetness, the name 
of the packing medium shall be accompanied by the name of such 
sweetener(s), as for example in the case of a mixture of brown sugar and 
honey, an appropriate statement would be ``___ sirup of brown sugar and 
honey'' the blank to be filled in with the word ``light'', ``heavy'', or 
``extra heavy'' as the case may be. When the liquid portion of the 
packing media provided for in paragraphs (a)(3) (i) and (ii) of this 
section consists of fruit juice(s), such juice(s) shall be designated in 
the name of the packing medium as:
    (a) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit''.
    (b) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (a)(4)(iii) of 
this section, and
    (c) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juice(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (a)(4)(iii) of this section.
    (iii) Whenever the names of the fruit juices used do not appear in 
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of 
this section, such names and the words ``from concentrate,'' as 
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an 
ingredient statement pursuant to the requirements of Sec. 101.3(d) of 
this chapter.
    (iv) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[[Page 588]]

    (b) Quality. (1) The standard of quality for canned apricots is as 
follows:
    (i) All units tested in accordance with the method prescribed in 
paragraph (b)(2) of this section are pierced by a weight of not more 
than 300 grams.
    (ii) In the cases of whole apricots, halves, and quarters, the 
weight of the largest unit in the container is not more than twice the 
weight of the smallest unit therein.
    (iii) Not more than 20 percent of the units in the container are 
blemished with scab, hail injury, discoloration, or other abnormalities.
    (iv) In the cases of whole apricots, halves, and quarters, all units 
are untrimmed, or are so trimmed as to preserve normal shape.
    (v) Except in the case of mixed pieces of irregular sizes and 
shapes, not more than 5 percent of the units in a container of 20 or 
more units, and not more than 1 unit in a container of less than 20 
units, are crushed or broken. (A unit which has lost its normal shape 
because of ripeness and which bears no mark of crushing shall not be 
considered to be crushed or broken.)
    (2) Canned apricots shall be tested by the following method to 
determine whether or not they meet the requirements of paragraph 
(b)(1)(i) of this section: So trim a test piece from the unit as to fit, 
with peel surface up, into a supporting receptacle. If the unit is of 
different firmness in different parts of its peel surface, trim the 
piece from the firmest part. If the piece is unpeeled, remove the peel. 
The top of the receptacle is circular in shape, of 1\1/8\ inches inside 
diameter, with vertical sides; or rectangular in shape, \3/4\ inch by 1 
inch inside measurements, with ends vertical and sides sloping downward 
and joining at the center at a vertical depth of \3/4\ inch. Use the 
circular receptacle for testing units of such size that a test piece can 
be trimmed therefrom to fit it. Use the rectangular receptacle for 
testing other units. Test no unit from which a test piece with 
rectangular peel surface at least \1/2\ inch by 1 inch cannot be 
trimmed. Test the piece by means of a round metal rod \3/16\ inch in 
diameter. To the upper end of the rod is affixed a device to which 
weight can be added. The rod is held vertically by a support through 
which it can freely move upward or downward. The lower end of the rod is 
a plane surface to which the vertical axis of the rod is perpendicular. 
Adjust the combined weight of the rod and device to 100 grams. Set the 
receptacle so that the surface of the test piece is held horizontally. 
Lower the end of the rod to the approximate center of such surface, and 
add weight to the device at a uniform, continuous rate of 12 grams per 
second until the rod pierces the test piece. Weigh the rod and weighted 
device. Test all units in containers of 50 units or less, except those 
units too small for testing or too soft for trimming. Test at least 50 
units, taken at random, in containers of more than 50 units; but if less 
than 50 units are of sufficient size and firmness for testing, test 
those which are of sufficient size and firmness.
    (3) If the quality of canned apricots falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified; but in lieu of 
such general statement of substandard quality, the label may bear the 
alternative statement ``Below standard in quality ___'', the blank to be 
filled in with the words specified after the corresponding number of 
each subparagraph of paragraph (b)(1) of this section which such canned 
apricots fail to meet, as follows:
    (i) ``Not tender'';
    (ii) ``Mixed sizes'';
    (iii) ``Blemished'';
    (iv) ``Unevenly trimmed'';
    (v) ``Partly crushed or broken''.

    Such alternative statement shall immediately and conspicuously 
precede or follow, without intervening written, printed, or graphic 
matter, the name ``apricots'' and any words and statements required or 
authorized to appear with such name by Sec. 145.115(a)(2).
    (c) Fill of container. (1) The standard of fill of container for 
canned apricots is the maximum quantity of the optional apricot 
ingredient that can be sealed in the container and processed by heat to 
prevent spoilage, without crushing or breaking such ingredient.

[[Page 589]]

    (2) If canned apricots fall below the standard of fill of container 
prescribed in paragraph (c)(1) of this section, the label shall bear the 
general statement of substandard fill specified in Sec. 130.14(b) of 
this chapter, in the manner and form therein specified.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993]



Sec. 145.116  Artificially sweetened canned apricots.

    (a) Artificially sweetened canned apricots is the food which 
conforms to the definition and standard of identity prescribed for 
canned apricots by Sec. 145.115(a), except that in lieu of a packing 
medium specified in Sec. 145.115(a)(3), the packing medium used is 
water artificially sweetened with saccharin, sodium saccharin, or a 
combination of both. Such packing medium may be thickened with pectin 
and may contain any mixture of any edible organic salt or salts and any 
edible organic acid or acids as a flavor-enhancing agent, in a quantity 
not more than is reasonably required for that purpose.
    (b)(1) The specified name of the food is ``artificially sweetened 
___'', the blank being filled in with the name prescribed by Sec. 
145.115(a) for canned apricots having the same optional apricot 
ingredient.
    (2) The artificially sweetened food is subject to the requirements 
for label statement of ingredients used, as prescribed for canned 
apricots by Sec. 145.115(a). If the packing medium is thickened with 
pectin, the label shall bear the statement ``thickened with pectin''. 
When any organic salt or acid or any mixture of two or more of these is 
added, the label shall bear the common or usual name of each such 
ingredient.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993]



Sec. 145.120  Canned berries.

    (a) Identity--(1) Ingredients. Canned berries is the food prepared 
from any suitable variety of one of the optional berry ingredients 
specified in paragraph (a)(2) of this section, which may be packed in 
one of the optional packing media specified in paragraph (a)(3) of this 
section, and may contain one or any combination of two or more of the 
safe and suitable optional ingredients specified in paragraph (a)(4) of 
this section. Such food is sealed in a container and before or after 
sealing is so processed by heat to prevent spoilage.
    (2) Varietal types. The optional berry ingredients referred to in 
paragraph (a)(1) of this section are prepared from stemmed fruit of the 
following optional varietal types of berry ingredient; namely:
    (i) Raspberry varieties conforming to the characteristics of Rubus 
idaeus L. or Rubus occidentalis L.
    (ii) Blackberries.
    (iii) Blueberries.
    (iv) Boysenberries.
    (v) Dewberries.
    (vi) Gooseberries.
    (vii) Huckleberries.
    (viii) Loganberries.
    (ix) Strawberry varieties conforming to the characteristics of 
Fragaria.
    (x) Youngberries.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section as defined in Sec. 145.3 are:
    (a) Water.
    (b) Fruit juice(s) and water.
    (c) Fruit juice(s).


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweeteners may be 
added. Sweeteners listed in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.3.
    (ii) When a sweetener is added as a part of any such liquid packing 
medium, the four density ranges of the resulting packing media 
hereinafter specified for each berry ingredient, expressed as percent by 
weight of sucrose (degrees Brix) as determined by the procedure 
described in Sec. 145.3(m), shall be designated by the appropriate name 
for each of the respective density ranges for each berry ingredient as:
    (a) ``Slightly sweetened water''; or ``extra light sirup''; 
``slightly sweetened fruit juice(s) and water''; or

[[Page 590]]

``slightly sweetened fruit juice(s)'', as the case may be.
    (b) ``Light sirup'', when the liquid used is water, ``lightly 
sweetened fruit juice(s) and water''; or ``lightly sweetened fruit 
juice(s)'', as the case may be.
    (c) ``Heavy sirup'', when the liquid used is water; or ``heavily 
sweetened fruit juice(s) and water''; or ``heavily sweetened fruit 
juice(s)'', as the case may be.
    (d) ``Extra heavy sirup'', when the liquid used is water; or ``extra 
heavily sweetened fruit juice(s) and water''; or ``extra heavily 
sweetened fruit juice(s)'', as the case may be.

The density ranges referred to herein are:

----------------------------------------------------------------------------------------------------------------
                                                                  Density ranges
                                 -------------------------------------------------------------------------------
                                          (a)                 (b)                 (c)                 (d)
    Optional berry ingredient    -------------------------------------------------------------------------------
                                             Maximum             Maximum             Maximum             Maximum
                                   Minimum    less     Minimum    less     Minimum    less     Minimum  not more
                                              than                than                than                than
----------------------------------------------------------------------------------------------------------------
Blackberries....................  ........        14        14        19        19        24        24        35
Blueberries.....................  ........        15        15        20        20        25        25        35
Boysenberries...................  ........        14        14        19        19        24        24        35
Dewberries......................  ........        14        14        19        19        24        24        35
Gooseberries....................  ........        14        14        20        20        25        25        35
Huckleberries...................  ........        15        15        20        20        25        25        35
Loganberries....................  ........        14        14        19        19        24        24        35
Raspberries.....................        11        15        15        20        20        27        27        35
Strawberries....................        10        14        14        19        19        27        27        35
Youngberries....................  ........        14        14        19        19        24        24        35
----------------------------------------------------------------------------------------------------------------
(a) ``Slightly sweetened water.'' (b) ``Light sirup.'' (c) ``Heavy sirup.'' (d) ``Extra heavy sirup.''

    (4) Optional ingredients. The optional ingredients referred to in 
paragraph (a)(1) of this section are:
    (i) Natural and artificial flavors.
    (ii) Calcium salts as firming agents provided that the calcium added 
is no more than 0.035 percent, calculated as calcium, of the weight of 
the finished canned berries.
    (iii) Organic acids.
    (5) Labeling requirements. (i) The name of the food is the 
appropriate name of the berry ingredient specified in paragraph (a)(2) 
of this section.
    (ii) The name of the packing medium, as used in paragraph (a)(3)(i) 
of this section preceded by ``In'' or ``Packed in.'' as provided in 
paragraph (a)(3) of this section and, in the case of raspberries other 
than red raspberries provided for in paragraph (a)(2) of this section, 
the name of such packing medium and the color of such raspberry shall be 
included as part of the name or in close proximity to the name of the 
food. When the liquid portion of the packing media provided for in 
paragraphs (a)(3) (i) and (ii) of this section consists of fruit 
juice(s), such juice(s) shall be designated in the name of the packing 
medium as:
    (a) In the cases of a single fruit juice, the name of the juice 
shall be used in lieu of the word ``fruit'';
    (b) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (a)(3) of this 
section; and
    (c) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juice(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (a)(5)(iii) of this section.
    (iii) Whenever the names of the fruit juices used do not appear in 
the name of the packing medium as provided in paragraph (a)(5)(ii)(b) of 
this section, such names and the words ``from concentrate'', as 
specified in paragraph (a)(5)(ii)(c) of this section, shall appear in an 
ingredient statement pursuant to the requirements of Sec. 101.3(d) of 
this chapter.

[[Page 591]]

    (iv) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) [Reserved]

[46 FR 2339, Jan. 9, 1981; 47 FR 6426, Feb. 12, 1982, as amended at 48 
FR 2748, Jan. 21, 1983; 58 FR 2879, Jan. 6, 1993]



Sec. 145.125  Canned cherries.

    (a) Identity--(1) Ingredients. Canned cherries is the food prepared 
from one of the optional fresh or previously canned cherry ingredients 
specified in paragraph (a)(2) of this section, which may be packed in 
one of the optional packing media specified in paragraph (a)(3) of this 
section. Such food may also contain one, or any combination of two or 
more, of the following safe and suitable optional ingredients:
    (i) Natural and artificial flavors.
    (ii) Spice.
    (iii) Vinegar, lemon juice, or organic acids. Such food is sealed in 
a container and before or after sealing is so processed by heat as to 
prevent spoilage.
    (2) Varietal types and styles. The optional cherry ingredients 
referred to in paragraph (a)(1) of this section are prepared from mature 
pitted or unpitted cherries of the red tart or alternatively, red sour, 
light sweet or dark sweet varietal group.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section, as defined in Sec. 145.3 are:
    (a) Water.
    (b) Fruit juice(s) and water.
    (c) Fruit juice(s).


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.3.
    (ii) When a sweetener is added as a part of any such liquid packing 
medium, the density range of the resulting packing medium expressed as 
percent by weight of sucrose (degrees Brix) as determined by the 
procedure prescribed in Sec. 145.3(m) shall be designated by the 
appropriate name for the respective density ranges, namely:
    (a) In the case of sweet cherries:
    (i) When the density of the solution is less than 16 percent, the 
medium shall be designated as ``slightly sweetened water''; or ``extra 
light sirup''; ``slightly sweetened fruit juice(s) and water''; or 
``slightly sweetened fruit juice(s)'', as the case may be.
    (ii) When the density of the solution is 16 percent or more but less 
than 20 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'', as the case may be.
    (iii) When the density of the solution is 20 percent or more but 
less than 25 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (iv) When the density of the solution is 25 percent or more but not 
more than 35 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened fruit juice(s) and water''; or 
``extra heavily sweetened fruit juice(s)'', as the case may be.
    (b) In the case of red tart cherries:
    (i) When the density of the solution is less than 18 percent, the 
medium shall be designated as ``slightly sweetened water''; ``slightly 
sweetened fruit juice(s) and water''; or ``slightly sweetened fruit 
juice(s)'', as the case may be.
    (ii) When the density of the solution is 18 percent or more but less 
than 22 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'', as the case may be.
    (iii) When the density of the solution is 22 percent or more but 
less than 28 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (iv) When the density of the solution is 28 percent or more but not 
more than 45 percent, the medium shall be designated as ``extra heavy 
sirup'';

[[Page 592]]

``extra heavily sweetened fruit juice(s) and water''; or ``extra heavily 
sweetened fruit juice(s)'', as the case may be.
    (4) Labeling requirements. (i) The name of the food is ``cherries''. 
The optional varietal type as set forth in paragraph (a)(2) of this 
section, preceded or followed by the word ``pitted'' when this is the 
fact, shall be a part of the name. The name of the food shall also 
include a declaration of any flavoring that characterizes the product as 
specified in Sec. 101.22 of this chapter and a declaration of any spice 
or seasoning that characterizes the product; for example, ``Spice 
added'', or in lieu of the word ``Spice'', the common name of the spice, 
or ``Seasoned with lemon juice''. When two or more of the optional 
ingredients specified in paragraph (a)(1) (ii) and (iii) of this section 
are used, such words may be combined as for example, ``Seasoned with 
cider vinegar, cloves, and cinnamon oil''.
    (ii) The color type and style of the cherry ingredient as provided 
in paragraph (a)(2) of this section and the name of the packing medium 
specified in paragraphs (a)(3) (i) and (ii) of this section, preceded by 
``In'' or ``Packed in'' or the words ``solid pack'', where applicable, 
shall be included as part of the name or in close proximity to the name 
of the food. When the packing medium is prepared with a sweetener(s) 
which imparts a taste, flavor or other characteristic to the finished 
food in addition to sweetness, the name of the packing medium shall be 
accompanied by the name of such sweetener(s), as for example in the case 
of a mixture of brown sugar and honey, an appropriate statement would be 
``___ sirup of brown sugar and honey'' the blank to be filled in with 
the word ``light'', ``heavy'', or ``extra heavy'' as the case may be. 
When the liquid portion of the packing media provided for in paragraphs 
(a)(3) (i) and (ii) of this section consists of fruit juice(s), such 
juice(s) shall be designated in the name of the packing medium as:
    (a) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit'';
    (b) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (a)(4)(iii) of 
this section; and
    (c) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juice(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (a)(4)(iii) of this section.
    (iii) Whenever the names of the fruit juices used do not appear in 
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of 
this section, such names and the words ``from concentrate'', as 
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an 
ingredient statement pursuant to the requirements of Sec. 101.3(d) of 
this chapter.
    (iv) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned cherries is as 
follows:
    (i) In the case of pitted cherries, not more than 1 pit is present 
in each 20 ounces of canned cherries, as determined by the method 
prescribed in paragraph (b)(2)(i) of this section.
    (ii) In the case of unpitted cherries, the weight of each cherry in 
the container is not less than \1/10\ ounce.
    (iii) In the case of unpitted cherries, the weight of the largest 
cherry in the container is not more than twice the weight of the 
smallest cherry therein.
    (iv) In the case of unpitted cherries, the total weight of pits is 
not more than 12 percent of the weight of drained cherries, as 
determined by the method prescribed in paragraph (b)(2)(ii) of this 
section.
    (v) Not more than 15 percent by count of the cherries in the 
container are blemished with scab, hail injury, discoloration, scar 
tissue or other abnormality. A cherry showing skin discoloration (other 
than scald) having an aggregate area exceeding that of a circle \9/32\ 
inch in diameter is considered to be blemished. A cherry showing 
discoloration of any area but extending into

[[Page 593]]

the fruit tissue is also considered to be blemished.
    (2)(i) Pitted canned cherries shall be tested by the following 
method to determine whether or not they comply with the requirements of 
paragraph (b)(1)(i) of this section: Take at random such number of 
containers as to have a total quantity of contents of at least 24 
pounds. Open the containers and weigh the contents. Count the pits and 
pieces of pit shell in such total quantity. Count a piece of pit shell 
equal to or smaller than one-half pit shell as one-half pit, and a piece 
of pit shell larger than one-half pit shell as one pit; but when two or 
more pieces of pit shell are within or attached to a single cherry, 
count such pieces as one-half pit if their combined size is equivalent 
to that of one-half pit shell or less, and as one pit if their combined 
size is equivalent to that of more than one-half pit shell. From the 
total number of pits so counted and the combined weight of the contents 
of all the containers, calculate the number of pits present in each 20 
ounces of canned cherries.
    (ii) Unpitted canned cherries shall be tested by the following 
method to determine whether or not they comply with the requirements of 
paragraph (b)(1)(iv) of this section: Tilt the opened container so as to 
distribute the contents over the meshes of a circular sieve which has 
previously been weighed. The diameter of the sieve is 8 inches if the 
quantity of the contents of the container is less than 3 pounds, or 12 
inches if such quantity is 3 pounds or more. The bottom of the sieve is 
No. 8 woven-wire cloth that complies with the specifications for such 
cloth set forth in the ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980), Table 1, ``Nominal 
Dimensions of Standard Test Sieves (U.S.A. Standard Series),'' under the 
heading ``Definitions of Terms and Explanatory Notes,'' which is 
incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD, 
20877-2504, or may be examined 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. 
Without shifting the cherries, so incline the sieve as to facilitate 
drainage. Two minutes from the time drainage begins, weigh the sieve and 
drained cherries. The weight so found, less the weight of the sieve, 
shall be considered to be the weight of drained cherries. Pit the 
cherries and wash the pits free from adhering flesh. Drain and weigh the 
pits by the method prescribed above. Divide the weight of pits so found 
by the weight of drained cherries, and multiply by 100.
    (3) If the quality of canned cherries falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified; but in lieu of 
such general statement of substandard quality, the label may bear the 
alternative statement ``Below Standard in Quality ___'', the blank to be 
filled in with the words specified after the corresponding number of 
each subparagraph of paragraph (b)(1) of this section which such canned 
cherries fail to meet, as follows:
    (i) ``Partially pitted'';
    (ii) ``Small'';
    (iii) ``Mixed sizes'';
    (iv) ``Thin-fleshed'';
    (v) ``Blemished''.


Such alternative statement shall immediately and conspicuously precede 
or follow, without intervening written, printed, or graphic matter, the 
name ``Cherries'' and any words and statements required or authorized to 
appear with such name by Sec. 145.125(a)(2).
    (c) Fill of container. (1) The standard of fill of container for 
canned cherries is the maximum quantity of the optional cherry 
ingredient that can be sealed in the container and processed by heat to 
prevent spoilage, without crushing such ingredient.
    (2) If canned cherries fall below the standard of fill of container 
prescribed in paragraph (c)(1) of this section, the label shall bear the 
general statement of substandard fill specified in

[[Page 594]]

Sec. 130.14(b) of this chapter, in the manner and form therein 
specified.

[42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 
49 FR 10099, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2879, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 145.126  Artificially sweetened canned cherries.

    (a) Artificially sweetened canned cherries is the food which 
conforms to the definition and standard of identity prescribed for 
canned cherries by Sec. 145.125(a), except that in lieu of a packing 
medium specified in Sec. 145.125(a)(3), the packing medium used is 
water artificially sweetened with saccharin, sodium saccharin, or a 
combination of both. Such packing medium may be thickened with pectin 
and may contain any mixture of any edible organic salt or salts and any 
edible organic acid or acids as a flavor-enhancing agent, in a quantity 
not more than is reasonably required for that purpose.
    (b)(1) The specified name of the food is ``artificially sweetened 
___'', the blank being filled in with the name prescribed by Sec. 
145.125(a) for canned cherries having the same optional cherry 
ingredient.
    (2) The artificially sweetened food is subject to the requirements 
for label statement of ingredients used, as prescribed for canned 
cherries by Sec. 145.125(a). If the packing medium is thickened with 
pectin, the label shall bear the statement ``thickened with pectin''. 
When any organic salt or acid or any mixture of two or more of these is 
added, the label shall bear the common or usual name of each such 
ingredient.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993]



Sec. 145.130  Canned figs.

    (a) Ingredients. Canned figs is the food prepared from one of the 
optional fig ingredients specified in paragraph (b) of this section and 
one of the optional packing media specified in paragraph (c) of this 
section, to which lemon juice, concentrated lemon juice or organic 
acid(s) is added, when necessary to reduce the pH of the finished 
product to pH 4.9 or below. Such food may also contain one, or any 
combination of two or more of the following safe and suitable optional 
ingredients:
    (1) Natural and artificial flavoring.
    (2) Spice.
    (3) Vinegar.
    (4) Unpeeled segments of citrus fruits.
    (5) Salt.


Such food is sealed in a container and before or after sealing is so 
processed by heat as to prevent spoilage.
    (b) Varietal types. The optional fig ingredients referred to in 
paragraph (a) of this section are prepared from mature figs of the light 
or dark varieties. Figs (or whole figs), split figs (or broken figs), or 
any combination thereof are optional fig ingredients. A ``whole fig'' is 
one which is whole, but may be slightly cracked, provided it retains its 
natural conformation without exposing the interior. A ``split'' or 
``broken'' fig is one that is open to such an extent that the seed 
cavity is exposed. The shape of the fruit may be distorted, and the 
fruit may or may not be broken apart into entirely separate pieces.
    (c) Packing media. (1) The optional packing media referred to in 
paragraph (a) of this section, as defined in Sec. 145.3 are:
    (i) Water.
    (ii) Fruit juice(s) and water.
    (iii) Fruit juice(s).


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.3.
    (2) When a sweetener is added as a part of any such liquid packing 
medium, the density range of the resulting packing medium expressed as 
percent by weight of sucrose (degrees Brix) as determined by the 
procedure prescribed in Sec. 145.3(m) shall be designated by the 
appropriate name for the respective density ranges, namely:
    (i) When the density of the solution is 11 percent or more but less 
than 16

[[Page 595]]

percent, the medium shall be designated as ``slightly sweetened water''; 
or ``extra light syrup''; ``slightly sweetened fruit juice(s) and 
water''; or ``slightly sweetened fruit juice(s)'', as the case may be.
    (ii) When the density of the solution is 16 percent or more but less 
than 21 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'', as the case may be.
    (iii) When the density of the solution is 21 percent or more but 
less than 26 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (iv) When the density of the solution is 26 percent or more but not 
more than 35 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened fruit juice(s) and water''; or 
``extra heavily sweetened fruit juice(s)'', as the case may be.
    (d) Labeling requirements. (1) The name of the food is ``figs''. The 
words ``broken'' or ``split'' shall be a part of the name when the 
optional fig ingredient is a broken or split fig. The name of the food 
shall also include a declaration of any flavoring that characterizes the 
product as specified in Sec. 101.22 of this chapter and a declaration 
of any spice or seasoning that characterizes the product; for example, 
``Spice added'', or in lieu of the word ``Spice'', the common name of 
the spice, ``Seasoned with vinegar'' or ``Seasoned with unpeeled 
segments of citrus fruits''. When two or more of the optional 
ingredients specified in paragraphs (a) (2) through (5), inclusive, of 
this section are used, such words may be combined as for example, 
``Seasoned with cider vinegar, cloves, cinnamon oil and unpeeled 
segments of citrus fruits.''
    (2) The name of the packing medium as used in paragraph (c)(1) of 
this section, preceded by ``In'' or ``Packed in'', as provided in 
paragraph (c) of this section, shall be included as part of the name or 
in close proximity to the name of the food. When the packing medium is 
prepared with a sweetener(s) which imparts a taste, flavor or other 
characteristic to the finished food other than sweetness, as for 
example, a mixture of brown sugar and honey, the statement ``___ sirup 
of brown sugar and honey'' the blank to be filled in with the word 
``light'', ``heavy'', or ``extra heavy'', as the case may be, shall be 
included as part of the name or in close proximity to the name of the 
food. When the liquid portion of the packing media provided for in 
paragraphs (c) (1) and (2) of this section consists of fruit juice(s), 
such juice(s) shall be designated in the name of the packing medium as:
    (i) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit'';
    (ii) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (d)(3) of this 
section; and
    (iii) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juice(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (d)(3) of this section.
    (3) Whenever the names of the fruit juices used do not appear in the 
name of the packing medium as provided in paragraph (d)(2)(ii) of this 
section, such names and the words ``from contrate'', as specified in 
paragraph (d)(2)(iii) of this section, shall appear in an ingredient 
statement pursuant to the requirements of Sec. 101.3(d) of this 
chapter.
    (4) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993]



Sec. 145.131  Artificially sweetened canned figs.

    (a) Artificially sweetened canned figs is the food which conforms to 
the definition and standard of identity prescribed for canned figs by 
Sec. 145.130, except that in lieu of a packing medium

[[Page 596]]

specified in Sec. 145.130(c), the packing medium used is water 
artificially sweetened with saccharin, sodium saccharin, or a 
combination of both. Such packing medium may be thickened with pectin 
and may contain any mixture of any edible organic salt or salts and any 
edible organic acid or acids as a flavor-enhancing agent, in a quantity 
not more than is reasonably required for that purpose.
    (b)(1) The specified name of the food is ``artificially sweetened 
___'', the blank being filled in with the name prescribed by Sec. 
145.130 for canned figs having the same optional fig ingredient.
    (2) The artificially sweetened food is subject to the requirements 
for label statement of ingredients used, as prescribed for canned figs 
by Sec. 145.130. If the packing medium is thickened with pectin, the 
label shall bear the statement ``thickened with pectin''. When any 
organic salt or acid or any mixture of two or more of these is added, 
the label shall bear the common or usual name of each such ingredient.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993]



Sec. 145.134  Canned preserved figs.

    (a) Canned preserved figs is the food prepared from one of the 
optional fig ingredients specified in paragraph (b) of this section and 
the packing medium specified in paragraph (c) of this section, to which 
citric acid or lemon juice or concentrated lemon juice is added, if 
necessary, in such quantity as to reduce the pH of the finished product 
to 4.9 or below. The figs are precooked in the packing medium, sealed in 
a container, and so processed by heat, either before or after sealing, 
as to prevent spoilage.
    (b) The optional fig ingredients referred to in paragraph (a) of 
this section are whole mature figs of the light or dark varieties that 
may be either peeled or unpeeled.
    (c)(1) The packing medium referred to in paragraph (a) of this 
section is prepared from water and one of the following optional 
sweetening ingredients:
    (i) Sugar.
    (ii) Invert sugar sirup.
    (iii) Any mixture of optional sweetening ingredients designated in 
paragraphs (c)(1) (i) and (ii) of this section.
    (iv) Any of the optional sweetening ingredients designated in 
paragraphs (c)(1) (i), (ii), and (iii) of this section with dextrose: 
Provided, That the weight of the solids of dextrose does not exceed one-
third of the total weight of the solids of the combined sweetening 
ingredients.
    (v) Any of the optional sweetening ingredients designated in 
paragraphs (c)(1) (i), (ii), and (iii) of this section with corn sirup 
or with dried corn sirup or with glucose sirup or with dried glucose 
sirup, or with any two or more of these: Provided, That the weight of 
the solids of corn sirup, dried corn sirup, glucose sirup, dried glucose 
sirup or the sum of the weights of the solids of corn sirup, dried corn 
sirup, glucose sirup, and dried glucose sirup, in case two or more of 
these are used, does not exceed one-fourth of the total weight of the 
solids of the combined sweetening ingredients.
    (vi) Any mixture of the optional ingredients designated in 
paragraphs (c)(1) (iv) and (v) of this section.
    (2) The density of the packing medium described in paragraph (c)(1) 
of this section, as measured on the Brix hydrometer 15 days or more 
after the figs are canned, is not less than 50[deg] and not more than 
55[deg].
    (d)(1) The name of the food is ``Preserved Figs--Precooked in 
Sirup''. For the purpose of label declaration, the words ``Precooked in 
Sirup'' may appear immediately below the words ``Preserved Figs'', but 
there shall be no intervening written, printed, or graphic matter, and 
the letters used for the words ``Precooked in Sirup'' shall be of the 
same type style and not less than one-half the height of the letters in 
the words ``Preserved Figs''.
    (2) The label shall indicate which optional fig ingredient specified 
in paragraph (b) of this section is used.
    (e) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the words herein specified, showing the optional fig 
ingredient used, shall immediately and conspicuously precede or follow 
such name without intervening written,

[[Page 597]]

printed, or graphic matter, except that the varietal name of the figs 
may so intervene.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993]



Sec. 145.135  Canned fruit cocktail.

    (a) Identity--(1) Ingredients. Canned fruit cocktail, canned 
cocktail fruits, canned fruits for cocktail, is the food prepared from 
the mixture of fresh, frozen, or previously canned fruit ingredients of 
mature fruits in the forms and proportions as provided in paragraph 
(a)(2) of this section, and one of the optional packing media specified 
in paragraph (a)(3) of this section. Such food may also contain one, or 
any combination of two or more, of the following safe and suitable 
optional ingredients:
    (i) Natural and artificial flavors.
    (ii) Spice.
    (iii) Vinegar, lemon juice, or organic acids.
    (iv) Ascorbic acid in an amount no greater than necessary to 
preserve color. Such food is sealed in a container and before or after 
sealing is so processed by heat as to prevent spoilage.
    (2) Varietal types and styles. The fruit ingredients referred to in 
paragraph (a)(1) of this section, the forms of each, and the percent by 
weight of each in the mixture of drained fruit from the finished canned 
fruit cocktail are as follows:
    (i) Peaches. Any firm yellow variety of the species Prunus persica 
L., excluding nectarine varieties, which are pitted, peeled, and diced, 
not less than 30 percent and not more than 50 percent.
    (ii) Pears. Any variety, of the species Pyrus communis L. or Pyrus 
sinensis L., which are peeled, cored, and diced, not less than 25 
percent and not more than 45 percent.
    (iii) Pineapples. Any variety, of the species Ananas comosus L., 
which are peeled, cored, and cut into sectors or into dice, not less 
than 6 percent and not more than 16 percent.
    (iv) Grapes. Any seedless variety, of the species Vitis vinifera L., 
or Vitis labrusca L., not less than 6 percent and not more than 20 
percent.
    (v) Cherries. Approximate halves or whole pitted cherries of the 
species Prunus cerasus L., not less than 2 percent and not more than 6 
percent, of the following types:
    (a) Cherries of any light, sweet variety;
    (b) Cherries artificially colored red; or
    (c) Cherries artificially colored red and flavored, natural or 
artificial.


Provided, That each 127.5 grams (4\1/2\ ounces avoirdupois) of the 
finished canned fruit cocktail and each fraction thereof greater than 
56.7 grams (2 ounces avoirdupois) contain not less than 2 sectors or 3 
dice of pineapple and not less than 1 approximate half of the optional 
cherry ingredient.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section, as defined in Sec. 145.3 are:
    (a) Water.
    (b) Fruit juice(s) and water.
    (c) Fruit juice(s).


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.3.
    (ii) When a sweetener is added as a part of any such liquid packing 
medium, the density range of the resulting packing medium expressed as 
percent by weight of sucrose (degrees Brix) as determined by the 
procedure prescribed in Sec. 145.3(m) shall be designated by the 
appropriate name for the respective density ranges, namely:
    (a) When the density of the solution is 10 percent or more, but less 
than 14 percent, the medium shall be designated as ``slightly sweetened 
water''; or ``extra light sirup''; ``slightly sweetened fruit juice(s) 
and water''; or ``slightly sweetened fruit juice(s)'', as the case may 
be.

[[Page 598]]

    (b) When the density of the solution is 14 percent or more but less 
than 18 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'', as the case may be.
    (c) When the density of the solution is 18 percent or more but less 
than 22 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (d) When the density of the solution is 22 percent or more but not 
more than 35 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened fruit juice(s) and water''; or 
``extra heavily sweetened fruit juice(s)'', as the case may be.
    (4) Labeling requirements. (i) The name of the food is ``fruit 
cocktail'', ``cocktail fruits'', or ``fruits for cocktail''. The name of 
the food shall also include a declaration of any flavoring that 
characterizes the product as specified in Sec. 101.22 of this chapter 
and a declaration of any spice or seasoning that characterizes the 
product; for example, ``Spice added'', or in lieu of the word ``Spice'', 
the common name of the spice, ``Seasoned with vinegar'' or ``Seasoned 
with lemon juice''. When two or more of the optional ingredients 
specified in paragraphs (a)(1) (ii) and (iii) of this section are used, 
such words may be combined as for example, ``Seasoned with cider 
vinegar, cloves, cinnamon oil and lemon juice''.
    (ii) The name of the packing medium as used in paragraphs (a)(3) (i) 
and (ii) of this section, preceded by ``In'' or ``Packed in'' shall be 
included as part of the name or in close proximity to the name of the 
food. When the packing medium is prepared with a sweetener(s) which 
imparts a taste, flavor or other characteristic to the finished food in 
addition to sweetness, the name of the packing medium shall be 
accompanied by the name of such sweetener(s), as for example, in the 
case of a mixture of brown sugar and honey, an appropriate statement 
would be ``___ sirup of brown sugar and honey'' the blank to be filled 
in with the word ``light'', ``heavy'', or ``extra heavy'' as the case 
may be. When the liquid portion of the packing media provided for in 
paragraphs (a)(3) (i) and (ii) of this section consists of fruit 
juice(s), such juice(s) shall be designated in the packing medium as:
    (a) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit'';
    (b) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (a)(4)(iii) of 
this section; and
    (c) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juice(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (a)(4)(iii) of this section.
    (iii) Whenever the names of the fruit juices used do not appear in 
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of 
this section, such names and the words ``from concentrate'', as 
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an 
ingredient statement pursuant to the requirements of Sec. 101.3(d) of 
this chapter.
    (iv) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned fruit cocktail 
is as follows:
    (i) Not more than 20 percent by weight of the units in the container 
of peach or pear, or of pineapple if the units thereof are diced, are 
more than \3/4\ inch in greatest edge dimension, or pass through the 
meshes of a sieve designated as \5/16\ inch that complies with the 
specifications for such cloth set forth in the ``Official Methods of 
Analysis of the Association of Official Analytical Chemists,'' 13th Ed. 
(1980), Table 1, ``Nominal Dimensions of Standard Test Sieves (U.S.A. 
Standard Series),'' under the heading ``Definitions of Terms and 
Explanatory

[[Page 599]]

Notes,'' which is incorporated by reference. Copies may be obtained from 
the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877, or may be examined 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 units of pineapple are in the form of 
sectors, not more than 20 percent of such sectors in the container fail 
to conform to the following dimensions: The length of the outside arc is 
not more than \3/4\ inch but is more than \3/8\ inch; the thickness is 
not more than \1/2\ inch but is more than \5/16\ inch; the length 
(measured along the radius from the inside arc to the outside arc) is 
not more than 1\1/4\ inches but is more than \3/4\ inch.
    (ii) Not more than 10 percent of the grapes in a container 
containing 10 grapes or more, and not more than 1 grape in a container 
containing less than 10 grapes, are cracked to the extent of being 
severed into two parts or are crushed to the extent that their normal 
shape is destroyed.
    (iii) Not more than 10 percent of the grapes in a container 
containing 10 grapes or more, and not more than a grape in a container 
containing less than 10 grapes, have the cap stem attached.
    (iv) There is present in the finished canned fruit cocktail not more 
than 1 square inch of pear peel per each 1 pound of drained weight of 
units of pear plus the weight of a proportion of the packing medium 
which is the same proportion as the drained weight of the units of pear 
bears to the drained weight of the entire contents of the can. Such 
drained weights shall be determined by the method prescribed in 
paragraph (c) of this section.
    (v) There is present in the finished canned fruit cocktail not more 
than 1 square inch of peach peel per each 1 pound of drained weight of 
units of peach plus the weight of a proportion of the packing medium 
which is the same proportion as the drained weight of units of peach 
bears to the drained weight of the entire contents of the can. Such 
drained weights shall be determined by the method prescribed in 
paragraph (c) of this section.
    (vi) Not more than 15 percent of the units of cherry ingredient, and 
not more than 20 percent of the units of peach, pear, or grape, in the 
container are blemished with scab, hail injury, scar tissue or other 
abnormality.
    (vii) If the cherry ingredient is artificially colored, the color of 
not more than 15 percent of the units thereof in a container containing 
more than six units and of not more than one unit in a container 
containing six units or less, is other than evenly distributed in the 
unit or other than uniform with the color of the other units of the 
cherry ingredient.
    (2) If the quality of canned fruit cocktail falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified.
    (c) Fill of container. (1) The standard of fill of container for 
canned fruit cocktail is a fill such that the total weight of drained 
fruit is not less than 65 percent of the water capacity of the 
container, as determined by the general method for water capacity of 
containers prescribed in Sec. 130.12(a) of this chapter. Such total 
weight of drained fruit is determined by the following method: Tilt the 
opened container so as to distribute the contents evenly over the meshes 
of a circular sieve which has been previously weighed. The diameter of 
the sieve is 8 inches if the quantity of contents of the container is 
less than 3 pounds, and 12 inches if such quantity is 3 pounds or more. 
The bottom of the sieve is woven-wire cloth that complies with the 
specifications for such cloth set forth under ``2.38 mm (No. 8)'' in 
Table 1, ``Nominal Dimensions of Standard Test Sieves (U.S.A. Standard 
Series),'' prescribed in paragraph (b)(1)(i) of this section, which is 
incorporated by reference. The availability of this incorporation by 
reference is given in paragraph (b)(1)(i) of this section. Without 
shifting the material on the sieve so incline the sieve as to facilitate 
drainage. Two minutes from the time drainage begins, weigh the sieve and 
drained fruit. The weight so found, less the

[[Page 600]]

weight of the sieve, shall be considered to be the total weight of 
drained fruit.
    (2) If canned fruit cocktail falls below the standard of fill of 
container prescribed in paragraph (c)(1) of this section, the label 
shall bear the general statement of substandard fill specified in Sec. 
130.14(b) of this chapter, in the manner and form therein prescribed.

[42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 
49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2880, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 145.136  Artificially sweetened canned fruit cocktail.

    (a) Artificially sweetened canned fruit cocktail is the food which 
conforms to the definition and standard of identity prescribed for 
canned fruit cocktail by Sec. 145.135(a), except that in lieu of a 
packing medium specified in Sec. 145.135(a)(3), the packing medium used 
is water artificially sweetened with saccharin, sodium saccharin, or a 
combination of both. Such packing medium may be thickened with pectin 
and may contain any mixture of any edible organic salt or salts and any 
edible organic acid or acids as a flavor-enhancing agent, in a quantity 
not more than is reasonably required for that purpose.
    (b)(1) The specified name of the food is ``artificially sweetened 
fruit cocktail''.
    (2) The artificially sweetened food is subject to the requirements 
for label statement of ingredients used, as prescribed for canned fruit 
cocktail by Sec. 145.135(a). If the packing medium is thickened with 
pectin, the label shall bear the statement ``thickened with pectin''. 
When any organic salt or acid or any mixture of two or more of these is 
added, the label shall bear the common or usual name of each such 
ingredient.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993]



Sec. 145.140  Canned seedless grapes.

    (a) Ingredients. Canned seedless grapes is the food prepared from 
one of the fresh or previously canned optional grape ingredients 
specified in paragraph (b) of this section which may be packed in one of 
the optional packing media specified in paragraph (c) of this section. 
Such food may also contain one, or any combination of two or more, of 
the following safe and suitable optional ingredients:
    (1) Natural and artificial flavors.
    (2) Spice.
    (3) Vinegar, lemon juice, or organic acids.


Such food is sealed in a container and before or after sealing is so 
processed by heat as to prevent spoilage.
    (b) Varietal types and styles. The optional grape ingredients 
referred to in paragraph (a) of this section are prepared from stemmed 
grapes of the light or dark seedless varieties or from unstemmed 
clusters of such grapes. For the purposes of paragraph (d) of this 
section, the names of such optional grape ingredients are ``light 
seedless grapes'' or ``dark seedless grapes'', as the case may be, 
preceded by the words ``unstemmed clusters'' where applicable.
    (c) Packing media. (1) The optional packing media referred to in 
paragraph (a) of this section, as defined in Sec. 145.3 are:
    (i) Water.
    (ii) Fruit juice(s) and water.
    (iii) Fruit juice(s).


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.3.
    (2) When a sweetener is added as a part of any such liquid packing 
medium, the density range of the resulting packing medium expressed as 
percent by weight of sucrose (degrees Brix) as determined by the 
procedure prescribed in Sec. 145.3(m) shall be designated by the 
appropriate name for the respective density ranges, namely:
    (i) When the density of the solution is less than 14 percent, the 
medium shall be designated as ``slightly sweetened water''; or ``extra 
light sirup''; ``slightly sweetened fruit juice(s) and water''; or 
``slightly sweetened fruit juice(s)'', as the case may be.

[[Page 601]]

    (ii) When the density of the solution is 14 percent or more but less 
than 18 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'', as the case may be.
    (iii) When the density of the solution is 18 percent or more but 
less than 22 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (iv) When the density of the solution is 22 percent or more but not 
more than 35 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened fruit juice(s) and water''; or 
``extra heavily sweetened fruit juice(s)'', as the case may be.
    (d) Labeling requirements. (1) The name of the food is ``seedless 
grapes.'' The name of the food shall also include a declaration of any 
flavoring that characterizes the product as specified in Sec. 101.22 of 
this chapter and a declaration of any spice or seasoning that 
characterizes the product; for example, ``Spice added'', or in lieu of 
the word ``Spice'', the common name of the spice, or ``Seasoned with 
lemon juice''. When two or more of the optional ingredients specified in 
paragraphs (a) (2) and (3) of this section are used, such words may be 
combined as for example, ``Seasoned with cider vinegar, cloves, and 
cinnamon oil''.
    (2) The color type and style of the grape ingredient as provided in 
paragraph (b) of this section and the name of the packing medium 
specified in paragraphs (c) (1) and (2) of this section, preceded by 
``In'' or ``Packed in'' or the words ``solid pack'', where applicable, 
shall be included as part of the name or in close proximity to the name 
of the food. When the packing medium is prepared with a sweetener(s) 
which imparts a taste, flavor or other characteristic to the finished 
food in addition to sweetness, the name of the packing medium shall be 
accompanied by the name of such sweetener(s), as for example in the case 
of a mixture of brown sugar and honey, an appropriate statement would be 
``___ sirup of brown sugar and honey'' the blank to be filled in with 
the word ``light'', ``heavy'', or ``extra heavy'' as the case may be. 
When the liquid portion of the packing media provided for in paragraphs 
(c) (1) and (2) of this section consists of fruit juice(s), such 
juice(s) shall be designated in the packing medium as:
    (i) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit'';
    (ii) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (d)(3) of this 
section; and
    (iii) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juice(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (d)(3) of this section.
    (3) Whenever the names of the fruit juices used do not appear in the 
name of the packing medium as provided in paragraph (d)(2)(ii) of this 
section, such names and the words ``from concentrate'', as specified in 
paragraph (d)(2)(iii) of this section, shall appear in an ingredient 
statement pursuant to the requirements of Sec. 101.3(d) of this 
chapter.
    (4) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993]



Sec. 145.145  Canned grapefruit.

    (a) Identity--(1) Product identification. Canned grapefruit is the 
food prepared from one of the optional grapefruit ingredients specified 
in paragraph (a)(2) of this section and one of the optional packing 
media specified in paragraph (a)(3) of this section. Such food may also 
contain one or more of the following safe and suitable optional 
ingredients:
    (i) Spices.
    (ii) Natural and artificial flavoring.
    (iii) Lemon juice.

[[Page 602]]

    (iv) Citric acid.
    (v) Calcium chloride or calcium lactate or a mixture of the two 
calcium salts in a quantity reasonably necessary to firm the grapefruit 
sections, but in no case in a quantity such that the calcium contained 
in such calcium salt or mixture is more than 0.035 percent by weight of 
the finished food.


Such food is sealed in a container and, before or after sealing, is so 
processed by heat as to prevent spoilage.
    (2) Optional grapefruit ingredient. The optional grapefruit 
ingredients referred to in paragraph (a)(1) of this section are prepared 
from sound, mature grapefruit (Citrus paradisi Macfadyen) of the color 
types white--produced from white-fleshed grapefruit, and pink--produced 
from pink or red-fleshed grapefruit and are in the following forms of 
units: Whole sections or broken sections. Each such form of units or a 
mixture of such forms of units prepared from a single varietal group 
(color type) is an optional grapefruit ingredient. The core, seeds, and 
major portions of membrane of such ingredient are removed. For the 
purpose of this section, a grapefruit section is considered whole when 
the unit is intact or an intact portion of such unit is not less than 75 
percent of its apparent original size and is not excessively trimmed.
    (i) For the purpose of paragraph (a)(4) of this section, the name of 
the optional grapefruit ingredient is:
    (a) ``Section'' or ``segments'', if 50 percent or more of the 
drained weight of the food consists of whole sections.
    (b) ``Broken sections'' or ``broken segments'', if less than 50 
percent of the drained weight of the food consists of whole sections.
    (ii) The drained weight is determined by the method prescribed in 
the standard of fill of container for canned grapefruit set forth in 
paragraph (c)(2) of this section.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section are:
    (a) Water.
    (b) Grapefruit juice and water.
    (c) Grapefruit juice.
    (d) Slightly sweetened sirup or slightly sweetened water.
    (e) Light sirup.
    (f) Heavy sirup.
    (g) Slightly sweetened grapefruit juice and water.
    (h) Lightly sweetened grapefruit juice and water.
    (i) Heavily sweetened grapefruit juice and water.
    (j) Slightly sweetened grapefruit juice.
    (k) Lightly sweetened grapefruit juice.
    (l) Heavily sweetened grapefruit juice.


As used in paragraph (a)(3)(i) of this section, the optional packing 
medium ``water'' means, in addition to water, any mixture of water and 
grapefruit juice in which there is less than 50 percent grapefruit 
juice; the optional packing medium ``grapefruit juice and water'' means 
the liquid packing medium in which juice of mature grapefruit and water 
are combined as a liquid packing medium with not less than 50 percent 
grapefruit juice and the term ``grapefruit juice'' means single strength 
expressed juice of sound, mature fruit. It may be fresh, canned, or made 
from concentrate. However, if it is made from concentrate, the juice 
shall be reconstituted with water to not less than the soluble solids 
the grapefruit juice had before concentration.
    (ii) Each of the packing media in paragraph (a)(3)(i) (d) to (l) of 
this section is prepared with a liquid ingredient and one or more safe 
and suitable nutritive carbohydrate sweeteners. Water is the liquid 
ingredient from which packing media in paragraph (a)(3)(i) (d) to (f) of 
this section are prepared. Grapefruit juice and water are the liquid 
ingredients from which the packing media in paragraph (a)(3)(i) (g) to 
(i) of this section are prepared. Grapefruit juice is the liquid 
ingredient from which the packing media in paragraph (a)(3)(i) (j) to 
(l) of this section are prepared. If one or more liquid nutritive 
carbohydrate sweeteners and grapefruit juice are combined as a liquid 
packing medium with not less than 50 percent grapefruit juice, the 
packing medium is as set forth in paragraph (a)(3)(i) (g) to (i) of this 
section.
    (iii) The respective densities of packing media in paragraph 
(a)(3)(i) (d) to (i) of this section as measured on the

[[Page 603]]

refractometer, expressed as percent by weight sucrose (degrees Brix) 
with correction for temperature to the equivalent at 20 [deg]C (68 
[deg]F), 15 days or more after the grapefruit are canned or the blended 
homogenized slurry of the comminuted entire contents of the container if 
canned for less than 15 days, according to the ``Official Methods of 
Analysis of the Association of Official Analytical Chemists'' (AOAC), 
13th Ed. (1980), section 31.011 under ``Solids By Means of 
Refractometer--Official Final Action,'' and Reference Tables, section 
52.012 (Refractive indices (n) of sucrose solutions at 20[deg]) and 
section 52.015 (Refractive indices of invert sugar solutions), which is 
incorporated by reference (copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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), but 
without correction for invert sugar or other substances, are as follows:
    (a) Packing media in paragraph (a)(3)(i) (d), (g), and (j) of this 
section: Twelve percent or more but less than 16 percent.
    (b) Packing media in paragraph (a)(3)(i) (e), (h), and (k) of this 
section: Sixteen percent or more but less than 18 percent.
    (c) Packing media in paragraph (a)(3)(i) (f), (i), and (l) of this 
section: Eighteen percent or more. A lot shall be deemed to be in 
compliance for packing medium density based on the average value for all 
the samples analyzed according to paragraph (b)(2) of this section but 
no container may have a value lower than that of the next lower category 
or 2 percent by weight sucrose (degrees Brix) lower if no lower category 
exists.
    (4) Labeling requirements. (i) The name of the food is 
``grapefruit'' or ``pink grapefruit'', as appropriate for the color type 
of the grapefruit used. The name of the food shall also include a 
declaration of any flavoring that characterizes the product as specified 
in Sec. 101.22 of this chapter and a declaration of any spice or 
seasoning that characterizes the product; for example, ``with added 
spice''. Whenever the word ``sirup'' is used, it may be alternatively 
spelled ``syrup''. When two or more of the optional ingredients 
specified in paragraphs (a)(1) (i), (ii), and (iii) of this section are 
used, such words may be combined; for example, ``with added cloves and 
cinnamon oil''.
    (ii) The form and style of the grapefruit ingredient as provided for 
in paragraph (a)(2) of this section and the name of the packing medium 
as used in paragraph (a)(3) of this section preceded by ``In'' or 
``Packed in'' shall be included as part of the name. When the packing 
medium is prepared from concentrated grapefruit juice, the words ``from 
concentrate'' shall follow the words ``grapefruit juice'' in the name of 
the packing medium.
    (iii) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned grapefruit is as 
follows:
    (i) The food is free from extraneous material such as leaves, 
portions of leaves, and pieces of peel.
    (ii) The finished food contains per 500 grams (17.6 ounces) not more 
than:
    (a) An aggregate area of 20 square centimeters (3.1 square inches) 
of tough membrane or albedo on the units.
    (b) Four developed seeds. A seed is considered a developed seed when 
it measures more than 9.0 millimeters (0.35 inches) in any dimension.
    (iii) Not more than 15 percent by weight of the drained grapefruit 
may be blemished units. A blemished unit is a grapefruit section or any 
portion thereof which is damaged by lye peeling, by discoloration, or by 
other visible injury. The drained weight is determined by the method 
prescribed in the standard of fill of container for canned grapefruit 
set forth in paragraph (c)(2) of this section.
    (2) Sampling and acceptance procedure. A lot is to be considered 
acceptable when the number of ``defectives'' does not exceed the 
acceptance number in the sampling plans given in paragraph (b)(2)(ii) of 
this section.

[[Page 604]]

    (i) Definitions of terms to be used in the sampling plans in 
paragraph (b)(2)(ii) of this section are as follows:
    (a) Lot. A collection of primary containers or units of the same 
size, type and style manufactured or packed under similar conditions and 
handled as a single unit of trade.
    (b) Lot size. The number of primary containers or units in the lot.
    (c) Sample size (n). The total number of sample units drawn for 
examination from a lot.
    (d) Sample unit. A container, the entire contents of a container, a 
portion of the contents of a container, or a composite mixture of 
product from small containers that is sufficient for the examination or 
testing as a single unit.
    (e) Defective. Any sample unit shall be regarded as defective when 
any of the defects or conditions specified in the quality standard 
(paragraph (b)(1) of this section) and paragraph (c)(3)(i) of this 
section for minimum fill of container are present in excess of the 
stated tolerances.
    (f) Accepted number (c). The maximum number of defective sample 
units permitted in the sample in order to consider the lot as meeting 
the specified requirements.
    (g) Acceptable quality level (AQL). The maximum percent of defective 
sample units permitted in a lot that will be accepted approximately 95 
percent of the time.
    (ii) Sampling plans and acceptance procedure:

------------------------------------------------------------------------
                                                      Size of container
           Lot size (primary containers)           ---------------------
                                                      n \1\      c \2\
------------------------------------------------------------------------
             net weight equal to or less than 1 kg (2.2 lb)
------------------------------------------------------------------------
4,800 or less.....................................         13          2
4,801-24,000......................................         21          3
24,001-48,000.....................................         29          4
48,001-84,000.....................................         48          6
84,001-144,000....................................         84          9
144,001-240,000...................................        126         13
Over 240,000......................................        200         19
------------------------------------------------------------------------
 net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
------------------------------------------------------------------------
2,400 or less.....................................         13          2
2,401-15,000......................................         21          3
15,001-24,000.....................................         29          4
24,001-42,000.....................................         48          6
42,001-72,000.....................................         84          9
72,001-120,000....................................        126         13
Over 120,000......................................        200         19
------------------------------------------------------------------------
                 net weight greater than 4.5 kg (10 lb)
------------------------------------------------------------------------
600 or less.......................................         13          2
601-2,000.........................................         21          3
2,001-7,200.......................................         29          4
7,201-15,000......................................         48          6
15,001-24,000.....................................         84          9
24,001-42,000.....................................        126         13
Over 42,000.......................................        200         19
------------------------------------------------------------------------
\1\ n = number of primary containers in sample
\2\ c = acceptance number

    (3) If the quality of canned grapefruit falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified; however, if the 
quality of the canned grapefruit falls below standard with respect to 
only one of the factors of quality specified by paragraph (b)(1) (i), 
(ii), or (iii) of this section, there may be substituted for the second 
line of such general statement of substandard quality, ``Good Food--Not 
High Grade'', a new line as specified after the corresponding 
designation of paragraph (b)(1) of this section which the canned 
grapefruit fail to meet:
    (i) ``Contains extraneous material''.
    (ii)(a) ``Excessive tough membrane''.
    (b) ``Excessive seeds''.
    (iii) ``Excessive blemished units''.
    (c) Fill of container. (1) The standard of fill of container for 
canned grapefruit is:
    (i) The fill of grapefruit and packing medium, as determined by the 
general method for fill of container prescribed in Sec. 130.12(b) of 
this chapter, is not less than 90 percent of the total capacity of the 
container.
    (ii) The drained weight of grapefruit ingredient is not less than 50 
percent of the water capacity of the container, as determined by the 
method prescribed in paragraph (c)(2) of this section and the general 
method for water capacity of containers prescribed in Sec. 130.12(a) of 
this chapter.
    (2) Drained weight is determined by the following method: Tilt the 
opened container so as to distribute the contents evenly over the meshes 
of a circular sieve which has previously been weighed. The diameter of 
the sieve is

[[Page 605]]

20.3 centimeters (8 inches) if the quantity of contents of the container 
is less than 1.4 kilograms (3 pounds) and 30.5 centimeters (12 inches) 
if such quantity is 1.4 kilograms (3 pounds) or more. The bottom of the 
sieve is woven-wire cloth that complies with the specifications for the 
No. 8 sieve set forth in the ``Definitions of Terms and Explanatory 
Notes'' of the AOAC, 13th Ed. (1980), Table 1, which is incorporated by 
reference. The availability of this incorporation by reference is given 
in paragraph (a)(3)(iii) of this section. Without shifting the material 
on the sieve, incline the sieve at an angle of 17[deg] to 20[deg] to 
facilitate drainage. Two minutes after the drainage begins, weigh the 
sieve and drained grapefruit. The weight so found, less the weight of 
the sieve, shall be considered to be the weight of the drained 
grapefruit.
    (3)(i) A container that falls below the requirement for minimum fill 
prescribed in paragraph (c)(1)(i) of this section shall be considered a 
``defective''. The food will be deemed to fall below the standard of 
fill when the number of defectives exceeds the acceptance number (c) in 
the sampling plans prescribed in paragraph (b)(2) of this section.
    (ii) Canned grapefruit will be deemed to fall below the standard of 
fill when the average drained weight of all containers analyzed when 
sampled according to the sampling plans prescribed in paragraph (b)(2) 
of this section is less than that prescribed in paragraph (c)(1)(ii) of 
this section.
    (4) If canned grapefruit falls below the standard of fill of 
container prescribed in paragraph (c)(1) of this section, the label 
shall bear the statement of substandard fill specified in Sec. 
130.14(b) of this chapter, in the manner and form therein specified.

[42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11830, Mar. 19, 1982; 
49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2880, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 145.170  Canned peaches.

    (a) Identity--(1) Ingredients. Canned peaches is the food prepared 
from one of the fresh, frozen, or previously canned optional peach 
ingredients Prunus persica L., of commercial canning varieties, but 
excluding nectarine varieties, specified in paragraph (a)(2) of this 
section, which may be packed as a solid pack or in one of the optional 
packing media specified in paragraph (a)(3) of this section. Such food 
may also contain one, or any combination of two or more, of the 
following safe and suitable optional ingredients:
    (i) Natural and artificial flavors.
    (ii) Spice.
    (iii) Vinegar, lemon juice, or organic acids.
    (iv) Peach pits, except in the cases of peeled whole peaches, in a 
quantity not more than 1 peach pit to each 227 grams (8 ounces) of 
finished canned peaches.
    (v) Peach kernels, except in the cases of peeled whole peaches and 
except when the optional ingredient in paragraph (a)(1)(iv) of this 
section is used.
    (vi) Ascorbic acid in an amount no greater than necessary to 
preserve color. Such food is sealed in a container and before or after 
sealing is so processed by heat as to prevent spoilage.
    (2) Varietal types and styles. The optional peach ingredients 
referred to in paragraph (a)(1) of this section are prepared from mature 
peaches of the following optional varietal and color types and styles of 
peach ingredients; namely:
    (i) The optional varietal types. (a) Freestone is the distinct 
varietal type where the pit separates readily from the flesh.
    (b) Clingstone is the distinct varietal type where the pit adheres 
to the flesh.
    (ii) The optional color types--(a) Yellow--the varietal types in 
which the predominant color ranges from pale yellow to rich red orange.
    (b) White--the varietal types in which the predominant color ranges 
from white to yellow-white.
    (c) Red--the varietal types in which the predominant color ranges 
from pale yellow to orange red and with variegated red coloring other 
than that associated with the pit cavity.
    (d) Green--varietal types in which the flesh has a green tint even 
when mature.
    (iii) The optional styles of the peach ingredients--(a) Whole--
consisting of whole peeled unpitted peaches.

[[Page 606]]

    (b) Halves--consisting of peeled pitted peaches cut into two 
approximately equal parts.
    (c) Halves and pieces--consisting of a mixture in which the peeled 
pitted peach halves are more than 50 percent by weight.
    (d) Quarters--consisting of peeled pitted peaches cut into four 
approximately equal parts.
    (e) Slices--consisting of peeled pitted peaches cut into wedge-
shaped sectors.
    (f) Dice--consisting of peeled pitted peaches cut into cube-like 
parts.
    (g) Chunky--consisting of peeled pitted peaches cut into parts 13 
millimeters (0.5 inch) or greater in the smallest dimension and 44 
millimeters (1.75 inches) or less in the largest dimension.
    (h) Pieces or irregular pieces--consisting of peeled pitted peaches 
cut into parts of irregular shapes and sizes.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section, as defined in Sec. 145.3 are:
    (a) Water.
    (b) Fruit juice(s) and water.
    (c) Fruit juice(s).


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.3.
    (ii) When a sweetener is added as a part of any such liquid packing 
medium, the density range of the resulting packing medium, expressed as 
percent by weight of sucrose (degrees Brix) as determined by the 
procedure prescribed in Sec. 145.3(m), shall be designated by the 
appropriate name for the respective density ranges, namely:
    (a) When the density of the solution is 10 percent or more but less 
than 14 percent, the medium shall be designated as ``slightly sweetened 
water''; or ``extra light sirup''; ``slightly sweetened fruit juice(s) 
and water''; or ``slightly sweetened fruit juice(s)'', as the case may 
be.
    (b) When the density of the solution is 14 percent or more but less 
than 18 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'', as the case may be.
    (c) When the density of the solution is 18 percent or more but less 
than 22 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (d) When the density of the solution is 22 percent or more but not 
more than 35 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened fruit juice(s) and water''; or 
``extra heavily sweetened fruit juice(s)'' as the case may be.
    (4) Labeling requirements. (i) The name of the food is ``peaches''. 
The optional varietal type as set forth in paragraph (a)(2)(i) of this 
section shall be a part of the name. The name of the food shall also 
include a declaration of any flavoring that characterizes the product as 
specified in Sec. 101.22 of this chapter and a declaration of any spice 
or seasoning that characterizes the product; for example, ``Spice 
added'', or in lieu of the word ``Spice'', the common name of the spice, 
``Seasoned with vinegar'' or ``Seasoned with peach kernels''. When two 
or more of the optional ingredients specified in paragraphs (a)(1) (ii) 
through (v) of this section are used, such words may be combined as for 
example, ``Seasoned with cider vinegar, cloves, cinnamon oil and peach 
kernels''.
    (ii) The color type and style of the peach ingredient as provided 
for in paragraphs (a)(2) (ii) and (iii) of this section and the name of 
the packing medium specified in paragraphs (a)(3) (i) and (ii) of this 
section, preceded by ``In'' or ``Packed in'' or the words ``Solid 
pack'', where applicable, shall be included as part of the name or in 
close proximity to the name of the food, except that ``Halves'' may be 
alternately designated as ``Halved'', ``Halves and pieces'' as ``Halved 
and pieces'', ``Quarters'' as ``Quartered'', ``Slices'' as ``Sliced'', 
and ``Dice'' as ``Diced''. Pieces or irregular pieces

[[Page 607]]

shall be designated ``Pieces'', ``Irregular pieces'', or ``Mixed pieces 
of irregular sizes and shapes''. ``Chunky'' may be designated as 
``Chunks''. The terms ``Cling'' and ``Free'' may be used as optional 
designations for ``Clingstone'' and ``Freestone'', respectively. When 
the packing medium is prepared with a sweetener(s) which imparts a 
taste, flavor, or other characteristic to the finished food in addition 
to sweetness, the name of the packing medium shall be accompanied by the 
name of such sweetener(s); as for example in the case of a mixture of 
brown sugar and honey, an appropriate statement would be ``___ sirup of 
brown sugar and honey'' the blank to be filled in with the word 
``light'', ``heavy'', or ``extra heavy'' as the case may be. When the 
liquid portion of the packing media provided for in paragraphs (a)(3) 
(i) and (ii) of this section consists of fruit juices(s), such juice(s) 
shall be designated in the name of the packing medium as:
    (a) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit'';
    (b) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (a)(4)(iii) of 
this section; and
    (c) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juices(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (a)(4)(iii) of this section.
    (iii) Whenever the names of the fruit juices used do not appear in 
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of 
this section, such names and the words ``from concentrate'', as 
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an 
ingredient statement pursuant to the requirements of Sec. 101.3(d) of 
this chapter.
    (iv) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned peaches is as 
follows:
    (i) Maturity. All units tested in accordance with the method 
prescribed in paragraph (b)(2) of this section are pierced by weight of 
not more than 300 grams (10.6 ounces).
    (ii) Minimum size. In the case of halves and quarters styles, the 
weight of each unit is not less than 17 grams (0.6 ounce) and 8.5 grams 
(0.3 ounce), respectively.
    (iii) Uniformity of size--(a) Whole, halves, and quarters. In the 
case of whole, halves, and quarters styles, the diameter (width) of the 
largest unit is not more than 1.5 centimeters (0.6 inch) greater than 
the diameter (width) of the smallest unit. In containers with more than 
20 units, 2 units may be disregarded in making the determination. Where 
a unit has broken in the container, the combined broken pieces are to be 
reassembled to approximate a single unit of the appropriate style.
    (b) Chunky. In the case of chunky style, not more than 25 percent of 
the drained weight of the contents of the container consists of units 
that will pass through an opening 13 millimeters (0.5 inch) wide or that 
are more than 44 millimeters (1.75 inches) along the longest cut edge.
    (iv) Peel. Not more than 15 square centimeters aggregate area of 
peel per 1,000 grams (1.05 square inches per 16 ounces) of net weight. 
Include any peel adhering to the peach or loose in the container.
    (v) Blemished units. Not more than 20 percent by count of the units 
in the container are blemished, e.g., with scab, hail injury, 
discoloration, or other abnormalities. Blemished units are units which 
contain surface discolorations that definitely contrast with the overall 
color and may penetrate into the flesh.
    (vi) Trimmed units. In the case of whole, halves, quarters, and 
slices styles, all units are untrimmed or are so trimmed as to preserve 
normal shape of the units.
    (vii) Crushed or broken units. In the case of whole, halves, halves 
and pieces, quarters, slices, dice and chunky styles, not more than 5 
percent

[[Page 608]]

by count of the units in containers of 20 or more units and not more 
than 1 unit in containers of fewer than 20 units are crushed or broken. 
A unit that has lost its normal shape because of ripeness and bears no 
mark of crushing shall not be considered crushed or broken.
    (viii) Pits and pieces of pit. In the case of all styles, except 
whole peaches and when whole peach pits or peach kernels are used as 
seasoning ingredients, there is not more than one loose pit or one loose 
large hard piece of pit (10 millimeters (\3/8\ inch) or larger) or one 
unit of peach (e.g., peach half or peach slice) to which one or more 
large hard pieces of pit are attached per 5.67 kilograms (200 ounces) 
net weight. In addition, there is not more than three of any one or any 
combination of two or more, per 2.83 kilograms (100 ounces) net weight 
of the following: (a) A unit to which one or more small hard pieces of 
pit less than 10 millimeters (\3/8\ inch) but not less than 1.6 
millimeters (\1/16\ inch) are attached, (b) a unit to which three or 
more small pieces of pit less than 1.6 millimeters (\1/16\ inch) are 
attached, or (c) a loose small hard piece of pit less than 10 
millimeters (\3/8\ inch).
    (2) Canned peaches shall be tested by the following method to 
determine whether or not they meet the requirements of paragraph 
(b)(1)(i) of this section: So trim a test piece from the unit as to fit, 
with peel surface up, into a supporting receptacle. If the unit is of 
different firmness in different parts of its peel surface, trim the 
piece from the firmest part. If the piece is unpeeled, remove the peel. 
The top of the receptacle is circular in shape, of 29 millimeters (1.125 
inches) inside diameter, with vertical sides; or rectangular in shape, 
19 millimeters (0.75 inch) by 25 millimeters (1 inch) inside 
measurements, with ends vertical and sides sloping downward and joining 
at the center at a vertical depth of 19 millimeters (0.75 inch). Use the 
circular receptacle for testing units of such size that a test piece can 
be trimmed therefrom to fit it. Use the rectangular receptacle for 
testing other units. Test no unit from which a test piece with a 
rectangular peel surface at least 13 millimeters (0.51 inch) by 25 
millimeters (1 inch) cannot be trimmed. Test the piece by means of a 
round metal rod 4 millimeters (0.16 inch) in diameter. To the upper end 
of the rod is affixed a device to which weight can be added. The rod is 
held vertically by a support through which it can freely move upward or 
downward. The lower end of the rod is a plane surface to which the 
vertical axis of the rod is perpendicular. Adjust the combined weight of 
the rod and device to 100 grams (3.53 ounces). Set the receptacle so 
that the surface of test piece is held horizontally. Lower the end of 
the rod to the approximate center of such surface, and add weight to the 
device at a uniform, continuous rate of 12 grams (0.45 ounce) per second 
until the rod pierces the test piece. Weigh the rod and weighted device. 
Test all units in containers of 50 units or less, except those units too 
small for testing or too soft for trimming. Test at least 50 units, 
taken at random, in containers of more than 50 units; but if less than 
50 units are of sufficient size and firmness for testing, test those 
which are of sufficient size and firmness.
    (3) Determine compliance as specified in Sec. 145.3(o) except that 
a lot shall be deemed to be in compliance for peel, pits, and pieces of 
pit based on the average of all samples analyzed according to the 
sampling plans set out in Sec. 145.3(p).
    (4) If the quality of canned peaches falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality defined in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified; however, if the 
quality of the canned peaches falls below standard with respect to only 
one of the factors of quality specified in paragraph (b)(1) (i) through 
(viii) of this section, there may be substituted for the second line of 
such general statement of substandard quality (``Good Food--Not High 
Grade'') a new line, as specified after the corresponding designation of 
paragraph (b)(1) of this section which the canned peaches fail to meet, 
as follows: (i) ``Not tender''; (ii) ``Small halves'' or ``Small 
quarters'' as the case may be; (iii) (a) ``Mixed sizes''; (b) 
``Undersized and/or oversized pieces'', (iv) ``Excess peel''; (v) 
``Blemished'';

[[Page 609]]

(vi) ``Unevenly trimmed''; (vii) ``Partly crushed or broken''; (viii) 
``Contains pits or pit fragments''. Such alternative statement shall 
immediately and conspicuously precede or follow, without intervening 
written, printed, or graphic matter, the name ``peaches'' and any words 
and statements required or authorized to appear with such name by 
paragraph (a)(2) of this section.
    (c) Fill of container. (1) The standard of fill of container for 
canned peaches is the maximum quantity of the optional peach ingredient 
that can be sealed in the container and processed by heat to prevent 
spoilage, without crushing or breaking such ingredient.
    (2) If canned peaches fall below the standard of fill of container 
prescribed in paragraph (c)(1) of this section, the label shall bear the 
general statement of substandard fill specified in Sec. 130.14(b) of 
this chapter, in the manner and form therein specified.

[42 FR 14414, Mar. 15, 1977, as amended at 46 FR 33028, June 26, 1981; 
50 FR 34677, Aug. 27, 1985; 51 FR 11434, Apr. 3, 1986; 58 FR 2880, Jan. 
6, 1993]



Sec. 145.171  Artificially sweetened canned peaches.

    (a) Artificially sweetened canned peaches is the food which conforms 
to the definition and standard of identity prescribed for canned peaches 
by Sec. 145.170(a), except that in lieu of a packing medium specified 
in Sec. 145.170(a)(3), the packing medium used is water artificially 
sweetened with saccharin, sodium saccharin, or a combination of both. 
Such packing medium may be thickened with pectin and may contain any 
mixture of any edible organic salt or salts and any edible organic acid 
or acids as a flavor-enhancing agent, in a quantity not more than is 
reasonably required for that purpose.
    (b)(1) The specified name of the food is ``artificially sweetened 
___'', the blank being filled in with the name prescribed by Sec. 
145.170(a) for canned peaches having the same optional peach ingredient.
    (2) The artificially sweetened food is subject to the requirements 
for label statement of ingredients used, as prescribed for canned 
peaches by Sec. 145.170(a). If the packing medium is thickened with 
pectin, the label shall bear the statement ``thickened with pectin''. 
When any organic salt or acid or any mixture of two or more of these is 
added, the label shall bear the common or usual name of each such 
ingredient.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993]



Sec. 145.175  Canned pears.

    (a) Identity--(1) Ingredients. Canned pears is the food prepared 
from one of the fresh or previously canned optional pear ingredients 
Pyrus communis or Pyrus sinensis specified in paragraph (a)(2) of this 
section which may be packed in one of the optional packing media 
specified in paragraph (a)(3) of this section. Such food may also 
contain one, or any combination of two or more, of the following safe 
and suitable optional ingredients.
    (i) Natural and artificial flavors.
    (ii) Spice.
    (iii) Vinegar, lemon juice, or organic acids.
    (iv) Artificial colors.


Such food is sealed in a container and before or after sealing is so 
processed by heat as to prevent spoilage.
    (2) Styles and forms of units. The optional pear styles and forms of 
units referred to in paragraph (a)(1) of this section are:
    (i) Whole--consisting of peeled or unpeeled pears with cores removed 
or left in.
    (ii) Halves--consisting of peeled or unpeeled pears with cores 
removed and cut into two approximately equal parts.
    (iii) Quarters--consisting of peeled pears with cores removed and 
cut into four approximately equal parts.
    (iv) Slices--consisting of peeled pears with cores removed and cut 
into wedge-shaped sectors.
    (v) Dice--consisting of peeled pears with cores removed and cut into 
cube-like parts.
    (vi) Pieces or irregular pieces--consisting of peeled pears with 
cores removed and cut into parts of irregular shapes and sizes.
    (vii) Chunky--consisting of peeled pears with cores removed and cut 
into parts 13 millimeters (0.51 inch) or

[[Page 610]]

greater in the smallest dimension and 44 millimeters (1.75 inches) or 
less in the largest dimension.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section, as defined in Sec. 145.3 are:
    (a) Water.
    (b) Fruit juice(s) and water.
    (c) Fruit juice(s).
    (d) Clarified juice.


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.30.
    (ii) If the concentration of clarified juice is such that the 
packing medium forms to the density range for one of the sirups under 
paragraph (a)(3)(ii) (a), (b), (c), or (d) of this section, the 
concentrated clarified juice is considered to be light sirup, heavy 
sirup, or extra heavy sirup, as the case may be. When a sweetener is 
added as a part of any such liquid packing medium, the density range of 
the resulting packing medium expressed as percent by weight of sucrose 
(degrees Brix) as determined by the procedure in Sec. 145.3(m) shall be 
designated by the appropriate name for the respective density ranges, 
namely:
    (a) When the density of the solution is less than 14 percent, the 
medium shall be designated as ``slightly sweetened water''; or ``extra 
light sirup''; ``slightly sweetened fruit juice(s) and water''; or 
``slightly sweetened fruit juice(s)'', as the case may be.
    (b) When the density of the solution is 14 percent or more but less 
than 18 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'' as the case may be.
    (c) When the density of the solution is 18 percent or more but less 
than 22 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (d) When the density of the solution is 22 percent or more but not 
more than 35 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened fruit juice(s) and water''; or 
``extra heavily sweetened fruit juice(s)'', as the case may be.
    (4) Labeling requirements. (i) The name of the food is ``pears''. 
The name of the food shall also include a declaration of any flavoring 
that characterizes the product as specified in Sec. 101.22 of this 
chapter and a declaration of any spice or seasoning that characterizes 
the product; for example, ``Spice added'', or in lieu of the word 
``Spice'', the common name of the spice, ``Seasoned with vinegar''. When 
two or more of the optional ingredients specified in paragraphs (a)(1) 
(ii) and (iii) of this section are used, such words may be combined as 
for example, ``Seasoned with cider vinegar, cloves, and cinnamon oil''.
    (ii) The style and forms of units of the pear ingredient as provided 
in paragraph (a)(2) of this section and the name of the packing medium 
specified in paragraph (a)(3) (i) and (ii) of this section, preceded by 
``In'' or ``Packed in'' or the words ``Solid pack'', where applicable, 
shall be included as part of the name or in close proximity to the name 
of the food, except that ``Halves'' may be alternatively designated as 
``Halved'', ``Quarters'' as ``Quartered'', ``Slices'' as ``Sliced'', and 
``Dice'' as ``Diced''. ``Pieces'' or ``Irregular pieces'' shall be 
designated as ``Pieces'', ``Irregular pieces'', or ``Mixed pieces of 
irregular sizes and shapes''. ``Chunky'' may be designated as 
``Chunks''. The style of the pear ingredient shall be preceded or 
followed by ``Unpeeled'' when the units are whole or halves and are 
unpeeled. When the packing medium is prepared with a sweetener(s) which 
imparts a taste, flavor or other characteristic to the finished food in 
addition to sweetness, the name of the packing medium shall be 
accompanied by the name of such sweetener(s), as for example in the case 
of a mixture of brown sugar and honey, an appropriate statement would be 
``___ sirup of brown sugar and honey'' the blank to be filled in with 
the word ``light'', ``heavy'', or ``extra

[[Page 611]]

heavy'', as the case may be. When the liquid portion of the packing 
media provided for in paragraphs (a)(3) (i) and (ii) of this section 
consists of fruit juice(s), such juice(s) shall be designated in the 
name of the packing medium as:
    (a) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit'';
    (b) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (a)(4)(iii) of 
this section; and
    (c) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juice(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (a)(4)(iii) of this section.
    (iii) Whenever the names of the fruit juices used do not appear in 
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of 
this section, such names and the words ``from concentrate'', as 
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an 
ingredient statement pursuant to the requirements of Sec. 101.3(d) of 
this chapter.
    (iv) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned pears is as 
follows:
    (i) Maturity. All units tested in accordance with the method 
prescribed in paragraph (b)(2) of this section are pierced by a weight 
of not more than 300 grams (10.6 ounces).
    (ii) Minimum size. In the case of halves and quarters styles, the 
weight of each unit is not less than 17 grams (0.6 ounce) and 8.5 grams 
(0.3 ounce), respectively.
    (iii) Uniformity of size--(a) Whole, halves, and quarters. In the 
case of whole, halves, and quarters styles, among those units comprising 
95 percent by count of those present in the container that are most 
uniform in size, the weight of the largest unit is not more than twice 
the weight of the smallest unit. In containers with fewer than 20 units, 
1 unit may be disregarded in making the determination. Where a unit has 
broken in the container, reassemble the broken pieces to approximate a 
single unit of the appropriate style.
    (b) Chunky. In the case of chunky style, not more than 25 percent of 
the drained weight of the contents of the container consists of units 
that will pass through an opening 13 millimeters (0.51 inch) wide or 
that are more than 44 millimeters (1.75 inches) along the longest cut 
edge.
    (iv) Peel (except unpeeled style). Not more than 10 square 
centimeters (1.6 square inches) of peel adhering to pears or loose in 
the container per kilogram (35.3 ounces) of net weight.
    (v) Blemished units. Not more than 20 percent by count of the units 
in the container are blemished with scab, hail injury, discoloration, or 
other abnormality aggregating the area of a circle more than 6.5 
millimeters (0.25 inch) in diameter; corky or hard spots on outer 
surfaces aggregating the area of a circle more than 13 millimeters (0.51 
inch) in diameter; or dark brown areas aggregating the area of a circle 
less than 6.5 millimeters (0.25 inch) in diameter which penetrate into 
the flesh or affect the appearance of the unit.
    (vi) Trimmed units. In the case of whole, halves, and quarters 
styles, all units are untrimmed or are so trimmed as to preserve normal 
shape of the unit.
    (vii) Crushed or broken units. In the case of whole, halves, 
quarter, slices, dice, and chunky styles, not more than 10 percent by 
count of the units in containers of 10 or more units and not more than 1 
unit in containers of less than 10 units are crushed or broken. A unit 
that lost its normal shape because of ripeness and bears no mark of 
crushing shall not be considered to be crushed or broken.
    (viii) Loose core material in all styles except uncored whole style. 
Not more than two units of loose core material per kilogram (35.3 
ounces) of net weight. A unit of such material is defined as a portion 
of loose core, with or

[[Page 612]]

without seeds, aggregating approximately one-half of a pear core.
    (ix) Partially cored units in all styles except uncored whole style. 
Not more than 40 percent by count partially cored units in halves, 
quarters, slices, and pieces or irregular pieces styles and not more 
than 5 percent by weight in dice style. A partially cored unit is a unit 
of pear that contains an attached portion of the seed cell cavity.
    (x) Seeds in all styles except whole uncored style. Not more than 8 
seeds or the equivalent in pieces of seeds per kilogram (35.3 ounces) of 
net weight. Seeds included as cored material in paragraph (b)(1) (viii) 
and (ix) of this section shall not be counted a second time.
    (2) Canned pears shall be tested by the following method to 
determine whether they meet the requirements of paragraph (b)(1)(i) of 
this section: So trim a test piece from the unit as to fit, with peel 
surface up, into a supporting receptacle. If the unit is of different 
firmness in different parts of its peel surface, trim the piece from the 
firmest part. If the piece is unpeeled, remove the peel. The top of the 
receptacle is circular in shape, of 28.6 millimeters (1.12 inches) 
inside diameter, with vertical sides; or rectangular in shape, 19 
millimeters (0.75 inch) by 25.4 millimeters (1 inch) inside 
measurements, with ends vertical and sides sloping downward and joining 
at the center at a vertical depth of 19 millimeters (0.75 inch). Use the 
circular receptacle for testing units of such size that a test piece can 
be trimmed therefrom to fit it. Use the rectangular receptacle for 
testing other units. Test no unit from which a test piece with 
rectangular peel surface at least 13 millimeters (0.51 inch) by 25.4 
millimeters (1 inch) cannot be trimmed. Test the piece by means of a 
round metal rod 4 millimeters (0.16 inch) in diameter. To the upper end 
of the rod is affixed a device to which weight can be added. The rod is 
held vertically by the support through which it can freely move upward 
or downward. The lower end of the rod is a plane surface to which the 
vertical axis of the rod is perpendicular. Adjust the combined weight of 
the rod and device to 100 grams (3.5 ounces). Set the receptacle so that 
the surface of the test piece is held horizontally. Lower the end of the 
rod to the approximate center of such surface, and add weight to the 
device at a uniform, continuous rate of 12 grams (0.42 ounce) per second 
until the rod pierces the test piece. Weigh the rod and weighted device. 
Test all units in containers of 50 units or less except those units too 
small for testing or too soft for trimming. Test at least 50 units, 
taken at random in containers of more than 50 units; but if less than 50 
units are of sufficient size and firmness for testing, test those which 
are of sufficient size and firmness.
    (3) Determine compliance as specified in Sec. 145.3(o) except that 
a lot shall be deemed to be in compliance for peel in all styles except 
unpeeled styles and seeds in all styles except whole uncored style based 
on the average of all samples analyzed according to the sampling plans 
set out in Sec. 145.3(p).
    (4) If the quality of canned pears falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified; however, if the 
quality of the canned pears falls below standard with respect to only 
one of the factors of quality specified in paragraph (b)(1) (i) through 
(x) of this section, there may be substituted for the second line of 
such general statement of substandard quality (``Good Food--Not High 
Grade'') a new line, as specified after the corresponding designation of 
paragraph (b)(1) of this section which the canned pears fail to meet, as 
follows:
    (i) ``Not tender'';
    (ii) ``Small halves'' or ``small quarters'', as the case may be;
    (iii)(a) ``Mixed sizes'';
    (b) ``Undersized and/or oversized pieces'';
    (iv) ``Excessive peel'';
    (v) ``Blemished'';
    (vi) ``Unevenly trimmed'';
    (vii) ``Partly crushed or broken'';
    (viii) ``Excessive core'';
    (ix) ``Excessive core'';
    (x) ``Excessive seeds''.


Such alternative statement shall immediately and conspicuously precede 
or follow, without intervening written,

[[Page 613]]

printed, or graphic matter, the name ``pears'' and any words and 
statements required or authorized to appear with such name by paragraph 
(a)(2) of this section.
    (c) Fill of container. (1) The standard of fill of container for 
canned pears is the maximum quantity of the optional pear ingredient 
that can be sealed in the container and processed by heat to prevent 
spoilage, without crushing or breaking such ingredient.
    (2) If canned pears fall below the standard of fill of container 
prescribed in paragraph (c)(1) of this section, the label shall bear the 
general statement of substandard fill specified in Sec. 130.14(b) of 
this chapter, in the manner and form therein specified.

[42 FR 14414, Mar. 15, 1977, as amended at 47 FR 41528, 41530, Sept. 21, 
1982; 58 FR 2880, Jan. 6, 1993]



Sec. 145.176  Artificially sweetened canned pears.

    (a) Artificially sweetened canned pears is the food which conforms 
to the definition and standard of identity prescribed for canned pears 
by Sec. 145.175(a) except that in lieu of a packing medium specified in 
Sec. 145.175(a)(3), the packing medium used is water artificially 
sweetened with saccharin, sodium saccharin, or a combination of both. 
Such packing medium may be thickened with pectin and may contain any 
mixture of any edible organic salt or salts and any edible organic acid 
or acids as a flavor-enhancing agent, in a quantity not more than is 
reasonably required for that purpose.
    (b)(1) The specified name of the food is ``artificially sweetened 
___'', the blank being filled in with the name prescribed by Sec. 
145.175(a) for canned pears having the same optional pear ingredient.
    (2) The artificially sweetened food is subject to the requirements 
for label statement of ingredients used, as prescribed for canned pears 
by Sec. 145.175(a). If the packing medium is thickened with pectin, the 
label shall bear the statement ``thickened with pectin''. When any 
organic salt or acid or any mixture of two or more of these is added, 
the label shall bear the common or usual name of each such ingredient.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993]



Sec. 145.180  Canned pineapple.

    (a) Identity--(1) Ingredients. Canned pineapple is the food prepared 
from mature, fresh or previously canned, pineapple conforming to the 
characteristics of Ananas comosus (L.) Merrill and from which peel and 
core have been removed. The food consists of one of the optional styles 
of the pineapple ingredient specified in paragraph (a)(2) of this 
section and may be packed in one of the optional packing media specified 
in paragraph (a)(3) of this section, except water is not a suitable 
packing medium for crushed style. Crushed style additionally may be 
packed as heavy or solid pack as specified in paragraph (a)(4) of this 
section. The food may also contain one, or any combination of two or 
more, of the following safe and suitable optional ingredients:
    (i) Natural fruit flavors.
    (ii) Mint flavor.
    (iii) Spices, spice oils.
    (iv) Vinegar or organic acids.
    (v) Dimethylpolysiloxane in an amount not greater than 10 
milligrams/kilogram (10 parts per million) by weight of the finished 
food as a defoaming agent.


The food is sealed in a container and, before or after sealing, is so 
processed by heat as to prevent spoilage.
    (2) Styles of pack. The optional styles of the pineapple ingredients 
referred to in paragraph (a)(1) of this section are:
    (i) Slices or whole slices or rings--consisting of uniformly cut 
circular slices or rings cut across the axis of the peeled, cored 
pineapple cylinders.
    (ii) Half slices--consisting of uniformly cut, approximately 
semicircular halves of slices.
    (iii) Quarter slices--consisting of uniformly cut, one-fourth 
portions of slices.
    (iv) Broken slices--consisting of arc-shaped portions which may not 
be uniform in size and/or shape.
    (v) Spears or fingers--consisting of long, slender pieces cut 
radially and

[[Page 614]]

lengthwise of the cored pineapple cylinder, predominantly 65 millimeters 
(2.5 inches) or longer.
    (vi) Tidbits--consisting of reasonably uniform, wedge-shaped sectors 
cut from slices or portions thereof, predominantly from 8 millimeters 
(0.31 inch) to 13 millimeters (0.51 inch) thick.
    (vii) Chunks--consisting of short, thick pieces cut from thick 
slices and/or from peeled cored pineapple and predominantly more than 13 
millimeters (0.51 inch) in both thickness and width, and less than 38 
millimeters (1.5 inches) in length and does not include large cubes.
    (viii) Small cubes or dice--consisting of reasonably uniform, cube-
shaped pieces, predominately 14 millimeters (0.55 inch) or less in the 
longest edge dimensions.
    (ix) Pieces or irregular pieces--consisting of irregular shapes and 
sizes not identifiable as a specific style and does not include chunks.
    (x) Crushed--consisting of finely cut or finely shredded or grated 
or diced pieces of pineapple.
    (xi) Large cubes--consisting of reasonably uniform, cube-shaped 
pieces, longer than 14 millimeters (0.55 inch) along any edge, but 
predominately 25 millimeters (1 inch) or less in the longest edge 
dimensions.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section and defined in Sec. 145.3 are:
    (a) Water.
    (b) Pineapple juice and water.
    (c) Pineapple juice.
    (d) Clarified pineapple juice.


Such packing media may be used as such, or any one of the optional 
sweetening ingredients specified in paragraph (a)(3)(ii) of this section 
may be added.
    (ii) The optional sweetening ingredients referred to in paragraph 
(a)(3)(i) of this section are:
    (a) Sugar.
    (b) Invert sugar sirup.
    (c) Any mixture of optional sweetening ingredients designated in 
paragraph (a)(3)(ii)(a) and (b) of this section.
    (d) Any of the optional sweetening ingredients designated in 
paragraph (a)(3)(ii)(a), (b), and (c) of this section with dextrose, as 
long as the weight of the solids of dextrose does not exceed one-third 
of the total weight of the solids of the combined sweetening 
ingredients.
    (e) Any of the optional sweetening ingredients designated in 
paragraph (a)(3)(ii)(a), (b), and (c) of this section with corn sirup or 
with dried corn sirup or with glucose sirup or with dried glucose sirup, 
or with any two or more of these, as long as the weight of the solids of 
corn sirup, dried corn sirup, glucose sirup, dried glucose sirup, or the 
sum of the weights of the solids of corn sirup, dried corn sirup, 
glucose sirup, and dried glucose sirup, in case two or more of these are 
used, does not exceed one-fourth of the total weight of the solids of 
the combined sweetening ingredients.
    (f) Any mixture of the optional ingredients designated in paragraph 
(a)(3)(ii)(d) and (e) of this section.
    (iii) If the concentration of clarified pineapple juice is such that 
the packing medium conforms to the density range for one of the sirups 
provided for in paragraph (a)(3)(iv)(b), (c), or (d) of this section, 
the concentrated clarified juice is considered to be light sirup, heavy 
sirup, or extra heavy sirup, as the case may be.
    (iv) When a sweetener is added as a part of any liquid packing 
medium as provided for in paragraph (a)(3)(i)(a), (b), and (c) of this 
section, the density range of the resulting packing medium, expressed as 
percent by weight of sucrose (degrees Brix) as determined by the 
procedure in Sec. 145.3(m), shall be designated by the appropriate name 
for the respective density ranges, namely:
    (a) When the density of the solution is 10 percent or more but less 
than 14 percent, the medium shall be designated as ``slightly sweetened 
water'' or ``extra light sirup''; ``slightly sweetened pineapple juice 
and water''; or ``slightly sweetened pineapple juice'', as the case may 
be.
    (b) When the density of the solution is 14 percent or more but less 
than 18 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened pineapple juice and water''; or ``lightly sweetened 
pineapple juice,'' as the case may be.

[[Page 615]]

    (c) When the density of the solution is 18 percent or more but less 
than 22 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened pineapple juice and water''; or ``heavily sweetened 
pineapple juice'', as the case may be.
    (d) When the density of the solution is 22 percent or more but not 
more than 35 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened pineapple juice and water''; or 
``extra heavily sweetened pineapple juice'', as the case may be.
    (v) Determine compliance as specified in Sec. 145.3(o).
    (4) Types of pack. The optional types of pack for crushed style 
referred to in paragraph (a)(1) of this section are as follows:
    (i) Heavy pack. Crushed style with or without sweetening ingredients 
and containing at least 73 percent drained fruit weight, as determined 
by the procedure set forth in Sec. 145.3(n).
    (ii) Solid pack. Crushed style with or without sweetening 
ingredients and containing at least 78 percent drained fruit weight, as 
determined by the procedure set forth in Sec. 145.3(n).
    (5) Labeling requirements. (i) The name of the food is 
``pineapple''. The name of the food shall also include a declaration of 
any flavoring that characterizes the product as specified in Sec. 
101.22 of this chapter and a declaration of any spice or seasoning that 
characterizes the product; for example, ``Spice added'', or, in lieu of 
the word ``Spice'', the common name of the spice; or ``Seasoned with 
vinegar'' or, in lieu of the word ``vinegar'', the name of the vinegar 
used. When two or more of the optional ingredients specified in 
paragraph (a)(1)(i) through (iv) of this section are used, such words 
may be combined, as, for example, ``Seasoned with cider vinegar, cloves, 
and cinnamon oil''.
    (ii) The style of the pineapple ingredient as provided for in 
paragraph (a)(2) of this section and the name of the packing medium as 
specified in paragraph (a)(3)(i) and (ii) of this section, preceded by 
``In'' or ``Packed in'' or the words ``Heavy pack'' or ``Solid pack'' as 
specified in paragraph (a)(4) of this section, where applicable, shall 
be included as part of the name or in close proximity to the name of the 
food. The word ``slices'' may be alternatively designated ``sliced,'' 
``dice'' as ``diced,'' and ``pieces'' or ``irregular pieces'' as ``mixed 
pieces of irregular sizes and shapes.'' Whenever pineapple juice, as 
provided for in paragraph (a)(3)(i)(c) of this section, is used, the 
declaration may be preceded by an appropriate statement such as 
``unsweetened''.
    (iii) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned pineapple is as 
follows:
    (i) Core material. In the case of all styles, not more than 7 
percent of the drained weight of the contents of the container consists 
of core material as determined by the method prescribed in paragraph 
(b)(3)(ii) of this section.
    (ii) Uniformity of weight and shape--(a) Slices. The drained weight 
of the largest unit in the container is not more than 1.4 times the 
drained weight of the smallest unit.
    (b) Half slices and quarter slices. The drained weight of the 
largest unit in a container is not more than 1.75 times the drained 
weight of the smallest unit, except for an occasional broken piece due 
to splitting or an occasional whole slice not completely cut through.
    (c) Broken slices. (1) Not more than 10 percent of the drained 
weight of the contents of the container consists of pieces having an arc 
of less than 90[deg].
    (2) Not more than 5 percent of the drained weight of the contents of 
the container:
    (i) Consists of pieces that measure in thickness less than 8 
millimeters (0.31 inch) or more than 25 millimeters (1 inch); or
    (ii) Consists of pieces that measure less than 19 millimeters (0.75 
inch) in width as measured from the outer edge to the inner edge.
    (3) Not more than 5 percent of the drained weight of the contents of 
the container consists of broken slices having an outside diameter 
differing by as much as 9.5 millimeters (0.37 inch) from that of those 
present in greatest proportion by weight.

[[Page 616]]

    (d) Spears. The drained weight of the largest unit in the container 
is not more than 1.4 times the drained weight of the smallest unit.
    (e) Tidbits. Not more than 15 percent of the drained weight of the 
contents of the container consists of units each of which weighs less 
than three-fourths as much as the average drained weight of all the 
untrimmed units in the container.
    (f) Chunks. Not more than 15 percent of the drained weight of the 
contents of the container consists of pieces weighing less than 5 grams 
(0.18 ounce) each.
    (g) Cubes. (1) Not more than 10 percent of the drained weight of the 
contents of the container consists of pieces that will pass through a 
screen with square openings of 8 millimeters (0.31 inch) in the case of 
the small cubes or large cubes.
    (2) Not more than 15 percent of the drained weight consists of 
pieces weighing more than 3 grams (0.11 ounce) each for small cubes and 
18 grams (0.63 ounce) each for large cubes.
    (h) Pieces. Not more than 20 percent of the drained weight of the 
contents of the container consists of units that will pass through a 
screen with square openings of 8 millimeters (0.31 inch).
    (iii) Blemishes. Blemishes consist of surface areas and spots that 
contrast strongly in color or texture with the normal pineapple tissue 
or that may penetrate the flesh. Blemishes are normally removed in 
preparation of pineapple for culinary use and include any of the 
following, if in excess of 1.6 millimeters (0.06 inch) in the longest 
dimension on the exposed surface of the unit: deep fruit eyes, pieces of 
shell, brown spots, bruised portions, and other abnormalities.
    (a) Slices, half slices, quarter slices, broken slices, spears, 
tidbits, chunks, cubes, and pieces. Not more than 12.5 percent by count 
of the units in the container may be blemished; but in containers having 
not more than 5 units, 1 unit may be blemished; in containers having 
more than 5 units, but not more than 10 units, 2 units may be blemished 
and in containers having more than 10 units, but not more than 32 units, 
4 units may be blemished.
    (b) Crushed. Not more than 1.5 percent of the drained weight of the 
contents of the container consists of fragments bearing blemishes.
    (iv) Excessively trimmed. Slices, half slices, and quarter slices 
are considered excessively trimmed if the portion trimmed away exceeds 5 
percent of the apparent physical bulk of the perfectly formed unit and 
if the trimming destroys the normal circular shape of the outer or inner 
edge of the unit. Broken slices, spears, and tidbits are excessively 
trimmed if the trimming destroys the normal shape of the unit.
    (a) Slices, half slices, and quarter slices. Not more than 7.5 
percent by count of the units in the container may be excessively 
trimmed, but in containers having not more than 10 units, 1 unit may be 
excessively trimmed; and in containers having more than 10 units, but 
not more than 27 units, 2 units may be excessively trimmed.
    (b) Broken slices and spears. Not more than 15 percent by count of 
the total units in the container may be excessively trimmed.
    (c) Tidbits. Not more than 15 percent of the drained weight of the 
contents of the container consists of excessively trimmed units.
    (v) Mashed. A unit that has lost its normal shape because of 
ripeness that bears no mark of mechanical injury is not to be considered 
mashed.
    (a) Slices, half slices, and quarter slices. Not more than one unit 
in containers of 25 units or less, and not more than 3 units in 
containers of more than 25 units, are mashed.
    (b) Broken slices. Not more than 5 percent by count of the units in 
the container are mashed.
    (c) Spears. Not more than 1 unit in the container is mashed.
    (d) Tidbits. Not more than 3 units in containers of less than 150 
units, and not more than 2 percent of the units in containers of 150 
units or more, are mashed.
    (e) Chunks. Not more than 3 units in containers of less than 70 
units, and not more than 5 percent of the units in containers of 70 
units or more, are mashed.
    (vi) Acidity. In the case of all styles, not more than 1.35 grams of 
acid, calculated as anhydrous citric acid, is

[[Page 617]]

contained in 100 milliliters of the liquid drained from the product 15 
days or more after the pineapple is canned.
    (vii) Excessive liquid. The drained weight of crushed pineapple is 
not less than 63 percent of the net weight of the contents of the 
container.
    (2) Sampling and acceptance. Determine compliance as specified in 
Sec. 145.3(o).
    (3) Methodology. The method to be employed to determine whether 
canned pineapple meets the requirements of paragraph (b)(1) (i) through 
(vi) of this section are as follows:
    (i) Determine the drained weight of the canned pineapple by the 
procedure prescribed in Sec. 145.3(n).
    (ii) Identify and separate any core material cleanly from each of 
the units in the container, and weigh the aggregate of the core 
material. Calculate the percent core material to determine compliance 
with paragraph (b)(1)(i) of this section.
    (iii) In the case of slices, half slices, quarter slices, spears, 
tidbits, chunks, and pieces, check the weight of the units against the 
requirements of paragraph (b)(1)(ii) (a), (b), (d), (e), (f), and (h) of 
this section.
    (iv) In the case of broken slices, check the dimensions of each unit 
against the requirements of paragraph (b)(1)(ii)(c) of this section.
    (v) In the case of cubes, and pieces, determine compliance with 
paragraph (b)(1)(ii) (g) and (h) of this section by placing the units, a 
few at a time, on the mesh of a U.S. Standard No. 8 sieve (8-millimeter 
(0.31 inch)) mesh. After shaking gently, remove those units that remain 
on the sieve before testing the next portion. Continue portion-wise 
until all units are tested, then determine the aggregate weight of those 
units that have passed through the sieve.
    (vi) Except in the case of crushed pineapple, segregate and count 
each unit that is blemished as defined in paragraph (b)(1)(iii) of this 
section. In the case of crushed pineapple, segregate each fragment of 
crushed pineapple bearing a blemish and determine the aggregate weight 
of such fragments to determine compliance with paragraph (b)(1)(iii)(b) 
of this section.
    (vii) Except in the case of chunks, cubes, pieces, and crushed 
pineapple, inspect all the units in the container to determine those 
that have been excessively trimmed, as defined in paragraph (b)(1)(iv) 
of this section.
    (viii) Except in the case of cubes, pieces, and crushed pineapple, 
count the total units in the container and the number of mashed units to 
determine compliance with paragraph (b)(1)(v) of this section.
    (ix) Determine the total acidity of the drained liquid by titration, 
using the following method: Measure with a pipette 10 milliliters of the 
unfiltered drained liquid into a 250-milliliter Erlenmeyer flask. Add 25 
milliliters of distilled or deionized water and 0.3 milliliter of 1-
percent phenolphthalein solution. Titrate with one-tenth normal sodium 
hydroxide solution to a faint, permanently pink coloration. Multiply the 
number of milliliters of one-tenth normal sodium hydroxide required by 
0.064 to calculate the number of grams of anhydrous citric acid per 100 
milliliters of drained liquid to determine compliance with paragraph 
(b)(3)(vi) of this section.
    (4) If the quality of canned pineapple falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form specified in that section; however, 
if the quality of the canned pineapple falls below standard with respect 
to only one of the factors of quality specified in paragraph (b)(1)(i) 
through (vii) of this section, there may be substituted for the second 
line of the general statement of substandard quality (``Good Food--Not 
High Grade'') one of the following new lines, placed after the 
corresponding designation of paragraph (b)(1) of this section that the 
canned pineapple fails to meet:
    (i) ``Poorly cored'' or ``Excessive core''.
    (ii) ``Mixed sizes'' or ``Irregular small pieces'', as appropriate.
    (iii) ``Blemished'' or ``Contains blemished pieces''.
    (iv) ``Excessively trimmed''.
    (v) ``Mashed units'' or ``Contains mashed units''.

[[Page 618]]

    (vi) ``Excessively tart''.
    (vii) ``Contains excess liquid''.
    (c) Fill of Container. (1) The standard of fill of container for 
canned crushed pineapple is a fill of not less than 90 percent of the 
total capacity of the container, as determined by the general method for 
fill of container prescribed in Sec. 130.12(b) of this chapter.
    (2) If canned crushed pineapple falls below the standard of fill of 
container prescribed in paragraph (c)(1) of this section, the label 
shall bear the general statement of substandard fill specified in Sec. 
130.14(b) of this chapter, in the manner and form therein specified.

[42 FR 14414, Mar. 15, 1977, as amended at 44 FR 40279, July 10, 1979; 
45 FR 43391 and 43392, June 27, 1980; 46 FR 57475, Nov. 24, 1981; 48 FR 
39916, Sept. 2, 1983; 58 FR 2880, Jan. 6, 1993]



Sec. 145.181  Artificially sweetened canned pineapple.

    (a) Artificially sweetened canned pineapple is the food that 
conforms to the definition and standard of identity prescribed for 
canned pineapple by Sec. 145.180(a), except that in lieu of a packing 
medium specified in Sec. 145.180(a)(2), the packing medium used is 
water artificially sweetened with saccharin, sodium saccharin, or a 
combination of both. Such packing medium may be thickened with pectin.
    (b)(1) The specified name of the food is ``artificially sweetened 
___'', the blank being filled in with the name prescribed by Sec. 
145.180(a) for canned pineapple having the same optional pineapple 
ingredient.
    (2) The artificially sweetened food is subject to the requirements 
for label statement of ingredients used, as prescribed for canned 
pineapple by Sec. 145.180(a). If the packing medium is thickened with 
pectin, the label shall bear the statement ``thickened with pectin''.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993]



Sec. 145.185  Canned plums.

    (a) Identity--(1) Ingredients. Canned plums is the food prepared 
from clean, sound, and mature fruit of plum varieties conforming to the 
characteristics of Prunus domestica L., greengage varieties conforming 
to the characteristics of Prunus italica L., mirabelle or damson 
varieties conforming to the characteristics of Prunus insititia L., or 
cherry varieties conforming to the characteristics of Prunus cerasifera 
Ehrh. The food consists of one of the optional styles of the plum 
ingredient, specified in paragraph (a)(2) of this section, and one of 
the optional packing media specified in paragraph (a)(3) of this 
section. Such food may also contain one, or any combination of two or 
more of the following safe and suitable optional ingredients:
    (i) Natural and artificial flavors.
    (ii) Spice.
    (iii) Vinegar, lemon juice, or organic acids.
    (iv) Artificial coloring.


Such food is sealed in a container and before or after sealing is so 
processed by heat so as to prevent spoilage.
    (2) Optional styles of the plum ingredient. The optional plum 
ingredients specified in paragraph (a)(1) of this section are peeled or 
unpeeled:
    (i) Whole.
    (ii) Halves.


Peeled or unpeeled whole plums are pitted or, alternatively, unpitted. 
Peeled or unpeeled plum halves are pitted.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section, as defined in Sec. 145.3 are:
    (a) Water.
    (b) Fruit juice(s) and water.
    (c) Fruit juice(s).


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.3.
    (ii) When a sweetener is added as a part of any such liquid packing 
medium, the density range of the resulting packing medium expressed as 
percent by weight of sucrose (degrees Brix) as determined by the 
procedure

[[Page 619]]

prescribed in Sec. 145.3(m) shall be designated by the appropriate name 
for the respective density ranges, namely:
    (a) When the density of the solution is 11 percent or more but less 
than 15 percent, the medium shall be designated as ``slightly sweetened 
water'', or ``extra light sirup'', ``slightly sweetened fruit juice(s) 
and water'' or ``slightly sweetened fruit juice(s)'', as the case may 
be.
    (b) When the density of the solution is 15 percent or more, but less 
than 19 percent, the medium shall be designated as ``light sirup'', 
``lightly sweetened fruit juice(s) and water'', or ``lightly sweetened 
fruit juice(s)'', as the case may be.
    (c) When the density of the solution is 19 percent or more, but less 
than 25 percent, the medium shall be designated as ``heavy sirup'', 
``heavily sweetened fruit juice(s) and water'', or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (d) When the density of the solution is 25 percent or more, but less 
than 35 percent, the medium shall be designated as ``extra heavy 
sirup'', ``extra heavily sweetened fruit juice(s) and water'', or 
``extra heavily sweetened fruit juice(s)'', as the case may be.
    (4) Labeling requirements. (i) The name of the food is ``plums'' 
accompanied by the color designation ``yellow'' or ``golden'' or ``red'' 
or ``purple'', as appropriate, or the specific name of the variety or 
``Greengage plums'', ``Damson plums'', ``Cherry plums'', ``Mirabelle 
plums''. The name of the food shall also include a declaration of any 
flavoring that characterizes the product as specified in Sec. 101.22 of 
this chapter and a declaration of any spice or seasoning that 
characterizes the product; for example, ``Spice added'', or in lieu of 
the word ``Spice'', the common name of the spice; ``Seasoned with 
vinegar''. When two or more of the optional ingredients specified in 
paragraphs (a)(1) (ii) and (iii) of this section are used, such words 
may be combined as for example, ``Seasoned with cider vinegar, cloves, 
and cinnamon oil''.
    (ii) The style of the plum ingredient as provided in paragraph 
(a)(2) of this section and the name of the packing medium specified in 
paragraphs (a)(3) (i) and (ii) of this section, preceded by ``In'' or 
``Packed in'' shall be included as part of the name or in close 
proximity to the name of the food. The style of the plum ingredient 
shall be preceded or followed by ``Peeled'' when the plums are peeled 
and by ``Pitted'' in the case of whole pitted plums. ``Halves'' may be 
alternatively designated ``Halved''. When the packing medium is prepared 
with a sweetener(s) which imparts a taste, flavor or other 
characteristics to the finished food in addition to sweetness, the name 
of the packing medium shall be accompanied by the name of such 
sweetener(s), as for example, in the case of a mixture of brown sugar 
and honey, an appropriate statement would be ``___ sirup of brown sugar 
and honey'', the blank to be filled in with the word ``light'', 
``heavy'', or ``extra heavy'', as the case may be. When the liquid 
portion of the packing media provided for in paragraphs (a)(3) (i) and 
(ii) of this section consists of fruit juice(s), such juice(s) shall be 
designated in the name of the packing medium as:
    (a) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit'',
    (b) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (a)(4)(iii) of 
this section, and
    (c) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juice(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (a)(4)(iii) of this section.
    (iii) Whenever the names of the fruit juices used do not appear in 
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of 
this section, such names and the words ``from concentrate'', as 
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an 
ingredient statement pursuant to the requirements of Sec. 101.3(d) of 
this chapter.

[[Page 620]]

    (iv) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned plums is as 
follows:
    (i) Blemishes (damaged). After draining in accordance with the 
procedure set out in Sec. 145.3(n) not more than 30 percent by weight 
of the drained plums consists of plums which have been blemished or 
damaged by any of the following factors either singly or in combination: 
Damaged by insects; appearance or eating quality materially affected by 
friction, disease, external stone gum or discoloration.
    (ii) Crushed or broken units in whole and halves styles. In the case 
of the whole styles, not more than 25 percent by weight of the drained 
plums are deformed or broken to an extent that the normal shape of the 
fruit is seriously affected. In the case of the halves style, not more 
than 25 percent by weight of the drained plums are damaged or torn to 
such an extent that they are smaller than 50 percent of a plum half.
    (iii) Blemishes and crushed or broken units. Not more than 35 
percent by weight of the drained plums consist of both blemishes as 
specified in paragraph (b)(1)(i) of this section and crushed or broken 
units in the case of the whole and halves styles as specified in 
paragraph (b)(2)(ii) of this section.
    (iv) Extraneous plant material. Not more than one piece of stalk or 
stem from the plum tree or other harmless extraneous plant material per 
200 grams (7 ounces) of drained plums.
    (v) Loose pits in whole style. Not more than three loose pits per 
500 grams (17.6 ounces) of drained plums.
    (vi) Pits or pieces of pits in whole pitted and halves styles. Not 
more than two pits or pieces of pits per 500 grams (17.8 ounces) of 
drained plums.
    (2) Determine compliance as specified in Sec. 145.3(o) except that 
a lot shall be deemed to be in compliance for extraneous plant material, 
loose pits in whole style, and pits or pieces of pits in whole pitted 
and halves styles based on the average of all samples analyzed according 
to the sampling plans set out in Sec. 145.3(p).
    (3) If the quality of canned plums falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified; however, if the 
quality of the canned plums falls below standard with respect to only 
one of the factors of quality specified in paragraphs (b)(1) (i) through 
(vi) of this section, there may be substituted for the second line of 
such general statement of substandard quality (``Good Food--Not High 
Grade'') a new line, as specified after the corresponding designation of 
paragraph (b)(1) of this section which the canned plums fail to meet, as 
follows:
    (i) ``Blemished'';
    (ii) ``Partly crushed or broken'';
    (iii) ``Blemished and partly crushed or broken'';
    (iv) ``Contains extraneous plant material'';
    (v) ``Contains loose pits''; or
    (vi) ``Contains pits'' or ``Contains pieces of pits''.
    (c) Fill of container. (1) The standard of fill of container for 
canned plums is:
    (i) The fill of the plums and packing medium, as determined by the 
general method for fill of container prescribed in Sec. 130.12(b) of 
this chapter, is not less than 90 percent of the total capacity of the 
container.
    (ii) The drained weight of the plum ingredient as determined by the 
method prescribed in Sec. 145.3(n) is not less than 50 percent for 
whole styles and 55 percent for halves styles based on the water 
capacity of containers as determined in Sec. 130.12(a) of this chapter.
    (2) Determine compliance for fill of container as specified in Sec. 
145.3(o).
    (3) If canned plums fall below the standard of fill of container 
prescribed in paragraph (c)(1) of this section, the label shall bear the 
statement of substandard fill specified in Sec. 130.14(b) of this 
chapter, in the manner and form therein specified. If canned plums fall 
below the standard of fill of container in respect to drained weight, 
the words ``Low drained weight'' shall follow the general statement of 
substandard fill on the label.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993]

[[Page 621]]



Sec. 145.190  Canned prunes.

    (a) Ingredients. Canned prunes is the food prepared from dried 
prunes, which may be packed as a solid pack or in one of the optional 
packing media specified in paragraph (b) of this section. Such food may 
also contain one, or any combination of two or more, of the following 
safe and suitable optional ingredients:
    (1) Natural and artificial flavors.
    (2) Spice.
    (3) Vinegar, lemon juice, or organic acids.
    (4) Unpeeled pieces of citrus fruits.


Such food is sealed in a container and before or after sealing is so 
processed by heat as to prevent spoilage.
    (b) Packing media. (1) The optional packing media referred to in 
paragraph (a) of this section, as defined in Sec. 145.3 are:
    (i) Water.
    (ii) Fruit juice(s) and water.
    (iii) Fruit juice(s).


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in Sec. 
145.3.
    (2) When a sweetener is added as a part of any such liquid packing 
medium, the density range of the resulting packing medium expressed as 
percent by weight of sucrose (degrees Brix) as determined by the 
procedure prescribed in Sec. 145.3(m) shall be designated by the 
appropriate name for the respective density ranges, namely:
    (i) When the density of the solution is less than 20 percent, the 
medium shall be designated as ``slightly sweetened water''; or ``extra 
light sirup''; ``slightly sweetened fruit juice(s) and water''; or 
``slightly sweetened fruit juice(s)'', as the case may be.
    (ii) When the density of the solution is 20 percent or more but less 
than 24 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'', as the case may be.
    (iii) When the density of the solution is 24 percent or more but 
less than 30 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (iv) When the density of the solution is 30 percent or more but not 
more than 45 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened fruit juice(s) and water''; or 
``extra heavily sweetened fruit juice(s)'', as the case may be.
    (c) Labeling requirements. (1) The name of the food is ``prunes--
prepared from dried prunes''. The words ``prepared from dried prunes'' 
shall be in close proximity to the word ``prunes'' and shall be of the 
same style and not less than \1/2\ of the point size of the type used 
for the word ``prunes''. The name of the food shall also include a 
declaration of any flavoring that characterizes the product as specified 
in Sec. 101.22 of this chapter and a declaration of any spice or 
seasoning that characterizes the product; for example, ``Spice added'', 
or in lieu of the word ``Spice'', the common name of the spice, 
``Seasoned with vinegar'' or ``Seasoned with unpeeled pieces of citrus 
fruit''. When two or more of the optional ingredients specified in 
paragraphs (a) (2) through (4) of this section are used, such words may 
be combined as for example, ``Seasoned with cider vinegar, cloves, 
cinnamon oil and unpeeled pieces of citrus fruit.''
    (2) When the food is prepared with a packing medium, the name of the 
packing medium specified in paragraphs (b) (1) and (2) of this section, 
preceded by ``In'' or ``Packed in'' and the words ``cooked'', 
``stewed'', or ``prepared'', shall be included as part of the name or in 
close proximity to the name of the food. When no packing medium is used, 
the words ``solid pack'' or ``moist pack'' or the word ``moistened'' 
followed by the words ``without sirup'' shall be included as part of the 
name or in close proximity to the name of the

[[Page 622]]

food. When the packing medium is prepared with a sweetener(s) which 
imparts a taste, flavor or other characteristic to the finished food in 
addition to sweetness, the name of the packing medium shall be 
accompanied by the name of such sweetener(s), as for example in the case 
of a mixture of brown sugar and honey, an appropriate statement would be 
``___ sirup of brown sugar and honey'', the blank to be filled in with 
the word ``light'', ``heavy'', or ``extra heavy'' as the case may be. 
When the liquid portion of the packing media provided for in paragraphs 
(b) (1) and (2) of this section consists of fruit juice(s), such 
juice(s) shall be designated in the name of the packing medium as:
    (i) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit'',
    (ii) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (c)(3) of this 
section, and
    (iii) In the case of the single fruit juice or a combination of two 
or more fruit juices any of which are made from concentrate(s), the 
words ``from concentrate(s)'' shall follow the word ``juice(s)'' in the 
name of the packing medium and in the name(s) of such juice(s) when 
declared as specified in paragraph (c)(3) of this section.
    (3) Whenever the names of the fruit juices used do not appear in the 
name of the packing medium as provided in paragraph (c)(2)(ii) of this 
section, such names and the words ``from concentrate'', as specified in 
paragraph (c)(2)(iii) of this section, shall appear in an ingredient 
statement pursuant to the requirements of Sec. 101.3(d) of this 
chapter.
    (4) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993]



PART 146_CANNED FRUIT JUICES--Table of Contents



                      Subpart A_General Provisions

Sec.
146.3 Definitions.

Subpart B_Requirements for Specific Standardized Canned Fruit Juices and 
                                Beverages

146.114 Lemon juice.
146.120 Frozen concentrate for lemonade.
146.121 Frozen concentrate for artificially sweetened lemonade.
146.126 Frozen concentrate for colored lemonade.
146.132 Grapefruit juice.
146.135 Orange juice.
146.137 Frozen orange juice.
146.140 Pasteurized orange juice.
146.141 Canned orange juice.
146.145 Orange juice from concentrate.
146.146 Frozen concentrated orange juice.
146.148 Reduced acid frozen concentrated orange juice.
146.150 Canned concentrated orange juice.
146.151 Orange juice for manufacturing.
146.152 Orange juice with preservative.
146.153 Concentrated orange juice for manufacturing.
146.154 Concentrated orange juice with preservative.
146.185 Pineapple juice.
146.187 Canned prune juice.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14433, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 146.3  Definitions.

    For the purposes of this part:
    (a) The term corn sirup means a clarified, concentrated, aqueous 
solution of the products obtained by the incomplete hydrolysis of 
cornstarch, and includes dried corn sirup. The solids of corn sirup and 
of dried corn sirup contain not less than 40 percent by weight of 
reducing sugars calculated as anhydrous dextrose.
    (b) The term dextrose means the hydrated or anhydrous, refined 
monosaccharide obtained from hydrolyzed starch.
    (c) The term dried glucose sirup means the product obtained by 
drying glucose sirup.

[[Page 623]]

    (d) The term glucose sirup means a clarified, concentrated, aqueous 
solution of the products obtained by the incomplete hydrolysis of any 
edible starch. The solids of glucose sirup contain not less than 40 
percent by weight of reducing sugars calculated as anhydrous dextrose.
    (e) The term invert sugar sirup means an aqueous solution of 
inverted or partly inverted, refined or partly refined sucrose, the 
solids of which contain not more than 0.3 percent by weight of ash, and 
which is colorless, odorless, and flavorless, except for sweetness.
    (f) The term sugar means refined sucrose.
    (g) Compliance means the following: Unless otherwise provided in a 
standard, a lot of canned fruits shall be deemed in compliance for the 
following factors, to be determined by the sampling and acceptance 
procedure as provided in paragraph (h) of this section, namely:
    (1) Quality. The quality of a lot shall be considered acceptable 
when the number of defectives does not exceed the acceptance number in 
the sampling plans.
    (2) Fill of container. A lot shall be deemed to be in compliance for 
fill of container when the number of defectives does not exceed the 
acceptance number (c) in the sampling plans.
    (h) The sampling and acceptance procedure means the following:
    (1) Definitions--(i) Lot. A collection of primary containers or 
units of the same size, type, and style manufactured or packed under 
similar conditions and handled as a single unit of trade.
    (ii) Lot size. The number of primary containers or units in the lot.
    (iii) Sample size. The total number of sample units drawn for 
examination from a lot.
    (iv) Sample unit. A container, a portion of the contents of a 
container, or a composite mixture of product from small containers that 
is sufficient for the examination or testing as a single unit.
    (v) Defective. Any sample unit shall be regarded as defective when 
the sample unit does not meet the criteria set forth in the standards.
    (vi) Acceptance number (c). The maximum number of defective sample 
units permitted in the sample in order to consider the lot as meeting 
the specified requirements.
    (vii) Acceptable quality level (AQL). The maximum percent of 
defective sample units permitted in a lot that will be accepted 
approximately 95 percent of the time.
    (2) Sampling plans:

------------------------------------------------------------------------
                                                      Size of container
           Lot size (primary containers)           ---------------------
                                                      n \1\      c \2\
------------------------------------------------------------------------
             net weight equal to or less than 1 kg (2.2 lb)
------------------------------------------------------------------------
4,800 or less.....................................         13          2
4,801 to 24,000...................................         21          3
24,001 to 48,000..................................         29          4
48,001 to 84,000..................................         48          6
84,001 to 144,000.................................         84          9
144,001 to 240,000................................        126         13
Over 240,000......................................        200         19
------------------------------------------------------------------------
 net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
------------------------------------------------------------------------
2,400 or less.....................................         13          2
2,401 to 15,000...................................         21          3
15,001 to 24,000..................................         29          4
24,001 to 42,000..................................         48          6
42,001 to 72,000..................................         84          9
72,001 to 120,000.................................        126         13
Over 120,000......................................        200         19
------------------------------------------------------------------------
                 net weight greater than 4.5 kg (10 lb)
------------------------------------------------------------------------
600 or less.......................................         13          2
601 to 2,000......................................         21          3
2,001 to 7,200....................................         29          4
7,201 to 15,000...................................         48          6
15,001 to 24,000..................................         84          9
24,001 to 42,000..................................        126         13
Over 42,000.......................................        200         19
------------------------------------------------------------------------
\1\ n = number of primary containers in sample.
\2\ c = acceptance number.



Subpart B_Requirements for Specific Standardized Canned Fruit Juices and 
                                Beverages



Sec. 146.114  Lemon juice.

    (a) Identity--(1) Description. Lemon juice is the unfermented juice, 
obtained by mechanical process, from sound, mature lemons (Citrus limon 
(L.) Burm. f.), from which seeds (except embryonic seeds and small 
fragments of seed which cannot be separated by good manufacturing 
practice) and excess pulp are removed. The juice may be adjusted by the 
addition of the optional concentrated lemon juice ingredient

[[Page 624]]

specified in paragraph (a)(2) of this section in such quantity so that 
the increase in acidity, calculated as anhydrous citric acid, does not 
exceed 15 percent of the acidity of the finished food. The lemon oil and 
lemon essence (derived from lemons) content may be adjusted in 
accordance with good manufacturing practice. The juice may have been 
concentrated and later reconstituted. When prepared from concentrated 
lemon juice, the finished food contains not less than 6 percent, by 
weight, of soluble solids taken as the refractometric sucrose value (of 
the filtrate), corrected to 20 [deg]C, but uncorrected for acidity, in 
accordance with the ``International Scale of Refractive Indices of 
Sucrose Solutions'' in section 52.012 of ``Official Methods of Analysis 
of the Association of Official Analytical Chemists,'' 13th Ed. (1980), 
which is incorporated by reference, and has a titratable acidity content 
of not less than 4.5 percent, by weight, calculated as anhydrous citrus 
acid. Copies of the incorporation by reference may be obtained from the 
AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, 
MD 20877, or may be examined 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. The 
food may contain one or any combination of the safe and suitable 
optional ingredients specified in paragraph (a)(2) of this section. 
Lemon juice, as defined in this paragraph, may be preserved by heat 
sterilization (canning), refrigeration, freezing, or by the addition of 
safe and suitable preservatives. When sealed in a container to be held 
at ambient temperatures, it is preserved by the addition of safe and 
suitable preservatives or so processed by heat, before or after sealing, 
as to prevent spoilage.
    (2) Optional ingredients. The optional safe and suitable ingredients 
referred to in paragraph (a)(1) of this section are:
    (i) Concentrated lemon juice (lemon juice from which part of the 
water has been removed).
    (ii) Water and/or lemon juice to reconstitute concentrated lemon 
juice in the manufacture of lemon juice from concentrate.
    (iii) Preservatives.
    (3) Labeling. (i) The name of the food is:
    (a) ``Lemon juice'' (1) if the food is prepared from unconcentrated, 
undiluted liquid extracted from mature lemons; or (2) if the food is 
prepared from unconcentrated, undiluted liquid extracted from mature 
lemons to which concentrated lemon juice is added to adjust acidity as 
provided for in paragraph (a)(1) of this section.
    (b) ``Lemon juice from concentrate'' or ``reconstituted lemon 
juice'' (1) if the food is prepared from concentrated lemon juice and 
water and/or lemon juice; or (2) if the food is prepared from lemon 
juice from concentrate and lemon juice. The words ``from concentrate'' 
or ``reconstituted'' shall be shown in letters not less than one-half 
the height of the letters in the word ``lemon juice.''
    (ii) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) [Reserved]
    (c) Fill of container. (1) The standard of fill of container for 
lemon juice, except when the food is frozen, is not less than 90 percent 
of the total capacity of the container as determined by the general 
method for fill of container prescribed in Sec. 130.12(b) of this 
chapter, except
    (i) When the food is frozen or
    (ii) When the food is packaged in individual serving-size packages, 
containing \1/2\ fluid ounce or less, for use as described in Sec. 
1.24(a)(3) of this chapter.
    (2) Compliance is determined as specified in Sec. 146.3(g)(2).
    (3) If the lemon juice fails to meet the standard of fill as 
prescribed in paragraph (c) (1) and (2) of this section, the label shall 
bear the general statement of substandard fill specified in Sec. 
130.14(b) of this chapter, in the manner and form therein prescribed.

[45 FR 7786, Feb. 5, 1980, as amended at 47 FR 11830, Mar. 19, 1982; 49 
FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2881, Jan. 6, 
1993; 63 FR 14035, Mar. 24, 1998]

[[Page 625]]



Sec. 146.120  Frozen concentrate for lemonade.

    (a) Frozen concentrate for lemonade is the frozen food prepared from 
one or both of the lemon juice ingredients specified in paragraph (b) of 
this section together with one or any mixture of safe and suitable 
nutritive carbohydrate sweeteners. The product contains not less than 
48.0 percent by weight of soluble solids taken as the sucrose value 
determined by refractometer and corrected for acidity prescribed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), section 22.025, ``Frozen Concentrate for 
Lemonade (12),'' under the heading ``Soluble Solids by Refractometer--
Official First Action,'' which is incorporated by reference. Copies may 
be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined 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 When the product is diluted according to directions 
for making lemonade which shall appear on the label, the acidity of the 
lemonade, calculated as anhydrous citric acid, shall be not less than 
0.70 gram per 100 milliliters, and the soluble solids, measured as 
described for the concentrate, shall be not less than 10.5 percent by 
weight.
    (b) The lemon juice ingredients referred to in paragraph (a) of this 
section are:
    (1) Lemon juice or frozen lemon juice or a mixture of these.
    (2) Concentrated lemon juice or frozen concentrated lemon juice or a 
mixture of these.


For the purposes of this section, lemon juice is the undiluted juice 
expressed from mature lemons of an acid variety; and concentrated lemon 
juice is lemon juice from which part of the water has been removed. In 
the preparation of the lemon juice ingredients, the lemon oil content 
may be adjusted by the addition of lemon oil or concentrated lemon oil 
in accordance with good manufacturing practice, and the lemon pulp in 
the juice as expressed may be left in the juice or may be separated. 
Lemon pulp that has been separated, which may have been preserved by 
freezing, may be added in preparing frozen concentrate for lemonade, 
provided that the amount of pulp added does not raise the proportion of 
pulp in the finished food to a level in excess of that which would be 
present by using lemon juice ingredients from which pulp has not been 
separated. The lemon juice ingredients may be treated by heat, either 
before or after the other ingredients are added, to reduce the enzymatic 
activity and the number of viable microorganisms.
    (c) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14433, Mar. 15, 1977, as amended at 47 FR 11830, Mar. 19, 1982; 
49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2881, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 146.121  Frozen concentrate for artificially sweetened lemonade.

    (a) Frozen concentrate for artificially sweetened lemonade conforms 
to the definition and standard of identity prescribed for frozen 
concentrate for lemonade by Sec. 146.120, except that in lieu of 
nutritive sweeteners it is sweetened with one or more of the artificial 
sweetening ingredients listed in and complying with the requirements of 
parts 172, 180 or 184 of this chapter, and the soluble solids 
specifications prescribed in Sec. 146.120(a) do not apply. When the 
product is diluted according to directions which shall appear on the 
label, the acidity of the artificially sweetened lemonade, calculated as 
anhydrous citric acid, shall be not less than 0.70 gram per 100 
milliliters. It may contain one or more safe and suitable dispersing 
ingredients serving the function of distributing the lemon oil 
throughout the food. It may also contain one or more safe and suitable 
thickening ingredients. Such dispersing and thickening ingredients are 
not food additives as defined in section 201(s) of the Federal Food, 
Drug, and

[[Page 626]]

Cosmetic Act; or if they are food additives as so defined, they are used 
in conformity with regulations established pursuant to section 409 of 
the act.
    (b) [Reserved]
    (c) The name of the food is ``Frozen concentrate for artificially 
sweetened lemonade''. The words ``artificially sweetened'' shall be of 
the same size and style of type as the word ``lemonade''.
    (d) If an optional thickening or dispersing ingredient referred to 
in paragraph (a) of this section is used, the label shall bear the 
statement ``___ added'' or ``with added ___'', the blank being filled in 
with the common name of the thickening or dispersing agent used. Such 
statement shall be set forth on the label with such prominence and 
conspicuousness as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase.
    (e) Frozen concentrate for artificially sweetened lemonade is 
labeled to conform to the labeling requirements prescribed for foods 
which purport to be or are represented for special dietary use by 
regulations promulgated pursuant to section 403(j) of the act.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]



Sec. 146.126  Frozen concentrate for colored lemonade.

    (a) Frozen concentrate for colored lemonade conforms to the 
definition and standard of identity prescribed for frozen concentrate 
for lemonade by Sec. 146.120, except that it is colored with a safe and 
suitable fruit juice, vegetable juice, or any such juice in concentrated 
form, or with any other color additive ingredient suitable for use in 
food, including artificial coloring, used in conformity with regulations 
established pursuant to section 721 of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The name of the food is ``Frozen concentrate for ___ lemonade'', 
the blank being filled in with the word describing the color: for 
example, ``Frozen concentrate for pink lemonade''.
    (c) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]



Sec. 146.132  Grapefruit juice.

    (a) Identity--(1) Description. Grapefruit juice is the unfermented 
juice, intended for direct consumption, obtained by mechanical process 
from sound, mature grapefruit (Citrus paradisi Macfadyen) from which 
seeds and peel (except embryonic seeds and small fragments of seeds and 
peel which cannot be separated by good manufacturing practice) and 
excess pulp are removed and to which may be added not more than 10 
percent by volume of the unfermented juice obtained from mature hybrids 
of grapefruit. The juice may be adjusted by the addition of the optional 
concentrated grapefruit juice ingredients specified in paragraph (a)(2) 
of this section, but the quantity of such concentrated grapefruit juice 
ingredient added shall not contribute more than 15 percent of the 
grapefruit juice soluble solids in the finished food. The grapefruit 
pulp, grapefruit oil, and grapefuit essence (components derived from 
grapefruit) content may be adjusted in accordance with good 
manufacturing practice. The juice may have been concentrated and later 
reconstituted with water suitable for the purpose of maintaining 
essential composition and quality factors of the juice. It may be 
sweetened with the dry nutritive sweeteners referred to in paragraph 
(a)(2)(iii) of this section. If the grapefruit juice is prepared from 
concentrate, such sweeteners, in liquid form, referred to in paragraph 
(a)(2)(iii) of this section, also may be used. When prepared from 
concentrated grapefruit juice, exclusive of added sweeteners, the 
finished food contains not less than 10 percent, by weight, of soluble 
solids taken as the refractometric sucrose value (of the filtrate), 
corrected to 20 [deg]C, and corrected for acidity by adding (0.012 + 
0.193x-0.0004x\2\), where x equals the percent anhydrous citric acid in 
the sample, to the refractometrically

[[Page 627]]

obtained sucrose value by the first method prescribed in ``Correction of 
Refractometer Sucrose Readings for Citric Acid Content for Lemonade,'' 
by Yeatman, Senzel, and Springer, ``Journal of the Association of 
Official Analytical Chemists,'' vol. 59 p. 368 (1976). Copies are 
available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or 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. The food may contain one or any combination of the 
optional ingredients specified in paragraph (a)(2) of this section. 
Grapefruit juice, as defined in this paragraph, may be preserved by heat 
sterlization (canning), refrigeration, or freezing. When sealed in a 
container to be held at ambient temperatures, it is so processed by 
heat, before or after sealing, as to prevent spoilage.
    (2) Optional ingredients. The optional ingredients referred to in 
paragraph (a)(1) of this section are:
    (i) Concentrated grapefruit juice (grapefruit juice from which part 
of the water has been removed).
    (ii) Water and/or grapefruit juice to reconstitute concentrated 
grapefruit juice in the manufacture of grapefruit juice from 
concentrate.
    (iii) One or any combination of two or more of the dry or liquid 
forms of sugar, invert sugar sirup, dextrose, glucose sirup, and 
fructose. Sweeteners defined in part 168 of this chapter shall be as 
defined therein.
    (3) Labeling. (i) The name of the food is:
    (a) ``Grapefruit juice'' (1) if the food is prepared from 
unconcentrated, undiluted liquid extracted from mature grapefruit; or 
(2) if the food is prepared from unconcentrated, undiluted liquid 
extracted from mature grapefruit to which concentrated grapefruit juice 
is added to adjust soluble solids as provided for in paragraph (a)(1) of 
this section.
    (b) ``Grapefruit juice from concentrate'' (1) if the food is 
prepared from concentrated grapefruit juice and water and/or grapefruit 
juice; or (2) if the food is prepared from grapefuit juice from 
concentrate and grapefruit juice. The words ``from concentrate'' shall 
be shown in letters not less than one-half the height of the letters in 
the words ``grapefruit juice.''
    (ii) If any nutritive sweetener is added, the principal display 
panel of the label shall bear the statement ``Sweetener added.'' If no 
sweetener is added, the word ``unsweetened'' may immediately precede or 
follow the words ``Grapefruit Juice'' or ``Grapefruit Juice from 
Concentrate.''
    (iii) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) [Reserved]
    (c) Fill of container. (1) The standard of fill of container for 
grapefruit juice, except when the food is frozen, is not less than 90 
percent of the total capacity of the container as determined by the 
general method for fill of container prescribed in Sec. 130.12(b) of 
this chapter.
    (2) Compliance is determined as specified in Sec. 146.3(g)(2).
    (3) If the grapefruit juice fails to meet the standard of fill as 
prescribed in paragraphs (c) (1) and (2) of this section, the label 
shall bear the general statement of substandard fill specified in Sec. 
130.14(b) of this chapter, in the manner and form therein prescribed.

[46 FR 8464, Jan. 27, 1981; 46 FR 21359, Apr. 10, 1981; 46 FR 26300, May 
12, 1981, as amended at 47 FR 11830, Mar. 19, 1982; 47 FR 24287, June 4, 
1982; 47 FR 43364, Oct. 1, 1982; 58 FR 2881, Jan. 6, 1993; 66 FR 17359, 
Mar. 30, 2001]



Sec. 146.135  Orange juice.

    (a) Orange juice is the unfermented juice obtained from mature 
oranges of the species Citrus sinensis or of the citrus hybrid commonly 
called ``Ambersweet'' (\1/2\ Citrus sinensis X \3/8\ Citrus reticulata X 
\1/8\ Citrus paradisi (USDA Selection:1-100-29: 1972 Whitmore Foundation 
Farm)). Seeds (except embryonic seeds and small fragments of seeds that 
cannot be separated by current good manufacturing practice) and excess 
pulp are removed. The juice may be chilled, but it is not frozen.

[[Page 628]]

    (b) The name of the food is ``orange juice''. The name ``orange 
juice'' may be preceded on the label by the varietal name of the oranges 
used, and if the oranges grew in a single State, the name of such State 
may be included in the name, as for example, ``California Valencia 
orange juice''.

[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992]



Sec. 146.137  Frozen orange juice.

    (a) Frozen orange juice is orange juice as defined in Sec. 146.135, 
except that it is frozen.
    (b) The name of the food is ``Frozen orange juice''. Such name may 
be preceded on the label by the varietal name of the oranges used, and 
if the oranges grew in a single State, the name of such State may be 
included in the name, as for example, ``California Valencia frozen 
orange juice''.



Sec. 146.140  Pasteurized orange juice.

    (a) Pasteurized orange juice is the food prepared from unfermented 
juice obtained from mature oranges as specified in Sec. 146.135, to 
which may be added not more that 10 percent by volume of the unfermented 
juice obtained from mature oranges of the species Citrus reticulata or 
Citrus reticulata hybrids (except that this limitation shall not apply 
to the hybrid species described in Sec. 146.135). Seeds (except 
embryonic seeds and small fragments of seeds that cannot be separated by 
good manufacturing practice) are removed, and pulp and orange oil may be 
adjusted in accordance with good manufacturing practice. If the 
adjustment involves the addition of pulp, then such pulp shall not be of 
the washed or spent type. The solids may be adjusted by the addition of 
one or more of the optional concentrated orange juice ingredients 
specified in paragraph (b) of this section. One or more of the optional 
sweetening ingredients listed in paragraph (c) of this section may be 
added in a quantity reasonably necessary to raise the Brix or the Brix-
acid ratio to any point within the normal range usually found in 
unfermented juice obtained from mature oranges as specified in Sec. 
146.135. The orange juice is so treated by heat as to reduce 
substantially the enzymatic activity and the number of viable 
microorganisms. Either before or after such heat treatment, all or a 
part of the product may be frozen. The finished pasteurized orange juice 
contains not less than 10.5 percent by weight of orange juice soluble 
solids, exclusive of the solids of any added optional sweetening 
ingredients, and the ratio of the Brix hydrometer reading to the grams 
of anhydrous citric acid per 100 milliliters of juice is not less than 
10 to 1.
    (b) The optional concentrated orange juice ingredients referred to 
in paragraph (a) of this section are frozen concentrated orange juice as 
specified in Sec. 146.146 and concentrated orange juice for 
manufacturing as specified in Sec. 146.153 when made from mature 
oranges; but the quantity of such concentrated orange juice ingredients 
added shall not contribute more than one-fourth of the total orange 
juice solids in the finished pasteurized orange juice.
    (c) The optional sweetening ingredients referred to in paragraph (a) 
of this section are sugar, invert sugar, dextrose, dried corn sirup, 
dried glucose sirup.
    (d)(1) The name of the food is ``Pasteurized orange juice''. If the 
food is filled into containers and preserved by freezing, the label 
shall bear the name ``Frozen pasteurized orange juice''. The words 
``pasteurized'' or ``frozen pasteurized'' shall be shown on labels in 
letters not less than one-half the height of the letters in the words 
``orange juice''.
    (2) If the pasteurized orange juice is filled into containers and 
refrigerated, the label shall bear the name of the food, ``chilled 
pasteurized orange juice''. If it does not purport to be either canned 
orange juice or frozen pasteurized orange juice, the word ``chilled'' 
may be omitted from the name. The words ``pasteurized'' or ``chilled 
pasteurized'' shall be shown in letters not less than one-half the 
height of the letters in the words ``orange juice''.
    (e)(1) If a concentrated orange juice ingredient specified in 
paragraph (b) of this section is used in adjusting the orange juice 
solids of the pasteurized orange juice, the label shall bear the

[[Page 629]]

statement ``prepared in part from concentrated orange juice'' or ``with 
added concentrated orange juice'' or ``concentrated orange juice 
added''.
    (2) If one or more of the sweetening ingredients specified in 
paragraph (c) of this section are added to the pasteurized orange juice, 
the label shall bear the statement ``___ added'', the blank being filled 
in with the name or an appropriate combination of the names of the 
sweetening ingredients used. However, for the purpose of this section, 
the name ``sweetener'' may be used in lieu of the specific name or names 
of the sweetening ingredients.
    (f) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statements specified in this section for naming the 
optional ingredients used shall immediately and conspicuously precede or 
follow the name of the food, without intervening written, printed, or 
graphic matter.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58 
FR 2881, Jan. 6, 1993]



Sec. 146.141  Canned orange juice.

    (a) Canned orange juice is the food prepared from orange juice as 
specified in Sec. 146.135 or frozen orange juice as specified in Sec. 
146.137, or a combination of both, to which may be added not more than 
10 percent by volume of the unfermented juice obtained from mature 
oranges of the species Citrus reticulata or Citrus reticulata hybrids 
(except that this limitation shall not apply to the hybrid species 
described in Sec. 146.135). Seeds (except embryonic seeds and small 
fragments of seeds that cannot be separated by good manufacturing 
practice) are removed. Orange oil and pulp may be adjusted in accordance 
with good manufacturing practice. The adjustment of pulp referred to in 
this paragraph does not permit the addition of washed or spent pulp. 
Liquid condensate recovered from the deoiling operation may be added 
back. One or more of the optional sweetening ingredients named in 
paragraph (b) of this section may be added, in a quantity reasonably 
necessary to raise the Brix or the Brix-acid ratio to any point within 
the normal range usually found in unfermented juice obtained from mature 
oranges as specified in Sec. 146.135. The food is sealed in containers 
and so processed by heat, either before or after sealing, as to prevent 
spoilage. The finished canned orange juice tests not less than 10[deg] 
Brix, and the ratio of the Brix hydrometer reading to the grams of 
anhydrous citric acid per 100 milliliters of juice is not less than 9 to 
1.
    (b) The optional sweetening ingredients referred to in paragraph (a) 
of this section are sugar, invert sugar, dextrose, dried corn sirup, 
dried glucose sirup.
    (c) The name of the food is ``Canned orange juice''. All the words 
in the name shall appear in the same size, color, and style of type and 
on the same color-contrasting background. If the food is not sold under 
refrigeration and if it does not purport to be chilled pasteurized 
orange juice or frozen pasteurized orange juice, the word ``canned'' may 
be omitted from the name.
    (d) If one or more of the sweetening ingredients specified in 
paragraph (b) of this section are added to the canned orange juice, the 
label shall bear the statement ``___ added'', the blank being filled in 
with the name or an appropriate combination of the names of the 
sweetening ingredients used. However, for the purpose of this section, 
the name ``sweetener'' may be used in lieu of the specific name or names 
of the sweetening ingredients.
    (e) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statement specified in this section for naming the 
optional ingredients used shall immediately and conspicuously precede or 
follow the name of the food, without intervening written, printed, or 
graphic matter.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the

[[Page 630]]

applicable sections of parts 101 and 130 of this chapter.

[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58 
FR 2881, Jan. 6, 1993]



Sec. 146.145  Orange juice from concentrate.

    (a) Orange juice from concentrate is the food prepared by mixing 
water with frozen concentrated orange juice as defined in Sec. 146.146 
or with concentrated orange juice for manufacturing as defined in Sec. 
146.153 (when made from mature oranges), or both. To such mixture may be 
added orange juice as defined in Sec. 146.135, frozen orange juice as 
defined in Sec. 146.137, pasteurized orange juice as defined in Sec. 
146.140, orange juice for manufacturing as defined in Sec. 146.151 
(when made from mature oranges and preserved by chilling or freezing but 
not by canning), orange oil, orange pulp, and one or more of the 
sweetening ingredients listed in paragraph (b) of this section. The 
finished orange juice from concentrate contains not less than 11.8 
percent orange juice soluble solids, exclusive of solids of any added 
optional sweetening ingredients. It may be so treated by heat as to 
reduce substantially the enzymatic activity and the number of viable 
microorganisms.
    (b) The sweetening ingredients referred to in paragraph (a) of this 
section are sugar, sugar sirup, invert sugar, invert sugar sirup, 
dextrose, corn sirup, dried corn sirup, glucose sirup, dried glucose 
sirup.
    (c) The name of the food is ``Orange juice from concentrate''. The 
words ``from concentrate'' shall be shown in letters not less than one-
half the height of the letters in the words ``orange juice''.
    (d) When orange juice from concentrate contains any optional 
sweetening ingredient as listed in paragraph (b) of this section, 
whether added directly as such or indirectly as an added ingredient of 
any orange juice product used, the label shall bear the statement ``___ 
added'', the blank being filled in with the name or an appropriate 
combination of the names of the sweetening ingredients added. However, 
for the purposes of this section the name ``sweetener'' may be used in 
lieu of the specific name or names of the sweetening ingredients.
    (e) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statements specified in this section for naming the 
optional ingredients used shall immediately and conspicuously precede or 
follow the name of the food, without intervening written, printed, or 
graphic matter.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]



Sec. 146.146  Frozen concentrated orange juice.

    (a) Frozen concentrated orange juice is the food prepared by 
removing water from the juice of mature oranges as provided in Sec. 
146.135, to which may be added unfermented juice obtained from mature 
oranges of the species Citrus reticulata, other Citrus reticulata 
hybrids, or of Citrus aurantium, or both. However, in the unconcentrated 
blend, the volume of juice from Citrus reticulata or Citrus reticulata 
hybrids shall not exceed 10 percent (except that this limitation shall 
not apply to the hybrid species described in Sec. 146.135) and from 
Citrus aurantium shall not exceed 5 percent. The concentrate so obtained 
is frozen. In its preparation, seeds (except embryonic seeds and small 
fragments of seeds that cannot be separated by good manufacturing 
practice) and excess pulp are removed, and a properly prepared water 
extract of the excess pulp so removed may be added. Orange oil, orange 
pulp, orange essence (obtained from orange juice), orange juice and 
other orange juice concentrate as provided in this section or 
concentrated orange juice for manufacturing provided in Sec. 146.153 
(when made from mature oranges), water, and one or more of the optional 
sweetening ingredients specified in paragraph (b) of this section may be 
added to adjust the final composition. The juice of Citrus reticulata 
and Citrus aurantium, as permitted by this paragraph, may be

[[Page 631]]

added in single strength or concentrated form prior to concentration of 
the Citrus sinensis juice, or in concentrated form during adjustment of 
the composition of the finished food. The addition of concentrated juice 
from Citrus reticulata or Citrus aurantium, or both, shall not exceed, 
on a single-strength basis, the 10 percent maximum for Citrus reticulata 
and the 5 percent maximum for Citrus aurantium prescribed by this 
paragraph. Any of the ingredients of the finished concentrate may have 
been so treated by heat as to reduce substantially the enzymatic 
activity and the number of viable microorganisms. The finished food is 
of such concentration that when diluted according to label directions 
the diluted article will contain not less than 11.8 percent by weight of 
orange juice soluble solids, exclusive of the solids of any added 
optional sweetening ingredients. The dilution ratio shall be not less 
than 3 plus 1. For the purposes of this section and Sec. 146.150, the 
term ``dilution ratio'' means the whole number of volumes of water per 
volume of frozen concentrate required to produce orange juice from 
concentrate having orange juice soluble solids of not less than 11.8 
percent by weight exclusive of the solids of any added optional 
sweetening ingredients.
    (b) The optional sweetening ingredients referred to in paragraph (a) 
of this section are sugar, sugar sirup, invert sugar, invert sugar 
sirup, dextrose, corn sirup, dried corn sirup, glucose sirup, and dried 
glucose sirup.
    (c) If one or more of the sweetening ingredients specified in 
paragraph (b) of this section are added to the frozen concentrated 
orange juice, the label shall bear the statement ``___ added'', the 
blank being filled in with the name or an appropriate combination of 
names of the sweetening ingredients used. However, for the purpose of 
this section, the name ``sweetener'' may be used in lieu of the specific 
name or names of the sweetening ingredients.
    (d) The name of the food concentrated to a dilution ratio of 3 plus 
1 is ``frozen concentrated orange juice'' or ``frozen orange juice 
concentrate''. The name of the food concentrated to a dilution ratio 
greater than 3 plus 1 is ``frozen concentrated orange juice, ___ plus 
1'' or ``frozen orange juice concentrate, ___ plus 1'', the blank being 
filled in with the whole number showing the dilution ratio; for example, 
``frozen orange juice concentrate, 4 plus 1''. However, where the label 
bears directions for making 1 quart of orange juice from concentrate (or 
multiples of a quart), the blank in the name may be filled in with a 
mixed number; for example, ``frozen orange juice concentrate, 4\1/3\ 
plus 1''. For containers larger than 1 pint, the dilution ratio in the 
name may be replaced by the concentration of orange juice soluble solids 
in degrees Brix; for example, a 62[deg] Brix concentrate in 3\1/2\-
gallon cans may be named on the label ``frozen concentrated orange 
juice, 62[deg] Brix''.
    (e) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statements specified in this section for naming the 
optional ingredients used shall immediately and conspicuously precede or 
follow the name of the food, without intervening written, printed, or 
graphic matter.
    (f) Nothing in this section is intended to interfere with the 
adoption and enforcement by any State, in regulating the production of 
frozen concentrated orange juice in such State, of State standards, 
consistent with this section, but which impose higher or more 
restrictive requirements than those set forth in this section.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58 
FR 2881, Jan. 6, 1993]



Sec. 146.148  Reduced acid frozen concentrated orange juice.

    (a) Reduced acid frozen concentrated orange juice is the food that 
complies with the requirements for composition and label declaration of 
ingredients prescribed for frozen concentrated orange juice by Sec. 
146.146, except that it may not contain any added sweetening ingredient. 
A process involving the use of anionic ion-exchange resins permitted by 
Sec. 173.25 of this chapter is used

[[Page 632]]

to reduce the acidity of the food so that the ratio of the Brix reading 
to the grams of acid, expressed as anhydrous citric acid, per 100 grams 
of juice is not less than 21 to 1 or more than 26 to 1.
    (b) The name of the food is ``Reduced acid frozen concentrated 
orange juice''.

[45 FR 12414, Feb. 26, 1980, as amended at 58 FR 2881, Jan. 6, 1993]



Sec. 146.150  Canned concentrated orange juice.

    (a) Canned concentrated orange juice is the food that complies with 
the requirements of composition, definition of dilution ratio, and 
labeling of ingredients prescribed for frozen concentrated orange juice 
by Sec. 146.146, except that it is not frozen and it is sealed in 
containers and so processed by heat, either before or after sealing, so 
as to prevent spoilage.
    (b) The name of the food when concentrated to a dilution ratio of 3 
plus 1 is ``Canned concentrated orange juice'' or ``Canned orange juice 
concentrate''. The name of the food when concentrated to a dilution 
ratio greater than 3 plus 1 is ``Canned concentrated orange juice, ___ 
plus 1'' or ``Canned orange juice concentrate, ___ plus 1'', the blank 
being filled in with the whole number showing the dilution ratio; for 
example, ``Canned orange juice concentrate, 4 plus 1''. However, where 
the label bears directions for making 1 quart of single-strength diluted 
product (or multiples of a quart) the blank in the name may be filled in 
with a mixed number; for example, ``Canned orange juice concentrate, 
4\1/3\ plus 1''. For containers larger than 1 pint, the dilution ratio 
in the name may be replaced by the concentration of orange juice soluble 
solids in degrees Brix; for example, a 62[deg] Brix concentrate in 1-
gallon cans may be named on the label ``canned concentrated orange 
juice, 62[deg] Brix''. If the food does not purport to be frozen 
concentrated orange juice, the word ``canned'' may be omitted from the 
name.

[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]



Sec. 146.151  Orange juice for manufacturing.

    (a) Orange juice for manufacturing is the food prepared for further 
manufacturing use. It is prepared from unfermented juice obtained from 
oranges as provided in Sec. 146.135, except that the oranges may 
deviate from the standards for maturity in that they are below the 
minimum for Brix and Brix-acid ratio for such oranges, and to which 
juice may be added not more than 10 percent by volume of the unfermented 
juice obtained from oranges of the species Citrus reticulata or Citrus 
reticulata hybrids (except that this limitation shall not apply to the 
hybrid species described in Sec. 146.135). Seeds (except embryonic 
seeds and small fragments of seeds that cannot be separated by good 
manufacturing practice) are removed, and pulp and orange oil may be 
adjusted in accordance with good manufacturing practice. If pulp is 
added it shall be other than washed or spent pulp. The juice or portions 
thereof may be so treated by heat as to reduce substantially the 
enzymatic activity and number of viable microorganisms, and it may be 
chilled or frozen, or it may be so treated by heat, either before or 
after sealing in containers, as to prevent spoilage.
    (b) The name of the food is ``Orange juice for manufacturing''.

[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992]



Sec. 146.152  Orange juice with preservative.

    (a) Orange juice with preservative is the food prepared for further 
manufacturing use. It complies with the requirements for composition of 
orange juice for manufacturing as provided for in Sec. 146.151, except 
that a preservative is added to inhibit spoilage. It may be heat-treated 
to reduce substantially the enzymatic activity and the number of viable 
microorganisms.
    (b) The preservatives referred to in paragraph (a) of this section 
are any safe and suitable preservatives or combinations thereof.
    (c) The name of the food is ``Orange juice with preservative''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the

[[Page 633]]

applicable sections of parts 101 and 130 of this chapter. In addition, 
the name of each preservative shall be proceeded by a statement of the 
percent by weight of the preservative used. If the food is packed in 
container sizes that are less than 19 liters (5 gallons), the label 
shall bear a statement indicating that the food is for further 
manufacturing use only.
    (e) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statement specified in paragraph (d) of this section for 
naming the preservative ingredient used shall immediately and 
conspicuously precede or follow the name of the food, without 
intervening written, printed, or graphic matter.

[42 FR 14414, Mar. 15, 1977, as amended at 44 FR 36378, June 22, 1979; 
58 FR 2881, Jan. 6, 1993]



Sec. 146.153  Concentrated orange juice for manufacturing.

    (a) Concentrated orange juice for manufacturing is the food that 
complies with the requirements of composition and label declaration of 
ingredients prescribed for frozen concentrated orange juice by Sec. 
146.146, except that it is either not frozen or is less concentrated, or 
both, and the oranges from which the juice is obtained may deviate from 
the standards for maturity in that they are below the minimum Brix and 
Brix-acid ratio for such oranges: Provided, however, that the 
concentration of orange juice soluble solids is not less than 20[deg] 
Brix.
    (b) The name of the food is ``Concentrated orange juice for 
manufacturing, ___'' or ``___ orange juice concentrate for 
manufacturing'', the blank being filled in with the figure showing the 
concentration of orange juice soluble solids in degrees Brix.

[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]



Sec. 146.154  Concentrated orange juice with preservative.

    (a) Concentrated orange juice with preservative complies with the 
requirements for composition and labeling of optional ingredients 
prescribed for concentrated orange juice for manufacturing by Sec. 
146.153, except that a preservative is added to inhibit spoilage.
    (b) The preservatives referred to in paragraph (a) of this section 
are any safe and suitable preservatives or combinations thereof.
    (c) The name of the food is ``Concentrated orange juice with 
preservative, ___'', the blank being filled in with the figure showing 
the concentration of orange juice soluble solids in degrees Brix.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter. In addition, the name of each 
preservative shall be preceded by a statement of the percent by weight 
of the preservative used. If the food is packed in container sizes that 
are less than 19 liters (5 gallons), the label shall bear a statement 
indicating that the food is for further manufacturing use only.
    (e) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statement specified in paragraph (d) of this section for 
naming the preservative ingredient used shall immediately and 
conspicuously precede or follow the name of the food, without 
intervening written, printed, or graphic matter.

[42 FR 14414, Mar. 15, 1977, as amended at 44 FR 36378, June 22, 1979; 
58 FR 2882, Jan. 6, 1993]



Sec. 146.185  Pineapple juice.

    (a) Identity. (1) Pineapple juice is the juice, intended for direct 
consumption, obtained by mechanical process from the flesh or parts 
thereof, with or without core material, of sound, ripe pineapple (Ananas 
comosus L. Merrill). The juice may have been concentrated and later 
reconstituted with water suitable for the purpose of maintaining 
essential composition and quality factors of the juice. Pineapple juice 
may contain finely divided insoluble solids, but it does not contain 
pieces of shell, seeds, or other coarse or hard substances or excess 
pulp. It may be sweetened with any safe and suitable dry nutritive 
carbohydrate sweetener. However, if the pineapple juice is prepared from 
concentrate, such sweeteners, in liquid

[[Page 634]]

form, also may be used. It may contain added vitamin C in a quantity 
such that the total vitamin C in each 4 fluid ounces of the finished 
food amounts to not less than 30 milligrams and not more than 60 
milligrams. In the processing of pineapple juice, di methyl poly sil 
oxane complying with the requirements of Sec. 173.340 of this chapter 
may be employed as a defoaming agent in an amount not greater than 10 
parts per million by weight of the finished food. Such food is prepared 
by heat sterilization, refrigeration, or freezing. When sealed in a 
container to be held at ambient temperatures, it is so processed by 
heat, before or after sealing, as to prevent spoilage.
    (2) The name of the food is ``Pineapple juice'' if the juice from 
which it is prepared has not been concentrated and/or diluted with 
water. The name of the food is ``Pineapple juice from concentrate'' if 
the finished juice has been made from pineapple juice concentrate as 
specified in paragraph (a) of this section. If a nutritive sweetener is 
added, the label shall bear the statement ``Sweetener added.'' If no 
sweetener is added, the word ``Unsweetened'' may immediately precede or 
follow the words ``Pineapple juice'' or ``Pineapple juice from 
concentrate.''
    (3) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for pineapple juice is as 
follows:
    (i) The soluble solids content of pineapple juice (exclusive of 
added sugars) without added water shall not be less than 10.5[deg] Brix 
as determined by refractometer at 20 [deg]C uncorrected for acidity and 
read as degrees Brix on International Sucrose Scales. Where the juice 
has been obtained using concentrated juice with addition of water, the 
soluble pineapple juice solids content (exclusive of added sugars) shall 
be not less than 12.8[deg] Brix, uncorrected for acidity and read as 
degrees Brix on the International Sucrose Scales.
    (ii) The acidity, as determined by the method prescribed in 
paragraph (b)(2)(ii) of this section, is not more than 1.35 grams of 
anhydrous citric acid per 100 milliliters of the juice.
    (iii) The ratio of the degrees Brix to total acidity, as determined 
by the method prescribed in paragraph (b)(2)(iii) of this section, is 
not less than 12.
    (iv) The quantity of finely divided ``insoluble solids'', as 
determined by the method prescribed in paragraph (b)(2)(iv) of this 
section, is not less than 5 percent nor more than 30 percent.
    (2) The methods referred to in paragraph (b)(1) of this section are 
as follows:
    (i) Determine the degrees Brix of the pineapple juice by the method 
prescribed in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), section 31.009, 
``Solids by Means of Spindle--Official Final Action,'' which is 
incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (ii) Determine the total acidity of the pineapple juice by titration 
by the method prescribed in Sec. 145.180(b)(2)(ix) of this chapter.
    (iii) Divide the degrees Brix determined as prescribed in paragraph 
(b)(2)(i) of this section by the grams of anhydrous citric acid per 100 
milliliters of juice, determined as prescribed in paragraph (b)(2)(ii) 
of this section, and report the results as ratio of degrees Brix to 
total acidity.
    (iv) Determine the quantity of ``insoluble solids'' in pineapple 
juice as follows: Measure 50 milliliters of thoroughly stirred pineapple 
juice into a cone-shaped graduated tube of the long-cone type, measuring 
approximately 4\3/16\ inches from tip to top calibration and having a 
capacity of 50 milliliters. Place the tube in a suitable centrifuge the 
approximate speed of which is related to diameter of swing in accordance 
with the table immediately below. The word ``diameter'' means the over-
all distance between

[[Page 635]]

the tips of opposing centrifuge tubes in operating position.

------------------------------------------------------------------------
                                                             Approximate
                     Diameter (inches)                       revolutions
                                                              per minute
------------------------------------------------------------------------
10.........................................................        1,609
10\1/2\....................................................        1,570
11.........................................................        1,534
11\1/2\....................................................        1,500
12.........................................................        1,468
12\1/2\....................................................        1,438
13.........................................................        1,410
13\1/2\....................................................        1,384
14.........................................................        1,359
14\1/2\....................................................        1,336
15.........................................................        1,313
15\1/2\....................................................        1,292
16.........................................................        1,271
16\1/2\....................................................        1,252
17.........................................................        1,234
17\1/2\....................................................        1,216
18.........................................................        1,199
18\1/2\....................................................        1,182
19.........................................................        1,167
19\1/2\....................................................        1,152
20.........................................................        1,137
------------------------------------------------------------------------


The milliliter reading at the top of the layer of ``insoluble solids,'' 
after centrifuging 3 minutes, is multiplied by two to obtain the 
percentage of ``insoluble solids.''
    (3) If the quality of pineapple juice falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14 (a) 
of this chapter, in the manner and form therein specified.
    (c) Fill of container. (1) The standard of fill of container for 
pineapple juice, except when the food is frozen, is not less than 90 
percent of the total capacity of the container, as determined by the 
general method for fill of container prescribed in Sec. 130.12(b) of 
this chapter.
    (2) If pineapple juice falls below the standard of fill of container 
prescribed in paragraph (c)(1) of this section, the label shall bear the 
statement of substandard fill specified in Sec. 130.14(b) of this 
chapter, in the manner and form therein specified.

[42 FR 14433, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19, 1982; 
47 FR 52694, Nov. 23, 1982; 49 FR 10101, Mar. 19, 1984; 50 FR 19524, May 
9, 1985; 54 FR 24895, June 12, 1989; 58 FR 2882, Jan. 6, 1993; 63 FR 
14035, Mar. 24, 1998]



Sec. 146.187  Canned prune juice.

    (a) Canned prune juice is the food prepared from a water extract of 
dried prunes and contains not less than 18.5 percent by weight of water-
soluble solids extracted from dried prunes. The quantity of prune solids 
may be adjusted by the concentration, dilution, or both, of the water 
extract or extracts made. Such food may contain one or more of the 
optional acidifying ingredients specified in paragraph (b)(1) of this 
section, in a quantity sufficient to render the food slightly tart; it 
may contain honey added within the quantitative limits prescribed by 
paragraph (b)(2) of this section; and it may contain added vitamin C in 
a quantity prescribed by paragraph (b)(3) of this section. Such food is 
sealed in a container and so processed by heat, before or after sealing, 
as to prevent spoilage.
    (b) The optional ingredients referred to in paragraph (a) of this 
section are:
    (1) One or any combination of two or more of the following 
acidifying ingredients:
    (i) Lemon juice.
    (ii) Lime juice.
    (iii) Citric acid.
    (2) Honey, in a quantity not less than 2 percent and not more than 3 
percent by weight of the finished food.
    (3) Vitamin C, in a quantity such that the total vitamin C in each 6 
fluid ounces of the finished food amounts to not less than 30 milligrams 
and not more than 50 milligrams.
    (c)(1) The name of the food is ``Prune juice--a water extract of 
dried prunes''. For the purposes of the Federal Food, Drug, and Cosmetic 
Act concerning the label declaration of the name of the food, the 
explanatory statement ``A water extract of dried prunes'' may appear 
immediately below the words ``prune juice'', but there shall be no 
intervening written, printed, or graphic matter, and the type used for 
the words ``A water extract of dried prunes'' shall be of the same style 
and not less than half the print size of the type used for the words 
``prune juice''.
    (2)(i) When one or more of the acidifying ingredients specified in 
paragraph (b)(1) of this section are used, the label shall bear the 
statement ``___ added'' or ``with added ___'', the blank being filled in 
with the name or names of the optional ingredients used.
    (ii) When honey, as specified in paragraph (b)(2) of this section, 
is used the

[[Page 636]]

label shall bear the statement ``with ___ honey'' or ``___ honey 
added'', the blank to be filled in with the percent by weight of the 
honey in the finished food or with the statement ``between 2 and 3%''.
    (iii) When one or more of the ingredients designated in paragraph 
(b)(1) of this section and the ingredient designated in paragraph (b)(2) 
of this section are used, the statements specified in paragraphs (c)(2) 
(i) and (ii) of this section may be combined, as for example, ``with 
lemon juice and between 2 and 3% honey added''.
    (iv) When vitamin C is added as provided in paragraph (b)(3) of this 
section, it shall be designated on the label as ``vitamin C added'' or 
``with added vitamin C''.
    (3) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the words specified in this paragraph, showing the optional 
ingredients used, shall immediately and conspicuously precede or follow 
such name, without intervening written, printed, or graphic matter.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2882, Jan. 6, 1993]



PART 150_FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS--
Table of Contents



Subpart A [Reserved]

Subpart B_Requirements for Specific Standardized Fruit Butters, Jellies, 
                     Preserves, and Related Products

Sec.
150.110 Fruit butter.
150.140 Fruit jelly.
150.160 Fruit preserves and jams.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14445, Mar. 15, 1977, unless otherwise noted.

Subpart A [Reserved]



Subpart B_Requirements for Specific Standardized Fruit Butters, Jellies, 
                     Preserves, and Related Products



Sec. 150.110  Fruit butter.

    (a) The fruit butters for which definitions and standards of 
identity are prescribed by this section are the smooth, semisolid foods 
each of which is made from a mixture of one or a permitted combination 
of the optional fruit ingredients specified in paragraph (b) of this 
section and one or any combination of the optional ingredients specified 
in paragraph (c) of this section, which meets the specifications in 
paragraph (d) of this section, and which is labeled in accordance with 
paragraph (e) of this section. Such mixture is concentrated with or 
without heat. The volatile flavoring materials or essence from such 
mixture may be captured during concentration, separately concentrated, 
and added back to any such mixture, together with any concentrated 
essence accompanying any optional fruit ingredient.
    (b)(1) Each of the optional fruit ingredients referred to in 
paragraph (a) of this section is prepared by cooking one of the 
following fresh, frozen, canned, and/or dried (evaporated) mature 
fruits, with or without added water, and screening out skins, seeds, 
pits, and cores:

         Factor Referred to in Paragraph (d)(2) of This Section
------------------------------------------------------------------------
                          Name of fruit
------------------------------------------------------------------------
Apple............................................................    7.5
Apricot..........................................................    7.0
Grape............................................................    7.0
Peach............................................................    8.5
Pear.............................................................    6.5
Plum (other than prune)..........................................    7.0
Prune............................................................    7.0
Quince...........................................................    7.5
------------------------------------------------------------------------

    (2) The permitted combinations are of two, three, four, and five of 
the fruit ingredients specified in paragraph (b)(1) of this section; the 
weight of each is not less than one-fifth of the weight of the 
combination. Each such fruit ingredient in any such combination is an 
optional ingredient.
    (c) The following safe and suitable optional ingredients may be 
used:

[[Page 637]]

    (1) Nutritive carbohydrate sweeteners.
    (2) Spice.
    (3) Flavoring (other than artificial flavoring).
    (4) Salt.
    (5) Acidifying agents.
    (6) Fruit juice or diluted fruit juice or concentrated fruit juice, 
in a quantity not less than one-half the weight of the optional fruit 
ingredient.
    (7) Preservatives.
    (8) Antifoaming agents except those derived from animal fats.
    (9) Pectin, in a quantity which reasonably compensates for 
deficiency, if any, of the natural pectin content of the fruit 
ingredient.
    (d) For the purposes of this section:
    (1) The mixture referred to in paragraph (a) of this section shall 
contain not less than five parts by weight of the fruit ingredient as 
measured in accordance with paragraph (d)(2) of this section to each two 
parts by weight of nutritive carbohydrate sweetener as measured in 
accordance with paragraph (d)(4) of this section.
    (2) Any requirement with respect to the weight of any optional fruit 
ingredient, whether concentrated, unconcentrated, or diluted, means the 
weight determined by the following method: (i) Determine the percent of 
soluble solids in the optional fruit ingredient by the method for 
soluble solids referred to in paragraph (d)(3) of this section; (ii) 
multiply the percent so found by the weight of such fruit ingredient; 
(iii) divide the result by 100; (iv) subtract from the quotient the 
weight of any nutritive sweetener solids or other added solids; and (v) 
multiply the remainder by the factor for such ingredient prescribed in 
paragraph (b)(1) of this section. The result is the weight of the 
optional fruit ingredient.
    (3) The soluble solids content of the finished fruit butter is not 
less than 43 percent, as determined by the method prescribed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists'' (AOAC), 13th Ed. (1980), section 22.024, under ``Soluble 
Solids by Refractometer in Fresh and Canned Fruits, Fruit Jellies, 
Marmalades, and Preserves--Official Final Action,'' which is 
incorporated by reference, except that no correction is made for water-
insoluble solids. Copies may be obtained from the AOAC INTERNATIONAL, 
481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
examined 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.
    (4) The weight of any nutritive carbohydrate sweetener means the 
weight of the solids of such ingredient.
    (5) The weight of fruit juice or diluted fruit juice or concentrated 
fruit juice (optional ingredient, paragraph (c)(6)) from a fruit 
specified in paragraph (b)(1) of this section is the weight of such 
juice, as determined by the method prescribed in paragraph (d)(2) of 
this section, except that the percent of soluble solids is determined by 
the method prescribed in the AOAC, 13th Ed. (1980), section 31.011, 
under ``Solids by Means of Refractometer--Official Final Action,'' which 
is incorporated by reference; the weight of diluted concentrated juice 
from any other fruits is the original weight of the juice before it was 
diluted or concentrated. The availability of this incorporation by 
reference is given in paragraph (d)(3) of this section.
    (e)(1) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (i) In case the fruit butter is made from a single fruit ingredient, 
the name is ``Butter'', preceded by the name where by such fruit is 
designated in paragraph (b)(1) of this section.
    (ii) In case the fruit butter is made from a combination of two, 
three, four, or five fruit ingredients, the name is ``Butter'', preceded 
by the words ``Mixed fruit'' or by the names whereby such fruits are 
designated in paragraph (b)(1) of this section, in the order of 
predominance, if any, of the weight of such fruit ingredients in the 
combination.
    (2) Each of the optional ingredients specified in paragraphs (b) and 
(c) of this section shall be declared on the

[[Page 638]]

label as required by the applicable sections of part 101 of this 
chapter, except that:
    (i) Other than in the case of dried (evaporated) fruit the name(s) 
of the fruit or fruits used may be declared without specifying the 
particular form of the fruit or fruits used. When the optional fruit 
ingredient is prepared in whole or in part from dried fruit, the label 
shall bear the words ``prepared from'' or ``prepared in part from'', as 
the case may be, followed by the word ``evaporated'' or ``dried'', 
followed by the name whereby such fruit is designated in paragraph (c) 
of this section. When two or more such optional fruit ingredients are 
used, such names, each preceded by the word ``evaporated'' or ``dried'', 
shall appear in the order of predominance, if any, of the weight of such 
ingredients in the combination.
    (ii) [Reserved]

[42 FR 14445, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19, 1982; 
49 FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2882, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 150.140  Fruit jelly.

    (a) The jellies for which definitions and standards of identity are 
prescribed by this section are the jelled foods each of which is made 
from a mixture of one or a permitted combination of the fruit juice 
ingredients specified in paragraph (b) of this section and one or any 
combination of the optional ingredients specified in paragraph (c) of 
this section, which meets the specifications in paragraph (d) of this 
section and which is labeled in accordance with paragraph (e) of this 
section. Such mixture is concentrated with or without heat. The volatile 
flavoring materials or essence from such mixture may be captured during 
concentration, separately concentrated, and added back to any such 
mixture, together with any concentrated essence accompanying any 
optional fruit ingredient.
    (b)(1) Each of the fruit juice ingredients referred to in paragraph 
(a) of this section is the filtered or strained liquid extracted with or 
without the application of heat and with or without the addition of 
water, from one of the following mature, properly prepared fruits which 
are fresh, frozen and/or canned:

         Factor Referred to in Paragraph (d)(2) of This Section
------------------------------------------------------------------------
                          Name of fruit
------------------------------------------------------------------------
Apple............................................................    7.5
Apricot..........................................................    7.0
Blackberry (other than dewberry).................................   10.0
Black raspberry..................................................    9.0
Boysenberry......................................................   10.0
Cherry...........................................................    7.0
Crabapple........................................................    6.5
Cranberry........................................................    9.5
Damson, damson plum..............................................    7.0
Dewberry (other than boysenberry, loganberry, and youngberry)....   10.0
Fig..............................................................    5.5
Gooseberry.......................................................   12.0
Grape............................................................    7.0
Grapefruit.......................................................   11.0
Greengage, greengage plum........................................    7.0
Guava............................................................   13.0
Loganberry.......................................................    9.5
Orange...........................................................    8.0
Peach............................................................    8.5
Pineapple........................................................    7.0
Plum (other than damson, greengage, and prune)...................    7.0
Pomegranate......................................................    5.5
Prickly pear.....................................................   11.0
Quince...........................................................    7.5
Raspberry, red raspberry.........................................    9.5
Red currant, currant (other than black currant)..................    9.5
Strawberry.......................................................   12.5
Youngberry.......................................................   10.0
------------------------------------------------------------------------

    (2) The permitted combinations are of two, three, four, or five of 
the fruit juice ingredients specified in paragraph (b)(1) of this 
section, the weight of each is not less than one-fifth of the weight of 
the combination. Each such fruit juice ingredient in any such 
combination is an optional ingredient.
    (c) The following safe and suitable optional ingredients may be 
used:
    (1) Nutritive carbohydrate sweeteners.
    (2) Spice.
    (3) Acidifying agents.
    (4) Pectin, in a quantity which reasonably compensates for 
deficiency, if any, of the natural pectin content of the fruit juice 
ingredient.
    (5) Buffering agents.
    (6) Preservatives.
    (7) Antifoaming agents except those derived from animal fats.
    (8) Mint flavoring and artificial green coloring, in case the fruit 
juice ingredient or combination of fruit juice ingredients is extracted 
from apple, crabapple, pineapple, or two or all of such fruits.
    (9) Cinnamon flavoring, other than artificial flavoring, and 
artificial red

[[Page 639]]

coloring in case the fruit juice ingredient or combination of fruit 
juice ingredients is extracted from apple or crabapple or both such 
fruits.
    (d) For the purposes of this section:
    (1) The mixture referred to in paragraph (a) of this section shall 
contain not less than 45 parts by weight of the fruit juice ingredients 
as measured in accordance with paragraph (d)(2) of this section to each 
55 parts by weight of saccharine ingredient as measured in accordance 
with paragraph (d)(4) of this section.
    (2) Any requirement with respect to the weight of any fruit juice 
ingredient, whether prepared from concentrated, unconcentrated, or 
diluted fruit juice means the weight determined by the following method: 
(i) Determine the percent of soluble solids in such fruit juice 
ingredient by the method for soluble solids referred to in paragraph 
(d)(3) of this section; (ii) multiply the percent so found by the weight 
of such fruit juice ingredient; (iii) divide the result by 100; (iv) 
subtract from the quotient the weight of any added saccharine ingredient 
solids or other added solids; and (v) multiply the remainder by the 
factor for such fruit juice ingredient prescribed in paragraph (b) of 
this section. The result is the weight of the fruit juice ingredient.
    (3) The soluble-solids content of the finished jelly is not less 
than 65 percent, as determined by the method prescribed in ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), section 31.011, under ``Solids by Means of 
Refractometer--Official Final Action,'' which is incorporated by 
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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.
    (4) The weight of any optional saccharine ingredient means the 
weight of the solids of such ingredient.
    (e)(1) The name of each jelly for which a definition and standard of 
identity is prescribed by this section is as follows:
    (i) In case the jelly is made with a single fruit juice ingredient, 
the name is ``Jelly'', preceded or followed by the name or synonym 
whereby the fruit from which such fruit juice ingredient was extracted 
is designated in paragraph (b) of this section.
    (ii) In case the jelly is made with a combination of two, three, 
four, or five fruit juice ingredients, the name is ``Jelly'', preceded 
or followed by the words ``Mixed fruit'' or by the names or synonyms 
whereby the fruits from which the fruit juice ingredients were extracted 
are designated in paragraph (b) of this section, in the order of 
predominance, if any, of the weights of any such fruit juice ingredients 
in the combination.
    (2) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (i) The name(s) of the fruit or fruits used may be declared without 
specifying the particular form of the fruit or fruits used.
    (ii) When the optional ingredients listed in paragraphs (c) (3), 
(4), and (5) of this section are declared on the label, the declaration 
may be followed by the statement ``Used as needed'' on all jellies to 
which they are customarily, but not always, added to compensate for 
natural variations in the fruit juice ingredients used.

[42 FR 14445, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19, 1982; 
49 FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2882, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 150.160  Fruit preserves and jams.

    (a) The preserves or jams for which definitions and standards of 
identity are prescribed by this section are the viscous or semi-solid 
foods, each of which is made from a mixture composed of one or a 
permitted combination of the fruit ingredients specified in paragraph 
(b) of this section and one or any combination of the optional 
ingredients specified in paragraph (c) of this section which meets the 
specifications in paragraph (d) of this section,

[[Page 640]]

and which is labeled in accordance with paragraph (e) of this section. 
Such mixture, with or without added water, is concentrated with or 
without heat. The volatile flavoring material from such mixture may be 
captured during concentration, separately concentrated, and added back 
to any such mixture, together with any concentrated essence accompanying 
any optional fruit ingredient.
    (b)(1) The fruit ingredients referred to in paragraph (a) of this 
section are the following mature, properly prepared fruits which are 
fresh, concentrated, frozen and/or canned:

                                 Group I

    Blackberry (other than dewberry), Black raspberry, Blueberry, 
Boysenberry, Cherry, Crabapple, Dewberry (other than boysenberry, 
loganberry, and youngberry) Elderberry, Grape, Grapefruit, Huckleberry, 
Loganberry, Orange, Pineapple, Raspberry, red raspberry, Rhubarb, 
Strawberry, Tangerine, Tomato, Yellow tomato, Youngberry

                                Group II

    Apricot, Cranberry, Damson, damson plum, Fig, Gooseberry, Greengage, 
greengage plum, Guava, Nectarine, Peach, Pear, Plum (other than 
greengage plum and damson plum), Quince, Red currant, currant (other 
than black currant)

    (2) The following combinations of fruit ingredients may be used:
    (i) Any combination of two, three, four, or five of such fruits in 
which the weight of each is not less than one-fifth of the weight of the 
combination; except that the weight of pineapple may be not less than 
one-tenth of the weight of the combination.
    (ii) Any combination of apple and one, two, three, or four of such 
fruits in which the weight of each is not less than one-fifth and the 
weight of apple is not more than one-half of the weight of the 
combination; except that the weight of pineapple may be not less than 
one-tenth of the weight of the combination.


In any combination of two, three, four, or five fruits, each such fruit 
is an optional ingredient. For the purposes of this section the word 
``fruit'' includes the vegetables specified in this paragraph.
    (c) The following safe and suitable optional ingredients may be 
used:
    (1) Nutritive carbohydrate sweeteners.
    (2) Spice.
    (3) Acidifying agents.
    (4) Pectin, in a quantity which reasonably compensates for 
deficiency, if any, of the natural pectin content of the fruit 
ingredient.
    (5) Buffering agents.
    (6) Preservatives.
    (7) Antifoaming agents, except those derived from animal fat.
    (d) For the purposes of this section:
    (1) The mixture referred to in paragraph (a) of this section shall 
be composed of not less than: (i) In the case of a fruit ingredient 
consisting of a Group I fruit or a permitted combination exclusively of 
Group I fruits, 47 parts by weight of the fruit ingredient to each 55 
parts by weight of the saccharine ingredient; and (ii) in all other 
cases, 45 parts by weight of the fruit ingredient to each 55 parts by 
weight of the saccharine ingredient. The weight of the fruit ingredient 
shall be determined in accordance with paragraph (d)(2) of this section, 
and the weight of the saccharine ingredient shall be determined in 
accordance with paragraph (d)(5) of this section.
    (2) Any requirement with respect to the weight of any fruit, 
combination of fruits, or fruit ingredient means:
    (i) The weight of fruit exclusive of the weight of any sugar, water, 
or other substance added for any processing or packing or canning, or 
otherwise added to such fruit.
    (ii) In the case of fruit prepared by the removal, in whole or in 
part, of pits, seeds, skins, cores, or other parts; the weight of such 
fruit, exclusive of the weight of all such substances removed therefrom.
    (iii) In the cases of apricots, cherries, grapes, nectarines, 
peaches, and all varieties of plums, whether or not pits and seeds are 
removed therefrom; the weight of such fruit, exclusive of the weight of 
such pits and seeds.
    (iv) In the case of concentrated fruit, the weight of the properly 
prepared fresh fruit used to produce such concentrated fruit.
    (3) The term concentrated fruit means a concentrate made from the 
properly prepared edible portion of mature fresh or frozen fruits by 
removal of moisture

[[Page 641]]

with or without the use of heat or vacuum, but not to the point of 
drying. Such concentrate is canned or frozen without the addition of 
sugar or other sweetening agents and is identified to show or permit the 
calculation of the weight of the properly prepared fresh fruit used to 
produce any given quantity of such concentrate. The volatile flavoring 
material or essence from such fruits may be captured during 
concentration and separately concentrated for subsequent addition to the 
concentrated fruit either directly or during manufacture of the preserve 
or jam, in the original proportions present in the fruit.
    (4) The weight of any optional saccharine ingredient means the 
weight of the solids of such ingredient.
    (5) The soluble-solids content of the finished jam or preserve is 
not less than 65 percent, as determined by the method prescribed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), section 22.024, under ``Soluble Solids by 
Refractometer in Fresh and Canned Fruits, Jellies, Marmalades, and 
Preserves--Official Final Action,'' which is incorporated by reference, 
except that no correction is made for water-insoluble solids. Copies may 
be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined 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.
    (e)(1) The name of each preserve or jam for which a definition and 
standard of identity is prescribed by this section is as follows:
    (i) If the fruit ingredient is a single fruit, the name is 
``Preserve'' or ``Jam'', preceded or followed by the name or synonym 
whereby such fruit is designated in paragraph (b) of this section.
    (ii) If the fruit ingredient is a combination of two, three, four, 
or five fruits, the name is ``Preserve'' or ``Jam'', preceded or 
followed by the words ``Mixed fruit'' or by the names or synonyms 
whereby such fruits are designated in paragraph (b) of this section, in 
the order of predominance, if any, of the weights of such fruits in the 
combination.
    (2) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (i) The name(s) of the fruit or fruits used may be declared without 
specifying the particular form of the fruit or fruits used.
    (ii) When the optional ingredients listed in paragraphs (c) (3), 
(4), and (5) of this section are declared on the label, the declaration 
may be followed by the statement ``used as needed'' on all preserves or 
jams to which they are customarily, but not always, added to compensate 
for natural variations in the fruit ingredients used.

[42 FR 14445, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19, 1982; 
49 FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2882, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



PART 152_FRUIT PIES--Table of Contents



    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

Subpart A [Reserved]



       Subpart B_Requirements for Specific Standardized Fruit Pies



Sec. 152.126  Frozen cherry pie.

    (a) Identity. (1) Frozen cherry pie (excluding baked and then 
frozen) is the food prepared by incorporating in a filling contained in 
a pastry shell mature, pitted, stemmed cherries that are fresh, frozen, 
and/or canned. The top of the pie may be open or it may be wholly or 
partly covered with pastry or other suitable topping. Filling, pastry, 
and topping components of the food consist of optional ingredients as 
prescribed by paragraph (a)(2) of this section. The finished food is 
frozen.
    (2) The optional ingredients referred to in paragraph (a)(1) of this 
section consist of suitable substances that are not food additives as 
defined in section 201(s) of the Federal Food, Drug, and

[[Page 642]]

Cosmetic Act or color additives as defined in section 201(t) of the act; 
or if they are food additives or color additives as so defined, they are 
used in conformity with regulations established pursuant to section 409 
or 721 of the act. Ingredients that perform a useful function in the 
formulation of the filling, pastry, and topping components, when used in 
amounts reasonably required to accomplish their intended effect, are 
regarded as suitable except that artificial sweeteners are not suitable 
ingredients of frozen cherry pie.
    (3) The name of the food for which a definition and standard of 
identity is established by this section is frozen cherry pie; however, 
if the maximum diameter of the food (measured across opposite outside 
edges of the pastry shell) is not more than 4 inches, the food 
alternatively may be designated by the name frozen cherry tart. The word 
``frozen'' may be omitted from the name on the label if such omission is 
not misleading.
    (4)(i) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (ii) The label shall not bear any misleading pictorial 
representation of the cherries in the pie.
    (b) Quality. (1) The standard of quality for frozen cherry pie is as 
follows:
    (i) The fruit content of the pie is such that the weight of the 
washed and drained cherry content is not less than 25 percent of the 
weight of the pie when determined by the procedure prescribed by 
paragraph (b)(2) of this section.
    (ii) Not more than 15 percent by count of the cherries in the pie 
are blemished with scab, hail injury, discoloration, scar tissue, or 
other abnormality. A cherry showing skin discoloration (other than 
scald) having an aggregate area exceeding that of a circle nine thirty-
seconds of an inch in diameter is considered to be blemished. A cherry 
showing discoloration of any area but extending into the fruit tissue is 
also considered to be blemished.
    (2) Compliance with the requirement for the weight of the washed and 
drained cherry content of the pie, as prescribed by paragraph (b)(1)(i) 
of this section, is determined by the following procedure:
    (i) Select a random sample from a lot:
    (a) At least 24 containers if they bear a weight declaration of 16 
ounces or less.
    (b) Enough containers to provide a total quantity of declared weight 
of at least 24 pounds if they bear a weight declaration of more than 16 
ounces.
    (ii) Determine net weight of each frozen pie.
    (iii) Temper the pie until the top crust can be removed.
    (iv) Remove the filling and cherries from the pie and transfer to 
the surface of a previously weighed 12-inch diameter U.S. No. 8 sieve 
(0.094-inch openings) stacked on a U.S. No. 20 sieve (0.033-inch 
openings).
    (v) Distribute evenly over the surface and wash with a gentle spray 
of water at 70[deg]-75 [deg]F to free the cherries and cherry fragments 
from the adhering material.
    (vi) Remove the U.S. No. 8 sieve and examine the U.S. No. 20 sieve 
and transfer all cherry fragments to the U.S. No. 8 sieve.
    (vii) Drain the cherry contents on the No. 8 sieve for 2 minutes in 
an inclined position (15[deg]-30[deg] slope). Weigh the U.S. No. 8 sieve 
and the washed and drained cherries to the nearest 0.01 ounce.
    (viii) The weight of the washed and drained cherries is the weight 
of the sieve and the cherry material less the weight of the sieve. 
Calculate the percent of the cherry content of each pie with the 
following formula, and then calculate the average percent of the entire 
random sample:

Percent of the cherry content of the pie = [(Weight of washed and 
drained cherries) / (Net weight of pie)] x 100.

    (3) If the quality of the frozen cherry pie falls below the standard 
of quality prescribed by paragraph (b)(1) of this section, the label 
shall bear the general statement of substandard quality specified in 
Sec. 130.14(a) of this chapter, in the manner and form specified 
therein; but in lieu of the words prescribed for the second line inside 
the rectangle, the label may bear the alternative statement ``Below 
standard in quality ______'', the blank being filled in with the 
following words, as applicable:


[[Page 643]]

``too few cherries'', or ``blemished cherries''. Such alternative 
statement shall immediately and conspicuously precede or follow, without 
intervening written, printed, or graphic matter, the name of the food as 
prescribed by paragraph (a) of this section.

[42 FR 14449, Mar. 15, 1977, as amended at 58 FR 2882, Jan. 6, 1993]



PART 155_CANNED VEGETABLES--Table of Contents



                      Subpart A_General Provisions

Sec.
155.3 Definitions.

   Subpart B_Requirements for Specific Standardized Canned Vegetables

155.120 Canned green beans and canned wax beans.
155.130 Canned corn.
155.131 Canned field corn.
155.170 Canned peas.
155.172 Canned dry peas.
155.190 Canned tomatoes.
155.191 Tomato concentrates.
155.194 Catsup.
155.200 Certain other canned vegetables.
155.201 Canned mushrooms.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14449, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 155.3  Definitions.

    For the purposes of this part:
    (a) The procedure for determining drained weight is set forth in the 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), sections 32.001-32.003, which is 
incorporated by reference. Copies are available from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or 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) Compliance means the following: Unless otherwise provided in a 
standard, a lot of canned vegetables shall be deemed in compliance for 
the following factors, to be determined by the sampling and acceptance 
procedure as provided in paragraph (c) of this section, namely:
    (1) Quality. The quality of a lot shall be considered acceptable 
when the number of defectives does not exceed the acceptance number (c) 
in the sampling plans.
    (2) Fill of container. A lot shall be deemed to be in compliance for 
fill of container (packing medium and vegetable ingredient) when the 
number of defectives does not exceed the acceptance number (c) in the 
sampling plans.
    (3) Drained weight. A lot shall be deemed to be in compliance for 
drained weight based on the average value of all samples analyzed 
according to the sampling plans.
    (c) The sampling and acceptance procedure means the following:
    (1) Definitions--(i) Lot. A collection of primary containers or 
units of the same size, type, and style manufactured or packed under 
similar conditions and handled as a single unit of trade.
    (ii) Lot size. The number of primary containers or units in the lot.
    (iii) Sample size. The total number of sample units drawn for 
examination from a lot.
    (iv) Sample unit. A container, a portion of the contents of a 
container, or a composite mixture of product from small containers that 
is sufficient for the examination or testing as a single unit. For fill 
of container, the sample unit shall be the entire contents of the 
container.
    (v) Defective. Any sample unit shall be regarded as defective when 
the sample unit does not meet the criteria set forth in the standards.
    (vi) Acceptance number (c). The maximum number of defective sample 
units permitted in the sample in order to consider the lot as meeting 
the specified requirements.
    (vii) Acceptable quality level (AQL). The maximum percent of 
defective sample units permitted in a lot that will be accepted 
approximately 95 percent of the time.
    (2) Sampling plans.

[[Page 644]]



------------------------------------------------------------------------
                                                      Size of container
           Lot size (primary containers            ---------------------
                                                      n \1\      c \2\
------------------------------------------------------------------------
             net weight equal to or less than 1 kg (2.2 lb)
------------------------------------------------------------------------
4,800 or less.....................................         13          2
4,801 to 24,000...................................         21          3
24,001 to 48,000..................................         29          4
48,001 to 84,000..................................         48          6
84,001 to 144,000.................................         84          9
144,001 to 240,000................................        126         13
Over 240,000......................................        200         19
------------------------------------------------------------------------
 net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
------------------------------------------------------------------------
2,400 or less.....................................         13          2
2,401 to 15,000...................................         21          3
15,001 to 24,000..................................         29          4
24,001 to 42,000..................................         48          6
42,001 to 72,000..................................         84          9
72,001 to 120,000.................................        126         13
Over 120,000......................................        200         19
------------------------------------------------------------------------
                 net weight greater than 4.5 kg (10 lb)
------------------------------------------------------------------------
600 or less.......................................         13          2
601 to 2,000......................................         21          3
2,001 to 7,200....................................         29          4
7,201 to 15,000...................................         48          6
15,001 to 24,000..................................         84          9
24,001 to 42,000..................................        126         13
Over 42,000.......................................        200         19
------------------------------------------------------------------------
\1\ n = number of primary containers in sample.
\2\ c = acceptance number.

    (d) Strength and redness of color means at least as much red as is 
obtained by comparison of the prepared product, with the blended color 
produced by spinning a combination of the following concentric Munsell 
color discs of equal diameter, or the color equivalent of such discs:

Disc 1--Red (5R 2.6/13) (glossy finish)
Disc 2--Yellow (2.5 YR 5/12) (glossy finish)
Disc 3--Black (N1) (glossy finish)
Disc 4--Grey (N4) (mat finish)


Such comparison is to be made in full diffused daylight or under a 
diffused light source of approximately 2691 lux (250 footcandles) and 
having a spectral quality approximating that of daylight under a 
moderately overcast sky, with a correlated color temperature of 7,500 
degrees Kelvin 200 degrees. With the light source 
directly over the disc and product, observation is made at an angle of 
45 degrees from a distance of about 24 inches from the product. 
Electronic color meters may be used as an alternate means of determining 
the color of tomato concentrates. Such meters shall be calibrated to 
indicate that the color of the product is as red or more red than that 
produced by spinning the Munsell color discs in the combination as set 
out above.
    (e) Tomato soluble solids means the sucrose value as determined by 
the method prescribed in the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed., 1980, sections 
32.014 to 32.016 and 52.012, under the headings ``Soluble Solids in 
Tomato Products Official Final Action'' and ``Refractive Indices (n) of 
Sucrose Solutions at 20[deg],'' which is incorporated by reference. 
Copies are available from the AOAC INTERNATIONAL, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877, or are 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. If no salt has been 
added, the sucrose value obtained from the referenced tables shall be 
considered the percent of tomato soluble solids. If salt has been added 
either intentionally or through the application of the acidified break, 
determine the percent of such added sodium chloride as specified in 
paragraph (f) of this section. Subtract the percentage so found from the 
percentage of total soluble solids found (sucrose value from the 
refractive index tables) and multiply the difference by 1.016. The 
resultant value is considered the percent of ``tomato soluble solids.''
    (f) Salt means sodium chloride, determined as chloride and 
calculated as percent sodium chloride, by the method prescribed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed., 1980, sections 32.025 to 32.030, under the heading 
``Method III (Potentiometric Method),'' which is incorporated by 
reference.

[45 FR 43398, June 27, 1980, as amended at 47 FR 11831, Mar. 19, 1982; 
48 FR 3954, Jan. 28, 1983; 54 FR 24895, June 12, 1989; 63 FR 14035, Mar. 
24, 1998]

[[Page 645]]



   Subpart B_Requirements for Specific Standardized Canned Vegetables



Sec. 155.120  Canned green beans and canned wax beans.

    (a) Identity--(1) Definition. Canned green beans and canned wax 
beans are the foods prepared from succulent pods of fresh green bean or 
wax bean plants conforming to the characteristics of Phaseolus vulgaris 
L. and Phaseolus coccineus L. The optional color and varietal types and 
styles of the bean ingredient are set forth in paragraph (a)(2) of this 
section. The product is packed with water or other suitable aqueous 
liquid medium to which may be added one or more of the other optional 
ingredients set forth in paragraph (a)(3) of this section. Such food is 
so processed by heat, in an appropriate manner before or after being 
sealed in a container, as to prevent spoilage.
    (2) Optional color and varietal types and styles of pack. The 
optional color and varietal types and styles of the bean ingredient 
referred to in paragraph (a)(1) of this section are:
    (i) Optional color types. The beans shall be one of the following 
distinct color types: (a) Green; or (b) Wax.
    (ii) Optional varietal types--(a) Round. Beans having a width not 
greater than 1\1/2\ times the thickness of the bean; or
    (b) Flat. Beans having a width greater than 1\1/2\ times the 
thickness of the bean.
    (iii) Optional styles of pack--(a) Whole. Whole pods of any length.
    (b) Shoestring or sliced lengthwise or French style. Pods sliced 
lengthwise.
    (c) Cuts. Transversely cut pods not less than 19 mm (0.75 in) long 
as measured along the longitudinal axis, which may contain the shorter 
end pieces that result from cutting such pods.
    (d) Short cuts. Pieces of pods cut transversely of which 75 percent, 
by count, or more are less than 19 mm (0.75 in) in length and not more 
than 1 percent by count are more than 32 mm (1\1/4\ in) in length.
    (e) Diagonal cuts. Pods cut in lengths as specified in paragraph 
(a)(2)(iii)(c) of this section, except the pods are cut at an angle 
approximately 45[deg] to the longitudinal axis.
    (f) Diagonal short cuts. Pods cut in lengths as specified in 
paragraph (a)(2)(iii)(d) of this section, except the pods are cut at an 
angle approximately 45[deg] to the longitudinal axis.
    (g) Mixture. Any mixture of two or more of the styles specified in 
paragraph (a)(2)(iii)(a) to (f), inclusive, of this section.
    (3) Optional ingredients. In addition to the optional packing media 
listed in paragraph (a)(1) of this section and the optional types and 
styles of beans ingredient listed in paragraph (a)(2) of this section, 
the following safe and suitable optional ingredients may be used:
    (i) Salt.
    (ii) Monosodium glutamate.
    (iii) Disodium inosinate.
    (iv) Disodium guanylate.
    (v) Hydrolyzed vegetable protein.
    (vi) Autolyzed yeast extract.
    (vii) Nutritive carbohydrate sweeteners.
    (viii) Spice.
    (ix) Flavoring (except artificial).
    (x) Pieces of green or red peppers or mixtures of both, either of 
which may be dried, or other vegetables not exceeding in total 15 
percent by weight of the finished product.
    (xi) Vinegar.
    (xii) Lemon juice or concentrated lemon juice.
    (xiii) Glucono delta-lactone.
    (xiv) Mint leaves.
    (xv) Butter or margarine in a quantity of not less than 3 percent by 
weight of the finished product. When butter or margarine is added, 
emulsifiers or stabilizers, or both, may be added. No spice or flavoring 
simulating the color or flavor imparted by butter or margarine is used.
    (4) Labeling. (i) The name of the food is ``green beans'' or ``wax 
beans'' as appropriate. Wax beans may be additionally designated 
``golden'' or ``yellow''.
    (ii) The following shall be included as part of the name or in 
conjunction with the name of the food:
    (a) A declaration of any flavoring that characterizes the product as 
specified in Sec. 101.22 of this chapter.
    (b) A declaration of any spice, seasoning, or garnishing that 
characterizes the product, e.g., ``with added spice'', or, in lieu of 
the word ``spice'',

[[Page 646]]

the common name of the spice, e.g., ``seasoned with green peppers''.
    (c) The words ``vacuum pack'' or ``vacuum packed'' when the weight 
of the liquid in the container, as determined by the method prescribed 
in paragraph (b)(2)(i) of this section is not more than 25 percent of 
the net weight, and the container is closed under conditions creating a 
high vacuum in the container.
    (d) The name of the optional style of bean ingredient as set forth 
in paragraph (a)(2)(iii) of this section or, if a product consists of a 
mixture of such styles, the words ``mixture of '' the blank to be filled 
in with the names of the styles present, arranged in the order of 
decreasing predominance, if any, by weight of such ingredients. If the 
product consists of whole beans and the pods are packed parallel to the 
sides of the container, the word ``whole'' may be preceded or followed 
by the words ``vertical pack'', or if the pods are cut at both ends and 
are of substantially equal lengths, the words ``asparagus style'' may be 
used in lieu of the words ``vertical pack''. If the product consists of 
short cuts or diagonal short cuts, a numerical expression indicating the 
predominate length of cut in the finished food may be used in lieu of 
the word ``short'', e.g., ``\1/2\ inch cut''.
    (iii) The following may be included in the name of the food:
    (a) The word ``stringless'' where the beans are in fact stringless.
    (b) The name of the optional varietal type as specified in paragraph 
(a)(2)(ii) of this section, or the specific varietal name, e.g., ``Blue 
Lake Green Beans'', or both.
    (iv) If a term designating diameter is used, it shall be supported 
by an exact graphic representation of the cross section of the bean pod 
or by a statement of the maximum diameter in common or decimal fractions 
of an inch and, optionally, by the millimeter equivalent stated 
parenthetically. The diameter of a whole, cut, diagonal cut, or short 
cut is determined by measuring the thickest portion of the pod at the 
shorter diameter of the bean perpendicular to the longitudinal axis.
    (5) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) When tested by the method prescribed in paragraph 
(b)(2) of this section:
    (i) In the case of cut beans and diagonal cut beans under paragraphs 
(a)(2)(iii) (c) and (d) of this section and mixtures of two or more 
optional forms under paragraph (a)(2)(iii)(g) of this section, not more 
than 60 units per 340 g (12 oz) drained weight are less than 13 mm (0.50 
in) long: Provided, That where the number of units per 340 g (12 oz) 
drained weight exceeds 240, not more than 25 percent by count of the 
total units are less than 13 mm (0.50 in) long.
    (ii) In case there are present pods or pieces of pods 10.7 mm (\27/
64\-inch) or more in diameter, there are not more than 12 strings per 
340 gm (12 ounces) of drained weight which will support 227 gm (one-half 
pound) for 5 seconds or longer.
    (iii) The deseeded pods contain not more than 0.15 percent by weight 
of fibrous material.
    (iv) There are not more than 10 percent by weight of blemished units 
of which amount not more than one-half may be materially damaged by 
insect or pathological injury. A unit is considered blemished when the 
aggregate blemished area exceeds the area of a circle 3 mm (\1/8\ in) in 
diameter. Materially damaged means that the unit is damaged to the 
extent that the appearance or eating quality of the unit is seriously 
affected.
    (v) There are not more than 8 unstemmed units per 340 g (12 oz) 
drained weight.
    (vi) The combined number of leaves, detached stems, and other 
extraneous vegetable matter shall not average more than 3 pieces per 340 
g (12 oz) drained beans.
    (2) Canned beans shall be tested by the following method to 
determine whether they meet the requirements of paragraph (b)(1) of this 
section:
    (i) Determine the gross weight of the container. Open and distribute 
the contents of the container over the meshes of a U.S. No. 8 circular 
sieve with openings of 2.36 mm (0.0937 in), which has been previously 
weighed. The diameter

[[Page 647]]

of the sieve is 20.3 cm (8 in) if the quantity of contents of the 
container is less than 1.36 kg (3 lb) and 30.5 cm (12 in) if such 
quantity is 1.36 kg (3 lb) or more. The bottom of the sieve is woven-
wire cloth that complies with the specifications of such cloth set forth 
in ``Official Methods of Analysis of the Association of Official 
Analytical Chemists,'' 15th ed. (1990), vol. 2, p. xii, Table 1, 
``Nominal Dimensions of Standard Test Sieves (USA Standard Series),'' 
under the heading ``Definitions of Terms and Explanatory Notes,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies may be obtained from the AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
examined 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. Without shifting the 
material on the sieve, incline the sieve 17 to 20[deg] to facilitate 
drainage. Two minutes after drainage begins, weigh the sieve and the 
drained material. Record in grams (ounces) the weight so found, less the 
weight of the sieve, as the drained weight. Dry and weigh the empty 
container and subtract this weight from the gross weight to obtain the 
net weight. Calculate the percent of drained liquid in the net weight.
    (ii) Pour the drained material from the sieve into a flat tray and 
spread it in a layer of fairly uniform thickness. Count the total number 
of units. For the purpose of this count, loose seeds, pieces of seed, 
loose stems, and extraneous material are not to be included. Divide the 
number of units by the drained weight recorded in paragraph (b)(2)(i) of 
this section and multiply by 340 to obtain the number of units per 340 g 
(12 oz) drained weight.
    (iii) Examine the drained material in the tray, weigh and record 
weight of blemished units, count and record the number of unstemmed 
units; and, in case the material consists of the optional ingredient 
specified in paragraph (a)(2)(iii) (c), (d) or (f) of this section, 
count and record the number of units which are less than 13 mm (0.50 
in.) long. If the number of units per 340 g (12 oz.) is 240 or less, 
divide the number of units which are less than 13 mm (0.50 in.) by the 
drained weight recorded in paragraph (b)(2)(i) of this section and 
multiply by 340 to obtain the number of such units per 340 g (12 oz.) 
drained weight. If the number of units per 340 g (12 oz.) exceeds 240, 
divide the number of units less than 13 mm (0.50 in.) long by the total 
number of units and multiply by 100 to determine the percentage by count 
of the total units which are less than 13 mm (0.50 in.) long.
    (a) Divide the weight of blemished units by the drained weight 
recorded in paragraph (b)(2)(i) of this section and multiply by 100 to 
obtain the percentage by weight of blemished units in the container.
    (b) Divide the number of unstemmed units by the drained weight 
recorded in paragraph (b)(2)(i) of this section and multiply by 340 to 
obtain the number of unstemmed units per 340 g (12 oz.) of drained 
weight.
    (iv) Remove from the tray the extraneous vegetable material, count, 
record count, and return to tray.
    (v) Remove from the tray one or more representative samples of 99 to 
113 g (3\1/2\ to 4 ounces) covering each sample as taken to prevent 
evaporation.
    (vi) From each representative sample selected in paragraph (b)(2)(v) 
of this section, discard any loose seed and extraneous vegetable 
material and detach and discard any attached stems. Except with optional 
style of ingredient specified in paragraph (a)(2)(iii)(b) of this 
section (pods sliced lengthwise), trim off, as far as the end of the 
space formerly occupied by the seed, any portion of pods from which the 
seed has become separated. Remove and discard any portions of seed from 
the trimmings and reserve the trimmings for paragraph (b)(2)(viii) of 
this section. Weigh and record the weight of the trimmed pods. Deseed 
the trimmed pods and reserve the deseeded pods for paragraph 
(b)(2)(viii) of this section. Remove strings from the pods during the 
deseeding operation. Reserve these strings for testing as prescribed in 
paragraph (b)(2)(vii) of this section. In

[[Page 648]]

the case of pods sliced lengthwise, remove seed and pieces of seed and 
reserve the deseeded pods for use as prescribed in paragraph 
(b)(2)(viii) of this section.
    (vii) If strings have been removed for testing, as prescribed in 
paragraph (b)(2)(vi) of this section, test them as follows:

    Fasten clamp, weighted to 250 g (8.8 oz.), to one end of the string, 
grasp the other end with the fingers (a cloth may be used to aid in 
holding the string), and lift gently. Count the string as tough if it 
supports the 250 g (8.8 oz.) weight for at least 5 seconds. If the 
string breaks before 5 seconds, test such parts into which it breaks as 
are 13 mm (\1/2\ in.) or more in length; and if any such part of the 
string supports the 250 g (8.8 oz.) weight for at least 5 seconds, count 
the string as tough. Divide the number of tough strings by the weight of 
the sample recorded in paragraph (b)(2)(v) of this section and multiply 
by 340 to obtain the number of tough strings per 340 g (12 oz.) drained 
weight.

    (viii) Combine the deseeded pods with the trimmings reserved in 
paragraph (b)(2)(vi) of this section, and, if strings were tested as 
prescribed in paragraph (b)(2)(vii) of this section, add such strings 
broken or unbroken. Weigh and record weight of combined material. 
Transfer to the metal cup of a malted-milk stirrer and mash with a 
pestle. Wash material adhering to the pestle back into cup with 200 cc 
of boiling water. Bring mixture nearly to a boil, add 25 cc of 50 
percent (by weight) sodium hydroxide solution and bring to a boil. (If 
foaming is excessive, 1 cc of capryl alcohol may be added.) Boil for 5 
minutes, then stir for 5 minutes with a malted-milk stirrer capable of a 
no-load speed of at least 7,200 rpm. Use a rotor with two scalloped 
buttons shaped as shown in exhibit 1 as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.377


Transfer the material from the cup to a previously weighed 30-mesh monel 
metal screen having a diameter of about 9-10 cm (3\1/2\ to 4 in.) and 
side walls about 2.5 cm (1 in.) high, and wash fiber on the screen with 
a stream of water using a pressure not exceeding a head (vertical 
distance between upper level of water and outlet of glass tube) of 152 
cm (60 in.), delivered through a glass tube 7.6 cm (3 in.) long and 3 mm 
(\1/8\ in.) inside diameter inserted into a rubber tube of 6 mm (\1/4\ 
in.) inside diameter. Wash the pulpy portion of the material through the 
screen and continue washing until the remaining fibrous material, 
moistened with phenolphthalein solution, does not show any red color 
after standing 5 minutes. Again wash to remove phenolphthalein. Dry the 
screen containing the fibrous material for 2 hours at 100 [deg]C, cool, 
weigh, and deduct weight of screen. Divide the weight of fibrous 
material by the weight of combined deseeded pods, trimmings, and strings 
and multiply by 100 to obtain the percentage of fibrous material.
    (ix) If the drained weight recorded in paragraph (b)(2)(i) of this 
section was less than 340 g (12 oz.), open and examine separately for 
extraneous material, as directed in paragraph (b)(2)(iv) of this 
section, additional containers until a total of not less than 340 g (12 
oz.) of drained material is obtained. To determine the number of pieces 
of extraneous vegetable material per 340 g (12 oz.) of drained weight, 
total the

[[Page 649]]

number of pieces of extraneous vegetable material found in all 
containers opened, divide this sum by the sum of the drained weights in 
these containers and multiply by 340.
    (3) Determine compliance as specified in Sec. 155.3(b) except that 
a lot shall be deemed to be in compliance for extraneous plant material 
based on an average of all containers examined.
    (4) If the quality of the canned green beans or canned wax beans 
falls below the standard of quality prescribed by paragraph (b)(1) of 
this section, the label shall bear the general statement of substandard 
quality specified in Sec. 130.14(a) of this chapter, in the manner and 
form therein specified; but in lieu of the words prescribed for the 
second line inside the rectangle the following words may be used, when 
the quality of canned green beans or canned wax beans falls below the 
standard in one only of the following respects:
    (i) ``Excessive number very short pieces'', if the canned green 
beans or canned wax beans fail to meet the requirements of paragraph 
(b)(1)(i) of this section.
    (ii) ``Excessive number blemished units'', if they fail to meet the 
requirements of paragraph (b)(1)(iv) of this section.
    (iii) ``Excessive number unstemmed units'', if they fail to meet the 
requirements of paragraph (b)(1)(v) of this section.
    (iv) ``Excessive foreign material'', if they fail to meet the 
requirements of paragraph (b)(1)(vi) of this section.

[42 FR 14449, Mar. 15, 1977, as amended at 42 FR 30359, 30360, June 14, 
1977; 45 FR 43398, June 27, 1980; 47 FR 11831, Mar. 19, 1982; 49 FR 
10101, Mar. 19, 1984; 57 FR 34245, Aug. 4, 1992; 58 FR 2882, Jan. 6, 
1993; 63 FR 14035, Mar. 24, 1998]



Sec. 155.130  Canned corn.

    (a) Identity--(1) Definition. Canned sweet corn is the product 
prepared from clean, sound kernels of sweet corn packed with a suitable 
liquid packing medium which may include water and the creamy component 
from corn kernels. The tip caps are removed. The product is of the 
optional styles specified in paragraph (a)(2) of this section. It may 
contain one, or any combination of two or more, of the optional 
ingredients set forth in paragraph (a)(3) of this section. Such food is 
processed by heat, in an appropriate manner, before or after being 
sealed in a container, so as to prevent spoilage.
    (2) Styles. The optional styles referred to in paragraph (a)(1) of 
this section consist of succulent sweet corn of the yellow (golden) or 
white color type, conforming to Zea mays L. having the sweet corn 
characteristic as follows:
    (i) Whole kernel or whole grain or cut kernel consisting of whole or 
substantially whole cut kernels packed with a liquid medium.
    (ii) Cream style consisting of whole or partially whole cut kernels 
packed in a creamy component from the corn kernels and other liquid or 
other ingredients to form a product of creamy consistency.
    (3) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (i) Salt.
    (ii) Monosodium glutamate.
    (iii) Disodium inosinate.
    (iv) Disodium guanylate.
    (v) Hydrolyzed vegetable protein.
    (vi) Autolyzed yeast extract.
    (vii) Nutritive carbohydrate sweeteners.
    (viii) Spice.
    (ix) Flavoring (except artificial).
    (x) Citric acid.
    (xi) Starch or food starch-modified in cream style corn when 
necessary to ensure smoothness.
    (xii) Seasonings and garnishes.
    (a) Mint leaves.
    (b) Pieces of green peppers or red peppers, or mixtures of both, 
either of which may be sweet or hot and may be dried, or other 
vegetables, not exceeding 15 percent by weight of the finished food.
    (c) Lemon juice or concentrated lemon juice.
    (d) Butter or margarine in a quantity not less than 3 percent by 
weight of the finished food. When butter or margarine is added, 
emulsifiers or stabilizers, or both, may be added. When butter or 
margarine is added, no spice, or flavoring simulating the color or 
flavor imparted by butter or margarine is used.

[[Page 650]]

    (4) Labeling. The name of the food is ``corn'' or ``sweet corn'' or 
``sugar corn'' and shall include a declaration of any flavoring that 
characterizes the product as specified in Sec. 101.22 of this chapter 
and a declaration of any spice, seasoning or garnishing that 
characterizes the product; for example, ``With added spice'', ``Seasoned 
with red peppers'', ``Seasoned with butter''. The name of the food shall 
also include the following:
    (i) The optional style of the corn ingredient as specified in 
paragraph (a)(2) of this section.
    (ii) The words ``vacuum pack'' or ``vacuum packed'' when the corn 
ingredient is as specified in paragraph (a)(2)(i) of this section and 
the weight of the liquid in the container, as determined by the method 
prescribed in paragraph (b)(2)(i) of this section, is not more than 20 
percent of the net weight, and the container is closed under conditions 
creating a high vacuum in the container.
    (iii) The color type used only when the product consists of white 
corn.
    (iv) The color type used only when the product consists of white 
corn.
    (5) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned corn is as 
follows:
    (i) When tested by the method prescribed in paragraph (b)(2) of this 
section, canned whole-kernel corn (paragraph (a)(2)(i) of this section):
    (a) Contains not more than seven brown or black discolored kernels 
or pieces of kernel per 400 g. (14 ounces) of drained weight;
    (b) Contains not more than 1 cubic centimeter of pieces of cob for 
each 400 g. (14 ounces) of drained weight;
    (c) Contains not more than 7 square centimeters (1.1 square inch) of 
husk per 400 g. (14 ounces) of drained weight; and
    (d) Contains not more than 180 mm. (7 inches) of silk per 28 g. (1 
ounce) of drained weight.
    (ii) When tested by the method prescribed in paragraph (b)(3) of 
this section, canned cream style corn (paragraph (a)(2)(ii) of this 
section):
    (a) Contains not more than 10 brown or black discolored kernels or 
pieces of kernel per 600 g. (21.4 ounces) of net weight;
    (b) Contains not more than 1 cubic centimeter of pieces of cob per 
600 g. (21.4 ounces) of net weight;
    (c) Contains not more than 7 square centimeters (1.1 square inch) of 
husk per 600 g. (21.4 ounces) of net weight;
    (d) Contains not more than 150 mm. (6 inches) of silk for each 28 g. 
(1 ounce) of net weight; and
    (e) Has a consistency such that the average diameter of the 
approximately circular area over which the prescribed sample spreads 
does not exceed 30.5 cm. (12 inches), except that when the washed 
drained material contains more than 20 percent of alcohol-insoluble 
solids, the average diameter of the approximately circular area over 
which the prescribed sample spreads does not exceed 25.4 cm. (10 
inches).
    (iii)(a) The weight of the alcohol-insoluble solids of whole-kernel 
corn (paragraph (a)(2)(i) of this section) does not exceed 27 percent of 
the drained weight, when tested by the method prescribed in paragraph 
(b)(2) of this section.
    (b) The weight of the alcohol-insoluble solids of the washed drained 
material of cream style corn (paragraph (a)(2)(ii) of this section) does 
not exceed 27 percent of the drained weight of such material, when 
tested by the method prescribed in paragraph (b)(3) of this section.
    (2) The method referred to in paragraph (b)(1) of this section for 
testing whole-kernel corn (paragraph (a)(2)(i) of this section) is as 
follows:
    (i) Determine the gross weight of the container. Open and distribute 
the contents of the container over the meshes of a U.S. No. 8 circular 
sieve which has previously been weighed. The diameter of the sieve is 
20.3 cm. (8 inches) if the quantity of the contents of the container is 
less than 1.36 kg. (3 pounds), and 30.5 cm. (12 inches) if such quantity 
is 1.36 kg. (3 pounds) or more. The bottom of the sieve is woven-wire 
cloth that complies with the specifications for such sieve set forth in 
the ``Definitions of Terms and Explanatory Notes'' prescribed in 
``Official Methods of Analysis of the Association of Official

[[Page 651]]

Analytical Chemists,'' 13th Ed. (1980), Table 1, ``Nominal Dimensions of 
Standard Test Sieves (U.S.A. Standard Series),'' under the heading 
``Definitions of Terms and Explanatory Notes,'' which is incorporated by 
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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. Without shifting the 
material on the sieve, so incline the sieve at approximately 17-20[deg] 
angle to facilitate drainage. Two minutes from the time drainage begins, 
weigh the sieve and the drained material. Record, in g. (ounces), the 
weight so found, less the weight of the sieve, as the drained weight. 
Dry and weigh the empty container and subtract this weight from the 
gross weight to obtain the net weight. Calculate the percent of drained 
liquid in the net weight.
    (ii) Pour the drained material from the sieve into a flat tray and 
spread it in a layer of fairly uniform thickness. Count, but do not 
remove, the brown or black discolored kernels or pieces of kernel and 
calculate the number per 400 g. (14 ounces) of drained material. Remove 
pieces of silk more than 12.7 mm. (one-half inch) long, husk, cob, and 
any pieces of material other than corn. Measure the aggregate length of 
such pieces of silk and calculate the length of silk per 28 g. (1 ounce) 
of drained weight. Spread the husk flat, measure its aggregate area, and 
calculate the area of husk per 400 g. (14 ounces) of drained weight. 
Place all pieces of cob under a measured amount of water in a cylinder 
which is so graduated that the volume can be measured to 0.1 cubic 
centimeter. Take the increase in volume as the aggregate volume of the 
cob and calculate the volume of cob per 400 g. (14 ounces) of drained 
weight.
    (iii) Comminute representative 100 g. sample of the drained corn 
from which the silk, husk, cob, and other material which is not corn 
(i.e., peppers) have been removed. An equal amount of water is used to 
facilitate this operation. Weigh to nearest 0.01 g. a portion of the 
comminuted material equivalent to approximately 10 g. of the drained 
corn into a 600 cubic centimeter beaker. Add 300 cubic centimeters of 80 
percent alcohol (by volume), stir, cover beaker, and bring to a boil. 
Simmer slowly for 30 minutes. Fit a Buchner funnel with a previously 
prepared filter paper of such sizes that its edges extend 12.7 mm. (one-
half inch) or more up the vertical sides of the funnel. The previous 
preparation of the filter paper consists of drying it in a flat-bottomed 
dish for 2 hours at 100 [deg]C, covering the dish with a tight fitting 
cover, cooling it in a desiccator, and promptly weighing to the nearest 
0.001 g. After the filter paper is fitted to the funnel, apply suction 
and transfer the contents of the beaker to the funnel. Do not allow any 
of the material to run over the edge of the paper. Wash the material on 
the filter with 80 percent alcohol (by volume) until the washings are 
clear and colorless. Transfer the filter paper with the material 
retained thereon to the dish used in preparing the filter paper. Dry the 
material in a ventilated oven, without covering the dish, for 2 hours at 
100 [deg]C. Place the cover on the dish, cool it in a desiccator, and 
promptly weigh to the nearest 0.001 g. From this weight subtract the 
weight of the dish, cover, and paper as previously found. Calculate the 
remainder to percentage.
    (3) The method referred to in paragraph (b)(1) of this section for 
testing cream-style corn (paragraph (a)(2)(ii) of this section) is as 
follows:
    (i) Allow the container to stand at least 24 hours at a temperature 
of 68 [deg]F to 85 [deg]F. Determine the gross weight, open, transfer 
the contents into a pan, and mix thoroughly in such a manner as not to 
incorporate air bubbles. (If the net contents of a single container is 
less than 510 g. (18 ounces) determine the gross weight, open, and mix 
the contents of the least number of containers necessary to obtain 510 
g. (18 ounces). Fill level full a hollow, truncated cone so placed on a 
polished horizontal plate as to prevent leakage. The cone has an inside 
bottom diameter of 7.62 cm. (3 inches), inside top diameter of 5.08 cm. 
(2 inches), and height of

[[Page 652]]

12.30 cm. (4\27/32\ inches). As soon as the cone is filled, lift it 
vertically. Determine the average of the longest and shortest diameters 
of the approximately circular area on the plate covered by the sample 30 
seconds after lifting the cone. Dry and weigh each empty container and 
subtract the weight so found from the gross weight to obtain the net 
weight.
    (ii) Transfer the material from the plate, cone, and pan onto a U.S. 
No. 8 sieve as prescribed in paragraph (b)(2)(i) of this section. The 
diameter of the sieve is 20.3 cm. (8 inches) if the quantity of the 
contents of the container is less than 1.36 kg. (3 pounds), and 30.5 cm. 
(12 inches) if such quantity is 1.36 kg. (3 pounds) or more. Set the 
sieve in a pan. Add enough water to bring the level within 9.53 mm. 
(three-eighth inch) to 6.35 mm. (one-fourth inch) of the top of the 
sieve. Gently wash the material on the sieve by combined up-and-down and 
circular motion for 30 seconds. Repeat washing with a second portion of 
water. Remove sieve from pan, incline to facilitate drainage, and drain 
for 2 minutes.
    (iii) From the material remaining on the U.S. No. 8 sieve, count, 
but do not remove, the brown or black discolored kernels or pieces of 
kernel and calculate the number per 600 g. (21.4 ounces) of net weight. 
Remove pieces of silk more than 12.7 mm. (one-half inch) long, husk, 
cob, and other material which is not corn (i.e., peppers). Measure 
aggregate length of such pieces of silk and calculate the length per 28 
g. (ounce) of net weight. Spread the husk flat and measure its aggregate 
area and calculate the area per 600 g. (21.4 ounces) of net weight. 
Place all pieces of cob under a measured amount of water in a cylinder 
which is so graduated that the volume may be measured to 0.1 cubic 
centimeter. Take the increase in volume as the aggregate volume of the 
cob and calculate the volume of cob per 600 g. (21.4 ounces) of net 
weight. Take a representative 100 g. sample of the material remaining on 
the U.S. No. 8 sieve (if such material weighs less than 100 g. take all 
of it) and determine the alcohol-insoluble solids as prescribed in 
paragraph (b)(2)(iii) of this section for whole kernel corn.
    (4) Determine compliance as specified in Sec. 155.3(b).
    (5) If the quality of canned corn falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified; however, if the 
quality of the canned corn falls below standard with respect to only one 
of the factors of quality specified by paragraphs (b)(1)(i) (a) to (d) 
of this section, or by paragraphs (b)(1)(ii) (a) to (e) of this section, 
there may be substituted for the second line of such general statement 
of substandard quality, ``Good food--not high grade'', a new line as 
specified after the corresponding subdivision designation of paragraph 
(b)(1) of this section, which the canned corn fails to meet:

(i)(a) or (ii)(a) ``Excessive discolored kernels''.
(i)(b) or (ii)(b) ``Excessive cob''.
(i)(c) or (ii)(c) ``Excessive husk''.
(i)(d) or (ii)(d) ``Excessive silk''.
(ii)(e) ``Excessively liquid''.

    (c) Fill of container. (1) The standard of fill of container for 
canned corn is:
    (i) Except in the case of vacuum pack corn the fill of the corn 
ingredient and packing medium, as determined by the general method for 
fill of container prescribed in Sec. 130.12(b) of this chapter, is not 
less than 90 percent of the total capacity of the container.
    (ii) In whole kernel corn, the drained weight of the corn 
ingredient, determined by the procedure set forth in Sec. 155.3, shall 
not be less than 61 percent of the water capacity of the container.
    (2) Determine compliance as specified in Sec. 155.3(b).
    (3) If canned corn falls below the standard of fill of container 
prescribed in paragraphs (c)(1) and (2) of this section, the label shall 
bear the general statement of substandard fill specified in Sec. 
130.14(b) of this chapter, in the manner and form therein specified.

[42 FR 14449, Mar. 15, 1977, as amended at 45 FR 43398, June 27, 1980; 
47 FR 11831, 11832, Mar. 19, 1982; 49 FR 10101, Mar. 19, 1984; 54 FR 
24895, June 12, 1989; 58 FR 2882, Jan. 6, 1993; 63 FR 14035, Mar. 24, 
1998]

[[Page 653]]



Sec. 155.131  Canned field corn.

    (a) Identity. (1) Canned field corn conforms to the definition and 
standard of identity, and is subject to the requirements for label 
declaration of ingredients, prescribed for canned corn by Sec. 
155.130(a), except that the corn ingredient consists of succulent field 
corn or a mixture of succulent field corn and succulent sweet corn.
    (2) The name of the food conforms to the name specified in Sec. 
155.130(a)(5), except that the words ``Corn'', ``Sweet corn'', and 
``Sugar corn'' are replaced by the words ``Field corn'', and the term 
``Golden field corn'' is not used.
    (b) [Reserved]
    (c) Fill of container. Canned cream-style field corn conforms to the 
standard of fill of container and label statement of substandard fill 
prescribed for canned cream-style corn by Sec. 155.130(c).

[42 FR 14449, Mar. 15, 1977, as amended at 58 FR 2882, Jan. 6, 1993]



Sec. 155.170  Canned peas.

    (a) Identity--(1) Definition. Canned peas is the food prepared from 
fresh or frozen succulent seeds of the pea plant of the species Pisum 
sativum L. but excluding the subspecies macrocarpum. Only sweet wrinkled 
varieties, smooth-skin varieties, or hybrids thereof may be used. The 
product is packed with water or other suitable aqueous liquid medium to 
which may be added one or more of the other optional ingredients set 
forth in paragraph (a)(2) of this section. Such food is sealed in a 
container and, before or after sealing, is so processed by heat as to 
prevent spoilage.
    (2) Optional ingredients. In addition to the optional packing media 
provided for in paragraph (a)(1) of this section, the following safe and 
suitable optional ingredients may be used:
    (i) Salt.
    (ii) Monosodium glutamate.
    (iii) Disodium inosinate.
    (iv) Disodium guanylate.
    (v) Hydrolyzed vegetable protein.
    (vi) Autolyzed yeast extract.
    (vii) One or any combination of two or more of the dry or liquid 
forms of sugar, invert sugar sirup, dextrose, glucose sirup, and 
fructose.
    (viii) Spice.
    (ix) Flavoring (except artificial).
    (x) Color additives.
    (xi) Calcium salts, the total amount of which added to firm the peas 
shall not result in more than 350 milligrams/kilogram (0.01 ounce/2.2 
pounds) of calcium in the finished food.
    (xii) Magnesium hydroxide, magnesium oxide, magnesium carbonate, or 
any mixture or combination of these in such quantity that the pH of the 
finished canned peas is not more than 8, as determined by the glass 
electrode method for the hydrogen ion concentration.
    (xiii) Seasonings and garnishes:
    (a) Pieces of green or red peppers or mixtures of both, either of 
which may be dried, or other vegetables not exceeding in total 15 
percent of the drained weight of the finished food.
    (b) Lemon juice or concentrated lemon juice.
    (c) Mint leaves.
    (d) Butter or margarine in a quantity not less that 3 percent by 
weight of the finished food, or other vegetable or animal fats or oils 
in a quantity not less than 2.4 percent by weight of the finished foods. 
When butter, margarine, or other vegetable or animal fats or oils are 
added, emulsifiers or stabilizers or both may be added, but no color, 
spice, or flavoring simulating the color or flavor imparted by butter or 
margarine may be used.
    (3) Labeling. (i) The name of the food is ``peas'' and may include 
the designation ``green.'' The term ``early,'' ``June,'' or ``early 
June'' shall precede or follow the name in the case of smooth-skin peas 
or substantially smooth-skin peas, such as Alaska-type peas or hybrids 
having similar characteristics. Where the peas are of sweet green 
wrinkled varieties or hybrids having similar characteristics, the name 
may include the designation ``sweet,'' ``wrinkled,'' or any combination 
thereof. The term ``petit pois'' may be used in conjunction with the 
name of the food when an average of 80 percent or more of the peas will 
pass through a circular opening of a diameter of 7.1 millimeters (0.28 
inch). If any color additive has been added, the name of the food shall 
include the term ``artificially colored.''

[[Page 654]]

    (ii) The following shall be included as part of the name or in close 
proximity to the name of the food:
    (a) A declaration of any flavoring that characterizes the food, as 
specified in Sec. 101.22 of this chapter.
    (b) A declaration of any spice, seasoning, or garnishing that 
characterizes the product, e.g., ``seasoned with green peppers'', 
``seasoned with butter'', ``seasoned with ___ oil'', the blank to be 
filled in with the common or usual name of the oil, ``with added 
spice'', or, in lieu of the word spice, the common or usual name of the 
spice.
    (c) The words ``vacuum pack'' or ``vacuum packed'' when the weight 
of the liquid in the container, as determined by the method prescribed 
in Sec. 155.3(a) is not more than 20 percent of the net weight, and the 
container is closed under conditions creating a high vacuum in the 
container.
    (4) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned peas is as 
follows:
    (i) Blond and yellow peas. Not more than 2 percent of the drained 
weight is blond and/or yellow peas, i.e., white or yellow but edible 
peas.
    (ii) Blemished peas. Not more than 5 percent of the drained weight 
is blemished peas, i.e., slightly stained or spotted peas.
    (iii) Seriously blemished peas. Not more than 1 percent of the 
drained weight is seriously blemished peas, i.e., peas that are hard, 
shrivelled, spotted, discolored, or otherwise blemished to an extent 
that the appearance or eating quality is seriously affected.
    (iv) Pea fragments. Not more than 10 percent of the drained weight 
is pea fragments, i.e., portions of peas, separated or individual 
cotyledons, crushed, partial or broken cotyledons, and loose skins, but 
excluding entire intact peas with skins detached.
    (v) Extraneous vegetable material. Not more than 0.5 percent of the 
drained weight is extraneous vegetable material, i.e., vine or leaf or 
pod material from the pea plant or other such material.
    (vi) Alcohol-insoluble solids. The alcohol-insoluble solids of 
smooth-skin or substantially smooth-skin peas, such as Alaska-type peas 
or hybrids having similar characteristics, may not be more than 23.5 
percent and, of sweet green wrinkled varieties or hybrids having similar 
characteristics, not more than 21 percent based on the procedure set 
forth in the ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), section 30.012, which 
is incorporated by reference. Copies are available from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or 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.
    (vii) Limitation. The sum of the pea material described in 
paragraphs (b)(1) (i), (ii), (iii), (iv), and (v) of this section shall 
not exceed 12 percent.
    (2) Determine compliance as specified in Sec. 155.3(b).
    (3) If the quality of canned peas falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified; but in lieu of 
such general statement of substandard quality when the quality of canned 
peas falls below the standard in only one respect, the label may bear 
the alternative statement, ``Below standard in quality '', the blank to 
be filled in with the words specified after the corresponding paragraph 
under paragraph (b)(1) of this section which such canned peas fail to 
meet, as follows: (i) ``Excessive blond and/or yellow peas''; (ii) 
``Excessive blemished peas''; (iii) ``Excessive seriously blemished 
peas''; (iv) ``Excessive pea fragments''; (v) ``Excessive vegetable 
material''; (vi) ``Excessive mealy''. Such alternative statement shall 
immediately and conspicuously precede or follow without intervening 
written, printed, or graphic matter, the name ``peas'' and any words and 
statements required

[[Page 655]]

or authorized to appear with such name by paragraph (a)(3) of this 
section.
    (c) Fill of container. (1) Except in the case of vacuum pack peas, 
the fill of pea ingredient and packing medium, as determined by the 
general method for fill of container prescribed in Sec. 130.12(b) of 
this chapter, is not less than 90 percent of the total capacity of the 
container.
    (2) When the peas and liquid are removed from the container and 
returned thereto, the leveled peas (irrespective of the quantity of the 
liquid), 15 seconds after they are so returned, completely fill the 
container. A container with lid attached by double seam shall be 
considered to be completely filled when it is filled to 5 millimeters 
(0.2 inch) vertical distance below the top of the double seam; and a 
glass container shall be considered to be completely filled when it is 
filled to 13 millimeters (0.5 inch) vertical distance below the top of 
the container.
    (3) Determine compliance for fill of container as specified in Sec. 
155.3(b).
    (4) If canned peas fall below the standard of fill of container 
prescribed in paragraph (c)(1) and/or (2) of this section, the label 
shall bear the general statement of substandard fill specified in Sec. 
130.14(b) of this chapter, in the manner and form therein specified.

[45 FR 43398, June 27, 1980, as amended at 47 FR 11832, Mar. 19, 1982; 
48 FR 15241, Apr. 8, 1983; 54 FR 24895, June 12, 1989; 58 FR 2882, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]

    Effective Date Note: In Sec. 155.170, those portions of paragraph 
(a)(2) pertaining to the deletion of magnesium, hydroxide, magnesium 
oxide, and magnesium carbonate were stayed until further notice at 46 FR 
35086, July 1, 1981, effective June 30, 1981.



Sec. 155.172  Canned dry peas.

    (a) Identity. Canned dry peas conforms to the definition and 
standard of identity, and is subject to the requirements for label 
declaration of ingredients, prescribed for canned peas by Sec. 
155.170(a), except that:
    (1) The optional pea ingredient is the dry seeds of the pea plant of 
the species Pisum sativum L. but excluding the subspecies macrocarpum.
    (2) The optional ingredients specified in Sec. 155.170(a)(2)(xii) 
shall not be used.
    (3) The name of the food is ``cooked dry peas'' or ``soaked dry 
peas''. The optional terms specified by Sec. 155.170(a)(3), ``early'', 
``June'', ``sweet'', ``green'', ``wrinkled'', or any combination 
thereof, shall not be used on the labels.
    (b) Quality. (1) The standard of quality for canned dry peas is that 
specified for canned peas by Sec. 155.170(b) except that:
    (i) The alcohol-insoluble solids maximums specified in Sec. 
155.170(b)(1)(vi) do not apply.
    (ii) The skins of not more than 25 percent by count of the peas in 
the container are ruptured to a width of 1.6 millimeters (0.06 inch) or 
more.
    (2) If the quality of canned dry peas falls below the standard of 
quality prescribed by paragraph (b)(1) of this section, the label shall 
bear the statement of substandard quality in the manner and form 
specified in Sec. 155.170(b)(3) for canned peas, except that the words 
``Excessively mealy'' shall not be used.
    (c) Fill of container. (1) The standard of fill of container for 
canned dry peas is that prescribed for canned peas by Sec. 155.170(c).
    (2) If canned dry peas fall below the standard of fill of container 
prescribed by paragraph (c)(1) of this section, the label shall bear the 
general statement of substandard fill specified in Sec. 130.14(b) of 
this chapter, in the manner and form therein specified.

[45 FR 43399, June 27, 1980, as amended at 48 FR 15241, Apr. 8, 1983; 58 
FR 2883, Jan. 6, 1993]



Sec. 155.190  Canned tomatoes.

    (a) Identity--(1) Description. (i) Canned tomatoes is the food 
prepared from mature tomatoes conforming to the characteristics of the 
fruit Lycopersicum esculentum P. Mill, of red or reddish varieties. The 
tomatoes may or may not be peeled, but shall have had the stems and 
calicies removed and shall have been cored, except where the internal 
core is insignificant to texture and appearance.
    (ii) Canned tomatoes may contain one or more of the safe and 
suitable optional ingredients specified in paragraph (a)(2) of this 
section, be packed without any added liquid or in one of the optional 
packing media specified in paragraph (a)(3) of this section and be

[[Page 656]]

prepared in one of the styles specified in paragraph (a)(4) of this 
section. Such food is sealed in a container and before or after sealing 
is so processed by heat as to prevent spoilage.
    (2) Optional ingredients. One or more of the following safe and 
suitable ingredients may be used:
    (i) Calcium salts in a quantity reasonably necessary to firm the 
tomatoes, but the amount of calcium in the finished canned tomatoes is 
not more than 0.045 percent of the weight, except that when the tomatoes 
are prepared in one of the styles specified in paragraphs (a)(4) (ii) to 
(iv) of this section the amount of calcium is not more than 0.08 percent 
of the weight of the food.
    (ii) Organic acids for the purpose of acidification.
    (iii) Dry nutritive carbohydrate sweeteners whenever any organic 
acid provided for in paragraph (a)(2)(ii) of this section is used, in a 
quantity reasonably necessary to compensate for the tartness resulting 
from such added acid.
    (iv) Salt.
    (v) Spices, spice oils.
    (vi) Flavoring and seasoning.
    (vii) Vegetable ingredients such as onion, peppers, and celery, that 
may be fresh or preserved by physical means, in a quantity not more than 
10 percent by weight of the finished food.
    (3) Packing media. (i) The liquid draining from the tomatoes during 
or after peeling or coring.
    (ii) The liquid strained from the residue from preparing tomatoes 
for canning consisting of peels and cores with or without tomatoes or 
pieces thereof.
    (iii) The liquid strained from mature tomatoes (tomato juice).
    (iv) Tomato paste, or tomato puree, or tomato pulp complying with 
the compositional requirements of Sec. 155.191.
    (4) Styles. (i) Whole.
    (ii) Diced.
    (iii) Sliced.
    (iv) Wedges.
    (5) Name of the food. (i) The name of the food is ``tomatoes'', 
except that when the tomatoes are not peeled the name is ``unpeeled 
tomatoes''.
    (ii) The following shall be included as part of the name or in close 
proximity to the name of the food:
    (a) A declaration of any flavoring that characterizes the product as 
specified in Sec. 101.22 of this chapter.
    (b) A declaration of any added spice, seasoning, or vegetable 
ingredient that characterizes the product, (e.g., ``with added ___'' or, 
``with ___'' the blank to be filled in with the word(s) ``spice(s)'', 
``seasoning(s)'', or the name(s) of the vegetable(s) used or in lieu of 
the word(s) ``spice(s)'' or ``seasoning (s)'' the common or usual 
name(s) of the spice(s) or seasoning(s) used) except that no declaration 
of the presence of onion, peppers, and celery is required for stewed 
tomatoes.
    (c) The word ``stewed'' if the tomatoes contain characterizing 
amounts of at least the three optional vegetables listed in paragraph 
(a)(2)(vii) of this section.
    (d) The styles: ``Diced'', ``sliced'', or ``wedges'' as appropriate.
    (e) The name of the packing medium: ``tomato paste'', ``tomato 
puree'', or ``tomato pulp'' as provided in paragraph (a)(3)(iv) of this 
section, or ``strained residual tomato material from preparation for 
canning'' as provided for in paragraph (a)(3)(ii) of this section, as 
appropriate. The name of the packing medium shall be preceded by the 
word ``with''.
    (iii) The following may be included as part of the name or in close 
proximity to the name:
    (a) The word ``whole'' if the tomato ingredient is whole or almost 
whole, and the weight of such ingredient is not less than 80 percent of 
the drained weight of the finished food as determined in accordance with 
the method prescribed in paragraph (b)(2) of this section.
    (b) The words ``solid pack'' when none of the optional packing media 
specified in paragraph (a)(3) of this section are used.
    (c) The words ``in tomato juice'' if the packing medium specified in 
paragraph (a)(3)(iii) of this section is used.
    (6) Label declaration. The name of each ingredient used shall be 
declared on the label as required by the applicable sections of parts 
101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned tomatoes is as 
follows:

[[Page 657]]

    (i) The drained weight, as determined by the method prescribed in 
paragraph (b)(2)(i) of this section, is not less than 50 percent of the 
weight of water required to fill the container, as determined by the 
general method for water capacity of containers prescribed in Sec. 
130.12(a) of this chapter;
    (ii) The strength and redness of color as determined by the method 
prescribed in paragraph (b)(2) of this section, are not less than that 
of the blended color of any combination of the color discs described in 
such method in which one-third the area of disc 1, and not more than 
one-third the area of disc 2, is exposed;
    (iii) Peel per kilogram (2.2 pounds) of the finished food covers an 
area of not more than 15 cm\2\ (2.3 square inches) which is equivalent 
to 6.8 cm\2\ (1.06 square inches) per pound based on an average of all 
containers examined provided, however, that the area of peel is not a 
factor of quality for canned unpeeled tomatoes labeled in accordance 
with paragraph (a)(5)(i) of this section; and
    (iv) Blemishes per kilogram (2.2 pounds) of the finished food cover 
an area of not more than 3.5 cm\2\ (0.54 square inch) which is 
equivalent to 1.6 cm\2\ (0.25 square inch) per pound based on an average 
of all containers examined.
    (2) Canned tomatoes shall be tested by the following method to 
determine whether or not they meet the requirements of paragraphs (b)(1) 
(i) and (ii) of this section:
    (i) Remove lid from container, but in the case of a container with 
lid attached by double seam, do not remove or alter the height of the 
double seam. Tilt the opened container so as to distribute the contents 
over the meshes of a circular sieve which has previously been weighed. 
The diameter of the sieve used is 20.3 centimeters (8 inches) if the 
quantity of the contents of the container is less than 1.4 kilograms (3 
pounds) or 30.5 centimeters (12 inches) if such quantity is 1.4 
kilograms (3 pounds) or more. The meshes of such sieve are made by so 
weaving wire of 1.4 mm (0.054 inch) diameter as to form square openings 
11.3 mm by 11.3 mm (0.446 inch by 0.446 inch). Without shifting the 
tomatoes, so incline the sieve as to facilitate drainage of the liquid. 
Two minutes from the time drainage begins, weigh the sieve and drained 
tomatoes. The weight so found, less the weight of the sieve, shall be 
considered to be the drained weight.
    (ii) Remove from the sieve the drained tomatoes, cut out and 
segregate successively those portions of least redness until 50 percent 
of the drained weight has been so segregated. Comminute the segregated 
portions to a uniform mixture without removing or breaking the seeds. 
Fill the mixture into a black container to a depth of at least 25.4 mm 
(1 inch). Free the mixture from air bubbles, and skim off or press below 
the surface all visible seeds. Compare the color of the mixture, in full 
diffused daylight or its equivalent, with the blended color of 
combinations of the following concentric Munsell color discs of equal 
diameter, or the color equivalent of such discs:
    (a) Red--Munsell 5 R 2.6/13 (glossy finish).
    (b) Yellow--Munsell 2.5 YR 5/12 (glossy finish).
    (c) Black--Munsell N 1/ (glossy finish).
    (d) Grey--Munsell N 4 (mat finish).
    (3) Determine compliance as specified in Sec. 155.3(b).
    (4) If the quality of canned tomatoes falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter in the manner and form therein specified; if, however, the 
quality of canned tomatoes falls below standard with respect to only one 
of the factors of quality specified by paragraphs (b)(1) (i) to (iii) of 
this section, there may be substituted for the second line of such 
general statement of substandard quality (``Good Food--Not High Grade'') 
a new line, appropriate for the corresponding subparagraph designation 
of paragraph (b)(1) of this section which the canned tomatoes fail to 
meet, to read as follows:
    (i) ``Poor color'' or
    (ii) ``Excessive peel'' or
    (iii) ``Excessive blemishes''.
    (c) Fill of container. (1) The standard of fill of container for 
canned tomatoes

[[Page 658]]

is a fill of not less than 90 percent of the total capacity of the 
container, as determined by the general method for fill of containers 
prescribed in Sec. 130.12(b) of this chapter.
    (2) Determine compliance as specified in Sec. 155.3(b).
    (3) If canned tomatoes fall below the standard of fill of container 
prescribed in paragraph (c)(1) of this section, the label shall bear the 
general statement of substandard fill specified in Sec. 130.14(b) of 
this chapter, in the manner and form therein specified.

[42 FR 14449, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978; 
43 FR 30274, July 14, 1978; 45 FR 43400, June 27, 1980; 58 FR 17103, 
Apr. 1, 1993; 59 FR 15051, Mar. 31, 1994]



Sec. 155.191  Tomato concentrates.

    (a) Identity--(1) Definition. Tomato concentrates are the class of 
foods each of which is prepared by concentrating one or any combination 
of two or more of the following optional tomato ingredients:
    (i) The liquid obtained from mature tomatoes of the red or reddish 
varieties (Lycopersicum esculentum P. Mill).
    (ii) The liquid obtained from the residue from preparing such 
tomatoes for canning, consisting of peelings and cores with or without 
such tomatoes or pieces thereof.
    (iii) The liquid obtained from the residue from partial extraction 
of juice from such tomatoes.


Such liquid is obtained by so straining the tomatoes, with or without 
heating, as to exclude skins (peel), seeds, and other coarse or hard 
substances in accordance with good manufacturing practice. Prior to 
straining, food-grade hydrochloric acid may be added to the tomato 
material in an amount to obtain a pH no lower than 2.0. Such acid is 
then neutralized with food-grade sodium hydroxide so that the treated 
tomato material is restored to a pH of 4.20.2. 
Water may be added to adjust the final composition. The food contains 
not less than 8.0 percent tomato soluble solids as defined in Sec. 
155.3(e). The food is preserved by heat sterilization (canning), 
refrigeration, or freezing. When sealed in a container to be held at 
ambient temperatures, it is so processed by heat, before or after 
sealing, as to prevent spoilage.
    (2) Optional ingredients. One or any combination of two or more of 
the following safe and suitable ingredients may be used in the foods:
    (i) Salt (sodium chloride formed during acid neutralization shall be 
considered added salt).
    (ii) Lemon juice, concentrated lemon juice, or organic acids.
    (iii) Sodium bicarbonate.
    (iv) Water, as provided for in paragraph (a)(1) of this section.
    (v) Spices.
    (vi) Flavoring.
    (3) Labeling. (i) The name of the food is:
    (a) ``Tomato puree'' or ``tomato pulp'' if the food contains not 
less than 8.0 percent but less than 24.0 percent tomato soluble solids.
    (b) ``Tomato paste'' if the food contains not less than 24.0 percent 
tomato soluble solids.
    (c) The name ``tomato concentrate'' may be used in lieu of the name 
``tomato puree,'' ``tomato pulp,'' or ``tomato paste'' whenever the 
concentrate complies with the requirements of such foods; except that 
the label shall bear the statement ``for remanufacturing purposes only'' 
when the concentrate is packaged in No. 10 containers (3.1 kilograms or 
109 avoirdupois ounces total water capacity) or containers that are 
smaller in size.
    (d) ``Concentrated tomato juice'' if the food is prepared from the 
optional tomato ingredient described in paragraph (a)(1)(i) of this 
section and is of such concentration that upon diluting the food 
according to label directions as set forth in paragraph (a)(3)(iii) of 
this section, the diluted article will contain not less than 5.0 percent 
by weight tomato soluble solids.
    (ii) The following shall be included as part of the name or in close 
proximity to the name of the food:
    (a) The statement ``Made from'' or ``Made in part from,'' as the 
case may be, ``residual tomato material from canning'' if the optional 
tomato ingredient specified in paragraph (a)(1)(ii) of this section is 
present.
    (b) The statement ``Made from'' or ``Made in part from,'' as the 
case may be, ``residual tomato material from partial extraction of 
juice'' if the optional tomato ingredient specified in

[[Page 659]]

paragraph (a)(1)(iii) of this section is present.
    (c) A declaration of any flavoring that characterizes the product as 
specified in Sec. 101.22 of this chapter and a declaration of any spice 
that characterizes the product, e.g., ``Seasoned with ___,'' the blank 
to be filled in with the words ``added spice'' or, in lieu of the word 
``spice,'' the common name of the spice.
    (iii) The label of concentrated tomato juice shall bear adequate 
directions for dilution to result in a diluted article containing not 
less than 5.0 percent by weight tomato soluble solids; except that 
alternative methods may be used to convey adequate dilution directions 
for containers that are larger than No. 10 containers (3.1 kilograms or 
109 avoirdupois ounces total water capacity).
    (iv) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter; except that water need not be 
declared in the ingredient statement when added to adjust the tomato 
soluble solids content of tomato concentrates within the range of 
soluble solids levels permitted for these foods.
    (v) Determine percent tomato soluble solids as specified in Sec. 
155.3(e). Determine compliance as specified in Sec. 155.3(b). A lot 
shall be deemed to be in compliance for tomato soluble solids as 
follows:
    (a) The sample average meets or exceeds the required minimum.
    (b) The number of sample units that are more than 1 percent tomato 
soluble solids below the minimum required does not exceed the acceptance 
number in the sampling plans set forth in Sec. 155.3(c)(2).
    (b) Quality. (1) The standard of quality for tomato concentrate 
(except for concentrated tomato juice, which when diluted to 5.0 percent 
tomato soluble solids shall conform to the standard of quality for 
tomato juice set forth in Sec. 156.145 of this chapter) is as follows:
    (i) The strength and redness of color of the food, when diluted with 
water (if necessary) to 8.10.1 percent tomato 
soluble solids is not less than the composite color produced by spinning 
the Munsell color discs in the following combination:

53 percent of the area of Disc 1;
28 percent of the area of Disc 2; and
19 percent of the area of either Disc 3 or Disc 4; or
9\1/2\ percent of the area of Disc 3 and 9\1/2\ percent of the area of 
Disc 4, whichever most nearly matches the appearance of the sample.

    (ii) Not more than one whole seed per 600 grams (21 ounces).
    (iii) Not more than 36 of the following defects, either singly or in 
combination, per 100 grams (3.5 ounces) of the product when diluted with 
water to 8.10.1 percent tomato soluble solids:
    (a) Pieces of peel 5 millimeters (0.20 inch) or greater in length 
(without unrolling).
    (b) Pieces of seed (seed particles) 1 millimeter (0.039 inch) or 
greater in length.
    (c) Blemishes, such as dark brown or black particles (specks)--not 
more than four exceed 1.6 millimeters (0.0625 inch) in length of which 
not more than one exceeds 3.2 millimeters (0.125 inch) and none exceed 
6.4 millimeters (0.25 inch).
    (2) Methodology. Dilute with water, if necessary, to 8.10.1 percent tomato soluble solids. (i) Determine 
strength and redness of color as prescribed in Sec. 155.3(d).
    (ii) Whole seeds--Weigh out 600 grams (21 ounces) of the well-mixed, 
diluted concentrate; place a U.S. No. 12 screen (1.68 millimeters (0.066 
inch) openings) over the sink drain; transfer the product sample onto 
the screen; rinse container thoroughly with water and pour through 
screen; flush sample through screen by using an adequate spray of water; 
check screen for whole seeds; apply the appropriate allowance.
    (iii) Peel, pieces of seed, and blemishes--Spread the prepared 
concentrate evenly on a large white tray and remove the individual 
defects, identify, classify, and measure.
    (3) Sampling and acceptance. Determine compliance as specified in 
Sec. 155.3(b).
    (4) If the quality of the tomato concentrate falls below the 
standard prescribed in paragraph (b) (1) and (3) of this section, the 
label shall bear the

[[Page 660]]

general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified, but in lieu of 
such general statement of substandard quality when the quality of the 
tomato concentrate falls below the standard in one or more respects, the 
label may bear the alternative statement, ``Below Standard in Quality 
___,'' the blank to be filled in with the words specified after the 
corresponding paragraph(s) under paragraph (b)(1) of this section which 
such tomato concentrate fails to meet, as follows:
    (i) ``Poor color.''
    (ii) ``Excessive seeds.''
    (iii)(a) ``Excessive pieces of peel.''
    (b) ``Excessive pieces of seed.''
    (c) ``Excessive blemishes.''
    (c) Fill of container. (1) The standard of fill of container for 
tomato concentrate, as determined by the general method for fill of 
container prescribed in Sec. 130.12(b) of this chapter, is not less 
than 90 percent of the total capacity, except when the food is frozen.
    (2) Determine compliance as specified in Sec. 155.3(b).
    (3) If the tomato concentrate falls below the standard of fill 
prescribed in paragraph (c) (1) and (2) of this section, the label shall 
bear the general statement of substandard fill specified in Sec. 
130.14(b) of this chapter, in the manner and form therein prescribed.

[48 FR 3954, Jan. 28, 1983, as amended at 49 FR 15073, Apr. 17, 1984; 58 
FR 2883, Jan. 6, 1993; 58 FR 17104, Apr. 1, 1993]



Sec. 155.194  Catsup.

    (a) Identity--(1) Definition. Catsup, ketchup, or catchup is the 
food prepared from one or any combination of two or more of the 
following optional tomato ingredients:
    (i) Tomato concentrate as defined in Sec. 155.191(a)(1), except 
that lemon juice, concentrated lemon juice, or safe and suitable organic 
acids may be used in quantities no greater than necessary to adjust the 
pH, and in compliance with Sec. 155.191(b).
    (ii) The liquid derived from mature tomatoes of the red or reddish 
varieties Lycopersicum esculentum P. Mill.
    (iii) The liquid obtained from the residue from preparing such 
tomatoes for canning, consisting of peelings and cores with or without 
such tomatoes or pieces thereof.
    (iv) The liquid obtained from the residue from partial extraction of 
juice from such tomatoes.


Such liquid is strained so as to exclude skins, seeds, and other coarse 
or hard substances in accordance with current good manufacturing 
practice. Prior to straining, food-grade hydrochloric acid may be added 
to the tomato material in an amount to obtain a pH no lower than 2.0. 
Such acid is then neutralized with food-grade sodium hydroxide so that 
the treated tomato material is restored to a pH of 4.20.2. The final composition of the food may be adjusted 
by concentration and/or by the addition of water. The food may contain 
salt (sodium chloride formed during acid neutralization shall be 
considered added salt) and is seasoned with ingredients as specified in 
paragraph (a)(2) of this section. The food is preserved by heat 
sterilization (canning), refrigeration, or freezing. When sealed in a 
container to be held at ambient temperatures, it is so processed by 
heat, before or after sealing, as to prevent spoilage.
    (2) Ingredients. One or any combination of two or more of the 
following safe and suitable ingredients in each of the following 
categories is added to the tomato ingredients specified in paragraph 
(a)(1) of this section:
    (i) Vinegars.
    (ii) Nutritive carbohydrate sweeteners. Such sweeteners if defined 
in part 168 of this chapter shall be as defined therein.
    (iii) Spices, flavoring, onions, or garlic.
    (3) Labeling. (i) The name of the food is ``Catsup,'' ``Ketchup,'' 
or ``Catchup.''
    (ii) The following shall be included as part of the name or in close 
proximity to the name of the food:
    (a) The statement ``Made from'' or ``Made in part from,'' as the 
case may be, ``residual tomato material from canning'' if the optional 
tomato ingredient specified in paragraph (a)(1)(iii) of this section or 
tomato concentrate containing the ingredient specified in Sec. 
155.191(a)(1)(ii) is present.
    (b) The statement ``Made from'' or ``Made in part from,'' as the 
case may be, ``residual tomato material from

[[Page 661]]

partial extraction of juice'' if the optional tomato ingredient 
specified in paragraph (a)(1)(iv) of this section or tomato concentrate 
containing the ingredient specified in Sec. 155.191(a)(1)(iii) is 
present.
    (iii) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter; except that the name ``tomato 
concentrate'' may be used in lieu of the names ``tomato puree,'' 
``tomato pulp,'' or ``tomato paste'' and when tomato concentrates are 
used, the labeling requirements of Sec. 155.191(a)(3)(ii)(a) and 
(a)(3)(ii)(b) do not apply.
    (b) Quality. (1) The standard of quality for catsup is as follows: 
The consistency of the finished food is such that its flow is not more 
than 14 centimeters in 30 seconds at 20 [deg]C when tested in a Bostwick 
Consistometer in the following manner: Check temperature of mixture and 
adjust to 201 [deg]C. The trough must also be at a 
temperature close to 20 [deg]C. Adjust end-to-end level of Bostwick 
Consistometer by means of the spirit level placed in trough of 
instrument. Side-to-side level may be adjusted by means of the built-in 
spirit level. Transfer sample to the dry sample chamber of the Bostwick 
Consistometer. Fill the chamber slightly more than level full, avoiding 
air bubbles as far as possible. Pass a straight edge across top of 
chamber starting from the gate end to remove excess product. Release 
gate of instrument by gradual pressure on lever, holding the instrument 
down at the same time to prevent its movement as the gate is released. 
Immediately start the stop watch or interval timer, and after 30 seconds 
read the maximum distance of flow to the nearest 0.1 centimeter. Clean 
and dry the instrument and repeat the reading on another portion of 
sample. Do not wash instrument with hot water if it is to be used 
immediately for the next determination, as this may result in an 
increase in temperature of the sample. For highest accuracy, the 
instrument should be maintained at a temperature of 201 [deg]C. If readings vary more than 0.2 centimeter, 
repeat a third time or until satisfactory agreement is obtained. Report 
the average of two or more readings, excluding any that appear to be 
abnormal.
    (2) Determine compliance as specified in Sec. 155.3(b).
    (3) If the quality of catsup falls below the standard prescribed in 
paragraphs (b) (1) and (2) of this section, the label shall bear the 
general statement of substandard quality specified in Sec. 130.14(a) of 
this chapter, in the manner and form therein specified, but in lieu of 
such general statement of substandard quality when the quality of the 
catsup falls below the standard, the label may bear the alternative 
statement, ``Below Standard in Quality--Low Consistency.''
    (c) Fill of container. (1) The standard of fill of container for 
catsup, as determined by the general method for fill of container 
prescribed in Sec. 130.12(b) of this chapter, is not less than 90 
percent of the total capacity except:
    (i) When the food is frozen, or
    (ii) When the food is packaged in individual serving-size packages 
containing 56.7 grams (2 ounces) or less.
    (2) Determine compliance as specified in Sec. 155.3(b).
    (3) If the catsup falls below the standard of fill prescribed in 
paragraphs (c) (1) and (2) of this section, the label shall bear the 
general statement of substandard fill as specified in Sec. 130.14(b) of 
this chapter, in the manner and form therein specified.

[48 FR 3956, Jan. 28, 1983, as amended at 49 FR 15073, Apr. 17, 1984; 58 
FR 2883, Jan. 6, 1993]



Sec. 155.200  Certain other canned vegetables.

    (a) The canned vegetables for which definitions and standards of 
identity are prescribed by this section are those named in column I of 
the table set forth in paragraph (b) of this section. The vegetable 
ingredient in each such canned vegetable is obtained by proper 
preparation from the succulent vegetable prescribed in column II of such 
table. If two or more forms of such ingredient are designated in column 
III of such table, the vegetable in each such form is an optional 
ingredient. To the vegetable ingredient additional ingredients as 
required or permitted by paragraph (c) of this section are added,

[[Page 662]]

and the food is sealed in a container and so processed by heat as to 
prevent spoilage.
    (b) The table referred to in paragraph (a) of this section is as 
follows:

----------------------------------------------------------------------------------------------------------------
                                                                               III--Optional forms of vegetable
 I--Name or synonym of canned vegetable               II--Source                          ingredient
----------------------------------------------------------------------------------------------------------------
Artichokes..............................  Flower buds of the artichoke plant  Whole; half or halves or halved;
                                                                               whole hearts; halved hearts;
                                                                               quartered hearts.
Asparagus...............................  Edible portions of sprouts of the
                                           asparagus plant, as follows:.
                                          3 and \3/4\ in or more of upper     Stalks or spears.
                                           end.
                                          3 and \3/4\ in or more of peeled    Peeled stalks or peeled spears.
                                           upper end.
                                          Not less than 2 and \3/4\ in but    Tips.
                                           less than 3 and \3/4\ in of upper
                                           end.
                                          Less than 2 and \3/4\ in of upper   Points.
                                           end.
                                          Sprouts cut in pieces.............  Cut stalks or cut spears.
                                          Sprouts from which the tip has      Bottom cuts or cuts--tips removed.
                                           been removed, cut in pieces.
Bean sprouts............................  Sprouts of the Mung bean..........
Shelled beans...........................  Seed shelled from green or wax
                                           bean pods, with or without snaps
                                           (pieces of immature unshelled
                                           pods).
Lima beans or butter beans..............  Seed shelled from the pods of the
                                           lima bean plant.
Beets...................................  Root of the beet plant............  Whole; slices or sliced; quarters
                                                                               or quartered; dice or diced; cut;
                                                                               shoestring or French style or
                                                                               julienne.
Beet greens.............................  Leaves, or leaves and immature
                                           root, of the beet plant.
Broccoli................................  Heads of the broccoli plant.......
Brussels sprouts........................  Sprouts of the brussels sprouts
                                           plant.
Cabbage.................................  Cut pieces of the heads of the
                                           cabbage plant.
Carrots.................................  Root of the carrot plant..........   Do.
Cauliflower.............................  Cut pieces of the head of the
                                           cauliflower plant.
Celery..................................  Stalks of the celery plant........  Cut; hearts.
Collards................................  Leaves of the collard plant.......
Dandelion greens........................  Leaves of the dandelion plant.....
Kale....................................  Leaves of the kale plant..........
Mustard greens..........................  Leaves of the mustard plant.......
Okra....................................  Pods of the okra plant............  Whole; cut.
Onions..................................  Bulb of the onion plant...........   Do.
Parsnips................................  Root of the parsnip plant.........  Whole; quarters or quartered;
                                                                               slices or sliced; cut; shoestring
                                                                               or French style or julienne.
Black-eye peas or black-eyed peas.......  Seed shelled from pods of the
                                           black-eye pea plant, with or
                                           without snaps (pieces of immature
                                           unshelled pods).
Field peas..............................  Seed shelled from pods of the
                                           field pea plant (other than the
                                           black-eye pea plant), with or
                                           without snaps (pieces of immature
                                           unshelled pods).
Green sweet peppers.....................  Green pods of the sweet pepper      Whole; halves or halved; pieces;
                                           plant.                              dice or diced; strips; chopped.
Red sweet peppers.......................  Red-ripe pods of the sweet pepper    Do.
                                           plant.
Pimientos or pimentos...................  Red-ripe pods of the pimiento,      Whole; halves or halved; pieces;
                                           pimento, pepper plant.              dice or diced; slices or sliced;
                                                                               chopped.
Potatoes................................  Tuber of the potato plant.........  Whole; slices or sliced; dice or
                                                                               diced; pieces; shoestring or
                                                                               French style or julienne; French
                                                                               fry cut.
Rutabagas...............................  Root of the rutabaga plant........  Whole; quarters or quartered;
                                                                               slices or sliced; dice or diced;
                                                                               cut.
Salsify.................................  Root of the salsify plant.........
Spinach.................................  Leaves of the spinach plant.......  Whole leaf; cut leaf or sliced;
                                                                               chopped.
Sweet potatoes..........................  Tuber of the sweet potato plant...  Whole; mashed; pieces or cuts or
                                                                               cut (longitudinally cut halves
                                                                               may be named on labels as halves
                                                                               or halved in lieu of pieces or
                                                                               cuts or cut).
Swiss chard.............................  Leaves of the Swiss chard plant...
Truffles................................  Fruit of the truffle..............
Turnip greens...........................  Leaves of the turnip plant........
Turnips.................................  Root of the turnip plant..........  Whole; quarters or quartered;
                                                                               slices or sliced; dice or diced;
                                                                               cut.
----------------------------------------------------------------------------------------------------------------


[[Page 663]]

    (c) Water is added to the vegetable ingredient, except that 
pimientos may be canned with or without added water, and sweet potatoes 
in mashed form are canned without added water. Asparagus may be canned 
with added water, asparagus juice, or a mixture of both. For the 
purposes of this section, asparagus juice is the clear, unfermented 
liquid expressed from the washed and heated sprouts or parts of sprouts 
of the asparagus plant, and mixtures of asparagus juice and water are 
considered to be water when such mixtures are used as a packing medium 
for canned asparagus. In the case of artichokes, a vinegar or any safe 
and suitable organic acid, which either is not a food additive as 
defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act, 
or if it is a food additive as so defined, is used in conformity with 
regulations established pursuant to section 409 of the act, is added in 
such quantity as to reduce the pH of the finished canned vegetable to 
4.5 or below. The following optional ingredients, in the case of the 
vegetables specified, may be added:
    (1) An edible vegetable oil, in the cases of artichokes and 
pimientos.
    (2) Snaps, in the cases of shelled beans, black-eyed peas, and field 
peas.
    (3) In the case of all vegetables (except canned mashed sweet 
potatoes as regards the seasonings listed in paragraph (c)(3)(iii) of 
this section) one or more of the following optional seasoning 
ingredients may be added in a quantity sufficient to season the food.
    (i) Refined sugar (sucrose).
    (ii) Refined corn sugar (dextrose).
    (iii) Corn sirup, glucose sirup.
    (iv) Dried corn sirup, dried glucose sirup.
    (v) Spice.
    (vi) A vinegar.
    (vii) Green peppers or red peppers which may be dried.
    (viii) Mint leaves.
    (ix) Onions, which may be dried.
    (x) Garlic, which may be dried.
    (xi) Horseradish.
    (xii) Lemon juice or concentrated lemon juice.
    (xiii) Butter or margarine in a quantity not less than 3 percent by 
weight of the finished food. When butter or margarine is added, safe and 
suitable emulsifiers or stabilizers, or both, may be added. When butter 
or margarine is added, no spice or flavoring simulating the color or 
flavor imparted by butter or margarine is used.
    (4) In the case of all vegetables, the following optional 
ingredients may be added:
    (i) Salt.
    (ii) Monosodium glutamate.
    (iii) Disodium inosinate complying with the provisions of Sec. 
172.535 of this chapter.
    (iv) Disodium guanylate complying with the provisions of Sec. 
172.530 of this chapter.
    (v) Hydrolyzed vegetable protein.
    (vi) Autolyzed yeast extract.
    (5) In the case of all vegetables flavoring (except artificial) may 
be added.
    (6) In the case of bean sprouts, lima beans, carrots, green sweet 
peppers, red sweet peppers, and potatoes, any safe and suitable calcium 
salts may be added as a firming agent.
    (7) In the case of canned artichokes packed in glass containers, 
ascorbic acid may be added in a quantity not to exceed 32 milligrams per 
100 grams of the finished food.
    (8) In the case of canned asparagus, ascorbic acid, erythorbic acid, 
or the sodium salts of ascorbic acid or erythorbic acid may be added in 
an amount necessary to preserve color in the ``white'' and ``green-
tipped and white'' color types.
    (9) In the case of canned asparagus packed in glass containers, 
stannous chloride may be added in a quantity not to exceed 15 parts per 
million calculated as tin (Sn), except that in the case of asparagus 
packed in glass containers with lids lined with an inert material the 
quantity of stannous chloride added may exceed 15 parts per million but 
not 20 parts per million calculated as tin (Sn).
    (10) In the case of canned black-eyed peas, disodium EDTA may be 
added in a quantity not to exceed 145 parts per million.
    (11) In the case of potatoes, calcium disodium EDTA may be added in 
a quantity not to exceed 110 parts per million.
    (12) A vinegar or any safe and suitable organic acid for all 
vegetables (except artichokes, in which the quantity

[[Page 664]]

of such optional ingredient is prescribed by the introductory text of 
paragraph (c) of this section) in a quantity which, together with the 
amount of any lemon juice or concentrated lemon juice that may be added, 
is not more than sufficient to permit effective processing by heat 
without discoloration or other impairment of the article.
    (d) The name of each canned vegetable for which a definition and 
standard of identity is prescribed by this section is the name or any 
synonym thereof whereby such vegetable is designated in column I of the 
table in paragraph (b) of this section.
    (e) When two or more forms of the vegetable are specified in column 
III of the table in paragraph (b) of this section, the label shall bear 
the specified word or words, or in case synonyms are so specified, one 
of such synonyms, showing the form of the vegetable ingredient present; 
except that in the case of canned spinach, if the whole leaf is the 
optional form used, the word ``spinach'' unmodified may be used in lieu 
of the words ``whole leaf spinach''.
    (f)(1) If the optional ingredient specified in paragraph (c)(1) of 
this section is present, the label shall bear the statement ``___ oil 
added'' or ``With added ___ oil'', the blank being filled in with the 
common or usual name of the oil.
    (2) If asparagus juice is used as a packing medium in canned 
asparagus, the label shall bear the statement ``Packed in asparagus 
juice''.
    (3) If the optional ingredient specified in paragraph (c)(2) of this 
section is present, the label shall bear the statement ``With snaps''.
    (g) The name of the food shall include a declaration of any 
flavoring that characterizes the product as specified in Sec. 101.22 of 
this chapter, and a declaration of any spice or seasoning that 
characterizes the product; for example, ``with added spice'', ``seasoned 
with red peppers'', ``seasoned with butter''. Wherever the name of the 
vegetable appears on the label so conspicuously as to be easily seen 
under customary conditions of purchase, the words and statements 
specified in paragraphs (e) and (f) (1) through (3) of this section 
shall immediately and conspicuously precede or follow such name, without 
intervening written, printed, or graphic matter, except that the 
varietal name of the vegetable may so intervene.
    (h) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14449, Mar. 15, 1977, as amended at 42 FR 30358, June 14, 1977; 
46 FR 56410, Nov. 17, 1981; 48 FR 10813, Mar. 15, 1983; 49 FR 6711, Feb. 
23, 1984; 58 FR 2883, Jan. 6, 1993; 59 FR 15052, Mar. 31, 1994]



Sec. 155.201  Canned mushrooms.

    (a) Identity--(1) Definition. Canned mushrooms is the food properly 
prepared from the caps and stems of succulent mushrooms conforming to 
the characteristics of the species Agaricus (Psalliota) bisporus or A. 
bitorquis, in one of the optional styles specified in paragraph (a)(2) 
of this section, packed with a suitable liquid medium which may include 
water; and may contain one or more safe and suitable optional 
ingredients specified in paragraph (a)(3) of this section. The food is 
sealed in a container and, before or after sealing, is so processed by 
heat as to prevent spoilage.
    (2) Styles. The optional styles of the mushroom ingredient referred 
to in paragraph (a)(1) of this section are:
    (i) Buttons--consisting of whole mushrooms with attached stems not 
exceeding 5 millimeters (0.2 inch) in length, measured from the bottom 
of the veil.
    (ii) Whole--consisting of whole mushrooms with attached stems cut to 
a length not exceeding the diameter of the cap, measured from the bottom 
of the veil.
    (iii) Quarters--consisting of buttons or whole style cut into four 
approximately equal parts.
    (iv) Slices or sliced--consisting of buttons or whole style of which 
not less than 50 percent are cut parallel to the longitudinal axis of 
the stem and 2 millimeters to 8 millimeters (0.08 inch to 0.32 inch) in 
thickness.
    (v) Random sliced--consisting of buttons or whole style sliced in a 
random manner.

[[Page 665]]

    (vi) Pieces and stems--consisting of pieces of caps and stems of 
irregular shapes and sizes.
    (3) Optional ingredients. One or any combination of two or more of 
the following safe and suitable optional ingredients as provided for in 
paragraph (a)(1) of this section may be used:
    (i) Salt.
    (ii) Monosodium glutamate.
    (iii) Disodium inosinate complying with the provisions of Sec. 
172.535 of this chapter.
    (iv) Disodium guanylate complying with the provisions of Sec. 
172.530 of this chapter.
    (v) Hydrolyzed vegetable protein.
    (vi) Autolyzed yeast extract.
    (vii) Ascorbic acid (vitamin C) in a quantity not to exceed 132 
milligrams for each 100 grams (37.5 milligrams for each ounce) of 
drained weight of mushrooms.
    (viii) Organic acids (except no vinegar is permitted), only where 
the inside metal of the container is fully enamel-lined and in glass 
containers with fully enamel-lined caps. Ascorbic acid as provided for 
in paragraph (a)(3)(vii) of this section.
    (ix) Calcium disodium ethylenediaminetetraacetate (CaNa2 
EDTA) in a quantity not to exceed 200 parts per million for use to 
promote color retention.
    (4) Labeling requirements. (i) The name of the food is mushrooms. 
The style as provided for in paragraph (a)(2) of this section shall be 
included as part of the name or in close proximity to the name of the 
food.
    (ii) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) [Reserved]
    (c) Fill of container. (1) The standard of fill of container for 
canned mushrooms is:
    (i) The fill of the mushroom ingredient and packing medium, as 
determined by the general method for fill of container prescribed in 
Sec. 130.12(b) of this chapter, is not less than 90 percent of the 
total capacity of the container.
    (ii) The drained weight of the mushroom ingredient is not less than 
56 percent of the water capacity of the container.
    (iii) Determine drained weight as specified in Sec. 155.3(a).
    (2) Determine compliance for minimum fill and drained weight as 
specified in Sec. 155.3(b).
    (3) If the canned mushrooms fall below the standard of fill 
prescribed in paragraph (c)(1) (i) and/or (ii) and (2) of this section, 
the label shall bear the general statement of substandard fill specified 
in Sec. 130.14(b) of this chapter, in the manner and form therein 
prescribed.

[48 FR 10813, Mar. 15, 1983, as amended at 58 FR 2883, Jan. 6, 1993]



PART 156_VEGETABLE JUICES--Table of Contents



                      Subpart A_General Provisions

Sec.
156.3 Definitions.

    Subpart B_Requirements for Specific Standardized Vegetable Juices

156.145 Tomato juice.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371.



                      Subpart A_General Provisions



Sec. 156.3  Definitions.

    For the purpose of this part:
    (a) Strength and redness of color means at least as much red as 
obtained by comparison of the prepared product, with the blended color 
produced by spinning a combination of the following concentric Munsell 
color discs of equal diameter, or the color equivalent of such discs:

Disc 1--Red (5R 2.6/13) (glossy finish)
Disc 2--Yellow (2.5 YR 5/12) (glossy finish)
Disc 3--Black (N1) (glossy finish)
Disc 4--Grey (N4) (mat finish)


Such comparison is to be made in full diffused daylight or under a 
diffused light source of approximately 2691 lux (250 footcandles) and 
having a spectral quality approximating that of daylight under a 
moderately overcast sky, with a correlated color temperature of 7,500 
degrees Kelvin 200 degrees. With the light source 
directly over the disc and product, observation is made at an angle of 
45 degrees from a distance of

[[Page 666]]

about 24 inches from the product. Electronic color meters may be used as 
an alternate means of determining the color of tomato juice. Such meters 
shall be calibrated to indicate that the color of the product is as red 
or more red than that produced by spinning the Munsell color discs in 
the combination as set out above.
    (b) Tomato soluble solids means the sucrose value as determined by 
the method prescribed in ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed., 1980, sections 
32.014 to 32.016 and 52.012, under the headings ``Soluble Solids in 
Tomato Products Official Final Action'' and ``Refractive Indices (n) of 
Sucrose Solutions at 20[deg],'' which is incorporated by reference. 
Copies are available from the AOAC INTERNATIONAL, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877, or 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. If no salt has been 
added, the sucrose value obtained from the referenced tables shall be 
considered the percent of tomato soluble solids. If salt has been added, 
either intentionally or through the application of the acidified break, 
determine the percent of such added sodium chloride as specified in 
paragraph (c) of this section. Subtract the percentage so found from the 
percentage of tomato soluble solids found (sucrose value from the 
refractive index tables) and multiply the difference by 1.016. The 
resultant value is considered the percent of ``tomato soluble solids.''
    (c) Salt means sodium chloride, determined as chloride and 
calculated as percent sodium chloride, by the method prescribed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed., 1980, sections 32.025 to 32.030, under the heading 
``Method III (Potentiometric Method),'' which is incorporated by 
reference.
    (d) Compliance means the following: Unless otherwise provided in a 
standard, a lot of canned vegetable juice shall be deemed in compliance 
for the following factors, to be determined by the sampling and 
acceptance procedure as provided in paragraph (e) of this section, 
namely:
    (1) Quality. The quality of a lot shall be considered acceptable 
when the number of defectives does not exceed the acceptance number (c) 
in the sampling plans.
    (2) Fill of container. A lot shall be deemed to be in compliance for 
fill of container when the number of defectives does not exceed the 
acceptance number (c) in the sampling plans.
    (e) Sampling and acceptance procedure means the following:
    (1) Definitions--(i) Lot. A collection of primary containers or 
units of the same size, type, and style manufactured or packed under 
similar conditions and handled as a single unit of trade.
    (ii) Lot size. The number of primary containers or units in the lot.
    (iii) Sample size (n). The total number of sample units drawn for 
examination from a lot.
    (iv) Sample unit. A container, a portion of the contents of a 
container, or a composite mixture of product from small containers that 
is sufficient for the examination or testing as a single unit. For fill 
of container, the sample unit shall be the entire contents of the 
container.
    (v) Defective. Any sample unit shall be regarded as defective when 
the sample unit does not meet the criteria set forth in the standards.
    (vi) Acceptance number (c). The maximum number of defective sample 
units permitted in the sample in order to consider the lot as meeting 
the specified requirements.
    (vii) Acceptable quality level (AQL). The maximum percent of 
defective sample units permitted in a lot that will be accepted 
approximately 95 percent of the time.
    (2) Sampling plans:

                   Acceptable Quality Level (AQL) 6.5
------------------------------------------------------------------------
                                                    Size of container
         Lot size (primary containers)         -------------------------
                                                     n            c
------------------------------------------------------------------------
             Net weight equal to or less than 1 kg (2.2 lb)
------------------------------------------------------------------------
4,800 or less.................................           13            2
4,801 to 24,000...............................           21            3

[[Page 667]]

 
24,001 to 48,000..............................           29            4
48,001 to 84,000..............................           48            6
84,001 to 144,000.............................           84            9
144,001 to 240,000............................          126           13
Over 240,000..................................          200           19
------------------------------------------------------------------------
 Net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
------------------------------------------------------------------------
2,400 or less.................................           13            2
2,401 to 15,000...............................           21            3
15,001 to 24,000..............................           29            4
24,001 to 42,000..............................           48            6
42,001 to 72,000..............................           84            9
72,001 to 120,000.............................          126           13
Over 120,000..................................          200           19
------------------------------------------------------------------------
                 Net weight greater than 4.5 kg (10 lb)
------------------------------------------------------------------------
600 or less...................................           13            2
601 to 2,000..................................           21            3
2,001 to 7,200................................           29            4
7,201 to 15,000...............................           48            6
15,001 to 24,000..............................           84            9
24,001 to 42,000..............................          126           13
Over 42,000...................................          200           19
------------------------------------------------------------------------
n = number of primary containers in sample.
c = acceptance number.


[48 FR 3956, Jan. 28, 1983, as amended at 54 FR 24895, June 12, 1989; 63 
FR 14035, Mar. 24, 1998]



    Subpart B_Requirements for Specific Standardized Vegetable Juices



Sec. 156.145  Tomato juice.

    (a) Identity--(1) Definition. Tomato juice is the food intended for 
direct consumption, obtained from the unfermented liquid extracted from 
mature tomatoes of the red or reddish varieties of Lycopersicum 
esculentum P. Mill, with or without scalding followed by draining. In 
the extraction of such liquid, heat may be applied by any method which 
does not add water thereto. Such juice is strained free from peel, 
seeds, and other coarse or hard substances, but contains finely divided 
insoluble solids from the flesh of the tomato in accordance with current 
good manufacturing practice. Such juice may be homogenized, may be 
seasoned with salt, and may be acidified with any safe and suitable 
organic acid. The juice may have been concentrated and later 
reconstituted with water and/or tomato juice to a tomato soluble solids 
content of not less than 5.0 percent by weight as determined by the 
method prescribed in Sec. 156.3(b). The food is preserved by heat 
sterilization (canning), refrigeration, or freezing. When sealed in a 
container to be held at ambient temperatures, it is so processed by 
heat, before or after sealing, as to prevent spoilage.
    (2) Labeling. (i) The name of the food is:
    (a) ``Tomato juice'' if it is prepared from unconcentrated undiluted 
liquid extracted from mature tomatoes of reddish varieties.
    (b) ``Tomato juice from concentrate'' if the finished juice has been 
prepared from concentrated tomato juice as specified in paragraph (a)(1) 
of this section or if the finished juice is a mixture of tomato juice 
and tomato juice from concentrate.
    (ii) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for tomato juice is as 
follows:
    (i) The strength and redness of color is not less than the composite 
color produced by spinning the Munsell color discs in the following 
combination: 53 percent of the area of Disc 1; 28 percent of the area of 
Disc 2; and 19 percent of the area of either Disc 3 or Disc 4; or 9\1/2\ 
percent of the area of Disc 3 and 9\1/2\ percent of the area of Disc 4, 
whichever most nearly matches the appearance of the tomato juice.
    (ii) Not more than two defects for peel and blemishes, either singly 
or in combination, in addition to three defects for seeds or pieces of 
seeds, defined as follows, per 500 milliliters (16.9 fluid ounces):
    (a) Pieces of peel 3.2 millimeters (0.125 inch) or greater in 
length.
    (b) Blemishes such as dark brown or black particles (specks) greater 
than 1.6 millimeters (0.0625 inch) in length.
    (c) Seeds or pieces of seeds 3.2 millimeters (0.125 inch) or greater 
in length.
    (2) Methodology. (i) Determine strength and redness of color as 
specified in Sec. 156.3(a).
    (ii) Examine a total of 500 milliliters for peel, blemishes, and 
seeds. Divide the 500-milliliter sample into two 250-

[[Page 668]]

milliliter aliquots and pour each aliquot onto separate 30.5 x 45.7 
centimeters (12 x 18 inches) white grading trays. Remove defects and 
evaluate for color and size as defined in paragraph (b)(1)(ii) of this 
section.
    (3) Determine compliance as specified in Sec. 156.3(d).
    (4) If the quality of the tomato juice falls below the standard 
prescribed in paragraph (b)(1) and (3) of this section, the label shall 
bear the general statement of substandard quality specified in Sec. 
130.14(a) of this chapter, in the manner and form therein specified, but 
in lieu of such general statement of substandard quality when the 
quality of the tomato juice falls below the standard in one or more 
respects, the label may bear the alternative statement, ``Below Standard 
in Quality ___'', the blank to be filled in with the words specified 
after the corresponding paragraph (s) under paragraph (b)(1) of this 
section which such tomato juice fails to meet, as follows:
    (i) ``Poor color''.
    (ii)(a) ``Excessive pieces of peel''.
    (b) ``Excessive blemishes''.
    (c) ``Excessive seeds'' or ``excessive pieces of seed''.
    (c) Fill of container. (1) The standard of fill of container for 
tomato juice, as determined by the general method for fill of container 
prescribed in Sec. 130.12(b) of this chapter, is not less than 90 
percent of the total capacity, except when the food is frozen.
    (2) Determine compliance as specified in Sec. 156.3(d).
    (3) If the tomato juice falls below the standard of fill prescribed 
in paragraph (c)(1) and (2) of this section, the label shall bear the 
general statement of substandard fill specified in Sec. 130.14(b) of 
this chapter, in the manner and form therein prescribed.

[48 FR 3957, Jan. 28, 1983, as amended at 58 FR 2883, Jan. 6, 1993]



PART 158_FROZEN VEGETABLES--Table of Contents



                      Subpart A_General Provisions

Sec.
158.3 Definitions.

   Subpart B_Requirements for Specific Standardized Frozen Vegetables

158.170 Frozen peas.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371.



                      Subpart A_General Provisions



Sec. 158.3  Definitions.

    For the purposes of this part the following definitions shall apply:
    (a) Lot. A collection of primary containers or units of the same 
size, type and style manufactured or packed under similar conditions and 
handled as a single unit of trade.
    (b) Lot size. The number of primary containers or units (pounds when 
in bulk) in the lot.
    (c) Sample size. The total number of sample units drawn for 
examination from a lot.
    (d) Sample unit. A container, a portion of the contents of a 
container, or a composite mixture of product from small containers that 
is sufficient for the examination or testing as a single unit.
    (e) Defective. Any sample unit shall be regarded as defective when 
the sample unit does not meet the criteria set forth in the standards.
    (f) Acceptance number. The maximum number of defective sample units 
permitted in the sample in order to consider the lot as meeting the 
specified requirements. The following acceptance numbers shall apply:

------------------------------------------------------------------------
                                                       Size container
           Lot size (primary container)            ---------------------
                                                      n \1\      c \2\
------------------------------------------------------------------------
             net weight equal to or less than 1 kg (2.2 lb)
------------------------------------------------------------------------
4,800 or less.....................................         13          2
4,801 to 24,000...................................         21          3
24,001 to 48,000..................................         29          4
48,001 to 84,000..................................         48          6
84,001 to 144,000.................................         84          9
144,001 to 240,000................................        126         13
Over 240,000......................................        200         19
------------------------------------------------------------------------
                  net weight greater than 1 kg (2.2 lb)
------------------------------------------------------------------------
                 Number of Pounds
20,000 or less....................................         13          2
More than 20,000 to 100,000.......................         21          3
More than 100,000 to 200,000......................         29          4
More than 200,000 to 400,000......................         48          6
More than 400,000 to 600,000......................         84          9
More than 600,000 to 1,000,000....................        126         13
More than 1,000,000...............................        200         19
------------------------------------------------------------------------
\1\ n = number of sample units.
\2\ c = acceptance number.


[[Page 669]]

    (g) Acceptable quality level (AQL). The maximum percent of defective 
sample units permitted in a lot that will be accepted approximately 95 
percent of the time.

[42 FR 14461, Mar. 15, 1977]



   Subpart B_Requirements for Specific Standardized Frozen Vegetables



Sec. 158.170  Frozen peas.

    (a) Identity--(1) Product definition. Frozen peas is the food in 
``package'' form as that term is defined in Sec. 1.20 of this chapter, 
prepared from the succulent seed of the pea plant of the species Pisum 
sativum L. Any suitable variety of pea may be used. It is blanched, 
drained, and preserved by freezing in such a way that the range of 
temperature of maximum crystallization is passed quickly. The freezing 
process shall not be regarded as complete until the product temperature 
has reached -18 [deg]C (0 [deg]F) or lower at the thermal center, after 
thermal stabilization. Such food may contain one, or any combination of 
two or more, of the following safe and suitable optional ingredients:
    (i) Natural and artificial flavors.
    (ii) Condiments such as spices and mint leaves.
    (iii) Dry nutritive carbohydrate sweeteners.
    (iv) Salt.
    (v) Monosodium glutamate and other glutamic acid salts.
    (2) Size specifications. If size graded, frozen peas shall contain 
not less than 80 percent by weight of peas of the size declared or of 
smaller sizes. The sample unit may not contain more than 20 percent by 
weight of peas of the next two larger sizes, of which not more than one 
quarter by weight of such peas may be of the larger of these two sizes, 
and may contain no peas larger than the next two larger sizes, if such 
there be. The following sizes and designations shall apply:

------------------------------------------------------------------------
                                         Round hole sieve size through
                                              which peas will pass
           Size designation           ----------------------------------
                                              Millimeters          Inch
------------------------------------------------------------------------
Extra small..........................  Up to 7.5...............    0.295
Very small...........................  Up to 8.2...............      .32
Small................................  Up to 8.75..............      .34
Medium...............................  Up to 10.2..............      .40
Large................................  Over 10.2...............      .40
------------------------------------------------------------------------

    (3) Labeling. The name of the product is ``peas''. The term 
``early'', ``June'', or ``early June'' shall precede or follow the name 
in the case of smooth-skin or substantially smooth-skin peas, such as 
Alaska-type peas. Where the peas are of sweet green wrinkled varieties, 
the name may include the designation ``sweet'', ``green'', ``wrinkled'', 
or any combination thereof. The label shall contain the words ``frozen'' 
or ``quick frozen''. The name of the food shall include a declaration of 
any flavoring that characterizes the product as specified in Sec. 
101.22 of this chapter and a declaration of any condiment such as spices 
and mint leaves that characterizes the product, e.g., ``Spice added''. 
Where a statement of pea size is made, such statement shall indicate 
either the size designation as specified in paragraph (a)(2) of this 
section or the applicable sieve size. However, the optional descriptive 
words ``petite'' or ``tiny'' may be used in conjunction with the product 
name when an average of 80 percent or more of the peas will pass through 
a circular opening of a diameter of 8.75 mm (0.34 in) or less for sweet 
green wrinkled peas and 8.2 mm (0.32 in) for smooth-skin or 
substantially smooth-skin peas, such as Alaska-type peas.
    (4) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for frozen peas is as 
follows:
    (i) Not more than 4 percent by weight blond peas, i.e., yellow or 
white but edible peas;
    (ii) Not more than 10 percent by weight blemished peas, i.e., 
slightly stained or spotted peas;
    (iii) Not more than 2 percent by weight seriously blemished peas, 
i.e., peas that are hard, shrivelled, spotted, discolored or otherwise 
blemished to an extent that the appearance or eating quality is 
seriously affected.

[[Page 670]]

    (iv) Not more than 15 percent by weight pea fragments, i.e., 
portions of peas, separated or individual cotyledons, crushed, partial 
or broken cotyledons and loose skins, but excluding entire intact peas 
with skins detached;
    (v) Not more than 0.5 percent by weight, or more than 12 sq cm (2 sq 
in) in area, extraneous vegetable material, i.e., vine or leaf or pod 
material from the pea plant or other such material per sample unit as 
defined in paragraph (b) of this section.
    (vi) The sum of the pea material described in paragraphs (b)(1) (i), 
(ii), (iii), and (iv) of this section shall not exceed 15 percent.
    (vii) For peas that meet the organoleptic and analytical 
characteristics of sweet green wrinkled varieties:
    (a) The alcohol-insoluble solids may not be more than 19 percent 
based on the procedure set forth in paragraph (b)(3) of this section.
    (b) Not more than 15 percent by count of the peas may sink in a 
solution containing 16 percent salt by weight according to the brine 
flotation test set forth in paragraph (b)(4) of this section;
    (viii) For smooth-skin or substantially smooth-skin varieties the 
alcohol insoluble solids may not be more than 23 percent based on the 
procedure set forth in paragraph (b)(3) of this section.
    (ix) The quality of a lot shall be considered acceptable when the 
number of defectives does not exceed the acceptance number in the 
sampling plans set forth in Sec. 158.3(f).
    (2) The sample unit for determining compliance with the requirements 
of paragraph (b)(1) of this section other than those of paragraphs 
(b)(1)(vii)(a) and (b)(1)(viii) of this section, shall be 500 g (17.6 
oz). For the determination of alcohol-insoluble solids as specified in 
paragraph (b)(3) of this section, the container may be the sample unit.
    (3) Alcohol-insoluble solids determination. (i) Extracting 
solutions:
    (a) One hundred parts of ethanol denatured with five parts of 
methanol volume to volume (formula 3A denatured alcohol), or
    (b) A mixture of 95 parts of formula 3A denatured alcohol and five 
parts of isopropanol v/v.
    (ii) Eighty percent alcohol (8 liters of extracting solutions, 
specified in paragraph (b)(3)(i) (a) or (b) of this section, diluted to 
9.5 liters with water).
    (iii) Drying dish--a flat-bottom dish with a tight fitting cover.
    (iv) Drying oven--a properly ventilated oven thermostatically 
controlled at 1002 [deg]C.
    (v) Procedure--Transfer frozen contents of package to plastic bag; 
tie bag securely and immerse in water bath with continuous flow at room 
temperature. Avoid agitation of bag during thawing by using clamps or 
weights. When sample completely thaws, remove bag, blot off adhering 
water, and transfer peas to U.S. No. 8 sieve, using (20 cm.) size for 
container of less than 3 lb. net weight and (30.5 cm.) for larger 
quantities. Without shifting peas, incline sieve to aid drainage, drain 
2 minutes. With cloth wipe surplus water from lower screen surface. 
Weigh 250 g. of peas into high-speed blender, add 250 g. of water and 
blend to smooth paste. For less than 250 g. sample, use entire sample 
with equal weight of water. Weight 20 g.10 mg. of 
the paste into 250 ml. distillation flask, add 120 ml. of extracting 
solutions specified in paragraph (b)(3)(i) (a) or (b) of this section, 
and reflux 30 minutes on steam or water bath or hotplate. Fit into a 
buchner funnel a filter paper of appropriate size (previously prepared 
by drying in flatbottom dish for 2 hours in drying oven, covering, 
cooling in desiccator, and weighing). Apply vacuum to buchner funnel and 
transfer contents of beaker so as to avoid running over edge of paper. 
Aspirate to dryness and wash material on filter with 80 percent alcohol 
until washings are clear and colorless. Transfer paper and alcohol-
insoluble solids to drying dish used to prepare paper, dry uncovered for 
2 hours in drying oven, cover, cool in desiccator, and weigh at once. 
From this weight deduct weight of dish, cover, and paper. Calculate 
percent by weight of alcohol-insoluble solids.
    (4) Brine flotation test. (i) Explanation--The brine flotation test 
utilizes salt solutions of various specific

[[Page 671]]

gravities to separate the peas according to maturity. The brine 
solutions are based on the percentage by weight of pure salt (NaCl) in 
solution at 20 [deg]C. In making the test the brine solutions are 
standardized to the proper specific gravity equivalent to the specified 
``percent of salt solutions at 20 [deg]C'' by using a salometer spindle 
accurately calibrated at 20 [deg]C. A 250 ml glass beaker or similar 
receptacle is filled with the brine solution to a depth of approximately 
50 mm. The brine solution and sample (100 peas per container) must be at 
the same temperature and should closely approximate 20 [deg]C.
    (ii) Procedure--After carefully removing the skins from the peas, 
place the peas into the solution. Pieces of peas and loose skins should 
not be used in making the brine flotation test. If cotyledons divide, 
use both cotyledons in the test and consider the two separated 
cotyledons as 1 pea; and, if an odd cotyledon sinks, consider it as one 
pea. Only peas that sink to the bottom of the receptacle within 10 
seconds after immersion are counted as ``peas that sink''.
    (5) If the quality of the frozen peas falls below the standard 
prescribed in paragraph (b)(1) of this section, the label shall bear the 
general statement of substandard quality specified in the Code of 
Federal Regulations but in lieu of the words prescribed in the second 
line of the rectangle the following words may be used where the frozen 
peas fall below the standard in only one respect: ``Below standard in 
quality ___'', the blank to be filled in with the specific reason for 
substandard quality as listed in the standard.

[42 FR 14461, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
58 FR 2883, Jan. 6, 1993]



PART 160_EGGS AND EGG PRODUCTS--Table of Contents



Subpart A [Reserved]

 Subpart B_Requirements for Specific Standardized Eggs and Egg Products

Sec.
160.100 Eggs.
160.105 Dried eggs.
160.110 Frozen eggs.
160.115 Liquid eggs.
160.140 Egg whites.
160.145 Dried egg whites.
160.150 Frozen egg whites.
160.180 Egg yolks.
160.185 Dried egg yolks.
160.190 Frozen egg yolks.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14462, Mar. 15, 1977, unless otherwise noted.

Subpart A [Reserved]



 Subpart B_Requirements for Specific Standardized Eggs and Egg Products



Sec. 160.100  Eggs.

    No regulation shall be promulgated fixing and establishing a 
reasonable definition and standard of identity for the food commonly 
known as eggs.



Sec. 160.105  Dried eggs.

    (a) Dried eggs, dried whole eggs are prepared by drying liquid eggs 
that conform to Sec. 160.115, with such precautions that the finished 
food is free of viable Salmonella microorganisms. They may be powdered. 
Before drying, the glucose content of the liquid eggs may be reduced by 
one of the optional procedures set forth in paragraph (b) of this 
section. Either silicon dioxide complying with the provisions of Sec. 
172.480 of this chapter or sodium silicoaluminate may be added as an 
optional anticaking ingredient, but the amount of silicon dioxide used 
is not more than 1 percent and the amount of sodium silicoaluminate used 
is less than 2 percent by weight of the finished food. The finished food 
shall contain not less than 95 percent by weight total egg solids.
    (b) The optional glucose-removing procedures are:
    (1) Enzyme procedure. A glucose-oxidase-catalase preparation and 
hydrogen peroxide solution are added to the liquid eggs. The quantity 
used and the time of reaction are sufficient to substantially reduce the 
glucose content of the liquid eggs. The glucose-oxidase-catalase 
preparation used is one that is generally recognized as safe within the 
meaning of section 201(s) of the Federal

[[Page 672]]

Food, Drug, and Cosmetic Act. The hydrogen peroxide solution used shall 
comply with the specifications of the United States Pharmacopeia, except 
that it may exceed the concentration specified therein and it does not 
contain a preservative.
    (2) Yeast procedure. The pH of the liquid eggs is adjusted to the 
range of 6.0 to 7.0, if necessary, by the addition of dilute, chemically 
pure hydrochloric acid, and controlled fermentation is maintained by 
adding food-grade baker's yeast (Saccharomyces cerevisiae). The quantity 
of yeast used and the time of reaction are sufficient to substantially 
reduce the glucose content of the liquid eggs.
    (c) The name of the food for which a definition and standard of 
identity is prescribed by this section is ``Dried eggs'' or ``Dried 
whole eggs'' and if the glucose content was reduced, as provided in 
paragraph (b) of this section, the name shall be followed immediately by 
the statement ``Glucose removed for stability'' or ``Stabilized, glucose 
removed''.
    (d)(1) When either of the optional anticaking ingredients specified 
in paragraph (a) of this section is used, the label shall bear the 
statement ``Not more than 1 percent silicon dioxide added as an 
anticaking agent'' or ``Less than 2 percent sodium silicoaluminate added 
as an anticaking agent'', whichever is applicable.
    (2) The name of any optional ingredient used, as provided in 
paragraph (d)(1) of this section, shall be listed on the principal 
display panel or panels of the label with such prominence and 
conspicuousness as to render such statement likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]



Sec. 160.110  Frozen eggs.

    (a) Frozen eggs, frozen whole eggs, frozen mixed eggs is the food 
prepared by freezing liquid eggs that conform to Sec. 160.115, with 
such precautions that the finished food is free of viable Salmonella 
microorganisms.
    (b) Monosodium phosphate or monopotassium phosphate may be added 
either directly or in a water carrier, but the amount added does not 
exceed 0.5 percent of the weight of the frozen eggs. If a water carrier 
is used, it shall contain not less than 50 percent by weight of such 
monosodium phosphate or monopotassium phosphate.
    (c) When one of the optional ingredients specified in paragraph (b) 
of this section is used, the label shall bear the statement ``Monosodium 
phosphate (or monopotassium phosphate) added to preserve color'', or, in 
case the optional ingredient used is added in a water carrier, the 
statement shall be ``Monosodium phosphate (or monopotassium phosphate), 
with _ percent water as a carrier, added to preserve color'', the blank 
being filled in to show the percent by weight of water used in 
proportion to the weight of the finished food. The statement declaring 
the optional ingredient used shall appear on the principal display panel 
or panels with such prominence and conspicuousness as to render it 
likely to be read and understood under customary conditions of purchase.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]



Sec. 160.115  Liquid eggs.

    (a) Liquid eggs, mixed eggs, liquid whole eggs, mixed whole eggs are 
eggs of the domestic hen broken from the shells and with yolks and 
whites in their natural proportion as so broken. They may be mixed, or 
mixed and strained, and they are pasteurized or otherwise treated to 
destroy all viable Salmonella microorganisms. Pasteurization or such 
other treatment is deemed to permit the adding of safe and suitable 
substances (other than chemical preservatives) that are essential to the 
method of pasteurization or other treatment used. For the purposes of 
this paragraph, safe and suitable substances are those that perform a 
useful function in the pasteurization or other

[[Page 673]]

treatment to render the liquid eggs free of viable Salmonella 
microorganisms, and that are not food additives as defined in section 
201(s) of the Federal Food, Drug, and Cosmetic Act; or, if they are food 
additives, they are used in conformity with regulations established 
pursuant to section 409 of the act.
    (b) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]



Sec. 160.140  Egg whites.

    (a) Egg whites, liquid egg whites, liquid egg albumen is the food 
obtained from eggs of the domestic hen, broken from the shells and 
separated from yolks. The food may be mixed, or mixed and strained, and 
is pasteurized or otherwise treated to destroy all viable Salmonella 
microorganisms. Pasteurization or such other treatment is deemed to 
permit the adding of safe and suitable substances (other than chemical 
preservatives) that are essential to the method of pasteurization or 
other treatment used. Safe and suitable substances that aid in 
protecting or restoring the whipping properties of liquid egg whites may 
be added. For the purposes of this paragraph, safe and suitable 
substances are those that perform a useful function as whipping aids or 
in the pasteurization or other treatment to render liquid egg whites 
free of viable Salmonella microorganisms and that are not food additives 
as defined in section 201(s) of the Federal Food, Drug, and Cosmetic 
Act; or, if they are food additives, they are used in conformity with 
regulations established pursuant to section 409 of the act.
    (b) Any optional ingredients used as whipping aids, as provided for 
in paragraph (a) of this section, shall be named on the principal 
display panel or panels of labels with such prominence and 
conspicuousness as to render such names likely to be read and understood 
by ordinary individuals under customary conditions of purchase.
    (c) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]



Sec. 160.145  Dried egg whites.

    (a) The food dried egg whites, egg white solids, dried egg albumen, 
egg albumen solids is prepared by drying liquid egg whites conforming to 
the requirements of Sec. 160.140 (or deviating from that section only 
by not being Salmonella free). As a preliminary step to drying, the 
lysozyme and avidin contents may be reduced. If lysozyme and avidin 
levels are reduced, cation exchange resins regulated for use under Sec. 
173.25 of this chapter shall be used. As a further preliminary step to 
drying, the glucose content of the liquid egg whites is reduced by 
adjusting the pH, where necessary, with food-grade acid and by following 
one of the optional procedures set forth in paragraph (b) of this 
section. If the food is prepared from liquid egg whites conforming in 
all respects to the requirements of Sec. 160.140, drying shall be done 
with such precautions that the finished food is free of viable 
Salmonella microorganisms. If the food is prepared from liquid egg 
whites that are not Salmonella free, the dried product shall be so 
treated by heat or otherwise as to render the finished food free of 
viable Salmonella microorganisms. Dried egg whites may be powdered.
    (b) The optional glucose-removing procedures are:
    (1) Enzyme procedure. A glucose-oxidase-catalase preparation and 
hydrogen peroxide solution are added to liquid egg whites. The quantity 
used and the time of reaction are sufficient to substantially reduce the 
glucose content. The glucose-oxidase-catalase preparation used is one 
that is generally recognized as safe within the meaning of section 
201(s) of the Federal Food, Drug, and Cosmetic Act. The hydrogen 
peroxide solution used shall comply with the specifications of the 
United States Pharmacopeia, except that it may exceed the concentration 
specified therein and it does not contain a preservative.
    (2) Controlled fermentation procedures--(i) Yeast procedure. Food-
grade

[[Page 674]]

baker's yeast (Saccharomyces cerevisiae) is added to the liquid egg 
whites and controlled fermentation is maintained. The quantity of yeast 
used and the time of reaction are sufficient to substantially reduce the 
glucose content.
    (ii) Bacterial procedure. The liquid egg whites are subjected to the 
action of a culture of glucose-fermenting bacteria either generally 
recognized as safe within the meaning of section 201(s) of the Federal 
Food, Drug, and Cosmetic Act or the subject of a regulation established 
pursuant to section 409 of the act, and the culture is used in 
conformity with such regulation. The quantity of the culture used is 
sufficient to predominate in the fermentation and the time and 
temperature of reaction are sufficient to substantially reduce the 
glucose content.
    (c)(1) Dried egg whites in which the lysozyme and avidin have been 
reduced shall not be nutritionally inferior, as defined in Sec. 
101.3(e)(4)(i) of this chapter, and shall be considered nutritionally 
equivalent to untreated egg whites if they meet the conditions that the 
biological quality of the protein contained is equal to or greater than 
that of untreated egg white from the same batch of liquid egg white.
    (2) Compliance with the biological quality of protein requirement of 
paragraph (c)(1) of this section shall be determined by the analytical 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 14th Ed. (1984), section 43.253-
43.257, ``Protein Efficiency Ratio, Rat Bioassay, Final Action,'' which 
is incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (d) When the dried egg whites are prepared from liquid egg whites 
containing any optional ingredients added as whipping aids, as provided 
for in Sec. 160.140(a), the common names of such optional ingredients 
shall be listed on the principal display panel or panels of the label 
with such prominence and conspicuousness as to render the names likely 
to be read and understood by ordinary individuals under customary 
conditions of purchase.
    (e) The name of the food for which a definition and standard of 
identity is prescribed in this section is alternatively ``Dried egg 
whites'', Egg white solids'', ``Dried egg albumen'', or ``Egg albumen 
solids''. If the lysozyme and avidin content is reduced as provided in 
paragraph (a) of this section, the name shall be immediately preceded or 
followed by the statement ``lysozyme and avidin reduced'' when the dried 
egg whites are sold as such. When the dried egg whites are used in a 
fabricated food, the statement ``lysozyme and avidin reduced'' may be 
omitted from any declaration of ingredients required under Sec. 101.4 
of this chapter.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14462, Mar. 15, 1977, as amended at 51 FR 11435, Apr. 3, 1986; 51 
FR 25362, July 14, 1986; 54 FR 24895, June 12, 1989; 58 FR 2883, Jan. 6, 
1993; 63 FR 14035, Mar. 24, 1998]



Sec. 160.150  Frozen egg whites.

    (a) Frozen egg whites, frozen egg albumen is the food prepared by 
freezing liquid egg whites that conform to Sec. 160.140, with such 
precautions that the finished food is free of viable Salmonella 
microorganisms.
    (b) When frozen egg whites are prepared from liquid egg whites 
containing any optional ingredients added as whipping aids, as provided 
for in Sec. 160.140(a), the common names of such optional ingredients 
shall be listed on the principal display panel or panels of the label 
with such prominence and conspicuousness as to render such names likely 
to be read and understood by ordinary individuals under customary 
conditions of purchase.
    (c) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]

[[Page 675]]



Sec. 160.180  Egg yolks.

    (a) Egg yolks, liquid egg yolks, yolks, liquid yolks are yolks of 
eggs of the domestic hen so separated from the whites thereof as to 
contain not less than 43 percent total egg solids, as determined by the 
method prescribed in ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed. (1980), sections 17.006 and 
17.007 under ``Total Solids, Vacuum Method (3)--Official Final Action,'' 
which is incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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. They 
may be mixed, or mixed and strained, and they are pasteurized or 
otherwise treated to destroy all viable Salmonella microorganisms. 
Pasteurization or such other treatment is deemed to permit the adding of 
safe and suitable substances (other than chemical preservatives) that 
are essential to the method of pasteurization or other treatment used. 
For the purposes of this paragraph, safe and suitable substances are 
those that perform a useful function in the pasteurization or other 
treatment to render the egg yolks free of viable Salmonella 
microorganisms, and that are not food additives as defined in section 
201(s) of the Federal Food, Drug, and Cosmetic Act; or, if they are food 
additives, they are used in conformity with regulations established 
pursuant to section 409 of the act.
    (b) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14462, Mar. 15, 1977, as amended at 47 FR 11832, Mar. 19, 1982; 
49 FR 10102, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2883, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 160.185  Dried egg yolks.

    (a) Dried egg yolks, dried yolks is the food prepared by drying egg 
yolks that conform to Sec. 160.180, with such precautions that the 
finished food is free of viable Salmonella microorganisms. Before 
drying, the glucose content of the liquid egg yolks may be reduced by 
one of the optional procedures set forth in paragraph (b) of this 
section. Either silicon dioxide complying with the provisions of Sec. 
172.480 of this chapter or sodium silicoaluminate may be added as an 
optional anticaking ingredient, but the amount of silicon dioxide used 
is not more than 1 percent and the amount of sodium silicoaluminate used 
is less than 2 percent by weight of the finished food. The finished food 
shall contain not less than 95 percent by weight total egg solids.
    (b) The optional glucose-removing procedures are:
    (1) Enzyme procedure. A glucose-oxidase-catalase preparation and 
hydrogen peroxide solution are added to the liquid egg yolks. The 
quantity used and the time of reaction are sufficient to substantially 
reduce the glucose content of the liquid egg yolks. The glucose-oxidase-
catalase preparation used is one that is generally recognized as safe 
within the meaning of section 201(s) of the Federal Food, Drug, and 
Cosmetic Act. The hydrogen peroxide solution used shall comply with the 
specification of the United States Pharmacopeia, except that it may 
exceed the concentration specified therein and it does not contain a 
preservative.
    (2) Yeast procedure. The pH of the liquid egg yolks is adjusted to 
the range of 6.0 to 7.0, if necessary, by the addition of dilute, 
chemically pure hydrochloric acid, and controlled fermentation is 
maintained by adding food-grade baker's yeast (Saccharomyces 
cerevisiae). The quantity of yeast used and the time of reaction are 
sufficient to substantially reduce the glucose content of the liquid egg 
yolks.
    (c) The name of the food for which a definition and standard of 
identity is prescribed by this section is ``Dried egg yolks'', or 
``Dried yolks'', and if the glucose content was reduced, as provided in 
paragraph (b) of this section, the name shall be followed immediately by 
the statement ``Glucose removed for stability'' or ``Stabilized, glucose 
removed''.

[[Page 676]]

    (d)(1) When either of the optional anticaking ingredients specified 
in paragraph (a) of this section is used, the label shall bear the 
statement ``Not more than 1 percent silicon dioxide added as an 
anticaking agent'' or ``Less than 2 percent sodium silicoaluminate added 
as an anticaking agent'', whichever is applicable.
    (2) The name of any optional ingredient used, as provided in 
paragraph (d)(1) of this section, shall be listed on the principal 
display panel or panels of the label with such prominence and 
conspicuousness as to render such statement likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]



Sec. 160.190  Frozen egg yolks.

    (a) Frozen egg yolks, frozen yolks is the food prepared by freezing 
egg yolks that conform to Sec. 160.180, with such precautions that the 
finished food is free of viable Salmonella microorganisms.
    (b) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2884, Jan. 6, 1993]



PART 161_FISH AND SHELLFISH--Table of Contents



                      Subpart A_General Provisions

Sec.
161.30 Declaration of quantity of contents on labels for canned oysters.

   Subpart B_Requirements for Specific Standardized Fish and Shellfish

161.130 Oysters.
161.136 Olympia oysters.
161.145 Canned oysters.
161.170 Canned Pacific salmon.
161.173 Canned wet pack shrimp in transparent or nontransparent 
          containers.
161.175 Frozen raw breaded shrimp.
161.176 Frozen raw lightly breaded shrimp.
161.190 Canned tuna.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14464, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 161 appear at 81 FR 
49896, July 29, 2016.



                      Subpart A_General Provisions



Sec. 161.30  Declaration of quantity of contents on labels for canned
oysters.

    (a) For many years packers of canned oysters in the Gulf area of the 
United States have labeled their output with a declaration of the 
drained weight of oysters in the containers. Packers in other areas have 
marketed canned oysters with a declaration of the total weight of the 
contents of the container. Investigation reveals that under present-day 
practice consumers generally do not discard the liquid packing medium, 
but use it as a part of the food. Section 403(e)(2) of the Federal Food, 
Drug, and Cosmetic Act and the regulations thereunder require food in 
package form to bear an accurate label statement of the quantity of food 
in the container.
    (b) It is concluded that compliance with the label declaration of 
quantity of contents requirement will be met by an accurate declaration 
of the total weight of the contents of the can. The requirements of 
Sec. 161.145(c), establishing a standard of fill of container for 
canned oysters and specifying the statement of substandard fill for 
those canned oysters failing to meet that standard remain unaffected by 
this interpretation.



   Subpart B_Requirements for Specific Standardized Fish and Shellfish



Sec. 161.130  Oysters.

    (a) Oysters, raw oysters, shucked oysters, are the class of foods 
each of which is obtained by shucking shell oysters and preparing them 
in accordance with the procedure prescribed in paragraph (b) of this 
section. The name of each such food is the name specified in the 
applicable definition and standard of identity prescribed in Sec. Sec. 
161.131 to 161.140, inclusive.

[[Page 677]]

    (b) If water, or salt water containing less than 0.75 percent salt, 
is used in any vessel into which the oysters are shucked the combined 
volume of oysters and liquid when such oysters are emptied from such 
vessel is not less than four times the volume of such water or salt 
water. Any liquid accumulated with the oysters is removed. The oysters 
are washed, by blowing or otherwise, in water or salt water, or both. 
The total time that the oysters are in contact with water or salt water 
after leaving the shucker, including the time of washing, rinsing, and 
any other contact with water or salt water is not more than 30 minutes. 
In computing the time of contact with water or salt water, the length of 
time that oysters are in contact with water or salt water that is 
agitated by blowing or otherwise, shall be calculated at twice its 
actual length. Any period of time that oysters are in contact with salt 
water containing not less than 0.75 percent salt before contact with 
oysters, shall not be included in computing the time that the oysters 
are in contact with water or salt water. Before packing into the 
containers for shipment or other delivery for consumption the oysters 
are thoroughly drained and are packed without any added substance.
    (c) For the purposes of this section:
    (1) Shell oysters means live oysters of any of the species, Ostrea 
virginica, Ostrea gigas, Ostrea lurida, in the shell, which, after 
removal from their beds, have not been floated or otherwise held under 
conditions which result in the addition of water.
    (2) Thoroughly drained means one of the following:
    (i) The oysters are drained on a strainer or skimmer which has an 
area of not less than 300 square inches per gallon of oysters, drained, 
and has perforations of at least \1/4\ of an inch in diameter and not 
more than 1\1/4\ inches apart, or perforations of equivalent areas and 
distribution. The oysters are distributed evenly over the draining 
surface of the skimmer and drained for not less than 5 minutes; or
    (ii) The oysters are drained by any method other than that 
prescribed by paragraph (c)(2)(i) of this section whereby liquid from 
the oysters is removed so that when the oysters are tested within 15 
minutes after packing by draining a representative gallon of oysters on 
a skimmer of the dimensions and in the manner described in paragraph 
(c)(2)(i) of this section for 2 minutes, not more than 5 percent of 
liquid by weight is removed by such draining.



Sec. 161.136  Olympia oysters.

    Olympia oysters, raw Olympia oysters, shucked Olympia oysters, are 
of the species Ostrea lurida and conform to the definition and standard 
of identity prescribed for oysters in Sec. 161.130.



Sec. 161.145  Canned oysters.

    (a) Identity. (1) Canned oysters is the food prepared from one or 
any mixture of two or all of the forms of oysters specified in paragraph 
(a)(2) of this section, and a packing medium of water, or the watery 
liquid draining from oysters before or during processing, or a mixture 
of such liquid and water. The food may be seasoned with salt. It is 
sealed in containers and so processed by heat as to prevent spoilage.
    (2) The forms of oysters referred to in paragraph (a)(1) of this 
section are prepared from oysters which have been removed from their 
shells and washed and which may be steamed while in the shell or steamed 
or blanched or both after removal therefrom, and are as follows:
    (i) Whole oysters with such broken pieces of oysters as normally 
occur in removing oysters from their shells, washing, and packing.
    (ii) Pieces of oysters obtained by segregating pieces of oysters 
broken in shucking, washing, or packing whole oysters.
    (iii) Cut oysters obtained by cutting whole oysters.
    (3)(i) When the form of oysters specified in paragraph (a)(2)(i) of 
this section is used, the name of the food is ``Oysters'' or ``Cove 
oysters'', if of the species Ostrea virginica; ``Oysters'' or ``Pacific 
oysters'', if of the species Ostrea gigas; ``Oysters'' or ``Olympia 
oysters'', if of the species Ostrea lurida.
    (ii) When the form of oysters specified in paragraph (a)(2)(ii) of 
this section is used, the name of the food is ``Pieces of ___'', the 
blank being

[[Page 678]]

filled in with the name ``Oysters'' or ``Cove oysters'', if of the 
species Ostrea virginica; ``Oysters'' or ``Pacific oysters'', if of the 
species Ostrea gigas; ``Oysters'' or ``Olympia oysters'', if of the 
species Ostrea lurida.
    (iii) When the form of oysters specified in paragraph (a)(2)(iii) of 
this section is used, the name of the food is ``Cut ___, the blank being 
filled in with the name ``Oysters'' or ``Cove oysters'', if of the 
species Ostrea virginica; ``Oysters'' or ``Pacific oysters'', if of the 
species Ostrea gigas; ``Oysters'' or ``Olympia oysters'', if of the 
species Ostrea lurida.
    (iv) In case a mixture of two or all such forms of oysters is used, 
the name is a combination of the names specified in this paragraph 
(a)(3) of the forms of oysters used, arranged in order of their 
predominance by weight.
    (4) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) [Reserved]
    (c) Fill of container. (1) The standard of fill of container for 
canned oysters is a fill such that the drained weight of oysters taken 
from each container is not less than 59 percent of the water capacity of 
the container.
    (2) Water capacity of containers is determined by the general method 
provided in Sec. 130.12(a) of this chapter.
    (3) Drained weight is determined by the following method: Keep the 
un-opened canned oyster container at a temperature of not less than 
68[deg] or more than 95 [deg]Fahrenheit for at least 12 hours 
immediately preceding the determination. After opening, tilt the 
container so as to distribute its contents evenly over the meshes of a 
circular sieve which has been previously weighed. The diameter of the 
sieve is 8 inches if the quantity of the contents of the container is 
less than 3 pounds, and 12 inches if such quantity is 3 pounds or more. 
The bottom of the sieve is woven-wire cloth that complies with the 
specifications for such cloth set forth under ``2.38 mm (No. 8)'' in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), Table 1, ``Nominal Dimensions of Standard 
Test Sieves (U.S.A. Standard Series),'' under the heading ``Definitions 
of Terms and Explanatory Notes,'' which is incorporated by reference. 
Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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. Without shifting the material on the sieve, so 
incline the sieve as to facilitate drainage. Two minutes from the time 
drainage begins, weigh the sieve and the drained oysters. The weight so 
found, less the weight of the sieve, shall be considered to be the 
drained weight of the oysters.
    (4) If canned oysters fall below the standard of fill of container 
prescribed in paragraph (a) of this section, the label shall bear the 
general statement of substandard fill specified in Sec. 130.14(b) of 
this chapter in the manner and form therein specified, followed by the 
statement, ``A can of this size should contain ___ oz. of oysters. This 
can contains only ___ oz.'', the blanks being filled in with the 
applicable figures.

[42 FR 14464, Mar. 15, 1977, as amended at 47 FR 11832, Mar. 19, 1982; 
49 FR 10102, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2884, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 161.170  Canned Pacific salmon.

    (a) Identity. (1) Canned Pacific salmon is the food prepared from 
one of the species of fish enumerated in paragraph (a)(2) of this 
section, prepared in one of the forms of pack specified in paragraph 
(a)(3) of this section, and to which may be added one or more of the 
optional ingredients specified in paragraph (a)(4) of this section. The 
food is packed in hermetically sealed containers and so processed by 
heat as to prevent spoilage and soften bones. The food is labeled in 
accordance with paragraph (a)(5) of this section.
    (2)(i) The species of fish which may be used in this food are:

Oncorhynchus tshawytscha..................  Chinook, king, spring.
Oncorhynchus nerka........................  Blueback, red, sockeye

[[Page 679]]

 
Oncorhynchus kisutch......................  Coho, Cohoe, medium red,
                                             silver
Oncorhynchus gorbuscha....................  Pink
Oncorhynchus keta.........................  Chum, keta
Oncorhynchus masou........................  Masou, cherry
 

    (ii) For the purpose of paragraph (a)(5)(i) of this section, the 
common or usual name or names of each species of fish enumerated in 
paragraph (a)(2)(i) of this section is (are) the name(s) immediately 
following the scientific name of each species.
    (3) The optional forms of canned Pacific salmon are processed from 
fish prepared by removing the head, gills, and tail, and the viscera, 
blood, fins, and damaged or discolored flesh to the greatest extent 
practicable in accordance with good manufacturing practice; and then 
washing. Canned Pacific salmon is prepared in one of the following forms 
of pack:
    (i) ``Regular'' consists of sections or steaks which are cut 
transversely from the fish and filled vertically into the can. In 
preparation, segments of skin or large backbone may be removed. The 
sections or steaks are so packed that the cut surfaces approximately 
parallel the ends of the container. A small portion of salmon may be 
added if necessary to complete the fill of the container.
    (ii) ``Skinless and backbone removed'' consists of the regular form 
of canned salmon set forth in paragraph (a)(3)(i) of this section from 
which the skin and vertebrae have been removed in accordance with good 
manufacturing practices.
    (iii) ``Minced salmon'' consists of salmon which has been minced or 
ground.
    (iv) ``Salmon tips or tidbits'' consists of small pieces of salmon.
    (v) ``No salt added'' consists of canned salmon to which no salt has 
been added.
    (4) One or more of the following optional ingredients may be added 
to the food:
    (i) Salt.
    (ii) Edible salmon oil comparable in color, viscosity, and flavor to 
the oil which would occur naturally in the species of salmon canned.
    (5)(i) The name of the food is ``salmon'' together with the common 
or usual name or names of the species. At least one species name shall 
be printed in letters of the same style of type and not less in height 
than those used for the word ``salmon''.
    (ii) Whenever the form of pack is that described in paragraph (a)(3) 
(ii), (iii), or (iv) of this section, the word or words describing the 
form of pack shall immediately precede or follow the name of the food 
without intervening written, printed, or graphic matter in the manner 
prescribed in Sec. 101.3(c) of this chapter; for example, ``red 
salmon'' as the name of the food followed by ``skinless and backbone 
removed''.
    (iii) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) [Reserved]
    (c) Fill of container. (1) The standard of fill of container for 
canned salmon is a fill including all the contents of the container and 
is not less than the minimum net weight specified for the corresponding 
can size in the following table:

------------------------------------------------------------------------
                I. Can size                    II. Minimum net weight
------------------------------------------------------------------------
603 x 405.................................  1.814 kg (64 oz).
301 x 411.................................  454 g (16 oz).
301 x 408.................................  439 g (15\1/2\ oz).
401 x 211.................................  439 g (15\1/2\ oz).
607 x 406 x 108...........................  439 g (15\1/2\ oz).
301 x 308.................................  340 g (12 oz).
307 x 200.25..............................  220 g (7\3/4\ oz).
513 x 307 x 103...........................  220 g (7\3/4\ oz).
307 x 113.................................  191 g (6\3/4\ oz).
301 x 106.................................  106 g (3\3/4\ oz).
407 x 213 x 015...........................  106 g (3\3/4\ oz).
------------------------------------------------------------------------


If the can size in question is not listed, calculate the value for 
Column II as follows: From the list, select as the comparable can size, 
that one having the nearest water capacity of the can size in question, 
multiply the net weight listed in Column II by the water capacity of the 
can size in question, and divide by the water capacity of the comparable 
can size. Water capacities are determined by the general method provided 
in Sec. 130.12(a) of this chapter.
    (2) Sampling and acceptance procedure: The sample size of the sample 
representing the lot will be selected in accordance with the sampling 
plan shown in paragraph (c)(2)(ii) of this section. A lot is to be 
considered acceptable when the average net weight of all the sample 
units is not less than the

[[Page 680]]

minimum net weight stated in paragraph (c)(1) of this section for the 
corresponding can size.
    (i) Definitions of terms to be used in the sampling plans in 
paragraph (c)(2)(ii) of this section are as follows:
    (a) Lot. A collection of primary containers or units of the same 
size, type, and style manufactured or packed under similar conditions 
and handled as a single unit of trade.
    (b) Lot size. The number of primary containers or units in the lot.
    (c) Sample size (n). The total number of sample units drawn for 
examination from a lot.
    (d) Sample unit. A container, the entire contents of a container, a 
portion of the contents of a container, or a composite mixture of 
product from small containers that is sufficient for examination or 
testing as a single unit.
    (ii) Sampling plans:

------------------------------------------------------------------------
                                                                Size of
                Lot size (primary containers)                  container
                                                                \1\ (n)
------------------------------------------------------------------------
4,800 or less...............................................          13
4,801 to 24,000.............................................          21
24,001 to 48,000............................................          29
48,001 to 84,000............................................          48
84,001 to 144,000...........................................          84
144,001 to 240,000..........................................         126
Over 240,000................................................         200
------------------------------------------------------------------------
\1\ Net weight equal to or less than 1 kg. (2.2 lb).


------------------------------------------------------------------------
                                                                Size of
                Lot size (primary containers)                  container
                                                                \1\ (n)
------------------------------------------------------------------------
2,400 or less...............................................          13
2,401 to 15,000.............................................          21
15,001 to 24,000............................................          29
24,001 to 42,000............................................          48
42,001 to 72,000............................................          84
72,001 to 120,000...........................................         126
Over 120,000................................................         200
------------------------------------------------------------------------
n-number of primary containers in sample.
\1\ Net weight greater than 1 kg (2.2 lb) but not more than 4.5 kgs (10
  lb).

    (3) If canned salmon falls below the standard of fill of container 
prescribed in paragraph (c)(1) of this section, the label shall bear the 
general statement of substandard fill specified in Sec. 130.14(b) of 
this chapter, in the manner and form therein specified.

[42 FR 14464, Mar. 15, 1977, as amended at 58 FR 2884, Jan. 6, 1993; 80 
FR 41436, July 15, 2015]



Sec. 161.173  Canned wet pack shrimp in transparent or nontransparent
containers.

    (a) Identity. (1) Canned wet pack shrimp is the food consisting of 
the processed meat of peeled shrimp, free of heads and, to the extent 
practicable under good manufacturing practice, free of shells, legs, and 
antennae; in one or any combination of species enumerated in paragraph 
(a)(2) of this section; prepared in one of the styles specified in 
paragraph (a)(3) of this section, in sufficient water or other suitable 
aqueous packing medium to fill the interstices and permit proper 
processing in accordance with good manufacturing practice. Canned shrimp 
may contain one or more of the optional ingredients specified in 
paragraph (a)(4) of this section. It is packed in hermetically sealed 
transparent or nontransparent containers and so processed by heat as to 
prevent spoilage.
    (2) The species of shrimp that may be used in the food are of the 
families: Penaeidae, Pandalidae, Crangonidae, and Palaemonidae.
    (3) Styles. Canned shrimp is prepared in one of the following 
styles:
    (i) Shrimp with readily visible dark vein (dorsal tract, back vein, 
or sand vein).
    (ii) Deveined shrimp containing not less than 95 percent by weight 
of shrimp prepared by removing the dark vein from the first five 
segments by deliberate cutting action.
    (iii) Shrimp, other than ``deveined'' as described in paragraph 
(a)(3)(ii) of this section, containing not less than 95 percent by 
weight of shrimp with no readily visible dark vein within the first five 
segments.
    (iv) Broken shrimp, consisting of less than four segments and 
otherwise conforming to one of the styles described in paragraph 
(a)(3)(i), (ii), or (iii) of this section.
    (4) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (i) Salt.
    (ii) Lemon juice.
    (iii) Organic acids.
    (iv) Nutritive carbohydrate sweeteners.
    (v) Spices or spice oils or spice extracts.

[[Page 681]]

    (vi) Flavorings.
    (vii) Sodium bisulfite.
    (viii) Calcium disodium EDTA (calcium disodium ethylene diamine 
tetra acetate), complying with the provisions of Sec. 172.120 of this 
chapter.
    (5) Labeling. (i) The name of the food is ``shrimp'' or ``shrimps.'' 
The word ``prawns'' may appear on the label in parentheses immediately 
after the word ``shrimp'' or ``shrimps'' if the shrimp are of large or 
extra large size as designated in paragraph (a)(5)(iv) of this section.
    (ii) When the food is of the style described in paragraph (a)(3)(ii) 
of this section, the words ``cleaned,'' ``cleaned (deveined),'' or 
``deveined'' may be declared on the label.
    (iii) When the food is of the style described in paragraph 
(a)(3)(iii) of this section, the words ``contain no dark veins'' or 
their equivalent may be declared on the label.
    (iv) When the food is whole shrimp within a size range designated in 
table I as ``extra large,'' ``large,'' ``medium,'' or ``small'' and does 
not contain broken shrimp as defined in paragraph (a)(3)(iv) of this 
section in excess of the amount listed in table II for the applicable 
size, the appropriate size designation may be declared on the label.

                                                     Table I
----------------------------------------------------------------------------------------------------------------
                                   Number of shrimp per 28.4 g (1 oz) of  Number of shrimp per 100 g (3.5 oz) of
                                              drained product                         drained product
              Size               -------------------------------------------------------------------------------
                                      Other than                              Other than
                                    deveined style      Deveined style      deveined style      Deveined style
----------------------------------------------------------------------------------------------------------------
Extra large or jumbo............  Less than 3.5.....  Less than 3.8.....  Less than 12.3....  Less than 13.4.
Large...........................  3.5 to 5.0          3.8 to 5.4          12.3 to 17.7        13.4 to 19.1
                                   inclusive.          inclusive.          inclusive.          inclusive.
Medium..........................  More than 5.0 but   More than 5.4 but   More than 17.7 but  More than 19.1 but
                                   not more than 9.0.  not more than 9.8.  not more than       not more than
                                                                           31.8.               34.6.
Small...........................  More than 9.0 but   More than 9.8 but   More than 31.8 but  More than 34.6 but
                                   not more than       not more than       not more than       not more than
                                   17.0.               18.4.               60.0.               65.3.
Tiny............................  More than 17.0....  More than 18.4....  More than 60.0....  More than 65.3.
----------------------------------------------------------------------------------------------------------------


                                Table II
------------------------------------------------------------------------
                                                                Maximum
                                                              percent by
                            Size                               weight of
                                                                broken
                                                              shrimp \a\
------------------------------------------------------------------------
Extra large or jumbo........................................           5
Large.......................................................           5
Medium......................................................           5
Small.......................................................          10
Tiny........................................................          15
------------------------------------------------------------------------
\a\ Grams of broken shrimp per 100 g of cut-out weight as determined in
  Sec. 161.173(c) of this section.

    (v) When the food consists of tiny shrimp, as designated in table I 
in paragraph (a)(5)(iv) of this section and does not contain broken 
shrimp as defined in paragraph (a)(3)(iv) of this section in excess of 
15 percent by weight, the name of the food on the label shall be 
accompanied by the word ``tiny'' in type size equal to that used in the 
name of the food.
    (vi) When the food consists of tiny shrimp, as designated in table I 
in paragraph (a)(5)(iv) of this section and contains more than 15 
percent by weight of broken shrimp as defined in paragraph (a)(3)(iv) of 
this section, the name of the food on the label shall be accompanied by 
the word ``broken'' or ``pieces'' rather than the word ``tiny,'' in type 
size equal to that used in the name of the food.
    (vii) When the food consists wholly or in part of sizes other than 
tiny, as designated in table I in paragraph (a)(5)(iv) of this section 
and contains more than 10 percent by weight of broken shrimp as defined 
in paragraph (a)(3)(iv) of this section, the name of the food on the 
label shall be accompanied by the word ``broken'' or ``pieces'' in type 
size equal to that used in the name of the food.
    (viii) The name of the food shall include a declaration of any 
flavoring that characterizes the food, as specified in Sec. 101.22 of 
this chapter, and the term ``spiced'' if spice characterizes the food.
    (ix) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (6) Sampling and acceptance procedure. A lot is to be considered 
acceptable when the number of defectives does not

[[Page 682]]

exceed the acceptance number in the sampling plans given in paragraph 
(a)(6)(ii) of this section.
    (i) Definitions of terms to be used in the sampling plans in 
paragraph (a)(6)(ii) of this section are as follows:
    (a) Lot. A collection of primary containers or units of the same 
size, type, and style manufactured or packed under similar conditions 
and handled as a single unit of trade.
    (b) Lot size. The number of primary containers or units in the lot.
    (c) Sample size (n). The total number of sample units drawn for 
examination from a lot.
    (d) Sample unit. A container, the entire contents of a container, a 
portion of the contents of a container, or a composite mixture of 
product from small containers that is sufficient for the examination or 
testing as a single unit.
    (e) Defective. Any sample unit shall be regarded as defective when 
it fails to meet the minimum requirements in paragraph (a)(3) (ii) or 
(iii) of this section for the applicable style, when it exceeds the 
tolerances in paragraph (a)(5)(iv) of this section for the applicable 
size, or when the labeling fails to meet the requirements of paragraph 
(a)(5) (v), (vi), or (vii) of this section of the applicable size.
    (f) Acceptance number (c). The maximum number of defective sample 
units permitted in the sample in order to consider the lot as meeting 
the specified requirements.
    (g) Acceptable quality level (AQL). The maximum percent of defective 
sample units permitted in a lot that will be accepted approximately 95 
percent of the time.
    (ii) Sampling plans:

                      Acceptable Quality Level 6.5
------------------------------------------------------------------------
                                                      Size of container
           Lot size (primary containers)           ---------------------
                                                      n \1\      c \2\
------------------------------------------------------------------------
             net weight equal to or less than 1 kg (2.2 lb)
------------------------------------------------------------------------
4,800 or less.....................................         13          2
4,801 to 24,000...................................         21          3
24,001 to 48,000..................................         29          4
48,001 to 84,000..................................         48          6
84,001 to 144,000.................................         84          9
144,001 to 240,000................................        126         13
Over 240,000......................................        200         19
------------------------------------------------------------------------
 net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
------------------------------------------------------------------------
2,400 or less.....................................         13          2
2,401 to 15,000...................................         21          3
15,001 to 24,000..................................         29          4
24,001 to 42,000..................................         48          6
42,001 to 72,000..................................         84          9
72,001 to 120,000.................................        126         13
Over 120,000......................................        200         19
------------------------------------------------------------------------
\1\ n = Number of primary containers in sample.
\2\ c = Acceptance number.

    (b) [Reserved]
    (c) Fill of container. (1) The standard of fill of transparent or 
nontransparent containers for canned wet pack shrimp is a fill such that 
the cut-out weight of shrimp taken from each container is not less than 
60 percent of the weight of the water required to fill the container. 
The weight of the water required to fill the container is determined by 
the general method provided in Sec. 130.12(a) of this chapter. Cut-out 
weight is determined by the following method: Keep the unopened canned 
shrimp container at a temperature of not less than 68[deg] nor more than 
75 [deg]Fahrenheit for at least 12 hours immediately preceding the 
determination. After opening, distribute the shrimp evenly over the 
meshes of a circular sieve that has been previously weighed. The 
diameter of the sieve is 20.3 centimeters (8 inches) if the quantity of 
the contents of the container is less than 1.36 kilograms (3 pounds), 
and 30.5 centimeters (12 inches), if such quantity is 1.36 kilograms (3 
pounds) or more. The bottom of the sieve is woven-wire cloth that 
complies with the specifications for such cloth set forth as a 2.38 mm 
(No. 8) sieve in the ``Definitions of Terms and Explanatory Notes'' of 
the ``Official Methods of Analysis of the Association of Official 
Analytical Chemists,'' 13th Ed. (1980), which is incorporated by 
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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/

[[Page 683]]

code_of_federal_regulations/ ibr_locations.html. Without shifting the 
material on the sieve, incline the sieve at an angle of approximately 
17[deg] to 20[deg] to facilitate drainage. Allow the shrimp to drain for 
2 minutes, measured from the moment the product is poured onto the 
sieve. Weigh the sieve and the drained shrimp. The weight so found, less 
the weight of the sieve, shall be considered to be the cut-out weight of 
the shrimp.
    (2) Sampling and acceptance procedure: A container that falls below 
the requirement for minimum fill prescribed in paragraph (c)(1) of this 
section is considered a ``defective.'' Determine compliance with 
paragraph (c)(1) of this section as specified in paragraph (a)(6) of 
this section except that the sample unit shall be the entire contents of 
the container.
    (3) If canned wet pack shrimp in transparent or nontransparent 
containers falls below the applicable standard of fill of container 
prescribed in paragraph (c)(1) of this section, the label shall bear the 
general statement of substandard fill provided in Sec. 130.14(b) of 
this chapter, in the manner and form therein specified.

[43 FR 19840, May 9, 1978; 43 FR 25423, June 13, 1978, as amended at 47 
FR 11833, Mar. 19, 1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24896, June 
12, 1989; 58 FR 2884, Jan. 6, 1994; 63 FR 14035, Mar. 24, 1998]

    Effective Date Note: Paragraphs (a) and (c) of Sec. 161.173 were 
stayed until further notice by a document published at 44 FR 50328, Aug. 
28, 1979.



Sec. 161.175  Frozen raw breaded shrimp.

    (a) Frozen raw breaded shrimp is the food prepared by coating one of 
the optional forms of shrimp specified in paragraph (c) of this section 
with safe and suitable batter and breading ingredients as provided in 
paragraph (d) of this section. The food is frozen.
    (b) The food tests not less than 50 percent of shrimp material as 
determined by the method prescribed in paragraph (g) of this section, 
except that if the shrimp are composite units the method prescribed in 
paragraph (h) of this section is used.
    (c) The term shrimp means the tail portion of properly prepared 
shrimp of commercial species. Except for composite units, each shrimp 
unit is individually coated. The optional forms of shrimp are:
    (1) Fantail or butterfly: Prepared by splitting the shrimp; the 
shrimp are peeled, except that tail fins remain attached and the shell 
segment immediately adjacent to the tail fins may be left attached.
    (2) Butterfly, tail off: Prepared by splitting the shrimp; tail fins 
and all shell segments are removed.
    (3) Round: Round shrimp, not split; the shrimp are peeled, except 
that tail fins remain attached and the shell segment immediately 
adjacent to the tail fins may be left attached.
    (4) Round, tail off: Round shrimp, not split; tail fins and all 
shell segments are removed.
    (5) Pieces: Each unit consists of a piece or a part of a shrimp; 
tail fins and all shell segments are removed.
    (6) Composite units: Each unit consists of two or more whole shrimp 
or pieces of shrimp, or both, formed and pressed into composite units 
prior to coating; tail fins and all shell segments are removed; large 
composite units, prior to coating, may be cut into smaller units.
    (d) The batter and breading ingredients referred to in paragraph (a) 
of this section are the fluid constituents and the solid constituents of 
the coating around the shrimp. These ingredients consist of suitable 
substances which are not food additives as defined in section 201(s) of 
the Federal Food, Drug, and Cosmetic Act; or if they are food additives 
as so defined, they are used in conformity with regulations established 
pursuant to section 409 of the act. Batter and breading ingredients that 
perform a useful function are regarded as suitable, except that 
artificial flavorings, artificial sweeteners, artificial colors, and 
chemical preservatives, other than those provided for in this paragraph, 
are not suitable ingredients of frozen raw breaded shrimp. Chemical 
preservatives that are suitable are:
    (1) Ascorbic acid, which may be used in a quantity sufficient to 
retard development of dark spots on the shrimp; and
    (2) The antioxidant preservatives listed in subpart D of part 182 of 
this

[[Page 684]]

chapter that may be used to retard development of rancidity of the fat 
content of the food, in amounts within the limits prescribed by that 
section.
    (e) The label shall name the food, as prepared from each of the 
optional forms of shrimp specified in paragraph (c) (1) to (6), 
inclusive, of this section, and following the numbered sequence of such 
subparagraph, as follows:
    (1) ``Breaded fantail shrimp.'' The word ``butterfly'' may be used 
in lieu of ``fantail'' in the name.
    (2) ``Breaded butterfly shrimp, tail off.''
    (3) ``Breaded round shrimp.''
    (4) ``Breaded round shrimp, tail off.''
    (5) ``Breaded shrimp pieces.''
    (6) Composite units:
    (i) If the composite units are in a shape similar to that of breaded 
fish sticks the name is ``Breaded shrimp sticks''; if they are in the 
shape of meat cutlets, the name is ``Breaded shrimp cutlets''.
    (ii) If prepared in a shape other than that of sticks or cutlets, 
the name is ``Breaded shrimp ___'', the blank to be filled in with the 
word or phrase that accurately describes the shape, but which is not 
misleading.


In the case of the names specified in paragraphs (e) (1) through (5) of 
this section, the words in each name may be arranged in any order, 
provided they are so arranged as to be accurately descriptive of the 
food. The word ``prawns'' may be added in parentheses immediately after 
the word ``shrimp'' in the name of the food if the shrimp are of large 
size; for example, ``Fantail breaded shrimp (prawns)''. If the shrimp 
are from a single geographical area, the adjectival designation of that 
area may appear as part of the name; for example, ``Breaded Alaskan 
shrimp sticks''.
    (f) The names of the optional ingredients used, as provided for in 
paragraph (d) of this section, shall be listed on the principal display 
panel or panels of the label with such prominence and conspicuousness as 
to render them likely to be read and understood by the ordinary 
individual under customary conditions of purchase. If a spice that also 
imparts color is used, it shall be designated as ``spice and coloring'', 
unless the spice is designated by its specific name. If ascorbic acid is 
used to retard development of dark spots on the shrimp, it shall be 
designated as ``Ascorbic acid added as a preservative'' or ``Ascorbic 
acid added to retard discoloration of shrimp''. If any other antioxidant 
preservative, as provided in paragraph (d) of this section, is used, 
such preservative shall be designated by its common name followed by the 
statement ``Added as a preservative''.
    (g) The method for determining percentage of shrimp material for 
those forms specified in paragraphs (c) (1) through (5) of this section 
is as follows:
    (1) Equipment needed. (i) Two-gallon container, approximately 9 
inches in diameter.
    (ii) Two-vaned wooden paddle, each vane measuring approximately 1\3/
4\ inches by 3\3/4\ inches.
    (iii) Stirring device capable of rotating the wooden paddle at 120 
r.p.m.
    (iv) Balance accurate to 0.01 ounce (or 0.1 gram).
    (v) U.S. Standard Sieve No. 20, 30.5 centimeter (12 inch) diameter. 
The sieves shall comply with the specifications for such cloth set forth 
in ``Official Methods of Analysis of the Association of Official 
Analytical Chemists'' (AOAC), 13th Ed. (1980), Table 1, ``Nominal 
Dimensions of Standard Test Sieves (U.S.A. Standard Series),'' under the 
heading ``Definitions of Terms and Explanatory Notes,'' which is 
incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (vi) U.S. Standard sieve, \1/2\-inch sieve opening, 12-inch 
diameter.
    (vii) Forceps, blunt points.
    (viii) Shallow baking pans.
    (ix) Rubber-tipped glass stirring rod.
    (2) Procedure. (i) Weigh the sample to be debreaded. Fill the 
container three-fourths full of water at 70[deg]-80 [deg]F. Suspend the 
paddle in the container, leaving a clearance of at least 5 inches below 
the paddle vanes, and adjust

[[Page 685]]

speed to 120 r.p.m. Add shrimp and stir for 10 minutes. Stack the 
sieves, the \1/2\-inch mesh over the No. 20, and pour the contents of 
the container onto them. Set the sieves under a faucet, preferably with 
spray attached, and rinse shrimp with no rubbing of flesh, being careful 
to keep all rinsings over the sieves and not having the stream of water 
hit the shrimp on the sieve directly. Lay the shrimp out singly on the 
sieve as rinsed. Inspect each shrimp and use the rubber-tipped rod and 
the spray to remove the breading material that may remain on any of 
them, being careful to avoid undue pressure or rubbing, and return each 
shrimp to the sieve. Remove the top sieve and drain on a slope for 2 
minutes, then remove the shrimp to weighing pan. Rinse contents of the 
No. 20 sieve onto a flat pan and collect any particles other than 
breading (i.e., flesh and tail fins) and add to shrimp on balance pan 
and weigh.
    (ii) Calculate percent shrimp material:

Percent shrimp material = (Weight of de breaded sample) / (Weight of 
sample) x 100 + 2

    (h) The method for determining percentage of shrimp material for 
composite units, specified in paragraph (c)(6) of this section, is as 
follows:
    (1) Equipment needed. (i) Water bath (for example a 3-liter to 4-
liter beaker).
    (ii) Balance accurate to 0.1 gram.
    (iii) Clip tongs of wire, plastic, or glass.
    (iv) Stop-watch or regular watch readable to a second.
    (v) Paper towels.
    (vi) Spatula, 4-inch blade with rounded tip.
    (vii) Nut picker.
    (viii) Thermometer (immersion type) accurate to 2 [deg]F.
    (ix) Copper sulfate crystals 
(CuSo4[middot]5H2O).
    (2) Procedure. (i) Weigh all composite units in the sample while 
they are still hard frozen.
    (ii) Place each composite unit individually in a water bath that is 
maintained at 63 [deg]F-86 [deg]F, and allow to remain until the 
breading becomes soft and can easily be removed from the still frozen 
shrimp material (between 10 seconds to 80 seconds for composite units 
held in storage at 0 [deg]F). If the composite units were prepared using 
batters that are difficult to remove after one dipping, redip them for 
up to 5 seconds after the initial debreading and remove residual batter 
materials.
    Note: Several preliminary trials may be necessary to determine the 
exact dip time required for ``debreading'' the composite units in a 
sample. For these trials only, a saturated solution of copper sulfate (1 
pound of copper sulfate in 2 liters of tap water) is necessary. The 
correct dip time is the minimum time of immersion in the copper sulfate 
solution required before the breading can easily be scraped off: 
Provided, That the ``debreaded'' units are still solidly frozen and only 
a slight trace of blue color is visible on the surface of the 
``debreaded'' shrimp material.
    (iii) Remove the unit from the bath; blot lightly with double 
thickness of paper toweling; and scrape off or pick out coating from the 
shrimp material with the spatula or nut picker.
    (iv) Weigh all the ``debreaded'' shrimp material.
    (v) Calculate the percentage of shrimp material in the sample, using 
the following formula:

Percent shrimp material = (Weight of de breaded shrimp sample) / Weight 
          of sample x 100

    (i) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14464, Mar. 15, 1977, as amended at 47 FR 11833, Mar. 19, 1982; 
49 FR 10102, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 58 FR 2884, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 161.176  Frozen raw lightly breaded shrimp.

    Frozen raw lightly breaded shrimp complies with the provisions of 
Sec. 161.175, except that it contains not less than 65 percent of 
shrimp material, as determined by the method prescribed in Sec. 161.175 
(g) or (h), as appropriate, and that in the name prescribed the word 
``lightly'' immediately precedes the words ``breaded shrimp''.



Sec. 161.190  Canned tuna.

    (a) Identity. (1) Canned tuna is the food consisting of processed 
flesh of

[[Page 686]]

fish of the species enumerated in paragraph (a)(2) of this section, 
prepared in one of the optional forms of pack specified in paragraph 
(a)(3) of this section, conforming to one of the color designations 
specified in paragraph (a)(4) of this section, in one of the optional 
packing media specified in paragraph (a)(5) of this section, and may 
contain one or more of the seasonings and flavorings specified in 
paragraph (a)(6) of this section. For the purpose of inhibiting the 
development of struvite crystals, sodium acid pyrophosphate may be added 
in a quantity not in excess of 0.5 percent by weight of the finished 
food. It is packed in hermetically sealed containers and so processed by 
heat as to prevent spoilage. It is labeled in accordance with the 
provisions of paragraph (a)(8) of this section.
    (2) The fish included in the class known as tuna fish are:

Thunnus thynnus (Linnaeus, 1758)--Northern bluefin tuna
Thunnus maccoyii (Castelnau, 1872)--Southern bluefin tuna
Thunnus alalunga (Bonnaterre, 1788)--Albacore
Thunnus atlanticus (Lesson, 1830)--Blackfin tuna
Thunnus obesus (Lowe, 1839)--Bigeye tuna
Thunnus albacares (Bonnaterre, 1788)--Yellowfin tuna
Thunnus tonggol (Bleeker, 1851)--Longtail tuna
Katsuwonus pelamis (Linnaeus, 1758)--Skipjack tuna
Euthynnus alletteratus (Rafinesque, 1810)--Spotted tunny
Euthynnus lineatus Kishinouye, 1920--Black skipjack tuna
Euthynnus affinis (Cantor, 1849)--Kawakawa
Allothunnus fallai Serventy, 1948--Slender tuna
Auxis rochei (Risso, 1810)--Bullet tuna
Auxis thazard (Lacepede, 1800)--Frigate tuna

    (3) The optional forms of processed tuna consist of loins and other 
striated muscular tissue of the fish. The loin is the longitudinal 
quarter of the great lateral muscle freed from skin, scales, visible 
blood clots, bones, gills, viscera and from the nonstriated part of such 
muscle, which part (known anatomically as the median superficial muscle) 
is highly vascular in structure, dark in color because of retained 
blood, and granular in form. Canned tuna is prepared in one of the 
following forms of pack, the identity of which is determined in 
accordance with the methods prescribed in paragraph (c)(2) of this 
section.
    (i) Solid or solid pack consists of loins freed from any surface 
tissue discolored by diffused hemolyzed blood, cut in transverse 
segments to which no free fragments are added. In containers of 1 pound 
or less of net contents, such segments are cut in lengths suitable for 
packing in one layer. In containers of more than 1 pound net contents, 
such segments may be cut in lengths suitable for packing in one or more 
layers of equal thickness. Segments are placed in the can with the 
planes of their transverse cut ends parallel to the ends of the can. A 
piece of a segment may be added if necessary to fill a container. The 
proportion of free flakes broken from loins in the canning operation 
shall not exceed 18 percent.
    (ii) Chunk, chunks, chunk style consists of a mixture of pieces of 
tuna in which the original muscle structure is retained. The pieces may 
vary in size, but not less than 50 percent of the weight of the pressed 
contents of a container is retained on a \1/2\-inch-mesh screen.
    (iii) Flake or flakes consist of a mixture of pieces of tuna in 
which more than 50 percent of the weight of the pressed contents of the 
container will pass through a \1/2\-inch-mesh screen, but in which the 
muscular structure of the flesh is retained.
    (iv) Grated consists of a mixture of particles of tuna that have 
been reduced to uniform size, that will pass through a \1/2\-inch-mesh 
screen, and in which the particles are discrete and do not comprise a 
paste.
    (v) Any of the specified forms of pack of canned tuna may be smoked. 
Canned smoked tuna shall be labeled in accordance with the provisions of 
paragraph (a)(8)(v) of this section.
    (4) Canned tuna, in any of the forms of pack specified in paragraph 
(a)(3) of this section, falls within one of the following color 
designations, measured by visual comparison with matte surface neutral 
reflectance standards corresponding to the specified Munsell units of 
value, determined in accordance with paragraph (a)(7) of this section.

[[Page 687]]

    (i) White. This color designation is limited to the species Thunnus 
alalunga (albacore), and is not darker than Munsell value 6.3.
    (ii) Light. This color designation includes any tuna not darker than 
Munsell value 5.3.
    (iii) Dark. This color designation includes all tuna darker than 
Munsell value 5.3.
    (iv) Blended. This color designation may be applied only to tuna 
flakes specified in paragraph (a)(3)(iii) of this section, consisting of 
a mixture of tuna flakes of which not less than 20 percent by weight 
meet the color standard for either white tuna or light tuna, and the 
remainder of which fall within the color standard for dark tuna. The 
color designation for blended tuna is determined in accordance with 
paragraph (a)(7) of this section.
    (5) Canned tuna is packed in one of the following optional packing 
media:
    (i) Any edible vegetable oil other than olive oil, or any mixture of 
such oils not containing olive oil.
    (ii) Olive oil.
    (iii) Water.
    (6) Canned tuna may be seasoned or flavored with one or more of the 
following:
    (i) Salt.
    (ii) Monosodium glutamate.
    (iii) Hydrolyzed protein declared in accordance with the applicable 
provisions of Sec. 101.22.
    (iv) Spices or spice oils or spice extracts.
    (v) Vegetable broth in an amount not in excess of 5 percent of the 
volume capacity of the container, such broth to consist of a minimum of 
0.5 percent by weight of vegetable extractives and to be prepared from 
two or more of the following vegetables: Beans, cabbage, carrots, 
celery, garlic, onions, parsley, peas, potatoes, green bell peppers, red 
bell peppers, spinach, and tomatoes.
    (vi) Garlic.
    (vii) Lemon flavoring to be prepared from lemon oil and citric acid 
together with safe and suitable carriers for the lemon oil which are 
present at nonfunctional and insignificant levels in the finished canned 
food. When lemon flavoring is added, a safe and suitable solubilizing 
and dispersing ingredient may be added in a quantity not exceeding 0.005 
percent by weight of the finished food. A substance used in accordance 
with this paragraph is deemed to be suitable if it is used in an amount 
no greater than necessary to achieve the intended flavor effect, and is 
deemed to be safe if it is not a food additive as defined in section 
201(s) of the Federal Food, Drug, and Cosmetic Act (the act), or if it 
is a food additive as so defined, it is used in conformity with 
regulations established pursuant to section 409 of the act.
    (viii) Edible vegetable oil or partially hydrogenated vegetable oil, 
excluding olive oil, used alone or in combination in an amount not to 
exceed 5 percent of the volume capacity of the container, with or 
without any suitable form of emulsifying and suspending ingredients that 
has been affirmed as GRAS or approved as a food additive to aid in 
dispersion of the oil, as seasoning in canned tuna packed in water.
    (7) For determination of the color designations specified in 
paragraph (a)(4) of this section, the following method shall be used: 
Recombine the separations of pressed cake resulting from the method 
prescribed in paragraph (c)(2) of this section. Pass the combined 
portions through a sieve fitted with woven-wire cloth of \1/4\-inch mesh 
complying with the specifications for such cloth set forth in ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), Table 1, ``Nominal Dimensions of Standard 
Test Sieves (U.S.A. Standard Series),'' under the heading ``Definitions 
of Terms and Explanatory Notes,'' which is incorporated by reference. 
Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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. Mix the sieved material and place a sufficient 
quantity into a 307 x 113 size container (bearing a top seam and having 
a false bottom approximately \1/2\-inch deep and painted flat black 
inside and outside) so that

[[Page 688]]

after tamping and smoothing the surface of the sample the material will 
be \1/8\-inch to \1/4\-inch below the top of the container. Within 10 
minutes after sieving through the \1/4\-inch mesh woven-wire cloth, 
determine the Munsell value of sample surface.
    (i) Determine the Munsell value of the sample surface so prepared. 
The following method may be used, employing an optical comparator, 
consisting of a lens and prism system which brings two beams of light, 
reflected from equal areas of sample surface and standard surface, 
respectively, together, within an eyepiece, so as to show an equally 
divided optical field. The scanned areas of sample and standard surface 
are not smaller than 2 square inches. Light reaching the eye is rendered 
sufficiently diffuse, by design of eyepiece and comparator, so that 
detail of the sample surface will remain undefined, to a degree such as 
to avoid visual confusion in observation of a match of over-all 
intensity of reflected light. The eyepiece contains a color filter 
centering at a wavelength between 550 m[micro] and 560 m[micro]. The 
filter does not pass appreciable visible radiation of wavelengths below 
540 m[micro] or above 570 m[micro]. The passed wavelength band is of a 
monochromaticity sufficient to cause a sample and a neutral standard of 
equal reflectance to appear of the same hue. The comparator is rigidly 
mounted on a vertical stand attached to a base in which arrangement is 
provided for securely and accurately positioning two cans of size 307 x 
113 in the two fields of view. Mounted on the base are two shaded lamps, 
which direct the center of their beams of light at about a 45[deg] angle 
to the plane of the sample and standard surfaces. The lamps are so 
positioned that light from one bears mainly upon the sample surface and 
light from the other mainly on the standard surface, and are so placed 
in relation to sample and standard that no shadows, as from the can 
rims, appear in the fields of view. The lamps are strong enough to 
furnish adequate and convenient illumination through eyepiece and 
filter. Means are provided to alter the light intensity of one lamp in 
relation to the other, as may conveniently be achieved by using a 100-
watt tungsten filament bulb in one lamp and using, in the other, a 
similar 150-watt bulb connected with the power source through a suitable 
rheostat. The stand is equipped with non-glossy black curtains on the 
side of the observer, to exclude variation in extraneous light reflected 
from the person of the observer.
    (ii) To adjust the comparator, place a pair of matte surface 
standards of Munsell value 5.3, mounted as described in paragraph 
(a)(7)(iv) of this section, in position in the comparator base, and 
adjust the intensity of the variable lamp until the two halves of the 
optical field, viewed through the eyepiece, are of equal brightness. 
Then remove one of the standards and replace it with the prepared 
sample. Without altering any other adjustments, observe through the 
eyepiece whether the sample appears lighter or darker than the standard. 
In case of examination of albacore designated ``white'', conduct the 
procedure using standards of Munsell value 6.3.
    (iii) The standards with which comparisons are made are essentially 
neutral matte-finish standards, equivalent in luminous reflectance of 
light of 555[micro] wavelength to 33.7 percent of the luminous 
reflectance of magnesium oxide (for Munsell value 6.3) and 22.6 percent 
of the luminous reflectance of magnesium oxide (for Munsell value 5.3), 
as given by the relationship between Munsell value and luminous 
reflectance derived by a subcommittee of the Optical Society of America 
and published in the ``Journal of the Optical Society of America,'' Vol. 
33, page 406 (1943), which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
150), Food and Drug Administration, 5001 Campus Dr., College Park, MD 
20740, or 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.
    (iv) These standards shall be cut in circles 3\1/4\ inches in 
diameter and shall be mounted in 307 x 113 size containers, bearing a 
top seam and painted flat

[[Page 689]]

black inside and outside, so that the surfaces of the standards are \3/
16\ inch below the top of the containers in which they are mounted.
    (v) In the case of blended tuna, the foregoing method shall be 
varied by first separating the tuna flakes of the two different colors 
before passing them through the \1/4\-inch mesh sieve, then proceeding 
with each portion separately for the determination of its color value, 
employing, if necessary, a sample container with false bottom greater 
than \1/2\ inch deep.
    (8)(i) The specified names of the canned tuna for which definitions 
and standards of identity are prescribed by this section, except where 
water is the packing medium or where the tuna is smoked, are formed by 
combining the designation of form of pack with the color designation of 
the tuna; for example, ``Solid pack white tuna'', ``Grated dark tuna'', 
etc. In the case of blended tuna, there shall be used both applicable 
color designations of the blended flakes, in precedence determined in 
accordance with the predominating portion found in the container; for 
example, ``Blended white and dark tuna flakes'', ``Blended dark and 
light tuna flakes''.
    (ii) The specified name of canned tuna when water is used as the 
packing medium is formed as described in paragraph (a)(8)(i) of this 
section, followed by the words ``in water''; for example, ``Grated light 
tuna in water''.
    (iii) When the packing medium is vegetable oil or olive oil, the 
label shall bear the name of the optional packing medium used, as 
specified in paragraph (a)(5) of this section, preceded by the word 
``in'' or the words ``packed in''. In case of the optional ingredient 
specified in paragraph (a)(5)(i) of this section, the name or names of 
the oil used may be stated, or the general term ``vegetable oil'' may be 
used.
    (iv) In case solid pack tuna is packed in olive oil, the designation 
``Tonno'' may also appear.
    (v) In case any of the specified forms of canned tuna are smoked, 
the word ``smoked'' shall appear as a part of the name on the label; for 
example, ``Smoked light tuna flakes''.
    (vi) Where the canned tuna contains one or more of the ingredients 
provided for in paragraph (a)(6) of this section, the label shall bear 
the statement ``Seasoned with ___'', the blank being filled in with the 
name or names of the ingredient or ingredients used, except that if the 
ingredient designated in paragraph (a)(6)(v) of this section is used, 
the blank shall be filled in with the term ``vegetable broth'', and if 
the ingredients designated in paragraph (a)(6)(viii) of this section are 
used, the blank may be filled in with the term ``oil'', and if the 
ingredient designated in paragraph (a)(6)(iv) of this section is used 
alone, the label may alternatively bear either the statement ``spiced'' 
or the statement ``with added spice''; and if salt is the only seasoning 
ingredient used, the label may alternatively bear any of the statements 
``salted'', ``with added salt'', or ``salt added''. If the flavoring 
ingredients designated in paragraph (a)(6)(vii) of this section are 
used, the words ``lemon flavored'' or ``with lemon flavoring'' shall 
appear as part of the name on the label; for example, ``lemon flavored 
chunk light tuna''. Citric acid and any optional solubilizing and 
dispersing agent used as specified in paragraph (a)(6)(vii) of this 
section in connection with lemon flavoring ingredients or emulsifying 
and suspending ingredients used as specified in paragraph (a)(6)(viii) 
of this section shall be designated on the label by their common or 
usual name.
    (vii) Where the canned tuna contains the optional ingredient sodium 
acid pyrophosphate as provided in paragraph (a)(1) of this section, the 
label shall bear the statement ``pyrophosphate added'' or ``with added 
pyrophosphate''.
    (viii) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the names of the optional ingredients used, as specified in 
paragraphs (a)(8)(iii), (vi), and (vii) of this section (except if lemon 
flavoring is added, this subparagraph applies only to the terms ``lemon 
flavored'' or ``with lemon flavoring'', not to the constituent 
ingredients of that flavoring or to any optional solubilizing or 
dispersing ingredient used in connection with lemon flavoring 
ingredients), shall immediately and conspicuously precede or follow such 
name

[[Page 690]]

without intervening, written, printed, or graphic matter except that the 
common name of the species of tuna fish may so intervene; but the 
species name ``albacore'' may be employed only for canned tuna of that 
species which meets the color designation ``white'' as prescribed by 
paragraph (a)(4)(i) of this section.
    (ix) Statements of optional ingredients present required by 
paragraph (a)(8)(vi) of this section, but not subject to the provisions 
of paragraph (a)(8)(viii) of this section shall be set forth on the 
label with such prominence and conspicuousness as to render them likely 
to be read and understood by the ordinary individual under customary 
conditions of purchase.
    (b) [Reserved]
    (c) Fill of container. (1) The standard of fill of container for 
canned tuna is a fill such that the average weight of the pressed cake 
from 24 cans, as determined by the method prescribed by paragraph (c)(2) 
of this section, is not less than the minimum value specified for the 
corresponding can size and form of tuna ingredient in the following 
table:

------------------------------------------------------------------------
                                                             II. Minimum
                                                              value for
                                                              weights of
                                                               pressed
          I. Can size and form of tuna ingredient                cake
                                                             (average of
                                                               24 cans)
                                                             (in ounces)
------------------------------------------------------------------------
211 x 109:
  Solid....................................................         2.25
  Chunks...................................................         1.98
  Flakes...................................................         1.98
  Grated...................................................         2.00
307 x 113:
  Solid....................................................         4.47
  Chunks...................................................         3.92
  Flakes...................................................         3.92
  Grated...................................................         3.96
401 x 206:
  Solid....................................................         8.76
  Chunks...................................................         7.68
  Flakes...................................................         7.68
  Grated...................................................         7.76
603 x 408:
  Solid....................................................         43.2
  Chunks...................................................         37.9
  Flakes...................................................         37.9
  Grated...................................................         38.3
------------------------------------------------------------------------


If the can size in question is not listed, calculate the value for 
column II as follows: From the list select as the comparable can size 
that one having nearest the water capacity of the can size in question, 
multiply the value listed in column II for the same form of tuna 
ingredient by the water capacity of the can size in question, and 
divided by the water capacity of the comparable can size. Water 
capacities are determined by the general method provided in Sec. 
130.12(a) of this chapter. For the purposes of this section, cans of 
dimensions 211 x 109 shall be deemed to have a water capacity at 68 
[deg]F of 3.55 avoirdupois ounces of water; cans of dimensions 307 x 
113, a water capacity of 7.05 avoirdupois ounces of water; cans of 
dimensions 401 x 206, a water capacity of 13.80 avoirdupois ounces of 
water; and cans of dimensions 603 x 408, a water capacity of 68.15 
avoirdupois ounces of water.
    (2) The methods referred to in paragraph (c)(1) of this section for 
determining the weight of the pressed cake and referred to in paragraph 
(a)(3)(i) of this section for determining the percent of free flakes and 
the percent of pieces that pass through a \1/2\-inch-mesh sieve are as 
follows:
    (i) Have each of the 24 cans and contents at a temperature of 75 
[deg]F within 5 [deg]F. Test each can in turn as 
follows:
    (ii) Cut out the top of the can (code end), using a can opener that 
does not remove nor distort the double seam.
    (iii) With the cut top held on the can contents, invert the can, and 
drain the free liquid by gentle finger pressure on the cut lid so that 
most of the free liquid drains from the can.
    (iv) With the cut lid still in place, cut out the bottom of the can 
with the can opener, then turn the can upright and remove the cut can 
top (code end). Scrape off any adhering tuna particles into the tuna 
mass in the can.
    (v) Place the proper size of press cylinder as provided in paragraph 
(c)(3)(i) of this section in a horizontal position on a table; then, 
using the cut bottom of the can as a pusher, gently force the can 
contents from the can into the cylinder so that the flat side of the can 
contents lies in contact with the bottom of the cylinder. Remove the 
bottom of the can that was used as the pusher and scrape any adhering 
particles from the can body and bottom of the can, and put them in the 
cylinder.
    (vi) Place the cylinder plunger on top of the can contents in the 
cylinder. Remove the eyebolt and put the cylinder

[[Page 691]]

and plunger in position on the press (paragraph (c)(3)(iii) of this 
section).
    (vii) Begin the operation of the press and as soon as liquid is 
observed coming from the cylinder start timing the operation. Apply 
pressure to the plunger slowly and at a uniform rate, so that a full 
minute is used to reach a pressure of 384 pounds per square inch of 
plunger face in contact with the can contents. Hold this pressure for 1 
additional minute and then release the pressure and disengage the 
plunger from the press shaft. Tip the press cylinder so that any free 
liquid is drained out.
    (viii) Remove press cylinder with plunger from the press, insert 
eyebolt in plunger and withdraw it from the cylinder. Loosen the pressed 
cake from the cylinder with a thin blade and remove the entire pressed 
cake as gently as possible, to keep the mass in a single cake during 
this operation. Place the pressed cake and any pieces that adhered to 
the plunger and cylinder in a tared receiving pan and determine the 
weight of the pressed material.
    (ix) For cans larger than 401 x 206, cut out the top of the can and 
drain off free liquid from the can contents as in operations described 
in paragraphs (c)(2)(ii) and (iii) of this section. Determine the gross 
weight of the can and remaining contents. Using a tared core cutter as 
provided for in paragraph (c)(3)(ii) of this section, cut vertically a 
core of the drained material in the can. Determine the weight of the 
core. With a thin spatula transfer the core to the pressing cylinder for 
401 x 206 cans. Determine the weight of the pressed cake as in the 
operations described in paragraphs (c)(2)(v) through (viii) of this 
section. Remove the remaining drained contents of the can, reserving the 
contents for the determination of free flakes (paragraph (c)(2)(xi) of 
this section), weigh the empty can, and calculate the weight of the 
total drained material. Calculate the weight of pressed cake on the 
entire can basis by multiplying the weight of the pressed cake of the 
core by the ratio of the weight of the drained contents of the can to 
the weight of the core before pressing.
    (x) Repeat the determination of weight of pressed cake on the 
remainder of the 24 cans and determine the average weight of pressed 
cake for the purpose of paragraph (c)(1) of this section.
    (xi) Determination of free flakes: If the optional form of tuna 
ingredient is solid pack, determine the percent of free flakes. Any 
flakes resulting from the operations described in this paragraph 
(c)(2)(xi) or in other parts of this paragraph are to be weighed as free 
flakes. Only fragments that were broken in the canning procedure are 
considered to be free flakes. If the can is of such size that its entire 
drained contents were pressed as described in paragraphs (c)(2)(i) to 
(viii) of this section, inclusive, examine the pressed cake carefully 
for free flakes. Using a spatula, scrape free flakes gently from the 
outside of the cake. Weigh the aggregate free flakes that were broken 
from the loin segments in the canning procedure and calculate their 
percentage of the total weight of pressed cake. If the can is of such 
size that a core was cut for pressing as described in paragraph 
(c)(2)(ix) of this section, make the examination for free flakes on a 
weighed portion of the drained material remaining after the core was 
removed. The weight of the portion examined should approximately equal 
the weight of the core before pressing. Calculate the weight of the free 
flakes that were broken from the loins in the canning procedure as a 
percentage of the weight of the portion examined.
    (xii) Determination of particle size: If the optional form of tuna 
ingredient is chunks, flakes, or grated, the pressed cake resulting from 
the operations described in paragraphs (c)(2)(i) to (ix) of this 
section, inclusive, is gently separated by hand, care being taken to 
avoid breaking the pieces. The separated pieces are evenly distributed 
over the top sieve of the screen separation equipment described in 
paragraph (c)(3)(iv) of this section. Beginning with the top sieve, lift 
and drop each sieve by its open edge three times. Each time, the open 
edge of the sieve is lifted the full distance permitted by the device. 
Combine and weigh the material remaining on the three top sieves (1\1/
2\-inch, 1-inch, \1/2\-inch screens), and determine the combined

[[Page 692]]

percentage retention by weight in relation to the total weight of the 
pressed cake.
    (3)(i) The press cylinder and plunger referred to in paragraph 
(c)(2) of this section are made of stainless steel. The press cylinders 
are made with a lip to facilitate drainage of the liquid. Plungers have 
a threaded center hole, about half as deep as the thickness of the 
plunger, for receiving a ringbolt to assist in removing the plunger from 
the press cylinder. Dimensions for press cylinders and plungers are as 
follows:

                         For can size 211 x 109

Press cylinder:
    Inside depth, approximately 3\3/4\ inches.
    Inside diameter, 2.593 inches.
    Wall thickness, approximately \3/8\ inch.
Plunger:
    Thickness, approximately 1 inch.
    Diameter, 2.568 inches.

                         For can size 307 x 113

Press cylinder:
    Inside depth, approximately 4 inches.
    Inside diameter, 3.344 inches.
    Wall thickness, approximately \3/8\ inch.
Plunger:
    Thickness, approximately 1\1/4\ inches.
    Diameter, 3.319 inches.

                         For can size 401 x 206

Press cylinder:
    Inside depth, approximately 4\1/8\ inches.
    Inside diameter, 3.969 inches.
    Wall thickness, approximately \1/2\ inch.
Plunger:
    Thickness, approximately 1\1/4\ inches.
    Diameter, 3.944 inches.


For can sizes where the diameter is greater than 401, the core cutter 
described in paragraph (c)(3)(ii) of this section shall be used and the 
resulting core pressed in the press cylinder for can size 401 x 206. For 
can sizes differing from those specified in this paragraph (c)(3)(i), 
special press cylinders and plungers may be used. Special press less 
than the outside diameters, at the cylinders have inside diameters \1/
10\-inch double seam, for the can sizes for which the cylinders are 
used; plunger diameters are 0.025-inch less than the inside diameters of 
the press cylinders.
    (ii) The core cutter referred to in paragraph (c)(2) (ix) and (xi) 
of this section and paragraph (c)(3)(i) of this section is made from a 
previously sealed 300 x 407 can. The cover, including the top seam, is 
cut out. The edge is smoothed and sharpened. A small hole to permit 
passage of air is made in the bottom.
    (iii) The hydraulic press referred to in paragraph (c)(2) (vi) to 
(x) of this section, inclusive, is made by so mounting a hydraulic jack, 
in a strong frame, that it will press horizontally against the center of 
the plunger in the press cylinder used. The frame is so braced that it 
does not change shape when pressure is applied. The gauge on the 
hydraulic jack is so calibrated that it will indicate, for the plunger 
being used, when the plunger is pressing against the contents of the 
press cylinder with a pressure of 384 pounds per square inch of plunger 
face.
    (iv) The sieving device referred to in paragraph (c)(2)(xii) of this 
section consists of three sieves, each approximately 1 foot square, 
loosely mounted, one above the other, in a metal frame. The mesh in the 
top sieve complies with the specifications for 1\1/2\-inch woven-wire 
cloth as prescribed in paragraph (a)(7) of this section. The meshes in 
the sieves below comply with similar specifications for 1-inch and \1/
2\-inch woven-wire cloth as set forth in the same publication. The sides 
of each sieve are formed, in a raised rim, from \3/4\-inch x \1/8\-inch 
metal strap. The frame has tracks made of \3/8\-inch angle metal to 
support each sieve under each side. The tracks are so positioned as to 
permit each sieve a free vertical travel of 1\3/4\ inches.
    (4) If canned tuna falls below the applicable standard of fill of 
container prescribed in paragraph (c)(1) of this section, the label 
shall bear the general statement of substandard fill provided in Sec. 
130.14(b) of this chapter, in the manner and form therein specified.

[42 FR 14464, Mar. 15, 1977, as amended at 47 FR 11833, Mar. 19, 1982; 
49 FR 10102, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 55 FR 45797, 
Oct. 31, 1990; 56 FR 6263, Feb. 15, 1991; 58 FR 2884, Jan. 6, 1993; 61 
FR 14480, Apr. 2, 1996; 63 FR 14035, Mar. 24, 1998; 66 FR 56035, Nov. 6, 
2001]

[[Page 693]]



PART 163_CACAO PRODUCTS--Table of Contents



                      Subpart A_General Provisions

Sec.
163.5 Methods of analysis.

     Subpart B_Requirements for Specific Standardized Cacao Products

163.110 Cacao nibs.
163.111 Chocolate liquor.
163.112 Breakfast cocoa.
163.113 Cocoa.
163.114 Lowfat cocoa.
163.117 Cocoa with dioctyl sodium sulfosuccinate for manufacturing.
163.123 Sweet chocolate.
163.124 White chocolate.
163.130 Milk chocolate.
163.135 Buttermilk chocolate.
163.140 Skim milk chocolate.
163.145 Mixed dairy product chocolates.
163.150 Sweet cocoa and vegetable fat coating.
163.153 Sweet chocolate and vegetable fat coating.
163.155 Milk chocolate and vegetable fat coating.

    Authority: 21 U.S.C. 321, 331, 341, 343, 348, 371, 379e.

    Source: 58 FR 29529, May 21, 1993, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 163.5  Methods of analysis.

    Shell and cacao fat content in cacao products shall be determined by 
the following methods of analysis prescribed in ``Official Methods of 
Analysis of the Association of Official Analytical Chemists,'' which are 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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.
    (a) Shell content--12th ed. (1975), methods 13.010-13.014, under the 
heading ``Shell in Cacao Nibs--Official Final Action,'' pp. 208-210.
    (b) Fat content--15th ed. (1990), method 963.15, under the heading 
``Fat in Cacao Products--Soxhlet Extraction Method--Final Action, 
1973,'' pp. 770-771.

[58 FR 29529, May 21, 1993, as amended at 63 FR 14035, Mar. 24, 1998]



     Subpart B_Requirements for Specific Standardized Cacao Products



Sec. 163.110  Cacao nibs.

    (a) Description. (1) Cacao nibs is the food prepared by removing the 
shell from cured, cleaned, dried, and cracked cacao beans. The cacao 
shell content is not more than 1.75 percent by weight, calculated on an 
alkali free basis, as determined by the method prescribed in Sec. 
163.5(a).
    (2) The cacao nibs, or the cacao beans from which they are prepared, 
may be processed by heating with one or more of the optional alkali 
ingredients specified in paragraph (b)(1) of this section.
    (3) The cacao nibs, or the cacao beans from which they are prepared, 
as appropriate, may be further processed with one or more of the 
optional neutralizing agents specified in paragraph (b)(2) of this 
section.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Alkali ingredients. Ammonium, potassium, or sodium bicarbonate, 
carbonate, or hydroxide, or magnesium carbonate or oxide, added as such, 
or in aqueous solution. For each 100 parts by weight of cacao nibs, used 
as such, or before shelling from the cacao beans, the total quantity of 
alkali ingredients used is not greater in neutralizing value (calculated 
from the respective combined weights of the alkali ingredients used) 
than the neutralizing value of 3 parts by weight of anhydrous potassium 
carbonate.
    (2) Neutralizing agents. Phosphoric acid, citric acid, and L-
tartaric acid, added as such, or in aqueous solution. For each 100 parts 
by weight of cacao nibs, used as such, or before shelling from the cacao 
beans, the total quantity of phosphoric acid used is not greater than 
0.5 part by weight, expressed as P2O5. The total 
amount, singly or in combination, of citric acid

[[Page 694]]

and L-tartaric acid is not greater than 1.0 part by weight.
    (c) Nomenclature. The name of the food is ``cacao nibs'', ``cocoa 
nibs'', or ``cracked cocoa''. (1) When the cacao nibs, or the cacao 
beans from which they are prepared, are processed with alkali 
ingredients specified in paragraph (b)(1) of this section, the name of 
the food shall be accompanied by the statement ``Processed with alkali'' 
or ``Processed with ___'', the blank being filled in with the common or 
usual name of the specific alkali ingredient used in the food.
    (2) When the cacao nibs, or the cacao beans from which they are 
prepared, are processed with neutralizing agents specified in paragraph 
(b)(2) of this section, the name of the food shall be accompanied by the 
statement ``Processed with neutralizing agent'' or ``Processed with 
___'', the blank being filled in with the common or usual name of the 
specific neutralizing agent used in the food.
    (3) Whenever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statements prescribed in paragraphs (c)(1) and (c)(2) of 
this section shall precede or follow the name without intervening 
printed or graphic matter.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.



Sec. 163.111  Chocolate liquor.

    (a) Description. (1) Chocolate liquor is the solid or semiplastic 
food prepared by finely grinding cacao nibs. The fat content of the food 
may be adjusted by adding one or more of the optional ingredients 
specified in paragraph (b)(1) of this section to the cacao nibs. 
Chocolate liquor contains not less than 50 percent nor more than 60 
percent by weight of cacao fat as determined by the method prescribed in 
Sec. 163.5(b).
    (2) Optional alkali ingredients specified in paragraph (b)(2) of 
this section may be used as such in the preparation of chocolate liquor 
under the conditions and limitations specified in Sec. 163.110(b)(1).
    (3) Optional neutralizing agents specified in paragraph (b)(3) of 
this section may be used as such in the preparation of the chocolate 
liquor under the conditions and limitations specified in Sec. 
163.110(b)(2).
    (4) Chocolate liquor may be spiced, flavored, or seasoned with one 
or more of the ingredients listed in paragraphs (b)(4), (b)(5), and 
(b)(6) of this section.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Cacao fat and cocoas (breakfast cocoa, cocoa, or lowfat cocoa);
    (2) Alkali ingredients. Ammonium, potassium, or sodium bicarbonate, 
carbonate, or hydroxide, or magnesium carbonate or oxide, added as such, 
or in aqueous solution;
    (3) Neutralizing agents. Phosphoric acid, citric acid, and L-
tartaric acid, added as such, or in aqueous solution;
    (4) Spices, natural and artificial flavorings, ground whole nut 
meats, ground coffee, dried malted cereal extract, and other seasonings 
that do not either singly or in combination impart a flavor that 
imitates the flavor of chocolate, milk, or butter;
    (5) Butter or milkfat; or
    (6) Salt.
    (c) Nomenclature. The name of the food is ``chocolate liquor'', 
``chocolate'', ``unsweetened chocolate'', ``bitter chocolate'', ``baking 
chocolate'', ``cooking chocolate'', ``chocolate coating'', or 
``unsweetened chocolate coating''.
    (1) When any optional alkali ingredient specified in paragraph 
(b)(2) of this section is used, including those used in the preparation 
of the cacao nibs and cocoas from which the chocolate liquor was 
prepared, the name of the food shall be accompanied by the statement 
``Processed with alkali'' or ``Processed with ___'', the blank being 
filled in with the common or usual name of the specific alkali 
ingredient used in the food.
    (2) When any optional neutralizing agent specified in paragraph 
(b)(3) of this section is used, including those used in the preparation 
of the cacao nibs and cocoas from which the chocolate liquor was 
prepared, the name of the food shall be accompanied by the

[[Page 695]]

statement ``Processed with neutralizing agent'' or ``Processed with 
___'', the blank being filled in with the common or usual name of the 
specific neutralizing ingredient used in the food.
    (3) When one or more spices, flavorings, or seasonings specified in 
paragraphs (b)(4) and (b)(5) of this section are used in the chocolate 
liquor, the label shall bear an appropriate statement, e.g., ``Spice 
added'', ``Flavored with ___'', ``Seasoned with ___'', or ``With ___ 
added'', the blank being filled in with the common or usual name of the 
spice, flavoring, or seasoning used, in accordance with Sec. 101.22 of 
this chapter.
    (4) When two or more of the statements set forth in this paragraph 
are required, such statements may be combined in a manner that is 
appropriate, but not misleading.
    (5) Whenever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statements prescribed in this section, showing optional 
ingredients used, shall precede or follow the name without intervening 
printed or graphic matter.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.



Sec. 163.112  Breakfast cocoa.

    (a) Description. (1) Breakfast cocoa is the food prepared by 
pulverizing the material remaining after part of the cacao fat has been 
removed from ground cacao nibs. Breakfast cocoa contains not less than 
22 percent by weight of cacao fat as determined by the method prescribed 
in Sec. 163.5(b).
    (2) Optional alkali ingredients specified in paragraph (b)(1) of 
this section may be used as such in the preparation of breakfast cocoa 
under the conditions and limitations specified in Sec. 163.110(b)(1).
    (3) Optional neutralizing agents specified in paragraph (b)(2) of 
this section may be used as such in the preparation of the breakfast 
cocoa under the conditions and limitations specified in Sec. 
163.110(b)(2).
    (4) Breakfast cocoa may be spiced, flavored, or seasoned with one or 
more of the ingredients listed in paragraphs (b)(3) and (b)(4) of this 
section.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Alkali ingredients. Ammonium, potassium, or sodium bicarbonate, 
carbonate, or hydroxide, or magnesium carbonate or oxide, used as such, 
or in aqueous solution;
    (2) Neutralizing agents. Phosphoric acid, citric acid and L-tartaric 
acid, used as such, or in aqueous solution;
    (3) Spices, natural and artificial flavorings, and other seasonings 
that do not either singly or in combination impart a flavor that 
imitates the flavor of chocolate, milk, or butter; or
    (4) Salt.
    (c) Nomenclature. The name of the food is ``breakfast cocoa'', or 
``high fat cocoa''.
    (1) When any optional alkali ingredient specified in paragraph 
(b)(1) of this section is used, including those used in the preparation 
of the cacao nibs from which the breakfast cocoa was prepared, the name 
of the food shall be accompanied by the statement ``Processed with 
alkali'', or ``Processed with ___'', the blank being filled in with the 
common or usual name of the specific alkali ingredient used in the food.
    (2) When any optional neutralizing agent specified in paragraph 
(b)(2) of this section is used, including those used in the preparation 
of the cacao nibs from which the breakfast cocoa was prepared, the name 
of the food shall be accompanied by the statement ``Processed with 
neutralizing agent'' or ``Processed with ___'', the blank being filled 
in with the common or usual name of the specific neutralizing agent used 
in the food.
    (3) When one or more of the spices, flavorings, or seasonings 
specified in paragraph (b)(3) of this section are used in the breakfast 
cocoa, the label shall bear an appropriate statement, e.g., ``Spice 
added'', ``Flavored with ___'', or ``With ___ added'', the blank being 
filled in with the common or usual name of the spice, flavoring, or 
seasoning used, in accordance with Sec. 101.22 of this chapter.

[[Page 696]]

    (4) When two or more of the statements set forth in this paragraph 
are required, such statements may be combined in a manner that is 
appropriate, but not misleading.
    (5) Whenever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statements prescribed in this paragraph showing optional 
ingredients used shall precede or follow the name without intervening 
printed or graphic matter.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.



Sec. 163.113  Cocoa.

    (a) Description. Cocoa is the food that conforms to the definition 
and standard of identity, and is subject to the requirements for label 
declaration of ingredients for breakfast cocoa in Sec. 163.112, except 
that the cacao fat content is less than 22 percent, but not less than 10 
percent by weight, as determined by the method prescribed in Sec. 
163.5(b).
    (b) Nomenclature. The name of the food is ``cocoa'' or ``medium fat 
cocoa''.



Sec. 163.114  Lowfat cocoa.

    (a) Description. Lowfat cocoa is the food that conforms to the 
definition and standard of identity, and is subject to the requirements 
for label declaration of ingredients for breakfast cocoa in Sec. 
163.112, except that the cacao fat content is less than 10 percent by 
weight, as determined by the method prescribed in Sec. 163.5(b).
    (b) Nomenclature. The name of the food is ``lowfat cocoa''.



Sec. 163.117  Cocoa with dioctyl sodium sulfosuccinate for 
manufacturing.

    (a) Description. Cocoa with dioctyl sodium sulfosuccinate for 
manufacturing is the food additive complying with the provisions 
prescribed in Sec. 172.520 of this chapter. It conforms to the 
definition and standard of identity, and is subject to the requirements 
for label declaration of ingredients, for breakfast cocoa in Sec. 
163.112, or for cocoa in Sec. 163.113, or for lowfat cocoa in Sec. 
163.114, except that the food additive contains dioctyl sodium 
sulfosuccinate (complying with the requirements of Sec. 172.810 of this 
chapter, including the limit of not more than 0.4 percent by weight of 
the finished food additive).
    (b) Nomenclature. The name of the food additive is ``cocoa with 
dioctyl sodium sulfosuccinate for manufacturing'' to which is added any 
modifier of the word ``cocoa'' required by the definition and standard 
of identity to which the food additive otherwise conforms. When the food 
additive is used in a fabricated food, the phrase ``for manufacturing'' 
may be omitted from any declaration of ingredients required under Sec. 
101.4 of this chapter.



Sec. 163.123  Sweet chocolate.

    (a) Description. (1) Sweet chocolate is the solid or semiplastic 
food prepared by intimately mixing and grinding chocolate liquor with 
one or more optional nutritive carbohydrate sweeteners, and may contain 
one or more of the other optional ingredients specified in paragraph (b) 
of this section.
    (2) Sweet chocolate contains not less than 15 percent by weight of 
chocolate liquor complying with the requirements of Sec. 163.111, as 
calculated by subtracting from the weight of the chocolate liquor used 
the weight of the cacao fat therein and the weights therein of any 
alkali, neutralizing, and seasoning ingredients, and multiplying the 
remainder by 2.2, dividing the result by the weight of the finished 
sweet chocolate, and multiplying the quotient by 100. The finished sweet 
chocolate contains less than 12 percent by weight of total milk solids 
based on those dairy ingredients specified in paragraph (b)(4) of this 
section, exclusive of any added sweetener or other dairy derived 
ingredient that is added beyond that amount that is normally present in 
the specified dairy ingredient.
    (3) Semisweet chocolate or bittersweet chocolate is sweet chocolate 
that contains not less than 35 percent by weight of chocolate liquor 
complying with the requirements of Sec. 163.111 and calculated in the 
same manner as set forth in paragraph (a)(2) of this section.
    (4) Cacao fat is determined by the method prescribed in Sec. 
163.5(b).

[[Page 697]]

    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Cacao fat;
    (2) Nutritive carbohydrate sweeteners;
    (3) Spices, natural and artificial flavorings, ground whole nut 
meats, ground coffee, dried malted cereal extract, salt, and other 
seasonings that do not either singly or in combination impart a flavor 
that imitates the flavor of chocolate, milk, or butter;
    (4) Dairy ingredients:
    (i) Cream, milkfat, butter;
    (ii) Milk, concentrated milk, evaporated milk, sweetened condensed 
milk, dried milk;
    (iii) Skim milk, concentrated skim milk, evaporated skim milk, 
sweetened condensed skim milk, nonfat dry milk;
    (iv) Concentrated buttermilk, dried buttermilk; and
    (v) Malted milk; or
    (5) Emulsifying agents, used singly or in combination, the total 
amount of which does not exceed 1.0 percent by weight.
    (c) Nomenclature. The name of the food is ``sweet chocolate'', 
``sweet chocolate coating'', ``semisweet chocolate'', ``semisweet 
chocolate coating'', ``bittersweet chocolate'', or ``bittersweet 
chocolate coating'', as appropriate.
    (1) When optional alkalizing ingredients are used in the preparation 
of the chocolate liquor or the cacao nibs from which the chocolate was 
prepared, the label shall bear the statement ``Processed with alkali'', 
or ``Processed with ___'', the blank being filled in with the common or 
usual name of the specific alkali ingredient used in the food.
    (2) When optional neutralizing agents are used in the preparation of 
the chocolate liquor or the cacao nibs from which the chocolate was 
prepared, the label shall bear the statement ``Processed with 
neutralizing agents'', or ``Processed with ___'', the blank being filled 
in with the common or usual name of the specific neutralizing agent used 
in the food.
    (3) When one or more of the spices, flavorings, or seasonings 
specified in paragraph (b)(3) of this section are used in the breakfast 
cocoa, the label shall bear an appropriate statement, e.g., ``Spice 
added'', ``Flavored with ___'', or ``With ___ added'', the blank being 
filled in with the common or usual name of the spice, flavoring, or 
seasoning used, in accordance with Sec. 101.22 of this chapter.
    (4) When two or more of the statements set forth in this paragraph 
are required, such statements may be combined in a manner that is 
appropriate, but not misleading.
    (5) Whenever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statements prescribed in this paragraph showing optional 
ingredients used shall precede or follow such name without intervening 
printed or graphic matter.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.



Sec. 163.124  White chocolate.

    (a) Description. (1) White chocolate is the solid or semiplastic 
food prepared by intimately mixing and grinding cacao fat with one or 
more of the optional dairy ingredients specified in paragraph (b)(2) of 
this section and one or more optional nutritive carbohydrate sweeteners 
and may contain one or more of the other optional ingredients specified 
in paragraph (b) of this section. White chocolate shall be free of 
coloring material.
    (2) White chocolate contains not less than 20 percent by weight of 
cacao fat as calculated by subtracting from the weight of the total fat 
the weight of the milkfat, dividing the result by the weight of the 
finished white chocolate, and multiplying the quotient by 100. The 
finished white chocolate contains not less than 3.5 percent by weight of 
milkfat and not less than 14 percent by weight of total milk solids, 
calculated by using only those dairy ingredients specified in paragraph 
(b)(2) of this section, and not more than 55 percent by weight nutritive 
carbohydrate sweetener.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Nutritive carbohydrate sweeteners;
    (2) Dairy ingredients:

[[Page 698]]

    (i) Cream, milkfat, butter;
    (ii) Milk, dry whole milk, concentrated milk, evaporated milk, 
sweetened condensed milk;
    (iii) Skim milk, concentrated skim milk, evaporated skim milk, 
sweetened condensed skim milk, nonfat dry milk;
    (iv) Concentrated buttermilk, dried buttermilk; and
    (v) Malted milk;
    (3) Emulsifying agents, used singly or in combination, the total 
amount of which does not exceed 1.5 percent by weight;
    (4) Spices, natural and artificial flavorings, ground whole nut 
meats, ground coffee, dried malted cereal extract, salt, and other 
seasonings that do not either singly or in combination impart a flavor 
that imitates the flavor of chocolate, milk, or butter;
    (5) Antioxidants; and
    (6) Whey or whey products, the total amount of which does not exceed 
5 percent by weight.
    (c) Nomenclature. The name of the food is ``white chocolate'' or 
``white chocolate coating.'' When one or more of the spices, flavorings, 
or seasonings specified in paragraph (b)(4) of this section are used, 
the label shall bear an appropriate statement, e.g., ``Spice added'', 
``Flavored with ___ '', or ``With ___ added'', the blank being filled in 
with the common or usual name of the spice, flavoring, or seasoning 
used, in accordance with Sec. 101.22 of this chapter.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[67 FR 62177, Oct. 4, 2002]



Sec. 163.130  Milk chocolate.

    (a) Description. (1) Milk chocolate is the solid or semiplastic food 
prepared by intimately mixing and grinding chocolate liquor with one or 
more of the optional dairy ingredients and one or more optional 
nutritive carbohydrate sweeteners, and may contain one or more of the 
other optional ingredients specified in paragraph (b) of this section.
    (2) Milk chocolate contains not less than 10 percent by weight of 
chocolate liquor complying with the requirements of Sec. 163.111 as 
calculated by subtracting from the weight of the chocolate liquor used 
the weight of cacao fat therein and the weights of alkali, neutralizing 
and seasoning ingredients, multiplying the remainder by 2.2, dividing 
the result by the weight of the finished milk chocolate, and multiplying 
the quotient by 100. The finished milk chocolate contains not less than 
3.39 percent by weight of milkfat and not less than 12 percent by weight 
of total milk solids based on those dairy ingredients specified in 
paragraph (b)(4) of this section, exclusive of any added sweetener or 
other dairy-derived ingredient that is added beyond that amount that is 
normally present in the specified dairy ingredient.
    (b) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Cacao fat;
    (2) Nutritive carbohydrate sweeteners;
    (3) Spices, natural and artificial flavorings, ground whole nut 
meats, ground coffee, dried malted cereal extract, salt, and other 
seasonings that do not either singly or in combination impart a flavor 
that imitates the flavor of chocolate, milk, or butter;
    (4) Dairy ingredients:
    (i) Cream, milkfat, butter;
    (ii) Milk, concentrated milk, evaporated milk, sweetened condensed 
milk, dried milk; and
    (iii) Skim milk, concentrated skim milk, evaporated skim milk, 
sweetened condensed skim milk, nonfat dry milk; or
    (5) Emulsifying agents, used singly or in combination, the total 
amount of which does not exceed 1.0 percent by weight.
    (c) Nomenclature. The name of the food is ``milk chocolate'' or 
``milk chocolate coating''.
    (1) When optional alkali ingredients are used in the preparation of 
the chocolate liquor or the cacao nibs from which the milk chocolate was 
prepared, the label shall bear the statement ``Processed with alkali'', 
or ``Processed with ___'', the blank being filled in with the common or 
usual name of the specific alkali ingredient used in the food.

[[Page 699]]

    (2) When optional neutralizing agents are used in the preparation of 
the chocolate liquor or the cacao nibs from which the milk chocolate was 
prepared, the label shall bear the statement ``Processed with 
neutralizing agents'', or ``Processed with ___'', the blank being filled 
in with the common or usual name of the specific neutralizing agent used 
in the food.
    (3) When one or more of the spices, flavorings, or seasonings 
specified in paragraph (b)(3) of this section are used in the breakfast 
cocoa, the label shall bear an appropriate statement, e.g., ``Spice 
added'', ``Flavored with ___'', or ``With ___ added'', the blank being 
filled in with the common or usual name of the spice, flavoring, or 
seasoning used, in accordance with Sec. 101.22 of this chapter.
    (4) When two or more of the statements set forth in this paragraph 
are required, such statements may be combined in a manner that is 
appropriate, but not misleading.
    (5) Whenever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the statements prescribed in this paragraph showing optional 
ingredients used shall precede or follow such name without intervening 
printed or graphic matter.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.



Sec. 163.135  Buttermilk chocolate.

    (a) Description. Buttermilk chocolate is the food that conforms to 
the standard of identity, and is subject to the requirements for label 
declaration of ingredients for milk chocolate in Sec. 163.130, except 
that:
    (1) The optional dairy ingredients are limited to sweet cream 
buttermilk, concentrated sweet cream buttermilk, dried sweet cream 
buttermilk, and any combination of these; and
    (2) The finished buttermilk chocolate contains less than 3.39 
percent by weight of milkfat and not less than 12 percent by weight of 
sweet cream buttermilk solids based on those dairy ingredients specified 
in paragraph (a)(1) of this section, exclusive of any added sweetener or 
other dairy-derived ingredient that is added beyond that amount that is 
normally present in the specified dairy ingredient.
    (b) Nomenclature. The name of the food is ``buttermilk chocolate'', 
``buttermilk chocolate coating'', ``sweet buttermilk chocolate'', 
``sweet buttermilk chocolate coating'', ``sweet cream buttermilk 
chocolate'', or ``sweet cream buttermilk chocolate coating''.



Sec. 163.140  Skim milk chocolate.

    (a) Description. Skim milk chocolate is the food that conforms to 
the standard of identity, and is subject to the requirements for label 
declaration of ingredients for milk chocolate in Sec. 163.130, except 
that:
    (1) The optional dairy ingredients are limited to skim milk, 
evaporated skim milk, concentrated skim milk, sweetened condensed skim 
milk, nonfat dry milk, and any combination of these; and
    (2) The finished skim milk chocolate contains less than 3.39 percent 
by weight of milkfat and not less than 12 percent by weight of skim milk 
solids based on those dairy ingredients specified in paragraph (a)(1) of 
this section, exclusive of any added sweetener or other dairy-derived 
ingredient that is added beyond that amount that is normally present in 
the specified dairy ingredient.
    (b) Nomenclature. The name of the food is ``skim milk chocolate'', 
``skim milk chocolate coating'', ``sweet skim milk chocolate'', or 
``sweet skim milk chocolate coating''.



Sec. 163.145  Mixed dairy product chocolates.

    (a) Description. Mixed dairy product chocolates are the foods that 
conform to the standard of identity, and are subject to the requirements 
for label declaration of ingredients for milk chocolate in Sec. 
163.130, except that:
    (1) The optional dairy ingredients for each of the foods are 
mixtures of two or more of the following:
    (i) Any dairy ingredients specified in Sec. 163.130;
    (ii) Any dairy ingredients specified in Sec. 163.135;
    (iii) Any dairy ingredients specified in Sec. 163.140; or

[[Page 700]]

    (iv) Malted milk; and
    (2) The finished mixed dairy product chocolates shall contain not 
less than 12 percent by weight of total milk solids derived from those 
dairy products referred to in paragraph (a)(1) of this section, 
exclusive of any added sweetener or other dairy-derived ingredient that 
is added beyond that amount that is normally present in the specified 
dairy product, and may contain less than 3.39 percent by weight of 
milkfat. The quantity of each component used in any such mixture is such 
that no component contributes less than one third of the weight of the 
total milk solids contributed by that component which is used in the 
largest proportion.
    (b) Nomenclature. The name of the food is ``chocolate'', or 
``chocolate coating'', preceded by the designation of the type of milk 
ingredients used as prescribed in paragraph (a) of this section in order 
of predominance by weight, e.g., ``milk and skim milk chocolate''.



Sec. 163.150  Sweet cocoa and vegetable fat coating.

    (a) Description. Sweet cocoa and vegetable fat coating is the food 
that conforms to the definition and standard of identity, and is subject 
to the requirements for label declaration of ingredients for sweet 
chocolate in Sec. 163.123, except that:
    (1) In the preparation of the product, cocoa or a mixture of cocoa 
and chocolate liquor is used in such quantity that the finished food 
contains not less than 6.8 percent by weight of nonfat cacao solids, 
calculated on a moisture-free basis;
    (2) One or more optional ingredients specified in paragraph (b) of 
this section are used; and
    (3) The requirement in Sec. 163.123(a)(2) limiting the total milk 
solids content to less than 12 percent by weight does not apply.
    (b) Optional ingredients. (1) Breakfast cocoa, cocoa, lowfat cocoa;
    (2) Chocolate liquor;
    (3) Safe and suitable vegetable derived fats, oils, and stearins 
other than cacao fat. The fats, oils, and stearins may be hydrogenated;
    (4) Safe and suitable dairy-derived ingredients; and
    (5) Safe and suitable bulking agents, formulation aids, humectants, 
and texturizers.
    (c) Nomenclature. The name of the food is ``sweet cocoa and 
vegetable fat coating''. Alternatively, the common or usual name of the 
vegetable derived fat ingredient may be used in the name of the food, 
e.g., ``sweet cocoa and ___ oil coating'', the blank being filled in 
with the common or usual name of the specific vegetable fat used.



Sec. 163.153  Sweet chocolate and vegetable fat coating.

    (a) Description. Sweet chocolate and vegetable fat coating is the 
food that conforms to the definition and standard of identity, and is 
subject to the requirements for label declaration of ingredients for 
sweet chocolate in Sec. 163.123, except that one or more optional 
ingredients specified in paragraph (b) of this section are used. 
Compliance with the requirement in Sec. 163.123(a)(2) limiting the 
total milk solids content to less than 12 percent by weight shall be 
calculated by including only those dairy ingredients referred to in 
Sec. 163.123(b)(4), exclusive of any added sweetener or other dairy-
derived ingredient that is added beyond that amount that is normally 
present in the specified dairy ingredient.
    (b) Optional ingredients. (1) Safe and suitable vegetable derived 
fats, oils, and stearins other than cacao fat. The fats, oils, and 
stearins may be hydrogenated;
    (2) Safe and suitable dairy-derived ingredients; and
    (3) Safe and suitable bulking agents, formulation aids, humectants, 
and texturizers.
    (c) Nomenclature. The name of the food is ``sweet chocolate and 
vegetable fat coating''. Alternatively, the common or usual name of the 
vegetable derived fat ingredient may be used in the name of the food, 
e.g., ``sweet chocolate and ___ oil coating'', the blank being filled in 
with the common or usual name of the specific vegetable fat used.



Sec. 163.155  Milk chocolate and vegetable fat coating.

    (a) Description. Milk chocolate and vegetable fat coating is the 
food that

[[Page 701]]

conforms to the standard of identity, and is subject to the requirements 
for label declaration of ingredients for milk chocolate in Sec. 163.130 
or skim milk chocolate in Sec. 163.140, except that one or more 
optional ingredients specified in paragraph (b) of this section are 
used. Compliance with the requirement in Sec. 163.130(a)(2) that the 
product contains not less than 12 percent by weight of nonfat milk 
solids shall be calculated using only those dairy ingredients referred 
to in Sec. 163.130(b)(4), exclusive of any added sweetener or other 
dairy-derived ingredient that is added beyond that amount that is 
normally present in the specified dairy ingredient.
    (b) Optional ingredients. (1) Safe and suitable vegetable derived 
oils, fats, and stearins other than cacao fat. The oils, fats, and 
stearins may be hydrogenated;
    (2) Safe and suitable dairy-derived ingredients; and
    (3) Safe and suitable bulking agents, formulation aids, humectants, 
and texturizers.
    (c) Nomenclature. The name of the food is ``milk chocolate and 
vegetable fat coating'' or ``skim milk chocolate and vegetable fat 
coating'', as appropriate. Alternatively, the common or usual name of 
the vegetable derived fat ingredient may be used in the name of the 
food, e.g., ``milk chocolate and ___ oil coating'', the blank being 
filled in with the common or usual name of the specific vegetable fat 
used.



PART 164_TREE NUT AND PEANUT PRODUCTS--Table of Contents



Subpart A [Reserved]

  Subpart B_Requirements for Specific Standardized Tree Nut and Peanut 
                                Products

Sec.
164.110 Mixed nuts.
164.120 Shelled nuts in rigid or semirigid containers.
164.150 Peanut butter.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14475, Mar. 15, 1977, unless otherwise noted.

Subpart A [Reserved]



  Subpart B_Requirements for Specific Standardized Tree Nut and Peanut 
                                Products



Sec. 164.110  Mixed nuts.

    (a) Mixed nuts is the food consisting of a mixture of four or more 
of the optional shelled tree nut ingredients, with or without one or 
more of the optional shelled peanut ingredients, of the kinds prescribed 
by paragraph (b) of this section; except that when 2 ounces or less of 
the food is packed in transparent containers, three or more of the 
optional tree nut ingredients shall be present. Each such kind of nut 
ingredient when used shall be present in a quantity not less than 2 
percent and not more than 80 percent by weight of the finished food. For 
purposes of this section, each kind of tree nut and peanut is an 
optional ingredient that may be prepared by any suitable method in 
accordance with good manufacturing practice. The finished food may 
contain one or more of the optional nonnut ingredients provided for in 
paragraph (c) of this section.
    (b) The optional shelled nut ingredients referred to in paragraph 
(a) of this section are:
    (1) Almonds, black walnuts, Brazil nuts, cashews, English walnuts 
(alternatively ``walnuts''), filberts, pecans, and other suitable kinds 
of tree nuts.
    (2) Peanuts of the Spanish, Valencia, Virginia, or similar 
varieties, or any combination of two or more such varieties.
    (c) The optional nonnut ingredients referred to in paragraph (a) of 
this section consist of suitable substances that are not food additives 
as defined in section 201(s) of the Federal Food, Drug, and Cosmetic 
Act; or if they are food additives as so defined, they are used in 
conformity with regulations established pursuant to section 409 of the 
act. Nonnut ingredients that perform a useful function are regarded as 
suitable, except that color additives are not suitable ingredients of 
the food.
    (d) The name of the food is ``mixed nuts''. If the percentage of a 
single tree

[[Page 702]]

nut ingredient or the total peanut content by weight of the finished 
food exceeds 50 percent but not 60 percent, the statement ``contains up 
to 60% ___'' or ``contains 60% ___'' or ``60% ___'' shall immediately 
follow the name ``mixed nuts'' and shall appear on the same background, 
be of the same color or, in the case of multicolors, in the color 
showing distinct contrast with the background, and be in letters not 
less than one-half the height of the largest letter in the words ``mixed 
nuts''. The blank is to be filled in with the appropriate name of the 
predominant nut ingredient; for example, ``contains up to 60% pecans'' 
or ``contains up to 60% Spanish peanuts''. The numbers ``70'' or ``80'' 
shall be substituted for the number ``60'' when the percentage of the 
predominant nut ingredient exceeds 60 but not 70, or exceeds 70 but not 
80, respectively. Compliance with the requirements for percentage of nut 
ingredients of this section and the fill of container requirements of 
Sec. 164.120(c) will be determined by the following procedure:
    (1) Take at random from a lot, in the case of containers bearing a 
weight declaration of 16 ounces or less, at least 24 containers, and for 
containers bearing a weight declaration of more than 16 ounces, enough 
containers to provide a total quantity of at least 24 pounds of nuts.
    (2) If compliance with Sec. 164.120(c) is to be determined, first 
follow the procedure set forth therein.
    (3) Determine the percent by weight of each nut ingredient present 
in each container separately. Calculate the average percentage of each 
nut ingredient present. If the average percent found for each nut 
ingredient present is 2 percent or more and none of the individual nut 
ingredients exceeds 80 percent by weight of the finished food, the lot 
will be deemed to be in compliance with the percentage requirements of 
paragraph (a) of this section. If the average percent found for a single 
nut ingredient exceeds 50 percent by weight of the finished food and the 
average percent found is within the range indicated by the number 
declared on the label in accordance with this paragraph, the lot will be 
deemed to be in compliance with the labeling requirements of this 
paragraph.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter, except that:
    (1) If the Spanish variety of peanuts is used, it shall be declared 
as ``Spanish peanuts''. Other varieties of peanuts shall be declared as 
``peanuts'', or alternatively ``___ peanuts'', the blank being filled in 
with the varietal name of the peanuts used.
    (2) If the peanut ingredient or ingredients as provided for in 
paragraph (b)(2) of this section are unblanched, the label shall show 
that fact by such statement as ``Peanuts unblanched'', ``Peanuts skins 
on'', or words of similar import, unless the vignette clearly depicts 
peanuts with skins on.
    (f) The words and statements specified in paragraph (e) of this 
section showing the ingredients present shall be listed on the principal 
display panel or panels or any appropriate information panel without 
obscuring design, vignettes, or crowding. The declaration shall appear 
in conspicuous and easily legible letters of boldface print or type the 
size of which shall be not less than one-half of that required by part 
101 of this chapter for the statement of net quantity of contents 
appearing on the label, but in no case less than one-sixteenth of an 
inch in height. The entire ingredient statement shall appear on at least 
one panel of the label. If the label bears any pictorial representation 
of the mixture of nuts, it shall depict the relative proportions of the 
nut ingredients of the food. If the label bears a pictorial 
representation of only one of each nut ingredient present, the nuts 
shall be depicted in the order of decreasing predominance by weight. A 
factual statement that the food does not contain a particular nut 
ingredient or ingredients may be shown on the label if the statement is 
not misleading and does not result in an insufficiency of label space 
for the proper declaration of information required by or under authority 
of the act to appear on the label.

[42 FR 14475, Mar. 15, 1977, as amended at 58 FR 2885, Jan. 6, 1993]

[[Page 703]]



Sec. 164.120  Shelled nuts in rigid or semirigid containers.

    (a)-(b) [Reserved]
    (c) Fill of container. (1) The standard of fill for shelled nuts in 
rigid or semirigid containers is a fill such that the average volume of 
nuts, from the number of containers specified in Sec. 164.110(d)(1), is 
not less than 85 percent of the container volume as determined by the 
method in paragraph (c)(2) of this section.
    (2) The method for determining the percent of fill is as follows:
    (i) For the shelled nuts in each container, determine the loose 
volume, the settled volume, and the average volume in cubic centimeters. 
For the purposes of this subparagraph, consider volume in milliliters to 
be numerically equal to volume in cubic centimeters. Open the container 
and pour the nuts loosely into a vertical graduated cylinder (do not 
tilt) of appropriate size fitted with a funnel which has been modified, 
if necessary, to provide a minimum opening of 1\1/2\-inch diameter. (If 
the loose volume of the nuts is less than 500 milliliters, use a 500-
milliliter cylinder with an inside diameter of approximately 1\7/8\ 
inches; but if the loose volume is 500 milliliters or more, use a 1,000-
milliliter cylinder with an inside diameter of approximately 2\1/4\ 
inches.) Without shaking the cylinder, estimate the location of a 
horizontal plane representing the average height of the product, read 
the volume of the nuts, and record as the loose volume. Raise the 
cylinder 2 inches and allow it a free vertical drop onto a level, firm, 
but resilient surface (do not tamp) for a total of 5 times and observe 
the volume as above. Repeat in successive five-drop increments until the 
nuts have so settled that the volume decreases less than 2 percent in 
the last five-drop increment. Read the last volume in the manner 
described above and record as the settled volume. The arithmetical 
average of the loose volume and the settled volume equals the average 
volume of nuts.
    (ii) Classify the container by shape and determine its volume in 
cubic centimeters according to one of the following methods as 
appropriate:
    (a) For containers of irregular shape, including glass jars, follow 
the general method for water capacity of containers as prescribed in 
Sec. 130.12(a) of this chapter and determine the container volume, 
considering the water capacity in grams to be numerically equivalent to 
volume in cubic centimeters, or the water capacity in ounces 
(avoirdupois) to be equivalent to 28.35 cubic centimeters per ounce.
    (b) For box-shaped containers (that is, with opposite sides 
parallel), measure the inside height, width, and depth and calculate the 
volume as the product of these three dimensions. For such containers 
used to enclose vacuum packs and containing 4 ounces or less of the 
product, consider the height to be the inside height minus three-eighths 
inch.
    (c) For cylindrical containers, calculate the container volume in 
cubic centimeters as the product of the height times the square of the 
diameter, both measured in inches, times 12.87; or as the product of the 
height times the square of the diameter, both measured in centimeters, 
times 0.7854. For containers that do not have indented ends, use the 
inside height and inside diameter as the dimensions. For metal cans with 
indented ends (that is, metal cans with ends attached by double seams), 
consider the height to be the outside height at the double seam minus 
three-eighths inch (0.953 centimeter) and the diameter to be the outside 
diameter at the double seam minus one-eighth inch (0.318 centimeter). 
For fiber-bodied containers with indented ends (that is, fiber-bodied 
cans with metal ends attached by double seams), consider the height to 
be the outside height at the double seam minus three-eighths inch (0.953 
centimeter) and the diameter to be the outside diameter at the double 
seam minus three-sixteenths inch (0.476 centimeter).
    (iii) Calculate the percent fill of the container as follows: Divide 
the average volume of nuts found according to paragraph (c)(2)(i) of 
this section by the appropriate container volume found according to 
paragraph (c)(2)(ii) of this section and multiply by 100. The result 
shall be considered to be the percent fill of the container.
    (3) If shelled nuts fall below the standard of fill of container 
prescribed

[[Page 704]]

in paragraph (c)(1) of this section, the label shall bear the general 
statement of substandard fill specified in Sec. 130.14(b) of this 
chapter, in the manner and form therein specified.



Sec. 164.150  Peanut butter.

    (a) Peanut butter is the food prepared by grinding one of the 
shelled and roasted peanut ingredients provided for by paragraph (b) of 
this section, to which may be added safe and suitable seasoning and 
stabilizing ingredients provided for by paragraph (c) of this section, 
but such seasoning and stabilizing ingredients do not in the aggregate 
exceed 10 percent of the weight of the finished food. To the ground 
peanuts, cut or chopped, shelled, and roasted peanuts may be added. 
During processing, the oil content of the peanut ingredient may be 
adjusted by the addition or subtraction of peanut oil. The fat content 
of the finished food shall not exceed 55 percent when determined as 
prescribed in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), section 27.006(a) under 
``Crude Fat--Official First Action, Direct Method,'' in paragraph (a), 
which is incorporated by reference. Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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 peanut ingredients referred to in paragraph (a) of this 
section are:
    (1) Blanched peanuts, in which the germ may or may not be included.
    (2) Unblanched peanuts, including the skins and germ.
    (c) The seasoning and stabilizing ingredients referred to in 
paragraph (a) of this section are suitable substances which are not food 
additives as defined in section 201(s) of the Federal Food, Drug, and 
Cosmetic Act (the act), or if they are food additives as so defined, 
they are used in conformity with regulations established pursuant to 
section 409 of the act. Seasoning and stabilizing ingredients that 
perform a useful function are regarded as suitable, except that 
artificial flavorings, artificial sweeteners, chemical preservatives, 
and color additives are not suitable ingredients in peanut butter. Oil 
products used as optional stabilizing ingredients shall be hydrogenated 
vegetable oils. For the purposes of this section, hydrogenated vegetable 
oil shall be considered to include partially hydrogenated vegetable oil.
    (d) If peanut butter is prepared from unblanched peanuts as 
specified in paragraph (b)(2) of this section, the name shall show that 
fact by some such statement as ``prepared from unblanched peanuts (skins 
left on).'' Such statement shall appear prominently and conspicuously 
and shall be in type of the same style and not less than half of the 
point size of that used for the words ``peanut butter.'' This statement 
shall immediately precede or follow the words ``peanut butter,'' without 
intervening written, printed, or graphic matter.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14475, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 
49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 58 FR 2886, Jan. 
6, 1993; 61 FR 9325, Mar. 8, 1996; 63 FR 14035, Mar. 24, 1998]



PART 165_BEVERAGES--Table of Contents



                      Subpart A_General Provisions

Sec.
165.3 Definitions.

       Subpart B_Requirements for Specific Standardized Beverages

165.110 Bottled water.

    Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.

    Source: 60 FR 57124, Nov. 13, 1995, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 165.3  Definitions.

    (a) A lot is:

[[Page 705]]

    (1) For purposes of determining quality factors related to 
manufacture, processing, or packing, a collection of primary containers 
or units of the same size, type, and style produced under conditions as 
nearly uniform as possible and usually designated by a common container 
code or marking, or in the absence of any common container code or 
marking, a day's production.
    (2) For purposes of determining quality factors related to 
distribution and storage, a collection of primary containers or units 
transported, stored, or held under conditions as nearly uniform as 
possible.
    (b) A sample consists of 10 subsamples (consumer units), one taken 
from each of 10 different randomly chosen shipping cases to be 
representative of a given lot, unless otherwise specified in a specific 
standard in this part.
    (c) An analytical unit is the portion(s) of food taken from a 
subsample of a sample for the purpose of analysis.



       Subpart B_Requirements for Specific Standardized Beverages



Sec. 165.110  Bottled water.

    (a) Identity--(1) Description. Bottled water is water that is 
intended for human consumption and that is sealed in bottles or other 
containers with no added ingredients except that it may optionally 
contain safe and suitable antimicrobial agents. Fluoride may be 
optionally added within the limitations established in Sec. 
165.110(b)(4)(ii). Bottled water may be used as an ingredient in 
beverages (e.g., diluted juices, flavored bottled waters). It does not 
include those food ingredients that are declared in ingredient labeling 
as ``water,'' ``carbonated water,'' ``disinfected water,'' ``filtered 
water,'' ``seltzer water,'' ``soda water,'' ``sparkling water,'' and 
``tonic water.'' The processing and bottling of bottled water shall 
comply with applicable regulations in part 129 of this chapter.
    (2) Nomenclature. The name of the food is ``bottled water,'' 
``drinking water,'' or alternatively one or more of the following terms 
as appropriate:
    (i) The name of water from a well tapping a confined aquifer in 
which the water level stands at some height above the top of the aquifer 
is ``artesian water'' or ``artesian well water.'' Artesian water may be 
collected with the assistance of external force to enhance the natural 
underground pressure. On request, plants shall demonstrate to 
appropriate regulatory officials that the water level stands at some 
height above the top of the aquifer.
    (ii) The name of water from a subsurface saturated zone that is 
under a pressure equal to or greater than atmospheric pressure is 
``ground water.'' Ground water must not be under the direct influence of 
surface water as defined in 40 CFR 141.2.
    (iii) The name of water containing not less than 250 parts per 
million (ppm) total dissolved solids (TDS), coming from a source tapped 
at one or more bore holes or springs, originating from a geologically 
and physically protected underground water source, may be ``mineral 
water.'' Mineral water shall be distinguished from other types of water 
by its constant level and relative proportions of minerals and trace 
elements at the point of emergence from the source, due account being 
taken of the cycles of natural fluctuations. No minerals may be added to 
this water.
    (iv) The name of water that has been produced by distillation, 
deionization, reverse osmosis, or other suitable processes and that 
meets the definition of ``purified water'' in the United States 
Pharmacopeia, 23d Revision, January 1, 1995, which is incorporated by 
reference in accordance with 5 U.S.C. 551(a) and 1 CFR part 51. (Copies 
may be obtained from the United States Pharmacopial Convention, Inc., 
12601 Twinbrook Pkwy., Rockville, MD 20852 and may be examined at the 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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.), may be ``purified water'' or ``demineralized 
water.'' Alternatively, the water may be called

[[Page 706]]

``deionized water'' if the water has been processed by deionization, 
``distilled water'' if it is produced by distillation, ``reverse osmosis 
water'' if the water has been processed by reverse osmosis, and ``___ 
drinking water'' with the blank being filled in with one of the defined 
terms describing the water in this paragraph (e.g., ``purified drinking 
water'' or ``deionized drinking water'').
    (v) The name of water that, after treatment and possible replacement 
of carbon dioxide, contains the same amount of carbon dioxide from the 
source that it had at emergence from the source may be ``sparkling 
bottled water.''
    (vi) The name of water derived from an underground formation from 
which water flows naturally to the surface of the earth may be ``spring 
water.'' Spring water shall be collected only at the spring or through a 
bore hole tapping the underground formation feeding the spring. There 
shall be a natural force causing the water to flow to the surface 
through a natural orifice. The location of the spring shall be 
identified. Spring water collected with the use of an external force 
shall be from the same underground stratum as the spring, as shown by a 
measurable hydraulic connection using a hydrogeologically valid method 
between the bore hole and the natural spring, and shall have all the 
physical properties, before treatment, and be of the same composition 
and quality, as the water that flows naturally to the surface of the 
earth. If spring water is collected with the use of an external force, 
water must continue to flow naturally to the surface of the earth 
through the spring's natural orifice. Plants shall demonstrate, on 
request, to appropriate regulatory officials, using a hydrogeologically 
valid method, that an appropriate hydraulic connection exists between 
the natural orifice of the spring and the bore hole.
    (vii) The name of water that meets the requirements under 
``Sterility Tests'' <71in the United States Pharmacopeia, 23d 
Revision, January 1, 1995, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR 51. (Copies may be obtained 
from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook 
Pkwy., Rockville, MD 20852 and may be examined at the Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039, 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.), may be ``sterile water.'' Alternatively, the water 
may be called ``sterilized water.''
    (viii) The name of water from a hole bored, drilled, or otherwise 
constructed in the ground which taps the water of an aquifer may be 
``well water.''
    (3) Other label statements. (i) If the TDS content of mineral water 
is below 500 ppm, or if it is greater than 1,500 ppm, the statement 
``low mineral content'' or the statement ``high mineral content'', 
respectively, shall appear on the principal display panel following the 
statement of identity in type size at least one-half the size of the 
statement of identity but in no case of less than one-sixteenth of an 
inch. If the TDS of mineral water is between 500 and 1,500 ppm, no 
additional statement need appear.
    (ii) When bottled water comes from a community water system, as 
defined in 40 CFR 141.2, except when it has been treated to meet the 
definitions in paragraphs (a)(2)(iv) and (a)(2)(vii) of this section and 
is labeled as such, the label shall state ``from a community water 
system'' or, alternatively, ``from a municipal source'' as appropriate, 
on the principal display panel or panels. This statement shall 
immediately and conspicuously precede or follow the name of the food 
without intervening written, printed, or graphic matter, other than 
statements required by paragraph (c) of this section, in type size at 
least one-half the size of the statement of identity but in no case of 
less than one-sixteenth of an inch.
    (iii) When the label or labeling of a bottled water product states 
or implies (e.g., through label statements or vignettes with references 
to infants) that the bottled water is for use in feeding infants, and 
the product is not commercially sterile under Sec. 113.3(e)(3)(i) of 
this chapter, the product's label shall

[[Page 707]]

bear conspicuously and on the principal display panel the statement 
``Not sterile. Use as directed by physician or by labeling directions 
for use of infant formula.''
    (4) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (b) Quality. The standard of quality for bottled water, including 
water for use as an ingredient in beverages (except those described in 
the labeling as ``water,'' ``carbonated water,'' ``disinfected water,'' 
``filtered water,'' ``seltzer water,'' ``soda water,'' ``sparkling 
water,'' and ``tonic water''), is as follows:
    (1) Definitions. (i) Trihalomethane (THM) means one of the family of 
organic compounds, named as derivatives of methane, wherein three of the 
four hydrogen atoms in methane are each substituted by a halogen atom in 
the molecular structure.
    (ii) Total trihalomethanes (TTHM) means the sum of the concentration 
in milligrams per liter of the trihalomethane compounds 
(trichloromethane, dibromochloromethane, bromodichloromethane, and 
tribromomethane), rounded to two significant figures.
    (iii) Haloacetic acids (five) (HAA5) means the sum of the 
concentrations in milligrams per liter of the haloacetic acid compounds 
(monochloroacetic acid, dichloroacetic acid, trichloroacetic acid, 
monobromoacetic acid, and dibromoacetic acid), rounded to two 
significant figures after addition.
    (2) Microbiological quality. (i) Bottled water shall, when a sample 
consisting of analytical units of equal volume is examined by the 
methods described in paragraph (b)(2)(ii) of this section, meet the 
following standards of microbiological quality:
    (A) Total coliform--(1) Multiple-tube fermentation (MTF) method. Not 
more than one of the analytical units in the sample shall have a most 
probable number (MPN) of 2.2 or more coliform organisms per 100 
milliliters and no analytical unit shall have an MPN of 9.2 or more 
coliform organisms per 100 milliliters; or
    (2) Membrane filter (MF) method. Not more than one of the analytical 
units in the sample shall have 4.0 or more coliform organisms per 100 
milliliters and the arithmetic mean of the coliform density of the 
sample shall not exceed one coliform organism per 100 milliliters.
    (B) E. coli. If E. coli is present, then the bottled water will be 
deemed adulterated under paragraph (d) of this section.
    (ii) Analyses conducted to determine compliance with paragraphs 
(b)(2)(i)(A) and (b)(2)(i)(B) of this section and Sec. 129.35(a)(3)(i) 
of this chapter shall be made in accordance with the multiple-tube 
fermentation (MTF) or the membrane filter (MF) methods described in the 
applicable sections of ``Standard Methods for the Examination of Water 
and Wastewater,'' 21st Ed. (2005), American Public Health Association. 
The Director of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may 
obtain a copy from the American Public Health Association, 800 I St. 
NW., Washington, DC 20001, 202-777-2742 (APHA). You may inspect a copy 
at the Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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) Physical quality. Bottled water shall, when a composite of 
analytical units of equal volume from a sample is examined by the method 
described in applicable sections of ``Standard Methods for the 
Examination of Water and Wastewater,'' 15th Ed. (1980), American Public 
Health Association, which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 (copies may be obtained from the 
American Public Health Association, 800 I St. NW., Washington, DC 20001, 
202-777-2742 (APHA), or a copy may be examined at the National Archives 
and Records Administration (NARA), or at the Food and Drug 
Administration's

[[Page 708]]

Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver 
Spring, MD 20993, 301-796-2039, 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), meet the following standards of physical quality:
    (i) The turbidity shall not exceed 5 units.
    (ii) The color shall not exceed 15 units. \1\
---------------------------------------------------------------------------

    \1\ Mineral water is exempt from allowable level. The exemptions are 
aesthetically based allowable levels and do not relate to a health 
concern.
---------------------------------------------------------------------------

    (iii) The odor shall not exceed threshold odor No. 3. \1\
    (4) Chemical quality. (i)(A) Bottled water shall, when a composite 
of analytical units of equal volume from a sample is examined by the 
methods described in paragraph (b)(4)(i)(B) of this section, meet 
standards of chemical quality and shall not contain chemical substances 
in excess of the following concentrations:

------------------------------------------------------------------------
                                                        Concentration in
                       Substance                         milligrams per
                                                              liter
------------------------------------------------------------------------
Chloride\1\...........................................          250.0
Iron\1\...............................................            0.3
Manganese\1\..........................................            0.05
Phenols...............................................            0.001
Total dissolved solids\1\.............................          500.0
Zinc \1\..............................................            5.0
------------------------------------------------------------------------
\1\ Mineral water is exempt from allowable level. The exemptions are
  aesthetically based allowable levels and do not relate to a health
  concern.

    (B) Analyses conducted to determine compliance with paragraph 
(b)(4)(i)(A) of this section shall be made in accordance with the 
methods described in the applicable sections of ``Standard Methods for 
the Examination of Water and Wastewater,'' 15th Ed. (1980), or ``Methods 
for Chemical Analysis of Water and Wastes,'' Environmental Monitoring 
and Support Laboratory (EMSL), EPA-600/4-79-020, March 1983, U.S. 
Environmental Protection Agency (EPA), both of which are incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
    (C) Analyses for organic substances shall be determined by the 
appropriate methods set forth below. The methods in paragraphs (b)(4)(i) 
(C)(1) and (C)(2) of this section are incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and are described in 
``Standard Methods for Examination of Water and Wastewater,'' 15th Ed. 
(1980). Copies may be obtained from the American Public Health 
Association, 800 I St. NW., Washington DC 20001, and examined at the 
National Archives and Records Administration (NARA) , or the Food and 
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, 
Third Floor, Silver Spring, MD 20993, 301-796-2039. 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. The methods in paragraphs (b)(4)(i)(C)(3) and (C)(4) 
are cross-referenced in 40 CFR part 141, subpart C, appendix C.
    (1) ``Methods for Organochlorine Pesticides in Industrial 
Effluents;''
    (2) ``Methods for Chlorinated Phenoxy Acid Herbicides in Industrial 
Effluents,'' November 28, 1973;
    (3) ``Part I: The Analysis of Trihalomethanes in Finished Waters by 
the Purge and Trap Method;'' which is cross-referenced in 40 CFR part 
141, subpart C, appendix C;
    (4) ``Part II: The Analysis of Trihalomethanes in Drinking Water by 
Liquid/Liquid Extraction,'' which is cross-referenced in 40 CFR part 
141, subpart C, appendix C;
    (ii)(A) Bottled water packaged in the United States to which no 
fluoride is added shall not contain fluoride in excess of the levels in 
Table 1 and these levels shall be based on the annual average of maximum 
daily air temperatures at the location where the bottled water is sold 
at retail.

                                 Table 1
------------------------------------------------------------------------
                                                            Fluoride
   Annual average of maximum daily air temperatures     concentration in
                       ([deg]F)                          milligrams per
                                                              liter
------------------------------------------------------------------------
53.7 and below........................................               2.4
53.8-58.3.............................................               2.2
58.4-63.8.............................................               2.0
63.9-70.6.............................................               1.8
70.7-79.2.............................................               1.6
79.3-90.5.............................................               1.4
------------------------------------------------------------------------

    (B) Imported bottled water to which no fluoride is added shall not 
contain

[[Page 709]]

fluoride in excess of 1.4 milligrams per liter.
    (C) Bottled water packaged in the United States to which fluoride is 
added shall not contain fluoride in excess of levels in Table 2 and 
these levels shall be based on the annual average of maximum daily air 
temperatures at the location where the bottled water is sold at retail.

                                 Table 2
------------------------------------------------------------------------
                                                            Fluoride
   Annual average of maximum daily air temperatures     concentration in
                       ([deg]F)                          milligrams per
                                                              liter
------------------------------------------------------------------------
53.7 and below........................................               1.7
53.8-58.3.............................................               1.5
58.4-63.8.............................................               1.3
63.9-70.6.............................................               1.2
70.7-79.2.............................................               1.0
79.3-90.5.............................................               0.8
------------------------------------------------------------------------

    (D) Imported bottled water to which fluoride is added shall not 
contain fluoride in excess of 0.8 milligram per liter.
    (iii) Having consulted with EPA as required by section 410 of the 
Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration 
has determined that bottled water, when a composite of analytical units 
of equal volume from a sample is examined by the methods listed in 
paragraphs (b)(4)(iii)(E) through (b)(4)(iii)(F), and (b)(4)(iii)(G) of 
this section, shall not contain the following chemical contaminants in 
excess of the concentrations specified in paragraphs (b)(4)(iii)(A) 
through (b)(4)(iii)(D) of this section.
    (A) The allowable levels for inorganic substances are as follows:

------------------------------------------------------------------------
                                                     Concentration in
                   Contaminant                     milligrams per liter
                                                     (or as specified)
------------------------------------------------------------------------
Arsenic.........................................                   0.010
Antimony........................................                    .006
Barium..........................................                   2
Beryllium.......................................                   0.004
Cadmium.........................................                   0.005
Chromium........................................                   0.1
Copper..........................................                   1.0
Cyanide.........................................                   0.2
Lead............................................                   0.005
Mercury.........................................                   0.002
Nickel..........................................                   0.1
Nitrate.........................................    10 (as nitrogen)
Nitrite.........................................     1 (as nitrogen)
Total Nitrate and Nitrite.......................    10 (as nitrogen)
Selenium........................................                   0.05
Thallium........................................                   0.002
------------------------------------------------------------------------

    (B) The allowable levels for volatile organic chemicals (VOC's) are 
as follows:

------------------------------------------------------------------------
                                                        Concentration in
              Contaminant (CAS Reg. No.)                 milligrams per
                                                             liter
------------------------------------------------------------------------
Benzene (71-43-2)....................................              0.005
Carbon tetrachloride (56-23-5).......................              0.005
o- Dichlorobenzene (95-50-1).........................              0.6
p- Dichlorobenzene (106-46-7)........................              0.075
1,2-Dichloroethane (107-06-2)........................              0.005
1,1-Dichloroethylene (75-35-4).......................              0.007
cis-1,2-Dichloroethylene (156-59-2)..................              0.07
trans-1,2-Dichloroethylene (156-60-5)................              0.1
Dichloromethane (75-09-2)............................              0.005
1,2-Dichloropropane (78-87-5)........................              0.005
Ethylbenzene (100-41-4)..............................              0.7
Monochlorobenzene (108-90-7).........................              0.1
Styrene (100-42-5)...................................              0.1
Tetrachloroethylene (127-18-4).......................              0.005
Toluene (108-88-3)...................................              1
1,2,4-Trichlorobenzene (120-82-1)....................              0.07
1,1,1-Trichloroethane (71-55-6)......................              0.20
1,1,2-Trichloroethane (79-00-5)......................              0.005
Trichloroethylene (79-01-6)..........................              0.005
Vinyl chloride (75-01-4).............................              0.002
Xylenes (1330-20-7)..................................             10
------------------------------------------------------------------------

    (C) The allowable levels for pesticides and other synthetic organic 
chemicals (SOC's) are as follows:

------------------------------------------------------------------------
                                                        Concentration in
              Contaminant (CAS Reg. No.)                 milligrams per
                                                              liter
------------------------------------------------------------------------
Alachlor (15972-60-8).................................           0.002
Atrazine (1912-24-9)..................................           0.003
Benzo(a)pyrene (50-32-8)..............................           0.0002
Carbofuran (1563-66-2)................................           0.04
Chlordane (57-74-9)...................................           0.002
Dalapon (75-99-0).....................................           0.2
1,2-Dibromo-3-chloropropane (96-12-8).................           0.0002
2,4-D (94-75-7).......................................           0.07
Di(2-ethylhexyl)adipate (103-23-1)....................           0.4
Di(2-ethylhexyl)phthalate (117-81-7)..................           0.006
Dinoseb (88-85-7).....................................           0.007
Diquat (85-00-7)......................................           0.02
Endothall (145-73-3)..................................           0.1
Endrin (72-20-8)......................................           0.002
Ethylene dibromide (106-93-4).........................           0.00005
Glyphosate (1071-53-6)................................           0.7
Heptachlor (76-44-8)..................................           0.0004
Heptachlor epoxide (1024-57-3)........................           0.0002
Hexachlorobenzene (118-74-4)..........................           0.001
Hexachlorocyclopentadiene (77-47-4)...................           0.05
Lindane (58-89-9).....................................           0.0002
Methoxychlor (72-43-5)................................           0.04
Oxamyl (23135-22-0)...................................           0.2
Pentachlorophenol (87-86-5)...........................           0.001
PCB's (as decachlorobiphenyl) (1336-36-3).............           0.0005
Picloram (1918-02-1)..................................           0.5
Simazine (122-34-9)...................................           0.004
2,3,7,8-TCDD (Dioxin) (1746-01-6).....................    3 x 10-8
Toxaphene (8001-35-2).................................           0.003
2,4,5-TP (Silvex) (93-72-1)...........................           0.05
------------------------------------------------------------------------

    (D) The allowable levels for certain chemicals for which EPA has 
established secondary maximum contaminant levels in its drinking water 
regulations (40 CFR part 143) are as follows:

[[Page 710]]



------------------------------------------------------------------------
                                                        Concentration in
                      Contaminant                        milligrams per
                                                              liter
------------------------------------------------------------------------
Aluminum..............................................               0.2
Silver................................................               0.1
Sulfate \1\...........................................             250.0
------------------------------------------------------------------------
\1\ Mineral water is exempt from allowable level. The exemptions are
  aesthetically based allowable levels and do not relate to a health
  concern.

    (E) Analyses to determine compliance with the requirements of 
paragraph (b)(4)(iii)(A) of this section shall be conducted in 
accordance with an applicable method and applicable revisions to the 
methods listed in paragraphs (b)(4)(iii)(E)(1) through 
(b)(4)(iii)(E)(14) of this section and described, unless otherwise 
noted, in ``Methods for Chemical Analysis of Water and Wastes,'' U.S. 
EPA Environmental Monitoring and Support Laboratory (EMSL), Cincinnati, 
OH 45258 (EPA-600/4-79-020), March 1983, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
of this publication are available from the National Technical 
Information Service (NTIS), U.S. Department of Commerce, 5825 Port Royal 
Rd., Springfield, VA 22161, or may be examined at the Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039, 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.
    (1) Antimony shall be measured using the following methods:
    (i) Method 204.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this 
publication are available from the National Technical Information 
Service, U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, 
VA 22161, or may be examined at the Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, 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.
    (iii) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 1.2, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method D-3697-92--``Standard Test Method for Antimony in 
Water,'' contained in the Annual Book of ASTM Standards, vols. 11.01 and 
11.02, 1995, American Society for Testing and Materials, 100 Barr Harbor 
Dr., West Conshohocken, PA 19428, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this 
publication are available from American Society for Testing and 
Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, or may be 
examined at the Food and Drug Administration's Main Library, 10903 New 
Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-
2039, 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/

[[Page 711]]

code_of_federal_regulations/ ibr_locations.html.
    (2) Barium shall be measured using the following methods:
    (i) Method 208.2--``Atomic Absorption; furnace technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 208.1--``Atomic Absorption; direct aspiration,'' 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 (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is 
contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (3) Beryllium shall be measured using the following methods:
    (i) Method 210.2--``Atomic Absorption; Furnace Technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is 
contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (iii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 1.2, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (4) Cadmium shall be measured using the following methods:
    (i) Method 213.2--``Atomic Absorption; Furnace Technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is 
contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, 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 (b)(4)(iii)(E)(1)(ii) of this section.

[[Page 712]]

    (5) Chromium shall be measured using the following methods:
    (i) Method 218.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is 
contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (6) Copper shall be measured as total recoverable metal without 
filtration using the following methods:
    (i) Method 220.2--``Atomic Absorption; furnace technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 220.1--``Atomic Absorption; direct aspiration,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. The availability of these incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is 
contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 1.2, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (7) Cyanide shall be measured using the following methods:
    (i) Method 335.1--``Titrimetric; Spectrophotometric'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 335.2--``Titrimetric; Spectrophotometric'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (iii) Method 335.3--``Colorimetric, Automated UV,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of these incorporation by reference is given 
in paragraph (b)(4)(iii)(E) of this section.
    (iv) Method D-2036-91--``Standard Test Methods for Cyanides in 
Water,'' contained in the Annual Book of ASTM Standards, vols. 11.01 and 
11.02, 1995, American Society for Testing and Materials, 100 Barr Harbor 
Dr., West Conshohocken, PA 19428, which is incorporated by reference in 
accordance

[[Page 713]]

with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are 
available from American Society for Testing and Materials, 100 Barr 
Harbor Dr., West Conshohocken, PA 19428, or may be examined at the Food 
and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 
2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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.
    (8) Lead shall be measured as total recoverable metal without 
filtration using the following methods:
    (i) Method 239.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iii) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 1.2, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (9) Mercury shall be measured using the following methods:
    (i) Method 245.1--``Manual cold vapor technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 245.2--``Automated cold vapor technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of these incorporation by reference is given 
in paragraph (b)(4)(iii)(E) of this section.
    (10) Nickel shall be measured using the following methods:
    (i) Method 249.1--``Atomic Absorption; direct aspiration,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 249.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. The availability of these incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is 
contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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

[[Page 714]]

paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 1.2, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (11) Nitrate and/or nitrite shall be measured using the following 
methods:
    (i) Method 300.0--``The Determination of Inorganic Anions in Water 
by Ion Chromatography--Method 300.0,'' EPA, EMSL (EPA-600/4-84-017), 
March 1984, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are 
available from NTIS, U.S. Department of Commerce, 5285 Port Royal Rd., 
Springfield, VA 22161, or may be examined at the Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039, 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.
    (ii) Method 353.1--``Colorimetric, automated, hydrazine reduction,'' 
for nitrate only, which is incorporated by reference in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51, or
    (iii) Method 353.2--``Colorimetric, automated, cadmium reduction,'' 
for both nitrate and nitrite, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (iv) Method 353.3--``Spectro photo metric, cadmium reduction,'' for 
both nitrate and nitrite, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (12) Selenium shall be measured using the following methods:
    (i) Method 270.2--``Atomic Absorption; furnace technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 270.3--``Atomic Absorption; gaseous hydride,'' 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 (b)(4)(iii)(E) of this section.
    (13) Thallium shall be measured using the following methods:
    (i) Method 279.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iii) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 1.2, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (14) Arsenic shall be measured using the following methods:
    (i) Method 200.8--``Determination of Trace Elements in Waters and 
Wastes

[[Page 715]]

by Inductively Coupled Plasma-Mass Spectrometry,'' Revision 5.4, which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Method 200.8 is contained in the manual entitled ``Methods 
for the Determination of Metals in Environmental Samples--Supplement 
1,'' EPA/600/R-94/111, May 1994. Copies of this publication are 
available from the National Technical Information Service (NTIS), PB95-
125472, U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, 
VA 22161, or may be examined at the Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, 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.
    (ii) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption,'' Revision 2.2, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Method 200.9 is contained in the manual entitled ``Methods for 
the Determination of Metals in Environmental Samples--Supplement 1,'' 
EPA/600/R-94/111, May 1994. The availability of this incorporation by 
reference is given in paragraph (b)(4)(iii)(E)(14)(i) of this section.
    (F) Analyses to determine compliance with the requirements of 
paragraphs (b)(4)(iii)(B) and (b)(4)(iii)(C) of this section shall be 
conducted in accordance with an applicable method or applicable 
revisions to the methods listed in paragraphs (b)(4)(iii)(F)(1) through 
(b)(4)(iii)(F)(22) of this section and described, unless otherwise 
noted, in ``Methods for the Determination of Organic Compounds in 
Drinking Water,'' Office of Research and Development, EMSL, EPA/600/4-
88/039, December 1988, or in ``Methods for the Determination of Organic 
Compounds in Drinking Water, Supplement 1,'' Office of Research and 
Development, EMSL, EPA/600/4-90/020, July 1990, or in ``Methods for the 
Determination of Organic Compounds in Drinking Water, Supplement III,'' 
EPA National Exposure Research Laboratory, Office of Research and 
Development, EPA/600/R-95/131, August 1995, including Errata, November 
27, 1995. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of these publications are available from National 
Technical Information Service, U.S. Department of Commerce, 5285 Port 
Royal Rd., Springfield, VA 22161. You may inspect a copy at the Division 
of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
301-827-6860 or at the National Archives and Records Administration 
(NARA). Hearing-impaired or speech-impaired individuals may access this 
number through TTY by calling the toll-free Federal Relay Service at 
800-877-8339. For information on the availability of this material at 
NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-
register/cfr/ibr-locations.html.
    (1) Method 502.1--``Volatile Halogenated Organic Compounds in Water 
by Purge and Trap Gas Chromatography,'' Rev. 2.0, 1989, (applicable to 
VOC's), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51, or
    (2) Method 502.2--``Volatile Organic Compounds in Water by Purge and 
Trap Capillary Column Gas Chromatography with Photoionization and 
Electrolytic Conductivity Detectors in Series,'' Rev. 2.0, 1989, 
(applicable to VOC's), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (3) Method 503.1--``Volatile Aromatic and Unsaturated Organic 
Compounds in Water by Purge and Trap Gas Chromatography,'' Rev. 2.0, 
1989, (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (4) Method 524.1--``Measurement of Purgeable Organic Compounds in 
Water by Packed Column Gas Chromatography/Mass Spectrometry,'' Rev. 3.0, 
1989, (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (5) Method 524.2--``Measurement of Purgeable Organic Compounds in

[[Page 716]]

Water by Capillary Column Gas Chromatography/Mass Spectrometry,'' Rev. 
3.0, 1989, (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (6) Method 504--``1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-Chloro 
pro pane (DBCP) in Water by Microextraction and Gas Chromatography,'' 
Rev. 2.0, 1989, (applicable to dibromochloropropane (DBCP) and ethylene 
dibromide (EDB)), which is incorporated by reference in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51, or
    (7) Method 505--``Analysis of Organohalide Pesticides and Commercial 
Polychlorinated Biphenyl (PCB) Products in Water by Microextraction and 
Gas Chromatography,'' Rev. 2.0, 1989, (applicable to alachlor, atrazine, 
chlordane, heptachlor, heptachlor epoxide, lindane, methoxychlor, 
toxaphene, endrin, hexachlorobenzene, hexachlorocyclopentadiene, 
simazine, and as a screen for PCB's), which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (8) Method 506--``Determination of Phthalate and Adipate Esters in 
Drinking Water by Liquid-Liquid Extraction or Liquid-Solid Extraction 
and Gas Chromatography with Photoionization Detection,'' applicable to 
di(2-ethyl hexyl) adipate which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (9) Method 507--``Determination of Nitrogen- and Phosphorus-
Containing Pesticides in Water by Gas Chromatography with a Nitrogen-
Phosphorus Detector,'' Rev. 2.0, 1989, (applicable to alachlor, 
atrazine, and simazine), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (10) Method 508--``Determination of Chlorinated Pesticides in Water 
by Gas Chromatography with an Electron Capture Detector,'' Rev. 3.0, 
1989, (applicable to chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, toxaphene, endrin, hexachlorobenzene, and as a screen for 
PCB's), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51, or
    (11) Method 508A--``Screening for Polychlorinated Biphenyls by Per 
chlori nation and Gas Chromatography,'' Rev. 1.0, 1989, (used to 
quantitate PCB's as decachlorobiphenyl if detected in methods 505 or 508 
in paragraph (b)(4)(iii)(F)(7) or (b)(4)(iii)(F)(9) of this section, 
respectively, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (12) Method 515.1--``Determination of Chlorinated Acids in Water by 
Gas Chromatography with an Electron Capture Detector,'' Rev. 5.0, 1991, 
(applicable to 2,4-D, 2,4,5-TP (Silvex), pentachlorophenol, dalapon, 
dinoseb, and picloram), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (13) Method 525.1--``Determination of Organic Compounds in Drinking 
Water by Liquid-Solid Extraction and Capillary Column Gas 
Chromatography/Mass Spectrometry,'' Rev. 2.2, May 1991, (applicable to 
alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, pentachlorophenol, benzo(a)pyrene, di(2-ethylhexyl) 
adipate, endrin, hexachlorobenzene, hexa chloro cyclo penta diene, and 
simazine), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (14) Method 531.1--``Measurement of N-Methylcarbamoyloximes and N-
Methylcarbamates in Water by Direct Aqueous Injection HPLC with Post 
Column Derivatization,'' Rev. 3.0, 1989, (applicable to carbofuran and 
oxamyl (vydate)), which is incorporated by reference in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51, or
    (15) Method 547--``Determination of Glyphosate in Drinking Water by 
Direct-Aqueous-Injection HPLC, Post-Column Derivatization, and 
Fluorescence Detection,'' (applicable to glyphosate), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (16) Method 548--``Determination of Endothall in Drinking Water by 
Aqueous Derivatization, Liquid-Solid Extraction, and Gas Chromatography

[[Page 717]]

with Electron-Capture Detection,'' (applicable to endothall), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (17) Method 549--``Determination of Diquat and Paraquat in Drinking 
Water by Liquid-Solid Extraction and HPLC with Ultraviolet Detection,'' 
(applicable to diquat), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (18) Method 550--``Determination of Polycyclic Aromatic Hydrocarbons 
in Drinking Water by Liquid-Liquid Extraction and HPLC with Coupled 
Ultraviolet and Fluorescence Detection,'' (applicable to benzo(a)pyrene 
and other polynuclear aromatic hydrocarbons), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (19) Method 550.1--``Determination of Polycyclic Aromatic 
Hydrocarbons in Drinking Water by Liquid-Solid Extraction and HPLC with 
Coupled Ultraviolet and Fluorescence Detection,'' (applicable to 
benzo(a)pyrene and other polynuclear aromatic hydrocarbons), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of these incorporation by reference is given 
in paragraph (b)(4)(iii)(F) of this section.
    (20) Method 1613--``Tetra- through Octa- Chlorinated Dioxins and 
Furans by Isotope Dilution HRGC/HRMS,'' Rev. A, 1990, EPA, Office of 
Water Regulations and Standards, Industrial Technology Division, 
(applicable to 2,3,7,8-TCDD (Dioxin)), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
of this publication are available from USEPA-OST, Sample Control Center, 
P.O. Box 1407, Alexandria, VA 22313, or may be examined at the Food and 
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, 
Third Floor, Silver Spring, MD 20993, 301-796-2039, 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.
    (21) Method 506, Rev. 1.1--``Determination of phthalate and adipate 
esters in drinking water by liquid/liquid extraction or liquid/solid 
extraction and gas chromatography with photoionization detection,'' EPA/
600/R-95/131, 1995, (applicable to di(2-ethylhexyl)phthalate), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (22) Method 525.2, Rev. 2.0--``Determination of organic compounds in 
drinking water by liquid-solid extraction and capillary column gas 
chromatography/mass spectrometry,'' EPA/600/R-95/131, 1995, (applicable 
to di(2-ethylhexyl)phthalate), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
    (G) Analyses to determine compliance with the requirements of 
paragraph (b)(4)(iii)(D) of this section shall be conducted in 
accordance with an applicable method and applicable revisions to the 
methods listed in paragraphs (b)(4)(iii)(G)(1) through (b)(4)(iii)(G)(3) 
of this section and described, unless otherwise noted, in ``Methods of 
Chemical Analysis of Water and Wastes,'' 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 
(b)(4)(iii)(E) of this section.
    (1) Aluminum shall be measured using the following methods:
    (i) Method 202.1--``Atomic Absorption; direct aspiration 
technique,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (ii) Method 202.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E).
    (iii) Method 200.7--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,'' 
Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the 
manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development,

[[Page 718]]

Washington, DC 20460, (EPA/600/4-91/010), June 1991, 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 1.2, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (2) Silver shall be measured using the following methods:
    (i) Method 272.1--``Atomic Absorption; direct aspiration 
technique,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (ii) Method 272.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,'' 
Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the 
manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development, Washington, 
DC 20460, (EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 1.2, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' Office of Research and Development, Washington, DC 20460, 
(EPA/600/4-91/010), June 1991, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of 
these incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (3) Sulfate shall be measured using the following methods:
    (i) Method 300.0--``The Determination of Inorganic Anions in Water 
by Ion Chromatography--Method 300.0,'' EPA, EMSL (EPA-600/4-84-017), 
March 1984, 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 (b)(4)(iii)(E)(11)(i) of this 
section.
    (ii) Method 375.1--``Colorimetric, Automated, Chloranilate,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or

[[Page 719]]

    (iii) Method 375.3--``Gravimetric,'' which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (iv) Method 375.4--``Turbidimetric,'' which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The 
availability of these incorporation by reference is given in paragraph 
(b)(4)(iii)(E) of this section.
    (H) The allowable levels for residual disinfectants and disinfection 
byproducts are as follows:

------------------------------------------------------------------------
                                            Concentration in milligrams
                Substance                            per liter
------------------------------------------------------------------------
Disinfection byproducts                    .............................
   Bromate...............................  0.010
  Chlorite...............................  1.0
  Haloacetic acids (five) (HAA5).........  0.060
  Total Trihalomethanes (TTHM)...........  0.080
Residual disinfectants                     .............................
  Chloramine.............................  4.0 (as Cl2)
  Chlorine...............................  4.0 (as Cl2)
  Chlorine dioxide.......................  0.8 (as ClO2)
------------------------------------------------------------------------

    (I) Analysis to determine compliance with the requirements of 
paragraph (b)(4)(iii)(H) of this section shall be conducted in 
accordance with an applicable method listed in paragraphs 
(b)(4)(iii)(I)(1) through (b)(4)(iii)(I)(7) of this section and 
described in ``Method 300.1, Determination of Inorganic Anions in 
Drinking Water by Ion Chromatography,'' Rev. 1.0, U.S. EPA, 1997, EPA/
600/R-98/118; ``Methods for the Determination of Inorganic Substances in 
Environmental Samples,'' U.S. EPA, August 1993, EPA/600/R-93/100; 
``Methods for the Determination of Organic Compounds in Drinking Water-
Supplement II,'' U.S. EPA, August 1992, EPA/600/R-92/129; ``Methods for 
the Determination of Organic Compounds in Drinking Water-Supplement 
III,'' U.S. EPA, August 1995, EPA/600/R-95/131; ``Standard Methods for 
the Examination of Water and Wastewater,'' 19th Ed., American Public 
Health Association, 1995; and ``Annual Book of ASTM Standards,'' vol. 
11.01, American Society for Testing and Materials, 1996, which are 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of the following publications are available from the 
National Technical Information Service (NTIS): EPA/600/R-95/131 (NTIS 
number PB95-261616), EPA/600/R-92/129 (NTIS number PB92-207703), EPA/
600/R-93/100 (NTIS number PB94-121811), and EPA/600/R-98/118 (NTIS 
number PB98-169196). NTIS can be contacted at NTIS, U.S. Department of 
Commerce, 5285 Port Royal Rd., Springfield, VA 22161, 1-800-553-6847 or 
703-605-6000, www.ntis.gov. Copies of the publication EPA/600/R-98/118 
are also available from the Chemical Exposure Research Branch, 
Microbiological and Chemical Exposure Assessment Research Division, 
National Exposure Research Laboratory, U.S. EPA, Cincinnati, OH 45268, 
513-569-7757, (FAX) 513-569-7757. Copies of ``Standard Methods for the 
Examination of Water and Wastewater,'' 19th Ed., are available from the 
American Public Health Association, 1015 15th Street, NW., Washington, 
DC 20005. All of the publications cited in paragraph (b)(4)(iii)(I) of 
this section may be examined at the National Archives and Records 
Administration (NARA), or at the Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039. 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 ``Annual Book of ASTM Standards,'' 1996, vol. 11.01, are 
available from the American Society for Testing and Materials, 100 Barr 
Harbor Dr., West Conshohoken, PA 19428, or may be examined at the Office 
of the Federal Register. Copies of the methods incorporated by reference 
in paragraph (b)(4)(iii)(I) of this section may also be examined at the 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.
    (1) Bromate shall be measured using the following method: Method 
300.1--``Determination of Inorganic Anions in Drinking Water by Ion 
Chromatography,'' Rev. 1.0, U.S. EPA, 1997, EPA/600/R-98/118, 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 (b)(4)(iii)(I) of this section.
    (2) Chlorite shall be measured using the following methods:

[[Page 720]]

    (i) Method 300.0--``Determination of Inorganic Anions by Ion 
Chromatography,'' Rev. 2.1. The revision is contained in the manual 
entitled ``Methods for the Determination of Inorganic Substances in 
Environmental Samples,'' U.S. EPA, August 1993, EPA/600/R-93/100, 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 (b)(4)(iii)(I) of this section.
    (ii) Method 300.1--``Determination of Inorganic Anions in Drinking 
Water by Ion Chromatography,'' Rev. 1.0, U.S. EPA, 1997, EPA/600/R-98/
118, 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 (b)(4)(iii)(I) of this section.
    (3) HAA5 shall be measured using the following methods:
    (i) Method 552.1--``Determination of Haloacetic Acids and Dalapon in 
Drinking Water by Ion Exchange Liquid-Solid Extraction and Gas 
Chromatography with Electron Capture Detection,'' Rev. 1.0. The revision 
is contained in the manual entitled ``Methods for the Determination of 
Organic Compounds in Drinking Water-Supplement II,'' U.S. EPA, August 
1992, EPA/600/R-92/129, 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 (b)(4)(iii)(I) of this 
section.
    (ii) Method 552.2--``Determination of Haloacetic Acids and Dalapon 
in Drinking Water by Liquid-Liquid Extraction, Derivatization and Gas 
Chromatography with Electron Capture Detection,'' Rev. 1.0. The revision 
is contained in the manual entitled ``Methods for the Determination of 
Organic Compounds in Drinking Water-Supplement III,'' U.S. EPA, August 
1993, EPA/600/R-95/131, 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 (b)(4)(iii)(I) of this 
section.
    (iii) Method 6251 B--``Disinfection By-Products: Haloacetic Acids 
and Trichlorophenol,'' which is contained in the book entitled 
``Standard Methods for the Examination of Water and Wastewater,'' 19th 
Ed., 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 (b)(4)(iii)(I) of this section.
    (4) TTHM shall be measured using the following methods:
    (i) Method 502.2--``Volatile Organic Compounds in Water by Purge and 
Trap Capillary Column Gas Chromatography with Photoionization and 
Electrolytic Conductivity Detectors in Series,'' Rev. 2.1. The revision 
is contained in the manual entitled ``Methods for the Determination of 
Organic Compounds in Drinking Water-Supplement III,'' U.S. EPA, August 
1993, EPA/600/R-95/131, 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 (b)(4)(iii)(I) of this 
section.
    (ii) Method 524.2--``Measurement of Purgeable Organic Compounds in 
Water by Capillary Column Gas Chromatography/Mass Spectrometry,'' Rev. 
1.0. The revision is contained in the manual entitled ``Methods for the 
Determination of Organic Compounds in Drinking Water-Supplement III,'' 
U.S. EPA, August 1993, EPA/600/R-95/131, 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 
(b)(4)(iii)(I) of this section.
    (iii) Method 551.1--``Determination of Chlorination Disinfection 
Byproducts, Chlorinated Solvents, and Halogenated Pesticides/Herbicides 
in Drinking Water by Liquid-Liquid Extraction and Gas Chromatography 
with Electron-Capture Detection,'' Rev. 1.0. The revision is contained 
in the manual entitled ``Methods for the Determination of Organic 
Compounds in Drinking Water-Supplement III,'' U.S. EPA, August 1993, 
EPA/600/R-95/131, 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 (b)(4)(iii)(I) of this 
section.

[[Page 721]]

    (5) Compliance with the chloramine standard can be determined by 
measuring combined or total chlorine. The following methods shall be 
used to measure chloramine:
    (i) ASTM Method D1253-86--`` Standard Test Method for Residual 
Chlorine in Water,'' which is contained in the book entitled ``Annual 
Book of ASTM Standards,'' 1996, vol. 11.01, 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 
(b)(4)(iii)(I) of this section.
    (ii) Method 4500-Cl D--``Amperometric Titration Method,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (iii) Method 4500-Cl F--``DPD Ferrous Titrimetric Method,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (iv) Method 4500-Cl G--``DPD Colorimetric Method,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (v) Method 4500-Cl E--``Low-Level Amperometric Titration Method,'' 
which is contained in the book entitled ``Standard Methods for the 
Examination of Water and Wastewater,'' 19th Ed., 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 
(b)(4)(iii)(I) of this section.
    (vi) Method 4500-Cl I--``Iodometric Electrode Technique,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (6) Compliance with the chlorine standard can be determined by 
measuring free or total chlorine. The following methods shall be used to 
measure chlorine:
    (i) ASTM Method D1253-86--``Standard Test Method for Residual 
Chlorine in Water,'' which is contained in the book entitled ``Annual 
Book of ASTM Standards,'' 1996, vol. 11.01, 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 
(b)(4)(iii)(I) of this section.
    (ii) Method 4500-Cl D--``Amperometric Titration Method,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (iii) Method 4500-Cl F--``DPD Ferrous Titrimetric Method,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (iv) Method 4500-Cl G--``DPD Colorimetric Method,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (v) Method 4500-Cl E--``Low-Level Amperometric Titration Method,'' 
which is contained in the book entitled ``Standard Methods for the 
Examination of Water and Wastewater,'' 19th Ed., which is incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1

[[Page 722]]

CFR part 51. The availability of this incorporation by reference is 
given in paragraph (b)(4)(iii)(I) of this section.
    (vi) Method 4500-Cl I--``Iodometric Electrode Technique,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (vii) Method 4500-Cl H--``Syringaldazine (FACTS) Method,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (7) Chlorine dioxide shall be measured using the following methods:
    (i) Method 4500-ClO2 D--``DPD Method,'' which is 
contained in the book entitled ``Standard Methods for the Examination of 
Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) of 
this section.
    (ii) Method 4500-ClO2E--``Amperometric Method II,'' which 
is contained in the book entitled ``Standard Methods for the Examination 
of Water and Wastewater,'' 19th Ed., 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 (b)(4)(iii)(I) 
of this section.
    (5) Radiological quality. (i) Bottled water shall, when a composite 
of analytical units of equal volume from a sample is examined by the 
methods described in paragraph (b)(5)(ii) of this section, meet 
standards of radiological quality as follows:
    (A) The bottled water shall not contain a combined radium-226 and 
radium-228 activity in excess of 5 picocuries per liter of water.
    (B) The bottled water shall not contain a gross alpha particle 
activity (including radium-226, but excluding radon and uranium) in 
excess of 15 picocuries per liter of water.
    (C) The bottled water shall not contain beta particle and photon 
radioactivity from manmade radionuclides in excess of that which would 
produce an annual dose equivalent to the total body or any internal 
organ of 4 millirems per year calculated on the basis of an intake of 2 
liters of the water per day. If two or more beta or photon-emitting 
radionuclides are present, the sum of their annual dose equivalent to 
the total body or to any internal organ shall not exceed 4 millirems per 
year.
    (D) The bottled water shall not contain uranium in excess of 30 
micrograms per liter of water.
    (ii) Analyses conducted to determine compliance with the 
requirements of paragraph (b)(5)(i) of this section shall be made in 
accordance with the methods described in the applicable sections of 
``Standard Methods for the Examination of Water and Wastewater,'' 20th 
Ed., which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies of ``Standard Methods for the 
Examination of Water and Wastewater,'' 20th Ed., may be obtained from 
the American Public Health Association, 1015 15th St. NW., Washington, 
DC 20005. Copies of the methods incorporated by reference in this 
paragraph (b)(5)(ii) may also be examined at the National Archives and 
Records Administration (NARA), or at the Food and Drug Administration's 
Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver 
Spring, MD 20993, 301-796-2039. 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.
    (A) Combined radium-226/-228 shall be measured using the following 
methods:
    (1) Method 7500-Ra B--``Precipitation Method,'' which is contained 
in ``Standard Methods for the Examination of Water and Wastewater,'' 
20th Ed., 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 the

[[Page 723]]

introductory text of paragraph (b)(5)(ii) of this section.
    (2) Method 7500-Ra D--``Sequential Precipitation Method,'' which is 
contained in ``Standard Methods for the Examination of Water and 
Wastewater,'' 20th Ed., 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 the introductory text of 
paragraph (b)(5)(ii) of this section.
    (B) Gross alpha particle radioactivity shall be measured using the 
following method: Method 7110 C--``Coprecipitation Method for Gross 
Alpha Radioactivity in Drinking Water,'' which is contained in 
``Standard Methods for the Examination of Water and Wastewater,'' 20th 
Ed., 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 the introductory text of paragraph (b)(5)(ii) of 
this section.
    (C) Beta particle and photon radioactivity shall be measured using 
the following methods:
    (1) Method 7500-Sr B--``Precipitation Method,'' which is contained 
in ``Standard Methods for the Examination of Water and Wastewater,'' 
20th Ed., 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 the introductory text of paragraph (b)(5)(ii) of 
this section.
    (2) Method 7500-\3\H B--``Liquid Scintillation Spectrometric 
Method,'' which is contained in ``Standard Methods for the Examination 
of Water and Wastewater,'' 20th Ed., 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 the introductory text of 
paragraph (b)(5)(ii) of this section.
    (3) Method 7120 B--``Gamma Spectroscopic Method,'' which is 
contained in ``Standard Methods for the Examination of Water and 
Wastewater,'' 20th Ed., 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 the introductory text of 
paragraph (b)(5)(ii) of this section.
    (D) Uranium shall be measured using the following methods:
    (1) Method 7500-U B--``Radiochemical Method'' which is contained in 
``Standard Methods for the Examination of Water and Wastewater,'' 20th 
Ed., 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 the introductory text of paragraph (b)(5)(ii) of 
this section.
    (2) Method 7500-U C--``Isotopic Method'' which is contained in 
``Standard Methods for the Examination of Water and Wastewater,'' 20th 
Ed., 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 the introductory text of paragraph (b)(5)(ii) of 
this section.
    (c) Label statements. When the microbiological, physical, chemical, 
or radiological quality of bottled water is below that prescribed by 
paragraphs (b)(2) through (b)(5), of this section, the label shall bear 
the statement of substandard quality specified in Sec. 130.14(a) of 
this chapter except that, as appropriate, instead of or in addition to 
the statement specified in Sec. 130.14(a) the following statement(s) 
shall be used:
    (1) ``Contains Excessive Bacteria'' if the bottled water fails to 
meet the requirements of paragraph (b)(2)(i)(A) of this section.
    (2) ``Excessively Turbid'', ``Abnormal Color'', and/or ``Abnormal 
Odor'' if the bottled water fails to meet the requirements of paragraph 
(b)(3) (i), (ii), or (iii), respectively, of this section.
    (3) ``Contains Excessive ___,'' with the blank filled in with the 
name of the chemical for which a maximum contaminant level in paragraph 
(b)(4) of this section is exceeded (e.g., ``Contains Excessive 
Arsenic,'' ``Contains Excessive Trihalomethanes'') except that 
``Contains Excessive Chemical Substances'' may be used if the bottled 
water is not mineral water.
    (4) ``Excessively Radioactive'' if the bottled water fails to meet 
the requirements of paragraph (b)(5) of this section.

[[Page 724]]

    (d) Adulteration. Bottled water containing a substance at a level 
considered injurious to health under section 402(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (the act), or that consists in whole or in 
part of any filthy, putrid, or decomposed substance, or that is 
otherwise unfit for food under section 402(a)(3) of the act is deemed to 
be adulterated, regardless of whether or not the water bears a label 
statement of substandard quality prescribed by paragraph (c) of this 
section. If E. coli is present in bottled water, then the bottled water 
will be deemed adulterated under section 402(a)(3) of the act.

[60 FR 57124, Nov. 13, 1995; 60 FR 66495, Dec. 22, 1995, as amended at 
61 FR 13264, Mar. 26, 1996; 61 FR 14480, Apr. 2, 1996; 63 FR 25769, May 
11, 1998; 66 FR 16865, Mar. 28, 2001; 66 FR 17359, Mar. 30, 2001; 66 FR 
35373, July 5, 2001; 66 FR 56035, Nov. 6, 2001; 58 FR 15355, Mar. 31, 
2003; 68 FR 9881, Mar. 3, 2003; 70 FR 33700, June 9, 2005; 74 FR 25665, 
May 29, 2009; 76 FR 64813, Oct. 19, 2011; 81 FR 5591, Feb. 3, 2016]



PART 166_MARGARINE--Table of Contents



                      Subpart A_General Provisions

Sec.
166.40 Labeling of margarine.

       Subpart B_Requirements for Specific Standardized Margarine

166.110 Margarine.

    Authority: 21 U.S.C. 321, 341, 343, 347, 348, 371, 379e.



                      Subpart A_General Provisions



Sec. 166.40  Labeling of margarine.

    The Federal Food, Drug, and Cosmetic Act was amended by Pub. L. 459, 
81st Congress (64 Stat. 20) on colored oleomargarine or margarine by 
adding thereto a new section numbered 407. Among other things, this 
section requires that there appear on the label of the package the word 
``oleomargarine'' or ``margarine'' in type or lettering at least as 
large as any other type or lettering on the label, and a full and 
accurate statement of all the ingredients contained in such 
oleomargarine or margarine. It provides that these requirements ``shall 
be in addition to and not in lieu of any of the other requirements of 
this Act''.
    (a) Under section 403(g) of the Federal Food, Drug, and Cosmetic 
Act, any article that is represented as or purports to be oleomargarine 
or margarine must conform to the definition and standard of identity for 
oleomargarine or margarine promulgated under section 401 of the act 
(Subpart B of this part), and its label must bear the name 
``oleomargarine'' or ``margarine''.
    (b) The identity standard for oleomargarine or margarine applies to 
both the uncolored and the colored article.
    (c) In considering the requirement that the word ``oleomargarine'' 
or ``margarine'' be in type or lettering at least as large as any other 
type or lettering on the label, it must be borne in mind that at least 
three factors are involved--the height of each letter, the area occupied 
by each letter as measured by a closely fitting rectangle drawn around 
it, and the boldness of letters or breadth of the lines forming the 
letters. The type or lettering used should meet the following tests:
    (1) The height of each letter in the word ``oleomargarine'' or 
``margarine'' should equal or exceed the height of any other letter 
elsewhere on the label.
    (2) The area of the closely fitting rectangle with respect to any of 
the letters in the word ``oleomargarine'' or ``margarine'' should equal 
or exceed the area of such rectangle applied to the same or a 
corresponding letter elsewhere on the label.
    (3) The letters in the word ``oleomargarine'' or ``margarine'' 
should be equal to or exceed in prominence and boldness, such as breadth 
of lines forming the letters, the same or corresponding letters 
elsewhere on the label.
    (d) [Reserved]
    (e) The word ``oleomargarine'' or ``margarine'' (and thus the other 
information called for by the statute) should appear on each panel of 
the package label that might reasonably be selected by the grocer for 
display purposes at the point of sale.
    (f) The amendment covering colored oleomargarine or colored 
margarine states that, ``for the purposes of * * * section 407 of the 
Federal Food, Drug, and Cosmetic Act, as amended, the term 
`oleomargarine' or `margarine' includes: (1) All substances, mixtures,

[[Page 725]]

and compounds known as oleomargarine or margarine; (2) all substances, 
mixtures, and compounds which have a consistency similar to that of 
butter and which contain any edible oils or fats other than milk fat if 
made in imitation or semblance of butter''. Notwithstanding the 
difference between this definition and the definition and standard of 
identity for oleomargarine or margarine promulgated under section 401 of 
the act, it was the clear intent of Congress that any article which is 
represented as or purports to be oleomargarine or margarine is 
misbranded if it fails to comply with the definition and standard of 
identity for oleomargarine or margarine even though it may meet the 
statutory definition.
    (g) Section 407(a) states that ``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''.
    (h) Section 407(b)(4) requires that each part of the contents of the 
package be ``contained in a wrapper which bears the word `oleomargarine' 
or `margarine' in type or lettering not smaller than 20-point type''. 
The Food and Drug Administration interprets this to mean that the height 
of the actual letters is no less than 20 points, or \20/72\ of 1 inch.
    (i) The wrappers on the subdivisions of oleomargarine or margarine 
contained within the package sold at retail are labels within the 
meaning of section 201(k) and shall contain all of the label information 
required by sections 403 and 407 of the Federal Food, Drug, and Cosmetic 
Act, just as in the case of 1-pound cartons, except that wrappers on the 
subdivisions contained within the retail package shall be exempt from 
compliance with the requirements of section 403 (e)(1), (g)(2), (i)(2), 
and (k) of the act with respect to the requirements for label 
declaration of the name and place of business of the manufacturer, 
packer, or distributor and label declaration of ingredients when (1) the 
subdivisions are securely enclosed within and are not intended to be 
separated from the retail package under conditions of retail sale; (2) 
the wrappers on the subdivisions are labeled with the statement ``This 
Unit Not Labeled For Retail Sale'' in type size not less than one-
sixteenth inch in height. The word ``Individual'' may be used in lieu of 
or immediately preceding the word ``Retail'' in the statement.

[42 FR 14477, Mar. 15, 1977, as amended at 46 FR 31005, June 12, 1981; 
47 FR 32421, July 27, 1982]



       Subpart B_Requirements for Specific Standardized Margarine



Sec. 166.110  Margarine.

    (a) Description. Margarine (or oleomargarine) is the food in plastic 
form or liquid emulsion, containing not less than 80 percent fat 
determined by the method prescribed in ``Official Methods of Analysis of 
the Association of Official Analytical Chemists,'' 13th Ed. (1980), 
section 16.206, ``Indirect Method,'' under the heading ``Fat (47)--
Official Final Action,'' which is incorporated by reference. Copies may 
be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined 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. Margarine contains only safe and suitable 
ingredients, as defined in Sec. 130.3(d) of this chapter. It is 
produced from one or more of the optional ingredients in paragraph 
(a)(1) of this section, and one or more of the optional ingredients in 
paragraph (a)(2) of this section, to which may be added one or more of 
the optional ingredients in paragraph (b) of this section. Margarine 
contains vitamin A as provided for in paragraph (a)(3) of this section.
    (1) Edible fats and/or oils, or mixtures of these, whose origin is 
vegetable or rendered animal carcass fats, or any form of oil from a 
marine species that has been affirmed as GRAS or listed as a food 
additive for this use, any or all of which may have been subjected to an 
accepted process of physico-chemical modification. They

[[Page 726]]

may contain small amounts of other lipids, such as phosphatides or 
unsaponifiable constituents, and of free fatty acids naturally present 
in the fat or oil.
    (2) One or more of the following aqueous phase ingredients:
    (i) Water and/or milk and/or milk products.
    (ii) Suitable edible protein including, but not limited to, the 
liquid, condensed, or dry form of whey, whey modified by the reduction 
of lactose and/or minerals, nonlactose containing whey components, 
albumin, casein, caseinate, vegetable proteins, or soy protein isolate, 
in amounts not greater than reasonably required to accomplish the 
desired effect.
    (iii) Any mixture of two or more of the articles named under 
paragraphs (a)(2) (i) and (ii) of this section.
    (iv) The ingredients in paragraphs (a)(2) (i), (ii), and (iii) of 
this section shall be pasteurized and then may be subjected to the 
action of harmless bacterial starters. One or more of the articles 
designated in paragraphs (a)(2) (i), (ii), and (iii) of this section is 
intimately mixed with the edible fat and/or ingredients to form a 
solidified or liquid emulsion.
    (3) Vitamin A in such quantity that the finished margarine contains 
not less than 15,000 international units per pound.
    (b) Optional ingredients. (1) Vitamin D in such quantity that the 
finished oleomargarine contains not less than 1,500 international units 
of vitamin D per pound.
    (2) Salt (sodium chloride); potassium chloride for dietary margarine 
or oleomargarine.
    (3) Nutritive carbohydrate sweeteners.
    (4) Emulsifiers.
    (5) Preservatives including but not limited to the following within 
these maximum amounts in percent by weight of the finished food: Sorbic 
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; propyl, octyl, and 
dodecyl gallates, BHT, BHA, ascorbyl palmitate, ascorbyl stearate, all 
individually or in combination, 0.02 percent; stearyl citrate, 0.15 
percent; isopropyl citrate mixture, 0.02 percent.
    (6) Color additives. For the purpose of this subparagraph, 
provitamin A (beta-carotene) shall be deemed to be a color additive.
    (7) Flavoring substances. If the flavoring ingredients impart to the 
food a flavor other than in semblance of butter, the characterizing 
flavor shall be declared as part of the name of the food in accordance 
with Sec. 101.22 of this chapter.
    (8) Acidulants.
    (9) Alkalizers.
    (c) Nomenclature. The name of the food for which a definition and 
standard of identity are prescribed in this section is ``margarine'' or 
``oleomargarine''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter. For the purposes of this section the 
use of 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. Colored margarine shall be subject to the provisions of 
section 407 of the Federal Food, Drug, and Cosmetic Act as amended.

[42 FR 14478, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 
48 FR 13024, Mar. 29, 1983; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, 
June 12, 1989; 58 FR 2886, Jan. 6, 1993; 58 FR 21649, Apr. 23, 1993; 59 
FR 26939, May 25, 1994; 63 FR 14035, Mar. 24, 1998]



PART 168_SWEETENERS AND TABLE SIRUPS--Table of Contents



Subpart A [Reserved]

 Subpart B_Requirements for Specific Standardized Sweeteners and Table 
                                 Sirups

Sec.
168.110 Dextrose anhydrous.
168.111 Dextrose monohydrate.
168.120 Glucose sirup.
168.121 Dried glucose sirup.
168.122 Lactose.
168.130 Cane sirup.
168.140 Maple sirup.
168.160 Sorghum sirup.
168.180 Table sirup.


[[Page 727]]


    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14479, Mar. 15, 1977, unless otherwise noted.

Subpart A [Reserved]



 Subpart B_Requirements for Specific Standardized Sweeteners and Table 
                                 Sirups



Sec. 168.110  Dextrose anhydrous.

    (a) Dextrose anhydrous is purified and crystallized D-glucose 
without water of crystallization and conforms to the specifications of 
Sec. 168.111, except that the total solids content is not less than 
98.0 percent m/m.
    (b) The name of the food is ``Dextrose anhydrous'' or ``Anhydrous 
dextrose'' or alternatively, ``___ sugar anhydrous'' or ``Anhydrous 
sugar'', with the blank to be filled with the name of the food source, 
for example, ``Corn sugar anhydrous''.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]



Sec. 168.111  Dextrose monohydrate.

    (a) Dextrose monohydrate is purified and crystallized D-glucose 
containing one molecule of water of crystallization with each molecule 
of D-glucose.
    (b) The food shall meet the following specifications:
    (1) The total solids content is not less than 90.0 percent mass/mass 
(m/m), and the reducing sugar content (dextrose equivalent), expressed 
as D-glucose, is not less than 99.5 percent m/m calculated on a dry 
basis.
    (2) The sulfated ash content is not more than 0.25 percent m/m 
(calculated on a dry basis), and the sulfur dioxide content is not more 
than 20 mg/kg.
    (c) The name of the food is ``Dextrose monohydrate'' or ``Dextrose'' 
or alternatively, ``___ sugar monohydrate'' or ``___ sugar'', with the 
blank to be filled with the name of the food source, for example, ``Corn 
sugar monohydrate'' or ``Corn sugar''.
    (d) For purposes of this section, the methods of analysis to be used 
to determine if the food meets the specifications of paragraph (b) (1) 
and (2) of this section are the following sections in ``Official Methods 
of Analysis of the Association of Official Analytical Chemists,'' 13th 
Ed. (1980), which is incorporated by reference. Copies may be obtained 
from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877, or may be examined 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.
    (1) Total solids content, 31.005.
    (2) Reducing sugar content, section 31.220(a).
    (3) Sulfated ash content, section 31.216.
    (4) Sulfur dioxide content, sections 20.106-20.111.

[42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 
49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 58 FR 2886, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]



Sec. 168.120  Glucose sirup.

    (a) Glucose sirup is the purified, concentrated, aqueous solution of 
nutritive saccharides obtained from edible starch.
    (b) The food shall meet the following specifications:
    (1) The total solids content is not less than 70.0 percent mass/mass 
(m/m), and the reducing sugar content (dextrose equivalent), expressed 
as D-glucose, is not less than 20.0 percent m/m calculated on a dry 
basis.
    (2) The sulfated ash content is not more than 1.0 percent m/m 
(calculated on a dry basis), and the sulfur dioxide content is not more 
than 40 mg/kg.
    (c) The name of the food is ``Glucose sirup''. When the food is 
derived from a specific type of starch, the name may alternatively be 
``___ sirup'', the blank to be filled in with the name of the starch. 
For example, ``Corn sirup'', ``Wheat sirup'', ``Tapioca sirup''. When 
the starch is derived from sorghum grain, the alternative name of the 
food is ``Sorghum grain sirup''. The word ``sirup'' may also be spelled 
``syrup''.
    (d) For purposes of this section, the methods of analysis to be used 
to determine if the food meets the specifications of paragraph (b)(1) 
and (2) of this section are the following sections in

[[Page 728]]

``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), which is incorporated by reference. Copies 
may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877, or may be examined 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.
    (1) Total solids content, sections 31.208-31.209.
    (2) Reducing sugar content, section 31.220(a).
    (3) Sulfated ash content, section 31.216.
    (4) Sulfur dioxide content, sections 20.106-20.111.

[42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 
49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 63 FR 14035, 
Mar. 24, 1998]



Sec. 168.121  Dried glucose sirup.

    (a) Dried glucose sirup is glucose sirup from which the water has 
been partially removed and conforms to the specifications of Sec. 
168.120, except that:
    (1) The total solids content is not less than 90.0 percent m/m when 
the reducing sugar content (dextrose equivalent), expressed as D-
glucose, is not less than 88.0 percent m/m, calculated on a dry basis; 
or
    (2) The total solids content is not less than 93.0 percent m/m when 
the reducing sugar content, (dextrose equivalent) expressed as D-
glucose, is less than 88.0 percent m/m, calculated on a dry basis.
    (b) The name of the food is ``Dried glucose sirup'' or ``Glucose 
sirup solids''. When the food is derived from a specific type of starch, 
the name may alternatively be ``Dried ___ sirup'' or ``___ sirup 
solids'', the blank to be filled in with the name of the starch; for 
example, ``Dried corn sirup'', ``Corn sirup solids'', ``Dried wheat 
sirup'', ``Wheat sirup solids'', ``Dried tapioca sirup'', ``Tapioca 
sirup solids''. When the starch is derived from sorghum grain, the 
alternative name of the food is ``Dried sorghum grain sirup'' or 
``Sorghum grain sirup solids''. The word ``sirup'' may also be spelled 
``syrup''.



Sec. 168.122  Lactose.

    (a) Lactose is the carbohydrate normally obtained from whey. It may 
be anhydrous or contain one molecule of water of crystallization or be a 
mixture of both forms.
    (b) The food shall meet the following specifications:
    (1) The lactose content is not less than 98.0 percent, mass over 
mass (m/m), calculated on a dry basis.
    (2) The sulfated ash content is not more than 0.3 percent, m/m, 
calculated on a dry basis.
    (3) The pH of a 10.0-percent m/m solution is not less than 4.5 nor 
more than 7.5.
    (4) The loss on drying for 16 hours at 120 [deg]C is not more than 
6.0 percent, m/m.
    (c) The name of the food is ``Lactose'' or, alternatively, ``Milk 
sugar''.
    (d) The methods of analysis in paragraphs (d)(1), (d)(2), (d)(3), 
(d)(4), and (d)(5) of this section are to be used to determine whether 
the food meets the requirements of paragraphs (b)(1), (b)(2), (b)(3), 
and (b)(4) of this section. The methods are contained in ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists'', 14th Ed. (1984), including the 4th Supp. (1988), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a). Copies of 
the material incorporated by reference may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined 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.
    (1) Lactose content, sections 31.064 to 31.071, ``Purity of Lactose, 
Liquid Chromatographic Method,'' First Action, 14th Ed. (1984), pp. 583 
and 584.
    (2) Lactose content, sections 31.064 to 31.071, ``Purity of Lactose, 
Liquid Chromatographic Method,'' ``Changes in Official Methods of 
Analysis,'' 14th

[[Page 729]]

Ed., 4th Supp. (1988), p. 212. This reference recognizes the change in 
status of the method from first action to final action.
    (3) Sulfated ash content, section 31.014, ``Ash of Sugars and 
Sirups,'' Final Action, Sulfated Ash, 14th Ed. (1984), p. 575.
    (4) pH, section 14.022, ``pH of Flour, Potentiometric Method,'' 
Final Action, except that a 10-percent m/m solution of lactose in water 
is used for the determination, 14th Ed. (1984), p. 252.
    (5) Loss on drying at 120 [deg]C, section 31.070, 14th Ed. (1984), 
p. 584.

[42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 
49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 55 FR 8459, Mar. 
8, 1990; 63 FR 14035, Mar. 24, 1998]



Sec. 168.130  Cane sirup.

    (a) Cane sirup is the liquid food derived by concentration and heat 
treatment of the juice of sugarcane (Saccharum officinarum L.) or by 
solution in water of sugarcane concrete made from such juice. It 
contains not less than 74 percent by weight of soluble solids derived 
solely from such juice. The concentration may be adjusted with or 
without added water. It may contain one or more of the optional 
ingredients provided for in paragraph (b) of this section. All 
ingredients from which the food is fabricated shall be safe and 
suitable.
    (b) The optional ingredients that may be used in cane sirup are:
    (1) Salt.
    (2) Preservatives.
    (3) Defoaming agents.
    (c) The name of the food is ``Cane sirup'' or ``Sugar cane sirup''. 
Alternatively, the word ``sirup'' may be spelled ``syrup''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]



Sec. 168.140  Maple sirup.

    (a) Maple sirup is the liquid food derived by concentration and heat 
treatment of the sap of the maple tree (Acer) or by solution in water of 
maple sugar (mapel concrete) made from such sap. It contains not less 
than 66 percent by weight of soluble solids derived solely from such 
sap. The concentration may be adjusted with or without added water. It 
may contain one or more of the optional ingredients provided for in 
paragraph (b) of this section. All ingredients from which the food is 
fabricated shall be safe and suitable.
    (b) The optional ingredients that may be used in maple sirup are:
    (1) Salt.
    (2) Chemical preservatives.
    (3) Defoaming agents.
    (c) The name of the food is ``Maple sirup''. Alternatively, the word 
``sirup'' may be spelled ``syrup''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2896, Jan. 6, 1993]



Sec. 168.160  Sorghum sirup.

    (a) Sorghum sirup is the liquid food derived by concentration and 
heat treatment of the juice of sorghum cane (sorgos) (Sorghum vulgare). 
It contains not less than 74 percent by weight of soluble solids derived 
solely from such juice. The concentration may be adjusted with or 
without added water. It may contain one or more of the optional 
ingredients provided for in paragraph (b) of this section. All 
ingredients from which the food is fabricated shall be safe and 
suitable.
    (b) The optional ingredients that may be used in sorghum sirup are:
    (1) Salt.
    (2) Chemical preservatives.
    (3) Defoaming agents.
    (4) Enzymes.
    (5) Anticrystallizing agents.
    (6) Antisolidifying agents.
    (c) The name of the food is ``Sorghum sirup'' or ``Sorghum''. 
Alternatively, the word ``sirup'' may be spelled ``syrup''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]

[[Page 730]]



Sec. 168.180  Table sirup.

    (a) Table sirup is the liquid food consisting of one or more of the 
optional sweetening ingredients provided for in paragraph (b)(1) of this 
section. The food contains not less than 65 percent soluble sweetener 
solids by weight and is prepared with or without added water. It may 
contain one or more of the optional ingredients prescribed in paragraphs 
(b)(2) through (12) of this section. All ingredients from which the food 
is fabricated shall be safe and suitable. (Vitamins, minerals, and 
protein added for nutritional purposes and artificial sweeteners are not 
considered to be suitable ingredients for this food.)
    (b) The optional ingredients that may be used in table sirup are:
    (1) One or more of the nutritive carbohydrate sweeteners provided 
for in this paragraph (b)(1). When a sweetener provided for in paragraph 
(b)(1)(i) or (ii) of this section is used it shall constitute not less 
than 2 percent by weight of the finished food.
    (i) The sirups identified by Sec. Sec. 168.130, 168.140, and 
168.160, except that the use of any such ingredient is so limited that 
the finished food does not meet the requirement prescribed for any sirup 
by Sec. 168.130, Sec. 168.140, or Sec. 168.160.
    (ii) Honey.
    (iii) Other nutritive carbohydrate sweeteners.
    (2) Butter, in a quantity not less than 2 percent by weight of the 
finished food.
    (3) Edible fats and oils, except that, in products designated as 
``buttered sirups'', butter as provided for in paragraph (b)(2) of this 
section is the only fat that may be used.
    (4) Emulsifiers or stabilizers or both.
    (5) Natural and artificial flavorings, either fruit or nonfruit, 
alone or in carriers.
    (6) Color additives.
    (7) Salt.
    (8) Chemical preservatives.
    (9) Viscosity adjusting agents.
    (10) Acidifying, alkalizing, or buffering agents.
    (11) Defoaming agents.
    (12) Any other ingredient (e.g., shredded coconut, ground orange 
peel) that is not incompatible with other ingredients in the food.
    (c) Except as provided for in this paragraph and in paragraphs (d) 
(2) and (3) of this section, the name of the food is ``Table sirup'', 
``Sirup'', ``Pancake sirup'', ``Waffle sirup'', ``Pancake and waffle 
sirup'', or ``___ sirup'', the blank being filled in with the word or 
words that designate the sweetening ingredient that characterizes the 
food, except ``maple'', ``cane'', or ``sorghum'' alone, such sirups 
being required to comply in all respects with Sec. Sec. 168.130, 
168.140, and 168.160, respectively, and in the case of more than one 
sweetening ingredient, in descending order of predominance by weight in 
the food. The type shall be of uniform style and size.
    (1) When one of the sweeteners constitutes at least 80 percent of 
the total sweetener solids, the name of the food may be designated as 
the corresponding sirup, for example, ``Corn sirup'', provided that the 
name is immediately and conspicuously followed, without intervening 
written, printed, or graphic matter, by the statement ``with ___'' as 
part of the name, the blank being filled in with the name or names of 
each additional sweetening ingredient present, stated in a clear legible 
manner in letters of uniform style and size not less than one-half the 
height of, nor larger than, the letters used in the name of the 
principal sweetener.
    (2) When butter is used, as provided for in paragraph (b)(2) of this 
section, the name of the food may be ``Buttered ___'', the blank being 
filled in with the name otherwise prescribed in this paragraph. The 
percentage by weight of butter present shall be declared as part of the 
name of the food as prescribed by part 102 of this chapter.
    (3) Alternatively, the word ``sirup'' may be spelled ``syrup''.
    (d)(1) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (2) A statement (other than in the ingredient listing) or a vignette 
identifying a flavor may be included on the label only if such flavor 
contributes the primary recognizable flavor that characterizes the 
sirup. When maple, honey, or both maple and honey are

[[Page 731]]

represented as the characterizing flavors, the total quantity of maple 
sirup or honey, singly, or of maple sirup and honey in combination, 
shall be not less than 10 percent by weight of the finished food. The 
presence of any natural or artificial flavor in the food shall be 
declared on the label as prescribed by the applicable sections of part 
101 of this chapter.
    (3) The percentage of any optional ingredient used shall be declared 
as part of the name of the food as prescribed by part 102 of this 
chapter when all of the following conditions apply to the use of the 
ingredient:
    (i) It is one of the characterizing ingredients permitted by 
paragraphs (b)(1) (i) and (ii) of this section.
    (ii) The ingredient is either named on the label other than in the 
list of ingredients or is suggested by vignette or other labeling.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]



PART 169_FOOD DRESSINGS AND FLAVORINGS--Table of Contents



                      Subpart A_General Provisions

Sec.
169.3 Definitions.

  Subpart B_Requirements for Specific Standardized Food Dressings and 
                               Flavorings

169.115 French dressing.
169.140 Mayonnaise.
169.150 Salad dressing.
169.175 Vanilla extract.
169.176 Concentrated vanilla extract.
169.177 Vanilla flavoring.
169.178 Concentrated vanilla flavoring.
169.179 Vanilla powder.
169.180 Vanilla-vanillin extract.
169.181 Vanilla-vanillin flavoring.
169.182 Vanilla-vanillin powder.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14481, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 169.3  Definitions.

    For the purposes of this part:
    (a) The term vanilla beans means the properly cured and dried fruit 
pods of Vanilla planifolia Andrews and of Vanilla tahitensis Moore.
    (b) The term unit weight of vanilla beans means, in the case of 
vanilla beans containing not more than 25 percent moisture, 13.35 ounces 
of such beans; and, in the case of vanilla beans containing more than 25 
percent moisture, it means the weight of such beans equivalent in 
content of moisture-free vanilla-bean solids to 13.35 ounces of vanilla 
beans containing 25 percent moisture. (For example, one unit weight of 
vanilla beans containing 33.25 percent moisture amounts to 15 ounces.) 
The moisture content of vanilla beans is determined by the method 
prescribed in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), sections 7.004 and 
7.005, which is incorporated by reference, except that the toluene used 
is blended with 20 percent by volume of benzene and the total 
distillation time is 4 hours. Copies of the material incorporated by 
reference may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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. To prepare samples for 
analysis, the pods are chopped into pieces approximately \1/4\-inch in 
longest dimension, using care to avoid moisture change.
    (c) The term unit of vanilla constituent means the total sapid and 
odorous principles extractable from one unit weight of vanilla beans, as 
defined in paragraph (b) of this section, by an aqueous alcohol solution 
in which the content of ethyl alcohol by volume amounts to not less than 
35 percent.

[42 FR 14481, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 
49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 63 FR 14035, 
Mar. 24, 1998]

[[Page 732]]



  Subpart B_Requirements for Specific Standardized Food Dressings and 
                               Flavorings



Sec. 169.115  French dressing.

    (a) Description. French dressing is the separable liquid food or the 
emulsified viscous fluid food prepared from vegetable oil(s) and one or 
both of the acidifying ingredients specified in paragraph (b) of this 
section. One or more of the ingredients specified in paragraph (c) of 
this section may also be used. The vegetable oil(s) used may contain an 
optional crystallization inhibitor as specified in paragraph (c)(11) of 
this section. All the ingredients from which the food is fabricated 
shall be safe and suitable. French dressing contains not less than 35 
percent by weight of vegetable oil. French dressing may be mixed and 
packed in an atmosphere in which air is replaced in whole or in part by 
carbon dioxide or nitrogen.
    (b) Acidifying ingredients. (1) Any vinegar or any vinegar diluted 
with water, or any such vinegar or diluted vinegar mixed with an 
optional acidifying ingredient as specified in paragraph (c)(9) of this 
section. For the purpose of this paragraph, any blend of two or more 
vinegars is considered to be a vinegar.
    (2) Lemon juice and/or lime juice in any appropriate form, which may 
be diluted with water.
    (c) Other optional ingredients. The following optional ingredients 
may also be used:
    (1) Salt.
    (2) Nutritive carbohydrate sweeteners.
    (3) Spices and/or natural flavorings.
    (4) Monosodium glutamate.
    (5) Tomato paste, tomato puree, catsup, sherry wine.
    (6) Eggs and ingredients derived from eggs.
    (7) Color additives that will impart the color traditionally 
expected.
    (8) Stabilizers and thickeners to which calcium carbonate or sodium 
hexametaphosphate may be added. Dioctyl sodium sulfosuccinate may be 
added in accordance with Sec. 172.810 of this chapter.
    (9) Citric and/or malic acid, in an amount not greater than 25 
percent of the weight of the acids of the vinegar or diluted vinegar 
calculated as acetic acid.
    (10) Sequestrant(s), including but not limited to calcium disodium 
EDTA (calcium disodium ethylenediamine- tetraacetate) and/or disodium 
EDTA (disodium ethylenediamine-tetraacetate), may be used to preserve 
color and/or flavor.
    (11) Crystallization inhibitors, including but not limited to 
oxystearin, lecithin, or polyglycerol esters of fatty acids.
    (d) Nomenclature. The name of the food is ``French dressing''.
    (e) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14481 Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]



Sec. 169.140  Mayonnaise.

    (a) Description. Mayonnaise is the emulsified semisolid food 
prepared from vegetable oil(s), one or both of the acidifying 
ingredients specified in paragraph (b) of this section, and one or more 
of the egg yolk-containing ingredients specified in paragraph (c) of 
this section. One or more of the ingredients specified in paragraph (d) 
of this section may also be used. The vegetable oil(s) used may contain 
an optional crystallization inhibitor as specified in paragraph (d)(7) 
of this section. All the ingredients from which the food is fabricated 
shall be safe and suitable. Mayonnaise contains not less than 65 percent 
by weight of vegetable oil. Mayonnaise may be mixed and packed in an 
atmosphere in which air is replaced in whole or in part by carbon 
dioxide or nitrogen.
    (b) Acidifying ingredients. (1) Any vinegar or any vinegar diluted 
with water to an acidity, calculated as acetic acid, of not less than 
2\1/2\ percent by weight, or any such vinegar or diluted vinegar mixed 
with an optional acidifying ingredient as specified in paragraph (d)(6) 
of this section. For the purpose of this paragraph, any blend of two or 
more vinegars is considered to be a vinegar.

[[Page 733]]

    (2) Lemon juice and/or lime juice in any appropriate form, which may 
be diluted with water to an acidity, calculated as citric acid, of not 
less than 2\1/2\ percent by weight.
    (c) Egg yolk-containing ingredients. Liquid egg yolks, frozen egg 
yolks, dried egg yolks, liquid whole eggs, frozen whole eggs, dried 
whole eggs, or any one or more of the foregoing ingredients listed in 
this paragraph with liquid egg white or frozen egg white.
    (d) Other optional ingredients. The following optional ingredients 
may also be used:
    (1) Salt.
    (2) Nutritive carbohydrate sweeteners.
    (3) Any spice (except saffron or turmeric) or natural flavoring, 
provided it does not impart to the mayonnaise a color simulating the 
color imparted by egg yolk.
    (4) Monosodium glutamate.
    (5) Sequestrant(s), including but not limited to calcium disodium 
EDTA (calcium disodium ethylenediamine- tetraacetate) and/or disodium 
EDTA (disodium ethylenediaminetetraacetate), may be used to preserve 
color and/or flavor.
    (6) Citric and/or malic acid in an amount not greater than 25 
percent of the weight of the acids of the vinegar or diluted vinegar, 
calculated as acetic acid.
    (7) Crystallization inhibitors, including but not limited to 
oxystearin, lecithin, or polyglycerol esters of fatty acids.
    (e) Nomenclature. The name of the food is ``Mayonnaise''.
    (f) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14481, Mar. 15, 1977, as amended at 57 FR 34246, Aug. 4, 1992; 58 
FR 2886, Jan. 6, 1993]



Sec. 169.150  Salad dressing.

    (a) Description. Salad dressing is the emulsified semisolid food 
prepared from vegetable oil(s), one or both of the acidifying 
ingredients specified in paragraph (b) of this section, one or more of 
the egg yolk-containing ingredients specified in paragraph (c) of this 
section, and a starchy paste prepared as specified in paragraph (e) of 
this section. One or more of the ingredients in paragraph (e) of this 
section may also be used. The vegetable oil(s) used may contain an 
optional crystallization inhibitor as specified in paragraph (e)(8) of 
this section. All the ingredients from which the food is fabricated 
shall be safe and suitable. Salad dressing contains not less than 30 
percent by weight of vegetable oil and not less egg yolk-containing 
ingredient than is equivalent in egg yolk solids content to 4 percent by 
weight of liquid egg yolks. Salad dressing may be mixed and packed in an 
atmosphere in which air is replaced in whole or in part by carbon 
dioxide or nitrogen.
    (b) Acidifying ingredients. (1) Any vinegar or any vinegar diluted 
with water, or any such vinegar or diluted vinegar mixed with an 
optional acidifying ingredient as specified in paragraph (e)(6) of this 
section. For the purpose of this paragraph, any blend of two or more 
vinegars is considered to be a vinegar.
    (2) Lemon juice and/or lime juice in any appropriate form, which may 
be diluted with water.
    (c) Egg yolk-containing ingredients. Liquid egg yolks, frozen egg 
yolks, dried egg yolks, liquid whole eggs, frozen whole eggs, dried 
whole eggs, or any one of more of the foregoing ingredients listed in 
this paragraph with liquid egg white or frozen egg white.
    (d) Starchy paste. It may be prepared from a food starch, food 
starch-modified, tapioca flour, wheat flour, rye flour, or any two or 
more of these. Water may be added in the preparation of the paste.
    (e) Other optional ingredients. The following optional ingredients 
may also be used:
    (1) Salt.
    (2) Nutritive carbohydrate sweeteners.
    (3) Any spice (except saffron or turmeric) or natural flavoring, 
provided it does not impart to the salad dressing a color simulating the 
color imparted by egg yolk.
    (4) Monosodium glutamate.
    (5) Stabilizers and thickeners. Dioctyl sodium sulfosuccinate may be 
added in accordance with Sec. 172.810 of this chapter.

[[Page 734]]

    (6) Citric and/or malic acid may be used in an amount not greater 
than 25 percent of the weight of the acids of the vinegar or diluted 
vinegar calculated as acetic acid.
    (7) Sequestrant(s), including but not limited to calcium disodium 
EDTA (calcium disodium ethylenediamine-tetraacetate) and/or disodium 
EDTA (disodium ethylenediamine-tetraactetate), may be used to preserve 
color and/or flavor.
    (8) Crystallization inhibitors, including but not limited to 
oxystearin, lecithin, or polyglycerol esters of fatty acids.
    (f) Nomenclature. The name of the food is ``Salad dressing''.
    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14481, Mar. 15, 1977, as amended at 42 FR 25325, May 17, 1977; 58 
FR 2886, Jan. 6, 1993]



Sec. 169.175  Vanilla extract.

    (a) Vanilla extract is the solution in aqueous ethyl alcohol of the 
sapid and odorous principles extractable from vanilla beans. In vanilla 
extract the content of ethyl alcohol is not less than 35 percent by 
volume and the content of vanilla constituent, as defined in Sec. 
169.3(c), is not less than one unit per gallon. The vanilla constituent 
may be extracted directly from vanilla beans or it may be added in the 
form of concentrated vanilla extract or concentrated vanilla flavoring 
or vanilla flavoring concentrated to the semisolid form called vanilla 
oleo-resin. Vanilla extract may contain one or more of the following 
optional ingredients:
    (1) Glycerin.
    (2) Propylene glycol.
    (3) Sugar (including invert sugar).
    (4) Dextrose.
    (5) Corn sirup (including dried corn sirup).
    (b)(1) The specified name of the food is ``Vanilla extract'' or 
``Extract of vanilla''.
    (2) When the vanilla extract is made in whole or in part by dilution 
of vanilla oleoresin, concentrated vanilla extract, or concentrated 
vanilla flavoring, the label shall bear the statement ``Made from ___'' 
or ``Made in part from ___'', the blank being filled in with the name or 
names ``vanilla oleoresin'', ``concentrated vanilla extract'', or 
``concentrated vanilla flavoring'', as appropriate. If the article 
contains two or more units of vanilla constituent, the name of the food 
shall include the designation ``_-fold'', the blank being filled in with 
the whole number (disregarding fractions) expressing the number of units 
of vanilla constituent per gallon of the article.
    (3) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the labeling required by paragraph (b)(2) of this section 
shall immediately and conspicuously precede or follow such name, without 
intervening written, printed, or graphic matter.
    (c) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]



Sec. 169.176  Concentrated vanilla extract.

    (a) Concentrated vanilla extract conforms to the definition and 
standard of identity and is subject to any requirement for label 
statement of ingredients prescribed for vanilla extract by Sec. 
169.175, except that it is concentrated to remove part of the solvent, 
and each gallon contains two or more units of vanilla constituent as 
defined in Sec. 169.3(c). The content of ethyl alcohol is not less than 
35 percent by volume.
    (b) The specified name of the food is ``Concentrated vanilla extract 
_-fold'' or ``_-fold concentrated vanilla extract'', the blank being 
filled in with the whole number (disregarding fractions) expressing the 
number of units of vanilla constituent per gallon of the article. (For 
example, ``Concentrated vanilla extract 2-fold''.)

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]



Sec. 169.177  Vanilla flavoring.

    (a) Vanilla flavoring conforms to the definition and standard of 
identity and is subject to any requirement for label

[[Page 735]]

statement of ingredients prescribed for vanilla extract by Sec. 
169.175, except that its content of ethyl alcohol is less than 35 
percent by volume.
    (b) The specified name of the food is ``Vanilla flavoring''.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]



Sec. 169.178  Concentrated vanilla flavoring.

    (a) Concentrated vanilla flavoring conforms to the definition and 
standard of identity and is subject to any requirement for label 
statement of ingredients prescribed for vanilla flavoring by Sec. 
169.177, except that it is concentrated to remove part of the solvent, 
and each gallon contains two or more units of vanilla constituent as 
defined in Sec. 169.3(c).
    (b) The specified name of the food is ``Concentrated vanilla 
flavoring _-fold'' or ``_-fold concentrated vanilla flavoring'', the 
blank being filled in with the whole number (disregarding fractions) 
expressing the number of units of vanilla constituent per gallon of the 
article. (For example, ``Concentrated vanilla flavoring 3-fold''.)

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]



Sec. 169.179  Vanilla powder.

    (a) Vanilla powder is a mixture of ground vanilla beans or vanilla 
oleoresin or both, with one or more of the following optional blending 
ingredients:
    (1) Sugar.
    (2) Dextrose.
    (3) Lactose.
    (4) Food starch (including food starch-modified as prescribed in 
Sec. 172.892 of this chapter).
    (5) Dried corn sirup.
    (6) Gum acacia.


Vanilla powder may contain one or any mixture of two or more of the 
anticaking ingredients specified in paragraph (b) of this section, but 
the total weight of any such ingredient or mixture is not more than 2 
percent of the weight of the finished vanilla powder. Vanilla powder 
contains in each 8 pounds not less than one unit of vanilla constituent, 
as defined in Sec. 169.3(c).
    (b) The anticaking ingredients referred to in paragraph (a) of this 
section are:
    (1) Aluminum calcium silicate.
    (2) Calcium silicate.
    (3) Calcium stearate.
    (4) Magnesium silicate.
    (5) Tricalcium phosphate.
    (c)(1) The specified name of the food is ``Vanilla powder _-fold'' 
or ``_-fold vanilla powder'', except that if sugar is the optional 
blending ingredient used, the word ``sugar'' may replace the word 
``powder''. The blank in the name is filled in with the whole number 
(disregarding fractions) expressing the number of units of vanilla 
constituent per 8 pounds of the article. However, if the strength of the 
article is less than 2-fold, the term ``_-fold'' is omitted from the 
name.
    (2) The label of vanilla powder shall bear the common names of any 
of the optional ingredients specified in paragraphs (a) and (b) of this 
section that are used, except that where the alternative name ``Vanilla 
sugar'' is used for designating the food it is not required that sugar 
be named as an optional ingredient.
    (3) Wherever the name of the food appears on the label so 
conspicuously as to be easily seen under customary conditions of 
purchase, the labeling required by paragraph (c)(2) of this section 
shall immediately and conspicuously precede or follow such name, without 
intervening written, printed, or graphic matter.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2887, Jan. 6, 1993]



Sec. 169.180  Vanilla-vanillin extract.

    (a) Vanilla-vanillin extract conforms to the definition and standard 
of identity and is subject to any requirement for label statement of 
ingredients prescribed for vanilla extract by Sec. 169.175, except that 
for each unit of vanilla constituent, as defined in Sec. 169.3(c), 
contained therein, the article also contains not more than 1 ounce of 
added vanillin.

[[Page 736]]

    (b) The specified name of the food is ``Vanilla-vanillin extract _-
fold'' or ``_-fold vanilla-vanillin extract'', followed immediately by 
the statement ``contains vanillin, an artificial flavor (or 
flavoring)''. The blank in the name is filled in with the whole number 
(disregarding fractions) expressing the sum of the number of units of 
vanilla constituent plus the number of ounces of added vanillin per 
gallon of the article. However, if the strength of the article is less 
than 2-fold, the term ``_-fold'' is omitted from the name.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2887, Jan. 6, 1993]



Sec. 169.181  Vanilla-vanillin flavoring.

    (a) Vanilla-vanillin flavoring conforms to the definition and 
standard of identity and is subject to any requirement for label 
statement of ingredients prescribed for vanilla-vanillin extract by 
Sec. 169.180, except that its content of ethyl alcohol is less than 35 
percent by volume.
    (b) The specified name of the food is ``Vanilla-vanillin flavoring 
_-fold'' or ``_-fold vanilla-vanillin flavoring'', followed immediately 
by the statement ``contains vanillin, an artificial flavor (or 
flavoring)''. The blank in the name is filled in with the whole number 
(disregarding fractions) expressing the sum of the number of units of 
vanilla constituent plus the number of ounces of added vanillin per 
gallon of the article. However, if the strength of the article is less 
than 2-fold, the term ``_-fold'' is omitted from the name.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2887, Jan. 6, 1993]



Sec. 169.182  Vanilla-vanillin powder.

    (a) Vanilla-vanillin powder conforms to the definition and standard 
of identity and is subject to any requirement for label statement of 
ingredients prescribed for vanilla powder by Sec. 169.179, except that 
for each unit of vanilla constituent as defined in Sec. 169.3(c) 
contained therein, the article also contains not more than 1 ounce of 
added vanillin.
    (b) The specified name of the food is ``Vanilla-vanillin powder _-
fold'' or ``_-fold vanilla-vanillin powder'', followed immediately by 
the statement ``contains vanillin, an artificial flavor (or 
flavoring)''. If sugar is the optional blending ingredient used, the 
word ``sugar'' may replace the word ``powder'' in the name. The blank in 
the name is filled in with the whole number (disregarding fractions) 
expressing the sum of the number of units of vanilla constituent plus 
the number of ounces of added vanillin per 8 pounds of the article. 
However, if the strength of the article is less than 2-fold the term 
``_-fold'' is omitted from the name.

[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2887, Jan. 6, 1993]

[[Page 737]]



                              FINDING AIDS




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  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.


  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 739]]



                    Table of CFR Titles and Chapters




                      (Revised as of April 1, 2021)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    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 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 740]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   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)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         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 (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600--3699)

[[Page 741]]

    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  U.S. International Development Finance Corporation 
                (Parts 4300--4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)

[[Page 742]]

     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)
        CI  National Mediation Board (Part 10101)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         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  Agricultural Marketing Service (Federal Grain 
                Inspection Service, Fair Trade Practices Program), 
                Department of Agriculture (Parts 800--899)

[[Page 743]]

        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  (Parts 1600--1699) [Reserved]
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  (Parts 2200--2299) [Reserved]
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      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  National Institute of Food and 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)

[[Page 744]]

         L  Rural Business-Cooperative Service, Rural Housing 
                Service, and Rural Utilities Service, Department 
                of Agriculture (Part 5001)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (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  Agricultural Marketing Service (Fair Trade Practices 
                Program), Department of Agriculture (Parts 200--
                299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           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 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      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  (Parts 500--599) [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  (Parts 900--999) [Reserved]
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)

[[Page 745]]

        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research, Department of the 
                Treasury (Parts 1600--1699)
      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 (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    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--1199)
         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)

[[Page 746]]

      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  National Technical Information Service, 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) [Reserved]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             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  U.S. 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  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

[[Page 747]]

                     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  Office of Workers' Compensation Programs, 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 Service, 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)

                      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  United States Agency for Global Media (Parts 500--599)
       VII  U.S. International Development Finance Corporation 
                (Parts 700--799)
        IX  Foreign Service Grievance Board (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)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       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)

[[Page 748]]

                          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)
        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) [Reserved]
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)

[[Page 749]]

      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       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--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900--999)
        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 (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--799)

                   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)

[[Page 750]]

                            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)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 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)

[[Page 751]]

        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 Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      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  Department of Defense, Defense Logistics Agency (Parts 
                1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     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)
    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, Department 
                of Defense (Parts 200--399)
        IV  Great Lakes St. 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

[[Page 752]]

         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 Career, Technical, and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  (Parts 1100--1199) [Reserved]
       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)
        VI  [Reserved]
       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 (Parts 1500--
                1599)
       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  U.S. Copyright Office, Library of Congress (Parts 
                200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

[[Page 753]]

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory 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)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)
        IX  Federal Permitting Improvement Steering Council (Part 
                1900)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            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)
   62--100  [Reserved]
            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)
  103--104  (Parts 103-001--104-099) [Reserved]
       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)
  129--200  [Reserved]

[[Page 754]]

            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System [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)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   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 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             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)

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare

[[Page 755]]

        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)
        IX  Denali Commission (Parts 900--999)
         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  Administration for Children and Families, 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 of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      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)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)

[[Page 756]]

       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

           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  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)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199) [Reserved]
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)

[[Page 757]]

        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        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 (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       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)
        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)

[[Page 758]]

        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 759]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of April 1, 2021)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, VIII, IX, X, XI; 9, 
                                                  II
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, VIII, IX, X, XI; 9, 
                                                  II
  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
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 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
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  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 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 of                          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
Architectural and Transportation Barriers         36, XI
   Compliance Board
[[Page 760]]

Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI; 38, II
Army, Department of                               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
  Federal Acquisition Regulation                  48, 19
Career, Technical, and Adult Education, Office    34, IV
     of
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazard Investigation Board    40, VI
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 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 of                           2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  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; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
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 Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense, Department of                            2, XI; 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

[[Page 761]]

  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy, Department of                             32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 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
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       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
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
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 Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 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                   2, XV; 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
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, II
  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           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II

[[Page 762]]

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                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
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 Agency                    5, LXXX; 12, XII
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
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 Permitting Improvement Steering Council   40, IX
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
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
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
  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

[[Page 763]]

  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
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 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, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Housing and Urban Development, Department of      2, XXIV; 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
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
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
Industry and Security, Bureau of                  15, VII

[[Page 764]]

Information Resources Management, Office of       7, XXVII
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, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior, Department of                           2, XIV
  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
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Enforcement Bureau, Bureau of        30, II
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  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 Development Finance Corporation,    5, XXXIII; 22, VII
     U.S.
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
Investment Security, Office of                    31, VIII
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 of                            2, XXVIII; 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
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor, Department of                              2, XXIX; 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
  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

[[Page 765]]

  Mine Safety and Health Administration           30, I
  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, VI
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Libraries and Information Science, National       45, XVII
     Commission on
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
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, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
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
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 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   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          5, CI; 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                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI; 47, II
National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
   Administration
[[Page 766]]

National Transportation Safety Board              49, VIII
Natural Resource Revenue, Office of               30, XII
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
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                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, IV, 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
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory 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
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Contracts, Department of Labor             41, 50
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
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 Utilities Service                           7, XVII, XVIII, XLII
Safety and Environmental Enforcement, Bureau of   30, II
Saint Lawrence Seaway Development Corporation     33, IV
Science and Technology Policy, Office of, and     32, XXIV; 47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 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 of                              2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6

[[Page 767]]

Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  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; 47, IV; 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
  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 of the                       2, X; 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                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
Truman, Harry S. Scholarship Foundation           45, XVIII
United States Agency for Global Media             22, V
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 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
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 769]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2016 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, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.govinfo.gov. For changes to this volume of the 
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. 
The ``List of CFR Sections Affected 1986-2000'' is available at 
www.govinfo.gov.

                                  2016

21 CFR
                                                                   81 FR
                                                                    Page
100 Nomenclature change............................................49895
100.155 (a) and (b) amended........................................59131
101 Policy statement.............8833, 43061, 54499, 54501, 66527, 85156
    Nomenclature change............................................49895
101.2 (c) introductory text amended................................59131
101.4 (h) introductory text and (2) amended.........................5590
101.7 Redesignated from 101.105; heading revised...................59131
101.8 Regulation at 79 FR 71291 compliance date extended in part 
        to 7-26-18.................................................50303
101.9 (c)(1)(ii), (j)(5)(ii)(C), (D), (E) and (13)(ii)(C) removed; 
        (c)(1)(iii) and (j)(13)(ii)(D) redesignated as new 
        (c)(1)(ii) and new (j)(13)(ii)(C); (c)(1)(i)(A) through 
        (E), new (ii), (2), (5), (6)(i) through (4), (7), (8) 
        introductory text, (i), (ii) introductory text, (iii), 
        (iv), (v), (9), (d)(1) introductory text, (iii), (iv), 
        (v), (2) through (5), (7) introductory text, (i), (8), 
        (9), (11)(ii), (iii), (12), (13)(ii), (e), (f) 
        introductory text, (2)(ii), (4), (5), (g) introductory 
        text, (2), (3)(ii), (4), (5), (6), (8), (h)(3)(iv), (4) 
        introductory text, (j)(5)(i), (ii) introductory text, (A), 
        (B), (13)(i), (ii)(A)(1), (2), (B) and (18)(iv) 
        introductory text revised; (c)(1)(i)(F), (8)(vii), 
        (g)(10), (11), (j)(5)(iii) and (l) added...................33979
    (b)(2)(i)(D), (6), (8)(iii), (10)(ii) and (h)(3)(ii) revised; 
(b)(2)(i)(E) removed; (b)(2)(i)(F) through (I) redesignated as new 
(b)(2)(i)(E) through (H); (b)(12) added............................34040
    (j)(1)(i), (2) introductory text and (3) introductory text 
revised; (j)(4) amended; eff. date note removed; CFR correction....84465

[[Page 770]]

    Regulation at 79 FR 71253 compliance date extended to 5-5-17 
                                                                   96364
101.10 Revised; CFR correction.....................................84465
    Regulation at 79 FR 71253 compliance date extended to 5-5-17 
                                                                   96364
101.11 Added; CFR correction.......................................84459
    Regulation at 79 FR 71253 compliance date extended to 5-5-17 
                                                                   96364
101.12 (f)(2) removed; (f)(3) redesignated as new (f)(2); (b) 
        tables 1 and 2, (c), (f)(1) and new (2) revised............34041
101.13 (d)(2), (h)(4)(i) and (i)(2) amended........................59131
101.30 (e)(2) revised..............................................33994
    (g) amended....................................................59131
101.36 (b)(2)(i) introductory text, (B), (ii)(A), (B), (iii) 
        introductory text, (D) through (G), (3)(ii)(A), (c)(4), 
        (e) introductory text, (8), (11)(i) through (viii), (12), 
        (f) and (i)(1) revised; (i) introductory text removed......33994
101.75 (c)(1) and (2)(ii) revised; interim.........................91722
101.80 (c)(2)(iii)(C) amended.......................................5590
101.81 (c)(2)(ii)(A) introductory text, (5), (B)(1) and (2) 
        amended.....................................................5590
101.83 (c)(2)(ii)(A)(2) and (B)(2) amended..........................5590
101.105 Redesignated as 101.7......................................59131
102 Nomenclature change............................................49895
104.5 (b) amended..................................................59131
106 Policy statement........................................22174, 57784
    Nomenclature change............................................49895
107 Nomenclature change............................................49895
108 Nomenclature change............................................49896
108.25 (c)(1) and (2) revised......................................46831
108.35 (c)(1), (2) introductory text, (ii) and (i) revised.........46831
109 Nomenclature change............................................49896
110 Nomenclature change............................................49896
    Policy statement...............................................57784
111 Meeting.........................................................9761
    Policy statement...............................................57784
112 Nomenclature change............................................49896
    Policy statement...............................................57784
112.3 (a), (b) and (c) introductory text removed; introductory 
        text added; amended........................................26467
112.55 (b) revised.................................................26468
114 Policy statement...............................................57784
117 Nomenclature change............................................49896
    Policy statement........................................57784, 75692
117.1 (b) revised...................................................3715
117.3 Amended.......................................................3715
    Regulation at 80 FR 56145 eff. date confirmed in part..........64060
117.5 (a) amended; (h)(3)(v) revised................................3716
117.8 Correctly revised.............................................3956
117.136 (a)(2) introductory text, (5) and (b)(5) revised............3716
117.145 (a) revised.................................................3716
117.201 (b)(2)(i)(B) and (ii) revised...............................3716
117.257 (e) revised.................................................3716
117.264 (a)(1) revised..............................................3716
117.405 (c) introductory text corrected.............................3956
118 Nomenclature change............................................49896
118.8 (a) and (b) amended...........................................5590
120 Policy statement...............................................57784
121 Added..........................................................34219
123 Policy statement...............................................57784
129 Policy statement...............................................57784
130 Nomenclature change............................................49896
161 Nomenclature change............................................49896
165.110 (a)(2)(iv), (vii), (b)(2)(ii), (3) introductory text, 
        (4)(i)(C), (iii)(E) introductory text, (1)(ii), (iv), 
        (7)(iv), (11)(i), (14)(i), (F)(20), (I) and (5)(ii) 
        introductory text amended...................................5591

                                  2017

21 CFR
                                                                   82 FR
                                                                    Page
Chapter I
101 Compliance notification; interim...............................20825
    Technical correction; interim..................................34401
101.8 Regulation at 82 FR 20825 comment period extended to 8-2-17; 
        interim....................................................30730
101.9 Regulation at 82 FR 20825 comment period extended to 8-2-17; 
        interim....................................................30730
101.17 (h)(7)(ii) introductory text, (B), (C) introductory text, 
        (1), (4), (5), (6), (D), (E) and (F) revised...............14144
112.209 Revised....................................................14145
115.50 (e)(2) introductory text, (ii), (iii) introductory text, 
        (A), (D), (E), (F), (iv), (v) and (vi) revised.............14145
117 Policy statement...............................................51345
117.274 Revised....................................................14146

[[Page 771]]

118.12 (a)(1)(i) introductory text, (2) introductory text, (ii), 
        (iii) introductory text, (A), (D), (E), (F), (iv), (v) and 
        (vi) revised...............................................14146
121 Notification...................................................40484
133 Policy statement...............................................37815

                                  2018

21 CFR
                                                                   83 FR
                                                                    Page
Chapter I
101 Policy statement..........................19619, 20731, 27894, 55266
101 Compliance notification........................................65294
101.9 (b)(5)(vi), (c)(6)(i) introductory text, (iii), (8)(ii) 
        introductory text, (iv), (d)(1)(iii), (e)(5), (6)(i), and 
        (ii) revised; (c)(2)(i) through (iv), (j)(13)(i)(A) and 
        (B) added..................................................65497
101.36 (b)(2)(i)(B) introductory text, (ii)(B), (e) introductory 
        text, (11)(ii), (iv), and (12) revised.....................65502
101 Appendix B revised.............................................65504
102.50 Table revised...............................................19431
106 Policy statement..........................................598, 22193
110 Policy statement..........................................598, 22193
110 Regulation at 80 FR 56144 withdrawn............................46107
111 Policy statement..........................................598, 22193
112 Policy statement..........................................598, 22193
114 Policy statement..........................................598, 22193
117 Policy statement...................................598, 22193, 46878
120 Policy statement..........................................598, 22193
123 Policy statement..........................................598, 22193
129 Policy statement..........................................598, 22193

                                  2019

21 CFR
                                                                   84 FR
                                                                    Page
Chapter I
101 Notification............................................28726, 72230
101.8 (b)(2) revised...............................................57610
112 Policy statement.........................................9706, 11644
112.4 (a) revised..................................................12490
112.5 (a)(1) and (2) revised.......................................12490
112.161 (b) revised................................................12491
117 Notification...................................................29054
117.126 (b)(5) revised.............................................12491

                                  2020

21 CFR
                                                                   85 FR
                                                                    Page
Chapter I
101 Notification......................................6045, 66217, 82332
101 Technical correction...........................................55587
101.17 (h)(7)(i)(A), (E) introductory text, (ii)(A), (B), (C) 
        introductory text, and (F) revised.........................16551
101.91 (b)(1), (2), and (c) revised................................49260
102 Notification...................................................82332
112 Policy statement...............................................34508
112.202 (a) revised................................................16552
112.203 (h) revised................................................16552
112.206 (a)(1) revised.............................................16552
112.208 (c)(2) revised.............................................16552
112.209 Revised....................................................16552
112.213 (a) and (b)(1) revised.....................................16552
115.50 (e)(1)(i), (iii), (v) introductory text, (2)(i), (ii), 
        (iii) introductory text, and (vi) revised..................16552
117 Notification...................................................17008
117.254 (a) revised................................................16553
117.257 (h) revised................................................16553
117.264 (a)(1) revised.............................................16553
117.270 (c)(2) revised.............................................16553
117.274 Revised....................................................16553
117.287 (a) and (b)(1) revised.....................................16553
118.12 (a)(1)(i) introductory text, (ii), (iv) introductory text, 
        (2)(i), (ii), (iii) introductory text, and (vi) revised....16554
133.116 (d) removed................................................72907
133.121 (f) removed................................................72907

                                  2021

   (Regulations published from January 1, 2021, through April 1, 2021)

21 CFR
                                                                   86 FR
                                                                    Page
Chapter I
101 Notification.....................................................462


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